-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, M+AmtKs14jivQ2QD8IYR/Bkmh1aXeKIg0BXMhX3JZyT1D4+s2sIbPLpMVlZ4Nmhr m332nQrI4wbnxWQyFZVoRw== 0000950133-00-001225.txt : 20000331 0000950133-00-001225.hdr.sgml : 20000331 ACCESSION NUMBER: 0000950133-00-001225 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000330 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GUILFORD PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000918066 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521841960 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-23736 FILM NUMBER: 584458 BUSINESS ADDRESS: STREET 1: 6611 TRIBUTARY ST CITY: BALTIMORE STATE: MD ZIP: 21224 BUSINESS PHONE: 4106316300 10-K 1 GUILFORD PHARMACEUTICALS FORM 10-K

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-K


		ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 1999
Commission File Number: 0-23736

GUILFORD PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)






Delaware		52-1841960
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

6611 Tributary Street

Baltimore, Maryland 21224

(410) 631-6300

(Address and telephone number of principal executive offices)

Securities registered pursuant to Section 12(b) of the Act:

None

Securities registered pursuant to Section 12(g) of the Act:

Common Stock, $.01 par value

Title of Class

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of Registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ]

As of March 13, 2000, the aggregate value of the approximately 23,562,733 shares of common stock of the Registrant issued and outstanding on such date, excluding approximately 1,772,958 shares held by all affiliates of the Registrant, was approximately $799,423,265. This figure is based on the closing sales price of $36.688 per share of the Registrant’s common stock as reported on the Nasdaq® National Market on March 10, 2000.

DOCUMENTS INCORPORATED BY REFERENCE

List hereunder the following documents incorporated by reference and the Part of the Form 10-K into which the document is incorporated:

Portions of the 1999 Annual Report to Stockholders are incorporated by reference into Part II. Portions of the Notice of Annual Meeting and Proxy Statement to be filed no later than 120 days following December 31, 1999 are incorporated by reference into Part III.

TABLE OF CONTENTS


PART I
Item 1. Business
Item 1A. Executive Officers and Other Significant Employees of Registrant
Item 2. Properties.
Item 3. Legal Proceedings
Item 4. Submission of Matters to a Vote of Security Holders
Item 4A. Risk Factors
PART II
Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters
Item 6. Selected Consolidated Financial Data
Item 7. Management’s Discussion and Analysis of Results of Operations and Financial Condition
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item 8. Financial Statements and Supplementary Data
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Item 10. Directors and Executive Officers of the Registrant
PART III
Item 11. Executive Compensation
Item 12. Security Ownership of Certain Beneficial Owners and Management
Item 13. Certain Relationships and Related Transactions
PART IV
Item 14. Exhibits, Financial Statement Schedules, and Reports on Form 8-K
Signatures and Power of Attorney

PART I

In this annual report, we may make forward-looking statements. You should note that we are making these forward-looking statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Generally the forward-looking statements in this annual report relate to our current expectations regarding future results of operations, economic performance, and financial condition of our business. In general, we have introduced these forward-looking statements by words such as “anticipates”, “believes”, “estimates”, “expects”, “hopes” and similar expressions. Although these statements reflect our current plans and expectations, we may nevertheless not be able to successfully implement these plans and we may not realize our expectations in whole or in part in the future.

The forward-looking statements in this annual report may cover, but are not necessarily limited to, the following topics: (1) our efforts in conjunction with Aventis to obtain international regulatory clearances to market and sell GLIADEL ® Wafer and to increase end-user sales of the product; (2) our efforts in conjunction with Aventis S.A., or “Aventis”, to expand the labeled uses for GLIADEL ® Wafer; (3) our efforts to develop polymer drug delivery product line extensions and new polymer drug delivery products; (4) the conduct and completion of research and development programs related to our FKBP neuroimmunophilin ligand technology and other technologies; (5) clinical development activities, including commencing, conducting and completing clinical trials related to our polymer-based drug delivery candidates and pharmaceutical product candidates; (6) our efforts to scale-up product candidates from laboratory bench quantities to commercial quantities; (7) our efforts to secure a supply of the active pharmaceutical ingredients for the clinical development and commercialization of our polymer-based and other drug candidates; (8) our efforts to manufacture drug candidates for clinical development and eventual commercial supply; (9) our strategic plans; and (10) anticipated expenditures and the potential need for additional funds, all of which involve significant risks and uncertainties. We caution you that our actual results may differ significantly from the results that we discuss in the forward-looking statements. We discuss some important factors that could cause or contribute to this difference in the “Risk Factors” section of this annual report. In addition, we intend any forward-looking statement that we make to speak only as of the date on which we make it. We are not undertaking any obligation to update any forward-looking statement to reflect events or circumstances that occur after the date on which we made the statement.

Item 1. Business

Guilford Pharmaceuticals Inc. is a biopharmaceutical company engaged in the development and commercialization of novel products in two principal areas: (1) targeted and controlled drug delivery systems using proprietary biodegradable polymers for the treatment of cancer and other diseases; and (2) therapeutic and diagnostic products for neurological diseases and conditions. Throughout this discussion, “we”, “us”, “our” and “Guilford” refer to Guilford Pharmaceuticals Inc. and its subsidiaries.

GLIADEL® Wafer and DOPASCAN® Injection are registered trademarks of Guilford. TAXOL® is a registered trademark of Bristol-Myers Squibb Company.

Product and Development Programs

The following table summarizes the current status of Guilford’s product, product candidates and research programs:


Program/ Product Candidates
Drug Delivery Business	Disease Indications/ Conditions	Status (1)	Corporate Partner
GLIADEL® Wafer (3.85% BCNU)	Recurrent glioblastoma Multiforme	Market	Aventis (2); Orion Corporation Pharma (3)
	Malignant glioma at time of Initial surgery	Phase III	Aventis (2); Orion Corporation Pharma (3)
GLIADEL® Wafer High-Dose (up to 28% BCNU)	Malignant glioma	Phase I/ II	Aventis (2); Orion Corporation Pharma (3)(4)
PACLIMER^™Microspheres (paclitaxel in PPE microspheres)	Ovarian cancer	Phase I	—
PACLIMER^™Microspheres (paclitaxel in PPE microspheres)	Prostate, head & neck and lungs	Pre-clinical	—
LIDOMER^™Microspheres (lidocaine in PPE microspheres)	Post-surgical pain management	Pre-clinical	—




Neurological Products Program
*Neurotrophic Drugs*
Neuroimmunophilin ligands	Parkinson’s disease	Phase I	Amgen
	Other nerve growth and repair indications (Alzheimer’s disease, traumatic brain injury, traumatic spinal cord injury, multiple sclerosis, neuropathy, stroke and others)	Pre-clinical	Amgen
*Neuroprotective Drugs*
NAALADase inhibitors	Glutamate neurotoxity (such as stroke and head trauma)	Pre-clinical	—
PARP inhibitors	Stroke, cardiac ischemia, septic shock, inflammation	Research	—
D-Serine Racemase	Stroke, head trauma, Amyotrophic Lateral Sclerosis, Parkinson’s disease, and peripheral neuropathics	Research	—
*Propofol Pro-Drug*	Surgical anesthesia/sedation	Pre-clinical	—
*Diagnostic Imaging Agent*
DOPASCAN® Injection	Imaging agent to diagnose and monitor Parkinson’s disease	Phase II	Daiichi Radioisotope Laboratories, Ltd. (5)
*Addiction Therapeutics*
Dopamine transporter ligand	Cocaine addiction	Research	—


(1)	“Research” includes initial research related to specific molecular targets, synthesis of new chemical entities, and assay development for the identification of lead compounds. “Pre-clinical” includes testing of lead compounds in vitro and in animal models, pharmacology and toxicology testing, product formulation and process development prior to the commencement of clinical trials.

(2)	Aventis is our corporate partner for GLIADEL® Wafer throughout the world, excluding Scandinavia and Japan.

(3) Orion Corporation Pharma, which was formerly Orion Corporation Farmos, is our corporate partner for GLIADEL® Wafer in Scandinavia.

(4) Orion Corporation Pharma has certain rights of first refusal for a high-dose GLIADEL® Wafer product in Scandinavia.

(5) Daiichi Radioisotope Laboratories, Ltd. is our corporate partner for DOPASCAN® Injection in Japan, Korea and Taiwan.

Our efforts to develop and commercialize GLIADEL® Wafer and our product candidates are subject to numerous risks and uncertainties. We describe some of these risks under the section captioned “Risk Factors” and elsewhere in this annual report.

