ANNUAL REPORT 2021
FINANCIAL INFORMATION
ANNUAL REPORT 2021
FINANCIAL INFORMATION
CONTENTS
1. GENERAL INFORMATION AND
RESPONSIBILITY FOR THE
ANNUAL REPORT AND FOR THE
AUDIT OF THE FINANCIAL
STATEMENTS 6
1.1 Responsibility for the contents of
this document 7
1.2 Responsibility for the audit of
the financial statements 7
1.3 Availability of the Annual Report 8
1.4 Forward-looking information 8
2. MESSAGE FROM THE CEO 10
3. MANAGEMENT REPORT
OF THE BOARD OF DIRECTORS 14
3.1 Key Figures 15
3.2 Activities of Oxurion 15
3.3 Comments to Consolidated
Financial Statements 21
3.4 Comments to Statutory Accounts 22
3.5 Description of the Principal Characteristics
of the Company’s Risks 24
3.6 Other information in accordance with
Belgian Company law 38
4. CORPORATE GOVERNANCE 42
4.1 General provisions 43
4.2 Compliance with the Corporate
Governance Code 43
4.3 Description of the Principal Characteristics
of the Company’s Internal Controls
and Risk Analysis 44
4.4 Fees to the Statutory Auditor 49
4.5 Notification of Important Participations 49
4.6 Composition and functioning of the
Company’s management 51
4.7 Policy regarding Transactions and other
Contractual Relationships between the
Company, including Affiliated Companies,
its Directors and the CEO 57
4.8 Capital Increase by the Board of Directors
with Respect to the Authorized Share Capital
and Provisions that may be triggered in the
Event of a Public Takeover on the Company
(Article 8:2 of the Royal Decree of April 29,
2019 (Article 34 of the old Royal Decree
of 14 November 2007)) 61
4.9 Remuneration Report Financial Year 2021 61
5. CONSOLIDATED FINANCIAL
STATEMENTS 72
5.1 Consolidated statement of profit and loss 73
5.2 Consolidated statement of financial position 74
5.3 Consolidated statement of cash flows 75
5.4 Consolidated statement of
changes in equity 76
5.5 General notes to the consolidated
financial statements 77
5.6 Notes to the consolidated statement of
profit and loss 97
5.7 Notes to the consolidated statement of
financial position 101
5.8 Other clarification notes to the
statement of financial position 116
6. STATUTORY AUDITOR’S REPORT
TO THE AGM FOR THE YEAR ENDED
31 DECEMBER 2021 (CONSOLIDATED
FINANCIAL STATEMENTS) 124
7. ABBREVIATED STATUTORY
FINANCIAL STATEMENTS 132
7.1 Balance sheet of Oxurion NV 133
7.2 Income statement of Oxurion NV 134
7.3 Appropriation account of Oxurion NV 134
7.4 Key valuation principles 135
8. GLOSSARY 140
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OXURION ANNUAL REPORT 2021
1. GENERAL INFORMATION AND
RESPONSIBILITY FOR THE
ANNUAL REPORT AND FOR
THE AUDIT OF THE FINANCIAL
STATEMENTS
7
OXURION ANNUAL REPORT 2021
1.1 RESPONSIBILITY FOR THE
CONTENTS OF THIS DOCUMENT
The board of directors of Oxurion NV (the “Company” or
“Oxurion”) is responsible for the contents of this document.
The board of directors (the “Board of Directors”) declares
that, having taken reasonable care to ensure that such is
the case, the information contained in this year’s annual
report (the “Annual Report”) is, to the best of its knowledge,
in accordance with the facts and contains no omissions
likely to affect it materially.
Dr. Patrik De Haes, M.D., (as representative of MeRoNo BV),
Non-Executive Director and Chairman, and Tom Graney,
CFA, Executive Director and Chief Executive Officer of
Oxurion, declare on behalf of the Company that to their
knowledge:
• The consolidated financial statements prepared in
accordance with International Financial Reporting
Standards (“IFRS”) as adopted by the EU, give a true
and fair view of the net worth, financial position and
the results of operations of the Group (as defined
hereinafter).
• The Annual Report regarding the consolidated financial
statements give a true and fair view of the develop-
ment and results of the Group (as defined hereinafter),
as well as the main risks and uncertainties.
This Annual Report was approved by the Board of Directors
on March 24, 2022.
1.2 RESPONSIBILITY FOR THE AUDIT OF
THE FINANCIAL STATEMENTS
BDO Bedrijfsrevisoren BV, a limited liability company in-
corporated under Belgian law, having its registered office
at Da Vincilaan 9, box E.6, B-1930 Zaventem, represented
by Gert Claes, auditor, and a member of the “Instituut van
de Bedrijfsrevisoren”, has been appointed as the statutory
auditor of Oxurion (the “Statutory Auditor”) for a term
of three years ending immediately after the closing of
the annual general shareholders’ meeting (“AGM”) to be
held in 2022, which will have deliberated and resolved on
the financial statements for the financial year ending on
December 31, 2021.
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OXURION ANNUAL REPORT 2021
1.3 AVAILABILITY OF THE
ANNUAL REPORT
Oxurion published its Annual Report in Dutch. Oxurion has
also produced an English translation of this Annual Report.
In the event of differences of interpretation between the
English and the Dutch versions of the Report, the original
Dutch version has priority.
The Annual Report is available to the public on the
Company’s website (www.oxurion.com) and in hard copy
free of charge in both languages by request to:
Oxurion NV
for the attention of Michaël DILLEN
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
e-mail: IR@oxurion.com
1.4 FORWARD-LOOKING
INFORMATION
This Annual Report includes forward-looking statements,
expectations and assessments regarding the expected
future performance of Oxurion and the market in which
it operates. Certain statements, expectations and assess-
ments can be recognized using words such as, but not
limited to, “believe”, “anticipate”, “expect”, “intend”, “plan”,
“strive”, “estimate”, “forecast”, “project”, “could”, “will” and
“continue” and comparable expressions. These relate to
future matters that are not historical facts. Such statements,
expectations and assessments are based on various as-
sumptions, expectations and assessments of known and
unknown risks, uncertainties and other factors that were
deemed to be reasonable when they were made, but
which may or may not prove to be correct. Actual events
are difficult to predict and depend on factors outside
the Company’s control. Consequently, the actual results,
financial condition and the results of the sector, may
diverge substantially from any future results, performance
or achievements expressed or implied by such statements,
expectations and assessments. Factors that can cause
such a divergence include, but are not limited to, the factors
that are discussed in the Chapter “Risk Factors”. Given
these uncertainties, absolutely no statement is made nor
reassurance given regarding the correctness or reasona-
bleness of such forward-looking statements, expectations
and assessments. Moreover, forward-looking statements,
expectations and assessments apply only on the date of
this Annual Report. The Company expressly disclaims any
obligation to adapt any of the forward-looking statements,
expectations and assessments in this Annual Report in
order to reflect any change in the expectations and as-
sessments of the Company or any change in the facts,
conditions or circumstances on which such statements,
expectations and assessments are based, except to the
extent that this is required by Belgian law.
All statements and information relate to the period up to
December 31, 2021, unless expressly stated otherwise.
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OXURION ANNUAL REPORT 2021
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OXURION ANNUAL REPORT 2021
2. MESSAGE FROM THE CEO
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OXURION ANNUAL REPORT 2021
Focusing on Strategic Opportunities,
Leveraging Our Strengths
Dear Fellow Shareholders,
I write this letter with a sense of excitement and pride for
Oxurion, despite a current backdrop of geopolitical unrest,
the continuing COVID-19 pandemic and stock market
declines, especially in the biotech sector. From the time
I joined Oxurion in October 2020, and was named Chief
Executive Officer in May 2021, our company has made
significant progress in our mission to develop the next
generation standard of care for retinal vascular diseases.
We are now solely focused on two novel and differentiat-
ed clinical-stage drug candidates, THR-149 and THR-687.
With this single-minded commitment to leverage our
strengths in support of these two clinical programs, our
team is energized about our potential to make a meaning-
ful difference in the lives of patients and their caregivers.
In addition, we are dedicated to maintaining our scientific
and clinical leadership and generating significant value for
payors and shareholders as we look to improve the lives
of patients by executing on our strategy of bringing first-in-
class and best-in-class innovation to patients.
High Unmet Need, Novel Approach
During the year we discontinued investments in non-core
activities, including early research in dry age-related
macular degeneration and oncology (Oncurious NV), and
have deployed all our resources and focus on advancing
our two innovative programs, THR-149 and THR-687.
This decision followed a detailed review of near and
mid-term value creation opportunities, with the conclusion
that progressing our two differentiated clinical programs
gives Oxurion the potential to create the most value while
enabling us to play a key role in improving the lives of
patients suffering from diabetic macular edema (DME),
wet age-related macular degeneration (wet AMD) and
macular edema following retinal vein occlusion (ME-RVO).
Progressive vision loss is a significant patient and caregiver
burden, and current treatments have many unresolved
challenges. Addressing vascular endothelial growth factor
(VEGF) is now the mainstay of therapy; however, up to 50%
of patients with DME respond suboptimally to anti-VEGF
therapy. In addition, anti-VEGF treatments address only a
subset of the disease hallmarks of DME, wet AMD and
ME-RVO. We think we can do better.
While many companies are working on developing “better”
anti-VEGF therapies by focusing solely on treatment
burden (i.e. durability), Oxurion offers a significant and
distinct opportunity to grow the $4.5 billion market for
DME and disrupt the entire $12 billion anti-VEGF market
by transforming the treatment outcomes (i.e., efficacy).
At Oxurion, our differentiated molecules offer novel mech-
anisms of action and first-in-class potential. THR-149
aims to grow the DME market by giving the up to 50% of
patients who respond suboptimally to anti-VEGFs and for
whom there are currently no suitable therapeutic options,
a new way to treat their disease. THR-687, with its broader
mechanism of action (MoA) than anti-VEGFs, has the
potential to disrupt the entire anti-VEGF market as a first-
line therapy for DME, wet AMD and ME-RVO.
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OXURION ANNUAL REPORT 2021
Differentiated Mechanism of Action for
Improving Treatment Outcomes
THR-149 is a highly potent plasma kallikrein (PKal) inhibitor,
which has the potential to provide the first novel approach
to treating unresolved DME in more than a decade. PKal is
a promising pathway independent of the VEGF pathway,
which has the potential to address the up to 50% of the
DME patients who respond suboptimally to anti-VEGFs.
THR-149 has neuroprotective and anti-inflammatory
properties in addition to addressing vascular leakage.
THR-687 is a highly potent pan-RGD integrin antagonist
that has a broader MoA than anti-VEGF treatments with
the potential for broader biological effect and improved
efficacy, helping patients see better. With its unique ability
to target all four hallmarks of retinal disease --fibrosis, an-
giogenesis, vascular leakage and inflammation --THR-687
has the potential to be a new superior treatment for first-line
therapy to treat DME, wet AMD and ME-RVO.
Clinical Progress
THR-149 | We are making significant progress on our
Phase 2 KALAHARI trial, which is designed to assess
THR-149 for the treatment of DME. During the year we
completed enrollment and reported positive results from
Part A with a mean change in Best Corrected Visual
Acuity (BCVA) of 6.1 letters from baseline to Month 3 of
the selected dose level. An independent reading center
undertook a post-hoc analysis of the Part A data (excluding
two subjects with anatomical abnormalities (biomarkers)),
which revealed a >9 letter improvement in mean BCVA
that was maintained for the remaining four months of
the trial after the last THR-149 injection, with no rescue
treatment required. These gains were seen in patients
who suboptimally respond to standard of care anti-VEGF
therapy. A five-letter BCVA gain is generally considered
clinically meaningful and 50% of the subjects had at least
a ten-letter BCVA gain. Based on the post-hoc analysis, an
amended trial design was approved by ethics committees
in the US, EU and other countries, to optimize the inclusion
and exclusion criteria to further refine the patient popula-
tion and increase the potential to demonstrate superiority
over the standard of care.
The first patients have been dosed as recruitment
continues in Part B of the trial, which is designed to
evaluate THR-149 against the anti-VEGF market leader af-
libercept for treatment of DME, in more than 100 patients
that suboptimally respond to anti-VEGF therapy. The trial is
powered for superiority against aflibercept in these patients
. The primary endpoint is BCVA, and secondary endpoints
include central subfield thickness (CST) and safety.
THR-687 | We are also making rapid progress on our
Phase 2 INTEGRAL trial, which is designed to evaluate
THR-687 for the treatment of DME in treatment-naïve
patients. The first patients were dosed in Part A of the
INTEGRAL trial during 2021, and enrollment completed
early in 2022 with topline data expected in the second
quarter of this year. Phase 1 results indicated a rapid onset
of action and positive extent and durability of effect in
treatment-experienced patients, leading to the decision to
advance to Phase 2.
Following the Phase 2 Part A data, if positive, we will advance
to Part B. The Phase 2 Part B trial is a multicenter, random-
ized trial with approximately 300 subjects at more than
90 sites in the US, EU and elsewhere in treatment-naïve
and treatment-experienced DME patients. THR-687 will
be compared to the anti-VEGF market leader aflibercept
for the treatment of DME. The primary endpoint is BCVA,
“Our team is energized
about our potential to
make a meaningful
difference in the lives
of patients and their
caregivers.”
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OXURION ANNUAL REPORT 2021
and secondary endpoints include CST and safety. We are
powering the trial to demonstrate superiority against the
standard of care, aflibercept, this time in treatment-naïve
patients.
Operational Progress
We have strengthened our leadership team with the ap-
pointment of Hanne Callewaert, PhD, as Chief Operating
Officer and Professor Alan Stitt as Chief Scientific Officer.
Both Hanne and Alan have been working with us for a
number of years and we are fortunate to be able to attract
and retain such world class talent, which confirms the
quality of our two important assets.
On the financial front, we entered into a capital commit-
ment with Negma Group for up to 30 million euro in
mandatory convertible bonds, of which we accessed 2.5
million euro during the year. We also secured a 10 million
euro convertible bond financing from Kreos Capital and
Pontifax Ventures in 2021.
We ended the year with 10 million euro in cash and
post-closing, we raised approximately 10 million euro
from a group of new global healthcare investors, led by
Fidelity Management and Research and other important
European investors, along with continued support from
current investors. We are gratified that these top-tier
investors recognize the value in our two novel Phase 2
assets and support our strategy.
Looking Ahead
For THR-149, Part B of the Phase 2 KALAHARI trial is
ongoing and enrollment of patients in more than 50 sites
in the US and other countries will continue during 2022,
with topline results expected in mid-2023.
For THR-687, topline data is expected from Part A of the
INTEGRAL trial in the second quarter of 2022, following
which we plan to immediately start Part B, with topline
data expected in the second half of 2023. We are also
planning to potentially initiate an additional Phase 2 trial in
wet AMD during 2022.
Our progress in 2021 has offered important validation of
our decision to focus our resources on clear market oppor-
tunities and leverage our scientific and clinical leadership
position in the global retina community.
I look forward to updating you on the continued progress
with our differentiated clinical assets as we work to address
the unmet needs of patients with retinal vascular diseases,
and generate value for patients, payors, and shareholders.
Our entire team appreciates the continued support and
confidence from all our shareholders.
Respectfully,
Tom Graney, CFA
Chief Executive Officer,
on behalf of the entire Oxurion Team
“We are dedicated to
maintaining our scientific
and clinical leadership
and generating
significant value for
payors and shareholders.”
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OXURION ANNUAL REPORT 2021
3. MANAGEMENT REPORT OF THE
BOARD OF DIRECTORS
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OXURION ANNUAL REPORT 2021
3.1 KEY FIGURES
3.1.1 Consolidated statement of
financial position
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Property, plant and equipment 120 230
Right-of-use assets 252 1,069
Intangible assets 1,000 2,127
Other non-current assets 95 96
Non-current tax credit 4,000 3,708
Inventories 60 85
Trade and other receivables 2,517 1,451
Current tax receivables 845 719
Investments 247 288
Cash and cash equivalents 9,740 24,511
Total assets 18,876 34,284
Total equity -1,108 25,048
Non-current liabilities 9,071 1,543
Current liabilities 10,913 7,693
Total equity and liabilities 18,876 34,284
3.1.2 Consolidated statement of profit
and loss
IN '000 EURO (EXCEPT PER SHARE AMOUNTS) (AS AT 31
DECEMBER)
2021 2020
Income 1,128 2,078
Operating result -28,495 -28,620
Finance income 171 468
Finance expense -1,268 -408
Result before income tax -29,592 -28,560
Taxes -3 0
Result of the year -29,595 -28,560
Result per share
Basic earnings/(loss) per share (euro) -0.77 -0.75
Diluted earnings/(loss) per share (euro) -0.77 -0.75
3.2 ACTIVITIES OF OXURION
3.2.1 General
Oxurion was incorporated on May 30, 2006, under its
former name, ‘ThromboGenics’, and is a public limited liability
company (in Dutch: Naamloze Vennootschap).
The registered office is established at:
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
The Company is registered in the Register of Legal Entities of
Leuven under enterprise number 0881.620.924.
3.2.2 Mission
Oxurion is dedicated to developing new pharmacologic
treatments addressing important unmet clinical needs in
ophthalmology. Oxurion is focused on developing novel
medicines for vascular retinal disorders, with an initial focus
on diabetic macular edema (“DME”), as well as compounds
targeting other vascular retinal disorders including in the
areas of wet age-related macular degeneration (“wet
AMD”) and retinal vein occlusion (“ME-RVO”).
3.2.3 History
Oxurion’s origin goes back to the incorporation of Thromb-X
NV (“Thromb-X”) in 1991 by Prof. Collen and the KU
Leuven to develop new thrombolytics with better efficacy,
less side effects and lower production costs by using the
experience of Prof. Collen gained during the development
of the successful thrombolytic drug Tissue Plasminogen
Activator (tPa).
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OXURION ANNUAL REPORT 2021
The initial R&D efforts of Thromb-X were aimed at the de-
velopment of staphylokinase, a promising thrombolytic for
acute myocardial infarction. For strategic and commercial
reasons, Thromb-X decided to progress this development
outside the western market. In the meantime, Thromb-X
successfully developed ocriplasmin, a recombinant deriv-
ative of the plasmin protein, in cooperation with the KU
Leuven and VIB.
In 2001, Thromb-X gained access to additional
financing when the US venture capital firm East Hill
Biopharmaceutical Partners became a shareholder. With
this funding, Thromb-X intensified the development of
ocriplasmin and began investigating it for ophthalmic
indications. In 2003, Thromb-X expanded its operations
by setting up a subsidiary in the US, ThromboGenics, Inc.
(“ThromboGenics Inc.”), which is incorporated in New York.
In May 2006, the Company was incorporated, under its
former name ‘ThromboGenics’, as a public limited liability
company with headquarters in Leuven.
In July 2006, the Company raised 35 million euro through
a successful Initial Public Offering (IPO) and listed on the
Eurolist of Euronext Brussels.
The Company pioneered the new drug category of phar-
macological vitreolysis, developing and commercializing
JETREA® (ocriplasmin) (“JETREA®”), which has been
approved for the treatment of vitreomacular adhesion/
vitreomacular traction in 54 countries worldwide.
In 2015, the Company took a strategic decision to focus
its main resources on developing novel medicines for
vascular retinal disorders, with an initial focus on DME,
as well as compounds targeting other vascular retinal
disorders including in the areas of wet AMD and ME-RVO.
1 Market size estimate based on GlobalData.
In 2018, the Company changed its name to Oxurion.
In order to focus its efforts on the development of new
medicines for vascular retinal disorders, Oxurion decided in
2019 to move towards a distribution model for JETREA®.
This was completed in 2020 when Oxurion granted a
world-wide license to the Inceptua Group (“Inceptua”) to
commercialize JETREA®.
Today, Oxurion is a biopharmaceutical company focused
on developing innovative treatments for vascular retinal
disorders, with two subsidiaries – ThromboGenics Inc.
(fully owned) and Oncurious NV (“Oncurious”), 83.34%
of the outstanding shares of which are held by Oxurion
and 16.66% by VIB. Oxurion, ThromboGenics Inc. and
Oncurious are collectively referred to as the “Group”.
3.2.4 Employees and
headcount development
As of December 31, 2021, the Group engaged 42 members
of personnel (including both employees and independent
contractors):
• Oxurion has 39 members of personnel, 35 based in
Belgium, 1 in France, 2 in Germany and 1 in Italy; and
• ThromboGenics Inc. has 3 members of personnel in
the United States of America (“US”).
Sixteen members of the personnel hold doctoral degrees
and eighteen hold master’s degrees.
3.2.5 Activities
The Company is engaged in the development of drugs to
treat back-of-the-eye diseases, more specifically ophthal-
mologic pharmaceuticals to treat vascular retinal disorders,
the market for which is estimated to be +$12 billion
1
. In
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OXURION ANNUAL REPORT 2021
this respect, the Company is primarily targeting DME. The
Company is also planning to potentially initiate an addi-
tional Phase 2 trial in wet AMD during 2022, and possibly
ME-RVO in the future.
Oxurion’s disease focus
DME. DME is caused by diabetic retinopathy (“DR”), which is
a complication of diabetes. DR damages the blood vessels
in the eye, allowing fluid to escape resulting in fluid accu-
mulation in the macula (central part of the retina), which
eventually leads to vision loss. DR is a chronic, progres-
sive, sight-threatening, and life-altering disease, and is the
leading cause of vision loss in working-age adults (20-65
years)
2
. DME can occur at any stage in the development
of DR.
DR and DME are growing public health concerns due to
the rapid growth in the number of people with diabetes
globally. More than one in three people living with diabetes
will develop some form of DR in their lifetime
3
. Along with
the development of diabetes as a global health issue, the
prevalence of DME is expected to rise for the foreseea-
ble future. The market value for drugs to treat DME was
estimated at approximately $4.5 billion in 2020
4
.
The current standard of care therapy for the treatment of
DME is monthly injections in the eye, also called intravitre-
al (“IVT”) injections, with anti-vascular endothelial growth
factor (“anti-VEGF”) compounds. These injections block
the vascular endothelial growth factor (“VEGF”) pathway,
which is considered to be one of the key causes in the
development of DME. Scientifically speaking, VEGF is a
2 Saaddine JB et al. Projection of diabetic retinopathy and other major eye diseases among people with diabetes mellitus. Arch Ophthalmol 2008;126(12):1740-
1747; Fong DS et al; Retinopathy in diabetes. Diabetes Care 2004;27(suppl_1):s84-s87.
3 Yau JW et al. Diabetes Care 2012;35(3):556-564; Thomas RL et al. Diabetes ResClin Pract 2019 ;157 :107840.
4 Market size estimates were derived from a combination of datasets extracted from multiple sources including curative databases with subscription
(Datamonitor Healthcare 2017-2020, Decision Resources Group 2019, GlobalData 2020) and publicly available data from the annual reports of publicly
traded companies.
5 Sun JK and Kampol LM. Ophthalmic Res 2019;62:225-230.
cytokine produced in conditions of cellular stress, resulting
in increased vascular permeability/proliferation by binding
to endothelial cell receptors. Anti-VEGF agents work by
binding to VEGF to inhibit endothelial receptor binding.
However, anti-VEGFs have been shown to deliver subopti-
mal results in a significant portion of the patient population.
Approximately 40-50% of DME patients have an un-
satisfactory visual response with anti-VEGF therapy, and in
many cases anti-VEGFs fail to achieve a clinically meaning-
ful visual improvement
5
. Moreover, despite the significant
success of anti-VEGFs, the Company expects that there
will always be a need from both physicians and patients
for improved therapies, not only to expand treatment ca-
pabilities for the 40-50% of DME patients who respond
suboptimally to anti-VEGFs, but also to deliver faster
onset of action, better therapeutic effect, longer duration
of response to the treatment, and improved convenience
of treatment through a simpler dosing regimen. This is
driving the development of the Company’s clinical assets,
THR-149 and THR-687 (the “Clinical Assets”), which are
designed to meet specific unmet needs in this market so
that these novel compounds could potentially become a
new standard of care for patients with DME.
WET AMD. In addition to DME, one of the assets being
developed by Oxurion, THR-687, also holds promise to
treat another retinal disorder currently being treated with
anti-VEGF therapy, namely wet AMD. Wet AMD is a chronic
back-of-the-eye disorder that causes blurred vision or a
blind spot in a person’s visual field. Wet AMD is generally
caused by abnormal blood vessels that leak fluid or blood
into the macula, which is the part of the retina responsible
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OXURION ANNUAL REPORT 2021
for central vision. Wet AMD is a degenerative disease that
generally occurs with aging and is the leading cause of
irreversible central vision loss in people over 55 years of
age in developed countries. With ageing demographics,
wet AMD is a growing public health concern, which was
estimated in 2020 to impact approximately 3.4 million
people in the US, EU, and Japan
6
. The market value for
drugs to treat wet AMD was estimated at approximately
$6.5 billion in 2020
7
.
ME-RVO. ME-RVO is another retina disorder causing vision
loss, which is triggered by a thrombus formation leading to
increased pressure in the retinal vascular structures. This
can lead to abnormal blood vessel formation and macular
edema, resulting in vision loss. Like with DME and wet
AMD, the most common therapy for ME-RVO is IVT in-
jections with anti-VEGF compounds. THR-687 also holds
promise for the treatment of ME-RVO. The market value
for drugs to treat ME-RVO was estimated at approximately
$1.3 billion in 2020
8
.
Alternative Treatments
The primary treatment for DME, wet AMD, and ME-RVO
currently are anti-VEGF therapies and IVT sustained-re-
lease corticosteroids. Anti-VEGF therapies represent more
than 90% of the market in value terms.
6 Owen CG et al. The estimated prevalence and incidence of late stage age related macular degeneration in the UK. Br J Ophthalmol 2012;96(5):752-756;
Rudnicka AR et al. Incidence of late-stage age-related macular degeneration in American whites: systematic review and meta-analysis. Am J Ophthalmol
2015;160:85-93; Rim TH et al. Prevalence and Pattern of Geographic Atrophy in Asia: The Asian Eye Epidemiology Consortium. Ophthalmology
2020;127(10):1371-1381.
7 Market size estimates were derived from a combination of datasets extracted from multiple sources including curative databases with subscription
(Datamonitor Healthcare 2017-2020, Decision Resources Group 2019, GlobalData 2020) and publicly available data from the annual reports of publicly
traded companies.
8 Market size estimates were derived from a combination of datasets extracted from multiple sources including curative databases with subscription
(Datamonitor Healthcare 2017-2020, Decision Resources Group 2019, GlobalData 2020) and publicly available data from the annual reports of publicly
traded companies.
Oxurion is developing alternatives to anti-VEGF therapies
to treat vascular retinal disorders in the back-of-the-eye.
Oxurion’s Clinical Assets are both being developed as a
possible alternative to anti-VEGF therapy for the treatment
of DME, and THR-687 also has the potential to deliver
improved treatment outcomes for the broader market
currently being treated by anti-VEGF therapies, including
wet AMD and ME-RVO.
THR-149 is a bicyclic peptide and acts through inhibition of
the plasma kallikrein kinin (PKaI-Kinin) system, a recognized
target for DME. THR-687 is a highly selective pan-RGD
integrin antagonist (small molecule) that is initially being
developed as a potential first line therapy for DME patients.
Scientifically, THR-687 has the potential to attenuate the
disease processes induced by multiple stress factors on
the retina (including but not limited to VEGF) by blocking
RGD-binding at integrin receptors, which has been shown
to play an important role in retinal vessel formation, fibrosis
and inflammation.
Status and recruitment of the Trials
Both THR-149 and THR-687 have already had positive
results with respect to safety from Phase 1 safety trials and
are engaged in Phase 2 clinical trials for the treatment of
DME. The Company is planning for a potential additional
Phase 2 trial of THR-687 in wet AMD and is exploring a
Phase 2 trial for THR-687 for ME-RVO.
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OXURION ANNUAL REPORT 2021
THR-149. The Company is engaged in a Phase 2 ran-
domised, multicentre clinical trial evaluating multiple
injections of THR-149 in DME patients previously
showing a suboptimal response to anti-VEGF therapy
(the “KALAHARI trial”). Part A of this Phase 2 trial (dose
selection) was successfully completed in September 2021,
and the first patient was treated in Part B of the KALAHARI
trial in October 2021.
This study will be conducted in ~80 sites in eight countries.
Approximately 108 subjects will be randomized in Part B
of the study.
The primary objective of Part B of the study is to assess the
difference in treatment effect between THR-149 0.13mg
(selected dose level from Part A) and aflibercept in terms
of increase in best corrected visual acuity (“BCVA”) from
Baseline at Month 3. The other study objectives of this part
of the study are to assess the efficacy of three monthly
intravitreal injections of THR-149, to assess the safety of
three monthly intravitreal injections of THR-149, to assess
the efficacy and safety of a single flip-over injection (af-
libercept or THR-149) when administered one month after
three monthly injections of THR-149 or aflibercept. Topline
data from the KALAHARI trial is expected in mid-2023.
THR-687. The Company is running a Phase 2 two-part,
randomized, multi-center clinical trial (the “INTEGRAL
trial”) which is the first trial in which multiple intravitreal
injections of THR-687 will be administered in humans.
Part A of the trial will assess two dose levels of multiple
THR-687 injections and, if successful, the trial’s results will
be used to select the appropriate dose for Part B of the
INTEGRAL trial that will evaluate the efficacy and safety of
THR-687 versus aflibercept (the current standard of care)
for the treatment of DME. Part B of the trial will include both
treatment experienced and treatment naïve subjects and
will be conducted in ~100 sites in more than 10 countries.
It is planned to randomise approximately 12 subjects (6
subjects per dose level) in Part A, 290 subjects in total,
including, approximately 230 treatment naïve subjects and
60 treatment experienced subjects.
The primary objective of this Part A of the study is to select
the THR-687 dose level (1.2mg or 2.0mg) to be further
assessed in Part B. Dose level selection will be based on
a benefit risk assessment conducted when all subjects
completed the Month 3 visit. The primary objective of
Part B of the study is to assess the difference in treatment
effect between THR 687 and aflibercept, in terms of the
change from Baseline in BCVA at Month 3, in treatment
naïve subjects. Other objectives are to assess the efficacy
of multiple IVT injections of THR-687 and to assess the
safety of multiple IVT injections of THR-687.
THR-687. In October 2021, the first patient was treated in
Part A (dose-finding) of the Phase 2 clinical trial evaluat-
ing THR-687 in treatment naïve patients with DME. Part
A of this Phase 2 trial is fully enrolled and topline results
are expected in the second quarter of 2022. If Part A is
successful, the Company plans to immediately start Part
B of the INTEGRAL trial, with topline data expected in the
second half of 2023. Moreover, if Part A is successful, the
Company is planning for a potential additional Phase 2
trial of THR-687 in wet AMD and is exploring a Phase 2
trial for THR-687 for ME-RVO.
The KALAHARI trial and the INTEGRAL trial are herein
collectively referred to as the “Trials”.
3.2.6 Intellectual property
The Company’s drug candidates are covered by several
patent families that are either owned by, or licensed to, the
Company.
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OXURION ANNUAL REPORT 2021
The licenses granted to Oxurion are exclusive licenses
with the right to sublicense and are subject to pre-agreed
royalties. Oxurion has the rights to all intellectual property
(“IP”) that was developed in-house. The Company engages
a contracted European patent counsel from an IP firm who
works in collaboration with several leading international IP
and patent law firms.
THR-149. Oxurion has licensed composition-of-matter
patents related to THR-149 from Bicycle Therapeutics.
Oxurion has an exclusive license to these patents under
a research collaboration and license agreement (defined
below as the “Bicycle Collaboration Agreement”). As
further described in section 5.8, the license is subject to de-
velopment milestone payments and royalties. The patents
related to THR-149 have been granted in Australia, Canada,
China, Europe, Hong Kong, Japan, Russia, Singapore and
US and are still pending in Brazil, India and New Zealand.
The duration of patent protection lasts until 2034. This
may be extended up to five years in countries with patent
extension regimes, such as Europe and the US.
THR-687. Galapagos has transferred certain composi-
tion-of-matter patents relating to THR-687 to Oxurion. As
further described in Section 5.8, the license agreement
between Galapagos and Oxurion (defined below as the
“Galapagos License Agreement” or the “Galapagos
License”) foresees development milestone payments,
sales based milestone payments and royalty rate. THR-687
is an improved molecule created by Oxurion and Oxurion
has filed new composition-of-matter patent applications
covering the THR-687 molecule. These patent applica-
tions are owned by Oxurion and have been granted in
Europe and the US and are still pending in Canada, Japan,
China, India, South Korea, Israel, Australia, New Zealand,
Brazil, Mexico, Eurasia, South Africa, Colombia, Indonesia,
Philippines, Singapore, Thailand, Vietnam, Malaysia. The
duration of patent protection lasts until 2039. This may be
extended up to five years in countries with patent extension
regimes, such as Europe and the US.
3.2.7 Group structure
As of December 31, 2021, the Group consists of three
companies, Oxurion and its subsidiaries, (i) ThromboGenics
Inc., which is fully owned and w incorporated in New York,
US and (ii) Oncurious, which based in Leuven, Belgium and
is owed 83.34% by Oxurion and 16.66% by VIB.
3.2.8 Facilities
Since January 2009, all the Company’s laboratories have
been located at the “Bio-Incubator” building at Gaston
Geenslaan 1, 3001 Leuven.
The Company is GMP certified (EU Regulation 2003/94/
EC) by the Belgian Health Authorities (FAGG/AFMPS) for
both Commercial and Investigational Medicinal Product
batch certification.
3.2.9 Investment policy
Apart from investments in laboratory materials, hardware
and software, Oxurion has not made any other significant
investments or any made commitments to make major
investments in the near future.
IP acquired from third parties is accounted for as invest-
ments and subject to impairment evaluation in accord-
ance with IFRS accounting policies.
Research and Development (“R&D”) expenses are directly
financed and as such are not considered as investments to
be capitalized on the balance sheet according to relevant
accounting rules. Under IFRS reporting and according to
the Company’s accounting policies, only development
costs made in Phase 3, will be capitalized.
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OXURION ANNUAL REPORT 2021
3.2.10 Health, safety and
environmental regulations
Oxurion is focused on creating a safe environment, not
only for the Company’s employees, but also for contrac-
tors, visitors and the overall environment.
As a biotech Company, Oxurion must deal with biological
products daily. The environmental, health and safety policy
is a key element of the Company’s business strategy and
is part of the training of each employee. This policy implies
a continuous process through which improvements and
innovations are implemented.
While biotech research is inherently associated with high
waste production, where possible the Company selects
reusable or recyclable material: disposable protective
garments are replaced by a washable alternative, plastics
are replaced by glassware and waste flows are separated
in different fractions to allow recycling. Orders are placed
with local (European) providers and grouped to reduce
transportation impact. Our processes are optimized to
generate as few waste materials as possible.
Furthermore, Oxurion actively promotes the use of public
transportation or bicycle for the regular commute to work
and work-related travel is replaced by interactive video-
conference calls to maintain business contacts. Oxurion is
conscious of the environmental impact of its activities, and
continuously evaluates its needs in order to minimize its
environmental footprint.
3.2.11 Corporate social responsibility
The Company is in contact with NGOs and patient
advocacy organizations. Oxurion continuously aims to
reach out to the broader eye community to join forces and
to demonstrate its dedication to fulfilling our mission: to
prevent vision loss and fight blindness worldwide by devel-
oping and delivering next-generation treatments.
3.3 COMMENTS TO CONSOLIDATED
FINANCIAL STATEMENTS
The consolidated financial statements were prepared in
accordance with IFRS as adopted by the EU and were
approved by the Board of Directors on March 24, 2022.
Statement of profit and loss
In 2021, Oxurion JETREA® income amounted to 1.1 million
euro compared to 2.1 million euro in 2020.
Oxurion’s gross profit in 2021 amounted to 0.5 million euro
compared to 1.5 million euro in 2020.
R&D expenses in 2021 were 20.7 million euro compared to
22.1 million euro in 2020. The R&D expenses were mainly
related to clinical activities in THR-687 and THR-149. The
2020 figure included a milestone payment of 2.0 million
euro related to the development of THR-149.
In 2021, the selling expenses of Oxurion were 1.3 million
euro compared with 3.3 million euro in 2020.
General and administrative expenses of 7.2 million euro in
2021, compared to 5.5 million euro in 2020.
In 2021, Oxurion obtained other operating income of 1.2
million euro compared to 0.8 million euro in 2020.
In 2021, Oxurion incurred an operating loss of 28.5 million
euro compared to an operating loss of 28.6 million euro
in 2020.
The 2021 financial results were as follows: 0.2 million euro
in finance income compared to 0.5 million euro in 2020
and 1.3 million euro in finance expense in 2021 compared
to 0.4 million euro in 2020.
22
OXURION ANNUAL REPORT 2021
In 2021, Oxurion incurred a loss for the year of 29.6
million euro, compared to a loss for the year in 2020 of
28.6 million euro resulting in negative diluted earnings
per share of 0.77 euro in 2021 versus 0.75 euro negative
diluted earnings per share in 2020.
Cash Flow
Oxurion’s cash position (including investments) at the end
of 2021 amounted to 10.0 million euro, in comparison to
24.8 million euro (including investments) at the end of
2020.
Statement of financial position
As of December 31, 2021, the Company’s statement of
financial position amounted to 18.9 million euro with cash,
cash equivalents and investments representing 53% of
the total balance sheet. This compares to the Company’s
December 31, 2020 balance sheet of 34.3 million euro
with cash, cash equivalents and investments representing
72% of the total balance sheet.
As of December 31, 2021, the Group has convertible loans
for a total amount of 11.8 million euro.
Oxurion was incorporated on May 30, 2006, under its
former name ‘ThromboGenics’, with a share capital of
62,000 euro represented by 11,124 shares. As of December
31, 2021, the share capital of the Company amounted to
46.0 million euro represented by 39,067,284 shares.
3.4 COMMENTS TO
STATUTORY ACCOUNTS
The 2021 financial year closed with a loss of 36.7 million
euro compared to a loss of 26.9 million euro for the 2020
financial year.
The operating income for the 2021 financial year amounted
to 26.5 million euro compared to 21.0 million euro in 2020,
consisting of:
• 1.1 million euro from product sales compared to 1.9
million euro in 2020;
• 0.2 million euro from royalties compared to 0.1 million
euro in 2020;
• 23.7 million euro capitalized R&D expenses compared
to 17.6 million euro in 2020; and
• 1.4 million euro from costs carried forward and other op-
erational revenue compared to 1.4 million euro in 2020.
The operating expenses for the financial year 2021
amounted to 51.9 million euro compared to 48.6 million
euro for the financial year 2020. These operating expenses
break down as follows:
• 4.5 million euro in purchases compared to 6.3 million
euro in 2020;
• 15.6 million euro in services and various goods
compared to 15.0 million euro in 2020. The 2020
figure included a milestone payment of 2.0 million euro
related to the development of THR-149;
• 7.4 million euro in salaries and social security contribu-
tions compared to 7.3 million euro in 2020;
• 24.0 million euro in depreciation and amortization
compared to 18.5 million euro in 2020;
• 0.4 million euro in other operating expenses compared
to 0.1 million euro in 2020; and
• No non-recurring operating charges compared to 1.4
million euro in 2020 due to the impairment of Non
Proliferative DR (Non Proliferative Diabetic Retinopathy).
23
OXURION ANNUAL REPORT 2021
Therefore, the operating loss amounts to 25.4 million euro,
compared to a loss of 27.6 million euro a year earlier.
The financial results were as follows: 0.1 million euro in
financial revenue in 2021 compared to 0.5 million euro in
2020, and 12.2 million euro in financial expenses in 2021
due to the impairment of Oncurious assets compared to
0.4 million euro in 2020.
Favorable adjustments of income taxes, tax credits,
amounted to 0.8 million euro in 2021 and 0.6 million euro
in 2020.
As a result, the 2021 financial year closed with a loss of
36.7 million euro compared to a loss of 26.9 million euro
for the 2020 financial year.
In addition, for the financial year 2021, an amount of
0.02 million euro was invested, mostly in IT & laboratory
equipment and office modelling, compared to 0.07 million
euro in 2020.
Going concern
According to Article 3:6, §1, 6° of the Belgian Code of
Companies and Associations (“BCCA”) and after deliber-
ation, the Board of Directors has decided to preserve the
valuation rules assuming continuation, for the following
reason:
The statutory financial statements were prepared on a
going concern basis.
