(1) Organization and Business Activities
Guilford Pharmaceuticals Inc. (together with its subsidiaries, Guilford or the Company) is a biopharmaceutical company, located in Baltimore, Maryland, engaged in the development and commercialization of novel products in two principal areas: (i) targeted and controlled drug delivery systems using proprietary biodegradable polymers for the treatment of cancer and other diseases; and (ii) therapeutic and diagnostic products for neurological diseases and conditions. (2) Summary of Significant Accounting Policies Principles of Consolidation Cash and Cash Equivalents Investments A decline in the market value of any available-for-sale or held-to-maturity security below cost that is deemed to be other than temporary is an impairment which would result in a reduction in the carrying amount to fair value. Such impairment, if any, is charged to earnings and a new cost basis for the security is established. Dividends and interest income are recognized when earned. Inventories Property and Equipment Revenue Recognition Royalty revenue is recognized at such time as the Companys sales, marketing and distribution partner sells the product (see Note 14). Collaborative research revenue is recognized, up to the contractual limits, when the Company meets its performance obligations under the respective agreements. Contract and non-refundable licensing revenue is recognized when milestones are met and the Companys significant performance obligations have been satisfied in accordance with the terms of the respective agreements. Payments received that relate to future performance are deferred and recognized as revenue at the time such future performance has been accomplished. Research and Development, Patent and Royalty Costs Accounting for Income Taxes Stock-Based Compensation Comprehensive Income Earnings (loss) per Share Impairment of Long-Lived Assets Interest Rate Swap Agreements Fair Value of Financial Instruments Concentration of Credit Risk Uncertainties Use of Estimates Significant Customer and Product Reclassifications New Accounting Standard (3) Investments Investments in marketable securities as of December 31, 1998 and 1997 are as follows:
At December 31, 1998 and 1997, investments of $16.5 million and $12.1 million, respectively, are classified as Investmentsrestricted in the accompanying consolidated balance sheets (see Notes 7 and 8). Maturities of debt securities classified as available-for-sale and held-to-maturity were as follows at December 31, 1998;
(4) Interest Rate Swap Agreements During 1998, the Company entered into interest rate swap agreements to reduce the impact of changes in interest rates on certain financial lease obligations (see Note 8). The interest rate swap agreements are with First Union National Bank (First Union), having a total notional principal amount of $20 million at December 31, 1998. In January 1999, the Company entered into additional interest rate swap agreements having a total notional principal amount of $10 million on its long-term debt (see Note 7). As a result of these interest rate swap agreements, the Company has effectively fixed the interest rates on its long-term debt and certain financial lease obligations to an annual rate of approximately 6%. The interest rate swap agreements have the same maturity as its long-term debt and certain financial lease obligations. First Union has the right to terminate these agreements on the fifth year anniversary date of each such agreement. The fair value of the Companys interest rate swap agreements approximate carrying value at December 31, 1998. The Company is not directly exposed to credit risk. In the event of non-performance by First Union, which is unlikely, the Company could be exposed to market risk related to interest rates. (5) Inventories Inventories consist of the following:
Inventories are net of applicable reserves and allowances. Inventories include products and materials that may be either available for sale and/or production or utilized internally in the Companys development activities. Inventories identified for development activities are expensed in the period in which such inventories are designated for such use. (6) Property and Equipment Property and equipment consist of the following:
(7) Indebtedness Long-term debt at December 31, 1998 and 1997 consists of the following:
Bond Financing Arrangement Term Loan Agreement The aggregate maturities of long-term debt for each of the five years subsequent to December 31, 1998 are approximately: 1999, $2.2 million; 2000, $2.2 million; 2001, $2.2 million; 2002, $2.2 million; and 2003, $1.3 million. Restrictive Covenants Revolving Line of Credit (8) Leases In February 1998, the Company entered into a Real Estate Development Agreement and an operating lease agreement in connection with the construction of a new research and development facility. The facility, which is expected to be approximately 73,000 square feet, will be adjacent to the Companys corporate headquarters in Baltimore, Maryland. Construction costs are estimated not to exceed $20 million in the aggregate. The lease term is for a maximum of 84 months, which includes a construction period of up to 24 months. The Company will not make rental payments during the construction period and will have the option to purchase the facility at the end of the lease term in February 2005. The Company anticipates that the annual lease payments will not exceed $1.5 million. In the event the Company chooses not to exercise its purchase option, the Company is obligated to arrange for the sale of the facility and is required to pay the lessor any difference between the net sales proceeds and the lessors net investment in the facility. If the sales proceeds are less than the lessors net investment in the facility, the Company has to pay an amount equal to the difference between 83% of the lessors net investment in the facility and the shortfall. During the construction period, the Company must maintain cash collateral equal to 100% of the cost of construction not to exceed $20 million. Upon completion of construction, the Company may reduce the amount of aggregate cash collateral by approximately $5.1 million. As of December 31, 1998, the Company had established cash collateral of approximately $8.1 million related to this transaction. The cash collateral is included in the accompanying consolidated balance sheets as Investments-restricted. In addition the Company is subject to certain financial covenants the most restrictive of which requires that the Company maintain unrestricted cash, cash equivalents and investments in the aggregate equal to $40 million. The Company has several non-cancelable operating leases for equipment and buildings. In March 1998, the Company entered into certain Master Lease Agreements to provide up to $10.8 million for computer and equipment financing. The Companys ability to draw on these Master Lease Agreements expires on December 31, 1999. The term of each operating lease may range from 24 to 48 months based upon the type of equipment being financed. As of December 31, 1998, the Company had leased approximately $4.1 million in computer and other equipment under these agreements. The Companys future minimum lease payments under these non-cancelable operating leases for years subsequent to December 31, 1998 are as follows:
Rent expense for operating leases was approximately $2.7 million, $1.5 million and $0.7 million in 1998, 1997 and 1996, respectively. (9) Income Taxes As of December 31, 1998, the Company had net operating loss (NOL) carryforwards available for federal income tax purposes of approximately $51 million, which expire at various dates between 2010 and 2018. NOL carryforwards are subject to ownership change limitations and may also be subject to various other limitations on the amounts to be utilized. As of December 31, 1998, the Company had tax credit carryforwards of approximately $1 million expiring between 2010 and 2015. Actual income tax expense differs from the expected income tax expense computed at the effective federal rate as follows:
Realization of net deferred tax assets related to the Companys NOL carryforwards and other items is dependent on future earnings, which are uncertain. Accordingly, a valuation allowance has been established equal to net deferred tax assets which are not likely to be realized in the future, resulting in net deferred tax assets of approximately $138,000 at December 31, 1998 and 1997. The change in the valuation allowance was an increase of approximately $12.6 million in 1998 and an increase of approximately $6.6 million in 1997. Significant components of the Companys deferred tax assets and liabilities as of December 31, 1998 and 1997 are shown below.