Drug Delivery Business

Our drug delivery business involves the use of biodegradable polymers for targeted and controlled delivery of drugs to treat cancer and other uses. Delivering high drug concentrations locally for a sustained period of time may increase the efficacy of chemotherapy in slowing tumor growth and/or reducing tumor mass and may decrease the side effects associated with systemic drug administration. Additionally, site-specific, controlled-release delivery of other agents may enhance the utility of those agents. Guilford has developed expertise in the discovery, clinical development and manufacturing of polymer-based drug delivery products.

GLIADEL® Wafer

Our first product in our drug delivery business is GLIADEL® Wafer, a novel treatment for glioblastoma multiforme, and the most common and rapidly fatal form of primary brain cancer. GLIADEL® Wafer is a proprietary biodegradable polymer that contains the cancer chemotherapeutic drug BCNU (carmustine). Up to eight GLIADEL® Wafer wafers are implanted in the cavity created when a neurosurgeon removes a brain tumor. The wafers gradually erode from the surface and deliver BCNU directly to the tumor site in high concentrations for an extended period of time without exposing the rest of the body to the toxic side effects of BCNU. GLIADEL® Wafer is used to complement surgery, radiation therapy and systemic intravenous chemotherapy in patients with recurrent glioblastoma multiforme. The availability of GLIADEL® Wafer gives physicians an additional treatment option for this rapidly fatal disease.

The FDA cleared GLIADEL® Wafer for marketing in September 1996 for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme for whom surgical resection is indicated. Glioblastoma multiforme is one of the most common and rapidly fatal forms of brain cancer. Our worldwide marketing partner, except in Scandinavia and Japan, Aventis, commercially launched GLIADEL® Wafer in the United States in February 1997.

Through December 31, 1999, GLIADEL® Wafer has received health authority approval in approximately 21 countries for use in patients with recurrent glioblastoma multiforme, including:


Argentina	Greece	Portugal
Austria	Ireland	Singapore
Brazil	Israel	South Korea
Canada	Luxembourg	Spain
France	Netherlands	United States
Germany	Peru	Uruguay

In the case of Canada, GLIADEL® Wafer has also received health authority approval for use upon the initial diagnosis of glioblastoma multiforme.

Applications for health authority approval are pending in other countries, including:


Australia	Italy	Taiwan
Ecuador	Philippines	Thailand
Indonesia	South Africa	United Kingdom

In a number of countries, including Canada, additional governmental approvals, e.g., relating to pricing and/or reimbursement, are necessary before a medicinal product may be marketed. As of December 31, 1999, almost all sales of GLIADEL® Wafer were in the United States and France, and in Scandinavia on a named hospital basis.

Guilford entered into a series of agreements with Aventis in June 1996, under which Aventis agreed to pay signing, milestone, transfer and royalty payments for the right to market, sell and distribute GLIADEL® Wafer worldwide, currently excluding Scandinavia and Japan, and agreed to seek international regulatory approvals for the product. During 1996, Aventis paid Guilford $27.5 million in milestone payments, purchased $7.5 million of our common stock, and extended to us a line of credit for up to $7.5 million to support future expansion of our GLIADEL® Wafer and other polymer manufacturing capacity. Under these agreements, Aventis pays to Guilford a combined transfer price and royalty of between 35% and 40% on Aventis’ net sales of GLIADEL® Wafer to hospitals.

Guilford and Aventis are working together to expand the label for GLIADEL® Wafer in the United States and other countries so that it may be marketed for use in malignant glioma at the time of initial surgery. Malignant glioma is a broader category of brain cancer including but not limited to glioblastoma multiforme. In the summer of 1999, patient enrollment was completed in a 240-person, placebo-controlled, Phase III clinical trial for GLIADEL® Wafer in patients undergoing initial surgery for malignant glioma at 42 clinical sites in Europe, the United States and Israel. We expect the results to be available in the second half of 2000, following a minimum of one year follow-up period for each study participant. If the results are favorable, Guilford and Aventis intend to file in the United States and other countries for use of GLIADEL® Wafer in first surgery for malignant glioma.

Pursuant to the terms of our marketing, sales and distribution rights agreement with Aventis, we are eligible to receive the following non-recurring milestone payments if and when Aventis obtains all the required approvals needed to sell GLIADEL® Wafer in the following countries for the following indications:


	Milestone for			Milestone for
Country	recurrent indication			First Surgery Indication

United States	$	20.0 million	*	$	15.0 million	**




France	$	2.5 million	*	$	2.5 million




Germany	$	2.0 million	*	$	2.0 million




Canada	$	2.0 million			—




Italy	$	1.5 million		$	1.5 million




Spain	$	1.0 million		$	1.0 million




United Kingdom	$	1.0 million		$	1.0 million




Australia	$	1.0 million		$	1.0 million


*	already earned

** $7.5 million cash and $7.5 million in equity investment

Thus, if GLIADEL® Wafer is approved for first surgery patients in all of the countries listed above, we are eligible to receive up to an aggregate of $30.5 million in milestone and equity payments from Aventis.

Our collaboration with Aventis also encompasses development of a high-dose formulation of GLIADEL® Wafer. The current formulation contains a 3.85% concentration of BCNU, the anti-cancer agent in the product. Based on promising preclinical data, Guilford and Aventis have been conducting a Phase I dose-escalation clinical trial of GLIADEL® Wafer using concentrations of BCNU ranging from 6.5% up to 28%. Final results of this trial are expected this summer.

We entered into our agreement with Orion Corporation Pharma, a major Scandinavian health care company, for the sales, marketing and distribution of GLIADEL® Wafer in Scandinavia in October 1995. Under this agreement, Orion Corporation Pharma purchases GLIADEL® Wafer from Guilford on an exclusive basis for sale in Scandinavia. Orion Corporation Pharma commenced sales of GLIADEL® Wafer in Scandinavia in 1997 on a named hospital basis.

For 1999, our revenues related to the sales and distribution of GLIADEL® Wafer were $6.8 million. Of this amount, we received $4.4 million as a transfer price on units sold to Aventis and to Orion Corporation Pharma and $2.4 million as royalties on sales by Aventis to hospitals and other end-users. In addition, under our agreements with Aventis, we are eligible for additional milestone payments totaling up to $30.5 million, including $7.5 million in the form of an equity investment, if Guilford and Aventis achieve certain regulatory objectives. These objectives include expanding the labeling in the United States to include the use of GLIADEL® Wafer at the time of initial surgery as well as obtaining specified international regulatory approvals to market and sell GLIADEL® Wafer. Guilford does not control the timing and extent of any future regulatory approvals for GLIADEL® Wafer, and thus we may not receive any or all of these payments. Whether we and Aventis will attain any or all of such regulatory objectives remains uncertain. We pay a royalty to Massachusetts Institute of Technology on sales of GLIADEL® Wafer pursuant to the license agreement under which we acquired the underlying technology for this product.

Future sales of GLIADEL® Wafer are subject to certain risks and uncertainties. We discuss a number of these risks in detail in the section of this annual report entitled “Risks Factors” below.

PACLIMER™ Microspheres

We are also working to broaden our line of polymer-based oncology products through the use of other chemotherapeutic agents, different polymer systems and various formulations. In November 1999, we filed an application for an Investigational New Drug, or an “IND,” for the intraperitoneal administration of our second generation polymer oncology product, PACLIMER™ Microspheres, in women with ovarian cancer. PACLIMER™ Microspheres is a site-specific, controlled release formulation of paclitaxel (TAXOL®) in a PPE polymer developed in collaboration with scientists at Johns Hopkins. We are conducting a Phase I clinical trial in association with the Gynecologic Oncology Group, a consortium of leading academic clinical investigators in the field. We are additionally engaged in research on the suitability of this site-specific, controlled release formulation of paclitaxel for other local cancers, such as tumors of the lung, prostate, and head and neck.

We are the exclusive licensee from MIT and Johns Hopkins of several issued U.S. patents relating to the use of polymers to deliver paclitaxel and certain other chemotherapeutics to solid tumors. In addition, we have applied for a number of patent applications in the U.S. and abroad relating to the composition of matter of PPE polymers and their use for various kinds of cancer, including ovarian cancer.

Other Polymer-Based Drug Delivery Products

We are also exploring the use of our proprietary biodegradable polymer platform to deliver other agents which may have therapeutic utility. Guilford scientists have demonstrated that PPEs can deliver agents ranging from DNA to proteins to peptides to small molecules in therapeutically effective doses in animal models. In the first quarter of 2000, we announced a new development

program for LIDOMER™ Microspheres, a site-specific, controlled release formulation of the widely used local anesthetic, lidocaine.