At December 31, 2021, the Company had cash and cash
equivalents (including investments) of 10.0 million euro
in comparison with 24.8 million euro at December 31,
2020. Post-closing, the Company raised approximately
10 million euro from a group of new global healthcare
investors, led by Fidelity Management and Research and
other important European investors. As more thorough-
ly set forth in section 3.6.1, on March 3, 2022, Oxurion
successfully raised an amount of 10.4 million euro in
gross proceeds by means of a private placement of
7,226,039 new shares at an issue price of 1.44 euro
per share representing a 4.35% premium to Oxurion’s
closing price on March 2, 2022.
In addition to available cash including that from the
post-closing private placement, the Company expects to
meet its working capital requirements through a com-
bination of debt and equity, including drawing future
tranches from the Negma funding program, accessing
the debt markets through Kreos/Pontifax and/or other
debt providers, raising additional equity capital, attracting
potential non-dilutive funding, and/or reducing spending,
all of which is uncertain. Under the funding program with
Negma, the Company will have access to up to 27.5
million euro in the 12-month period starting from these
financial statements provided the Company can and
does draw the maximum tranche on a monthly basis,
which is subject to certain conditions that may not be
met.
The Board of Directors considers that there is a material
uncertainty with respect to the Company’s ability to
continue as a going concern. However, considering the
current available cash position, the budgets for 2022,
the funding possibilities potentially available to the
Company from Negma and others, and the possibility
the Company has to reduce its working capital require-
ments if necessary, the Board of Directors considers that,
notwithstanding the material going concern uncertainty,
it is appropriate for the Company to continue to account
on the basis of going concern accounting because that
risk is sufficiently mitigated by the factors mentioned
above.
.
24
OXURION ANNUAL REPORT 2021
3.5 DESCRIPTION OF THE PRINCIPAL
CHARACTERISTICS OF THE
COMPANY’S RISKS
The risks and uncertainties that the Company believes to
be material are described below. The occurrence of one or
more of these risks may have a material adverse effect on
the Company’s cash flows, results of operations, financial
condition and/or prospects and may even endanger the
Company’s ability to continue as a going concern. Moreover,
the Company’s share price could fall significantly if any of these
risks were to materialize. Further, these risks and uncertainties
may not be the only ones the Company faces. Additional
risks, including those currently unknown or deemed immate-
rial, may also impair the Company’s business operations.
The risk factors are presented in eight categories, depending
on their nature. In each category, the risk factor which in the
assessment of the Company is the most material, taking into
account the negative impact on the Company (including any
relevant mitigation measures) and the probability of its oc-
currence, is mentioned at the outset, and the remainder of
the risks in each category are listed in order of importance
based on the Company’s assessment, although prospective
investors should consider them all.
3.5.1 Risks related to Insufficient Funding
and Continuation as a Going Concern
3.5.1.1 The Company is of the opinion that there is
a material risk that it will not have sufficient
working capital to meet its capital require-
ments from fully committed sources either
over the 12-month period starting from the
date of this Annual Report or thereafter. The
Company’s ability to complete the milestones
in the development of its Clinical Assets will be
put at risk if it is not able to access available
funding due to the conditions attached to
that funding, raise additional funding and/or
reduce its expenditures when required to do
so during the 12-month period starting from
the date of this Annual Report or thereaf-
ter, all of which is uncertain. Furthermore, if
the Company is not able to access available
funding due to the conditions attached to that
funding, increase its funding and/or reduce
its expenditures when required to do so, all of
which is uncertain, during the 12-month period
starting from the date of this Annual Report
or thereafter, its ability to continue as a going
concern will be threatened, which would have a
material adverse impact on the Company and
its shareholders leading to the potential total
loss of their entire investment
The Company is of the opinion that it currently does
not have sufficient working capital from fully committed
sources to meet its capital requirements over the
12-month period following the date of this Annual Report
or thereafter.
The Company included a statement in its 2020
Annual Report, its 2021 HY Report and its 2021 Annual
Communiqué that there is a material uncertainty with
respect to the Company’s ability to continue as a going
concern. Furthermore, after the 2021 HY Report was issued,
25
OXURION ANNUAL REPORT 2021
the Board of Directors established that the net assets of
the Company fell below one quarter of the share capital
and convened a special general shareholders’ meeting in
accordance with article 7:228 of the BCCA, at which the
shareholders decided (i) to continue the Company’s oper-
ations and (ii) to approve the recovery measures proposed
by the Board of Directors to improve the Company’s equity.
The amount of the funding required depends on many
factors affecting the Company’s working capital require-
ments over the 12-month period following the date of this
Annual Report or thereafter, for example the success of
the Part A of the INTEGRAL trial, the speed of recruitment
for patients for the Trials, and the timing of any further
Phase 2 trials of THR-687 in DME and/or wet AMD.
Concerning the possible sources of funding, the Company
has entered into a funding program with Negma Group
Ltd. (“Negma”) pursuant to which Negma has committed
to subscribe to up to 30 million euro in Oxurion equity
through mandatory convertible bonds to be issued in
tranches and subject to certain conditions (“Funding
Program”). As of the date of this Annual Report, Negma
has subscribed to 3.025 million euro
9
in convertible
bonds, of which it has converted 740 convertible bonds
in exchange for (in aggregate) 1,110,903 new shares. The
terms of the Funding Program are more fully described
in the Negma Board Report prepared in accordance with
article 7:198 juncto articles 7:180, 7:191 and 7:193 of the
BCCA dated July 15, 2021.
Under the Funding Program, based on the amounts drawn
thus far, the Company will have access to another up to
27.5 million euro in the 12-month period starting from the
date of this Annual Report provided the Company can and
does draw the maximum tranche on a monthly basis. Any
balance remaining after the afore-mentioned 12-month
9 Consisting of 2.5 million euro in convertible bonds and 525,000 euro in commitment fee convertible bonds.
10 The amount of 28.675 million euro consists of 27.5 million euro (i.e. 11,000 (not yet issued) convertible bonds with a value of 2,500 euro each) and 1.175
million euro (i.e. 470 (issued) convertible bonds) with a value of 2,500 euro each.
period (out of a maximum committed amount of 30 million
euro) will be available for a subsequent 12-month period,
which can be extended with another 12-month period. The
Company intends to rely in part on the Funding Program
for purposes of meeting its working capital requirements
Over the 12-month period from the date of this Annual
Report and thereafter. However, the Company’s ability to
draw a tranche is subject to certain conditions such that it
may not be able to draw a tranche when it desires to do so.
In addition to drawing future tranches from the Funding
Program, the Company expects to meet its working capital
requirements through a combination of debt, equity and
spending reductions, including accessing the debt markets
through Kreos/Pontifax and/or other debt providers and/
or raising additional equity capital, all of which is uncertain.
Should the Company decide to rely on the entire available
amount under the Funding Program (which at the date of
this Annual Report amounts to 27.5 million euro) and meet
the conditions to do so, a subsequent conversion of the
hypothetical conversion amount of maximum 29.2 million
euro (consisting of 28.675 million euro
10
in convertible
bonds and 525,000 euro in commitment fee convertible
bonds) at a conversion price of 1.36 euro, would result in
a substantial dilution of voting-dividend rights, as well as a
financial dilution.
Furthermore, the Company may consider outlicensing one
or both of its Clinical Assets, which would be expected to
reduce its costs because the licensee would pay all or part
of the relevant trial, and potentially increase its revenues
through upfront and milestone payments (and even-
tually royalties). However, if due to cash constraints, the
Company enters into a license at an inopportune moment
or on disadvantageous terms, this could have a significant
negative impact on the Company’s valuation and on its
shareholders.
26
OXURION ANNUAL REPORT 2021
The Company’s ability to complete the milestones in the
development of its Clinical Assets will be put at risk if it is
not able to access available funding due to the conditions
attached to that funding, raise additional funding and/or
reduce its expenditures when required to do so, all of which
is uncertain, during the 12-month period following the date
of this Annual Report or thereafter. Furthermore, if the
Company is not able to access available funding due to
the conditions attached to that funding, increase its funding
and/or reduce its expenditures when required to do so,
all of which is uncertain, the 12-month period following
the date of this Annual Report or thereafter, its ability to
continue as a going concern will be threatened, which
would have a material adverse impact on the Company
and its shareholders leading to the potential total loss of
their entire investment. This material risk applies both
during the 12-month period and thereafter.
3.5.1.2 The Company is a clinical stage biotech with
no history of profitability due to substantial
investments in product development, and
the Company requires additional external
funding on a going forward basis to continue
and complete the development of its Clinical
Assets
Oxurion is dedicated to developing and bringing new phar-
macologic treatments addressing important unmet clinical
needs for the treatment of vascular retinal disorders to a
commercial stage of development.
The risks Oxurion faces include that it requires additional
funding to continue the Trials and further development of
the Clinical Assets. Oxurion plans to continue preclinical
testing, product development, clinical trials and regulatory
compliance activities for its Clinical Assets, which, together
with anticipated general and administrative expenses,
will result in significant additional investments for several
years before achieving any return. These investments in
its Clinical Assets require Oxurion to attract significant ad-
ditional external funding in order to realize the value of its
Clinical Assets.
The extent of Oxurion’s future financing needs is dependent
on many factors, including the progress, costs and timing
of its research and development activities, preclinical trials,
clinical trials, the costs of managing its patent and IP
portfolio and obtaining regulatory approval, and the terms
and timing of its product supply arrangements, commercial
relationships, license agreements and other partnerships,
and/or re-establishing sales and marketing capabilities.
However, although the amount of additional funding that is
required is uncertain, it is certain that substantial additional
funding will be necessary to complete the Company’s
existing and future drug development programs.
The Company is currently engaged in the Trials with its
Clinical Assets for DME. The Company estimates that the
Trials, together with any further Phase 2 trial of THR-687
in wet AMD, will be completed in 2023. Furthermore, if
those Trials are successful, a number of Phase 3 clinical
trials will be required before either of the Clinical Assets
are approved, which are larger and more expensive trials,
and which are not expected to be completed until 2028.
Oxurion does not know if it will generate positive clinical
data, receive regulatory approval, or obtain reimbursement
for its Clinical Assets/ Further, the Company may encounter
unforeseen events (potentially including expenses, difficul-
ties, complications, delays and other unknown factors), all
of which could impair Oxurion’s ability to attract the addi-
tional funding required to complete the Trials.
This means that Oxurion will have to attract significant ad-
ditional funding from third parties to continue operations
until 2028 before it is able to generate revenues from the
marketing of its Clinical Assets. Alternatively, the Company
could decide to enter into outlicensing arrangements for
further development beyond Phase 2 for one or both of
27
OXURION ANNUAL REPORT 2021
the Clinical Assets. This would reduce or eliminate future
development costs and could generate revenues from
milestone payments as early as 2023 or even earlier for
certain markets.
Should Oxurion not be able to secure adequate future
external funding to continue its development programs
for its Clinical Assets in a timely manner and/or to enter
into outlicensing arrangements, this would have a material
adverse effect on Oxurion as it may be forced to delay,
reduce or terminate the development or commercializa-
tion of all or part of the development of its Clinical Assets,
out-license one or both of its Clinical Assets prematurely, or
not be able to take advantage of future business opportu-
nities, all of which could potentially impair Oxurion’s ability
to sustain operations or to continue as a going concern.
If either the KALAHARI trial or the INTEGRAL trial are sig-
nificantly delayed or fail, the risk that it will be difficult to
obtain additional funding for the Trials increases substan-
tially. If both fail, funding will become extremely difficult and
potentially impossible, and would threaten the Company’s
ability to continue as a going concern and potentially result
in shareholders losing the total value of their investment
(please refer to section 3.5.1.1 of this section 3 ‘Risk Factors’,
for further information).
3.5.2 Clinical Development
3.5.2.1 The Company only has two products in
development, one or both of which could fail
Oxurion cannot market or promote its Clinical Assets until
they receive all necessary regulatory approvals, which may
never be received. Oxurion’s success therefore depends on
the Company’s ability to successfully develop (or for a third
party to successfully develop) one or both of its Clinical
Assets through completion of Phase 2 and Phase 3 clinical
trials and regulatory marketing authorization.
Oxurion only has two Clinical Assets in the pipeline.
Generally speaking, a significant percentage of Phase
2 clinical trials fail. If either the KALAHARI trial or the
INTEGRAL trial were to fail, this would impact Oxurion’s
value as a company, taking into account that if Part A of the
INTEGRAL trial fails, this is likely to preclude the Company
from developing THR-687 for wet AMD or ME-RVO. If
either of the Trials fail, the likelihood of obtaining additional
funding decreases significantly and if both Trials fail this
would threaten the Company’s ability to continue as a
going concern (please refer to section 3.5.1.1 of section 3
‘Risk Factors’, for further information) which could result
in shareholders losing the total value of their investment.
3.5.2.2 One or both of the Clinical Assets could be
significantly delayed
The clinical trials of Oxurion’s Clinical Assets may be delayed
for a variety of reasons, including, but not limited to, recruiting a
sufficient number of suitable patients to participate in the Trials
and in having them complete the trial or return for follow-up;
the recruitment and retention of clinical sites; the impact of
COVID-19; maintaining the Company’s relationships with its
clinical research organizations (“CROs”), clinical investigators
and clinical trial sites; the reliability of its third-party manu-
facturing organizations; any possible safety or efficacy issues
that could be raised in the future; potential delays in obtaining
regulatory approval for the Trials, and any supply failures or
delays with respect to the clinical trial materials.
Patient enrollment and the inclusion of sites and investigators
is a particularly significant factor in the timing of clinical trials
and is affected by many factors including, but not limited to,
the number of patients available for clinical trials, competing
trials and patient concerns about COVID-19, as well as
numerous other factors.
28
OXURION ANNUAL REPORT 2021
If Oxurion experiences lower/slower than expected enrolment
in the Trials, the Trials may be delayed, may not be completed
as envisaged or may become more expensive to complete,
which would have an adverse impact on Oxurion’s ability to
raise funds (please refer to section 3.5.1.1 of section 3 ‘Risk
Factors’, for further information), as well as its business,
prospects, financial condition and results of operations.
A significant delay in either of the Trials could cause the costs
of those Trials to increase and seriously impact the Company’s
value and ability to raise additional funding. Delays in clinical
trials are not unusual, but if they become significant, especially
for both Trials, this would be likely to have a material adverse
impact on the Company’s activities, costs, and ultimately on
its valuation, which would adversely impact shareholders, and
if both Trials were significantly delayed, this could threaten
the Company’s ability to continue as a going concern (please
refer to section 3.5.1.1 of this section 3 ‘Risk Factors’, for further
information), which could result in shareholders losing the
total value of their investment.
3.5.2.3 One or both of the Clinical Assets may develop
adverse side effects that may delay or prevent
marketing approval
Oxurion’s Clinical Assets may cause undesirable side
effects or have other properties that could delay or prevent
further development or regulatory approval, limit the com-
mercial profile of an approved label, or result in significant
negative consequences following marketing approval, if
achieved.
At the clinical stage, adverse side effects could affect
patient recruitment or the ability of enrolled patients to
complete the Trial or the completion of the Trial itself.
The Phase 1 trials for both Clinical Assets and Part A of the
KALAHARI trial, have shown the Clinical Assets to be safe.
However, THR-687 is still in the Part A dose finding part
of the INTEGRAL trial, the purpose of which is to evaluate
safety with multiple doses, which could be unsuccessful.
Furthermore, for both Clinical Assets, undesirable side
effects could appear in subsequent clinical phases and
could cause Oxurion or the regulators to interrupt, delay or
halt clinical trials or, even if the trials are completed, could
cause delay or denial of regulatory approval by the regula-
tors or result in a more restrictive label.
Although some adverse effects are expected in a clinical
trial, if either of the Clinical Assets were to cause serious
adverse effects, depending on their nature, this could
have a significant adverse impact on Oxurion’s ability to
bring the Clinical Assets to market. This would impact the
Company’s valuation and ability to raise additional funding.
Considering that Oxurion only has two Clinical Assets in
the pipeline), if both of the Clinical Assets were to cause
serious adverse effects, this could threaten the Company’s
ability to continue as a going concern, which could result
in shareholders losing the total value of their investment
(please refer to section 3.5.1.1 of this section 3 ‘Risk Factors’,
for further information).
3.5.3 Regulatory Risks
3.5.3.1 The Company may not obtain marketing au-
thorization for one or both of its Clinical Assets
in important territories
Oxurion’s Clinical Assets must receive marketing approval
from the regulators before they may be marketed and com-
mercialized. Each regulator can impose its own requirements
(thereby limiting the market potential), can request additional
data before giving the marketing approval for the respective
drug candidate, which can cause delay, or can refuse to give
approval, even if such approval was already given by other
regulators.
Oxurion’s current Clinical Assets are in Phase 2 Trials and may
not receive marketing approval. Furthermore, clinical data is
often susceptible to varying interpretations and analyses and
even a product that performed satisfactorily during clinical
29
OXURION ANNUAL REPORT 2021
trials may nonetheless fail to obtain regulatory approval for
marketing. Due to the inherent risk in the development of
biopharmaceutical products, it is possible that neither of the
Clinical Assets will be successfully developed and approved.
Once approved, products may also be subject to post-au-
thorization safety trials or other pharmacovigilance or biovig-
ilance activities, may be subject to dosing or other limitations
on their uses, or may be withdrawn from the market for
various reasons, including if they are shown to be unsafe or
ineffective when used in a larger population, which may be
different from the trial population studied prior to introducing
the product on the market. It is also possible that regulatory
approval guidelines may change during the product develop-
ment and review process, making the chosen development
strategy suboptimal. These factors may result in significant
delays, increased trial costs, substantial changes to commer-
cial assumptions or the failure of the Clinical Assets to obtain
marketing authorization. Furthermore, even if a marketing
authorization is obtained, the regulator may impose ongoing
requirements for potentially costly post-approval trials or
post-market surveillance.
If one of the Clinical Assets is not granted marketing authori-
zation in important markets, this is likely to have a materially
adverse effect on the Company’s ability to generate revenues.
Furthermore, if both Clinical Assets were to be denied
marketing authorization, funding would become extremely
difficult, and would threaten the Company’s ability to continue
as a going concern and potentially result in shareholders
losing the value of their investment (please refer to section
3.5.1.1 of this section 3 ‘Risk Factors’, for further information).
11 Sun JK and Kampol LM. Ophthalmic Res 2019;62:225-230.
3.5.4 Market Acceptance Risk
3.5.4.1 The Clinical Assets will have to compete
against the established market for anti-VEGFs,
which are widely accepted by physicians
Anti-VEGFs have wide-spread market acceptance with
retina-physicians for the treatment of DME (and wet
AMD). Although 40-50% of DME patients do not respond
adequately to anti-VEGF therapy
11
, retina-physicians may
resist trying the Clinical Assets, which address innova-
tive pathways and mechanisms of action that may be
perceived as untested. Moreover, given their novelty, the
Clinical Assets may result in unexpected correlations or
the lack of correlations that would not be predicted based
on the current standard of care, which may have an
adverse impact on market acceptance. Furthermore, this
type of advanced research sometimes requires additional
preclinical and clinical activities to generate more extensive
data and hence additional costs, triggering increased time
to market and funding.
The market for treatments for vascular retinal disorders is
characterized by increased innovation, and major invest-
ments are being made in new therapies and improving
the existing standard of care, which is anti-VEGF therapies.
Although the pathways Oxurion is focused on currently do
not have significant competition, competitors with more
financial wherewithal and other benefits, may be currently
developing, or may in the future develop, technologies and
products that are equally or more effective, safe and/or
economical than the Clinical Assets.
If the Clinical Assets are not able to achieve market ac-
ceptance, this will reduce Oxurion’s income and lower its
valuation, which could have a material adverse impact
on the Company and its shareholders, and could impact
the Company’s ability to continue as a going concern and
potentially result in shareholders losing the value of their
investment (please refer to section 3.5.1.1 of this section 3
‘Risk Factors’, for further information).
30
OXURION ANNUAL REPORT 2021
3.5.4.2 Price setting, availability, and level of reim-
bursement for the Clinical Assets by third
parties is uncertain and may impede Oxurion’s
ability to be commercially successful
The commercial success of Oxurion’s Clinical Assets
depends on the conditions for setting the sales price of
its products and the conditions of their reimbursement by
the health agencies, insurance companies, health tech-
nology assessment agencies or other healthcare payers
in the countries where Oxurion’s Clinical Assets would be
marketed.
As discussed in section 3.2.5 of this Annual Report, the
Clinical Assets are geared at creating alternatives to
anti-VEGF therapy. Considering the innovative nature of
Oxurion’s Clinical Assets and the lack of similar products,
reimbursement levels are difficult to predict and Oxurion’s
ability to adopt an adequate pricing strategy is uncertain.
Oxurion’s Clinical Assets may not fit within the existing
health technology assessment and reimbursement
processes applied throughout the different jurisdictions in
which Oxurion’s Clinical Assets would be sold. The Clinical
Assets may also be subject to different reimbursement
mechanisms and amounts depending on the jurisdic-
tion in which they are being offered for sale. Moreover,
anti-VEGF therapies will lose market exclusivity, which is
expected to create an increased pressure on reimburse-
ment. There is also a general increased pressure on
healthcare spending, including reimbursement and price
levels, in most countries, due to, among other things, the
current environment of healthcare cost control (e.g., in-
ternational reference pricing) and increase in healthcare
budgets caused by an aging population, which will be
further expanded by the impact of COVID.
If the Clinical Assets fail to obtain a favorable price and/
or adequate reimbursement by third parties, such as
insurance companies, governmental and other healthcare
payers, this would impede Oxurion’s ability to generate
revenue from the Clinical Assets, which would have an
adverse impact on its revenue, which in turn would have an
impact on its valuation in the market and reduce the benefit
to its shareholders to be derived from the Clinical Assets.
If Oxurion’s is unable to generate revenue from either of
its Clinical Assets, the Company’s ability to continue as a
going concern could be threatened, which could potentially
result in shareholders losing the value of their investment
(please refer to section 3.5.1.1 of this section 3 ‘Risk Factors’,
for further information).
3.5.5 Legal Risks
3.5.5.1 One or both of the Clinical Assets may be
deemed to infringe on the patents or other in-
tellectual property rights of others
Oxurion’s success depends on its ability to operate without
infringing on or misappropriating the intellectual property
rights of others. Oxurion cannot guarantee that its activities,
or those of its licensors, will not infringe on the patents or
other intellectual property rights owned by others.
There is significant litigation activity in the pharmaceutical
industry regarding patents and other intellectual property
rights. Oxurion or its licensors may expend significant time
and effort and may incur substantial costs in litigation if the
Company is required to defend patent or other intellectu-
al property right claims regardless of whether the claims
have any merit. Oxurion also cannot predict whether it or
its licensors will prevail in any litigation.
If Oxurion or its licensors are found to have infringed the
patents or other intellectual property rights of others,
Oxurion or its licensors may be subject to substantial
claims for damages, which could materially impact its cash
flow and financial position. Oxurion may also be required
to cease development, use or sale of the relevant research
program, Clinical Assets or process, or be required to
obtain a license for the disputed rights, which may not be
available on commercially reasonable terms, if at all.
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OXURION ANNUAL REPORT 2021
Although to date no patent infringement claim has been
made against Oxurion, if either of the Clinical Assets were
to be found to infringe on the patents or other intellectual
property of others, Oxurion could be liable for significant
damages, potentially including a substantial unexpected
royalty and potentially even be required to withdraw one
or both Clinical Assets from the market. This would have
a material adverse impact on Oxurion’s cash flow and rep-
utation, which could result in the investors losing the total
value of their investment.
3.5.5.2 Product liability claims could be successfully
brought against Oxurion or its partners
Product liability claims due to unpredicted adverse side
effects of the Clinical Assets may be brought against
Oxurion or its partners by participants enrolled in clinical
trials, patients, practitioners, researchers, other health/
research professionals or others using, administering, or
selling any of Oxurion’s Clinical Assets once approved.
Furthermore, JETREA® is a product developed by Oxurion
and marketed by its partner, Inceptua, on its behalf, for the
treatment of vitreomacular traction (VMT), which could
also lead to product liability claims.
Oxurion is currently insured for product liability risks.
However, claims could be made that exceed this insurance.
Oxurion may incur substantial liability if it is found liable
for product liability to the extent that such claims are not
adequately covered by its insurance. Furthermore, a suc-
cessful product liability claim (or even an unsuccessful
one) could potentially harm the Company’s reputation
and hinder its ability to market other products, especially
given that the Company has only two products in develop-
ment (please refer to section 3.5.1.1 of this section 3 ‘Risk
Factors’, for further information). To date, no such claims
or legal actions have been filed against Oxurion, but this
could happen in the future, in which case it could have a
material adverse impact on the Company depending on
the circumstances, resulting in a potential diminution of the
Company’s value and an adverse impact on shareholders.
3.5.5.3 Data protection violation or data breach claims
may have an adverse effect on Oxurion’s
business, prospects, financial condition and
results of operations and its ability to execute
its Trials
Oxurion is required to comply with applicable data pro-
tection laws, including the European Union’s General Data
Protection Regulation (“GDPR”), which imposes strict obliga-
tions and restrictions on the collection and use of personal
data. This includes cybersecurity measures addressed to
prevent loss or exposure of data, intrusion into or blockage
of Oxurion’s or its collaborators’ systems. Even stricter re-
quirements apply to sensitive data (including data related
to health).
Oxurion collects, uses and stores personal data including
sensitive data during the ordinary course of its opera-
tions. Oxurion’s third-party vendors also have access to
and process personal data, including sensitive data, on its
behalf.
Oxurion has established processes and controls for compli-
ance with its data protection obligations and for the proper
prevention, detection and response to cybersecurity risk.
This includes the fact that all data from its clinical trials is
pseudonymized before being transferred to Oxurion or its
vendors, which do not have access to any patient details
concerning the subjects taking part in its clinical trials.
Oxurion has taken preventative measures and established
procedures regarding data processing and data security.
However, data protection violations, data breaches, loss
of data and unauthorized access could still occur. This
could result in legal claims or proceedings, liability under
the data protection and other laws, significant regulatory
penalties, disruption of Oxurion’s operations and damage
to its reputation.
32
OXURION ANNUAL REPORT 2021
A significant data protection violation or data breach could
have a material adverse effect on Oxurion’s business,
prospects, financial condition and results of operations. As
a biopharmaceutical company engaged in clinical trials, if
the Company were to be considered a data protection risk
by competent authorities, the CROs, investigators, hospitals,
patients or third parties, it would make it more difficult for
the Company to recruit the clinical trial sites, clinical in-
vestigators, and patients required for its Trials and hence
more difficult to carry out the Trials, potentially resulting in
delay, and this could even impact approval of the Clinical
Assets. This would result in a potential loss of value for
the Company and its shareholders as the Trials could take
longer and become more expensive.
3.5.6 Intellectual Property Protection
3.5.6.1 The Clinical Assets are licensed from third
parties, which creates risks of the loss of the
license rights, and the Clinical Assets may not
be adequately protected by the patents and
other intellectual property rights
The Clinical Assets are covered by several patent families,
which are either licensed to, or owned by, Oxurion. The
Company’s success will depend in part on its and its
licensors’ ability to obtain, maintain and enforce its patents
and other intellectual property rights.
Licenses. The Clinical Assets are subject to license
agreements with Bicycle Therapeutics for the intellectual
property that protects THR-149 and with Galapagos NV
for THR-687. As further described in sections 3.2.6 and 5.8,
the conditions under which the Company may use this in-
tellectual property include, but are not limited to, payments
being due upon achievement of certain milestones and
royalties on net sales of relevant products, as well as the
performance of other obligations.
If Oxurion fails to comply with its obligations under the
respective license agreements, the licensors may reduce
the scope of the license or terminate the license, resulting
in the loss of the use of the related intellectual property
rights. Loss of the rights to the intellectual property pro-
tecting the Clinical Assets is likely to mean that Oxurion
is unable to develop, manufacture or sell its products or
have them sold. Although in the case of THR-687, these
patent rights have been transferred to Oxurion subject to
payment, if the Company fails to comply with the terms of
the agreement, Galapagos NV has recourse to remedies
that would materially harm Oxurion’s ability to market
THR-687, and which therefore could damage a substantial
part of Oxurion’s business.
Patent Protection. As further described in section 3.2.6,
Oxurion and its licensors have a robust patent portfolio
protecting its Clinical Assets in the most important
markets. However, Oxurion cannot guarantee that it or its
licensors will be able to obtain or maintain these patent
rights against third-party challenges to their validity, scope
and enforceability, potentially enabling competitors to
circumvent the patents and to use the patented intellec-
tual property, thereby depriving Oxurion of the protection
it would expect against competitors. Moreover, Oxurion
and its licensors have not sought to protect its intellectual
property rights in all jurisdictions throughout the world, and
may not be able to adequately enforce their intellectual
property rights in the jurisdictions where they have sought
or obtained protection.
A biopharmaceutical company such as Oxurion that
licenses rights from third parties relies on being able to
exercise those rights and that they will be enforceable
and enforced, for its market and commercial value. Any
diminution of those rights or that protection could have a
material adverse impact on the Company and its share-
holders, and therefore could result in a significant loss of
investment. If Oxurion were to lose the license rights to
33
OXURION ANNUAL REPORT 2021
both of the Clinical Assets that are currently in the pipeline,
the Company’s ability to continue as a going concern could
be threatened (please refer to section 3.5.1.1 of this section
3 ‘Risk Factors’, for further information).
In summary, if Oxurion were to lose the license rights to
either of the Clinical Assets, this would have a material
impact on its business and its shareholders. Furthermore,
if Oxurion and its licensors would be unsuccessful in
enforcing their patents and other intellectual property
protection to protect the Clinical Assets, this could have
a material adverse effect on the Company’s ability to
maximize the market potential of the Clinical Assets, which
also could have a material impact on its business and its
shareholders.
3.5.6.2 If Oxurion is not able to prevent disclosure of
its trade secrets, know-how, or other propri-
etary information, the value of its technolo-
gy and Clinical Assets could be significantly
diminished
Oxurion relies on trade secret protection to protect its
interests in its know-how and other proprietary information
and processes for which patents are difficult to obtain or
enforce, all of which constitutes confidential information.
Oxurion may not be able to protect its confidential informa-
tion adequately. Oxurion has a policy of requiring anyone
to which it discloses confidential information, including for
example, its employees, actual or potential consultants,
contract personnel, advisers, some investors and potential
investors and third-party partners (“Receiving Parties”), to
enter into confidentiality agreements. However, there is no
assurance that such agreements will provide sufficient pro-
tection of confidential information in the event of any unau-
thorized use or disclosure of confidential information.
Furthermore, Oxurion cannot provide any assurance that any
of its Receiving Parties, either accidentally or through willful
misconduct, will not cause serious damage to its programs
and/or its strategy, by, for example, disclosing confidential
information to its competitors. It is also possible that confi-
dential information could be obtained by third parties as a
result of breaches of physical or electronic security systems
of Oxurion, its Receiving Parties or other parties that have
had access to its confidential information.
Any disclosure of confidential data into the public domain
or to third parties could allow Oxurion’s competitors to learn
confidential information and use it in competition against
Oxurion. In addition, others may independently discover
Oxurion’s confidential information through intrusion on its
systems or those of third parties.
Enforcing Oxurion’s rights against any misappropriation or
unauthorized use and/or disclosure of confidential informa-
tion is time-consuming and expensive, and may ultimately
be unsuccessful, or may result in a remedy that is not com-
mercially viable. If Oxurion were unable to protect its confi-
dential information, this could significantly diminish the value
of its Clinical Assets by allowing competitors to gain access
to competitive information, which could have a significant
adverse impact on Oxurion and its shareholders. A clinical
stage biopharmaceutical company such as Oxurion relies
heavily on the confidentiality of its information and trade
secrets for its market and commercial value and any loss of
confidentiality with respect to its Clinical Assets could have a
material adverse impact on the Company and its sharehold-
ers, and therefore could result in a significant reduction in the
Company’s value and shareholders’ investment.
34
OXURION ANNUAL REPORT 2021
3.5.7 Risks related to reliance on third
parties, key personnel, grants and tax
carry forwards
3.5.7.1 Oxurion relies on third parties to conduct its
clinical trials and to manufacture the Clinical
Assets, which creates interdependencies and
risks
Oxurion has relied upon and plans to continue to rely
upon third parties, including independent laboratories,
clinical investigators, CROs and third-party manufacturers,
to conduct its clinical trials and to manufacture its Clinical
Assets.
Clinical trials. Oxurion relies on third parties for the
execution of its preclinical trials and clinical trials and can
control only certain aspects of their activities. However,
Oxurion’s reliance on these third parties does not relieve
it of its regulatory responsibilities and it continues to be
responsible for ensuring that each of its trials is conducted
in accordance with the applicable protocol, scientific
standards and legal and regulatory obligations, such as
Good Laboratory Practice (“GLP”), Good Clinical Practice
(”GCP”) and Good Clinical Manufacturing (”cGMP”) regu-
lations. If Oxurion, third-party laboratories, clinical investiga-
tors or any of its CROs fail to comply with applicable GLPs,
GCPs or the tested products do not meet cGMP regula-
tions, the preclinical or clinical data may be deemed unre-
liable and regulators may deny approval or may require
Oxurion to perform additional preclinical trials, clinical trials
or other activities before approving further trials or the
marketing applications for its Clinical Assets.
Further, with respect to the trials, the clinical investigators
and CROs are not employees of Oxurion and Oxurion will
not be able to control, other than by contract, the quality
and extent of resources, including time, which they devote
to the Clinical Assets and the trials. The trials may be
extended, delayed or terminated if clinical investigators or
CROs fail to devote sufficient quality resources to the de-
velopment of the Clinical Assets, do not successfully carry
out their contractual duties or obligations or meet expected
deadlines, need to be replaced, or if the quality or accuracy
of the clinical data they obtain is compromised due to their
failure to adhere to Company’s clinical protocols, regulato-
ry requirements or for other reasons.
There are a limited number of third-party service providers
that specialize in, or have the expertise required to,
undertake Oxurion’s preclinical and clinical trials in DME
and other vascular retinal disorders. If Oxurion’s relation-
ships with these third-party CROs or clinical and preclini-
cal investigators or laboratories would be compromised or
terminated, it may not be able to enter into alternative ar-
rangements with alternative CROs or clinical investigators
or to do so on commercially reasonable terms. Switching
or adding additional CROs (or investigators or laborato-
ries) involves additional cost and requires management
time and focus. In addition, the use of third-party service
providers requires Oxurion to disclose its proprietary infor-
mation to these third parties, which increases the risk that
this information may be misappropriated.
If these third parties do not successfully carry out their
contractual duties or meet expected deadlines, Oxurion’s
results of operations and the commercial prospects for the
Clinical Assets could be damaged, its costs could increase,
and its ability to generate revenues could be delayed.
Oxurion may not be able to obtain regulatory approval for,
or commercialize, its Clinical Assets in a timely manner, or
at all, and as a result, the Company and its shareholders
could be substantially harmed.
Third Party Manufacturers. Oxurion also relies on third
party manufacturers to produce and supply trial medica-
tion for its clinical trials, drug discovery, and development
process, as well as for the commercial supply of JETREA®.
Due to the size of Oxurion’s business, most goods and
services are provided by only one and not several different
suppliers, which creates the risk of loss of key suppliers.
Expanding the supplier network would be time-consuming
35
OXURION ANNUAL REPORT 2021
and expensive as all source suppliers are subject to
rigorous quality control standards. Oxurion’s suppliers are
required to adhere to strict contractual terms that include
regulatory, quality (including adherence to cGMP), as well
as anti-bribery and anti-corruption provisions.
Notwithstanding these contractual requirements, a third
party manufacturer may not comply with the required
quality standards or devote sufficient resources to the
manufacturing of Oxurion’s products or may otherwise fail
in the manufacturing of such compounds, in which event
the development and commercialization of the Clinical
Asset could be delayed (for example because of product
reruns) or even terminated. Were concerns to arise with the
manufacturing of the Clinical Assets, Oxurion’s business
could be substantially harmed.
In summary, Oxurion’s reliance upon CROs and third party
manufacturers, to conduct its clinical trials and to man-
ufacture its Clinical Assets creates risk to the Company
and its shareholders. If these CROs and third party man-
ufacturers do not successfully carry out their contractual
duties or meet expected deadlines, Oxurion may not be
able to obtain regulatory approval for or commercialize
its Clinical Assets and its business could be substantially
harmed, which could have a significant negative impact on
its shareholders.
3.5.7.2 Oxurion is subject to competition for its skilled
personnel, and challenges in identifying and
retaining key personnel could impair Oxurion’s
ability to do business
Oxurion is a small company with approximately 42
employees and managers. Oxurion’s success depends on
the continued contributions of Oxurion’s CEO/CFO and
his direct reports (“Executive Committee”), its scientific
personnel, and on the Company’s ability to develop and
maintain important relationships with leading academic
institutions, scientists and companies in the face of intense
competition for such personnel, institutions and companies.
Oxurion’s ability to compete in the highly competitive bio-
technology and pharmaceuticals market depends on its
ability to attract and retain highly qualified management,
scientific and medical personnel. Many of the other bio-
technology and pharmaceutical companies and academic
institutions that Oxurion competes against for qualified
personnel have greater financial and other resources and
different risk profiles than Oxurion does.
The Company’s CEO/CFO, Executive Committee
members, and its key clinical and scientific personnel may
terminate their employment or services with the Company
at any time with relatively short notice. The departure of
the CEO/CFO or certain Executive Committee members
and clinical and scientific personnel may seriously and
adversely affect Oxurion’s business prospects, its clinical
and research and development efforts, and its ability to
obtain funding.
Although this has not occurred in the past, were Oxurion
to lose key members of its personnel or be unable to
attract and retain key personnel, this lack of resources
would create risks for the business and the Clinical Assets
by preventing the Company from achieving its objectives
due to the lack of qualified resources, which could have a
significant negative impact on its shareholders.
3.5.7.3 Oxurion has obtained grants and subsidies,
which would need to be reimbursed if it
breaches the conditions
The terms of certain of Oxurion’s grant agreements may
significantly hamper Oxurion in its flexibility to choose a
different location for its activities.
At the end of 2021, Oxurion has received several techno-
logical innovation grants in an amount of 2.5 million euro,
to support various research programs from an agency
of the Flemish government that supports technological
innovation in Flanders. If Oxurion fails to comply with its
contractual obligations under the applicable technological
36
OXURION ANNUAL REPORT 2021
innovation grant agreements, Oxurion could be forced to
repay all or part of the grants received, which, for example,
inhibit Oxurion’s ability to relocate its activities without
repaying the grants because certain of the grants require
Oxurion to be located in Flanders. A violation of these grant
agreements creates a risk of repaying 2.5 million euro in
grants, which would result in a loss of this amount to the
Company and its shareholders.
3.5.7.4 Oxurion has significant deductible carry
forward tax losses and potential tax benefits in
Belgium, which could be adversely affected by
changes in Belgian legislation and regulation
At the end of 2021 Oxurion had 330 million euro of de-
ductible carry-forward tax losses in Belgium.
Being active in research and development in Belgium,
Oxurion benefits from a patent income deduction, tax
credit for R&D expenses, tax exemption for regional grants
and subsidies and tax advantages for qualified personnel
as well as the expatriate regime for foreign researchers
and executives. The introduction of a minimum taxable
base and any other future adverse changes of Belgian tax
legislation in relation to the items detailed above may ma-
terially adversely affect Oxurion’s future average corporate
tax rate, results of operations and financial position.
3.5.8 Risks relating to the Shares
3.5.8.1 The market price of the Shares may fluctuate
wildly in response to various factors
Publicly traded securities from time-to-time experience
significant price and volume fluctuations that may be
unrelated to the results of operations or the financial
condition of the companies that have issued them. These
market shifts may be more pronounced in the biotech
market than in the broader market because the biotech
market is considered to be riskier and may react more
strongly to perceptions of market shifts. In addition, the
market price of the existing shares has historically been
volatile, ranging during the last 12 months prior to the
date of this Annual Report from a high of 2.83 euro on
April 6, 2021 and a low of 1.26 euro on March 16, 2022.
The market price of the shares may continue to fluctuate
significantly in response to a number of factors, some of
which are beyond the Company’s control, including fluctu-
ations in the Company’s results of its clinical trials, changes
in estimates by securities analysts and the potential or
actual sales of the shares, which is exacerbated because
the Company has limited news flow and analyst coverage
with approximately five analysts covering the stock.