(10) Capital Transactions In September 1998, the Company announced that a Committee of the Companys Board of Directors had authorized a common stock repurchase program of up to 1,000,000 shares of the Companys common stock in the aggregate. The Company plans to purchase its common stock in the open market or in block transactions from time to time as it deems appropriate. As of December 31, 1998, the Company has repurchased 39,600 shares of its common stock under this repurchase program at an aggregate cost of approximately $475,000. On October 1, 1997, the Company sold 640,095 shares of common stock to Amgen Inc. (Amgen) for $15 million (see note 14). In addition, the Company issued for $5 million a five-year warrant to purchase up to 700,000 shares of the Companys common stock at an exercise price of $35.15 per share. In April 1997, the Company completed a follow-on public equity offering of approximately 3.7 million shares of its common stock providing net proceeds of approximately $71 million to the Company. In March 1997, The Abell Foundation, Inc. exercised its put option to receive the 750,000 shares of the Companys common stock in exchange for its 80% interest in Gell Pharmaceuticals Inc. (Gell). After such date, Gell became a wholly owned subsidiary of the Company and is included in the accompanying consolidated financial statements. On October 15, 1996, the Board of Directors declared a three-for-two stock split. Equity transactions (including number of shares) prior to that date have been adjusted to reflect the stock split. In June 1996, the Company entered into a stock purchase agreement with Rhône-Poulenc Rorer Pharmaceuticals Inc. and its parent corporation (collectively RPR) (see note 14) whereby, RPR purchased 281,531 shares of the Companys common stock for $7.5 million. In March 1996, the Company completed a follow-on public equity offering of approximately 3.5 million shares of its common stock, providing net proceeds of approximately $43 million to the Company. The Company is authorized to issue up to 4,700,000 shares of preferred stock in one or more different series with terms fixed by the Board of Directors. Stockholder approval is not required to issue this preferred stock. There are no shares of this preferred stock outstanding at December 31, 1998. (11) Stockholder Rights Plan In September 1995, the Board of Directors adopted a Stockholder Rights Plan in which preferred stock purchase rights (Rights) were granted at the rate of one Right for each share of common stock. All Rights expire on October 10, 2005. At December 31, 1998, the Rights were neither exercisable nor traded separately from the Companys common stock, and become exercisable only if a person or group becomes the beneficial owner of 20% or more of the Companys common stock or announces a tender or exchange offer which would result in its ownership of 20% or more of the Companys common stock. Each holder of a Right, other than the acquiring person, would be entitled to purchase $120 worth of common stock of the Company for each Right at the exercise price of $60 per Right, which would effectively enable such Rights holders to purchase common stock at one-half of the then current price. If the Company is acquired in a merger, or 50% or more of the Companys assets are sold in one or more related transactions, each Right would entitle the holder thereof to purchase $120 worth of common stock of the acquiring company at the exercise price of $60 per Right. At any time after a person or group of persons becomes the beneficial owner of 20% or more of the common stock, the Board of Directors, on behalf of all stockholders, may exchange one share of common stock for each Right, other than Rights held by the acquiring person. (12) Share Option and Restricted Share Plans Employee Share Option and Restricted Share Plans Shares awarded under the restricted share provisions of the Plans are valued at the fair market value of the stock on the day immediately preceding the date of award (date of grant, if later) and require a vesting period determined by the Board of Directors. Should an individual leave the employment of the Company for any reason (other than by reason of death or permanent disability), the award recipient would forfeit their ownership rights for all share options and restricted shares not otherwise fully vested. At December 31, 1998, the maximum share options issuable under the Plans are 4,035,000, of which up to 350,000 shares may be issued under the restricted share provisions. At December 31, 1998, there were 1,898,239 share options available for grant under the Plans. The Directors Plan Consultants Additional information with respect to the Companys share option plan(s) activity is summarized as follows:
Share options outstanding and exercisable by price range are as follows: |
|
Pro Forma Option Information The per share weighted-average fair value of all share options granted during 1998, 1997 and 1996 was $10.00, $10.00 and $7.21, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions.