Neurological Programs

Guilford is extensively engaged in the research and development of small molecules that regenerate damaged nerves, our neurotrophic program, or protect nerves from damage, our neuroprotectant program, for potential treatment of a range of neurodegenerative diseases and conditions, such as Parkinson’s disease, Alzheimer’s disease, stroke, Amyotrophic Lateral Sclerosis (ALS), multiple sclerosis, spinal cord injury and peripheral neuropathies. We also announced in the first quarter of 2000 that we have licensed exclusive worldwide rights to a pro-drug of the widely used anesthetic, propofol, at a late pre-clinical stage of development. We have also been developing an imaging agent for the diagnosis and monitoring of Parkinson’s disease, DOPASCAN® Injection, which is expected to enter Phase III in Japan in the second half of 2000. In addition, we are researching small molecule therapeutics for cocaine abuse and possibly other addictive behaviors.

Neurotrophic Program

Guilford is a pioneer in the effort to develop small molecule, orally-bioavailable compounds to promote nerve growth and repair, called neurotrophic agents, for the treatment of neurological disorders. The degeneration or damage of nerve cells in the brain and peripheral neurons resulting from certain diseases and conditions causes a loss of either central nervous system function, such as Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, spinal cord injury and stroke, or peripheral nerve function, such as diabetic neuropathy and other peripheral neuropathies. Under normal circumstances, damaged nerves have limited ability to regrow or otherwise recover, which poses a major obstacle for the treatment of these conditions.

Our neurotrophic program originated from observations first made in the laboratory of Dr. Solomon Snyder, Director of the Department of Neuroscience at Johns Hopkins and Chairman of our Scientific Advisory Board. These observations revealed that certain intracellular proteins, known as “immunophilins”, which are targets of immunosuppressant drugs such as FK 506, are enriched 10-40 fold in certain areas of the central nervous system. Johns Hopkins scientists went on to discover that commonly used immunosuppressive drugs, and other immunophilin ligands, can promote nerve growth. Guilford exclusively licensed rights to these inventions from Johns Hopkins. Subsequently, Guilford scientists and their academic collaborators demonstrated that the pathway leading to nerve regeneration could be separated from the immunosuppressant pathway. Guilford scientists have synthesized a large number of proprietary small molecules, called “neuroimmunophilin ligands,” a number of which have been shown in cell culture and animal models to be neurotrophic without being immunosuppressive, orally-bioavailable and able to cross the blood-brain barrier. In contrast, many naturally occurring nerve growth factors, proteins and peptides are not orally-bioavailable and do not normally cross the blood-brain barrier.

Some of our neuroimmunophilin ligands have induced functional and histological recovery of damaged dopamine nerve cells, which are the nerve cells that degenerate in Parkinson’s disease, in rodent and primate models. Neuroimmunophilin ligands have also shown similar neurotrophic effects in a range of different neurons, including dopaminergic, cholinergic, serotonergic and sensory neurons, which means they may be useful in a range of disorders characterized by degeneration of these types of neurons, and in animal models of a range of neurodegenerative diseases and conditions, such as Alzheimer’s disease, stroke, traumatic brain and spinal cord injury and peripheral neuropathy. Moreover, our scientists are researching the potential of these compounds in certain non-neurological diseases and conditions.

In August 1997, we entered into a collaboration with Amgen to research, develop and commercialize a broad class of neuroimmunophilin ligands, referred to as FKBP neuroimmunophilin ligands, as well as any other compounds that may result from the collaboration, for all human therapeutic and diagnostic applications. Amgen initially paid us a one time, non-refundable signing

fee of $15 million in 1997 and also invested an additional $20 million in Guilford in exchange for 640,095 shares of our common stock and five-year warrants to purchase up to an additional 700,000 shares of Guilford common stock at an exercise price of $35.15 per share. In connection with the sale of these securities, we granted Amgen certain demand and “piggyback” registration rights under applicable securities laws.

As part of this collaboration, Amgen agreed to fund up to a total of $13.5 million to support research at Guilford relating to the FKBP neuroimmunophilin ligand technology. This research funding began on October 1, 1997 and is payable quarterly over three years. Amgen also has the option to fund a fourth year of research.

If Amgen achieves certain specified development objectives in each of ten different clinical indications, Amgen has agreed to pay to Guilford up to a total of $392 million in milestone payments. Of these ten clinical indications, seven are neurological, consisting of Parkinson’s disease, Alzheimer’s disease, traumatic brain injury, traumatic spinal cord injury, multiple sclerosis, neuropathy and stroke, and three are non-neurological.

In 1998, Amgen nominated a second-generation lead FKBP neuroimmunophilin compound, called “NIL-A”, initially targeted for the treatment of Parkinson’s disease. Amgen completed a one-month Good Laboratory Practice study of NIL-A, the initiation of which triggered a one-time, non-refundable milestone payment to Guilford of $1 million under the collaboration agreement. In the summer of 1999, Amgen initiated a Phase I safety, tolerability and pharmacokinetics study in healthy human volunteers in Europe of a second-generation lead FKBP neuroimmunophilin compound, NIL-A. In the fourth quarter of 1999, Amgen filed an IND for human testing in the United States of NIL-A, initially targeting Parkinson’s disease. This milestone earned Guilford a $5 million payment under the collaboration agreement with Amgen. Amgen has conducted, and is preparing to conduct, additional clinical trials pursuant to its clinical development plan.

Under a license agreement pursuant to which we acquired rights to certain patent applications relating to the FKBP neuroimmunophilin ligand technology, we are obligated to pay to Johns Hopkins a portion of all milestone payments paid by Amgen as well as a royalty on any and all net sales of any FKBP neuroimmunophilin ligand product Amgen markets and sells in the future.

We have filed a number of patent applications in the United States and internationally relating to both novel compositions and methods of treating neurological disorders utilizing these compounds. These compounds induce nerve growth directly, as well as potentiate nerve growth in the presence of nerve growth factors. As of December 31, 1999, we have rights to approximately 20 issued U.S. patents in the field, including those claiming multiple proprietary chemical series of neuroimmunophilin ligands and their neurotrophic uses.

As noted in the section herein captioned “Risk Factors” and elsewhere in this annual report, there is no guarantee that Guilford or Amgen will be able to successfully develop any FKBP neuroimmunophilin compounds or other product candidates into safe and effective drug(s) for neurological or other uses. Consequently, Guilford may not earn additional milestone payments related to Amgen’s development activities or revenues related to product sales.

In particular, the research, development and commercialization of early-stage technology like the FKBP neuroimmunophilin ligand technology is subject to significant risks and uncertainty. For discussion of these and other risks, see the section herein captioned “Risk Factors”.

Neuroprotectant Program

In Guilford’s neuroprotectant program, Guilford scientists are developing novel compounds to protect brain and other cells from ischemia, which is the lack of oxygen delivery from reduced blood flow, and other disorders caused by massive release of excitatory amino acid neurotransmitters such as glutamate. We are exploring distinct intervention points in a biochemical pathway that can lead to neuronal damage, including the pre-synaptic inhibition of glutamate release by inhibiting the enzyme,

N-acetylated alpha-linked acidic dipeptidase (“NAALADase”), and the post-synaptic inhibition of the enzyme, poly(ADP-ribose) polymerase (“PARP”).

It has been hypothesized that the release of the neurotransmitter glutamate may be mediated in part by the enzyme NAALADase, which cleaves glutamate from the abundant neuro-peptide, N-acetyl-aspartyl-glutamate (NAAG), and results in stimulation of post-synaptic glutamate receptors (including n-methyl-D-aspartate (NMDA) receptors). This release plays a critical role in many central neuronal functions. However, in conditions such as ischemia and epilepsy, there is a massive increase in synaptic glutamate concentrations, which results in excessive activation of glutamate receptors. Dr. Solomon Snyder and his colleagues at Johns Hopkins have shown that this activation, in turn, causes excess production of the neurotransmitter nitric oxide, mediated by the enzyme NOS, which results in damage to cellular DNA. DNA damage activates PARP, a nuclear repair enzyme, which can deplete cellular energy stores and lead to cell death. In 1999, Dr. Snyder’s laboratory announced the discovery of an enzyme, D-Serine Racemase, which plays a key role in the activation of an important post-synaptic glutamate receptor, the N-Methyl D-Aspartate (NMDA) receptor. Guilford is working on the selective inhibition of NAALADase, PARP, D-Serine Racemase and other enzymes in the biochemical pathway to neuronal damage and death as possible mechanisms for inhibiting the toxic effects of excess glutamate in neurological diseases and conditions.