The Company’s shares also have a relatively limited
trading volume. For example, the average daily trading
volume of the Company’s shares in February 2022 was
53,849 shares. There is no guarantee that the existing
trading market for the shares can be sustained or that it
will be sufficiently liquid. If an active trading market is not
developed or sustained, the liquidity and trading price of
the shares of the Company could be adversely affected.
Any sale of a significant number of the shares on the public
markets, notably by the sale of a large number of shares
by one of the Company’s major shareholders (based
upon their respective shareholdings following the private
placement, as described in section 3.6.1), e.g. (i) Epacria
Capital Partners, LLC (representing the shareholding of
Mr. Thomas Clay) which holds an aggregate of 4,542,110
shares of the Company (i.e. 9.74%), (ii) Bareldam SA
(representing the shareholding of Baron Philippe Vlerick)
which holds 3,544,787 shares in the Company (i.e. 7.60%),
(iii) Fidelity Management & Research Company LLC which
holds 3,128,819 shares in the Company (i.e. 6.71%) or (iv)
Novartis Pharma AG which holds 2,177,226 shares in the
Company (i.e. 4.67%), or the perception that such sales
could or will occur, may adversely affect the market price
of the shares.
37
OXURION ANNUAL REPORT 2021
In addition, stock markets have recently experienced
significant price and volume fluctuations, especially with
respect to biotech stocks, including in the Company’s
view as a result of the ongoing COVID-19 pandemic on
the macroeconomic outlook. These fluctuations have not
always been related to the performance of the specific
companies whose shares are traded. These fluctuations,
as well as general economic and political conditions, could
have an adverse effect on the market price of the shares.
3.5.8.2 Future capital increases by the Company
could have a negative impact on the price of
the shares and could dilute the interests of
existing shareholders
The Company will need to raise additional funds for the
completion of its Clinical Trials and is likely in the future to
increase its share capital against cash or contributions in
kind to finance the further development of its products or
to strengthen its balance sheet. The Company has and may
continue to issue subscription rights that are exercisable
for new shares, or raise capital through public or private
offerings of convertible debt (in the context of the Funding
Program, the convertible loans with Kreos Capital/Pontifax
Ventures (the ‘’Loan Facility’’) or otherwise) or equity secu-
rities, or rights to acquire these securities. In connection with
such transactions, the Company may, subject to certain
conditions, limit or decide to cancel preferential subscrip-
tion rights of existing shareholders that would otherwise
be applicable to capital increases through contributions
in cash. In addition, preferential subscription rights do not
apply to capital increases through contributions in kind.
Such transactions could therefore dilute the shareholders
in the Company’s share capital, potentially at a price below
the stock price, which could have a negative impact on the
price of the shares and the shareholders.
The potential dilutive consequences of the Company’s
existing financing programs (i.e. the Funding Program and
the Loan Facility) on the economic and voting rights of the
shareholders of the Company, have been included in the
reports of the Board of Directors in accordance with article
7:198 juncto articles 7:180, 7:191 and 7:193 of the BCCA
(respectively the “Negma Board Report” and the “Loan
Facility Board Report”). The Negma Board Report and
the Loan Facility Board Report should be read together
with the respective reports prepared by the Statutory
Auditor, which are available on the Company’s website
(respectively the “Negma Statutory Auditor’s Report” and
the “Loan Facility Statutory Auditor’s Report”).
The Negma Board Report, provides for a potential financial
dilution ranging from 6.25% to -6.49% (including subscrip-
tion rights) and from 4.30% to -2.49% (excluding subscrip-
tion rights) and a potential dilution of voting rights ranging
from 13.74% to 7.93% (including subscription rights) and
from 9.47% to 3.04% (excluding subscription rights).
Based on a conversion price of 2.90 euro, the Loan Facility
Board Report, provides for a potential financial dilution
of 4.10% and a potential dilution of voting rights ranging
from 8.15% (excluding subscription rights and conversion
of existing bonds under the Funding Program) to 15.27%
(including subscription rights and conversion of existing
bonds under the Funding Program).
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OXURION ANNUAL REPORT 2021
3.5.8.3 The Company will not be in a position to pay
dividends in the near future and intends to
retain all earnings
The Company is not allowed to declare any dividends as
long as it does not have any distributable reserves in accor-
dance with article 7:212 of the BCCA, and has not declared
or paid dividends on the shares in the past. Any declaration
of dividends will be based upon the Company’s earnings,
financial condition, capital requirements and other factors
considered important by the Board of Directors.
The Company is not required to declare dividends.
Currently, the Board of Directors expects to retain all
earnings, if any, generated by the Company’s operations
for the development and growth of its business and does
not anticipate paying any dividends to the shareholders in
the near future as the Company expects losses to continue
as a result of costs relating to the ongoing Trials and for
future R&D.
The Company therefore will not be in a position to pay
dividends in the near future and intends to retain all
earnings.
3.6 OTHER INFORMATION IN
ACCORDANCE WITH BELGIAN
COMPANY LAW
3.6.1 Events after the end of the
financial year
On February 8, 2022, Oxurion’s share capital was increased
with an amount of 483,219.36 euro following the conver-
sion of 200 convertible bonds issued to Negma. The share
premium for this transaction amounts to 16,780.64 euro.
On February 24, 2022, Russia invaded Ukraine. Combined
with the impact of the pandemic, the result has been sig-
nificant price increases/inflation in Europe and the US.
Although the Company does not have any supply chain
or CRO activities with Ukraine, these general economic
stressors could impact Oxurion generally. Oxurion does
have five principal investigators and clinical sites for the
THR-687 trial in Poland, which already have experienced
significant price increases due to Polish inflation and the
impact on currency. Further, the THR-687 trial has another
14 sites in the Baltic states and Eastern Europe that may
be impacted. It is difficult to predict at this time the extent
to which the conflict will impact these sites. Further, the
impact of the conflict on the economic outlook and
investor appetite could affect the Company’s ability to raise
funds when needed.
Moreover, on March 3, 2022, Oxurion successfully raised
an amount of 10.4 million euro in gross proceeds by
means of a private placement of 7,226,039 new shares at
an issue price of 1.44 euro per share representing a 4.35%
premium to Oxurion’s closing price on March 2, 2022. The
financing was led by new top-tier healthcare institutional
investors and included participation from current major
shareholders. Two-thirds of the proceeds were provided by
new US and European investors, including Belgian-based
NOSHAQ SA and Banque CPH CV. As a result of the
issuance of new shares, Oxurion’s share capital increased
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OXURION ANNUAL REPORT 2021
from 56,925,661.32 euro to 67,331,161.32 euro and its
issued and outstanding shares increased from 39,402,853
to 46,628,892 shares, representing an increase of the
share capital and number of shares of 18.34%.
Finally, on March 23, 2022, Oxurion’s share capital was
increased with an amount of 600,000.00 euro following
the conversion of 240 convertible bonds issued to Negma.
As a result of the issuance of new shares, Oxurion’s share
capital increased from 67,331,161.32 euro to 67,931,161.32
euro and its issued and outstanding shares increased from
46,628,892 shares to 47,128,892 shares.
3.6.2 Major trends influencing evolution of
the Company
The assets potentially subject to impairment on the
balance sheet of Oxurion are the carrying value of the in-
tangible asset composed of the in-licensed THR-687 from
Galapagos under the Galapagos License and the value of
immuno-oncology assets in Oncurious in-licensed from
VIB.
The test made on the in-licensed THR-687 from Galapagos
has concluded that there is no need for impairment. With
respect to the in-licensed immuno-oncology assets from
VIB, as of June 30, 2021, the Company concluded there is
a need for impairment as Oxurion would no longer make
direct investments in these assets and the Company was
unable to secure a transaction with an additional investor
in Oncurious. The assets were therefore fully impaired as
of that date.
Concerning JETREA®, the declining sales of the asset
signalled the need for impairment. On June 30, 2019, the
value of all JETREA® intangibles were written off.
The cash situation at year-end is sufficient to enable
Oxurion to continue clinical development to reach a dosing
selection and confirmation of clinical effect for THR-687
in the second quarter of 2022. The Company is actively
pursuing additional funding to enable completion of the
Phase 2 studies for THR-149 and THR-687.
3.6.3 R&D
Given the activities of Oxurion, R&D costs are very signifi-
cant and represent more than 70% of total operating costs
in 2021 and 2020.
Starting from financial year 2014, the government grants
and income from recharge of costs have been deducted
from the R&D expenses. These costs mainly consist of
costs for clinical trials paid to third parties, personnel costs
and depreciation. In 2013, a first depreciation on the capi-
talized costs related to the development in the context of
Phase 3 of ocriplasmin for the treatment of vitreomacular
adhesion was booked. The JETREA® asset was impaired as
of June 30, 2019, and from that date substantially lowered
the depreciations as shown in section 5.7.3.
3.6.4 Going concern
We refer to section 3.4.
3.6.5 Subsidiary activity –
business combinations
ThromboGenics Inc.
As of December 31, 2021, ThromboGenics Inc. is a fully
owned subsidiary of Oxurion and is incorporated in New
York, US.
40
OXURION ANNUAL REPORT 2021
Oncurious
As of December 31, 2021, Oncurious NV is a partially
owned subsidiary of Oxurion based in Leuven, Belgium
(83.34% of the outstanding shares are held by Oxurion
and 16.66% by VIB).
Oncurious was incorporated on April 3, 2015, as a
public limited liability company (in Dutch: Naamloze
Vennootschap) by Oxurion and ThromboGenics Inc.
Oncurious is an oncology company focusing on the
development of innovative medicines. Upon incorpora-
tion, Oxurion made a contribution in kind of the TB-403
patents, the TB-403 know-how and the rights and obli-
gations under the TB-403 contracts representing 1.375
million euro. ThromboGenics Inc. made a contribution in
cash of 1,000 euro.
On August 6, 2015, VIB made a contribution in kind in
Oncurious of the potential future royalties of TB-403
(oncology) representing 125,000 euro. After this trans-
action, VIB became a minority shareholder in Oncurious
alongside Oxurion, holding 125 shares of a total of 1,501
shares.
On December 12, 2017, Oxurion exercised the right to
convert a 3.0 million euro convertible loan granted by
Oxurion to Oncurious into 3,000 shares in the share
capital of Oncurious.
On December 12, 2017, Oncurious made congruent
agreements with VIB and Oxurion in which VIB made a
contribution in kind of the rights to five immuno-oncolo-
gy targets in exchange for 857 new shares. As a result of
these agreements, Oxurion held 4,376 shares or 81.67%
and VIB held 982 shares or 18.33% of the total number of
5,358 outstanding shares of Oncurious.
On July 23, 2020, by decision of the extraordinary general
shareholders’ meeting (“EGM”) of Oncurious, the share
capital of Oncurious was increased by several contributions
in kind of Oxurion and VIB receivables from Oncurious
and a contribution in cash, followed by a formal capital
decrease to absorb accumulated losses.
On March 31, 2021, Oxurion and VIB entered into a share
purchase agreement pertaining to the acquisition of 680
shares in the share capital of Oncurious following the
exercise of a call-option granted by Oxurion to VIB under
the call option agreement between VIB and Oxurion of
December 12, 2017.
On April 30, 2021, by decision of the EGM of Oncurious,
the share capital of Oncurious was increased by a con-
tribution in kind of a VIB receivable from Oncurious. As
a result thereof, on December 31, 2021, out of a total of
12,011 shares, Oxurion owns 10,093 shares (representing
83.34%) and VIB owns 2018 shares (or 16.66%).
We refer to the information on key arrangements in note
5.8 for more details on terms and accounting treatment.
3.6.6 Financial instruments
We refer to section 5.5.6.
3.6.7 Financial risk management
We refer to section 5.5.7.
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OXURION ANNUAL REPORT 2021
3.6.8 Independence and competence in the
Audit Committee
The Company’s audit committee is validly composed in
compliance with the 2020 Belgian Code on Corporate
Governance (the “Corporate Governance Code”) and the
BCCA. The audit committee is made up of INVESTEA
SRL, represented by Emmanuèle Attout, who chairs the
Audit Committee, Thomas Clay and Philippe Vlerick (the
“Audit Committee”). All three Audit Committee members
qualify as independent directors. Investea SRL represen-
ted by Emmanuèle Attout, as former audit partner at
PriceWaterhouseCoopers, has the necessary credentials
to bring the required accounting and auditing expertise in
this committee.
42
OXURION ANNUAL REPORT 2021
4. CORPORATE GOVERNANCE
43
OXURION ANNUAL REPORT 2021
4.1 GENERAL PROVISIONS
This section summarizes the rules and principles applica-
ble to the corporate governance of Oxurion. It is based on
the articles of association (the “Articles of Association”)
and on the corporate governance charter of the Company
(the “Corporate Governance Charter”) which was drawn
up on October 19, 2006, and which has been updated
since on a regular basis. The last update was approved
by the Board of Directors in December 2019 and is
published on Oxurion’s website (https://www.oxurion.com/
corporate-governance).
The Corporate Governance Charter can be obtained free
of charge via the Company’s registered office.
The Corporate Governance Charter of Oxurion contains
the following specific appendices:
• Board of Directors
• Management Structure
• Dealing Code – Rules for the prevention of insider
trading and market abuse
• Audit Committee
• Nomination and Remuneration Committee (as defined
hereinafter)
4.2 COMPLIANCE WITH THE
CORPORATE GOVERNANCE CODE
The Company notes that under principle 7.6 of the
Corporate Governance Code, Non-Executive Directors
should receive part of their remuneration in the form of
shares in the Company. The Company does not comply
with this provision of the Corporate Governance Code
because the Company has no distributable reserves and
therefore it cannot acquire its own shares to be granted to
its Non-Executive Directors.
The Company further notes that under principle 7.6 of
the Corporate Governance Code, Non-Executive Directors
should not receive subscription rights in the Company as
part of their remuneration. The Company does not comply
with this provision of the Corporate Governance Code
because the Company has no distributable reserves and
therefore it cannot acquire its own shares to be granted
to its Non-Executive Directors. Consequently, the Company
has decided to grant Non-Executive Directors a limited
number of subscription rights to allow them to acquire
shares of the Company following the exercise of their re-
spective subscription rights, as approved by the AGM of
Oxurion of May 7, 2019.
Principle 7.9 of the Corporate Governance Code requires
the Board of Directors to set a minimum threshold of
shares to be held by the Executives (as defined below). The
Company deviates from this provision of the Corporate
Governance Code because the Company has no distrib-
utable reserves and therefore it cannot acquire its own
shares to be granted to its Executives (as defined below).
44
OXURION ANNUAL REPORT 2021
Principle 7.11 of the Corporate Governance Code provides
that subscription rights should not vest and be exercisa-
ble within less than three years. The Company deviates
from this standard because it considers it to be necessary
to attract high quality biotech executives, where vesting
of less than three years is not exceptional and Oxurion
considers to be necessary to be competitive.
The Company does not consider that it is necessary to
apply claw back provisions and therefore deviates from
principle 7.12 of the Corporate Governance Code. The
only variable compensation the Company pays are
bonuses based on the achievement of corporate targets,
which are paid only upon achievement of the objective.
Subject to one deviation described and justified in Section
4.9.2.1 (D), the Company does not apply any other perfor-
mance-based remuneration or variable compensation as
the subscription rights granted to Executives vest over time
and are not performance related.
4.3 DESCRIPTION OF THE PRINCIPAL
CHARACTERISTICS OF THE
COMPANY’S INTERNAL CONTROLS
AND RISK ANALYSIS
The Corporate Governance Charter describes how the
Company addresses internal controls and risk analysis.
The following paragraphs summarize the most relevant
characteristics of the Company’s internal controls and
risk analysis which make part of the roles of the statutory
bodies as described in the Corporate Governance Charter.
Internal control systems play a central role in directing the
activities and in risk management. They allow for a better
management and control of the possible risks (strategic
risks, financial risks, compliance with rules and legislations),
in order to achieve the corporate goals. The internal control
system is based on five pillars:
• Control environment
• Risk analysis
• Control activities
• Information and communication
• Supervision and modification
4.3.1 Control environment
Oxurion’s control environment includes both formal and
informal rules on which the functioning of the Company
relies.
Oxurion has defined Drive and Initiative, Team Play,
Flexibility and Quality of Work as being the values driving
Oxurion’s team with the aim to create an open corporate
culture, in which communication and respect for patients,
suppliers and staff play a central role. Oxurion’s employees
45
OXURION ANNUAL REPORT 2021
are required to manage the Company’s means with due
diligence and to act with the necessary common sense.
The informal rules are complemented by formal rules
where necessary.
Oxurion’s intent is to attract, motivate and retain qualified
employees, in a cooperative work environment and with
possibilities for personal development. Their expertise
and experience will contribute to the Company’s effective
management.
The control environment is further created and supported
by the Board of Directors, the committees within the Board
of Directors, being the Audit Committee and the nomina-
tion and remuneration committee, consisting of Thomas
Clay (chairman), Dr. Adrienne Graves and Dr. David Guyer
(the “Nomination and Remuneration Committee”), the
CEO, the Executive Committee and the staff.
Board of Directors
The Board of Directors consists of a majority of Non-
Executive, Independent Directors. The Board of Directors
undertakes the following functions in creating the control
environment:
• The Board of Directors pursues sustainable value
creation by the Company, by setting the Company’s
strategy, putting in place effective, responsible and
ethical leadership and monitoring the Company’s
performance.
• The Board of Directors supports the CEO in the fulfil-
ment of his duties and constructively challenges the
CEO whenever appropriate.
• The Board of Directors decides on and regularly reviews
the Company’s medium and long-term strategy based
on the proposals from the CEO.
• The Board of Directors approves the operational plans
and main policies developed by the CEO to give effect
to the approved Company strategy.
• The Board of Directors determines the risk appetite
of the Company in order to achieve the Company’s
strategic objectives.
To achieve its duties, the Board of Directors relies on its
committees, as well as the CEO as follows:
Committees within the Board of Directors
• The Audit Committee evaluates the strength of the
controls in place at regular intervals and assists the
Board of Directors in fulfilling its monitoring respon-
sibilities in respect of the financial reporting process,
the effectiveness of the internal control and risk mana-
gement systems, the internal audit and the Statutory
Auditor’s work and independence.
• The Audit Committee also monitors the integrity of the
financial information provided by the Company. The
Audit Committee ensures that the financial reporting
provides a true, honest and clear picture of the situation
and the prospects of the Company. For this monitor-
ing, the Audit Committee in particular reviews the
relevance and consistency of the accounting standards
and the accuracy, completeness and consistency of the
financial information.
• The Nomination and Remuneration Committee
controls the quality and compensation for the Board of
Directors, the CEO and the Executive Committee, and
evaluates the remuneration policy on a going forward
basis. Under the BCCA, any material changes to the
Remuneration Policy must be approved by the general
shareholders’ meeting of the Company.
CEO and Executive Committee
• The day-to-day management is the responsibility of the
CEO who is supported by the Executive Committee,
which is made up of the CEO and his direct reports.
The CEO controls the operations and activities of the
Executive Committee and all other personnel.
46
OXURION ANNUAL REPORT 2021
• For the sake of effective management, authority is
partially delegated from the CEO to the various de-
partments within Oxurion. The delegation of authori-
ties is not linked to a person, but rather to the position.
The CEO is responsible at a Group level and is finally
responsible for activities that have been delegated.All
individuals concerned are informed of the extent of
their authority (approval requirements and limitations
of authority).
• In managing internal controls and risks, the CEO is
entrusted with proposing, developing, implementing
and monitoring the Company strategy, taking into
account Oxurion’s values, its risk profile and key policies.
4.3.2 Risk analysis
As set forth above, the Board of Directors decides on the
Group’s strategy, risk profile and its policies. The Board of
Directors is tasked with ensuring the Company’s long-term
success by employing appropriate risk assessment and
management.
The CEO is responsible for the development of systems that
identify, evaluate and monitor risks. The CEO undertakes
a risk analysis in all departments of the Group and takes
relevant risks into account in developing the Group’s strategy.
Implementation includes a set of means, codes of conduct,
procedures and measures that fits with the Group’s structure,
which are intended to maintain risks at an acceptable level.
The control environment is supported by Oxurion’s code of
business conduct (the “Code of Business Conduct”) covering
a wide range of business practices and procedures. It does
not cover every issue that may arise, but rather establishes
basic principles to guide the motives and actions of Oxurion’s
directors, officers and employees. All directors, officers and
employees must conduct themselves in accordance with
those principles and seek to avoid even the appearance of
improper behaviour. The Code of Business Conduct should
also be provided to, and followed by, Oxurion’s agents and
representatives, including consultants.
The Code of Business Conduct seeks to deter wrongdoing
and to promote:
• Honest and ethical conduct, including the ethical handling
of actual or apparent conflicts of interest in personal and
professional relationships
• Full, fair, accurate, timely and understandable disclosure
in reports and documents that Oxurion submits to the
Financial Services and Markets Authority (the “FSMA”)
and in other public communications made by Oxurion
• Compliance with all applicable governmental laws, rules,
regulations and industry codes
• Accountability for adherence to the Code of Business
Conduct
• Prompt internal reporting of violations of the Code of
Business Conduct
Oxurion divides its objectives into four categories:
• Strategic
• Operational
• Reliability of the internal and external information
• Compliance with rules and legislations and internal
instructions
Risk identification consists of examining the factors that could
influence the objectives put forward in each category. Internal
or external factors may influence the realization of these
objectives:
• Internal factors: are closely related to the internal organiza-
tion and could have several causes (for example, change
in the Company or Group structure, staff, ERP system).
• External factors: can be the result of changes in the
economic climate, regulations or competition affecting
the Company or the Group and the sector.
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OXURION ANNUAL REPORT 2021
The risks identified by the Company are detailed under
section 3.5.
4.3.3 Control activities
In order to properly manage the identified risks, Oxurion takes
the following control measures:
• Installation of access and security systems at the
premises and offices
• Establishment of internal operational and control
procedures
• Modifications and updates of the existing proce-
dures; use of a reporting tool that permits financial
data reporting on a regular basis (quarter, year). The
reporting tool also permits development of KPIs and
regular assessments thereof
The risk mitigation comprises numerous day-to-day activ-
ities such as:
• Regular updates of the Company’s risk management
plans
• Management by operational supervisors
• Data exchange with third parties for confirmation
purposes (e.g. suppliers/customers)
• Segregation of duties
• Control by external auditors
4.3.4 Information and communication
The Board of Directors takes all necessary measures to
ensure the integrity and timely disclosure of the Company’s
financial statements and other material financial and non-fi-
nancial information in accordance with applicable law.
In order to be able to present reliable financial information,
Oxurion makes use of a standardized reporting of accounts
and a global application of IFRS recognition criteria and
applies a uniform administration and implementation of the
same ERP system in all subsidiaries.
Oxurion has a robust information management system.
Depending on the type of data at issue, controls are in place to
ensure that the information is limited to authorized persons. A
back-up policy is available, and all data is backed up centrally
on a weekly basis and locally on a daily basis.
4.3.5 Supervision and modification
Supervision of the Company’s activities is carried out by the
Board of Directors, the Audit Committee and the Company’s
CEO.
Role of the Board of Directors
• The Board of Directors approves a framework of internal
control and risk management, proposed by the CEO. It
reviews the implementation of the framework, consider-
ing the evaluation made by the Audit Committee. The
Board of Directors is also responsible for describing the
main features of the internal control and risk manage-
ment systems of the Company and disclosing them in the
corporate governance statement in the Annual Report.
• The Board of Directors ensures that there is a process
in place for monitoring the Company’s compliance with
laws and other regulations, as well as for the application of
internal guidelines relating thereto.
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OXURION ANNUAL REPORT 2021
Role of the Audit Committee
• The Audit Committee informs the Board of Directors
of the outcome of the statutory audit and explains how
the statutory audit contributed to the integrity of financial
reporting and the role that the Audit Committee played
in that process.
• At least once a year, the Audit Committee reviews the
internal control and risk management systems esta-
blished by the CEO. It ensures that the main risks are
properly identified, managed and disclosed in accordance
with the framework approved by the Board of Directors.
The risks identified by the Company are detailed under
section 3.5.
• The role of the Audit Committee also includes review
and approval of the statements on internal control and
risk management included in the corporate governance
statement in the Annual Report, as well as review of the
specific arrangements in place which the staff of the
Company may use, in confidence, to raise concerns about
possible improprieties.
• The Audit Committee monitors the external auditor’s work
program and reviews the effectiveness of the external
audit process and the responsiveness of the management
to the recommendations made by the external auditor in
his or her management letter. The external auditor must
report to the Audit Committee on the key matters arising
from the statutory audit of the financial statements, and
in particular on material weaknesses in internal control in
relation to the financial reporting process.
• The Audit Committee annually reviews the need for an
internal audit function and advises the Board of Directors
on the Audit Committee’s annual assessment whether an
internal audit function is required.
Role of the CEO
The CEO is responsible for:
• Supervising compliance with the legislation and regula-
tions that apply to the Company;
• Establishing internal controls (i.e. systems to identify,
assess, manage and monitor financial and other risks)
without prejudice to the Board of Directors’ monitoring
role, based on the framework approved by the Board of
Directors;
• Presenting a complete, timely, reliable and accurate prepa-
ration of the Company’s financial statements to the Board
of Directors, in accordance with the applicable accounting
standards and policies of the Company; and
• Presenting a balanced and understandable assessment
of the Company’s financial situation to the Board of
Directors.
Oxurion believes that periodic evaluations are necessary
to assess the effectiveness of the internal control function
and the implemented procedures. Oxurion thus far has not
assigned an internal audit role as the size of the business does
not justify a permanent internal audit position. As required, the
Audit Committee outsources internal audit activities to cover
selected and/or recurring topics.
External Audit
External auditing within Oxurion is performed by the Statutory
Auditor. This includes the auditing of the statutory financial
statements and the consolidated financial statements of
Oxurion and its subsidiaries.
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OXURION ANNUAL REPORT 2021
4.4 FEES TO THE STATUTORY AUDITOR
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Remuneration audit mandate 90 90
Other legal assignments of the Statutory Auditor 48 18
Other services provided by the BDO network 3 21
In 2021, fees totalling 90,225 euro were paid for the audit
mandates of Oxurion and Oncurious.
The 2021 fees involved other services provided by the
Statutory Auditor’s network related to tax services provided
in the UK and closing of the Irish Branch in Ireland and
were pre-approved by the Audit Committee.
4.5 NOTIFICATION OF
IMPORTANT PARTICIPATIONS
4.5.1 Share capital and shares
On December 31, 2021, the share capital of Oxurion was
56,442,441.96 euro, represented by 39,067,284 shares,
all with the same fractional value. Section 5.4 provides an
overview of the evolution of the Company’s share capital
over time. Section 5.7.7 also specifies the Board of Directors’
powers with respect to authorized share capital.
During financial year 2021, Oxurion’s share capital has been
increased on several occasions following the conversion of
(in aggregate) 540 convertible bonds issued to Negma:
• On September 29, 2021, the Company’s share capital
was increased by 219,512.16 euro following the conver-
sion of 100 convertible bonds issued to Negma;
• On October 7, 2021, the Company’s share capital was
increased by 225,000 euro following the conversion of
100 convertible bonds issued to Negma;
• On November 10, 2021, the Company’s share capital
was increased by 378,946.08 euro following the con-
version of 200 convertible bonds issued to Negma;
and
• On December 23, 2021, the Company’s share capital
was increased by 293,022.72 euro following the con-
version of 140 convertible bonds issued to Negma.
In accordance with Article 7:215 of the BCCA, the Board
of Directors is authorized to proceed on one or more
occasions with the acquisition, by purchase or exchange, of
its own shares for a price to be determined by the Board
of Directors at the time of acquisition. This authorization
also applies to the acquisition of the Company’s shares
by one of its directly controlled subsidiaries pursuant to
Article 7:221 of the BCCA. This authorization is granted for
a period of five years starting from June 13, 2019.
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OXURION ANNUAL REPORT 2021
4.5.2 Subscription rights plans
As of December 31, 2021, Oxurion has the following sub-
scription rights plans in place:
• Four subscription rights plans for personnel,
including employees and consultants, being the 2017
Subscription Rights Plan (formerly referred to as the
2017 warrants plan) and the three 2021 Subscription
Rights Plans (consisting of the 2021-1, 2021-2 and
2021-3 Subscription Rights Plans); and
• One subscription rights plan for Non-Executive
Directors.
Paragraph 5.7.8 gives more detailed information on the
subscription rights plans and the outstanding number of
subscription rights as of December 31, 2021.
4.5.3 Shareholders
On December 31, 2021, based on all transparency declara-
tions and information received by the Company, Oxurion is
aware of the following participations:
SHARES
% OF TOTAL NUMBER OF
SHARES
Mr. Thomas M. Clay and entities control-
led by him
3,361,555 8.60%
Baron Philippe Vlerick and entities
controlled by him
2,364,232 6.05%
Novartis Pharma AG 2,177,226 5.57%
4.5.4 Notification of important participations
Belgian law, in conjunction with the Articles of Association,
imposes disclosure requirements on any individual or entity
acquiring or transferring voting securities or securities which
give a right to voting securities, as soon as the total number
of voting rights directly or indirectly held by such individu-
al or entity, alone or jointly with others, increases above, or
falls below, a threshold of three percent, five percent, or
any multiple of five percent, of the total number of voting
rights attached to the Company’s securities. A sharehold-
er whose shareholding increases above or falls below any
such threshold must disclose this fact to the FSMA and to
the Company each time it occurs and submit the related
documentation to the FSMA. The Company is required to
publicly disclose any transparency notifications it receives on
the next business day and must mention these notifications
in the notes to its financial statements. Euronext Brussels
also publishes details of the notifications.
4.5.5 Financial service – paying agent services
KBC Bank NV provides financial services related to the shares
in Belgium free of charge for the shareholders.
If shareholders prefer to use other intermediaries, they must
themselves solicit information with regards to costs relating to
the financial services.
51
OXURION ANNUAL REPORT 2021
4.6 COMPOSITION AND FUNCTIONING
OF THE COMPANY’S MANAGEMENT
4.6.1 Composition of the Board of Directors
The Company is led by a collegiate Board of Directors,
which is the Company’s most senior administrative body.
The Company establishes the Board of Directors’ internal
rules and regulations and publishes them in its Corporate
Governance Charter. The Board of Directors is charged with
achieving the Company’s long-term success by guarantee-
ing entrepreneurial leadership and ensuring that risks are
assessed and managed in an appropriate way. The Board
of Directors’ responsibilities are stipulated in the Articles of
Association and in the Board of Directors’ internal rules and
regulations. The Board of Directors is organized in view of an
effective execution of its tasks.
The Board of Directors decides upon the Company’s strategic
direction, policies geared towards achieving its objectives, and
its risk profile.
The Board of Directors ensures that the necessary leadership
and financial and human resources are available so that the
Company is able to realize its goals. Also, when determining
the values and strategies contained in the Company’s overall
business plan, the Board of Directors considers corporate
social responsibility, gender diversity and diversity in general.
MeRoNo BV (represented by Dr. Patrik De Haes, M.D.) was
appointed Chairman of the Board of Directors on May 15,
2021, replacing Thomas Clay who remains on the Board of
Directors as Non-Executive, Independent Director.
As of December 31, 2021, the Board of Directors consists of
seven members:
• MeRoNo BV, represented by Dr. Patrik De Haes, M.D., Non-
Executive Director, Chairman
• Thomas Clay, Non-Executive, Independent Director
• Dr. David Guyer, M.D., Non-Executive, Independent Director
• INVESTEA SRL, represented by Emmanuèle Attout, Non-
Executive, Independent Director
• Baron Philippe Vlerick, Non-Executive, Independent
Director
• Dr. Adrienne Graves, Non-Executive, Independent Director
• Tom Graney, CFA, Executive Director, Chief Executive
Officer
The Board of Directors includes two female members and
five male members.
The following paragraphs contain a brief biography of each
director in function during the year 2021.
Dr. Patrik De Haes, M.D., (MeRoNo BV (formerly ViBio BV)),
Non-Executive Director, Chairman
Dr. Patrik De Haes, M.D., has over 25 years of experience in
the global healthcare industry, covering product development,
marketing and general management. Patrik joined Oxurion
in 2008 and before taking up the role of Chairman of the
Board of Directors, he was Oxurion’s CEO for 14 years. Prior
to Oxurion, Patrik was head of Roche’s Global Insulin Infusion
business, as well as President and CEO of Disetronic Medical
Systems Inc., a medical device company based in Minneapolis,
US. He also led the global development and commerciali-
zation of the first biotech product at Sandoz Pharma (now
Novartis) in Switzerland. As past Chairman of FlandersBio,
Patrik is an active member of the local and regional biotech
and life sciences community in Belgium. Patrik holds a degree
in Medicine from the University of Leuven.
Thomas Clay, Non-Executive, Non-Executive, Independent
Director
Thomas Clay is the Managing Member of Epacria Capital
Partners, LLC, a single-family office managing public and
private investments for members of the Clay family. He
also serves as a Director of several private companies and
of the Clay Mathematics Institute, Inc. Thomas is a graduate
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OXURION ANNUAL REPORT 2021
of Harvard College, Oxford University and Harvard Business
School. Thomas replaced his father, Landon Clay, who led the
first external investment into Oxurion and resigned from the
Board of Directors in 2011.
Dr. David Guyer, M.D., Non-Executive, Independent Director
Dr. David Guyer, M.D., is a long-standing member of the US
retina community and is currently the Co-founder, President,
and CEO of EyeBio. David is also a Venture Partner at SV
Health Investors and is Co-Founder and former CEO and
Executive Chairman of IVERIC bio (formerly Ophthotech
Corporation). He was previously the CEO of Ophthotech. Dr.
Guyer is also on the board of directors of iStar Medical and
Eye-Point Pharmaceuticals. He co-founded and served as
CEO and a Director of Eyetech Pharmaceuticals, Inc., where
he led the company through private, public and corporate fi-
nancings, and oversaw the rapid development and successful
commercialization of Macugen® (pegaptanib sodium), the
first FDA-approved anti-VEGF pharmacological treatment for
the treatment of wet AMD. Dr. Guyer has also had a success-
ful career in academic medicine as Professor and Chairman
of the Department of Ophthalmology at New York University
School of Medicine. Dr. Guyer received his Bachelor of
Science (BSc) degree from Yale College summa cum laude
and his medical degree (MD) from Johns Hopkins Medical
School. He completed his ophthalmology residency at Wilmer
Ophthalmological Institute at Johns Hopkins Hospital and a
retinal fellowship at the Massachusetts Eye and Ear Infirmary
at Harvard Medical School.
Emmanuèle Attout (INVESTEA SRL), Non-Executive,
Independent Director
Emmanuèle Attout was an audit partner at
PriceWaterhouseCoopers from 1994 to 2014, in charge of
audits of a range of clients in various sectors, including listed
companies and pharmaceutical and life sciences companies,
from which she brings substantial relevant experience to the
Board of Directors and to the Audit Committee. Emmanuèle
is an independent Non-Executive Director, chair of the Audit
Committee, of Atenor SA, AG Insurance SA/NV and Schréder
SA. She is a supervisory board member of Eurocommercial
Properties NV. Since 2009, Emmanuèle is co-founder
and director of the NGO Women on Board. Emmanuèle
graduated in Applied Economic Sciences at the UC Louvain.
Baron Philippe Vlerick, Non-Executive, Independent
Director
Philippe Vlerick is the owner, Chairman and CEO of several
businesses in Belgium and abroad. He currently serves as
the Chairman and Chief Executive Officer of Vlerick Group
(Belgium), and as Chairman and CEO of UCO NV, Chairman
of Pentahold, Chairman of Smartphoto Group and Chairman
of the Festival Van Vlaanderen. Baron Vlerick is also Vice-
chairman of KBC Group and is a member of the board of
directors of Exmar, Besix Group, Mediahuis, BMT and L.V.D.
(Belgium). Mr Vlerick holds a Degree in Philosophy and
Law from the University of Leuven, and an MBA General
Management degree (PUB) (Ghent, Vlerick School of
Management – 1979). He also holds a master’s degree in
Business Administration from Indiana University, Bloomington
(US – 1980). In 2006, he was voted Manager of the Year
by Trends, a leading business magazine in Belgium. He was
granted the title of Baron in 2008 and became Commander
of the Order of Leopold in 2013.
Dr. Adrienne Graves, Non-Executive, Independent
Director
Dr. Graves is a board member of multiple companies and
organizations including IVERIC bio, Nicox, the American
Society of Cataract and Refractive Surgery, the Glaucoma
Research Foundation, and the Foundation Fighting Blindness.
She was the president and chief executive officer of Santen,
Inc., the US arm of Japan’s largest ophthalmic pharma-
ceutical company, Santen Pharmaceutical Co., Ltd. Before
becoming the president and chief executive officer, she was
the vice president of clinical affairs and senior vice president
of worldwide clinical affairs for Japan, US and Europe at
Santen, Inc. Prior to Santen, Inc., Dr. Graves was the director
53
OXURION ANNUAL REPORT 2021
of international ophthalmology at Alcon Laboratories, Inc.
She was also the co-founder of Glaucoma 360 (Glaucoma
Research Foundation) and Ophthalmic Women Leaders
(OWL). Dr. Graves received her bachelor’s degree in psy-
chology with honors from Brown University, her Ph.D. from
the University of Michigan in psychobiology and completed
a postdoctoral fellowship in visual neuroscience from the
University of Paris.
Tom Graney, CFA, Executive Director, Chief Executive
Officer
Tom Graney has extensive global finance and operational
experience that spans corporate development, commer-
cial strategy, portfolio management and supply chain
management, communication and investor relations. He
is the former Chief Financial Officer of Generation Bio,
was Senior Vice President and Chief Financial Officer at
Vertex Pharmaceuticals Inc. and Chief Financial Officer
and Senior Vice President of Finance & Corporate
Strategy at Ironwood Pharmaceuticals. Prior to Ironwood
Pharmaceuticals, Tom spent 20 years working with
Johnson and Johnson and its affiliates, including four years
as worldwide vice president of finance and Chief Financial
Officer of Ethicon. Tom is a Charted Financial Analyst and
holds a B.S. in accounting from the University of Delaware
and an M.B.A. in Marketing, Finance and International
Business from the Leonard N. Stern School of Business at
New York University. Tom is an independent director and
member of the audit and compensation committees of
AC Immune (Nasdaq: ASIU) and independent director and
chair of the audit committee of Mogrify, a private biotech-
nology company.
4.6.2 Evaluation of Board of Directors’
activity and members
The Board of Directors does not use a formalized process
for the assessment of its operation, the functioning of the
Committees or the involvement of each director in Board of
Directors’ activities. Rather, the Chairman, in consultation with
individual directors and with support from the Nomination
and Remuneration Committee, regularly conducts an evalu-
ation of all components of the Board of Directors. A global
evaluation is further informally debated in the various Board
of Directors’ meetings and Committee meetings to ensure
that all components of the Board of Directors and interac-
tions with the CEO are functioning well. In particular, when
proposing election or re-election of directors, the Board of
Directors ensures through its discussions that its composition
delivers the appropriate skills and diversity to the Company.
4.6.3 Board of Directors’ meetings in 2021
The Board of Directors met fourteen times in 2021. With
regard to its supervisory responsibilities, the following topics
were discussed and assessed:
• The Board of Directors decides on the Company’s strategy,
its risk profile, its values and major policies. The Board of
Directors was actively engaged with the preclinical and
clinical progress of the Company’s program candidates
and considered possible partnership opportunities,
matters of a strategic nature, new and current invest-
ments, analysis, discussion and evaluation of acquisition
opportunities.
• The Board of Directors ensures that the necessary lead-
ership and the necessary financial and human resources
are available so that the Company is able to realize its
goals.
• The Board of Directors decides on the conduct and design
of Phase 2B of its THR-149 program.
54
OXURION ANNUAL REPORT 2021
• The Board of Directors ensures that the necessary financial
resources are in place so as to allow the Company to meet
its objectives , i.e. by entering into a Capital Commitment
of up to 30 million euro with Negma, and by securing a
10 million euro Convertible Bond Financing from Kreos
Capital and Pontifax Ventures.
• Upon determining the values and strategies in the overall
policy plan, the Board of Directors considers corporate
social responsibility, gender diversity and diversity in
general.
• The Board of Directors is responsible for the quality and
comprehensiveness of the financial information published
and application of the IFRS and FSMA requirements. The
Board of Directors considered the Company financial
data such as the summary half year financials, year-end
financials, budget and consolidated results. At the same
time, the Board of Directors is responsible for the integrity
and timely publication of the annual results and other
important financial and non-financial information that is
communicated to shareholders and potential sharehold-
ers, the General Meeting, and the Annual Report. This
included on-going discussion of the budget and going
concern considerations.