The per share weighted-average fair value of share options granted during 1996 to consultants was $6.12 using similar assumptions. The Company applies APB 25 in accounting for share options granted to employees and, accordingly, no compensation expense has been recognized related to such share options to the extent that such share options were granted at an exercise price that equaled the fair market value at the grant date. Had the Company determined compensation cost based on the fair value at the grant date for its share options under FAS 123, (using the Black-Scholes pricing model), the Companys net income (loss) would have been reduced (increased) to the pro forma amounts indicated below:
(13) 401(k) Profit Sharing Plan The Company has a 401(k) Profit Sharing Plan (the 401(k) Plan) available to all employees meeting certain eligibility criteria which permits participants to contribute up to certain limits as established by the Internal Revenue Code. The Company may make matching contributions equal to a percentage of a participants contribution or may contribute a discretionary amount to the 401(k) Plan. Effective January 1997, the Company elected to make matching contributions in the Companys common stock equal to 50% of the first 6% of an employees salary contributed to such employees 401(k) Plan account. Such amounts vest 25% per year based on a participants years of service with the Company. The Company has made matching contributions of approximately $308,000 and $241,000 for the years ended December 31, 1998 and 1997, respectively. (14) Significant Contracts and Licensing Agreements Agreements with Amgen Inc. Under the terms of the Agreement, Amgen agreed to provide the Company up to $13.5 million over three years in the aggregate to support research activities relating to the FKBP Neuroimmunophilin Technology, with an option to fund a fourth year of research. The Company has recognized approximately $4.5 million and $1.1 million in research support for the years ended December 31, 1998 and 1997, respectively. Additionally, the Agreement provides for certain milestone payments to the Company, in up to ten different specified clinical indications, in the event Amgen achieves certain development milestones. In addition, the Company will receive royalties on product sales, if any, related to the FKBP Neuroimmunophilin Technology. Agreements with Rhône-Poulenc Rorer Pharmaceuticals Inc. Under the RPR Agreements, the Company has the right to borrow up to an aggregate of $7.5 million under certain conditions, including $4 million which became available January 2, 1997, and the remainder no earlier than 12 nor later than 18 months following funding of the initial $4 million. The loan proceeds are available to provide for expansion of the Companys existing facility supporting the production of GLIADEL and the construction of a second facility for the scale-up, production of GLIADEL and other polymer systems. Any principal amounts borrowed under this loan agreement are due five years from the date borrowed and will carry an interest rate equal to the lowest rate paid by RPR on its most senior indebtedness. Both the principal and interest due under this agreement may, at the Companys election, be repaid by offsetting certain amounts due to the Company under the RPR Agreements. The Company has not drawn down any of the available funds under the RPR Agreements. In September 1998, the Company and RPR amended its RPR Agreements. Under the original Marketing, Sales and Distribution Rights agreement, the Company was to conduct and pay for an U.S. Phase III clinical trial for a first surgery indication for GLIADEL. Independently, RPR was already conducting and paying for an international Phase III clinical trial to support the first surgery indication for GLIADEL which included clinical sites in the United States. One of the principal amendments to the agreement now provides for the companies to share the costs (subject to an aggregate cap of $3 million for the Company) of this single, multinational Phase III clinical trial. A second principal amendment provides for an equal splitting of the previously determined international regulatory milestones (previously $40 million, amended to $35 million) between first and recurrent surgery for market clearances of GLIADEL in France, Germany, Italy, Spain, U.K. and Australia. Under the amended agreement, the Company is entitled to receive up to $11 million upon receipt of marketing clearance with a claim for use in recurrent surgery and an additional $16.5 million (of which $7.5 million would be as an equity investment), payable upon receipt of marketing clearance for use in first surgery. Other amendments include a scale back of RPRs right of first offer, from six months on all new polymer oncology products, to 90 days only on products being developed directly by Guilford specifically for brain cancer; elimination of RPRs right to a seat on Guilfords Board of Directors at the time RPR subscribes to $7.5 million in the Companys common stock upon any market clearance in the U.S. of GLIADEL for first surgery; a clarification of the allocation of certain costs; and an acknowledgment that rights to GLIADEL in Japan have reverted back to the Company thereby reducing the original milestone payments from a total of $40 million to $35 million. Other Significant Contracts and Agreements The Company has also entered into various other licensing, research and development agreements which commit the Company to fund certain mutually agreed-upon research and development projects, either on a best efforts basis or upon attainment of certain performance milestones, as defined, or both, for various periods unless canceled by the respective parties. Such future amounts to be paid are approximately $778,000 through 2001. In addition, the Company will be required to pay a royalty on future net sales of all licensed products, if any, as well as a percentage of all payments received by the Company from sublicensees, if any. (15) Related Party Transactions Scios Inc., a significant stockholder, has billed the Company for facility rents related to the Companys research and development activities aggregating $883,000, $341,000 and $295,000 in 1998, 1997 and 1996, respectively. (16) Earnings (loss) per Share The following table presents the computations of basic and diluted EPS: |
|
(17) Legal Matters
The Company from time to time is involved in routine legal matters incidental to its normal operations. In managements opinion, the resolution of such matters will not have a material adverse effect on the Companys consolidated financial condition, results of operations or liquidity. |