NAALADase Inhibitors

Glutamate is a neurotransmitter which is required for normal brain functioning. However, excess amounts of glutamate can be toxic and can kill brain cells. Excess glutamate neurotransmission has been implicated in a number of neurological disorders, such as diabetic peripheral neuropathy, pain, head trauma, stroke, ALS, Alzheimer’s disease, schizophrenia, Huntington’s disease and Parkinson’s disease. Because of the large range of potential applications, blocking excess glutamate has been an intense area of research in the pharmaceutical industry. However, to date much of the research and development activity has focused on blocking post-synaptic glutamate receptors, with compounds such as NMDA antagonists, glycine antagonists, and other post-synaptic excitatory amino acid (EAA) receptor blockers. Unfortunately, these agents have generally been associated with severe toxicities, both in pre-clinical and clinical studies, which have greatly limited their clinical potential.

In contrast, scientists at Guilford have been pioneers in investigating a novel means of blocking excess glutamate release mediated by inhibition of NAALADase. Guilford chemists have identified a number of chemical series of novel NAALADase inhibitors, some of which have nanomolar potency in inhibiting NAALADase activity and robustly protect against neurodegeneration both in cell and animal models. Since Guilford’s NAALADase inhibitors do not appear to interact with post-synaptic glutamate receptors, they seem to be devoid of the behavioral toxicities associated with post-synaptic glutamate antagonists. For example, neuropathology studies in rats dosed with a NAALADase inhibitor have shown no evidence of the neuronal degeneration seen with post-synaptic glutamate inhibitors.

We are closely investigating a novel, orally-bioavailable lead compound, which may advance into clinical development later this year. The initial therapeutic target is expected to be diabetic peripheral neuropathy. Diabetic peripheral neuropathy is a debilitating and progressive disorder involving severe pain sensitivity, tingling, weakness and numbness in a patient’s extremities. It may affect close to one million Americans, yet there is currently no therapy that is approved to treat this disorder in the United States. Guilford researchers have demonstrated in animal models that treatment with a NAALADase inhibitor can normalize pain sensitivity, improve nerve conduction velocity, which is the speed at which a nerve impulse travels, and promote re-myelination of peripheral nerves. Additional potential target indications for NAALADase inhibitors may include chronic pain, schizophrenia, head trauma, stroke, ALS, Alzheimer’s disease and Parkinson’s disease.

We have filed numerous patent applications in the U.S. and abroad relating to novel compositions of matter and methods of use. As of December 31, 1999, we have rights to

approximately 13 issued U.S. patents in the field, relating to novel compositions of matter and methods of use of NAALADase inhibitors, including those claiming multiple proprietary chemical series of NAALADase inhibitors for uses ranging from stroke to prostate cancer.

PARP Inhibitors

During conditions of nerve degeneration, the cascade of events that is believed to result in cell death is initiated by an increase in synaptic glutamate levels, which results in an over-stimulation of post-synaptic glutamate receptors. This stimulation results in a dramatic increase in intracellular calcium, which leads to the formation of free radicals, such as nitric oxide, a neurotransmitter involved in normal brain functioning. However, too much nitric oxide, which can arise under conditions of neurological disease or damage, can be toxic and can cause DNA damage. This damage in turn leads to over-activation of the enzyme, poly(ADP-ribose) polymerase (PARP), which is involved in the repair of damaged DNA. This repair process is very energy intensive, and excessive activation of PARP rapidly leads to a drop in the cellular energy level, resulting in cell death.

The inhibition of PARP may represent a common intervention point for neurodegeneration resulting from several different pathways of damage, including the generation of nitric oxide and other oxygen species, all of which trigger PARP activation. Thus the inhibition of PARP may offer a unique approach to the development of neuroprotective agents for a range of neurological conditions. In addition, the over-stimulation of PARP has been implicated in a broad spectrum of other diseases, including myocardial ischemia, which occurs in heart attacks, traumatic head and spinal cord injuries, neurodegenerative disorders such as Alzheimer’s disease, Parkinson’s, disease, Huntington’s disease, septic or hemorrhagic shock, arthritis, type I diabetes and inflammatory bowel disease.

Guilford scientists and their academic collaborators were among the first to investigate the use of PARP inhibitors for the prevention of glutamate neurotoxicity. Recent studies by several academic laboratories using mice that have been genetically altered to possess no or greatly diminished PARP activity suggest that absence of PARP activity may reduce the area of neuronal damage from stroke by up to 85%-90%, and the area of heart muscle damage during a heart attack by about 40%. Strikingly, some of our prototype PARP inhibitors have achieved similar results in preclinical models of stroke and heart attack in animals whose PARP genes had not been knocked out. In addition, our scientists have achieved neuroprotective results not only in transient ischemia models of stroke, but also in the more rigorous global ischemia models of stroke.

Guilford chemists have identified a number of distinct chemical series of novel PARP inhibitors with pre-clinical efficacy. In addition, our biologists have obtained results in animal experiments suggesting that PARP inhibitors may have potential utility in a range of therapeutic areas, including traumatic head and spinal cord injuries, Alzheimer’s disease, septic shock and arthritis.

We have filed numerous patent applications in the U.S. and abroad relating to novel compositions of matter and methods of use. As of December 31, 1999, we had rights to two issued U.S. patents in the field, including one generally claiming the use of PARP inhibitors for the prevention of glutamate neurotoxicity.

As used in this annual report, a “prototype” compound is one which Guilford uses to establish scientific proof-of-principle respecting the relevant biomedical mechanism of action. In general, we do not intend to develop prototype compounds into products because of sub-optimal drug metabolism or pharmacokinetic characteristics, our proprietary position with respect to the compound, or for other reasons. Once we have in vitro and in vivo proof of principal of intervention in what we believe to be a medically relevant biochemical mechanism of action, we seek to develop proprietary lead compounds through medicinal chemistry. We seek to develop these proprietary lead compounds both around the prototype compounds and other promising chemical structures generated by molecular modeling, combinatorial or computational chemistry, and/or high throughput screening.

D-Serine Racemase and Other Inhibitors

In the first quarter of 2000, we announced that we had licensed from Johns Hopkins rights relating to another potential intervention point in the biochemical cascade of glutamate neurotoxicity. Dr. Snyder’s laboratory demonstrated that an enzyme, D-Serine Racemase, plays a key role in the activation of an important post-synaptic glutamate receptor, the NMDA receptor. Guilford is engaged in research on the selective inhibition of this and several other enzymes, which may result in neuroprotection during neurodegenerative diseases and conditions.

Propofol Pro-Drug

Also in the first quarter of 2000, we announced that we had licensed from ProQuest Pharmaceuticals Inc. rights relating to a novel pro-drug of a widely used anesthetic, propofol. A pro-drug is a compound that is metabolized in the body into a drug. The compound, GPI-15715, is water soluble and rapidly converts to propofol once administered intravenously in animals. In contrast, propofol is administered in a lipid emulsion, which can cause complications, such as short shelf-life, clogged IV routes of administration, elevated blood lipids and a potentially higher incidence of bacterial contamination. GPI-15715 may offer a clinical benefit to patients both as an ICU sedating agent and an anesthesia-induction drug. GPI-15715, is at a late pre-clinical stage of development, and we hope to commence human trials later in 2000 or in early 2001.

Imaging Agent Program — DOPASCAN® Injection

Our product candidate for the diagnosis and monitoring of Parkinson’s disease, DOPASCAN® Injection, is administered intravenously in trace quantities. It allows physicians to obtain images and measure the degeneration of dopamine neurons in the brain. Dopamine neurons are highly concentrated in a specialized area of the brain that degenerates in Parkinson’s disease. Parkinson’s disease is a common neurodegenerative disorder affecting more than 900,000 patients in the United States. In Parkinson’s disease, there is a decrease in the dopaminergic nerve terminals and thus dopamine release.

In its early stages, Parkinson’s disease can be very difficult to distinguish clinically from other diseases with similar symptoms but which do not respond well or at all to specific therapy for Parkinson’s disease. Unfortunately, there are no diagnostic tests currently marketed or commercially available that can reliably detect the neuronal degeneration in Parkinson’s disease, and the typical delay between the onset of symptoms and clinical diagnosis is more than two years. The primary way to establish the diagnosis at present is through repeated physician visits and the use of therapeutic trials of drugs such as L-Dopa, which carry with them the risk of unnecessary, sometimes severe side effects.