• The Board of Directors supervises the Company’s obliga-
tions towards its shareholders and considers the interests
at stake of those involved in the Company. The Board of
Directors was actively involved in discussions with future
funding opportunities.
• The Board of Directors stimulates an effective dialogue
with the shareholders and potential shareholders, on the
basis of mutual understanding of goals and expectations.
• Following the recommendations of the Nomination
and Remuneration Committee, the Board of Directors
approves the contracts that appoint the CEO and the
Executive Committee, if any. The contracts, if any, refer to
the criteria adopted when determining short-term incen-
tives through variable remuneration and long-term incen-
tives through subscription rights. To ensure alliance with
the corporate objectives, the Board of Directors decided to
emphasize the corporate objectives in compensating the
CEO and Executive Committee. The contracts, if any, also
include specific provisions addressing termination.
• The Board of Directors decides the CEO, and stipulates
their powers and obligations, and supervises and evaluates
the CEO’s performance. The Board of Directors decides if
there was over, full or partial achievement of the corporate
objectives and the resulting bonuses, subscription rights
and retention plans.
• The Board of Directors is responsible for the corporate
governance structure of the Company and compliance
with the corporate governance stipulations. The Board
of Directors has decided to adopt a one-tier gover-
nance structure and to have an Audit Committee and a
combined Nomination and Remuneration Committee.
The Board of Directors can only validly deliberate if at least
half of its members are present or represented. Should a
quorum not be achieved, a new Board of Directors’ meeting
shall be convened with the same agenda, which meeting
may deliberate and validly pass resolutions if at least two
directors are present or represented. Resolutions made by
the Board of Directors shall be passed by a majority of the
votes. The Board of Directors is only allowed to deliberate
on items not specified on the agenda with the agreement
of all members.
In accordance with principles 3.19 and following the
Corporate Governance Code, the Board of Directors
appointed Midico BV (represented by Michaël Dillen) as
Company Secretary in March 2020.
55
OXURION ANNUAL REPORT 2021
Below is the attendance grid at the 2021 Board of Directors’
meetings:
BOARD OF DIRECTORS
VIBIO BV / MERONO
BV, CHAIRMAN
(PATRIK DE HAES)
THOMAS CLAY DR. DAVID GUYER
INVESTEA SRL
(EMMANUÈLE
ATTOUT)
BARON PHILIPPE
VLERICK
DR. ADRIENNE
GRAVES
TOM GRANEY
17 March 2021 present present present present present present N/A
1 April 2021 present present present present present present N/A
5 May 2021 present present present present present present N/A
17 June 2021 present present present present present present N/A
9 September 2021 present present present present present present present
17 September 2021 present present present present present present present
22 September 2021 present present present present present present present
29 September 2021 present present present present present present present
9 November 2021 present present present present present present present
7 December 2021 present present present present present present present
12 December 2021 present present present present present excused present
20 December 2021 present present present present present present present
23 December 2021 present present excused present excused present present
30 December 2021 present present present present present present present
Committees within the Board of Directors
The Board of Directors has established an Audit Committee
and a combined Nomination and Remuneration
Committee. The Board of Directors appoints the members
and the chairman of each committee. Each committee
consists of at least three members. The composition of
the Committees for 2021 was as follows:
Audit Committee: INVESTEA SRL (represented by
Emmanuèle Attout), chairman; Thomas Clay; Philippe
Vlerick.
The Audit Committee held five meetings during 2021.
Nomination and Remuneration Committee: Thomas Clay,
chairman; Dr. Adrienne Graves; Dr. David Guyer.
The Nomination and Remuneration Committee held four
meetings during 2021.
The powers of these Committees are described in the
Company’s Corporate Governance Charter (Appendix
4 and 5), which is available on Oxurion’s website
(www.oxurion.com).
Below is the attendance grid at the 2021 Committee
meetings:
AUDIT COMMITTEE INVESTEA SRL, CHAIRMAN THOMAS CLAY PHILIPPE VLERICK
23 February 2021 present present present
15 March 2021 present present present
15 June 2021 present present present
1 September 2021 present present present
6 December 2021 present present present
NOMINATION AND REMUNERATION COMMITEE THOMAS CLAY, CHAIRMAN ADRIENNE GRAVES DR. DAVID GUYER
17 March 2021 present present present
17 June 2021 present present present
2 September 2021 present present present
7 December 2021 present present present
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OXURION ANNUAL REPORT 2021
4.6.4 CEO
The CEO is appointed by the Board of Directors in ac-
cordance with Oxurion’s Corporate Governance Charter.
The CEO has the power to propose and implement the
corporate strategy, by taking into account the Company’s
values, its risk tolerance and key policies. The CEO is,
among other things, entrusted with the day-to-day man-
agement of the Company.
The powers of the CEO are defined by the Board of
Directors in close consultation with the CEO. The CEO su-
pervises the Company’s on-going activities.
In 2021, the role of CEO was carried out by:
• Until May 15, 2021, ViBio BV, represented by Dr. Patrik
De Haes, M.D.
• Starting on May 15, 2021, Tom Graney
The details of the CEO’s remuneration is laid out in the
Remuneration Report.
This section provides a brief biography of the CEO in place
on December 31, 2021.
Tom Graney – Chief Executive Officer
We refer to section 4.6.1.
4.6.5 Executive Committee
In addition to the CEO, several managers are members
of the Executive Committee. The Executive Committee
is not mentioned in the Corporate Governance Charter.
The members of the Executive Committee includes the
CEO and provides support and assistance to the CEO
(members of the Executive Committee are referred to
herein as “Executives”). The Executive Committee has no
statutory delegated powers to represent the Company or
to propose or implement corporate strategy.
Executive Committee meetings are attended by the
following executives (December 31, 2021):
• Julie Binon – Chief People Officer
• Andy De Deene – Chief Development Officer
• Tom Graney – Chief Executive Officer and Chief
Financial Officer
• Hanne Callewaert – Chief Operating Officer
• Midico BV represented by Michaël Dillen – Chief
Business Officer and Company Secretary
• Paisley BV represented by Kathleen Paisley – Chief
Legal Officer and Compliance Officer
• Alan Stitt – Chief Scientific Officer
57
OXURION ANNUAL REPORT 2021
4.7 POLICY REGARDING
TRANSACTIONS AND OTHER
CONTRACTUAL RELATIONSHIPS
BETWEEN THE COMPANY,
INCLUDING AFFILIATED COMPANIES,
ITS DIRECTORS AND THE CEO
4.7.1 Conflicts of Interest of Directors and
the CEO
Article 7:96 of the BCCA contains special provisions which
must be complied with whenever a director has a direct
or indirect conflict of interest of a patrimonial nature in a
decision or transaction within the authority of the Board of
Directors.
According to Appendix 1 and 2 of the Corporate
Governance Charter of the Company regarding transac-
tions or other contractual relations between the Company
including affiliated companies, and its directors and the
CEO, such transactions need to be submitted to the Board
of Directors.
In 2021, three conflicts of interest occurred:
(A) Board of Directors of April 14, 2021
Conflict of interest with respect to the Subscription Rights
Plan 2021-1:
“Before proceeding with the resolutions, the Director Sub
1, being the CEO who is the sole executive Director of the
Company, represented as said, (i) that he or his permanent
representative in the decisions to be taken on the points
on the agenda have an interest of a patrimonial nature
within the meaning of Article 7:96, §1 BCCA due to the fact
that they are co-beneficiaries of the issuance of the 2021
Subscription Rights Plan for Personnel proposed in the
agenda and (ii) that it and its permanent representative are
thus beneficiary(ies) of the cancellation of the pre-emptive
right as referred to in Article 7:200, 2° BCCA. The Director
Sub 1 will therefore not participate in the deliberations or
in the voting on the items on the agenda of this meeting.
The Non-Executive Directors Sub 2 to Sub 6, present or
represented as mentioned above, confirm that they can
participate without any hindrance in the decision-making
on the items on the agenda of this meeting of the Board
of Directors.
In application of Article 7:96 §1, second paragraph, BCCA,
the Board of Directors requests the instrumental civil-law
notary to act as follows:
• the nature of the envisaged decision/transaction is: in
concrete terms it concerns the issuance of fixed sub-
scription rights for personnel, including the CEO of the
Company;
• the pecuniary consequences for the Company are: a
total of one million eighty-five thousand (1,085,000)
new subscription rights will be issued free of charge,
each giving the right to one share of the Company
at an exercise price per share equal to the lower of
(i) the volume weighted average price (“VWAP”) of
the Company’s shares on the stock exchange during
the thirty (30) calendar days preceding the date of
the offering or (ii) the closing price of the Company’s
shares on the last trading day prior to the date of the
offering as set out in further detail and regulated in the
2021 Subscription Rights Plan for Personnel, and of
which subscription rights a number may be allocated
to the CEO (namely ViBio BV, the Director Sub 1); upon
grant, acceptance and exercise of all Subscription
Rights, a maximum of one million eighty-five thousand
(1,085,000) new shares will (may) be issued in the
Company, representing approximately 2.83% of the
currently existing number of shares in the Company;
• the justification for the decision to be taken is as follows:
the 2021 Personnel Subscription Rights Plan aims to:
(a) create a long-term incentive for the personnel of
the Company and its subsidiaries (i.e. all companies or
entities directly or indirectly controlled by the Company
where “control” is defined in accordance with Article
58
OXURION ANNUAL REPORT 2021
1:14 BCCA, hereinafter referred to as “Subsidiaries”),
which may also include the CEO, which can make
an important contribution to the success and the
growth of the group; (b) promoting the participation
in the capital of the Company by the personnel of
the Company and its Subsidiaries, which may also
include the CEO, as well as entering into a continuous
and long-term collaboration as well as ensuring their
personal commitment in the under the development
and success of the Company; (c) allow the Company
and its Subsidiaries to recruit experienced and skilled
personnel (including employees and consultants as
defined in the 2021 Personnel Enrollment Rights
Plan); and (d) to create a common interest between
the personnel of the Company and of its Subsidiaries,
which may also include the CEO, who participate in the
2021 Personnel Subscription Rights Plan, on the one
hand, who, through the exercise of their Subscription
writing rights are given the opportunity to participate in
the added value and growth of the Company and the
shareholders of the Company, on the other hand, which
is aimed at increasing the value of the Company’s
share price. In order to avoid any doubt about this, it
is expressly stated that the aforementioned statutory
authorization of the Board of Directors to increase the
capital and to issue convertible bonds or subscription
rights within the framework of the authorized capital
also expressly provides for the transaction referred to
in Article 7: 200, 2° BCCA,”
(B) Board of Directors of May 15, 2021
Conflict of interest with respect to the appointment of the
CEO:
“CONFLICT OF INTEREST Prior to the start of the deliber-
ations, the procedure set out in the Company’s Corporate
Governance Charter (Appendix I, Section 8) and/or in
article 7:96 of the BCCA was applied. In accordance with
article 7:96 of the BCCA every Director present at the
meeting was asked to, if relevant, disclose his/her direct
or indirect conflicts of interest regarding each point on the
agenda of the meeting of the Board of Directors.
Declaration
Patrik De Haes declares that he had a conflict of interest
within the meaning of article 7:96 of the BCCA about
the agenda item regarding his position as CEO of the
Company. This conflict of interest results from the
following circumstances: Patrik De Haes is the permanent
representative of ViBio BV which serves as CEO of the
Company. As an executive member of the Board, he is
therefore conflicted regarding this matter.
Consequences
Patrik De Haes (permanent representative of ViBio BV)
was not present during the deliberation and decision-mak-
ing process regarding the CEO position.
RESIGNATION OF VIBIO BV (REPRESENTED BY
PERMANENT REPRESENTATIVE PATRIK DE HAES) The
Chairman of the Board discusses the resignation of, ViBio
BV (represented by permanent representative Patrik De
Haes) from its mandate as CEO. This also ends the man-
agement agreement with ViBio BV. The financial conse-
quences of the end of contract is expected to represent
approximately 12 months of fees. The exact impact will be
determined during the next meeting of the Board who will
decide on the final “end of CEO agreement”.
Decision
The Board unanimously accepts the resignation of ViBio
BV (represented by permanent representative Patrik De
Haes). The decision will be implemented immediately,
(incl. the termination of all ancillary mandates related to
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OXURION ANNUAL REPORT 2021
Oxurion or its affiliates, currently exercised by ViBio BV).
The authority to negotiate and execute the “end of CEO
agreement” is delegated to Thomas Clay, who will present
the result for ratification at the next Board.”
In execution thereof on the Board of Directors of June 17,
2021:
“For the next 2 topics MeRoNo BV (with permanent rep-
resentative Patrik De Haes) leaves the meeting due to a
conflict of interest which was raised during last meeting.
(This conflict of interest results from the following circum-
stances: Patrik De Haes is the permanent representative
of ViBio BV. ViBio BV is now replaced by another man-
agement company of Patrik De Haes, namely MeRoNo
BV. As a member of the Board, he is therefore conflicted
regarding this matter of which concern ViBio BV’s end of
CEO agreement, as well as the remuneration package he
will receive as Chairman and Director of this Board.
• Ratification end of CEO agreement ViBio BV: The
outcome of the negotiations with ViBio (with permanent
representative Patrik De Haes). This power of attorney
was delegated to the Chairman of the Committee
during last Board of Directors of May 15. Committee
took note of the outcome and made no reservations.
It recommends the Board to ratify the arrangement as
debriefed by Thomas Clay.
• The Board is aligned with the arrangement as debriefed
by Thomas Clay.
• The President of the Committee discusses a bench-
marking that has been performed to assess a com-
petitive compensation package for the new Chairman
of the Board of Directors (i.e., MeRoNo BV). The Board
agrees to set the total compensation of MeRoNo
(Company in formation) as Chairman to the Board of
Directors (incl. the fact that he is Boardmember) at 90k
euro per year. On top of this cash amount, MeRoNo
will receive as non-executive Chairman 7,500 warrants
on a yearly basis. This decision will be included in an
updated Remuneration policy, which shall be submitted
for vote in a Shareholder meeting.”
(C) Board of Directors of September 22, 2021
Conflicts of interest with respect to the Subscription Rights
Plan 2021-2:
“Prior to the start of the deliberation on the agenda, the
chairman explained that Mr. GRANEY Tom Nicholas,
director mentioned sub 2., has declared that he has a
conflict of interest within the meaning of article 7:96 of the
Belgian Code of Companies and Associations, in view of
the resolution approving the issuance of subscription rights
under the Subscription Rights Plan 2021. Consequently,
this director, pursuant to article 7:96 of the Belgian Code
of Companies and Associations, does not participate in the
deliberation nor in the vote on the approval of the issuance
of subscription rights under the aforementioned subscrip-
tion rights plan.
Since the subscription rights are granted by the Company
to (among others) Mr. GRANEY Tom Nicholas as director
of the Company, article 7:96 of the Belgian Code of
Companies and Associations is applicable due to the
nature of this issue of subscription rights.
The other directors are of the opinion that the issuance
of subscription rights to Mr. GRANEY Tom Nicholas is
justified in the interest of the Company. The Company is
offering these subscription rights to the aforementioned
director because of his dedication to the Company and his
current and future contribution to its success and growth.
For this reason, the Company is able to create a financial
environment such that the aforementioned director will be
committed to the Company and its subsidiaries in the long
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OXURION ANNUAL REPORT 2021
term and will improve the results of the Company and its
subsidiaries. In view thereof, the other directors are of the
opinion that the issue of subscription rights to Mr GRANEY
Tom Nicholas is therefore in the interest of the Company.
The other directors, present or represented as aforemen-
tioned, have declared, each individually, not to have a
conflict of interest within the meaning of article 7:96 and/
or article 7:97 of the Belgian Code of Companies and
Associations in connection with the decisions or transac-
tions that are described in the agenda.”
4.7.2 Transactions with
Affiliated Companies
Article 7:97 of the BCCA provides for a special procedure
which must be followed for transactions with Oxurion’s
affiliated companies or subsidiaries. Such a procedure
does not apply to decisions or transactions that are
entered in the ordinary course of business under at arm’s
length conditions or for decisions and transactions whose
value does not exceed one percent of the Company’s
consolidated net assets. According to Appendix 2 of the
Corporate Governance Charter of the Company regarding
transactions or other contractual relations between the
Company including affiliated companies, and its directors
and members of the CEO, such transactions need to be
submitted to the Board of Directors.
4.7.3 Protocol regarding transactions with
Related Parties
Transactions with related parties are exclusively with
members of the Board of Directors.
We refer to section 4.9 for the remuneration report con-
cerning 2021.
4.7.4 Market Abuse regulations
Oxurion’s Corporate Governance Charter Appendix 3 as
published on its website describes the rules in place to
prevent privileged knowledge being used illegally or the
impression of such illegal use being created by directors,
shareholders, members of the management and important
employees (insiders).
The precautionary measures against insider trading
include, among other things, the obligation to compose
lists of insiders, the requirements concerning investment
recommendations, the obligation to report insider trans-
actions, and the obligation for the intermediary to report
suspicious transactions. The measures are stipulated in
Regulation (EU) No 596/2014 of the European Parliament
and of the Council of April 16, 2014, on Market Abuse
(the “Market Abuse Regulation”) and repealing Directive
2003/6/EC of the European Parliament and the Council
and Commission Directives 2003/124/EC, 2003/125/EC
and 2004/72/EC.
In accordance with the Market Abuse Regulation, Oxurion
has drawn up a list of persons in the Company who are
employed or consulted for the Company and who have
regular or occasional access to insider information directly
or indirectly concerning Oxurion. These lists are updated
frequently and remain at the disposal of the FSMA for five
years.
In accordance with the Market Abuse Regulation, the
members of the Board of Directors and the management
are obliged to report their transactions involving shares of
Oxurion to the FSMA.
The Company has established a disclosure committee
and has a Chief Compliance Officer.
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OXURION ANNUAL REPORT 2021
4.8 CAPITAL INCREASE BY THE BOARD
OF DIRECTORS WITH RESPECT
TO THE AUTHORIZED SHARE
CAPITAL AND PROVISIONS THAT
MAY BE TRIGGERED IN THE EVENT
OF A PUBLIC TAKEOVER ON THE
COMPANY (ARTICLE 8:2 OF THE
ROYAL DECREE OF APRIL 29, 2019
(ARTICLE 34 OF THE OLD ROYAL
DECREE OF 14 NOVEMBER 2007))
The Powers of the Board of Directors with Respect to
the Authorized Share Capital
Article 46 of the Articles of Association contains the
following provisions with respect to the authorized share
capital. The powers of the Board of Directors with respect
to the authorized share capital were renewed at the EGM
of May 24, 2019, for a period of five years starting from the
publication of the deed of amendment of the Articles of
Association in the Belgian Official Gazette (June 13, 2019).
The Board of Directors is authorized to increase the share
capital of the Company on one or more occasions up to
an amount of 55,325,961 euro through cash, in kind contri-
bution, or by conversion of the reserves in accordance with
Article 7:199 of the BCCA.
4.9 REMUNERATION REPORT FINANCIAL
YEAR 2021
In accordance with Belgian law, the Company has adopted
a new remuneration policy in 2021 (Article 3:6, §3 of the
BCCA), the “2021 Remuneration Policy” or the “Policy”),
which was approved by the Board of Directors on March
17, 2021, on the recommendation by the Nomination and
Remuneration Committee. At the AGM in May 2021, the
Company submitted its 2021 Remuneration Policy to the
shareholders, which was approved. The Policy applies for
the next four years unless materially modified by the Board
of Directors and approved by the shareholders.
The purpose of a remuneration policy is to provide the
fundamental principles based on which the Company will
remunerate the members of its Board of Directors, CEO,
and Executive Committee on a going forward basis.
This section of the Annual Report first provides an overview
of the 2021 Remuneration Policy. This is followed by the
remuneration report for 2021 applying the 2021 Policy.
The purpose of the Remuneration Report is to report on
the remuneration paid by the Company in 2021 in ac-
cordance with the Belgian legislation (Article 7:89/1 of the
BCCA).
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OXURION ANNUAL REPORT 2021
4.9.1 Overview of Remuneration Policy
4.9.1.1 Executives
(A) Structure
The CEO is appointed by the Board of Directors in accor-
dance with Oxurion’s Corporate Governance Charter. The
CEO has the power to propose and implement corporate
strategy, taking into account the Company’s values, its risk
tolerance and key policies. The CEO is, among other things,
entrusted with the running of the Company.
The CEO is assisted by an Executive Committee, which
provides support and assistance to the CEO but has no
statutory delegated powers to represent the Company or
to propose or implement corporate strategy.
The CEO and other members of the Executive Committee
are all referred to in this Remuneration Report as the
“Executives”.
(B) Remuneration of Executives
Oxurion’s approach to remuneration of its Executives
is geared at attracting, motivating and retaining highly
qualified individuals with the necessary skill set and expe-
rience to ensure its continuing sustainable and profitable
growth. As such, the Policy is designed to support the
retention and motivation of the Executives.
The total remuneration package for Oxurion Executives is
made up of three components:
• Fixed compensation, including pension and other
benefits
• Variable compensation which is based on achieving
corporate objectives
• Equity-based compensation in the form of subscription
rights
Fixed Compensation. Each Oxurion Executive is entitled to
a fixed annual compensation package including pension
and other benefits.
Variable Compensation. Executives are also entitled
to variable compensation based on achieving annual
corporate performance objectives.
This variable component is an incentive linked to the
achievement of annual corporate objectives. The level of
achievement of each of the corporate objectives defines
the total percentage of the target amount that is paid. As it
is typically annual in nature, this component qualifies as a
short-term cash incentive.
At the EGM of November 20, 2017, it was decided that
Oxurion would expressly deviate from the specific provi-
sions of Art. 7:91 BCCA, according to which directors are
not allowed to exercise subscription rights allocated to
them prior to the expiry of a three-year period following
their allocation. The decision to do so was not consid-
ered to be exceptional in the biotech and pharmaceutical
industry where such plans are common in order to ensure
longevity.
Share Subscription Rights. The Company offers subscrip-
tion rights to Executives through various subscription rights
plans (previously referred to as warrants).
Subscription rights are granted free of charge according
to rules set by the Board of Directors on the advice of the
Nomination and Remuneration Committee. The vesting of
subscription rights is not linked to individual performance
but rather is based on continued service to ensure that
Executives have a long-term commitment to maximizing
long-term shareholder value. Paragraph 5.7.10 gives more
detailed information on the subscription right plans and
outstanding subscription rights at the end of 2021 including
the value per subscription right at the time of each grant
applying the Black & Scholes valuation method.
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OXURION ANNUAL REPORT 2021
The Company does not consider the subscription rights
granted to Executives to be variable remuneration as
defined by the BCCA.
Oxurion does not provide for any performance-related
premiums in shares, options or other rights to acquire
shares.
Ownership of Shares. The Company is not able to make
share grants as it does not have distributable reserves and
therefore is not able to hold treasury shares and hence has
not put in place any requirements for share ownership by
the Board of Directors or by Executives.
Claw backs. In line with its remuneration policy, Oxurion
does not operate any claw back arrangements in relation
to remuneration paid to Executives.
The Company does not consider that it is necessary to
apply claw back provisions and therefore deviates from
principle 7.12 of the Corporate Governance Code on the
basis that:
• The payout of the variable compensation, based on
the achievement of corporate targets as set by the
Board of Directors, is paid only upon achievement of
the objective.
• The Company does not apply any other perfor-
mance-based remuneration or variable compensation
as the subscription rights granted to Executives vest
over time and are not performance related.
Consequently, no claw back arrangements were applied
during 2021.
Conflicts of interest. The remuneration of the non-execu-
tive directors is subject to approval by the general share-
holders’ meeting.
The CEO does not participate in the preparation and
the decision making regarding his own remunera-
tion. Furthermore, the Nomination and Remuneration
Committee is composed exclusively of non-executive
board members and a majority of its members qualify
as independent directors. The CEO/executive director
only participates in the meetings of the Nomination and
Remuneration Committee in an advisory capacity. He
recuses himself and does not participate in the discussions
relating to his own remuneration in either the Nomination
and Remuneration Committee or the Board of Directors.
4.9.1.2 Board of Directors
The procedure for establishing the remuneration policy
and setting remuneration for members of the Board of
Directors is determined by the Board of Directors on the
basis of proposals from the Nomination and Remuneration
Committee, taking into account relevant benchmarks with
appropriate peer companies.
The remuneration of the Non-Executive Directors is
submitted by the Board of Directors to the shareholders’
meeting for approval and is only implemented after such
approval.
The fixed and variable remuneration of the CEO (who is
a member of the Board of Directors) is established by the
Board of Directors based upon an authorization from the
shareholders’ meeting and described above. Executive
Directors are not separately remunerated for their board
role.
(A) Non-Executive Directors
Based on a peer review of the compensation of the
Board of Director against peer companies (Euronext
listed biotech companies), the AGM of Oxurion of May
7, 2019, approved a new remuneration and compensa-
tion scheme and decided to issue a subscription rights
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OXURION ANNUAL REPORT 2021
plan for Non-Executive Directors with the objective of
avoiding disadvantages compared to competitors and
peer companies. This was further implemented in the
Company’s Remuneration Policy.
In accordance with the policy terms decided by the
shareholders, Non-Executive Directors are entitled to the
following fees:
ROLES
ANNUAL
FEES
AUDIT CO
MEMBER
AUDIT CO
CHAIR
NOM REM CO
MEMBER
NOM REM CO
CHAIR
Chairman 90,000
Board
Member
30,000 6,000 6,000 4,000 4,000
The Chairman of the Board of Directors does not receive
any fees for his membership or chairmanship of any of the
Committees. If a director attends less than at least 75%
of the scheduled annual Board of Directors’ or Committee
meetings of which he or she is a member either in person
or by phone, the fees are reduced on a pro rata basis.
Where members attend Board of Directors’ meetings in
person, they are entitled to reimbursement of reasonable
out-of-pocket expenses actually incurred as a result of par-
ticipation in meetings of the Board of Directors.
Apart from the above remuneration, the shareholders
decided at the AGM in May 2019 that Non-Executive
Directors should be entitled to subscription rights for 7,500
shares in the Company per year. This was implemented
by decision of the Board of Directors to adopt a Board
of Directors’ Subscription Rights Plan 2020 for 150,000
shares before the Public Notary on December 23, 2020.
These rights are not subject to any vesting criteria and can
be freely exercised during any exercise period for the life
of the Plan. The Company does not consider them to be
variable compensation.
The Company recognizes that the Corporate Governance
Code recommends against granting subscription rights
to Board of Directors’ members, but at the same time
advises companies that members of the Board of
Directors should own shares of the Company. Oxurion is
not able to grant shares to its directors because it does
not have distributable reserves and cannot own treasury
shares. Therefore, the Company considers that the grant
of subscription rights to Non-Executive Directors that vest
on grant operates as closely as possible to a share. The
shareholders have already expressly agreed to the grant
of subscription rights to the Board of Directors at the 2019
AGM and again at the 2021 AGM as part of the approval
of the 2021 Remuneration Policy.
The Board of Directors’ remuneration structure encourag-
es an active participation in both Board of Directors’ and
Committee meetings. The fixed remuneration for the Non-
Executive Directors is justified by the fact that the proper
operation of these Committees requires adequate prepa-
ration by the members. The grant of subscription rights
to Non-Executive Directors further aligns the Directors’
interests with those of the shareholders and allows the
Company to attract and retain top quality directors.
The objective and independent judgment of the Non-
Executive Directors is further encouraged by the fact
that they do not draw any other remuneration from the
Company other than their fixed Directors’ remuneration
and their subscription rights, except for David Guyer who
provides additional ad hoc consultancy services.
The remuneration of the Non-Executive Directors does
not contain a variable component; hence no performance
criteria apply to the remuneration of the Non-Executive
Directors.
The Directors’ mandate may be terminated “ad nutum” (at
any time) without any form of compensation.
(B) Executive Directors
Executive Directors are not compensated for their role on
the Board of Directors in addition to the compensation
they receive as Executives.
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OXURION ANNUAL REPORT 2021
4.9.2 Remuneration report
4.9.2.1 Executives
(A) Total Remuneration Summary for Executives
This Remuneration Report covers Oxurion Executives,
including the CEO and the Executive Committee. During
fiscal year 2021, the Executive Committee was made up
the following Executives (plus the CEO):
• Julie Binon – Chief People Officer
• Andy De Deene – Chief Development Officer
• Tom Graney – Chief Financial Officer (also Chief
Executive Officer since May 15, 2021)
• Midico BV represented by Michaël Dillen – Chief
Business Officer and Company Secretary
• Paisley BV represented by Kathleen Paisley – Chief
Legal Officer and Compliance Officer
• Hanne Callewaert – Chief Operating Officer (since
July 1, 2021)
• Alan Stitt – Chief Scientific Officer (since January
18, 2021), replacing Panéga BV represented by Jean
Feyen who retired in January, 2021
• Dr. Grace Chang – Chief Medical Officer (until June
30, 2021)
During the course of 2021, a number of changes were
made to the composition of the Executive Committee. The
global remuneration figures included in this Remuneration
Report for the Executive Committee for fixed compensa-
tion, other benefits and pensions include amounts paid to
all members of the Executive Committee and relating to
the 2021 financial year in euros. The amounts included for
variable compensation are those relating to the financial
year regardless of when they were paid.
The overview below demonstrates the total remuneration of the CEO and Executive Committee members in 2021 in euros:
NAME AND TITLE FIXED COMPENSATION OTHER BENEFITS PENSION
VARIABLE COMPEN-
SATION
TOTAL
RATIO OF VARIABLE TO
FIXED COMPENSATION
ViBio BV, CEO 178,000 0 0 0 178,000 0%
Tom Graney 298,000 18,000 8,000 149,000 473,000 50%
Executive Committee 1,245,000 49,000 44,000
566,000
(279,000 ~2020 &
288,000 ~2021)
1,860,000 45%
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OXURION ANNUAL REPORT 2021
(B) Fixed Remuneration
We refer to the table above that reflects the base com-
pensation, pension and other benefits for the CEO and
Executive Committee members in 2021 in euros.
Base Compensation. Each Oxurion Executive is entitled to
base compensation in line with his/her position.
Other Benefits. Depending on their location and status,
Executives may be entitled to statutory benefits plus a
contribution to a healthcare plan, a company car, and/or
similar arrangements. These amounts can vary from year-
to-year but are reported here due to their recurring nature.
Pension. Depending on their location and status, Executives
may receive defined contribution benefits under Oxurion’s
group insurance plan or through matching arrangements
under 401 (k) plans in the US. These amounts can vary
from year-to-year but are reported here due to their
recurring nature.
Variable Compensation. According to the Remuneration
Policy, the performance criteria are set at the beginning of
the year together with the Nomination and Remuneration
Committee and the Board of Directors to align with what
they consider creates most shareholder value. They have
four primary components - (1) funding of the company
in relation to a specific plan, developed by the Board of
Directors; (2) delivery of the development programs via
clinical trial milestones; (3) enhancing the Company’s
assets in key strategic areas, for example, through in/out-li-
censing and (4) a relevant people objective. Those four
components of the performance criteria are weighted in
light of their importance to the Company’s success and
linked to the specific year.
At year-end, the Nomination and Remuneration Committee
and the Board of Directors decide whether corporate ob-
jectives are achieved. The objectives are SMART, so they
are achieved or not achieved by the timeline set for the
period. In some cases, they are partially achieved. In the
latter case, the Nomination and Remuneration Committee
and the Board of Directors shall award a reduced target
incentive amount based on criteria for partial achievement
that have been established in advance.
For 2020, the performance criteria included elements
related to clinical trial progression, cash position and
corporate development. In light of the force majeure
circumstances related to the pandemic, the Board of
Directors decided, based on the advice of the Nomination
and Remuneration Committee, to defer the 2020 bonus
to 2021 and make the payment of all (or part) of the 2020
variable compensation dependent on the achievement of
the corporate objectives set for 2020 and 2021 as a whole.
For the year 2021 (which thus also includes 2020), the
objectives were set relating to funding (both amount and
timing), clinical trial timelines for THR-149 and THR-687
and employee engagement. The Nomination and
Remuneration Committee and the Board of Directors
decided that the corporate objectives set for 2020 and
2021 were fully met. Therefore, the variable compensation
relative to the fiscal years 2020 and 2021 have been paid
out altogether in the course of March 2022.
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OXURION ANNUAL REPORT 2021
(C) Subscription Rights
The Executives are also entitled to participate, free of charge, in the different subscription rights plans that Oxurion has in
place for its personnel.
In respect of 2021, the table below represents the subscription right grants to Executives:
NAME FIRST NAME DATE OF GRANT PLAN GRANTED & ACCEPTED EXERCISE PRICE
N° OF SR'S VESTED
DURING 2021
Binon Julie 2019-07-03 2017 plan 15,000 3.822 7,500
Binon Julie 2021-04-28 2021-1 plan 10,000 2.600 5,000
Binon Julie 2021-09-30 2021-2 plan 17,500 1.750
Binon Julie 2021-12-30 2021-3 plan 65,000 1.820
Callewaert Hanne 2018-06-29 2017 plan 10,000 6.549 5,000
Callewaert Hanne 2019-07-03 2017 plan 4,000 3.822 2,000
Callewaert Hanne 2021-04-28 2021-1 plan 7,500 2.600 3,750
Callewaert Hanne 2021-09-30 2021-2 plan 47,500 1.750
Callewaert Hanne 2021-12-30 2021-3 plan 90,000 1.820
De Deene Andy 2018-12-28 2017 plan 25,000 3.400 12,500
De Deene Andy 2019-12-27 2017 plan 25,000 2.640 12,500
De Deene Andy 2021-04-28 2021-1 plan 40,000 2.600 20,000
De Deene Andy 2021-09-30 2021-2 plan 150,000 1.750
De Deene Andy 2021-12-30 2021-3 plan 220,000 1.820
Graney Tom 2021-04-28 2021-1 plan 400,000 2.600 200,000
Graney Tom 2021-09-30 2021-1 plan 165,000 1.750
Graney Tom 2021-09-30 2021-2 plan 235,000 1.750
MIDICO BV 2021-04-28 2021-1 plan 52,500 2.600 26,250
MIDICO BV 2021-09-30 2021-2 plan 45,000 1.750
MIDICO BV 2021-12-30 2021-3 plan 90,000 1.820
Paisley BV 2021-04-28 2021-1 plan 52,500 2.600 26,250
Paisley BV 2021-09-30 2021-2 plan 55,000 1.750
Paisley BV 2021-12-30 2021-3 plan 90,000 1.820
Sander Claude 2018-06-29 2017 plan 25,000 3.400 12,500
ViBio BV 2018-12-28 2017 plan 100,000 4.593 50,000
ViBio BV 2019-12-27 2017 plan 100,000 4.593 50,000
ViBio BV 2021-04-28 2021-1 plan 200,000 2.600 100,000
The subscription rights granted in 2021 were granted
under the 2021-1 (April 2021), 2021-2 (September 2021)
or 2021-3 (December 2021) plans. Half of the subscrip-
tion rights under these plans vest after one year and the
other half vest quarterly over the following two years.
For the 2021-1 (April 2021) grant, the vesting period ex-
ceptionally commenced on December 28, 2020. The
Company adopted a new Subscription Rights Plan in line
with the 2021 Remuneration Policy in April 2021, and the
Subscription Rights related to the fiscal year 2020 were
granted under that plan at the same time (the “Subscription
Rights Plan 2021-1”).
The Company then undertook a benchmark study of the
subscription rights granted to Executives and, based on the
results of the study, the Board decided to make a true up
grant to all Executives (except for the CEO and COO) on
September 30, 2021. Moreover, Tom Graney and Hanne
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OXURION ANNUAL REPORT 2021
Callewaert were granted subscription rights in the context
of their promotion to CEO and COO, respectively. As an
exception, the subscription rights granted to Tom Graney
on his appointment as CEO vest upon the achievement of
certain performance related criteria related to funding. All
other subscription rights vest over time. In order to allow
these grants to be made, the Company adopted another
Subscription Rights Plan on September 22, 2021 (the
“Subscription Rights Plan 2021-2”).
The Board of Directors adopted a new Subscription Rights
Plan on December 30, 2021 (the “Subscription Rights
Plan 2021-3”) following which all Executives (except the
CEO) were granted their yearly grant relating to the fiscal
year 2021.
No subscription rights were exercised by Executives in 2021.
The following subscription rights of Executives were forfeited
in 2021:
NAME FIRST NAME
DATE OF
GRANT
PLAN
N° OF SR'S
FORFEITED
EXERCISE
PRICE
Panéga BV 2017-12-28 2017 plan 25,000 4.593
Panéga BV 2018-12-28 2017 plan 25,000 4.593
Vangeers-
daele
Vinciane 2017-12-28 2017 plan 12,500 3.380
All the rights that were forfeited in 2021 were granted under
the 2017 plan where half of the subscription rights vest after
two years, and the other half after three years.
(D) 2021 Executive Remuneration and alignment
with Remuneration Policy
The remuneration for 2021 is in line with the Remuneration
Policy and contributes to the long-term performance of the
Company as intended by the Remuneration Policy (as set out
above).
The Oxurion remuneration policy is defined in a manner that
remunerates the Company’s executives to drive and reward
actions, decisions and behavior that makes the Company
successful in the long run. Variable compensation at the
Company is directly linked to tangible corporate objectives,
each one contributing to the Company’s performance.
Executives are incentivized to focus on those actions or
decisions that will make the Company successful. This short-
term incentive plan is expressed on a percentage of base
salary. Besides that, Oxurion also has a long-term incentive
component, which is intended to focus its executives on value
creation for the shareholders, employees, patients, and other
stakeholders over the long run, this via a subscription rights
plan.
When Tom Graney was appointed CEO, the Company
decided to grant him 400,000 subscription rights, with
vesting based upon performance based criteria related to
funding the Company. This deviates from the Remuneration
Policy’s provision that subscription rights are granted and vest
based on time served, but is consistent with the Remuneration
Policy’s goal to align the remuneration of executives with the
long term interests of the Company and its shareholders. In
light of these considerations, the Board of Directors consid-
ered the granting of subscription rights with performance
based vesting criteria to be necessary and appropriate in the
context of Mr. Graney’s appointment as CEO.
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OXURION ANNUAL REPORT 2021
4.9.2.2 Directors’ remuneration
(A) Non-Executive Directors
Cash Compensation
The 2021 remuneration of the Non-Executive Directors and the Chairman of the Board of Directors is set forth in the chart
below. Note that no benefits are provided to members of the Board of Directors.
NAME ANNUAL FEES AUDIT CO MEMBER AUDIT CO CHAIR NOM REM CO MEMBER NOM REM CO CHAIR TOTAL PAYMENTS
Chairman (through
May 15, 2021),
Thomas Clay
22,500 Unpaid Unpaid 22,500 22,500
Chairman (as of
May 15, 2021),
MeRoNo BV, repre-
sented by Patrik De
Haes
56,250 Unpaid Unpaid 56,250 56,250
Thomas Clay 18,750 3,750 2,500 2,500 27,500 27,500
Investea SRL,
represented by
Emmanuèle Attout
30,000 6,000 6,000 42,000 42,000
Philippe Vlerick 30,000 6,000 36,000 36,000
Dr. Adrienne Graves 30,000 4,000 34,000 34,000
Dr. David Guyer 30,000 4,000 34,000 34,000
David Guyer received, in addition to his Director’s remuneration, compensation of 35,000 USD for consultancy services in
2021.
Share Subscription Rights
In 2021, 15,000 subscription rights relating to 2019 and 2020 were granted to each member of the Board of Directors (in
function at the time the subscription rights were granted).
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OXURION ANNUAL REPORT 2021
(B) Executive directors
The executive directors, Patrik De Haes (ViBio BV) (through
May 15, 2021) and Tom Graney (as of August 13, 2021), do
not receive any compensation for their Board of Directors’
mandate. The compensation paid in respect of their
function as CEO is outlined above.
4.9.2.3 Evolution of Executives remuneration and
average employee remuneration and pay ratio
(A) Evolution of Executives remuneration and
average employee remuneration
The chart below shows the evolution of the Executive
Remuneration, share price (as a proxy for Company per-
formance) and average remuneration:
NAME AND TITLE TOTAL REMUNERATION
2019 2020 2021
CEO (ViBio BV & Tom Graney)
(*)
557,000 455,000 652,000 (*)
Change year on year -18.3% + 43.3%
Non-Executive Directors 206,000 196,949 252,250
Change year on year -4.4% +28.1%
Executive Committee (**) 1,472,000 1,674,000 1,860,000
Change year on year +13.7% +11%
Share Price at YE 2.95 2.56 1.82
Change year on year -13.2% -29%
Average Compensation per
FTE (***)
107,000 102,000 159,000
Change year on year -4.67% +56.9%
(*) The increase in CEO remuneration is related to the fact that the CEO is now ba-
sed in the US where comparable compensation is higher and because the variable
compensation in 2021 related to both fiscal years 2020 and 2021.
(**) The increase in the Executive Committee remuneration in 2021 is mainly due
to the fact that the variable compensation in 2021 related to both fiscal year 2020
and 2021. This increase was mitigated by a reduction in the number of Executive
Committee members.
(***) The increase in average compensation per FTE is mainly due to the fact that
the variable compensation in 2021 related to both fiscal year 2020 and 2021.
For the calculation of the average compensation per
FTE, the fixed remuneration and employee benefits in
December 2021 have been taken into account, as well as
the variable remuneration related to fiscal year 2021 and
the deferred (corporate) 2020 variable compensation. The
compensation data includes US and European employees,
in full time equivalent, employed in December 2021, and
does not include Executive Committee members.
(B) Ratio of the Total Remuneration of Highest
Paid versus Lowest Remunerated Personnel
The ratio of the 2021 remuneration of the lowest full time
FTE (in euro) to the highest fulltime FTE (in euro), was 1:15.
For the calculation of this ratio, the compensation data
of US and European employees, full time equivalent, and
employed in December 2021, are considered and is based
upon the fixed remuneration and employee benefits in the
month of December 2021 as well as upon the variable
remuneration related to fiscal year 2021 and the deferred
(corporate) 2020 variable compensation, and the value of
subscription rights vested during the period based on the
Black & Scholes valuation of the subscription right on the
date of grant.
4.9.2.4 Extraordinary Items
Severance Payments
During 2021, two members of the Executive Committee
left the Company.
• Grace Chang, Chief Medical Officer, left the Company
on June 30, 2021, and was paid six months compensa-
tion as well as a deferred sign-on bonus.
• ViBio BV, represented by Patrik De Haes, and
the Company decided to terminate their existing
agreement in mutual agreement on May 15, 2021.
The Board of Directors on the recommendation of the
Nomination and Remuneration Committee decided to
pay ViBio BV 12-month compensation to be paid in
three equal instalments spread over three years.
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OXURION ANNUAL REPORT 2021
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OXURION ANNUAL REPORT 2021
5. CONSOLIDATED FINANCIAL
STATEMENTS
73
OXURION ANNUAL REPORT 2021
5.1 CONSOLIDATED STATEMENT OF PROFIT AND LOSS
IN '000 EURO (EXCEPT PER SHARE) (FOR THE YEAR ENDED 31 DECEMBER) NOTE 2021 2020
Income 1 ,128 2,078
Sales 5.6.1 967 2,000
Income from royalties 5.6.1 161 78
Cost of sales 5.6.2 -612 -550
Gross profit 516 1 ,528
Research and development expenses 5.6.3 -20 ,696 -22,053
General and administrative expenses 5.6.4 -7 ,150 -5,489
Selling expenses 5.6.5 -1,27 4 -3 ,252
Other operating income 5.6.6 1,2 45 777
Other operating expense -9 -6
Impairment losses 5.7.3 -1,127 -125
Operating result -28,495 -28 ,620
Finance income 5.6.7 171 468
Finance expense 5.6.8 -1,268 -408
Result before income tax -29 ,592 -28 ,560
Taxes 5.6.10 -3 0
Result of the year -29 ,595 -28 ,560
Attributable to:
Equity holders of the company -29 ,158 -28,012
Non-controlling interest -437 -548
Result per share
Basic earnings / loss (-) per share (euro) 5.6.11 -0.77 -0 .75
Diluted earnings / loss (-) per share (euro) 5.6.11 -0.77 -0 .75
IN '000 EURO (AS AT 31 DECEMBER) NOTE 2021 2020
Result of the year -29 ,595 -28 ,560
Other comprehensive income:
Remeasurement of defined benefit pension schemes 5.7.9 566 -297
Fair value gain/(loss) on investments designated as at FVTOCI -5 0
Other comprehensive income that will not be reclassified to profit or loss 561 -297
Exchange differences arising on translation of foreign operations 122 -127
Other comprehensive income that will or may be reclassified to profit or loss 122 -127
Other comprehensive income, net of income tax 683 -424
Total comprehensive loss (-) / income for the year -28 ,912 -28 ,984
Attributable to:
Equity holders of the company -28 ,475 -28 ,436
Non-controlling interest -437 -548
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
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OXURION ANNUAL REPORT 2021
5.2 CONSOLIDATED STATEMENT OF FINANCIAL POSITION
IN ‘000 EURO (AS AT 31 DECEMBER) NOTE 2021 2020
ASSETS
Property, plant and equipment 5.7.1 120 230
Right-of-use assets 5.7.2 252 1,069
Intangible assets 5.7.3 1 ,000 2,127
Other non-current assets 95 96
Non-current tax credit 5.7.4 4,000 3,708
Non-current assets 5,467 7 ,230
Inventories 5.7.5 60 85
Trade and other receivables 5.7.4 2,517 1,451
Current tax receivables 5.7.4 845 719
Investments 5.7.6 247 288
Cash and cash equivalents 9 ,7 40 24,511
Current assets 13 ,409 27 ,054
Total assets 18 ,876 34,284
EQUITY AND LIABILITIES
Share capital 5.7.7 46 ,029 44,913
Share premium 5.7.7 234 0
Other comprehensive income 5.7.8 -356 -1,039
Other reserves 5.7.8 -5 ,266 -6 ,133
Retained earnings -41 ,719 -12,561
Equity attributable to equity holders of the company -1 ,078 25 ,180
Non-controlling interest -30 -132
Total equity -1 ,108 25,048
Lease liabilities 44 447
Employee benefit liabilities 5.7.9 594 1,096
Convertible loans 5.7.11 8 ,433 0
Non-current liabilities 9 ,071 1 ,543
Trade payables 4,979 4,377
Lease liabilities 221 649
Convertible loans 5.7.11 3,401 0
Other short-term liabilities 5.7.10 2,312 2,667
Current liabilities 10 ,913 7 ,693
Total equity and liabilities 18 ,876 34,284
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
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OXURION ANNUAL REPORT 2021
5.3 CONSOLIDATED STATEMENT OF CASH FLOWS
IN '000 EURO (FOR THE YEAR ENDED 31 DECEMBER) NOTE 2021 2020
Cash flows from operating activities
Loss for the period -29 ,595 -28,560
Finance expense 5.6.8 896 408
Finance income 5.6.7 -171 -468
Depreciation of property, plant and equipment 5.7.1 77 194
Amortization and impairment of intangible assets 5.7.3 1,127 125
Amortization of right-of-use assets 5.7.2 600 916
Gain on sale of property, plant and equipment -344 -7
Fair value adjustments of financial instruments 372 0
(Reversal of) impairment losses on current assets 629 801 *
Increase / Decrease (-) in provisions 64 0
Equity settled share-based payment transactions 5.6.9 1 ,107 458
Increase (-) / Decrease in trade and other receivables and inventories -2,037 700 *
Increase / Decrease (-) in short-term liabilities 297 -1,646
Net cash flows generated / used (-) in operating activities -26,978 -27 ,079
Cash flows from investing activities
Disposal of property, plant and equipment (following a sale) 5.7.1 394 35
Decrease / Increase (-) in investments 5.7.6 36 10 ,154
Interest received and similar income 5.6.7/8 9 -6
Purchase of property, plant and equipment 5.7.1 -32 -119
Net cash flows generated / used (-) in investing activities 407 10,064
Cash flows from financing activities
Principal paid on lease liabilities 5.7.2 -599 -903
Proceeds from loans and borrowings 11,150 0
Other financial income / expense (-) -20 0
Interest paid on lease liabilities 5.7.2 -3 -16
Proceeds from capital increases in subsidiaries from non-controlling interest 86 0
Proceeds from capital and share premium increases, gross amount 5.7.7 1,350 0
Paid interests and other bank charges 5.6.8 -186 -12
Net cash flows used (-) / generated in financing activities 11,778 -931
Net change in cash and cash equivalents -14,793 -17 ,946
Net cash and cash equivalents at the beginning of the period 24,511 42,492
Effect of exchange rate fluctuations 22 -35
Net cash and cash equivalents at the end of the period 9 ,7 40 24 ,511
(*) During 2021, the Group identified that an impairment loss on inventories in the amount of 0.801 million euro was included in the line item ‘Increase (-) / Decrease in trade and
other receivables and inventories’ of the consolidated statement of cash flows as per December 31, 2020. An impairment loss on inventories is considered a non-cash adjustment,
whereas a working capital adjustment implies a cash flow. Therefore, the consolidated statement of cash flows for the year ended 31 December 2020 has been restated.
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
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OXURION ANNUAL REPORT 2021
5.4 CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
SHARE CAPITAL SHARE PREMIUM
OTHER COMPRE-
HENSIVE INCOME
RESERVE
OTHER
RESERVES
RETAINED
EARNINGS
ATTRIBUTABLE
TO EQUITY
HOLDERS OF THE
COMPANY
NON-CONTROLLING
INTEREST
TOTAL
Balance as at 1 January 2020 100 ,644 0 -615 -12,122 -34,7 47 53,160 146 53 ,306
Total comprehensive income of
the year
Result of the year 0 0 0 0 -28,012 -28 ,012 -548 -28,560
Change to foreign currency
translation difference
Remeasurement of DBO 0 0 -297 0 0 -297 0 -297
Net change in fair value of
investments
Contributions by and distributions
to owners
Issue of ordinary shares 0 0 0 0 0 0 270 270
Capital decrease -55 ,731 0 0 5,533 50 ,198 0 0 0
Share-based payment
transactions
Balance as at 31 December 2020 44,913 0 -1 ,039 -6 ,133 -12,561 25 ,180 -132 25 ,048
Balance as at 1 January 2021 44,913 0 -1,039 -6 ,133 -12,561 25 ,180 -132 25 ,048
Total comprehensive income of
the year
Result of the year 0 0 0 0 -29 ,158 -29 ,158 -437 -29 ,595
Change to foreign currency
translation difference
Remeasurement of DBO 0 0 566 0 0 566 0 566
Net change in fair value of
investments
Total comprehensive income for
the year
Contributions by and distributions
to owners
Issue of ordinary shares 1 ,116 234 0 213 0 1,563 0 1,563
Share-based payment
transactions
Total contributions by and
distributions to owners
Transactions with non-controlling
interests
Balance as at 31 December 2021 46 ,029 234 -356 -5,266 -4 1,719 -1,078 -30 -1 ,108
The accompanying notes from section 5.5 to 5.7 form integral part of these consolidated financial statements.
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OXURION ANNUAL REPORT 2021
5.5 GENERAL NOTES TO
THE CONSOLIDATED
FINANCIAL STATEMENTS
5.5.1 Reporting entity
Naamloze Vennootschap) established under Belgian
law with its registered office at Gaston Geenslaan 1,
(fully owned) and Oncurious (majority owned). Oxurion ,
ThromboGenics and Oncurious are biopharmaceutical
pipeline of drug candidates, a number of which are at the
clinical trial stage. The Group’s research and development
facilities are located in Belgium .
The consolidated financial statements of Oxurion for the
year ending December 31, 2021, include the entire Group.
These consolidated financial statements were approved
by the Board of Directors on March 24, 2022. Possible
changes to this Annual Report can be carried out until the
AGM of May 3, 2022.
5.5.2 Application of new and revised
standards and interpretations to the
consolidated financial statements
New Standards, Interpretations and Amendments adopted
by the Group
During 2021, the Group has adopted all the new and
revised Standards and Interpretations issued by the
International Accounting Standards Board (“IASB”) and
the IFRS Interpretations Committee (“IFRS IC”) of the IASB
as adopted by the European Union (“EU”) and effective for
the accounting year starting on January 1, 2021. The Group
has not applied any new IFRS requirements that are not
yet effective as of December 31, 2021.
The following new Standards, Interpretations and
Amendments issued by the IASB and the IFRS IC as
adopted by the European Union are effective for the
financial period:
• Amendments to IFRS 9, International Accounting
Standard (“IAS”) 39, IFRS 7, IFRS 4 and IFRS 16 Interest
Rate Benchmark Reform– Phase 2
• Amendment to IFRS 16 Leases: COVID-19-Related
Rent Concessions beyond June 1, 2020 (applicable for
annual periods beginning on or after June 1, 2020)
The adoption of these new standards and amendments
has not led to major changes in the Group’s accounting
policies.
Standards and Interpretations issued but not yet effective
in the current year
The Group elected not to early adopt the following new
Standards, Interpretations and Amendments, which have
been issued by the IASB and the IFRS IC but are not yet
mandatory for December 31, 2021 reporting periods and/
or not yet adopted by the EU as per December 31, 2021:
• Amendment to IFRS 16 Leases: COVID-19-Related
Rent Concessions beyond June 30, 2021 (applicable
for annual periods beginning on or after April 1, 2021)
• Amendments to IAS 16 Property, Plant and Equipment:
Proceeds before Intended Use (applicable for annual
periods beginning on or after January 1, 2022)
• Amendments to IAS 37 Provisions, Contingent
Liabilities and Contingent Assets: Onerous Contracts
— Cost of Fulfilling a Contract (applicable for annual
periods beginning on or after January 1, 2022)
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OXURION ANNUAL REPORT 2021
• Amendments to IFRS 3 Business Combinations:
Reference to the Conceptual Framework (applicable for
annual periods beginning on or after January 1, 2022)
• Annual Improvements to IFRS Standards 2018–2020
(applicable for annual periods beginning on or after
January 1, 2022)
• IFRS 17 Insurance Contracts, including Amendments to
IFRS 17 (applicable for annual periods beginning on or
after January 1, 2023)
• Amendments to IFRS 4 Insurance Contracts –
Extension of the Temporary Exemption from Applying
IFRS 9 (applicable for annual periods beginning on or
after January 1, 2023, but not yet endorsed in the EU)
• Amendments to IAS 1 Presentation of Financial
Statements: Classification of Liabilities as Current or
Non-current (applicable for annual periods beginning
on or after January 1, 2023, but not yet endorsed in
the EU)
• Amendments to IAS 1 Presentation of Financial
Statements and IFRS Practice Statement 2: Disclosure
of Accounting Policies (applicable for annual periods
beginning on or after January 1, 2023, but not yet
endorsed in the EU)
• Amendments to IAS 8 Accounting policies, Changes
in Accounting Estimates and Errors: Definition of
Accounting Estimates (applicable for annual periods
beginning on or after January 1, 2023, but not yet
endorsed in the EU)
• Amendments to IAS 12 Income Taxes: Deferred Tax
related to Assets and Liabilities arising from a Single
Transaction (applicable for annual periods beginning
on or after January 1, 2023, but not yet endorsed in
the EU)
None of the new Standards, Interpretations and
Amendments, which are effective for periods beginning
after January 1, 2021, that have been issued by the IASB
and the IFRS IC but are not yet effective as per December
31, 2021, and/or not yet adopted by the EU as per
December 31, 2021, are expected to have a material effect
on the Group’s current or future financial statements and
on foreseeable future transactions.
5.5.3 Basis of preparation and significant
accounting policies
The main basis adopted when preparing these consolidat-
ed financial statements are set out below.
(A) STATEMENT OF COMPLIANCE
These consolidated financial statements were prepared
in accordance with the IFRS as issued by the IASB and
adopted by the EU. The consolidated financial statements
are presented in thousands of euro except per share
amounts which are in euro.
(B) GOING CONCERN
At December 31, 2021, the Group had cash and cash
equivalents (including investments) of 10.0 million euro
in comparison with 24.8 million euro at December 31,
2020. Post-closing, the Group raised approximately
10 million euro from a group of new global healthcare
investors, led by Fidelity Management and Research and
other important European investors. As more thoroughly
set forth in section 3.6.1, on March 3, 2022, Oxurion suc-
cessfully raised an amount of 10.4 million euro in gross
proceeds by means of a private placement of 7,226,039
new shares at an issue price of 1.44 euro per share rep-
resenting a 4.35% premium to Oxurion’s closing price on
March 2, 2022.
In addition to available cash including that from the
post-closing private placement, the Group expects to meet
its working capital requirements through a combination of
debt and equity, including drawing future tranches from
the Negma Funding Program, accessing the debt markets
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OXURION ANNUAL REPORT 2021
through Kreos/Pontifax and/or other debt providers,
raising additional equity capital, attracting potential non-di-
lutive funding, and/or reducing spending, all of which is
uncertain. Under the Funding Program with Negma, the
Group will have access to up to 27.5 million euro in the
12-month period starting from these financial statements
provided the Group can and does draw the maximum
tranche on a monthly basis, which is subject to certain
conditions that may not be met.
The Board of Directors considers that there is a material un-
certainty with respect to the Group’s ability to continue as a
going concern. However, considering the current available
cash position, the budget for 2022, the funding possibilities
potentially available to the Group from Negma and others,
and the possibility the Group has to reduce its working
capital requirements if necessary, the Board of Directors
considers that, notwithstanding the material going concern
risk, it is appropriate for the Group to continue to account
on the basis of going concern accounting because that un-
certainty is sufficiently mitigated by the factors mentioned
above.
(C) BASIS OF CONSOLIDATION
Subsidiaries
The consolidated financial statements include all the
entities that are controlled by the Group. Control exists
when Oxurion directly or indirectly has the ability to direct
the relevant activities that significantly affect the entities’
returns, has exposure or rights to variable returns and the
ability to use its power over the entity to affect investors’
returns, Control is presumed to exist when Oxurion owns,
directly or indirectly, more than 50 percent of the voting
rights linked to the share capital. The existence and effect
of potential voting rights that are currently exercisable or
convertible are considered when assessing whether the
Group controls another entity. Applying this standard,
Oxurion’s subsidiaries ThromboGenics and Oncurious
have been consolidated.
Subsidiaries are fully consolidated from the date on which
control is transferred to the Group. They are deconsolidat-
ed from the date on which control ceases. A change in
the ownership interest of a subsidiary, without a change
in control, is accounted for as an equity transaction. Cash
flows from transactions relating to changes in ownership
that do not result in a change of control are classified as
financing activities.
Intra-group transactions, balances and unrealized profits
and losses on transactions between companies in the
Group are eliminated in preparing the consolidated
financial statements. Unrealized losses are eliminated in
the same way as unrealized profits unless the transaction
indicates an impairment loss on the assets transferred.
The accounting principles of the subsidiaries have been
adjusted where necessary to be consistent with the
principles adopted by the Group.
(D) BUSINESS COMBINATIONS AND
GOODWILL
Business combinations are accounted for by applying
the acquisition method. The cost of an acquisition is
measured as the aggregate of the consideration trans-
ferred as measured at fair value on the acquisition date
and the amount of any non-controlling interests in the
acquiree. For each business combination, the Company
elects whether to measure the non-controlling interests
in the acquiree at fair value or at the proportionate share
of the acquiree’s identifiable net assets. Acquisition-related
costs are expensed as incurred. The cost is attributed to
the identifiable assets, liabilities and contingent liabilities of
the acquiree. These acquired identifiable assets and (con-
tingent) liabilities are initially measured at their fair value on
the date of acquisition.
Goodwill is initially measured at cost (being the excess
of the aggregate of the consideration transferred and the
amount recognized for non-controlling interests) and any
previous interest held over the identifiable assets acquired
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OXURION ANNUAL REPORT 2021
and liabilities assumed. If the fair value of the net assets
acquired is in excess of the aggregate consideration trans-
ferred, the Company re-assesses whether it has correctly
identified all of the assets acquired and all of the liabilities
assumed and reviews the procedures used to measure
the amounts to be recognized at the acquisition date. If
the reassessment still results in an excess of the fair value
of net assets acquired over the aggregate consideration
transferred, then the gain is recognized in the profit or loss.
(E) FOREIGN CURRENCY TRANSLATION
Functional and presentation currency
The consolidated financial statements are presented in
thousands of euro, which is the functional currency of
Oxurion. All companies within the Group use the euro
as their functional currency, except for the US subsidiary,
whose functional currency is the US dollar (USD).
Transactions and balances in foreign currencies
Transactions in currencies other than the functional
currency of the entities are recorded at the exchange rates
prevailing on the date of the transaction. On each balance
sheet date, monetary assets and liabilities denominated
in foreign currencies are translated into the functional
currency at the exchange rates prevailing on the balance
sheet date.
Exchange rate differences relating to monetary items
include the difference between the amortized costs in the
functional currency at the start of the period, adjusted for
the actual interest (payments) during the period, and the
amortized costs of foreign currencies are translated at the
exchange rate at the end of the period.
Non-monetary assets and liabilities that are measured
at historical cost in a foreign currency by the Company’s
entities are translated using the exchange rates at the
dates of the initial transactions. Non-monetary assets
and liabilities carried at fair value that are denominated
in foreign currencies are translated at the exchange rates
prevailing on the date when the fair value was determined.
Gains and losses arising on retranslation using a foreign
currency are included in the net profit or loss for the period,
except for exchange differences arising on non-monetary
assets and liabilities at fair value where the fluctuations in
fair value are recognized directly in equity.
Foreign operations
On consolidation, the assets and liabilities including
goodwill and fair value adjustments arising on consoli-
dation of the Group’s foreign operations are translated at
the exchange rates prevailing on the balance sheet date.
Income and expense items are translated at the average
exchange rates for the period. Exchange rate differences
arising, if any, are classified as equity and transferred to the
Group’s translation reserve. Such translation differences
are recognized as income or expense items in the period
in which the operation is disposed of.
(F) REVENUE RECOGNITION
Revenue recognition for Oxurion consists of JETREA® vial
sales to distributors, royalties for JETREA® vial sales from
licensees, occasional upfront and milestone payments
agreed through license or collaboration contracts which
could include recharging of incurred services of cost, and
royalties.
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OXURION ANNUAL REPORT 2021
JETREA® sales
Performance obligations
Oxurion has identified one performance obligation within
its customer contracts for the sale of JETREA® product, i.e.
the delivery of goods to its customers.
Timing of revenue recognition
Oxurion recognizes revenue upon delivery of the goods to
the customers as that is the moment the customer obtains
control over the goods.
Transaction price – variable consideration
The variable consideration is estimated at contract
inception and constrained until it is highly probable that a
significant revenue reversal in the amount of cumulative
revenue recognized will not occur when the associated
uncertainty with the variable consideration is subsequently
resolved. The sales prices are fixed in the contract. However,
some contracts provide customers with a right of return
and rebates.
Oxurion accepts returns in certain limited cases, and they
need to be approved by Oxurion in order to be processed
by the distributors. The amount of revenue recognized is the
amount allocated to the satisfied performance obligation
taking into account variable consideration (incl. expected
returns). The estimated amount of variable consideration
is included in the transaction price only to the extent that it
is highly probable that a significant reversal in the amount
of cumulative revenue recognized will not occur and is
estimated on the basis of historical experience and the
specific terms in the individual agreements. A liability is
recognized for expected sales returns, rebates, trade and
cash discounts, charge-backs or other reimbursements
payable directly or indirectly to customers in relation to
sales made until the end of the reporting period. Oxurion
applies the ‘expected value method’ in order to estimate
such return accruals, and related asset.
Oxurion does not offer warranties, customer loyalty point
programs or any material financing component to its
customers. Oxurion has not received any non-cash consid-
eration. There are no costs to acquire customer contracts,
or costs to fulfill the customer contracts. Therefore, contract
balances are only recognized to the extent of accounts re-
ceivable, and refund liability (return accrual).
Royalty revenue on JETREA® sales
In the case of one distributor, royalties are generated
under license agreements based on licensee’s sales of
JETREA® products to the end-customers. As explained
above, revenue from the sale of goods is recognized at
the moment of delivery to the distributor. However, the
agreement stipulates that the royalty is earned once the
distributor subsequently sells the product to the end-cus-
tomer. Therefore, the royalty revenue is recognized once
the product is sold to the end-customer, based on quarterly
invoicing data. There is no specific performance obligation
for Oxurion to satisfy in order to be entitled to this royalty.
Occasional upfront, milestone and other payments
Revenue is only recognized at an amount that reflects the
consideration to which the Group expects to be entitled
in exchange for the satisfied performance obligation. A
performance obligation is satisfied when the control of
goods or services is transferred to a customer. Any upfront
payments or license fees for which there are subsequent
performance obligations, are initially reported as deferred
revenue and are recognized as revenue when perfor-
mance obligations are satisfied over the period of the de-
velopment, collaboration or manufacturing obligation.
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OXURION ANNUAL REPORT 2021
(G) RESEARCH GRANTS
On certain specific research projects, the research costs
incurred are partially reimbursed by Flanders Innovation
& Entrepreneurship (Vlaams Instituut Innoveren en
Ondernemen) (“VLAIO”), formerly known as IWT
(Agency for Innovation by Science and Technology in
Flanders – Agentschap voor Innovatie door Wetenschap
en Technologie in Vlaanderen). In line with IAS 20
“Government grants”, these grants are recognized as
government grant income over the term of the project
for which the grant was given when there is reasonable
assurance that the Group will comply with the conditions
attached to them and the grants will be received. Grants
that compensate the Company for expenses incurred are
deducted from the ‘Research and Development Expenses’
on a systematic basis in the same period in which the
expenses are incurred.
Oxurion has a track record of more than 10 years with these
types of projects for which it receives grants from VLAIO.
Grants are provided to Oxurion in order to support certain
R&D activities. Activities, related budget and types of costs
that will be paid are defined in the grant agreement. Over
the course of the project, Oxurion reports on the status of
activities and incurred expenditure to VLAIO on a regular
(quarterly) basis in order to receive grant advances. The
final assessment is performed by VLAIO at the end of
the project in order to determine the final grant amount.
Projects can take on average between two to five years.
Over the course of funded projects, Oxurion is confident
that all activities performed will not deviate from the agreed
scope, and that the final grant amount will not deviate from
the initially agreed amount (except in a limited number of
cases when Oxurion had finalized the project earlier and did
not spend the whole budget but has still received the grant
based on actual expenditure). Overall, Oxurion is confident
that the reasonable assurance as defined in the standard
is reached over the course of the project for the amounts
spent up to that moment, as the only condition attached
to the grant is to perform R&D activities in line with the
agreed-upon scope and in line with the set budget. There
are no other conditions attached to the grants and the
outcome of R&D activities does not impact the decision
of VLAIO whether the final grant will be received or not.
(H) INTANGIBLE ASSETS
Internally generated intangible assets
Research costs are charged to statement of profit and loss
as incurred.
An internally generated intangible fixed asset (see note
5.7.3) which arises from development activities undertak-
en in the Group is recognized only if all of the following
conditions are met:
• Technical possibility of making the intangible asset
ready for use.
• The intention is to complete the intangible asset and
use or sell it.
• Possibility of using or selling the intangible asset.
• It is probable that the intangible asset will generate
future economic benefit or demonstrate the existence
of a market.
• Availability of adequate technical and financial
resources to complete the development; and
• Availability to reliably measure the attributed expenses
for the intangible asset during development.
The patent costs for protecting the intangible assets are
recognized as an expense.
Where the criteria for capitalization of the development
expenses are not met, these expenses are recorded as
incurred during the period.
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OXURION ANNUAL REPORT 2021
After their initial recording on the statement of financial
position intangible assets are valued at cost less accumu-
lated depreciation and accumulated impairment losses.
Amortization of capitalized development costs are recog-
nized in the statement of profit and loss under ‘Research
and Development Expenses’. We refer to note 5.6.3 on
‘Research and Development Expenses’.
The capitalized costs of the patent are amortized over the
life of the patent as of the moment that it would generate
revenue.
Software licenses are amortized over three years.
Externally acquired intangible assets and outsourced
R&D costs
Payments made to third parties for subcontracted R&D,
where there is no transfer of intellectual property to
Oxurion, are expensed as internal R&D expenses in the
period in which they are incurred. Such payments are only
capitalized if they meet the criteria for recognition of an
internally generated intangible asset, as indicated above.
Oxurion has entered into various contracts for the ac-
quisition of licenses to intellectual property or third-party
know-how, as disclosed further in note 5.8 under the key
arrangements section. These assets are typically acquired
for consideration including upfront, milestone and royalty
payments.
Upfront payments made to third parties to in-license or
acquire intellectual property rights, patents, compounds,
products and know-how technologies to be used in R&D
activities, are capitalized as costs paid for a separately
acquired intangible asset under IAS 38.
The related milestone payments can only be capitalized
if they meet the criteria for recognition of an internally
generated intangible asset.
Royalties paid/payable for acquired intellectual property
are accrued for in line with the underlying sales and recog-
nized under the cost of sales.
(I) PROPERTY, PLANT AND EQUIPMENT
Property, plant and equipment are included at the historical
cost (material costs only) less accumulated depreciation
and impairment. Subsequent costs are included in the
carrying amount for the asset or booked as a separate
asset as appropriate, but only when it is probable that
future economic benefits associated with the item will be
generated for the Group and the cost price of the item can
be measured reliably. All other repair and maintenance
costs are charged to the statement of profit and loss as
incurred. The cost of assets retired or otherwise disposed
of, and the related accumulated depreciation, are included
in the statement of profit and loss as part of the gain or
loss on disposal in the year of disposal. Gains and losses
on disposal of property, plant and equipment are included
in other income or expense.
Depreciation is calculated using the straight-line method to
allocate the cost of property, plant and equipment to their
estimated residual values over their estimated useful lives
as follows:
• Property, plant and equipment: three to five years
• Furniture and fittings: three to five years
The depreciation methods, useful life and residual value
are revalued on each reporting date.
We refer to the notes 5.6.3 until 5.6.5 for the disclosures
of where the depreciation charges are recognized in the
statement of profit and loss.
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Subsequent costs
The cost of replacing part of an item of property, plant
and equipment is recognized in the carrying amount of
the item if it is probable that the future economic benefits
embodied within the part replaced will flow to the Group
and its cost can be measured reliably. The carrying amount
of the replaced part is derecognized. The costs of the day-
to-day servicing of property, plant and equipment are rec-
ognized in profit or loss as incurred.
(J) LEASED ASSETS
IFRS 16
The Group leases various offices, copiers, and cars. Rental
contracts are typically made for fixed periods of 3 to 4
years but may have extension options as described below.
Lease terms are negotiated on an individual basis and
contain a wide range of different terms and conditions.
The lease agreements do not impose any covenants, but
leased assets may not be used as security for borrowing
purposes.
Leases are recognized as right-of-use assets and a cor-
responding liability at the date at which the leased asset
is available for use by the Group. Each lease payment
is allocated between the liability and finance cost. The
finance cost is charged to profit or loss over the lease
period so as to produce a constant periodic rate of interest
on the remaining balance of the liability for each period.
The right-of-use asset is depreciated over the shorter of
these asset’s useful life and the lease term on a straight-
line basis
Assets and liabilities arising from a lease are initially
measured on a present value basis. Lease liabilities are
exclusively composed of fixed payments less any lease
incentives receivable.
The lease payments are discounted using the lessee’s in-
cremental borrowing rate, being the rate that the lessee
would have to pay to borrow the funds necessary to obtain
an asset of similar value in a similar economic environ-
ment with similar terms and conditions.
Right-of-use assets are measured at cost comprising the
amount of the initial measurement of the lease liability and
any lease payments made at or before the commence-
ment date.
Payments associated with short-term leases and leases of
low-value assets are recognized on a straight-line basis as
an expense in profit or loss. Short-term leases comprise
of some car leases and are leases with a lease term of
12 months or less. Low-value assets only comprise of one
copier.
We refer to note 5.7.2 for more information.
(K) IMPAIRMENT LOSSES ON GOODWILL,
INTANGIBLE ASSETS AND PROPERTY,
PLANT AND EQUIPMENT
Intangible assets with an indefinite useful life or not yet
available for use and goodwill are not subject to amortiza-
tion but are tested annually for impairment or if there is an
indication that an asset may be impaired.
Assets that are subject to amortization or depreciation are
reviewed for impairment whenever events or changes in
circumstances indicate that the carrying amount may not
be recoverable.
An impairment loss is recognized for the amount by
which the carrying amount of the asset exceeds its recov-
erable amount. The recoverable amount is the higher of
an asset’s fair value less the costs to sell the asset and
its value in use. These values are generally determined
based on discounted cash flow calculations. For the
purpose of assessing impairment, assets are grouped at
the lowest levels for which there are separately identifiable
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cash flows (cash-generating units). The impairment loss
is allocated first to reduce the carrying amount of any
goodwill allocated to the cash-generating unit pro rata to
the carrying amount of each asset in the unit. An impair-
ment loss recognized for goodwill cannot be reversed in a
subsequent period. For assets other than goodwill, where
an impairment loss is subsequently reversed, the carrying
amount of the asset (cash-generating unit) is increased
to the revised estimate of its recoverable value, but in
such a way that the increased carrying amount does not
exceed the carrying amount that would have been deter-
mined had no impairment loss been included for the asset
(cash-generating unit) in prior years. The reversal of an
impairment loss is included immediately in the statement
of profit and loss.
(L) INCOME TAXES
Income tax expenses in the statement of profit and loss
comprise the tax currently payable.
The tax currently payable is based on taxable profit for
the year. Taxable profit differs from net profit as reported
on the statement of profit and loss because it excludes
items of income or expense that are taxable or deductible
in other years, and it further excludes items that are never
taxable or deductible. The Group’s liability for current tax
is calculated using tax rates that have been enacted or
substantially enacted on the reporting date.
Deferred tax is the tax expected to be payable or recove-
rable on differences between the carrying amounts of
assets and liabilities in the financial statements and the
corresponding tax bases used in the computation of
taxable profit and is accounted for using the balance sheet
method.
Deferred tax liabilities are generally recognized for all
taxable temporary differences. Deferred tax assets are rec-
ognized to the extent that it is probable that taxable profits
will be available against which deductible temporary
differences can be utilized. Such assets and liabilities are
not recognized if the temporary difference arises from
goodwill (or negative goodwill) or from the initial recogni-
tion (other than in a business combination) of other assets
and liabilities in a transaction that affects neither the tax
profit nor the accounting profit.
Deferred tax liabilities are recognized for taxable temporary
differences arising on investments in subsidiaries and as-
sociates, and interests in joint ventures, except where the
Group is able to control the reversal of the temporary dif-
ference and it is probable that the temporary difference
will not reverse in the foreseeable future.
Deferred tax is calculated at the tax rates that are expected
to apply in the period when the liability is settled, or the
asset realized. Deferred tax is charged or credited in the
statement of profit and loss, except when it relates to items
charged or credited directly to equity, in which case the
deferred tax is also dealt with in equity.
Deferred tax assets and liabilities are offset when they
relate to income taxes levied by the same taxation authority
and the Group intends to settle its current tax assets and
liabilities on a net basis.
The Group also receives tax credits for R&D expenses.
These R&D expenses are recorded through P&L under
IFRS in the line item ‘Research and development expenses’
as the expenses do not meet the requirements in IAS 38
to be capitalized. The tax credit is not subject to unfulfilled
conditions. In case insufficient tax against which to set off
the tax credit, the credit can be carried forward during 5
consecutive assessment years. The tax credit receivable is
presented for the non-current portion in the line item ‘Non-
current tax credit’ and for the current portion in the line item
‘Current tax receivables’ of the consolidated statement of
financial position. At the end of 5 consecutive assessment
years, the balance of the unused tax credit is received in
cash from the government. The income from those tax
credits is included in the line item ‘Other operating income’
in the statement of profit and loss.
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(M) EMPLOYEE BENEFIT PLAN
Short-term employee benefits
Liabilities for wages and salaries that are expected to be
settled wholly within 12 months after the end of the period
in which the employees render the related service are rec-
ognized in respect of employees’ services up to the end
of the reporting period and are measured at the amounts
expected to be paid when the liabilities are settled. The
liabilities are presented as current employee benefit obli-
gations in the statement of financial position.
Pension benefits
Starting July 1, 2009, the Group changed the defined
benefit pension plan into a new defined contribution
pension plan. All acquired rights up to June 30, 2009, are
retained. Therefore, the Group has two pension plans: (i)
the initial defined benefit plan and (ii) the pension plan,
which is a defined contribution plan in structure.
The assets of both plans are held in separate trustee-ad-
ministered funds.
According to the Belgian legislation applicable to the
second pillar pension plans (the minimum guaranteed
return under the so-called “Law Vandenbroucke”), all
Belgian pension plans that are structured as defined con-
tribution plans are considered defined benefit plans under
IFRS and therefore are accounted for as such.
Because of this minimum guaranteed return, the employer
is exposed to a financial risk since further contributions
could be required if the return on the assets is not suffi-
cient to reach the minimum benefits to be paid.
The Group’s commitments under defined benefit plans,
and the related costs, are measured using the “projected
unit credit method” with actuarial valuations being carried
out at each balance sheet date by a qualified actuary. Past
service cost is included immediately to the extent that the
benefits are already vested, and otherwise the service is
amortized on a straight-line basis over the average period
until the benefits become vested. Remeasurements of the
net defined obligation are recognised directly within equity.
The retirement benefit obligation recognized in the
statement of financial position represents the fair value of
plan assets at the reporting date, less plan liabilities calcu-
lated using the projected unit credit method discounted
to its present value using yields available on high quality
corporate bonds that have maturity dates approximating
to the terms of the liabilities and are denominated in the
same currency as the post-employment benefit obliga-
tions less the effect of minimum funding requirements
agreed with scheme trustees.
No other long- or short-term benefits are granted to
employees.
Share-based compensation
The Group operates equity-settled, share-based compensa-
tion plans through which it grants share subscription rights
(giving the holder the right to subscribe to a specific number
of shares in accordance with the share option plan, hereafter
referred to as ‘subscription rights’) to the CEO, personnel,
and consultants as consideration in exchange for services
performed. The fair value of the services received in exchange
for the granting of the subscription rights is recognized as
an expense over the vesting period with a corresponding
increase in equity.
The total amount to be expensed over the vesting period
is determined by reference to the fair value at the date on
which the subscription rights are granted, measured using
the Black & Scholes model, taking into account the term and
conditions upon which the subscription rights were granted
excluding the impact of any non-market vesting conditions. At
each balance sheet date, the entity revises its estimates of the
number of subscription rights that are expected to become
exercisable except where forfeiture is only due to shares not
achieving the threshold for vesting. It recognizes the impact
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OXURION ANNUAL REPORT 2021
of the revision of original estimates, if any, in the statement
of profit and loss, and a corresponding adjustment to equity
over the remaining vesting period. The proceeds received, net
of any directly attributable transaction costs, are credited to
share capital (nominal value) and share premium when the
subscription rights are exercised.
(N) FINANCIAL INSTRUMENTS
Financial assets
INITIAL RECOGNITION AND MEASUREMENT
Financial assets are classified, at initial recognition, and subse-
quently measured, at either amortized cost, fair value through
other comprehensive income (“OCI”) or fair value through
profit or loss.
The classification of financial assets at initial recognition
depends on the financial asset’s contractual cash flow
characteristics and the Company’s business model for
managing them. With the exception of trade receivables
that do not contain a significant financing component,
the Company initially measures a financial asset at its fair
value plus, in the case of a financial asset not at fair value
through profit or loss, transaction costs.
Trade receivables that do not contain a significant financing
component are measured initially at the transaction price de-
termined under IFRS 15.
In order for a financial asset to be classified and measured
at amortized cost or fair value through OCI, it needs to give
rise to cash flows that are ‘solely payments of principal and
interest’ (“SPPI”) on the principal amount outstanding. This
assessment is referred to as the SPPI test and is performed
at an instrument level.
The Company’s business model for managing financial
assets refers to how it manages its financial assets in order
to generate cash flows. The business model determines
whether cash flows will result from collecting contractual cash
flows, selling the financial assets, or both.
SUBSEQUENT MEASUREMENT
For purposes of subsequent measurement, the following cat-
egories of financial assets are relevant to the Company:
• Financial assets at amortized costs (trade receivables,
term deposits); and
• Financial assets at fair value through OCI (investments in
debt instruments (bonds)).
FINANCIAL ASSETS AT AMORTIZED COST
This category is the most relevant to the Company. The
Company measures financial assets at amortized cost if both
of the following conditions are met:
• The financial asset is held within a business model with
the objective to hold financial assets in order to collect
contractual cash flows; and
• The contractual terms of the financial asset give rise on
specified dates to cash flows that are solely payments of
principal and interest on the principal amount outstanding.
Financial assets at amortized cost are subsequently measured
using the effective interest rate (“EIR”) method and are subject
to impairment. Gains and losses are recognized in profit or
loss when the asset is derecognized, modified or impaired.