Following intravenous injections with DOPASCAN® Injection, images of a subject’s brain are obtained with a SPECT camera and can identify the loss of dopamine neurons in the brain. To date, over 2,000 patients have been imaged in the United States and Europe using DOPASCAN® Injection. In a multi-center Phase IIb clinical trial conducted by the Parkinson’s Study Group in the United States and completed in 1997, DOPASCAN® Injection accurately differentiated patients clinically diagnosed with a Parkinsonian disorder, i.e., Parkinson’s disease and progressive supranuclear palsy, from subjects without a Parkinsonian disorder, e.g., essential tremor and healthy controls, with a sensitivity of 98% and specificity of 97%. In addition, no serious adverse events were attributed to DOPASCAN® Injection in this study. In addition, in late 1998 we completed a multi-center Phase IIb trial in Europe.

We have entered into an agreement with Daiichi Radioisotope Laboratories, Ltd., a leading Japanese radiopharmaceutical company, to develop and commercialize DOPASCAN® Injection in Japan, Korea and Taiwan. Daiichi Radioisotope Laboratories, Ltd. has informed us that it plans to commence Phase III clinical trials in the second half of 2000. We have sought partners for the manufacture and/or distribution of this product in other territories, including the United States and

Europe. However, to date, we have not been able to enter into an arrangement with a third-party manufacturer for the supply of DOPASCAN® Injection for commercial supply on acceptable terms. Unless and until Guilford comes to agreement with a suitable manufacturer or corporate partner, the development of DOPASCAN®Injection will be limited to the activities of our Japanese partner.

Addiction Therapeutics

We are also researching therapeutics for cocaine addiction and other addictive behaviors. Researchers have shown that cocaine binds to structures in the brain known as dopamine transporters. Our cocaine addiction therapeutics program focuses on the research and development of drugs which will prevent cocaine from binding to dopamine transporters, thus potentially limiting the effects of cocaine, and at the same time will minimally affect normal dopamine transporter function.

Based on reported findings about the cocaine binding site, Guilford scientists have used rational drug design techniques to identify and synthesize novel compounds with recognition site in the brain. In addition, we have generated further lead chemical series from screening our own library of compounds. We are in the process of chemical optimization and testing in animal models. We have filed patent applications covering several novel classes of compounds for use in cocaine addiction. Guilford also intends to test its optimized lead compounds on other forms of addiction, including alcohol and heroin addiction, which may result from facilitation of dopaminergic neurotransmission in certain areas of the brain.

Manufacturing and Raw Materials

We currently manufacture GLIADEL® Wafer using a proprietary process at our 18,000 square foot manufacturing facility in Baltimore, Maryland. This facility, which includes areas designated for packaging, quality control, laboratory, and warehousing, has been in operation since April 1995. The FDA initially inspected it in October 1995 and recently re-inspected it in February 1999. Our current facilities are designed to enable us to produce up to 8,000 GLIADEL® Wafer treatments annually, with each treatment consisting of eight GLIADEL® Wafers.

In January 1998, we completed construction of an expansion of our manufacturing facilities to allow for the additional synthesis of the polyanhydride co-polymer used in the manufacture of GLIADEL® Wafer. We will also be able to use this facility to produce our newest proprietary biodegradable polymers, the PPEs, in connection with the development of other polymer-based products. In addition, we completed construction of a second clean room facility in 1998, which we expect could increase our GLIADEL® Wafer manufacturing capacity to 20,000-30,000 treatments annually. Furthermore, we expect that this second clean room facility will also provide sufficient capacity to produce any clinical supply of PPE polymer-based product candidates needed in the future, including its paclitaxel/ PPE polymer product candidate currently under development for ovarian cancer.

We believe that the various materials used in GLIADEL® Wafer are readily available and will continue to be available at reasonable prices. Nevertheless, while we believe that we have an adequate supply of BCNU, the active chemotherapeutic ingredient in GLIADEL® Wafer, to meet current demand, any interruption in the ability of the two current suppliers to deliver this ingredient could prevent us from delivering the product on a timely basis. We depend upon the availability of certain single-source raw materials in our formulations, but are seeking alternate suppliers for most of these raw materials. We cannot be sure that we will be able to secure alternate sources successfully on terms acceptable to us or at all. Failure of any supplier to provide sufficient quantities of raw material in accordance with the FDA’s current Good Manufacturing Practice regulations could cause delays in clinical trials and commercialization of products, including GLIADEL® Wafer.

Government Regulation and Product Testing

All domestic prescription pharmaceutical manufacturers are subject to extensive regulation by the federal government, principally the FDA and, to a lesser extent, by state and local governments as well as foreign governments if products are marketed abroad. Biologics and controlled drug products, such as vaccines and narcotics, and radiolabeled drugs, are often regulated more stringently than are other drugs. The Federal Food, Drug, and Cosmetic Act and other federal statutes and regulations govern or influence the development, testing, manufacture, labeling, storage, approval, advertising, promotion, sale and distribution of prescription pharmaceutical products. Pharmaceutical manufacturers are also subject to certain recordkeeping and reporting requirements. Noncompliance with applicable requirements can result in warning letters, fines, recall or seizure of products, total or partial suspension of production and/or distribution, refusal of the government to enter into supply contracts or to approve marketing applications and criminal prosecution.

Upon FDA approval, a drug may only be marketed in the United States for the approved indications in the approved dosage forms and at the approved dosage levels. The FDA also may require post-marketing testing and surveillance to monitor a drug in larger and more diverse patient populations. Manufacturers of approved drug products are subject to ongoing compliance with FDA regulations. For example, the FDA mandates that drugs be manufactured in conformity with the FDA’s applicable current Good Manufacturing Practice regulations. In complying with the current Good Manufacturing Practice regulations, manufacturers must continue to expend time, money and effort in production, recordkeeping and quality control to ensure that the product meets applicable specifications and other requirements. The FDA periodically inspects drug manufacturing facilities to ensure compliance with its current Good Manufacturing Practice regulations. Failure to comply subjects the manufacturer to possible FDA action, such as suspension of manufacturing, seizure of the product or voluntary recall of a product. Adverse experiences with the commercialized product must be reported to the FDA. The FDA also may require the submission of any lot of the product for inspection and may restrict the release of any lot that does not comply with FDA regulations, or may otherwise order the suspension of manufacture, voluntary recall or seizure. Product approvals may be withdrawn if compliance with regulatory requirements is not maintained or if problems concerning safety or efficacy of the product occur following approval.

Full Clinical Testing Requirements

The steps required before a newly marketed drug may be commercially distributed in the United States include:

(1) conducting appropriate preclinical laboratory and animal tests;

(2) submitting to the FDA an application for an IND, which must become effective before clinical trials may commence;

(3) conducting well-controlled human clinical trials that establish the safety and efficacy of the drug product;

(4) filing with the FDA a New Drug Application, or “NDA”, for non-biological drugs; and

(5) obtaining FDA approval of the NDA prior to any commercial sale or shipment of the non-biological drug.

In addition to obtaining FDA approval for each indication to be treated with each product, each domestic drug manufacturing establishment must register with the FDA, list its drug products with the FDA, comply with the FDA’s current Good Manufacturing Practice requirements and be subject to inspection by the FDA. Foreign manufacturing establishments distributing drugs in the United States also must comply with current Good Manufacturing Practice requirements, register and list their products, and are subject to periodic inspection by FDA or by local authorities under agreement with the FDA. The FDA also regulates drug advertising and promotion as well as the distribution physician samples. Individual states also often impose licensing requirements on drug manufacturers

and distributors. NDA’s also must include a description of the manufacturing processes, including quality control procedures and validation requirements.

With respect to a drug product with an active ingredient not previously approved by the FDA, the manufacturer must usually submit a full NDA to prove that the product is safe and effective. The NDA must include complete reports of pre-clinical, clinical and laboratory studies. A full NDA may also need to be submitted for a drug product with a previously approved active ingredient if studies are required to demonstrate safety and efficacy. This could occur when the drug will be used to treat an indication for which the drug was not previously approved or where the dose or method of drug delivery is changed. In addition, the manufacturer of an approved drug may be required to submit for the FDA’s review and approval a supplemental NDA, including reports of appropriate clinical testing, prior to marketing the drug with additional indications or making other significant changes to the product or its manufacture. A manufacturer intending to conduct clinical trials ordinarily will be required first to submit an IND to the FDA containing information relating to previously conducted pre-clinical studies.