The Company’s financial assets at amortized cost mainly
includes trade receivables and term deposits.
FINANCIAL ASSETS THROUGH OCI (DEBT INSTRUMENTS)
The Company measures debt instruments at fair value
through OCI if both of the following conditions are met:
• The financial asset is held within a business model with
the objective of both holding to collect contractual cash
flows and selling; and
• The contractual terms of the financial asset give rise on
specified dates to cash flows that are solely payments of
principal and interest on the principal amount outstanding.
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For debt instruments at fair value through OCI, interest
income, foreign exchange revaluation and impairment losses
or reversals are recognized in the statement of profit or loss
and computed in the same manner as for financial assets
measured at amortized cost. The remaining fair value changes
are recognized in OCI. Upon derecognition, the cumulative fair
value change recognized in OCI is recycled to profit or loss.
The Company’s debt instruments at fair value through OCI
includes investments in quoted debt instruments (bonds).
DERECOGNITION
A financial asset (or, where applicable, a part of a financial
asset or part of a group of similar financial assets) is primarily
derecognized (i.e., removed from the Company’s consolidated
statement of financial position) when:
• The rights to receive cash flows from the asset have
expired; or
• The Company has transferred its rights to receive cash
flows from the asset or has assumed an obligation to
pay the received cash flows in full without material delay
to a third party under a ‘pass-through’ arrangement and
either (a) the Company has transferred substantially all
the risks and rewards of the asset, or (b) the Company
has neither transferred nor retained substantially all the
risks and rewards of the asset but has transferred control
of the asset.
IMPAIRMENT OF FINANCIAL ASSETS
The Company recognizes an allowance for expected credit
losses (“ECLs”) for all debt instruments not held at fair value
through profit or loss. ECLs are based on the difference
between the contractual cash flows due in accordance with
the contract and all the cash flows that the Company expects
to receive, discounted at an approximation of the original
effective interest rate. The expected cash flows will include
cash flows from the sale of collateral held or other credit en-
hancements that are integral to the contractual terms.
For trade receivables and term deposits, the Company applies
a simplified approach in calculating ECLs. Therefore, the
Company does not track changes in credit risk, but instead
recognizes a loss allowance based on lifetime ECLs at each
reporting date.
Upon impairment, the carrying amount of the financial assets
is directly reduced by the impairment loss, with the exception
of trade receivables. For trade receivables, the carrying amount
is reduced by means of a separate impairment account. If a
trade receivable is considered uncollectible, it is written off in
the impairment account. Subsequent collection of amounts
that had previously been written off is credited in the impair-
ment account. Modifications in the carrying amount of the
impairment account are recognized in the statement of profit
and loss.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents comprise demand deposits and
other short-term, highly liquid investments (with less than
three months to maturity) that are readily convertible into a
known amount of cash and are subject to an insignificant risk
of fluctuations in value.
Financial liabilities
DISTINCTION BETWEEN FINANCIAL LIABILITIES
AND EQUITY
Financial liabilities and equity instruments issued by the Group
are classified according to the substance of the contractual
arrangements entered into and the definitions of a financial
liability and an equity instrument. An equity instrument is any
contract that evidences a residual interest in the assets of the
Group after deducting all its liabilities. The accounting policies
adopted for specific financial liabilities and equity instruments
are set out below.
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INITIAL RECOGNITION AND MEASUREMENT
Financial liabilities are classified, at initial recognition, at fair
value through profit or loss, loans and borrowings, payables,
or as derivatives designated as hedging instruments in an
effective hedge, as appropriate. All financial liabilities are
recognized initially at fair value and, in the case of loans
and borrowings and payables, net of directly attributable
transaction costs.
The Company’s financial liabilities include trade and other
payables and convertible loans.
SUBSEQUENT MEASUREMENT
For purposes of subsequent measurement, financial liabili-
ties are classified in two categories:
• Financial liabilities at fair value through profit or loss
• Financial liabilities at amortised cost (loans and
borrowings)
Financial liabilities at fair value through profit and loss
include financial liabilities designated upon initial recogni-
tion as at fair value through profit or loss and only if the
criteria in IFRS 9 are satisfied. The Group has designated
convertible loans at fair value through profit and loss, since
the convertible loans contain embedded derivatives for
which assessment of whether it is required to separate the
embedded derivative from the host contract to measure
the derivative at fair value, would be more complex or
result in less reliable measures than measuring the entire
instrument at fair value through profit or loss As such the
conditions in IFRS 9 4.3.5 are met and designation at fair
value through profit or loss is permitted.
The convertible loans are measured at fair value through
profit or loss, using the valuation methods described in
note 5.7.11. Transaction costs in relation to these financial
liabilities at fair value through profit or loss are expensed as
incurred and included in the line item ‘Finance expense’ in
the consolidated statement of profit and loss.
Trade and other payables are subsequently measured at
amortized cost, using the effective interest rate method.
(O) EQUITY INSTRUMENTS
Equity instruments issued by the Group are recorded at
the proceeds received. Direct issue costs are processed as
a deduction on equity.
(P) FINANCIAL INCOME AND EXPENSES
Financial income includes interest income on invested
funds. Realized and unrealized exchange differences are
reported under financial income and expenses.
(Q) SEGMENT REPORTING
An operational segment is a component of an entity:
• which exercises operating activities with which profits
are gained and costs can be made (including profits
and costs from transactions with other components of
the entity);
• where the operational results are judged regularly by
the highest managerial function of the entity who can
take important operational decisions in order to make
decisions regarding the granting of resources and to
evaluate the financial results of the segment (chief
operating decision maker); and
• for which separate financial information is available and
that is engaged either in providing specific products or
services (business segment), or in providing products
or services within a particular economic environment
(geographical segment), and which is subject to risks
and rewards that are different from those of other
segments.
The segment information is represented in a consistent
manner regarding the internal reporting to the chief
operating decision maker of the entity, i.e., the institu-
tion which takes the most important decisions, enabling
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OXURION ANNUAL REPORT 2021
decision-making of allocating resources to the segment
and evaluating financial performances of the segment. At
this moment, reporting is being done at global level within
Oxurion.
(R) INVENTORIES
Raw and ancillary materials and commodities are stated
at the lower of cost or net realizable value. The inventory
costing system is based on the FIFO-method.
Goods in process and finished goods are stated at the
standard manufacturing cost or net realizable value. The
inventory costing system is based on the FIFO-method.
The net realizable value test is performed for each reporting
period. Net realizable value is the estimated selling price in
the ordinary course of business less the estimated costs
of completion and the estimated costs necessary to make
the sale.
The standard manufacturing price of the goods in process
and of the finished goods, includes (i) the acquisition
value of the raw materials, (ii) consumables and ancillary
materials, (iii) the production costs that are directly attrib-
utable to the product, and (iv) the proportioned part of the
production costs that are only indirectly attributable to the
product, in so far that these costs cover the normal pro-
duction period.
The standard manufacturing price is compared to the
actual manufacturing price on annual basis, and adjust-
ments are made to the value of the inventory.
Impairment losses are calculated on the goods in process,
if their manufacturing cost, increased with the estimated
amount of the costs to be incurred is higher than the net
sales price at year-end.
Impairment losses on inventories are analyzed on a case-
by-case basis if the net realizable value is lower than the
cost. The calculation of the net realizable value takes into
account the specific characteristics of the inventories,
including the due date and if there are indications of a low
rotation.
5.5.4 Main accounting estimates,
assumptions and judgments
Reporting the financial statements in accordance with IFRS
requires management to rely on estimates, assumptions and
judgments that impact the amounts reported under assets
and liabilities, the notes on the latent assets and liabilities on the
date of the financial statements, and the reported amounts of
income and expenditure in the course of the reporting period.
The actual results may differ from these estimates.
The main assumptions relating to future developments
and the main sources of uncertainty regarding estimates
on the reporting date are set out below:
Going Concern
The consolidated financial statements were prepared on a
going concern basis.
At December 31, 2021, the Group had cash and cash
equivalents (including investments) of 10.0 million euro
in comparison with 24.8 million euro at December 31,
2020. Post-closing, the Group raised approximately
10 million euro from a group of new global healthcare
investors, led by Fidelity Management and Research and
other important European investors. As more thoroughly
set forth in section 3.6.1, on March 3, 2022, Oxurion suc-
cessfully raised an amount of 10.4 million euro in gross
proceeds by means of a private placement of 7,226,039
new shares at an issue price of 1.44 euro per share rep-
resenting a 4.35% premium to Oxurion’s closing price on
March 2, 2022.
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OXURION ANNUAL REPORT 2021
In addition to available cash including that from the
post-closing private placement, the Group expects to meet
its working capital requirements through a combination of
debt and equity, including drawing future tranches from
the Negma funding program, accessing the debt markets
through Kreos/Pontifax and/or other debt providers,
raising additional equity capital, attracting potential non-di-
lutive funding, and/or reducing spending, all of which is
uncertain. Under the funding program with Negma, the
Group will have access to up to 27.5 million euro in the
12-month period starting from these financial statements
provided the Group can and does draw the maximum
tranche on a monthly basis, which is subject to certain
conditions that may not be met.
The Board of Directors considers that there is a material
uncertainty with respect to the Group’s ability to continue
as a going concern. However, considering the current
available cash position, the budgets for 2022, the funding
possibilities potentially available to the Group from Negma
and others, and the possibility the Group has to reduce
its working capital requirements if necessary, the Board
of Directors considers that, notwithstanding the material
going concern uncertainty, it is appropriate for the Group
to continue to account on the basis of going concern ac-
counting because that risk is sufficiently mitigated by the
factors mentioned above.
Convertible loans
The Group has convertible loans with Negma and Kreos
Capital / Pontifax Ventures (the “The Convertible Loans”).
The Convertible Loans are measured at fair value through
profit and loss. In determing the fair value, the Group
makes certain judgments on the valuation model to be
applied and the probability that certain scenarios will occur
or not in the future. The terms and conditions and further
information is provided in note 5.7.11.
Revenue from Contracts with Customers
Under the five-step model established by the IFRS 15
standard, the Group’s main estimates and assessments relate
to identifying the performance obligations under its contracts
and allocating the transaction price according to the stand-
alone price of each of the performance obligations.
The majority of the Company’s sources of revenue are
derived from sales of JETREA® vials through our worldwide
license agreement with Inceptua and the tripartite agreement
with Eumedica. The Group has determined that there is
only one performance obligation for all contracts in place
with customers, that is to deliver the JETREA® product to
the customer. Therefore, the transaction price is equal to the
stand-alone selling price of each vial.
STEP REVENUE FROM SALE OF VIALS
1. Identification of the contract
Oxurion has a contract in place
with Inceptua and Eumedica for
the commercialization of JETREA®
as disclosed in Note 5.8 under Key
Agreements.
2. Identification of performance obli-
gations
In all distribution contracts, there is
only one performance obligation:
supply of goods to a third party.
3. Identification of the transaction price
Stand-alone price per vial is defined
in each agreement with the customer.
4. Allocation of the transaction price
As there is only one performance
obligation, there is no allocation of the
price, and therefore stand-alone price
per vial is recognized.
5. Revenue recognition
Revenue is recognized upon delivery
to the customer. Returns are credited
strictly at discretion of Oxurion, and
a provision for US returns is made
based on historical data. Rebate
provisions for sales made outside the
US, are made based on contractual
agreements and/or local regulations.
Share-based payment plans
The Group defines the cost of share-based payment plans
on the basis of the fair value of the equity instrument on
the grant date. Determining the fair value involves choosing
the most suitable valuation model for these equity instru-
ments, and the characteristics of the equity instrument and
its issue have a decisive impact. It also assumes the input
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OXURION ANNUAL REPORT 2021
in the valuation model of a number of relevant assump-
tions, such as the estimated useful life of the right, volatility,
etc. The assessments and the model are specified in more
detail in note 5.7.8.
Capitalization and impairment of intangible assets
The Group accounts for as intangible assets only rights
and intellectual property if acquired from third parties and
costs of internal development only if the conditions for the
recognition of intangible assets are met, otherwise such
costs are included in the statement of profit and loss when
they arise. The costs are capitalized only if the product is in
Phase 3 and the chances of future success are estimated
as highly probable. Accounting estimates and assess-
ments of future business evolution, growth, sales, likelihood
of success and discount rate are factors used in valuing
the intangible asset to execute the annual impairment test.
Taxes
The Group considers that there is a considerable un-
certainty regarding the future use of the tax losses of
Oxurion as it is very difficult to estimate the impact of the
patent deduction on the future tax result at this moment.
As the Group can only use the abovementioned patent
deduction on the basis of a tax ruling, the expectation
exists that the future tax gains will be rather limited. There
is also the uncertainty regarding the future use of the tax
losses with ThromboGenics.
5.5.5 Segment information
Segment information is represented in a consistent
manner regarding the internal reporting to the chief
operating decision maker of the entity, i.e., the person or
persons that takes the most important decisions, enabling
decision-making of allocating resources to the segment
and evaluating financial performances of the segment. At
this moment, reporting is being done at global level within
Oxurion.
5.5.5.1 Product sales information
Product sales relate only to JETREA® and are reported in
note 5.6.1.
5.5.5.2 Geographic information
The Global R&D, Clinical Operations and the General and
Administrative functions are located in Leuven , Belgium .
These operations represent approximately 95% of the
operating result. In the context of the Company’s business,
these activities do not lead to the need for geographic
information.
100% of intangible assets and almost all non-current
assets are located in Belgium.
5.5.5.3 Business unit reporting
Oxurion is a biotechnology company with focus on
diseases related to the retina and immuno-oncology.
Our molecules, ocriplasmin on the market with brand
name JETREA®, the plasma kallikrein inhibitor in a Phase
2 clinical trial, the pan-RGD integrin inhibitor in a Phase 2
clinical trial. These molecules represent more than 95%
of the income and expenses of the Company. As a con-
sequence, the consolidated statement of profit and loss
and of financial position are a valid representation of its
business unit as a whole.
5.5.5.4 Information about major customers
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Oxurion has one customer that individually accounts for
more than 73% of the total income at the end of 2021
(2020: 85%).
5.5.6 Financial instruments
The Company has trade receivables and payables and
cash, cash equivalents and investments amounting to 10.0
million euro compared to 24.8 million euro in cash, cash
equivalents and investments in 2020.
As of December 31, 2021, the majority of cash and cash
equivalents are cash at banks available on demand.
Besides these financial instruments, the Company also
issued convertible bonds during 2021 with two parties as
described in note 5.7.11.
Financial assets and financial liabilities are included in the
Group’s statement of financial position when the Group
becomes a party to the contractual provisions of the
instrument.
Fair Values
There is no significant difference between the fair value
and carrying amount of the Group’s cash and cash equiv-
alents, investments, trade and other receivables, other
current assets, trade payables and other current liabilities.
The carrying amount of cash and cash equivalents and
investments is equal to their fair value, given the short-
term maturity of these financial instruments. Similarly, the
carrying amounts of receivables and payables, which are
all subject to normal trade credit terms, are equivalent to
their fair values. Investments in bonds are measured at
fair value based on quoted market prices. The fair value
movements are recorded in OCI.
The Negma convertible loan are measured at fair value as
the nominal amount of the convertible loan plus 8%, which
is the difference between the share price and the 92% of
the lowest closing VWAP (8%) (level 1).
The Kreos Capital / Pontifax Ventures convertible loan
is measured at fair value whereby fair value is estimated
considering probabilities of the occurrence of different
scenarios. The probabilities are estimated by the Group
and consist level 3 fair value assessments. A reasonable
change of the probabilities between the different scenario’s
would not lead to a material change in the fair value.
5.5.7 Financial risk management
The financial department of the parent Company coor-
dinates access to the national and international financial
markets and considers and manages the financial risks
relating to the activities of the Group. The financial risks
related to the operating activities of the Group are confined
to a minimal currency exchange rate risk. There are no
risks worth mentioning, such as liquidity risks or interest
rate risks as the Group has no debts with variable interest
rates. The Group does not buy or trade in financial instru-
ments for speculative purposes.
(A) CAPITAL MANAGEMENT
The Group manages its capital with the aim of ensuring
that the Group can continue to operate. At the same
time, the Group wishes to generate a return for its stake-
holders via the results of its research activities, which in
turn are expected to lead to an increase in the value of
the Company’s shares. This strategy has not changed
compared to previous years.
The capital structure of the Group consists of investments,
cash, cash equivalents and restricted cash, and equity at-
tributable to the equity holders of the Company, including
capital, reserves and results carried over, as indicated in
notes 5.7.7 and 5.7.8 respectively.
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OXURION ANNUAL REPORT 2021
The Group manages its capital structure and makes the
necessary adjustments in light of changes in economic
circumstances, the risk characteristics of the underlying
assets and the projected cash requirements of current
research activities. When assessing the capital structure,
the current cash position and projected cash burn are used
as the key parameters. Cash burn is defined as the net
result corrected for depreciation and amortization, stock-
based compensation and less investments in fixed assets.
The Group wishes to maintain a capital structure that is
sufficient to fund research activities during a period of at
least twelve months. Any cash inflows from possible coop-
eration agreements or other cash generating activities are
not taken into account. To maintain the capital structure,
the Group can issue new shares or conclude new finance
arrangements.
The Group is not subject to any externally imposed capital
requirements.
(B) MAIN ACCOUNTING PRINCIPLES
Details of the main accounting principles and methods,
including the inclusion criteria, the valuation basis, and the
basis on which income and costs are recognized, for each
category of financial assets, liabilities and equity instru-
ments, are explained under 5.5.3.
(C) CATEGORIES OF FINANCIAL
INSTRUMENTS
The financial instruments currently held by the Company
are:
• Trade receivables and payables
• Short-term financial liabilities
• Cash, cash equivalents and investments (we refer to
note 5.7.6) amounting to 10.0 million euro (2020: 24.8
million euro). Investments are mainly in very low risk
bonds and term investments.
• Convertible bonds (we refer to note 5.5.6)
(D) MARKET RISK
The Group’s activities are such that the Group’s income is
exposed to financial risks arising from currency exchange
rate fluctuations because a substantial proportion of
the research expenditure is invoiced in USD and pound
sterling (GBP). The Group tries to compensate the inflows
and outflows in foreign currency.
Analysis of sensitivity to exchange rates
The Group is mainly exposed to fluctuations in GBP and
USD against the euro.
The sensitivity of loss to changes in the exchange rates
arises mainly from USD and GBP denominated financial
instruments.
IN ‘000 EURO IMPACT ON POST TAX LOSS
2021 2020
USD/euro exchange rate increase 10% -339 -47
USD/euro exchange rate decrease 10% 415 57
GBP/euro exchange rate increase 10% 6 -25
GBP/euro exchange rate decrease 10% -7 30
(E) INTEREST RISK MANAGEMENT
At the moment, the Group has external debt financing
with a fixed interest rate. The Group does not have any
contracts with a variable interest rate. Consequently, there
is currently no need for a specific interest risk manage-
ment policy in the Group.
(F) CREDIT RISK MANAGEMENT
Credit risk relates to the risk that a counterparty will fail to
fulfill their contractual obligations with the result that the
Group would suffer a loss. The Group’s policy focuses on
only working with credit-worthy counterparties and, where
necessary, requiring adequate securities. Information about
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OXURION ANNUAL REPORT 2021
the creditworthiness of counterparties is provided by inde-
pendent ratings agencies and, if this is not available, the
Group uses information that is publicly available as well
as its own internal records. Credit risk is managed by the
financial department of Oxurion by means of individual
follow-up of credit per counterparty.
The Group has a limited number of customers. Credit
risk is considered as remote due to a history of no issues
with payment collection. So far, the collection of payments
happened without any delay and with limited credit risk.
The credit risk on cash investments is limited given that
the counterparties are banks with high credit scores attrib-
uted by international rating agencies.
(G) LIQUIDITY RISK MANAGEMENT
The Group manages its liquidity risk by ensuring adequate
reserves and by constantly checking the projected and
actual cash flows. At the moment, the Group is not subject
to any substantial liquidity risk.
5.5.8 Remuneration of Key
Management Personnel
Key management personnel were constituted in 2021 of:
• ViBio BV, represented by Dr. Patrik De Haes – CEO
(until May 15, 2021)
• Tom Graney – CEO (as of May 15, 2021)
The key management personnel constitute the CEO as
per Company’s corporate chapter.
Remuneration of key management personnel was as
follows:
IN '000 EURO (EXCEPT FOR THE NUMBER OF STOCK
OPTIONS) (AS AT 31 DECEMBER)
2021 2020
Short-term benefits - consultancy fees / salary 652 455
Termination benefits 159 0
Cost of stock options granted in the year 662 0
Number of stock options granted in the year 600,000 0
No loans, quasi-loans or other guarantees have been given
to any of the executive directors.
5.5.9 COVID-19 impact
The primary impact of the COVID-19 pandemic on the
Company was to (i) cause a short delay in the time
required for completing Part A of the KALAHARI trial
due to the increased time required to obtain regulato-
ry approvals, recruit sites and to recruit patients and the
increased strain on Clinical Research Organization (CRO)
resources, and (ii) contribute to the delay in the start of
Part A of the INTEGRAL trial due to delays in obtaining the
prerequisites required to update the Investigational New
Drug application and begin the trial.
Mitigation measures
Personnel
The Group has always placed priority on the health of its
employees and their capacity to continue working.
As the Group’s premises are not of such size that could
guarantee social distancing, during confinement 100% of
personnel were working from home, except staff working
on ongoing trials in labs where this could be done following
the safety protocols. Lab personnel who were about to
start trials were put on temporary unemployment during
April and May 2020 to allow for social distancing in the
labs.
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OXURION ANNUAL REPORT 2021
Measures imposing circulation routes and restrictions on
the number of employees present in meeting rooms were
put in place in order to ensure social distancing for staff
present in the office.
Operations
At the start of COVID-19 crisis, Oxurion was preparing the
launch of two Phase 2 clinical trials. In agreement with
our third-party CRO, preparation work was shifted from
the sequential activation of clinical trial centres to bringing
more clinical trials in administrative readiness status faster,
allowing faster activation of clinical trial centres when the
COVID-19 situation would allow. By this approach Oxurion
was able to avoid a major delay in starting the THR-149
Phase 2 trial.
Special transactions (relief & support measures)
In line with the impact of COVID-19 outlined above, Oxurion
utilized in 2020 the relief and support measures proposed
by the Belgian authorities in the following manner:
• Laboratory personnel were put on temporary unem-
ployment receiving unemployment benefits offered by
the state.
• The working days of other employees were reduced
from 100% to 80% with COVID-19 unemployment
compensation offered by the Belgian measures.
• Contractors have voluntarily followed the same 20%
reduction of working hours.
• Directors have agreed to a reduction of 20% of their
compensation.
The above measure lasted from mid-April to end of June
2020.
Ability to continue as a going concern
Oxurion is a development stage biotech company and as
such is utilizing cash. While the absolute amount of the
delay caused by the pandemic was not significant, given
the significant costs related to the clinical trials and the
running cost of the Company, this contributed to the
financial strain on the Company by delaying the data from
Part A of the KALAHARI trial and increasing costs. Further,
the issues are expected to continue in the future and to
impact the time required for the Trials, but less significantly
and this has to the extent possible been factored into the
trial timelines.
We refer to note 5.5.3 (B) for more information.
Impact on carrying amount of assets
The COVID-19 measures had no impact on the carrying
amount of assets. The delays regarding the initiation of
the studies outlined above are considered not to have a
material impact on the timing of the trial results, as such
the Company did not change the assumptions in the value
in use models and therefore there were no indicators for
impairment.
Tax assets
In the Group’s view, COVID-19 will not influence the
Company’s recovery of loss carryforwards and the tax
credit for R&D, which are the most important tax assets
of the Company. It is the Company’s success in develop-
ment of its compounds that will generate value eventually
enabling the Group to benefit from deduction of carry
forward losses and the tax credit refund.
Contingent assets and liabilities
No specific contingent assets and liabilities can be linked
to the COVID-19 situation.
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OXURION ANNUAL REPORT 2021
5.6 NOTES TO THE CONSOLIDATED
STATEMENT OF PROFIT AND LOSS
5.6.1 Income
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Sales 967 2,000
Income from royalties 161 78
Total income 1,128 2,078
In 2020, Oxurion entered into a global license agreement with
Inceptua for the commercialization of JETREA®.
In 2021, Oxurion JETREA® sales amounted to 1.0 million euro
out of which 61% is attributed to Belgium and the remaining
to other countries. In 2020, Oxurion JETREA® sales amounted
to 2.0 million euro out of which 13% was attributed to Belgium,
55% to Germany, 12% to the US and the remaining to other
countries.
For further details we refer to the Key Agreements’ section as
disclosed in note 5.8.
5.6.2 Cost of sales
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
License rights on sales -48 -64
Cost of goods -564 -486
Total cost of sales -612 -550
The license rights on sales include the royalties that Oxurion
owes to the companies RCT and LSRP on the basis of
JETREA® sales.
5.6.3 Research and development expenses
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Employee benefits -5,900 -5,287
Subcontracted R&D activities -11,451 -10,443
Reagents and materials -419 -725
Patent expenses -279 -379
Consultancy fees -1,984 -2,446
Other -260 -2,452
Depreciation and amortization -584 -963
Government grants 84 489
Income from recharge of costs 97 153
Total research and development expenses -20,696 -22,053
The increase in employee benefits in 2021 compared to
2020 is mainly the result of the decision of the Company
to reduce the headcount to focus on its clinical assets,
hence the severance attributable to these reductions are
included in 2021.
The subcontracted R&D activities relate to the outsourced
services used to develop Oxurion’s projects in the pre-
clinical and clinical phase. The costs in 2020 and 2021,
are mainly the concurrent running of the THR-149 and
THR-687 clinical studies.
In 2021, other expenses were 0.3 million euro compared
to 2.5 million euro in 2020 as there was a 2.0 million euro
milestone due to Bicycle Therapeutics in 2020.
The government grants are grants received from the
VLAIO, formerly known as IWT. Oxurion currently has
one grant agreement with VLAIO. The Company doesn’t
expect to receive amounts in the future for the currently
approved grant agreements. These grants are provided to
Oxurion to support certain R&D activities. We refer to the
accounting policy in note 5.5.3.
Over the course of the project, Oxurion reports on the
status of activities and incurred expenditure to VLAIO on a
regular basis to receive grant advances. As such Oxurion
and VLAIO follow up over the course of the projects that
all activities performed will not deviate from the agreed
scope and that the final grant amount will not deviate from
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OXURION ANNUAL REPORT 2021
the initially agreed amounts. Overall, Oxurion is confident
that the reasonable assurance as defined in the standard
is reached over the course of the project for the amounts
spent up to that moment, as the only condition attached
to the grant is to perform R&D activities in line with the
agreed-upon scope and in line with the set budget and
maintain a presence in the same region. There are no
other conditions attached to the grants and the outcome
of R&D activities does not impact the decision of VLAIO
whether the final grant will be received or not.
Government grants that compensate the Company for
expenses incurred and income from the recharge of
costs are deducted from the research and development
expenses on a systematic basis in the same period in
which the expenses are incurred.
5.6.4 General and administrative expenses
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Employee benefits -2,653 -1,397
Consultancy fees -3,470 -2,889
Insurance -343 -336
Other -622 -771
Depreciation and amortization -62 -96
Total general and administrative expenses -7,150 -5,489
The most important piece of the general and administra-
tive expenses are ICT contractors, management, audit fees,
Board of Directors’ fees, investor relations contractors, legal
and funding fees and HR services.
5.6.5 Selling expenses
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Employee benefits -975 -1,682
Distribution costs -91 -407
Contractor and consultancy fees -296 -874
Other -116 -239
Depreciation and amortization -31 -50
Income from recharge of costs 235 0
Total selling expenses -1,274 -3,252
In 2021, the selling expenses of Oxurion were 1.3 million
euro compared to 3.3 million euro in 2020. The decrease
is mainly an effect of the outlicensing of JETREA® to
Inceptua.
5.6.6 Other operating income
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Other operating income 1,245 777
Total other operating income 1,245 777
In 2021, Oxurion received other operating income of 1.3
million euro compared to 0.8 million euro in 2020. The
accrued tax credit amounts to 0.9 million euro in 2021
compared to 0.7 million euro in 2020.
5.6.7 Finance income
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Interest 9 21
Exchange rate gain (on USD and GBP) 162 447
Total finance income 171 468
As a result of USD revaluations, the unrealized exchange
gain in 2021 amounted to 0.146 million euro (2020: 0.419
million euro) whereas 0.016 million euro exchange gains
were realized (2020: 0.028 million euro).
5.6.8 Finance expense
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Bank costs -26 -26
Impairment on short-term financial investments -5 -6
Fair value adjustment convertible bonds -372 0
Other -713 -28
Exchange rate loss (on USD and GBP) -152 -348
Total finance expense -1,268 -408
The fair value adjustment convertible bonds relate for
0.347 million euro to the Negma convertible bond and for
0.025 million euro to the Kreos/Pontifax convertible bond.
We refer to note 5.7.11 for more information.
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OXURION ANNUAL REPORT 2021
The other financial expenses relate for 0.525 million euro
to the Negma convertible bond, 0.177 million euro to the
Kreos/Pontifax convertible bond and 0.011 million euro to
other.
As a result of USD revaluations, the unrealized exchange
losses in 2021 amounted to 0.138 million euro (2020:
0.309 million euro) whereas 0.014 million euro exchange
losses were realized (2020: 0.039 million euro).
5.6.9 Employee benefits
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Wages, salaries and bonuses -8,030 -7,507
Share-based compensation expenses -1,107 -458
Pension costs -391 -401
Total -9,528 -8,366
The pension costs included in the table above consists
for 0.374 million euro (2020: 0.373 million euro) of costs
related to defined benefit plans and for 0.017 million euro
(2020: 0.028 million euro) of costs related to defined con-
tribution plans. We refer to note 5.7.9 for more information
on the defined benefit plans.
The average number of full-time equivalents (including
executive directors) was as follows:
IN NUMBERS 2021 2020
Research and development 45 55
General and administration 10 12
Selling 1 3
Total 56 70
The share-based compensation expense included in the
statement of profit and loss is given below:
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Research and development expenses 289 203
General and administrative expenses 798 209
Selling expenses 20 46
Total 1,107 458
We refer to note 5.7.8, for further information regarding the
share-based payment plans.
5.6.10 Taxes
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Current tax expense -3 0
Deferred tax expense 0 0
Tax expenses in statement of profit and loss -3 0
Effective tax rate 0.00% 0.00%
The tax expense as shown above has been calculated in
conformity with local and international tax laws. The tax
on the Company’s loss (-)/ profit before tax differs from
the theoretical amount that would arise using the domestic
rate in Belgium on loss (-) / profit of the year and is as
follows:
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
Loss (-) / profit before tax -29,592 -28,560
Expected tax based on tax rate of the parent
company (25% - theoretical)
7,398 7,140
Disallowed expenses -51 -65
Tax deductions and non-taxable income 144 296
Change in unrecognized deferred taxes -9,947 -7,255
Difference in tax rates from other jurisdictions -6 -1
Permanent differences 2,460 -115
Tax expense of the year (effective) -3 0
The main difference between the theoretical tax and the
effective tax for the year 2020 and 2021 can be primarily
explained by the unrecognized deferred taxes for which
the Company conservatively assesses that it is not likely
that these will be utilized in the foreseeable future.
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OXURION ANNUAL REPORT 2021
5.6.11 Result per share
Earnings per share
The calculation of basic earnings/loss per share on
December 31, 2021, is based on the holders of ordinary
shares attributable loss (-) / profit from 2021 (29.595)
million euro (2020: (28.560) million euro) and a weighted
average number of ordinary shares outstanding during
2021 of 38,410,532 (2020: 38,291,950), calculated as
follows:
2021 2020
Issued ordinary shares per 1 January 38,291,950 38,291,950
Effect of capital increases through issue of
shares
118,582 0
Average number of ordinary shares per 31
December
38,410,532 38,291,950
IN '000 EURO, EXCEPT FOR RESULT PER SHARE 2021 2020
Result of the year -29,595 -28,560
Basic/Diluted result per share -0.77 -0.75
As consideration in exchange for services performed, the
Group has granted subscription rights to buy ordinary
shares to the CEO and personnel.
In addition, the Group also has convertible loans with
Negma and Kreos/Pontifax (see note 5.7.11) for which
potential ordinary shares can be issued upon conversion.
The effect of these potential ordinary shares are anti-
dilutive as there was a loss in 2021 and 2020. As such,
the diluted earnings per share are the same as the basic
earnings per share.
See note 5.7.8 for an overview of the number of outstand-
ing subscription rights at each year-end.
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5.7 NOTES TO THE CONSOLIDATED STATEMENT OF FINANCIAL POSITION
5.7.1 Property, plant and equipment
IN '000 EURO
MACHINES, PLANT
AND EQUIPMENT
FURNITURE AND
FITTINGS
TOTAL
As at 1 January 2020
Cost 6,577 4,288 10,865
Accumulated depreciation and disposals -6,382 -4,139 -10,521
Exchange differences -22 18 -4
Net carrying amount 173 167 340
Year ended on 31 December 2020
Additions 97 22 119
Depreciation expenses -69 -125 -194
Disposals -18 -12 -30
Exchange differences -4 -1 -5
Net carrying amount 179 51 230
As at 31 December 2020
Cost 6,674 4,310 10,984
Accumulated depreciation and disposals -6,469 -4,276 -10,745
Exchange differences -26 17 -9
Net carrying amount 179 51 230
Year ended on 31 December 2021
Additions 25 7 32
Depreciation expenses -47 -30 -77
Disposals -60 -8 -68
Exchange differences 0 3 3
Net carrying amount 97 23 120
As at 31 December 2021
Cost 6,699 4,317 11,016
Accumulated depreciation and disposals -6,576 -4,314 -10,890
Exchange differences -26 20 -6
Net carrying amount 97 23 120
As at December 31, 2021, property, plant and equipment with an original cost of 3.4 million euro (2020: 6.5 million euro) that
has already been fully depreciated is still in use. No property, plant and equipment is pledged or in limited use.
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OXURION ANNUAL REPORT 2021
5.7.2 Leases
IN ‘000 EURO
LAND AND
BUILDINGS
PROPERTY, PLANT
AND EQUIPMENT
TOTAL
Right-of-use assets
As at January 1, 2020 1,826 386 2,212
Additions 0 30 30
Amortization -751 -164 -915
Modification* -258 0 -258
As at December 31, 2020 817 252 1,069
As at January 1, 2021 817 252 1,069
Additions 0 34 34
Amortization -466 -134 -600
Modification** -251 0 -251
As at December 31, 2021 100 152 252
Lease liabilities
As at January 1, 2020 1,846 387 2,233
Additions 0 30 30
Lease payments -740 -163 -903
Modification* -264 0 -264
As at December 31, 2020 842 254 1,096
Of which are:
current lease liabilities 517 133 649
non-current lease liabilities 325 121 447
Total 842 254 1,096
As at January 1, 2021 842 254 1,096
Additions 0 34 34
Lease payments -463 -136 -599
Modification** -266 0 -266
As at December 31, 2021 113 152 265
Of which are:
current lease liabilities 113 108 221
non-current lease liabilities 0 44 44
Total 113 152 265
(*) Oxurion moved forward to more structural telework and decided to terminate
part of the lease agreement with Bio-Incubator
(**) Oxurion decided to focus on its clinical development strategy and decided to
terminate part of the lease agreement with Bio-Incubator
The lease payments in the table above of 0.599 million
euro (2020: 0.903 million euro) is reconciled to the line
item ‘Principal paid on lease liabilities’ in the consolidated
statement of cash flows.
The amortization of the right-of-use assets is reconciled
to the line item ‘Amortization of right-of-use assets’ in the
consolidated statement of cash flows.
On December 31, 2021, Oxurion had outstanding lease
obligations, which become due as follows:
IN ‘000 EURO
UP TO 3
MONTHS
BETWEEN
3 AND 12
MONTHS
BETWEEN
1 AND 2
YEAR(S)
BETWEEN
2 AND 5
YEARS
Lease obligations 91 129 30 15
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OXURION ANNUAL REPORT 2021
5.7.3 Intangible assets
IN '000 EURO
INTERNALLY
GENERATED
MICROPLAS-
MIN PHASE III
LICENSE
NUVUE
LICENSE
GRIFOLS
LICENSE
GALAPAGOS
LICENSE VIB
LICENSES
OTHER
TOTAL
As at 1 January 2020
Cost 53,597 12,019 9,935 1,000 982 168 77,701
Accumulated amortization expenses -22,700 -6,578 -5,381 0 0 -168 -34,827
Accumulated impairment losses -30,897 -5,441 -4,554 0 0 0 -40,892
Net carrying amount 0 0 0 1,000 982 0 1,982
Year ended December 31, 2020
Additions 0 0 0 0 270 0 270
Disposals 0 0 0 0 0 0 0
Amortization expenses 0 0 0 0 0 0 0
Impairment losses 0 0 0 0 -125 0 -125
Net carrying amount 0 0 0 1,000 1,127 0 2,127
As at December 31, 2020
Cost 53,597 12,019 9,935 1,000 1,252 168 77,971
Accumulated amortization expenses -22,700 -6,578 -5,381 0 0 -168 -34,827
Accumulated impairment losses -30,897 -5,441 -4,554 0 -125 0 -41,017
Net carrying amount 0 0 0 1,000 1,127 0 2,127
For the period ended on December 31, 2021
Additions 0 0 0 0 0 0 0
Disposals 0 0 0 0 0 0 0
Amortization expenses 0 0 0 0 0 0 0
Impairment losses 0 0 0 0 -1,127 0 -1,127
Net carrying amount 0 0 0 1,000 0 0 1,000
As at December 31, 2021
Cost 53,597 12,019 9,935 1,000 1,252 168 77,971
Accumulated amortization expenses -22,700 -6,578 -5,381 0 0 -168 -34,827
Accumulated impairment losses -30,897 -5,441 -4,554 0 -1,252 0 -42,144
Net carrying amount 0 0 0 1,000 0 0 1,000
Intangible assets with definite useful lives:
In the development of JETREA®, Oxurion has capital-
ized ocriplasmin clinical trial costs (internally generated
Microplasmin Phase 3), and two externally acquired
licenses that were used for development of JETREA®:
NuVue and Grifols. The capitalized costs were amortized
from the date of commercialization of JETREA® in 2013,
over the life of the patent which was determined to be
11.8 years, but as there was an impairment indicator, they
were fully impaired before that date. We refer to the ac-
counting policy section for more details on ocriplasmin.
Intangible assets pledged:
In the context of the Kreos/Pontifax convertible bond,
the Group has created a pledge up to 10 million euro
over (i) the Company’s business and (ii) the patents and
patent application in families WO2020043533 and
WO2005123734, which have been registered in the
Belgian national pledge register. In addition, a pledge will
be registered over the US patent 10,703,752 (applica-
tion 16/554,259 filed on August 19, 2019) in the United
States Patent and Trademark Office.
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OXURION ANNUAL REPORT 2021
Intangible assets with indefinite useful lives:
The Galapagos License relates to an externally acquired
license by Oxurion in relation to program THR-687, for
the development and commercialization of integrin
antagonists. The license is not yet amortized as the de-
velopment of the product under program THR-687 for
which this license is used, is currently still in progress. In
light of this fact, the IP does currently not have a fore-
seeable time period during which the asset would be
expected to generate cash inflows. The useful life of this
license will therefore be re-assessed when the devel-
opment program reaches a stage when the Group can
estimate the foreseeable time period during which the
license would be expected to generate revenues. Annual
impairment reviews are performed, and there is no need
for impairment of this license. For more details on the
agreement and accounting policy treatment, we refer to
note 5.8 under key arrangements section.
The VIB license relates to an externally acquired license
by Oncurious for a portfolio of five unique next generation
immuno-oncology assets which are being used in further
development. This asset was given as a contribution in
kind by VIB and was capitalized based on fair value deter-
mined by an independent valuator. The license is impaired
as per June 30, 2021, as Oxurion would no longer make
direct investments in these assets. The Company also
explored the option of taking on an additional investor in
Oncurious, but was unable to secure a transaction under
acceptable terms. For more details on the agreement and
accounting policy treatment, refer to note 5.8 under key
arrangements section. Besides the portfolio of five immu-
no-oncology assets the VIB License column also contains
TB-403 with a gross book value of 0.125 million euro,
which was impaired during 2020.
Impairment test at December 31, 2021
Indefinite lived intangible assets are tested for impair-
ment annually since these are not subject to amortization.