Pre-clinical testing includes formulation development, laboratory evaluation of product chemistry and animal studies to assess the potential safety and efficacy of the product formulation. Pre-clinical tests to support an FDA application must be conducted in accordance with the FDA regulations concerning Good Laboratory Practices. The results of the pre-clinical tests are submitted to the FDA as part of the IND and are reviewed by the FDA prior to authorizing the sponsor to conduct clinical trials in human subjects. Unless the FDA issues a clinical hold on an IND, the IND will become effective 30 days following its receipt by the FDA. There is no certainty that submission of an IND will result in the commencement of clinical trials or that the commencement of one phase of a clinical trial will result in commencement of other phases or that the performance of any clinical trials will result in FDA approval.

Clinical trials for new drugs typically are conducted in three phases, are subject to detailed protocols and must be conducted in accordance with the FDA’s regulations concerning good clinical practices. Clinical trials involve the administration of the investigational drug product to human subjects. Each protocol indicating how the clinical trial will be conducted in the United States must be submitted for review to the FDA as part of the IND. The FDA’s review of a study protocol does not necessarily mean that, if the study is successful, it will constitute proof of efficacy or safety. Further, each clinical study must be conducted under the auspices of an independent institutional review board, or “IRB”, established pursuant to FDA regulations. The IRB considers, among other factors, ethical concerns and informed consent requirements. The FDA or the IRB may require changes in a protocol both prior to and after the commencement of a trial. There is no assurance that the IRB or the FDA will permit a study to go forward or, once started, to be completed. Clinical trials may be placed on hold at any time for a variety of reasons, particularly if safety concerns arise, or regulatory requirements are not met.

The three phases of clinical trials are generally conducted sequentially, but they may overlap. In Phase I, the initial introduction of the drug into humans, the drug is tested for safety, side effects, dosage tolerance, metabolism and clinical pharmacology. Phase II involves controlled tests in a larger but still limited patient population to determine the efficacy of the drug for specific indications, to determine optimal dosage and to identify possible side effects and safety risks. Phase II testing for an indication typically takes at least from one and one-half to two and one-half years to complete. If preliminary evidence suggesting effectiveness has been obtained during Phase II evaluations, expanded Phase III trials are undertaken to gather additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase III studies for a specific indication generally take at least from two and one-half to five years to complete. We cannot be sure that we will successfully complete Phase I, Phase II or Phase III testing within any specified time period, if at all, with respect to any of our product candidates.

Reports of results of the preclinical studies and clinical trials for non-biological drugs are submitted to the FDA in the form of an NDA for approval of marketing and commercial shipment. User fee legislation now requires the submission in fiscal year 2000 of $285,740 to cover the costs of FDA review of a full NDA. Annual fees also exist for certain approved prescription drugs and the establishments that make them. The NDA typically includes information pertaining to the preparation of drug substances, analytical methods, drug product formulation, details on the manufacture of finished product as well as proposed product packaging and labeling. Submission of an NDA does not assure FDA approval for marketing. In May 1999, the FDA published final regulations describing criteria that the FDA will use to evaluate the safety and efficacy of diagnostic radiopharmaceuticals like DOPASCAN® Injection. It is unclear how these provisions may affect the potential for approval of DOPASCAN® Injection.

The median FDA approval time is currently about 12 months, although clinical development, reviews, or approvals of treatments for cancer and other serious or life-threatening diseases may be accelerated, expedited or fast-tracked. In addition, approval times can vary widely among the various reviewing branches of the FDA. The approval process may take substantially longer if, among other things, the FDA has questions or concerns about the safety and/or efficacy of a product. In general, the FDA requires at least two properly conducted, adequate and well-controlled clinical studies demonstrating safety and efficacy with sufficient levels of statistical assurance. In certain limited cases, the FDA may consider one clinical study sufficient. The FDA also may request long-term toxicity studies or other studies relating to product safety or efficacy. For example, the FDA may require additional clinical tests following NDA approval to confirm product safety and efficacy, known as Phase IV clinical tests, or require other conditions for approval. Notwithstanding the submission of such data, the FDA ultimately may decide that the application does not satisfy its regulatory criteria for approval.

Confirmatory studies similar to Phase III clinical studies may be conducted after, rather than before, FDA approval under certain circumstances. The FDA may determine under its expedited, accelerated, or fast-track provisions that previous limited studies establish an adequate basis for drug product approval, provided that the sponsor agrees to conduct additional studies after approval to verify safety and effectiveness. Treatment of patients not in clinical trials with an experimental drug may also be allowed under a Treatment IND before general marketing begins. Charging for an investigational drug also may be allowed under a Treatment IND to recover certain costs of development if various requirements are met. These cost-recovery, Treatment IND, and expedited, accelerated or fast-track approval provisions are limited, for example, to drug products (1) intended to treat AIDS or other serious severely debilitating or life-threatening diseases especially and that provide meaningful therapeutic benefit to patients over existing treatments, (2) that are for diseases for which no satisfactory alternative therapy exists, or (3) that address an unmet medical need. We cannot assure you that any of our product candidates will qualify for cost-recovery, expedited, accelerated, or fast-track approvals or for treatment use under the FDA’s regulations or the current statutory provisions.

The full NDA process for newly marketed non-biological drugs, such as those being developed by Guilford, including FKBP neuroimmunophilin ligand products and inhibitors of NAALADase and PARP, can take a number of years and involves the expenditure of substantial resources. We cannot be sure that any approval will be granted on a timely basis, or at all, or that we will have sufficient resources to carry potential products through the regulatory approval process.

Abbreviated Testing Requirements

The Drug Price Competition and Patent Term Restoration Act of 1984 established abbreviated procedures for obtaining FDA approval for many non-biological drugs which are off-patent and whose marketing exclusivity has expired. Applicability of the Drug and Patent Act of 1984 means that a full NDA is not required for approval of a competitive product. Abbreviated requirements are applicable to drugs which are, for example, either bioequivalent to brand-name drugs, or otherwise similar to

brand-name drugs, such that all the safety and efficacy studies previously done on the innovator product need not be repeated for approval. Changes in approved drug products, such as in the delivery system, dosage form, or strength, can be the subject of abbreviated application requirements. We cannot assure you that abbreviated applications will be available or suitable for our non-biological drug products, including our efforts to develop a controlled-release formulation of the chemotherapeutic agent, paclitaxel (TAXOL®) using our PPE polymers, or that we will be able to obtain FDA approval of such applications.

Newly marketed active ingredients of drug products not previously approved have a five-year period of market exclusivity and certain changes in approved drug products for which reports of new clinical investigations are essential for approval, other than bioequivalence studies, have a three-year period of market exclusivity. A period of three years is available for changes in approved products, such as in delivery systems of previously approved products. Both periods of marketing exclusivity mean that abbreviated applications, which generally rely to some degree on approvals or on some data submitted by previous applicants for comparable innovator drug products, cannot be marketed during the period of exclusivity. The market exclusivity provisions of the Drug and Patent Act of 1984 bar only the marketing of competitive products that are the subject of abbreviated applications, not products that are the subject of full NDAs. The Drug and Patent Act of 1984 also may provide a maximum time of five years to be restored to the life of any one patent for the period it takes to obtain FDA approval of a drug product, including biological drugs. We cannot offer any assurance that the exclusivity or patent restoration benefits of the Drug and Patent Act of 1984 will apply to any of our product candidates.

Other Regulation

Products marketed outside the United States which are manufactured in the United States are subject to certain FDA export regulations, as well as regulation by the country in which the products are to be sold. U.S. law can prohibit the export of unapproved drugs to certain countries abroad. Guilford also would be subject to foreign regulatory requirements governing clinical trials and pharmaceutical sales, if products are marketed abroad. Whether or not a company has obtained FDA approval, it must usually obtain approval of a product by the comparable regulatory authorities of foreign countries before beginning to market the product in those countries. The approval process varies from country to country and the time required may be longer or shorter than that required for FDA approval.

In addition to the requirements for product approval, before a pharmaceutical product may be marketed and sold in certain foreign countries the proposed pricing for the product must be approved as well. Products may be subject to price controls and/or limits on reimbursement. The requirements governing product pricing and reimbursement vary widely from country to country and can be implemented disparately at the national level. As to reimbursement, the European Union generally provides options for its fifteen Member States to restrict the range of medicinal products that are covered by their national health insurance systems. Member States in the European Union can opt to have a “positive” or a “negative” list. A positive list is a listing of all medicinal products covered under the national health insurance system, whereas a negative list designates which medicinal products are excluded from coverage. In the European Union, the United Kingdom and Spain use a negative list approach, while France uses a positive list approach. In Canada, each province decides on reimbursement measures.