Definite lived intangible assets are tested for impairment
if indicators exist.
The Galapagos license, with a carrying value as per
December 31, 2021, of 1 million euro is an indefinite lived
intangible assets and is tested for impairment annually
on a standalone basis and as part of its cash-generating
units.
The Galapagos license was tested for annual impair-
ment as per December 31, 2021, based on a discount-
ed cash flow model in which the revenues are based
on patient-based algorithms for estimating the number
of patients treated over time with the considered asset,
resulting in sales volume and value estimated from
sources such as peer-reviewed publications for popu-
lation as well as market potential. The time period over
which the discounted cash flow model was applied is the
period to end of data exclusivity and as such the lifetime
of the individual IP of the program. The key assumptions
used in the determination of the recoverable amount are
the WACC, the development success probabilities and
the population estimates.
The recoverable amount of the asset in the risk-adjusted
net present value model significantly exceeds the carrying
amount considering a WACC of 13% (2020: 13%). The
risk-adjusted net present value model considers the
industry standard clinical development success probabil-
ities for a molecule to reach the market. A reasonable
increase in the WACC would not lead to an impairment
loss.
Based upon the above analyses management concluded
that no impairment needed to be recorded.
105
OXURION ANNUAL REPORT 2021
The VIB IP license has been fully impaired as per June
30, 2021, as a result of the existence of an impairment
indicator given the announcement in the first half of 2021
that Oxurion would no longer make direct investments in
Oncurious (oncology) and as a result the oncology assets
were impaired in the amount of 1.127 million euro.
5.7.4 Trade and other receivables, non-
current tax credit and current
tax receivables
Trade and other receivables
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Trade receivables 81 691
Other receivables 2,276 523
Prepaid expenses and other current assets 160 237
Total 2,517 1,451
Other receivables relate mainly to prepayments: 2.228
million euro in 2021, compared to 0.523 million euro in
2020. These advances were paid upfront to various CRO
partners mainly in relation to direct costs and pass-through
costs.
Allowance for bad debt is booked on the basis of an
estimate of lifetime credit losses at each reporting, taking
into account the payment history of the other party. As per
December 31, 2021, and 2020, there are no material aged
trade receivables.
The table below shows the evolution of key trade receiv-
able amounts on the reporting date:
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
BioInvent 0 325
Eumedica 25 216
Inceptua Group 56 52
Syneos Health 0 61
Other trade receivables 0 37
Total 81 691
Management has sufficient confidence in the creditworthi-
ness of the counterparty that the trade receivable amounts
are considered collectable in full.
Aging balance of receivables that are due, but that are
still considered collectable based on contractual payment
terms:
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
0 – 60 days 81 551
60 – 90 days 0 71
90 – 120 days 0 65
more than 120 days 0 4
Total 81 691
When determining the collectability of a trade receivable,
the Group takes into account any change in the quality of
the receivable between the date on which the credit was
granted and the reporting date.
The Group has no securities linked to these receivables.
Taxes
Non-current tax receivables
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Tax credit 4,000 3,708
Total 4,000 3,708
Oxurion receives tax credits for R&D expenses. In case
insufficient tax against which to set off the tax credit, the
credit can be carried forward during five consecutive fiscal
years. At the end of these five fiscal years, the balance of the
unused tax credit is received in cash from the government.
106
OXURION ANNUAL REPORT 2021
Current tax receivables
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Recoverable VAT 242 311
Recoverable withholding tax 4 9
Tax credit 568 370
Other taxes 31 29
Total 845 719
The outstanding tax claims relate to recoverable VAT, re-
coverable withholding tax on interest, US corporate income
tax and short-term tax credit.
5.7.5 Inventories
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Raw and ancillary materials, goods in process and
finished goods
60 85
Total 60 85
The inventories of raw and ancillary materials, goods in
process and finished goods are based on the net value,
after impairment losses. The impairment losses on the
inventories recognized in cost of goods amount to 0.629
million euro in 2021, compared to 0.801 million euro in
2021.
5.7.6 Investments
IN ‘000 EURO (AS AT 31 DECEMBER) 2021 2020
Other investments 247 288
Total investments 247 288
FINANCE ASSETS ACCORDING TO CATEGORIES
DEFINED IN IFRS 9
INVESTMENTS AT
AMORTIZED COST
INVESTMENTS
AT FVOCI
Balance at 1 January 2020 10,000 444
Exchange rate differences 0 -8
Additions 0 0
Retirements -10,000 -145
Impairments 0 -1
Appreciation at market value 0 -2
Balance at 31 December 2020 0 288
-/- of which taken in fixed assets - -
Taken in current assets 0 288
Composition
- Other bonds 0 288
- Term investments 0 0
Breakdown per currency
- in EUR 0 186
- in other currency 0 102
Total 0 288
Balance at 1 January 2021 0 288
Exchange rate differences 0 7
Additions 0 0
Retirements 0 -40
Impairments 0 -1
Appreciation at market value 0 -7
Balance at 31 December 2021 0 247
-/- of which taken in fixed assets - -
Taken in current assets 0 247
Composition
- Other bonds 0 247
- Term investments 0 0
Breakdown per currency
- in EUR 0 140
- in other currency 0 107
Total 0 247
The Group decided to invest mainly in saving accounts
and term deposits. The remaining bonds are held by KBC
and are distributed in five bonds of private and public insti-
tutions. The credit rating varies from A, A+, to BBB. Bonds
are measured at fair value at level 1 hierarchy based on
quoted market prices.
107
OXURION ANNUAL REPORT 2021
5.7.7 Share capital
Oxurion was incorporated on May 30, 2006, under its
former name ‘ThromboGenics’, with a share capital of
62,000 euro represented by 11,124 shares.
On December 31, 2021, the share capital of the Company
on a consolidated basis amounted to 46.029 million
euro represented by 39,067,284 ordinary shares without
indication of nominal value. All shares are fully paid up and
have the same rights.
NUMBER OF SHARES
31 December 2019 38,291,950
- 0
31 December 2020 38,291,950
Capital increase due to conversion of convertible
bonds
775,334
31 December 2021 39,067,284
IN ‘000 EURO CAPITAL
SHARE
PREMIUM
31 December 2019 100,644 13
Capital decrease -55,731 -13
31 December 2020 44,913 0
Capital increase due to conversion of
convertible bonds
1,116 234
31 December 2021 46,029 234
The Board of Directors’ powers with respect to the autho-
rized share capital were renewed at the EGM of Oxurion
held on May 24, 2019, for a period of five years starting
from the publication of the notary deed pertaining to the
modification of the Articles of Association in the Belgian
Official Gazette (June 13, 2019). The Board of Directors is
authorized to increase the share capital of the Company
upon one or more occasions up to an amount of
55,325,961 euro (less the authorized capital which is used
in view of the issuance of subscription rights and convert-
ible bonds) through contribution(s) in cash, contribution(s)
in kind, or by conversion of the reserves in accordance with
the special report drawn up pursuant to Article 7:199 of
the BCCA.
On August 24, 2020, the EGM of Oxurion decided to (i)
carry out an initial formal decrease of Oxurion’s share
capital with an amount of 50,198,374.38 euro in order to
absorb Oxurion’s losses carried forward as at December 31,
2019, and (ii) carry out a second formal capital decrease
of Oxurion’s share capital with an amount of 5,532,596.62
euro in order to create a reserve to cover a foreseeable
loss in accordance with Article 7:210 of the BCCA.
During financial year 2021, Oxurion’s share capital and
share premium has been increased on several occasions
following the conversion of (in aggregate) 540 convertible
bonds issued to Negma:
• on September 29, 2021, the Company’s share capital
was increased with an amount of 219,512.16 euro
following the conversion of 100 convertible bonds
issued to Negma. The share premium for this transac-
tion amounts to 30,487.84 euro.
• on October 7, 2021, the Company’s share capital was
increased with an amount of 225,000 euro following
the conversion of 100 convertible bonds issued to
Negma. The share premium for this transaction
amounts to 25,000.00 euro.
• on November 10, 2021, the Board of Directors decided,
within the framework of Oxurion’s authorized share
capital, to increase the Company’s share capital with an
amount of 378,946.08 euro following the conversion
of 200 convertible bonds issued to Negma. The share
premium for this transaction amounts to 121,053.92
euro; and
• on December 23, 2021, the Company’s share capital
was increased with an amount of 293,022.72 euro
following the conversion of 140 convertible bonds
issued to Negma. The share premium for this transac-
tion amounts to 56,977.28 euro.
108
OXURION ANNUAL REPORT 2021
5.7.8 Other comprehensive income and
other reserves
The other comprehensive income is detailed as follows:
IN ‘000 EURO
CURRENCY
TRANSLATION
ADJUSTMENT
REMEASURE-
MENT DEFINED
BENEFIT
PLANS
FAIR VALUE ADJUST-
MENTS OF DEBT
INSTRUMENTS
TOTAL
OCI
31 December 2019 -251 -364 0 -615
Movements in OCI -127 -297 0 -424
31 December 2020 -378 -661 0 -1,039
Movements in OCI 122 566 -5 683
31 December 2021 -256 -95 -5 -356
The other reserves movement is detailed as follows:
IN ‘000 EURO
SHARE-BASED
PAYMENT
RESERVE
RETAINED
EARNINGS
RESERVE
FUND
FAIR VALUE
ADJUSTMENT
RESERVE
OTHER
RESERVES
31 December 2019 12,116 -24,239 1 -12,122
Movements in
other reserves
458 5,533 -2 5,989
31 December 2020 12,574 -18,706 -1 -6,133
Movements in
other reserves
1,107 -453 213 867
31 December 2021 13,681 -19,159 212 -5,266
On August 24, 2020, by decision of the EGM of Oxurion, a
capital decrease was initiated and transferred within equity
to create a reserve fund classified as other reserves for an
amount of 5,532,596.62 euro to be able to absorb future
losses within the other reserves. For the movement in the
share-based payment reserve we also refer to note 5.6.9
where the share-based payment expense of the period is
disclosed as employee benefit expense.
Share-based payment plans
The Group has created various subscription rights plans
that can be granted to personnel and research institutions
and a subscription rights plan for Non-Executive Directors.
Since the public listing, all subscription rights plans have
been created in respect of Oxurion.
At December 31, 2021, there are five outstanding subscrip-
tion rights plans, as follows:
CREATION DATE OF PLAN
DATE
GRANTED
EXERCISE PRICE
(IN EURO)
BENEFICIARY
Warrant Plan Belgium 2017
2017-
2020
Between 2.64
and 6.55
Employees, key
consultants and
directors of the
Group
Subscription Rights Plan
Belgium 2020
2021 2.57
Non- Executive
Directors of the
Group
Subscription Rights Plan
2021-1
2021
Between 1.75
and 2.60
Employees and
key consultants
of the Group
Subscription Rights Plan
2021-2
2021 1.75
Employees and
key consultants
of the Group
Subscription Rights Plan
2021-3
2021 1.82
Employees and
key consultants
of the Group
Brief overview of all outstanding subscription rights granted
between 2017 and December 31, 2021.
109
OXURION ANNUAL REPORT 2021
Subscription Rights Plan 2017
On November 20, 2017, the EGM of Oxurion decided to
issue the Subscription Rights Plan 2017 (formerly referred
to as the warrants plan 2017). Under this Subscription
Rights Plan 2017, which has a term of ten years and all
will lapse in 2027, a maximum of 1,440,000 subscription
rights can be issued and granted to employees, directors,
and consultants of the Group. Each subscription right
entitles the holder to subscribe to one Oxurion share.
Subscription rights are granted under this plan by the
Board of Directors or the Remuneration Committee,
except for directors. Authority to grant subscription rights
to directors is held by the general meeting of sharehold-
ers. Subscription rights are offered free of charge. The
exercise price is equal to the lower of (i) the average of
the closing prices of the share on the stock market during
the 30 days prior to the offering of a subscription right or
(ii) the closing price on the last stock market day prior to
the offer. Subscription rights granted under this plan have
a three year graded vesting (50% after 2 years and 50%
after 3 years) with no performance conditions. The con-
ditions under which a subscription right holder is entitled
to exercise a subscription right are established by the
Remuneration Committee.
Subscription Rights Plan 2020
On December 23, 2020, the Board of Directors of Oxurion
decided to issue the Oxurion 2020 Subscription Rights
Plan as decided by the AGM held in May 2019. Under
this Subscription Rights Plan 2020, which has a term
of ten years and all will lapse in 2030, a maximum of
150,000 subscription rights can be issued and granted
to Non-Executive Directors of Oxurion. Each subscription
right entitles the holder to subscribe to one Oxurion share
subject to the payment of the exercise price.
The exercise price is equal to the lower of (i) the average of
the closing prices of the share on the stock market during
the 30 days prior to the offering of a subscription right or
(ii) the closing price on the last stock market day prior to
the offer. Subscription rights granted under this plan have
a contractual term of ten years and vest immediately.
Subscription Rights Plans 2021
On April 14, 2021, the Board of Directors of Oxurion
decided to issue the Subscription Rights Plan 2021-1.
Under this Subscription Rights Plan 2021-1, which has a
term of ten years and all will lapse in 2031, a maximum of
1.085 million subscription rights can be issued and granted
to employees, directors, and consultants of the Group.
Each subscription right entitles the holder to subscribe to
one Oxurion share.
On September 22, 2021, the Board of Directors of Oxurion
has decided to issue the Subscription Rights Plan 2021-2.
Under this Subscription Rights Plan 2021-2, which has a
term of ten years and all will lapse in 2031, a maximum of
550,000 subscription rights can be issued and granted to
employees, directors, and consultants of the Group. Each
subscription right entitles the holder to subscribe to one
Oxurion share.
On December 30, 2021, the Board of Directors of Oxurion
has decided to issue the Subscription Rights Plan 2021-3.
Under this Subscription Rights Plan 2021-3, which has a
term of ten years and all will lapse in 2031, a maximum of
862,000 subscription rights can be issued and granted to
employees, directors, and consultants of the Group. Each
subscription right entitles the holder to subscribe to one
Oxurion share.
Subscription rights are granted under the Subscription
Rights Plans 2021 by the Board of Directors or the
Remuneration Committee. Subscription rights are offered
free of charge. The exercise price is equal to the lower
of (i) the volume weighted average price (VWAP) of the
Company’s shares on the stock exchange over a period
110
OXURION ANNUAL REPORT 2021
of thirty calendar days prior to the date of the offer or
(ii) the closing price of the Company’s shares on the last
business day prior to the date of the offer. Half of the
subscription rights under these plans vest after one year
and the other half vest quarterly over the following two
years. For the subscription rights granted in April 2021
under the Subscription Rights Plan 2021-1, the vesting
period exceptionally commenced on December 28, 2020.
The conditions under which a subscription rights holder is
entitled to exercise a subscription right are established by
the Remuneration Committee.
The grant date fair values of the subscription rights
granted under the different Subscription Plans have been
determined by using the Black & Scholes model, taking
into account the following assumptions:
2017 SUBSCRIPTION PLAN ASSUMPTIONS
GRANT DATE DEC 17 DEC 17 JUN 18 DEC 18 DEC 18 JUL 19 DEC 19 DEC 19 JUN 20 AUG 20
Number of warrants granted 251,000 150,000 33,500 208,000 150,000 44,300 136,000 125,000 43,500 10,000
Current share price on grant
date (in euro)
3.38 3.38 7.07 3.52 3.52 4.65 2.875 2.875 3.07 2.72
Exercise price 3.38 4.593 6.549 3.4 4.593 3.822 2.64 4.593 2.847 2.8
Expected dividend yield - - - - - - - - - -
Expected stock price volatility 40% 40% 40% 40% 40% 40% 60% 60% 60% 60%
Risk-free interest rate -0.51% -0.51% -0.46% -0.38% -0.38% -0.67% -0.58% -0.58% -0.54% -0.62%
Expected duration 10 10 9.5 9 9 8.5 8 8 7.5 7.5
Fair value 1.56 1.29 3.33 1.58 1.3 2.23 1.75 1.43 1.83 1.56
111
OXURION ANNUAL REPORT 2021
2020 SUBSCRIPTION PLAN ASSUMPTIONS
GRANT DATE MAR 21
Number of warrants granted 75,000
Current share price on date (in euro) 2.55
Exercise price 2.57
Expected dividend yield -
Expected stock price volatility 45%
Risk-free interest rate -0.65%
Expected duration 9
Fair value 1.23
2021 SUBSCRIPTION PLAN ASSUMPTIONS
GRANT DATE APR 21 JUN 21 SEP 21 SEP 21 DEC 21
Number of war-
rants granted
888,500 7,500 550,000 165,000 804,000
Current share
price on date
(in euro)
2.6 2.505 1.928 1.928 1.82
Exercise price 2.6 2.52 1.75 1.75 1.82
Expected
dividend yield
- - - - -
Expected stock
price volatility
45% 45% 45% 45% 45%
Risk-free
interest rate
-0.63% -0.62% -0.68% -0.68% -0.64%
Expected
duration
10 10 10 9.5 10
Fair value 1.3 1.27 1.01 1.00 0.91
The assumptions used in determining the fair value of the
subscription rights granted are based on the following data:
• Current share price on grant date – the closing price
on the stock market of Euronext Brussels.
• Expected stock price volatility – the historical volatility
of Oxurion’s share price.
• Expected duration – calculated as the estimated
duration until exercise, taking into account the specific
features of the plans.
• Risk-free interest rate – based on the Belgium govern-
ment bond rates at the date of granting with a term
equal to the expected life of the subscription rights.
Movements in the number of subscription rights outstand-
ing and their related weighted average exercise prices are
as follows:
2021 2020
AVERAGE
EXERCISE
PRICE IN EUR
SUB-
SCRIPTION
RIGHTS
AVERAGE
EXERCISE
PRICE IN EUR
SUB-
SCRIPTION
RIGHTS
As at 1 Jan. 3.84 893,800 3.94 958,800
Granted, accepted 2.24 1,689,500 2.84 53,500
Granted, not yet
accepted
1.82 804,000 3.25 0
Forfeited 3.30 -193,550 4.13 -118,500
Exercised 0.00 0 0.00 0
As at 31 Dec. 2.52 3,193,750 3.84 893,800
Outstanding vested subscription rights as at December 31,
2021, have the following earliest exercise date, maturities
and exercise prices:
EARLIEST EXERCISE
DATE
EXPIRY DATE
EXERCISE PRICE
(IN EUR)
NUMBER
(THOUSANDS)
2022 2027 4.00 606
2022 2030 2.57 60
2022 2031 2.60 424
Total weighted
average
3.38 1,090
5.7.9 Employee Benefit Obligations
Oxurion offers its employees retirement benefits that are
funded through a group insurance plan managed by an
insurance fund. Until June 30, 2009, the insurance group
plan was based on a “defined benefit” system. In a defined
benefit pension plan, an employer commits to paying its
employee a specific benefit for life beginning at his or her
retirement. The amount of the benefit is known in advance,
and is usually based on factors such as age, earnings, and
years of service. Defined benefit plans do not have con-
tribution limits, but they do have a limit on the maximum
annual retirement benefit.
112
OXURION ANNUAL REPORT 2021
Since July 1, 2009, the defined benefit plan was changed
into a pension plan that is structured as a defined con-
tribution plan, but that should be accounted for as a
defined benefit plan in accordance with IFRS, since the
company offers a minimum guaranteed return to the plan
participants.
The amounts recognized in the statement of financial
position can be broken down as follows:
2021 2020
Defined benefit obligation 5,015 5,361
Fair value of plan assets -4,421 -4,265
Net defined benefit liability 594 1,096
The amounts recognized in the statement of financial
position and the movements in the net defined benefit
obligations are as follows:
IN ‘000 EURO
PRESENT
VALUE OF
OBLIGATION
FAIR VALUE OF
PLAN ASSETS
TOTAL
As at January 1 2020 4,684 -3,883 801
Current service cost 366 0 366
Past service cost 0 0 0
Interest expense/(income) 58 -50 8
Total amount recognized in profit
or loss
424 -50 373
Actuarial gains/(losses) on
DBO due to change in financial
assumptions
187 0 187
Changes in return of plan assets 0 -33 -33
Actuarial gains/(losses) on DBO
due to experience adjustments
143 0 143
Total amount recognized in other
comprehensive income
330 -33 298
Employer contributions 0 -376 -376
Employee contributions 87 -87 0
Benefit payments -42 42 0
Taxes on contributions -47 47 0
Insurance premiums related to
risk coverages
-75 75 0
As at 31 December 2020 5,361 -4,265 1,096
Current service cost 369 0 369
Past service cost 0 0 0
Interest expense/(income) 31 -26 6
Total amount recognized in profit
or loss
400 -26 374
Actuarial gains/(losses) on
DBO due to change in financial
assumptions
-165 0 -165
Changes in return of plan assets 0 -66 -66
Actuarial gains/(losses) on DBO
due to experience adjustments
-335 0 -335
Total amount recognized in other
comprehensive income
-500 -66 -566
Employer contributions 0 -310 -310
Employee contributions 67 -67 0
Benefit payments -214 214 0
Taxes on contributions -39 39 0
Insurance premiums related to
risk coverages
-61 61 0
As at 31 December 2021 5,015 -4,421 594
113
OXURION ANNUAL REPORT 2021
The significant actuarial assumptions used to calculate the
net defined benefit liability were as follows:
2021 2020
Discount rate 1.1% 0.6%
Inflation rate 1.8% 1.8%
Salary increase rate on top of
inflation rate
1.2% 1.2%
Mortality tables
MR/FR with age
correction of 3 years
MR/FR with age
correction of 3 years
Sensitivity analysis considering a change of 0.25% in the
discount rate:
IN ‘000 EURO TOTAL
DBO considering an increase of 0,25% in the discount rate -4,934
DBO considering a decrease of 0,25% in the discount rate -5,101
The expected future benefits to be paid are as follows:
IN ‘000 EURO
2022 136
2023 95
2024 21
2025 22
2026 119
5.7.10 Other short-term liabilities
IN ‘000 EURO (AS AT 31
DECEMBER)
2021 2020
Employee benefits 1,684 1,053
Other current liabilities 628 1,614
Total other short-term
liabilities
2,312 2,667
Oxurion’s Defined Benefit Obligation (“DBO”) is a non-cur-
rent liability.
Employee benefits include holiday pay, bonus, and out-
standing employee taxes.
The other current liabilities consist of commitments that
expire before year-end, but for which an invoice was not
yet received.
5.7.11 Convertible loans
The Company issued convertible bonds during 2021 with
two parties as described below:
Negma Group Ltd.
On August 26, 2021, Oxurion (the Company or the Issuer)
entered into an agreement whereby Negma as investor
is willing to subscribe to, up to 12,000 zero coupon au-
tomatically convertible bonds with each a nominal value
of 2,500 euro, in several tranches of minimum 200 and
maximum 1,000 bonds for a total committed amount up
to 30 million euro. The Company as issuer controls the
timing and amount of the tranche calls.
The Investor is entitled to a commitment fee for an
amount equal to up to 3.5% of the total commitment, i.e,.
up to 1.050 million euro, payable, at the option of the Issuer,
either in cash or in commitment fee convertible bonds.
50% of the commitment fee is due upon signing of the
agreement, the remaining 50% is due only if a tranche call
is exercised by the Issuer, as a result of which in total half of
the commitment will have been called by the Issuer.
The conversion price is 92% of the lowest closing volume-
weighted average price (VWAP) over a period of 15
consecutive trading days expiring on the trading day
immediately preceding the date of issuance of a con-
version notice. Each convertible bond and commitment
fee convertible bond has a duration of twelve months as
from its date of issuance and shall accrue no interest. Any
convertible bond and commitment fee convertible bond
not converted into shares prior to the maturity date, shall
114
OXURION ANNUAL REPORT 2021
convert automatically into shares at maturity date. The
Investor has the right to convert all or any of the convert-
ible bonds and commitment fee convertible bonds into
new shares at any time.
The number of shares to be issued upon conversion shall
be equal to the conversion amount divided by the appli-
cable conversion price, provided that it shall not exceed
a maximum of 38,291,950 shares. If the Investor does
not receive the relevant shares, the Issuer shall pay to the
Investor an amount in cash.
The convertible bond described above meets the defini-
tion of a financial liability given that the conversion price
is not fixed and upon conversion, will result in a variable
number of shares being issued, being the nominal amount
of the convertible loan divided by the conversion price. The
convertible bond is also a derivative financial liability as the
conversion feature is an embedded derivative of the loan
host. The host and the derivative will not be separated and
are accounted for as one hybrid financial liability.
The financial liability is measured at fair value through
profit or loss. The initial fair value of the convertible loan
equals the amount of cash received in the amount of 2.5
million euro of which a total of 1.350 million euro was
converted into shares before December 31, 2021. The fair
value of the converted loan was 1.563 million euro. The
difference between the fair value and the nominal amount
of 0.213 million euro was recorded in profit and loss as fair
value loss included in the line item ‘Finance expense’ and
in other reserves upon conversion.
Subsequently the fair value is determined as the nominal
amount of the convertible loan plus 8%. The 8% rep-
resents the difference between the share price and the
92% of the lowest closing VWAP. Considering the term of
the convertible loan to be less than 12 months, no option
pricing model is used. The fair value of the outstanding
loan amount of 1.675 million euro as per December 31,
2021, is determined at 1.809 million euro with changes
in the fair value recorded in profit and loss as fair value
gains and losses on the convertible loan. The fair value loss
in the amount of 0.134 million euro as per December 31,
2021 is included in the line item ‘Finance expense’ in the
consolidated statement of profit and loss.
Upon conversion, the financial liability measured at fair
value at date of conversion, will be reclassified to share-
holders’ equity.
The liability for first instalment of the commitment fee of
0.525 million euro (50% upon signing of the agreement)
takes place once the first Tranche Call is called by the
Company. The commitment fee is recorded in profit and
loss as transaction cost due, given the Company cannot
avoid cash settlement if the Investor requests eventual
payment in cash. These transaction costs are included
in the line item ‘Finance expense’ in the consolidated
statement of profit and loss.
The second instalment of the commitment fee of 0.525
million euro is recognized if and only if a tranche call is
exercised by the Issuer, as a result of which in total more
than half of the total commitment will have been called.
This commitment fee is considered as a transaction cost
in accordance with IFRS 9 and expensed as incurred as
financial expense, given it is an incremental cost that the
Company would not incur if the triggering condition is not
met. This second instalment has not been accounted for
as per December 31, 2021 since there is no present obli-
gation yet.
Kreos Capital / Pontifax Ventures
On November 21, 2021, Oxurion (the Company or the
Issuer) entered into an agreement whereby Kreos Capital
VI Limited together with Pontifax Medison Finance L.P.
(the Investors) as investors are willing to subscribe to
convertible bonds with each a nominal value of 0.1 million
euro, in two tranches of each 10.0 million euro for a total
committed amount up to 20.0 million euro.
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OXURION ANNUAL REPORT 2021
The Investors are entitled to a transaction fee of 0.125
million euro and an end of loan payment equal to 3.5%
that shall accrue on the amount drawn under each tranche.
The convertible bonds accrue interest in the amount of
7.95% per year.
The convertible bonds may be either:
1. Converted in shares at the option of the Investors at
any time
2. Converted in shares at the option of the Issuer when
certain conditions are met
3. Repaid based on the amortization schedule without
extension
4. Repaid based on the amortization schedule with
extension
5. Prepaid when certain conditions are met
6. Paid in full in case of events of default or change in
control
The number of shares to be issued upon conversion shall
be equal to the conversion amount divided by the applica-
ble conversion price:
1. The conversion price of the Bonds is equal to 2.90 euro
2. In the event that the Issuer issues more than 7.5 million
euro convertible bonds to Negma between the issue
date and the earlier of either June 30, 2022, or the date
on which the Issuer has raised a gross amount of at
least 30 million euro through an equity fundraising, the
conversion price is adjusted to 140% of the average
conversion price of all shares issued to Negma
3. In the event that, between the issue date and November
21, 2022, the issuer issues any shares in the context of
an equity financing at an issue price per share which
represents a discount of more than 20% to the VWAP
over the 30 trading days period preceding the date
of such issuance of shares, the Conversion Price shall
be adjusted to 140% of the average issue price of all
shares issued by the Company in the context of any
equity financing since the issue date
4. The conversion price may be adjusted from time to
time upon the occurrence of corporate actions, such
as merger, demerger, stock splits or reverse stock split,
in accordance with the adjustment policy set out in the
Euronext Corporate Action Policy
The convertible bond described above meets the definition
of a financial liability given that the Company cannot avoid
delivering cash to the investors and the conversion price
is not fixed. The Company cannot avoid delivering cash as
they do not have control over the different scenarios. The
conversion price can also change upon certain scenario’s
as described above and as such the number of shares
being issued will vary based on the conversion price. The
convertible bond is also a derivative financial liability as the
conversion feature is an embedded derivative of the loan
host. The host and the derivative will not be separated and
are accounted for as one hybrid financial liability.
The financial liability is measured at fair value through profit
or loss. The initial fair value of the convertible loan equals
the amount of cash received which is 10.0 million euro
as per December 31, 2021. Subsequently the fair value is
determined as the probability weighted average of the fair
values of the five different scenarios described above. No
probability is allocated to scenario’s 1 and 2. The fair value
of each of the other scenarios has been determined by
application of the effective interest rate method.
The above fair value measurement is a level 3 as a result
of the unobservable input for the probabilities. A reason-
able change of the probabilities between the different sce-
nario’s would not lead to a material change in the fair value.
The fair value as per December 31, 2021, is determined at
10.025 million euro with changes in the fair value recorded
in profit and loss as fair value gains and losses on the con-
vertible loan. The fair value losses in the amount of 0.025
million euro as per December 31, 2021, are included in the
line item ‘Finance expense’ in the consolidated statement
of profit and loss.
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OXURION ANNUAL REPORT 2021
Upon conversion, the financial liability measured at fair
value at date of conversion, will be reclassified to share-
holders’ equity, being share capital and share premium and
other reserves for the fair value adjustment portion.
The transaction costs are not deducted from the carrying
value but expensed as incurred and are included in the line
item ‘Finance expense’ in the consolidated statement of
profit and loss for an amount of 0.155 million euro and in
the line item ‘General and administrative expenses’ for an
amount of 0.040 million euro as per December 31, 2021.
The Loan Facility is subject to a financial covenant whereby
the Group is required to maintain at all times a minimum
aggregate amount of cash in the bank of an amount equal
to the lower of 4 million euro and the principal amount
outstanding. The Group has complied with the financial
covenant at December 31, 2021.
5.7.12 Deferred taxes
Deferred tax assets have not been recognized in respect
of the items below because it is not probable that future
taxable profits will be available against which the Group
can utilize the loss carryforwards or deductible temporary
differences. The losses available for offsetting future
taxable income are mainly related to Belgium and can be
carried-forward indefinitely.
In ‘000 euro (as at 31 December) 2021 2020
Losses available for offsetting against
future taxable income
342,145 305,688
Deductible temporary differences 24,518 21,646
Taxable temporary differences -46 0
Total unused tax losses and other deducti-
ble temporary differences not recognized
366,617 327,334
No deferred tax liability is recognized on the unremitted
earnings of subsidiaries since no tax is expected to be
payable on them in the foreseeable future.
5.8 OTHER CLARIFICATION NOTES
TO THE STATEMENT OF
FINANCIAL POSITION
Subsidiaries and branches
NAME OF THE
SUBSIDIARY
PLACE OF IN-
CORPORATION
AND OPERATION
2021 2020
PRINCIPAL
ACTIVITY
ThromboGe-
nics
US 100% 100% Distributor
Oncurious BE 83.34% 89.59%
Research
(oncology)
Name of the
branch
Place of incor-
poration and
operation
2021 2020
Principal
activity
Irish branch* IE N/A N/A
No current
activity
*As there were no activities in the Irish branch, the Company closed it in 2020.
At year-end 2021, out of a new total of 12,111 shares in the
share capital of Oncurious, Oxurion owned 10,093 shares
or 83.34%.
Due to a capital increase in Oncurious by VIB through a
contribution in kind of a receivable from VIB to Oncurious
for 86,299 euro, VIB’s non-controlling interest increased
with 0.5 million euro and the equity attributable to equity
holders of the company decreased with 0.5 million euro.
The effect of which is presented in the line item ‘trans-
actions with non-controlling interests’ in the statement of
changes in equity.
In the line item ‘transactions with non-controlling interests’
presented in the statement of changes in equity, the
effect of the transfer between equity attributable to equity
holders of the company and the non-controlling interest
is presented resulting from the exercise of the call option
by VIB leading to the transfer of 680 shares in the share
capital of Oncurious from Oxurion to VIB. We refer to note
5.8 under the heading Flanders Institute for Biotechnology
for more information on the exercise of the call options
which were granted by Oxurion to VIB.
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OXURION ANNUAL REPORT 2021
Key Agreements, Commitments and Contingent
Liabilities
The Group has a number of material agreements with third
parties.
Please find below an overview of Oxurion’s material agree-
ments. An agreement is considered as “material” when the
contractual commitments reach over 1 million euro, or in
case of a new agreement, when such an impact is expected
in the 12-month period after the reporting date.
Note that certain agreements may include sharing of R&D
costs and/or sharing of revenue. Although these agreements
may include the establishment of a joint committee which
monitors the joint activities, these arrangements are out of
the scope of IFRS 11 “Joint Arrangements”, as the Company
has concluded that no joint control exists. The main indica-
tors found in the multiple arrangements that resulted in the
conclusion that Oxurion has control over the operations and
relevant activities and therefore is the decision-making party
in the agreements are as follows:
• Oxurion has sole and exclusive decision-making
authority on the development activities, including but
not limited to the development plan.
• Oxurion bears the costs and expenses for all activities
under the development plan.
• Oxurion is responsible for preparing, filing and main-
taining regulatory approvals.
• Oxurion has the sole responsibility and decision-mak-
ing authority for manufacturing and commercialization.
• Oxurion shall be the sole and exclusive owner of all
intellectual property in most agreements.
Research and Development Agreements
Bicycle Therapeutics
In August 2013, Oxurion entered into a research collabora-
tion and license agreement with Bicycle Therapeutics (the
“Bicycle Collaboration Agreement”). Under this agreement,
Bicycle is responsible for identifying Bicycle-peptides related
to the collaboration target, human plasma kallikrein, for use
in various indications. Oxurion is responsible for further de-
velopment and product commercialization after the defined
research screening is performed by Bicycle.
The collaboration includes two stages. During Stage 1, which
has been completed, Bicycle was obligated to perform
specific research activities in accordance with the research
plan focused on screening the target using the Bicycle
platform to identify compounds that meet the criteria set
by the parties. During Stage 2, which is ongoing, Oxurion has
continued research activities on selected Bicycle-peptides
with the goal of identifying compounds for further develop-
ment and commercialization. THR-149 has been selected as
a development compound under the Bicycle Collaboration
Agreement.
Bicycle granted certain worldwide intellectual property rights
to Oxurion for the development, manufacture and commer-
cialization of licensed compounds associated with plasma
kallikrein.
The Bicycle Collaboration Agreement provided an upfront
payment of 1.0 million euro and potential additional
research and development funding, at an agreed upon FTE
rate, should the research effort require more than one FTE,
or the research plan be amended or extended by Oxurion.
In addition, Oxurion is required to make certain milestone
payments to Bicycle upon the achievement of specified
research, development, regulatory and commercial mile-
stones. In addition, to the extent any of the collaboration
products covered by the licenses granted to Oxurion are
commercialized, Bicycle would be entitled to receive tiered
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OXURION ANNUAL REPORT 2021
royalty payments of mid-single digits based on a percentage
of net sales. Royalty payments are subject to certain reduc-
tions. Also, if Oxurion grants a sublicense to a third party for
rights to the program for non-ophthalmic use, Bicycle would
be entitled to receive tiered payments of mid-single digits to
low-double digits (no higher than first quartile) based on a
percentage of non-royalty sublicensing income.
In November 2017, the parties entered into an amendment
to the Bicycle collaboration agreement. This amendment
provides for additional research services to be performed
by Bicycle related to the identification of additional Bicycle-
peptides binding to the target for Oxurion, in its discretion, to
select as development compounds. Bicycle was obligated to
perform the work in accordance with an amended research
plan under Stage 1 of the collaboration and was funded at
a specified FTE rate, plus any direct out of pocket expenses,
and Oxurion will be responsible for Stage 2 research and
any development after the selection of a development
compound. Bicycle has completed Stage 1 of the research
plan. Additional milestones were added for the potential ad-
ditional licensed compounds, consistent with those of the
initial Bicycle Collaboration Agreement.
Based on IAS 38 “Intangible assets”, Oxurion has not
acquired a separate intangible asset that meets the defini-
tion of IAS 38, and therefore these expenses are recorded
under R&D expenses. So far, the following upfront and
milestones payments to Bicycle were recognized: 1.0 million
euro in 2013, 0.750 million euro in 2017, 1.0 million euro in
2018 and 2.0 million in 2020. These were all expensed as
R&D costs.
Galapagos
Oxurion signed a global and exclusive in-licensing agreement
with Galapagos NV to develop and commercialize integrin
antagonists for the treatment of diseases, disorder, states or
conditions in humans (the “Galapagos License Agreement”
or the “Galapagos License”). The Company’s THR-687
program is a result of this agreement.
The license agreement gives Oxurion access to a collec-
tion of integrin antagonists developed by Galapagos that
Oxurion is using in its R&D activities. Oxurion believes that
by gaining access to these molecules, including THR-687,
the most advanced drug candidate, it has the potential to
develop a novel small molecule integrin antagonist that
could be used to treat a broad range of patients with vascular
retinal disorders. Oxurion has obtained the exclusive rights
for the clinical development, manufacturing and commer-
cialization under this agreement, while Galapagos is entitled
to a non-refundable upfront fee for technology access, de-
velopment milestone payments and tiered sales milestone
payments as well as market conforming royalties on sales
over the period of 10 years from the first sale.
In September 2017, the parties entered into an amendment
to the Galapagos License Agreement. According to this
amendment, Oxurion has taken over the prosecution and
maintenance of the licensed patents and consequently has
acquired all rights in the licensed patents with effective date
as of September 25, 2017. Oxurion will be entitled to deduct
its documented and reasonable costs for prosecution and
maintenance for the licensed patents from the royalty due
and payable to Galapagos under the Galapagos License
Agreement.
In addition to the upfront payment already made, Oxurion is
required to make certain milestone payments to Galapagos
upon the achievement of certain development, regulatory
and commercial milestones of up to 12.5 million euro , unless
there is only one Phase 3 trial required in which case the
total regulatory and commercial milestones increase to 13.5
million euro (e.g., 1.5 million euro related to the first Phase 3
if the Company decides to do one, and 5 million euro when
the first regulatory approval in either the US or the European
Union is granted for the first indication). In addition, to the
extent any of the collaboration products covered by the
licenses granted to Oxurion are commercialized, Galapagos
would be entitled to receive certain sales-based milestone
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OXURION ANNUAL REPORT 2021
payments and tiered royalty payments of mid-single digits
based on a percentage of net sales, except in the case of
annual sales exceeding 500 million euro, in which case the
royalty is higher.
Oxurion has paid to Galapagos an upfront fee of 1.0 million
euro in April 2016, upon Galapagos supplying to Oxurion
the licensed compounds, including THR-687, and all data
and manufacturing know-how related to the licensed
compounds, which was capitalized as an intangible asset
as it meets the conditions of a separately acquired intan-
gible asset under IAS 38, par. 25. Galapagos has no further
performance obligations for development services. Since
no commercialization was achieved and no profit was
generated, no amortization was recorded so far. Until now,
no other advance payments have been made to Galapagos.
The future milestones must be assessed to determine if
they meet the capitalization criteria under IAS 38, once they
are paid. We refer to the accounting policy section on intan-
gible assets for more details.
License, Development and Commercial Agreement
Eumedica and Inceptua
In June 2018, Oxurion and Eumedica entered into an
exclusive commercial agreement, pursuant to which
Eumedica agreed to provide distribution services for
JETREA® (the “2018 Agreement”). Eumedica acts as an
agent of Oxurion, as Oxurion takes primary responsibility
for product quality, inventory risk, and has discretion in es-
tablishing the sales price. The arrangement has the char-
acteristics of a consignment where Eumedica does not
have control of the product, and Oxurion can direct its use
and ask for its return. Eumedica collects payments from
end-customers for Oxurion. Eumedica charges a monthly
distribution fee that covers the services provided including
customer service, shipment preparation, packaging,
storage, labeling/repackaging, administration, destruction
& waste handling, etc.