The European Union also generally provides options for its Member States to control the prices of medicinal products for human use. A Member State may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. For example, the regulation of prices of pharmaceuticals in the United Kingdom is generally designed to provide controls on the overall profits pharmaceutical companies may derive from their sales to the U.K. National Health Service. The U.K. system is generally based on profitability targets or limits for individual companies which are

normally assessed as a return on capital employed by the company in servicing the National Health Service market, comparing capital employed and profits.

In comparison, Italy generally establishes prices for pharmaceuticals based on a price monitoring system. The reference price is the European average price calculated on the basis of the prices in four reference markets: France, Spain, Germany and the United Kingdom. Italy typically levels the price of medicines belonging to the same therapeutic class on the lowest price for a medicine belonging to that category. Medicines are in the same therapeutic class if, for example, they have the same active principle, same pharmaceutical form or same route of administration. Spain generally establishes the selling price for new pharmaceuticals based on the prime cost, plus a profit margin within a range established each year by the Spanish Commission for Economic Affairs. Promotional and advertising costs are limited.

In Canada, prices for most new drugs are generally limited such that the cost of therapy for the new drug is in the range of the cost of therapy for existing drugs used to treat the same disease in Canada. Prices of breakthrough drugs and those which bring a substantial improvement are generally limited to the median of the prices charged for those drugs in other industrialized countries, such as France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States.

We cannot be sure that any country which has price controls or reimbursement limitations for pharmaceuticals will allow favorable reimbursement and pricing arrangements with respect to us or our corporate partners, including Aventis and its applications for GLIADEL in Canada and elsewhere outside of the United States.

Guilford also is governed by other federal, state and local laws of general applicability. These laws include, but are not limited to, those regulating working conditions enforced by the Occupational Safety and Health Administration and regulating environmental hazards under such statutes as the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other environmental laws enforced by the United States Environmental Protection Agency. The DEA regulates controlled substances, such as narcotics. A precursor compound to DOPASCAN® Injection is a tropane-derivative similar to cocaine and thus is subject to DEA regulations. Establishments handling controlled substances must, for example, be licensed and inspected by the DEA, and may be subject to export, import, security and production quota requirements. Radiolabeled products, including drugs, are also subject to regulation by the Department of Transportation and to state and federal licensing requirements. Various states often have comparable health and environmental laws, such as those governing the use and disposal of controlled and radiolabeled products.

While we are currently focused on polymer drug delivery and small molecule therapies, we are not actively involved in product areas involving biotechnology and have no current plans to develop products utilizing modern biotechnology. If we were to move in that direction, we would potentially be subject to extensive regulation. The EPA, the FDA and other federal and state regulatory bodies have developed or are in the process of developing specific requirements concerning products of biotechnology that may affect research and development programs and product lines. We are unable to predict whether any governmental agency will adopt requirements, including regulations, which would have a material and adverse effect on any future product applications involving biotechnology.

Patents and Proprietary Technology

Guilford believes that intellectual property protection is crucial to its business and that its future will depend in large part on its ability to obtain intellectual property protection and operate without infringing the proprietary rights of others. As of December 31, 1999, we owned or had licensed rights to more than 160 U.S. patents and patent applications protecting our key technologies and to corresponding foreign patents and patent applications.

The role, validity and value of Guilford’s intellectual property are subject to various uncertainties and contingencies. Guilford’s success will depend in part on its ability to obtain, maintain and enforce intellectual property protection for its products and processes and operate without infringing upon the

proprietary rights of others. The degree of intellectual property protection afforded to pharmaceutical and biotechnological inventions is uncertain, and a number of Guilford’s product candidates are subject to this uncertainty.

We are aware that other companies have been issued patents, and have filed or may be engaged in filing patent applications, that claim matter relating to polymer drug delivery technology, including polymer-based oncology products, and neurological therapeutics and diagnostics, including small molecule neuroimmunophilin ligands and neuroprotectants. While we do not believe that we are infringing valid third-party patents of which we are aware, we cannot give you any assurance as to the ability of our patents and patent applications to adequately protect our products or product candidates. In addition, our products or product candidates may infringe or be dominated by patents that have issued or may issue in the future to third parties.

We cannot be sure that any patent applications filed by, or assigned or licensed to, us will be granted, that we will develop additional products or processes that are patentable, or that any patents issued to, or licensed by, us will provide us with any competitive advantages or adequate protection for our products. In addition, existing or future patents or intellectual property issued to, or licensed by, us may subsequently be challenged, invalidated or circumvented by others.

It is Guilford’s policy to control the disclosure and use of Guilford’s proprietary information under confidentiality agreements with employees, consultants and other parties. We cannot be sure, however, that our confidentiality agreements will be honored, that others will not independently develop equivalent or competing technology, that disputes will not arise concerning the ownership of intellectual property or the applicability of confidentiality obligations, or that disclosure of Guilford’s proprietary information will not occur. To the extent that consultants or other research collaborators use intellectual property owned by others in their work with us, disputes may also arise as to the rights to related or resulting intellectual property.

Guilford supports and collaborates in research conducted by other companies, universities and governmental research organizations. We cannot be sure that we will have or be able to acquire exclusive rights to the inventions or technical information derived from such collaborations. Also, disputes may arise as to rights in derivative or related research programs conducted by us. In addition, in the event of a contractual breach by Guilford, certain of Guilford’s collaborative research contracts provide for transfer of technology, including any patents or patent applications, to the relevant organization. In addition, this type of breach may cause us to lose our rights to use technology, including any patents or patent applications, licensed from the relevant company or organization.

If we are required to defend against charges of infringement of patent or proprietary rights of third parties or to protect our own patent or proprietary rights against third parties, we may incur substantial costs. We could also lose rights to develop or market certain products or be required to pay monetary damages or royalties to license proprietary rights from third parties. In response to actual or threatened litigation, we may seek licenses from third parties or attempt to redesign our products or processes to avoid infringement. However, we cannot be sure that we will be able to obtain licenses on acceptable terms or at all or redesign our products or processes. In addition to being a party to patent infringement litigation, we could be required to participate in U.S. or foreign opposition patent interference proceedings. We may also be forced to initiate legal proceedings to protect its intellectual property position. Even if we were to prevail, those types of proceedings are usually costly and extremely lengthy.

In order to protect its intellectual property position with respect to its neuroimmunophilin ligands, Guilford filed an opposition in 1998 in an effort to prevent the final issuance of a European patent to a competing company. While Guilford does not believe the claims of this European patent would be valid, any final issuance could result in future litigation if this company were to allege that Guilford or Amgen infringed the claims of this patent in Europe.

Technology Licensing Agreements

In March 1994, we entered into an agreement called the “GLIADEL® Wafer Agreement” with Scios Inc. Under the GLIADEL® Wafer Agreement, we licensed from Scios exclusive worldwide rights to numerous U.S. patents and patent applications and corresponding international patents and patent applications for polyanhydride biodegradable polymer technology for use in the field of tumors of the central nervous system and cerebral edema. GLIADEL® Wafer is covered by two of the U.S. patents under this license which expire in 2005 and certain related international patents and patent applications. In April 1994, Scios assigned all of its rights and obligations under the GLIADEL® Wafer Agreement to the Massachusetts Institute of Technology.

Under this agreement, Guilford is obligated to pay a royalty on all net sales of products incorporating such technology as well as a percentage of all royalties received by Guilford from sublicensees and certain advance and minimum annual royalty payments. Guilford has exclusive worldwide rights to the technology for brain cancer therapeutics, subject to certain conditions, including a requirement to perform appropriate pre-clinical tests and file an IND with the FDA within 24 months of the identification of a drug-polymer product having greater efficacy than GLIADEL® Wafer. In addition, Guilford is obligated to meet certain development milestones. Although we believe that we can comply with these obligations, our failure to perform these obligations could result in the loss of our right to new polymer-based product(s).

In June 1996, we entered into a license agreement with the Massachusetts Institute of Technology and Johns Hopkins respecting a patent application covering certain biodegradable polymers for use in connection with the controlled local delivery of certain chemotherapeutic agents (including paclitaxel (TAXOL®) and camptothecin) for treating solid tumors. Under this agreement, we are obligated to make certain annual and milestone payments to the Massachusetts Institute of Technology and to pay royalties based on any sales of products incorporating the technology licensed to Guilford. Furthermore, under the terms of the agreement, we have committed to spend minimum amounts to develop the technology and to meet certain development milestones. Although we believe that we can comply with such obligations, our failure to perform these obligations could result in the loss of our rights to that technology.