Under IFRS 15, Oxurion has only one performance obliga-
tion, which is to deliver the product to the end-customer.
This performance obligation is satisfied when Eumedica
transfers (delivers) the product to the end-customer, as this
is the moment when the customer obtains the control over
the product. Therefore, revenue is recognized for the price
of the product at the point in time when it is delivered by
Eumedica to the end-customer. While inventory is located
at Eumedica, it is recognized as inventory of Oxurion due to
consignment terms. Eumedica fees are recognized partly
under distribution costs and partly under selling expenses,
as they are charged on a monthly basis.
For 2021, Oxurion paid 0.072 million euro (2020: 0.079
million euro) for distribution costs, 0.225 million euro
(2020: 0.327 million euro) for selling expenses and
received 0.588 million euro (2020: 1.701 million euro)
revenue for the select number of markets served by
Eumedica.
On March 12, 2020, Oxurion entered into an exclusive
license with Inceptua for the commercialization and
marketing of JETREA® outside of the US in certain transfer
countries. Transfer countries include all countries of the
European Union, Norway, Liechtenstein, Switzerland, the
UK and Australia and sales may also be made in non-ap-
proved countries on a named patient basis under respect
of applicable law. The parties further agreed that Oxurion
would withdraw the marketing authorizations in the US
and Canada and would transfer the EMEA marketing au-
thorization to Inceptua. The license became effective on
September 15, 2020, when the EMEA market authoriza-
tion was transferred. Under the terms of the agreement,
Inceptua purchases JETREA® from Oxurion in final product
form for a fixed amount per vial and pays Oxurion a market
rate royalty on sales based on quarterly royalty reports.
As a result of its agreement with Inceptua, Oxurion entered
into a tripartite agreement with Eumedica and Inceptua
pursuant to which Eumedica provides certain packaging,
labelling and storage services directly to Oxurion and
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OXURION ANNUAL REPORT 2021
purchases the finished product from Oxurion and sells
its to Inceptua (the “Tripartite Agreement”). The Tripartite
Agreement replaces the 2018 Agreement. Eumedica also
provides certain services to Oxurion on behalf of Inceptua,
including storage, customer services and delivery, which
are re-charged to Inceptua.
After a transition period which was completed in December
2020, Oxurion’s obligations under the Tripartite Agreement
will be limited to supply of the JETREA® product to Inceptua
until 2023 or potentially longer if Inceptua obtains a shelf
life extension. All other activities related to JETREA® will be
transferred to Inceptua or will cease.
Under IFRS 15, Oxurion’s only performance obligation
is to deliver final products to Inceptua. This obligation is
completed when Eumedica sells the products to Inceptua.
Oxurion therefore recognizes the revenue from the sale
of the goods when the assets are sold by Eumedica to
Inceptua. Royalties are recognised quarterly upon reception
of royalty report from Inceptua.
Oxurion received 0.159 million euro royalties (2020: 0.060
million euro) for the select number of markets served by
Inceptua.
Clinical Trial Agreements
INC Research (Syneos Health)
INC Research provides clinical research services for the
development of THR-149 and THR-687. Services are
billed on a project basis via Statements of Work based on
a Services Agreement for Clinical Research and Related
Services dated as of August 19, 2016. Based on IAS 38
“Intangible assets”, the costs paid to INC Research are not
made in order to acquire an asset, or to increase economic
benefits already embodied into an asset. Rather, they are an
outsourced R&D cost. Therefore, such costs are expensed
to the statement of profit and loss as R&D expenses, as
incurred. In case of prepayments, an asset is recognized
for such prepayment, and prepayment is released to
statement of profit and loss as costs are incurred. In 2021
and 2020, 6.5 million euro and 3.2 million euro were paid
respectively to INC Research and recognized as R&D
expenses. At year-end 2021, a prepayment in the amount
of .2.2 million euro is recorded on the statement of profit
and loss.
Academic Agreements
The Company has concluded agreements with various
academic institutions that are interested in the study of
drug candidates, including the following:
Flanders Institute for Biotechnology
The Company has entered into several agreements
with the Vesalius Research Centre (formerly the Dept. of
Transgene Technology and Gene Therapy), a department
of VIB, relating to the preclinical characterization of two of
the programs under license with the Vesalius Research
Centre, i.e., Anti-PlGF and PlGF.
On December 12, 2017, Oncurious and VIB entered into
a research collaboration and license agreement on the
basis of which Oncurious acquired exclusive licenses on a
portfolio of five unique next generation immuno-oncology
assets, based on seminal work originating from the VIB-KU
Leuven labs of Massimiliano Mazzone and Gabriele
Bergers, and from the VIB-VUB lab of Jo Van Ginderachter.
In the context of the abovementioned research collabora-
tion and license agreement, VIB has been granted two call
options from Oxurion for an aggregate maximum of 1,230
shares in Oncurious, subject to the achievement of certain
milestones linked to the achievement of one or two proof
of concepts (call option agreement of December 12, 2017).
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OXURION ANNUAL REPORT 2021
On October 22, 2021, Oncurious announced the achieve-
ment of a second preclinical proof of concept for its im-
muno-oncology program aimed at depleting regulatory T
cells (Tregs) by targeting C-C motif chemokine receptor
8 (CCR8). Consequently, at year end 2021, VIB is entitled
to execute its remaining call option of 550 shares. Post-
closing VIB indicated it is executing this remaining call
option in full.
As per June 30, 2021, the VIB IP license has been impaired,
compared with a net carrying amount of 1.127 million euro
in 2020.
During 2021 and 2020, Oxurion has paid 0.211 million euro
and 0.343 million euro of R&D costs respectively to VIB in
relation to this research program.
Other Commitments
Research and development commitments
As at December 31, 2021, the Group had commitments
outstanding in the context of research and development
agreements amounting to 18.0 million euro compared to
8.033 million euro in 2020, payable over the course of the
following 12 months to various research subcontractors.
Contingent liability
The expenses incurred in several of the Group’s research
and development programs have been reimbursed by
VLAIO, formerly known as IWT, as a government grant.
Contracts with VLAIO generally include a clause that
defines the need for validation of the project results in
order for the grant to be effectively earned. Should this
validation not occur, VLAIO has the right to reclaim the
funds previously granted. The Group considers this as a
remote possibility. Please refer to the accounting policy
described in section 5.5.3 (G) and the rationale used in
order to recognize grant income over the course of the
project. Total amounts received in 2021 with respect to
government grants from VLAIO amount to 0.228 million
euro, compared to 0.441 million euro in 2020.
Related parties
Other than members of the Board of Directors, no other
related parties have been identified.
Subsequent events
On February 8, 2022, Oxurion’s share capital was increased
with an amount of 483,219.36 euro following the conver-
sion of 200 convertible bonds issued to Negma. The share
premium for this transaction amounts to 16,780.64 euro.
On February 24, 2022, Russia invaded Ukraine. Combined
with the impact of the pandemic, the result has been sig-
nificant price increases/inflation in Europe and the US.
Although the Company does not have any supply chain
or CRO activities with Ukraine, these general economic
stressors could impact Oxurion generally. Oxurion does
have five principal investigators and clinical sites for the
THR-687 trial in Poland, which already have experienced
significant price increases due to Polish inflation and the
impact on currency. Further, the THR-687 trial has another
14 sites in the Baltic states and Eastern Europe that may
be impacted. It is difficult to predict at this time the extent
to which the conflict will impact these sites. Further, the
impact of the conflict on the economic outlook and
investor appetite could affect the Company’s ability to raise
funds when needed.
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OXURION ANNUAL REPORT 2021
Moreover, on March 3, 2022, Oxurion successfully raised
an amount of 10.4 million euro in gross proceeds by
means of a private placement of 7,226,039 new shares at
an issue price of 1.44 euro per share representing a 4.35%
premium to Oxurion’s closing price on March 2, 2022. The
financing was led by new top-tier healthcare institutional
investors and included participation from current major
shareholders. Two-thirds of the proceeds were provided by
new US and European investors, including Belgian-based
NOSHAQ SA and Banque CPH CV. As a result of the
issuance of new shares, Oxurion’s share capital increased
from 56,925,661.32 euro to 67,331,161.32 euro and its
issued and outstanding shares increased from 39,402,853
to 46,628,892 shares, representing an increase of the
share capital and number of shares of 18.34%.
Finally, on March 23, 2022, Oxurion’s share capital was
increased with an amount of 600,000.00 euro following
the conversion of 240 convertible bonds issued to Negma.
As a result of the issuance of new shares, Oxurion’s share
capital increased from 67,331,161.32 euro to 67,931,161.32
euro and its issued and outstanding shares increased from
46,628,892 shares to 47,128,892 shares.
Done on March 24, 2022,
On behalf of the Board of Directors
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OXURION ANNUAL REPORT 2021
6. STATUTORY AUDITOR’S REPORT
TO THE AGM FOR THE YEAR
ENDED 31 DECEMBER 2021
(CONSOLIDATED FINANCIAL
STATEMENTS)
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OXURION ANNUAL REPORT 2021
In the context of the statutory audit of the consolidated financial statements of Oxurion
NV (‘the Company’) and its subsidiaries (together referred to as ‘the Group’), we hereby
present our statutory auditor’s report. It includes our report of the consolidated financial
statements and the other legal and regulatory requirements. This report is an integrated
whole and is indivisible.
We have been appointed as statutory auditor by the general meeting of 7 May 2019,
following the proposal formulated by the board of directors issued upon recommendation
of the Audit Committee. Our statutory auditor’s mandate expires on the date of the
General Meeting deliberating on the financial statements closed on 31 December 2021.
We have performed the statutory audit of the consolidated financial statements of Oxurion
NV for twelve consecutive years.
REPORT ON THE CONSOLIDATED FINANCIAL
STATEMENTS
Unqualified opinion
We have performed the statutory audit of the Group’s con-
solidated financial statements, which comprise the consol-
idated statement of financial position as at 31 December
2021, and the consolidated statement of profit or loss and
other comprehensive income , the consolidated statement
of changes in equity and the consolidated statement of cash
flows for the year then ended, and notes to the consolidat-
ed financial statements, including a summary of significant
accounting policies and other explanatory information,
and which is characterised by a consolidated statement of
financial position total of 18,876 (000) EUR and for which
consolidated income statement and other comprehensive
income shows a loss for the year of 29,595 (000) EUR.
In our opinion, the consolidated financial statements give a
true and fair view of the Group’s net equity and financial
position as at 31 December 2021, as well as of its consoli-
dated financial performance and its consolidated cash flows
for the year then ended, in accordance with International
Financial Reporting Standards (IFRS) as adopted by the
European Union and with the legal and regulatory require-
ments applicable in Belgium.
Basis for unqualified opinion
We conducted our audit in accordance with International
Standards on Auditing (ISA) as applicable in Belgium.
Our responsibilities under those standards are further
described in the ‘Statutory auditor’s responsibilities for
the audit of the consolidated financial statements’ section
in this report. We have complied with all the ethical re-
quirements that are relevant to the audit of consolidated
financial statements in Belgium, including those concern-
ing independence.
We have obtained from the administrative body and
company officials the explanations and information
necessary for performing our audit.
We believe that the audit evidence we have obtained is suf-
ficient and appropriate to provide a basis for our opinion.
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OXURION ANNUAL REPORT 2021
Material uncertainty related to going concern
We draw attention to section 5.5.3 (B) in the Consolidated
Financial Statements, which indicates that the actual cash
position of the Group is not sufficient to finance its opera-
tions during the next twelve months. The Group describes
its action plan to safeguard its continuity during the next
twelve months, and decided to maintain its valuation rules
in the assumption of going concern. This is only justified
if the Group will be successful in the timely and effective
realization of its action plan. These conditions indicate the
existence of a material uncertainty that may cast signifi-
cant doubt about the Group’s ability to continue as a going
concern. Our opinion is not modified in respect of this
matter.
Key audit matter
Key audit matters are those matters that, in our profes-
sional judgment, were of most significance in our audit of
the consolidated financial statements of the current year.
These matters were addressed in the context of our audit
of the consolidated financial statements as a whole, and
in forming our opinion thereon, and we do not provide a
separate opinion on these matters.
Issuance and valuation of convertible bonds under
the Negma Group Ltd. issuance and subscription
agreement
Description of the Matter
As described in Note 5.7.11 to the consolidated financial
statements, the Company entered into an agreement
whereby Negma Group Ltd. as investor can subscribe
to, up to 12,000 mandatory convertible bonds with each
a nominal value of 2,500 euro, in several tranches of
minimum 200 and maximum 1,000 bonds for a total
committed amount up to 30 million euro. The initial cash
received amounted to 2.5 million euro of which a total
of 1.350 million euro was converted into shares before
December 31, 2021. The Company evaluated and deter-
mined that the convertible bonds described meets the
definition of a derivative financial liability, and designated
the entire instrument at fair value through profit and loss.
The fair value of the outstanding convertible loan amount
of 1.675 million euro as per December 31, 2021 is deter-
mined at 1.809 million euro with changes in the fair value
recorded in profit and loss as fair value gains and losses on
the convertible loan.
We identified the accounting and the valuation of the
issuance of the convertible bonds as a key audit matter.
Auditing the following elements involved especially chal-
lenging and complex auditor judgment with respect to
(i) the Company’s accounting assessment related to the
financial instrument and (ii) the calculation of the valuation
related to the financial liability.
Procedures performed
Our audit procedures included, amongst others:
• We have analyzed and read the convertible transaction,
issuance and subscription, agreement, to create an un-
derstanding of the impact on the financial statements
and its disclosures.
• We have utilized personnel with specialized knowledge
and skill at our firm in accounting to evaluate the
appropriateness of management’s application of ac-
counting guidance for complex financial instruments
as adopted by the Company in accordance with IFRS.
• We have utilized personnel with specialized knowledge
and skill in valuation at our firm to assist in evaluating
the appropriateness of the methodology and the rea-
sonableness of assumptions used by the Company’s
valuation of the financial liability.
• We assessed the adequacy of the Company’s dis-
closures in the notes of the Consolidated Financial
Statements.
.
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OXURION ANNUAL REPORT 2021
Issuance and valuation of convertible bonds under
the Kreos Capital VI Ltd and Pontifax Medison
Finance LP loan facility agreement
Description of the Matter
As described in Note 5.7.11 to the consolidated financial state-
ments, the Company entered into an agreement whereby
Kreos Capital VI Ltd. together with Pontifax Medison Finance
L.P. as investors can subscribe to convertible bonds with
each a nominal value of 0.1 million euro, in two tranches of
each 10 million euro for a total committed amount up to 20
million euro. The convertible bonds accrue interest in the
amount of 7.95% per year.
The initial cash received amounted to 10 million euro as
per December 31, 2021. The Company evaluated and de-
termined that the convertible bonds described meets the
definition of a derivative financial liability, and designated the
entire instrument at fair value through profit and loss. The
fair value as per December 31, 2021 is determined at 10.025
million euro with changes in the fair value recorded in profit
and loss as fair value gains and losses on the convertible
loan.
We identified the accounting and the valuation of the
issuance of the convertible bonds as a key audit matter.
Auditing the following elements involved especially chal-
lenging and complex auditor judgment with respect to (i) the
Company’s accounting assessment related to the financial
instrument and (ii) the calculation of the valuation related to
the financial liability.
Procedures performed
Our audit procedures included, amongst others:
• We have analyzed and read the convertible, loan facility,
agreement, to create an understanding of the impact
on the financial statements and its disclosures.
• We have utilized personnel with specialized knowledge
and skill at our firm in accounting to evaluate the
appropriateness of management’s application of ac-
counting guidance for complex financial instruments
as adopted by the Company in accordance with IFRS.
• We have utilized personnel with specialized knowledge
and skill in valuation at our firm to assist in evaluating
the appropriateness of the methodology and the rea-
sonableness of assumptions used by the Company’s
valuation of the financial liability.
• We assessed the adequacy of the Company’s dis-
closures in the notes of the Consolidated Financial
Statements.
Responsibilities of the administrative body for the
drafting of the consolidated financial statements
The administrative body is responsible for the preparation
of consolidated financial statements that give a true and
fair view in accordance with the International Financial
Reporting Standards (IFRS) as adopted by the European
Union and with the legal and regulatory provisions ap-
plicable in Belgium, and for such internal control as the
administrative body determines is necessary to enable the
preparation of consolidated financial statements that are
free from material misstatements, whether due to fraud
or error.
In preparing the consolidated financial statements, the ad-
ministrative body is responsible for assessing the Group’s
ability to continue as a going concern, disclosing, as ap-
plicable, matters related to going concern and using the
going concern basis of accounting unless the administra-
tive body either intends to liquidate the Group or to cease
operations, or has no realistic alternative but to do so.
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OXURION ANNUAL REPORT 2021
Statutory auditor’s responsibilities for the audit of the
consolidated financial statements
Our objectives are to obtain reasonable assurance about
whether the consolidated financial statements as a whole
are free from material misstatement, whether due to
fraud or error, and to issue a statutory auditor’s report
that includes our opinion. Reasonable assurance is a high
level of assurance, but it is not a guarantee that an audit
conducted in accordance with ISAs will always detect a
material misstatement when it exists. Misstatements can
arise from fraud or error and are considered material if,
individually or in the aggregate, they could reasonably
be expected to influence the economic decisions of
users taken on the basis of these consolidated financial
statements.
When executing our audit, we respect the legal, regulatory
and normative framework applicable for the audit of the
consolidated financial statements in Belgium. However, a
statutory audit does not guarantee the future viability of
the Group, neither the efficiency and effectiveness of the
management of the Group by the administrative body.
Our responsibilities regarding the continuity assumption
applied by the administrative body are described below.
As part of an audit in accordance with ISAs, we exercise
professional judgment and maintain professional skepti-
cism throughout the audit. We also:
• Identify and assess the risks of material misstatement
of the consolidated financial statements, whether due
to fraud or error, design and perform audit procedures
responsive to those risks, and obtain audit evidence
that is sufficient and appropriate to provide a basis
for our opinion. The risk of not detecting a material
misstatement resulting from fraud is higher than for
one resulting from error, as fraud may involve collusion,
forgery, intentional omissions, misrepresentations, or
the override of internal control;
• Obtain an understanding of internal control relevant
to the audit in order to design audit procedures that
are appropriate in the circumstances, but not for the
purpose of expressing an opinion on the effectiveness
of the Group’s internal control;
• Evaluate the appropriateness of accounting policies
used and the reasonableness of accounting estimates
and related disclosures made by the administrative
body;
• Conclude on the appropriateness of the administrative
body’s use of the going concern basis of accounting
and, based on the audit evidence obtained, whether a
material uncertainty exists related to events or condi-
tions that may cast significant doubt on the Group’s
ability to continue as a going concern. If we conclude
that a material uncertainty exists, we are required to
draw attention in our statutory auditor’s report to the
related disclosures in the consolidated financial state-
ments or, if such disclosures are inadequate, to modify
our opinion. Our conclusions are based on the audit
evidence obtained up to the date of our statutory
auditor’s report. However, future events or conditions
may cause the Group to cease to continue as a going
concern;
• Evaluate the overall presentation, structure and content
of the consolidated financial statements and whether
the consolidated financial statements represent the
underlying transactions and events in a manner that
achieves fair presentation;
• Obtain sufficient appropriate audit evidence regarding
the financial information of the entities or business ac-
tivities within the Group to express an opinion on the
consolidated financial statements. We are responsible
for the management, the supervision and the perfor-
mance of the Group audit. We assume full responsibil-
ity for the auditor’s opinion.
We communicate with the Audit Committee regarding,
among other matters, the planned scope and timing of the
audit and significant audit findings, including any significant
deficiencies in internal control identified during the audit.
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OXURION ANNUAL REPORT 2021
We also provide the audit committee with a statement that
we respected the relevant ethical requirements relating to
independence, and we communicate with them about all
relationships and other issues which may influence our in-
dependence, and, if applicable, about the related measures
to guarantee our independence.
From the matters communicated with the Audit
Committee, we determine those matters that were of
most significance in the audit of the consolidated financial
statements of the current year, and are therefore the key
audit matters. We describe these matters in our statutory
auditor’s report, unless law or regulation precludes public
disclosure about the matter.
OTHER LEGAL AND REGULATORY REQUIREMENTS
Responsibilities of the administrative body
The administrative body is responsible for the prepara-
tion and the contents of the management report on the
consolidated financial statements and for the other infor-
mation included in the annual report on the consolidated
financial statements.
Responsibilities of the statutory auditor
In the context of our mission and in accordance with the
Belgian standard (version revised 2020) which is comple-
mentary to the International Standards on Auditing (ISA)
as applicable in Belgium, it is our responsibility to verify, in
all material aspects, the management report on the con-
solidated financial statements and the other information
included in the management report on the consolidated
financial statements, as well as to report on this element
these elements.
Aspects relating to the management report on the
consolidated financial statements and to the other
information included in the annual report on the
consolidated financial statements
In our opinion, after having performed specific procedures
in relation to the management report, this report is con-
sistent with the consolidated financial statements for the
same financial year, and it is prepared in accordance with
article 3:32 of the Code of companies and associations.
In the context of our audit of the consolidated financial
statements, we are also responsible for considering, in par-
ticular based on the knowledge we have obtained during
the audit, whether the management report on the con-
solidated financial statements and the other information
included in the annual report on the consolidated financial
statements, namely:
• Chapter 3.1 Key Figures
• Chapter 3.3 Comments to Consolidated Financial
Statements
• Chapter 3.5 Description of the Principal Characteristics
of the Company’s Risks
contain a material misstatement, i.e. information which is
inadequately disclosed or otherwise misleading. Based on
the procedures we have performed, there are no material
misstatements we have to report to you.
Statement concerning independence
• Our audit firm and our network did not provide services
which are incompatible with the statutory audit of the
consolidated financial statements and our audit firm
remained independent of the Group during the terms
of our mandate.
• The fees related to additional services which are com-
patible with the statutory audit as referred to in article
3:65 of the Code of companies and associations were
duly itemised and valued in the notes to the consolidat-
ed financial statements.
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OXURION ANNUAL REPORT 2021
European Single Electronic Format (ESEF)
In accordance with the standard on auditing the confor-
mity of financial statements with the European Single
Electronic Format (hereinafter “ESEF”), we are required to
verify whether the ESEF format complies with the regu-
latory technical standards established by Commission
Delegated Regulation (EU) 2019/815 of 17 December
2018 (hereinafter: “Delegated Regulation”).
The managing body is responsible for preparing, in accor-
dance with ESEF requirements, the consolidated financial
statements in the form of an electronic file in ESEF format
(hereinafter “digital consolidated financial statements”)
included in the annual financial report.
It is our responsibility to obtain sufficient and appropriate
supporting information to conclude that the format and
mark-up language of the digital consolidated financial
statements comply in all material aspects with the ESEF
requirements under the Delegated Regulation.
The annual financial report and the digital consolidated
financial statements have not yet been delivered to us on
the date of this report.
If, when auditing the digital consolidated financial state-
ments, we conclude that there is a material misstatement,
we will be required to report the matter to the managing
body and ask it to make the necessary changes. Failing
that, we will be required to amend this report to the effect
that the format and marking of information in the official
version of the digital consolidated financial statements
included in the annual financial report of Oxurion NV
comply in all material aspects with the ESEF requirements
under the Delegated Regulation.
Other statements
This report is in compliance with the contents of our ad-
ditional report to the Audit Committee as referred to in
article 11 of regulation (EU) No 537/2014.
Zaventem, 25 March 2022
BDO Réviseurs d’Entreprises SRL
Statutory auditor
Represented by Gert Claes
Auditor
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OXURION ANNUAL REPORT 2021
132
OXURION ANNUAL REPORT 2021
7. ABBREVIATED STATUTORY
FINANCIAL STATEMENTS
133
OXURION ANNUAL REPORT 2021
The financial statements of Oxurion are presented in an
abbreviated form.
The Annual Report, the financial statements and the
opinion of the Statutory Auditor are filed at the National
Bank of Belgium in accordance with Articles 3:10 and 3:12
of the BCCA.
The full version of the statutory financial statements and
the reports are available free of charge for the public in
English and Dutch upon request to:
Oxurion NV
to the attention of Michaël DILLEN
Gaston Geenslaan 1
B-3001 Leuven
Belgium
Tel: +32 16 75 13 10
Fax: +32 16 75 13 11
e-mail: IR@oxurion.com
There is also an electronic version of the full statutory
Annual Report and the reports which can be obtained
via Oxurion’s website (www.oxurion.com). The statutory
financial statements as filed with the National Bank of
Belgium are based upon Belgian GAAP. An unqualified
audit opinion was issued by the Statutory Auditor.
7.1 BALANCE SHEET OF OXURION NV
IN '000 EURO (AS AT 31 DECEMBER) 2021 2020
ASSETS
Fixed Assets 2,084 12,425
Intangible fixed assets 1,000 1,000
Tangible fixed assets 118 196
Financial fixed assets 966 11,230
Current assets 14,666 28,629
Amounts receivable after more than
one year
3,647 3,372
Inventories and work in progress 60 161
Amounts receivable within one year 1,142 1,034
Current investments 242 278
Cash and banks 9,426 23,707
Deferred charges and accrued income 149 77
TOTAL ASSETS 16,750 41,054
LIABILITIES
Equity -1,389 33,956
Capital 56,442 55,326
Share premium account 234 0
Reserves 5,533 5,533
Accumulated profits (losses) -63,597 -26,903
Amounts payable 18,139 7,098
Amounts payable after more than one
year
8,412 0
Amounts payable within one year 9,283 6,263
Accrued charges and deferred income 444 836
TOTAL LIABILITIES 16,750 41,054
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OXURION ANNUAL REPORT 2021
7.2 INCOME STATEMENT OF
OXURION NV
IN '000 EURO (FOR THE YEAR ENDED 31 DECEM-
BER)
2021 2020
Operating income and charges
Gross margin 6,069 -330
Remuneration, social security costs and
pensions
-7,376 -7,336
Depreciation of and amounts written off
formation expenses, intangible and tangible
fixed assets
-23,744 -17,761
Amounts written down stock, contracts in
progress and trade debtors - Appropriations
(write-backs)
-283 -697
Other operating charges -431 -112
Non-recurring operating charges / operating
income
-10,991 -1,371
Operating profit (loss) -36,756 -27,607
Financial income 138 481
Financial charges -875 -371
Profit (loss) for the period before taxes -37,493 -27,497
Income taxes 799 594
Profit (loss) for the period -36,694 -26,903
Profit (loss) for the period available for
appropriation
-36,694 -26,903
7.3 APPROPRIATION ACCOUNT OF
OXURION NV
IN '000 EURO (FOR THE YEAR ENDED AT 31
DECEMBER)
2021 2020
Profit (loss) to be appropriated -63,597 -77,101
Gain (loss) to be appropriated -36,694 -26,903
Profit (loss) to be carried forward -26,903 -50,198
Transfers from capital and reserves 0 50,198
from capital and share premium
account
0 50,198
from reserves 0 0
Profit (loss) to be carried forward -63,597 -26,903
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OXURION ANNUAL REPORT 2021
7.4 KEY VALUATION PRINCIPLES
INTANGIBLE ASSETS
Internally generated intangible assets
Research costs are charged to the income statement as
incurred.
An internally generated intangible fixed asset (see note
5.7.3) which arises from development activities undertak-
en in the Group is recognized only if all of the following
conditions are met:
• Technical possibility of making the intangible asset
ready for use.
• Intention is to complete the intangible asset and use
or sell it.
• Possibility of using or selling the intangible asset.
• Probability that the intangible asset will generate future
economic benefit or demonstrate the existence of a
market.
• Availability of adequate technical, sufficient financial
resources to complete the development; and
• Availability to reliably measure the attributed expenses
for this intangible asset during development.
Patent costs for protecting intangible assets are recog-
nized as an expense.
After their initial recording on the balance sheet, intangible
assets are valued at cost less accumulated depreciation
and accumulated impairment losses. Depreciation of cap-
italized development costs are recognized in the income
statement under ‘Research and Development Expenses’.
The capitalized costs are amortized over the life of a patent
as of the moment that it will generate revenue.
Where the criteria for capitalization of the research and
development expenses are not met, these expenses are
recorded as incurred during the period.
Oxurion has capitalized ocriplasmin clinical trial costs since
2008 due to the fact that this project was at that moment
in Phase 3 and future commercialization was estimated
to be highly probable. The intangible assets consist of
external trial and production costs with subcontractors and
internal development costs regarding all projects in Phase
3. An impairment test determined that the value of these
assets was no longer justified and as a consequence these
assets were written off on June 30, 2019.
Intangible assets purchased
Computer software licenses acquired are capitalized on
the basis of the costs incurred to acquire and bring to use
the specific software. These costs are amortized over their
estimated useful life which is typically considered to be
three years.
Knowledge acquired in the form of licenses is recorded
at cost less accumulated amortization and impairment.
These amounts are amortized on a straight-line basis over
their estimated useful life, which is the period over which
the Group expects to receive economic benefits from such
licenses.
TANGIBLE ASSETS
Property, plant and equipment are included at the histori-
cal cost (material costs only) less accumulated deprecia-
tion. Subsequent costs are included in the carrying amount
for the asset or booked as a separate asset as appropriate,
but only when it is probable that future economic benefits
associated with the item will be generated for the Group
and the cost price of the item can be measured reliably.
All other repair and maintenance costs are charged to the
income statement as incurred. The cost of assets retired
or otherwise disposed of and the related accumulated
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OXURION ANNUAL REPORT 2021
depreciation are included in the income statement as part
of the gain or loss on disposal in the year of disposal. Gains
and losses on disposal of property, plant and equipment
are included in other income or expense.
Depreciation is calculated using the straight-line method to
allocate the cost of property, plant and equipment to their
estimated residual values over their estimated useful lives
as follows:
• Property, plant and equipment: 3 to 5 years
• Furniture and fittings: 3 to 5 years
The depreciation and amortization methods, useful life and
residual value are re-valued on each reporting date.
Subsequent costs
The cost of replacing part of an item of property, plant
and equipment is recognized in the carrying amount of
the item if it is probable that the future economic benefits
embodied within the part will flow to the Group and its
cost can be measured reliably. The carrying amount of the
replaced part is derecognized. The costs of the day-to-day
servicing of property, plant and equipment are expensed
as incurred.
INVENTORIES
Raw and ancillary materials and commodities are stated
at the lower of cost or net realizable value. The inventory
costing system is based on the FIFO-method.
Goods in process and finished goods are stated at the
standard manufacturing cost or net realizable value. The
inventory costing system is based on the FIFO-method.
Net realizable value test is performed each reporting
period. Net realizable value is the estimated selling price
in the ordinary course of business less the estimated costs
of completion and the estimated costs necessary to make
the sale.
The standard manufacturing price of the goods in process
and of the finished goods, includes (i) the acquisition value
of the raw materials, consumables and ancillary materials,
(ii) the production costs which are directly attributable
to the product, and (iii) the proportioned part of the pro-
duction costs which are only indirectly attributable to the
product, in so far that these costs cover the normal pro-
duction period.
The standard manufacturing price is compared to the
actual manufacturing price on annual basis. The difference
results in an adjustment of the value of the inventory.
TRADE RECEIVABLES
When initially recognized, trade receivables are measured
at fair value, and are subsequently measured at amortized
cost using the effective interest rate method. Appropriate
allowances for estimated irrecoverable amounts are
included in the income statement when there is objective
evidence that the asset is impaired. Allowance for bad
debts are booked on the basis of an estimate of lifetime
credit losses at each reporting date, taking into account
the payment history of the other party. An allowance for
impairment of trade and other receivables is established
when there is objective evidence that the Company will
not be able to collect all amounts due according to the
original terms of the receivables. Impairment losses are
generally recorded on receivables in the event of insolven-
cy or similar proceedings being launched, financial restruc-
turing at business partners, or the initiation of enforcement
measures. Payment history and past-due receivables are
also analyzed, with customer-specific facts assessed in
each case.
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OXURION ANNUAL REPORT 2021
INVESTMENTS
The investments are held as available for sale and annual
closing date stated at market value. The fair value adjust-
ment is included in other reserves until the investment is
derecognized or has been impaired. The impairment is
included in the income statement.
CASH AND CASH EQUIVALENTS
Cash and cash equivalents comprise demand deposits
and other short-term, highly liquid investments (with less
than three months to maturity) that are readily convertible
into a known amount of cash and are subject to an insig-
nificant risk of fluctuations in value.
FINANCIAL LIABILITIES AND EQUITY
Financial liabilities and equity instruments issued by the
Group are classified according to the substance of the con-
tractual arrangements entered into and the definitions of a
financial liability and an equity instrument. An equity instru-
ment is any contract that evidences a residual interest in
the assets of the Group after deducting all its liabilities. The
accounting policies adopted for specific financial liabilities
and equity instruments are set out below.
TRADE PAYABLES
Trade payables are initially measured at fair value, and
are subsequently measured at amortized cost, using the
effective interest rate method.
CONVERTIBLE LOANS
The convertible loans are - in line with the CBN advice
2019/07 of July 3, 2019 - valued at issue value. The costs
associated with the issuance of these loans are recognized
in the income statement.
The Company currently has 2 convertible loans:
• Negma Group Ltd.
On August 26, 2021, Oxurion (the Company or the Issuer)
entered into an agreement whereby Negma as investor
is willing to subscribe to, up to 12,000 zero coupon au-
tomatically convertible bonds with each a nominal value
of 2,500 euro, in several tranches of minimum 200 and
maximum 1,000 bonds for a total committed amount up
to 30 million euro. The Company as issuer controls the
timing and amount of the tranche calls.
Since the term of the convertible loan is less than 12
months, it is included in “Amounts payable within one year”.
As of December 31, 2021, the Company has received
2.5 million euro of which a total of 1.350 million euro has
already been converted into shares.
• Kreos Capital / Pontifax Ventures
On November 21, 2021, Oxurion (the Company or the
Issuer) entered into an agreement whereby Kreos Capital
VI Limited together with Pontifax Medison Finance L.P.
(the Investors) as investors are willing to subscribe to
convertible bonds with each a nominal value of 0.1 million
euro, in two tranches of each 10.0 million euro for a total
committed amount up to 20.0 million euro. The convert-
ible bonds accrue interest in the amount of 7.95% per year.
The convertible bonds may be either:
1. Converted in shares at the option of the Investors at
any time
2. Converted in shares at the option of the Issuer when
certain conditions are met
3. Repaid based on the amortization schedule without
extension
4. Repaid based on the amortization schedule with
extension
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OXURION ANNUAL REPORT 2021
5. Prepaid when certain conditions are met
6. Paid in full in case of events of default or change in
control
For the classification as of December 31, 2021, the amor-
tization schedule without extension has been taken into
account to divide the loan into “Amounts payable after
more than one year” and “Amounts payable within one
year”.
As of December 31, 2021, the Company has received 10
million euro and has not yet repaid anything.
TAX CREDIT RECEIVABLES AFTER MORE THAN ONE
YEAR
As from 2018, based on the CBN opinion 2018/02
published on March 21, 2018, the tax credit to be received
within one year is recorded under taxes and withhold-
ing taxes to be recovered (#412). To the extent that the
repayment is estimated to occur only after more than one
year, this receivable is recorded as other receivables after
more than one year (#291).
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OXURION ANNUAL REPORT 2021
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OXURION ANNUAL REPORT 2021
8. GLOSSARY
141
OXURION ANNUAL REPORT 2021
AGM Annual General shareholders’ Meeting
Annual Report Has the meaning given to it in Section 1.1.
Anti-VEGF Anti–vascular endothelial growth factor
Articles of Association The Company’s co-ordinated articles of association dated March 23, 2022
Audit Committee Has the meaning given to it in Section 3.6.8.
BCCA The Belgian Code of Companies and Associations of March 23, 2019 (as amended from time
to time)
Bicycle Collaboration
Agreement
Collaboration agreement entered into between Oxurion and Bicycle Therapeutics in August 2013
Board of Directors Has the meaning given to it in Section 1.1.
CEO Chief Executive Officer
CFO Chief Financial Officer
cGMP Good Clinical Manufacturing
Clinical Assets Means THR-149 and THR-687
Code of Business
Conduct
Has the meaning given to it in Section 4.3.2.
Company Oxurion NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0881.620.924
Corporate Governance
Charter
Oxurion’s Corporate Governance Charter
Corporate Governance
Code
The 2020 Belgian Code on Corporate Governance
CROs Clinical Research Organizations
DBO Defined Benefit Obligation
DME Diabetic Macular Edema
DR Diabetic Retinopathy
ECLs Expected credit losses
EGM Extraordinary general shareholders’ meeting
EIR Effective interest rate
EMA European Medicines Agency
ERP Enterprise resource planning
EU European Union
Executives Members of the Executive Committee
Executive Committee Has the meaning given to it in Section 3.5.7.2.
FDA US Food and Drug Administration
FSMA Financial Services and Markets Authority (Belgium)
Funding Program Has the meaning given to it in Section 3.5.1.1.
Galapagos License
Agreement or the
Galapagos License
Global and exclusive in-licensing agreement entered into between Oxurion and Galapagos NV
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OXURION ANNUAL REPORT 2021
GCP Good Clinical Practice
GLP Good Laboratory Practice
GDPR General Data Protection Regulation
Group Has the meaning given to it in Section 3.2.3.
IAS International Accounting Standard
IASB International Accounting Standards Board
IFRS International Financial Reporting Standards
IFRS IC IFRS Interpretations Committee
Inceptua Has the meaning given to it in Section 3.2.3.
INTEGRAL trial Has the meaning given to it in Section 3.2.5.
IP Intellectual Property
IT Information Technology
IVT Intravitreal
IWT Agency for Innovation by Science and Technology in Flanders
JETREA® Has the meaning given to it in Section 3.2.3.
KALAHARI trial Has the meaning given to it in Section 3.2.5.
KU Leuven Catholic University of Leuven
Loan Facility Has the meaning given to it in Section 3.5.8.2.
Market Abuse
Regulation
Regulation (EU) No 596/2014 of the European Parliament and of the Council of April 16, 2014,
on Market Abuse
MBA Master of Business Administration
ME-RVO Retinal Vein Occlusion
Negma Negma Group Ltd.
NGO Non-Governmental Organization
Nomination and
Remuneration
Committee
Has the meaning given to it in Section 4.3.1.
NV Public limited liability company (in Dutch: Naamloze Vennootschap)
OCI Other Comprehensive Income
Oncurious Oncurious NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0627.952.462
Ophthalmology The branch of medicine that deals with the diagnosis, prevention, and treatment of disorders of
the eye
Oxurion Oxurion NV, having its registered office at Gaston Geenslaan 1, 3001 Leuven, registered in the
register of legal entities (Leuven) under number 0881.620.924
Policy Has the meaning given to it in Section 4.9.
Receiving Parties Has the meaning given to it in Section 3.5.6.2.
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Regulator(s) FDA, EMA and other similar regulatory agencies
R&D Research and Development
SPPI Solely payments of principal and interest
Statutory Auditor BDO Bedrijfsrevisoren BV, having its registered office at Da Vincilaan 9, box E.6, B-1930 Zaventem,
represented by Gert Claes, auditor
Subscription Rights
Plan 2021-1
Has the meaning given to it in Section 4.9.2.1 (C).
Subscription Rights
Plan 2021-2
Has the meaning given to it in Section 4.9.2.1 (C).
Subscription Rights
Plan 2021-3
Has the meaning given to it in Section 4.9.2.1 (C).
Thromb-X Has the meaning given to it in Section 3.2.3.
ThromboGenics Inc. Has the meaning given to it in Section 3.2.3.
Trials The KALAHARI trial and the INTEGRAL trial
Tripartite Agreement Has the meaning given to it in Section 5.8.
UC Louvain Université Catholique de Louvain
US United States of America
VEGF Vascular Endothelial Growth Factor
VIB or Flanders Institute
for Biotechnology
Flanders Institute for Biotechnology VZW, having its registered office at Rijvisschestraat 120, 9052
Zwijnaarde, registered in the register of legal entities (Ghent – Division Ghent) under number
0456.343.923
VLAIO Flanders Innovation & Entrepreneurship
wet AMD Wet age-related macular degeneration
2018 Agreement exclusive commercial agreement entered into between Oxurion and Eumedica in view of JETREA®
2021 Remuneration
Policy
Oxurion’s remuneration policy, as adopted in 2021
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Headquarters
Oxurion NV
Gaston Geenslaan 1
3001 Leuven
Belgium
T +32 16 75 13 10
F +32 16 75 13 11
United States subsidiary
ThromboGenics, Inc.
Belgian subsidiary
Oncurious NV
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