In July 1996, we entered into a license agreement with Johns Hopkins relating to U.S. patents respecting certain PPE polymers developed at Johns Hopkins and additional PPE patent applications. This agreement, among other things, requires Guilford to pay certain processing, maintenance and/or up-front fees, milestone payments and royalties, a portion of proceeds from sublicenses, and fees and costs related to patent prosecution and maintenance and to spend minimum amounts for, and meet deadlines regarding, development of this technology. Although we believe that we can comply with such obligations, our failure to perform these obligations could result in the loss of our rights to that technology.

Guilford and Johns Hopkins are parties to exclusive license agreements covering certain patents and patent applications relating to neuroimmunophilin ligands and their neurotrophic and other uses, and inhibition of PARP for neuroprotective uses and certain other technologies. These agreements, among other things, require Guilford to pay certain processing, maintenance, and/or up-front fees, milestone payments and royalties, a portion of proceeds from sublicenses, and fees and costs related to patent prosecution and maintenance and to spend minimum amounts for, and meet deadlines regarding, development of the technologies. Although we believe that we can comply with these obligations, our failure to perform these obligations could result in the loss of our rights to that technology or in the case of joint inventions, exclusive use of the technology. In the case of Guilford’s license with Johns Hopkins relating to neuroimmunophilin ligands, Johns Hopkins is entitled to a portion of all milestone payments paid to Guilford, including payments under Guilford’s collaboration

with Amgen, and a royalty on net sales of neuroimmunophilin ligand products, including sale of products under Guilford’s collaboration with Amgen.

We obtained exclusive worldwide rights to DOPASCAN® Injection pursuant to a March 1994 license agreement with Research Triangle Institute, which grants Guilford rights to various U.S. and international patents and patent applications relating to binding ligands for certain receptors in the brain which are or may be useful as dopamine neuron imaging agents. DOPASCAN® Injection and certain related precursors and analogues are covered by U.S. patents which start expiring in 2009, as well as certain related international patents and patent applications.

Under the Research Triangle Institute Agreement, we reimbursed Research Triangle Institute for certain past patent-related expenses and made certain annual payments to Research Triangle Institute to support research conducted at Research Triangle Institute through March 1999. In addition, we are obligated to pay Research Triangle Institute a royalty on gross revenues to Guilford from products derived from the licensed technology and from sublicensee proceeds and to make certain minimum royalty payments following the first commercial sale of such products. Guilford must use commercially reasonable efforts to develop products related to the licensed technology and to meet certain performance milestones. Our failure to perform our obligations under the RTI Agreement in the future could result in termination of the license.

United States Government Rights

Aspects of the technology licensed by us under agreements with third party licensors may be subject to certain government rights. Government rights in inventions conceived or reduced to practice under a government-funded program may include a non-exclusive, royalty-free worldwide license to practice or have practiced those inventions for any governmental purpose. In addition, the U.S. government has the right to grant licenses which may be exclusive under any of such inventions to a third party if it determines that: (1) adequate steps have not been taken to commercialize such inventions; (2) the action is necessary to meet public health or safety needs; or (3) the action is necessary to meet requirements for public use under federal regulations. The U.S. government also has the right to take title to a subject invention if there is a failure to disclose the invention and elect title within specified time limits. In addition, the U.S. government may acquire title in any country in which a patent application is not filed within specified time limits. Federal law requires any licensor of an invention that was partially funded by the federal government to obtain a covenant from any exclusive licensee to manufacture products using the invention substantially in the United States. Further, the government rights include the right to use and disclose without limitation technical data relating to licensed technology that was developed in whole or in part at government expense. Our principal technology license agreements contain provisions recognizing these government rights.

Sales, Marketing and Distribution

In general, our strategy is to establish strategic alliances with larger pharmaceutical companies where possible to develop and promote products that require extensive development, sales and marketing resources. Within the United States, we may seek to retain co-promotion rights with respect to some or all compounds or indications in any such strategic alliances, or we may elect to market and distribute our products directly where the commercial prospects so warrant.

Aventis Agreement

In June 1996, we entered into a marketing, sales and distribution rights agreement and other related agreements with Aventis. Under these agreements Aventis has worldwide, with the exclusion of Scandinavia and Japan, marketing, sales, promotion and distribution rights for GLIADEL® Wafer. Upon execution of these agreements, we received $7.5 million for 281,531 shares of our common stock. Furthermore, in addition to an aggregate of $27.5 million in rights payments made by Aventis upon execution of the agreements in June 1996 and FDA clearance of the GLIADEL® Wafer NDA in September 1996, the agreements with Aventis currently provide for up to an additional

$30.5 million in payments, including $7.5 million in the form of an equity investment, in the event that certain regulatory and other milestones are achieved. We caution you that we cannot be sure that any or all of these milestones will be attained and that certain of these payments are contingent on international regulatory filings and clearances, the timing and extent of which are largely within the control of Aventis.

Aventis may, under certain circumstances, fund up to approximately $17 million for the development of higher dose forms of GLIADEL® Wafer that we are developing and for certain additional clinical studies related to GLIADEL® Wafer. We have the right under certain circumstances to borrow up to an aggregate of $7.5 million to expand our GLIADEL® Wafer manufacturing and related facilities.

In addition to the payments outlined above, we act as the exclusive manufacturer of GLIADEL® Wafer and receive transfer price payments and royalties based on any “net sales”, as defined in the agreements with Aventis, of GLIADEL® Wafer. Aventis’ exclusive rights terminate in a particular country upon the later of the expiration of the last to expire of certain patents applicable in that country or the last commercial sale of GLIADEL® Wafer in that country. Aventis also has an exclusive 90-day period following development by Guilford of new polymer technology for brain cancer to make an offer to license such technology.

Amgen Collaboration

As described in more detail above under “Product and Development Programs — Neurological Programs”, in August 1997, we entered into a collaboration with Amgen to research, develop and commercialize FKBP neuroimmunophilin ligands, as well as any other compounds that may result from the collaboration, for all human therapeutic and diagnostic applications. Under this agreement, Amgen initially paid Guilford a total of $35 million and agreed to fund future FKBP neuroimmunophilin ligand technology research up to $13.5 million. Amgen also agreed to pay Guilford a total of $392 million in milestone payments if Amgen achieves specified development objectives.

We will receive royalties on any future sales of products resulting from the collaboration. Amgen has agreed to fund, develop and commercialize the FKBP neuroimmunophilin ligand technology. Under limited circumstances, Guilford has the option to conduct certain Phase I and Phase II clinical trials on one product candidate and has the right to co-promote in the United States one product resulting from the collaboration. Subject to its obligation to fund two years of research at Guilford, Amgen has the right to discontinue all its development and commercialization activities under the collaboration at any time.

Other Agreements

In October 1995, we entered into an agreement appointing Orion Corporation Pharma distributor for GLIADEL® Wafer in Scandinavia, and in December 1995 we entered into an agreement with Daiichi Radioisotope Laboratories, Ltd. for the marketing, sale and distribution of DOPASCAN® Injection in Japan, Korea and Taiwan.

Competition

We are involved in evolving technological fields in which developments are expected to continue at a rapid pace. Guilford’s success depends upon its ability to compete effectively in the research, development and commercialization of products and technologies in its areas of focus. Competition from pharmaceutical, chemical and biotechnology companies, universities and research institutes is intense and expected to increase. Many of these competitors have substantially greater research and development capabilities, experience and manufacturing, marketing, financial and managerial resources than Guilford and represent significant competition for Guilford. Acquisitions of competing companies by large pharmaceutical or other companies could enhance the financial, marketing and

other resources available to these competitors. These competitors may develop products which are superior to those under development by Guilford.

We are aware of several competing approaches under development for the treatment of malignant glioma including using radioactive seeds for interstitial radiotherapy, increasing the permeability of the blood-brain barrier to chemotherapeutic agents, sensitizing cancer cells to chemotherapeutic agents using gene therapy and developing chemotherapeutics directed to specific receptors in brain tumors.

A number of companies are working on products for the treatment of ovarian cancer, using approaches ranging from novel chemotherapeutics to antibody technologies. Further, controlled release polymers and liposomes are being explored by various companies to enhance the efficacy of current and novel therapies.

A number of companies have shown interest in trying to develop neurotrophic agents to promote nerve growth and repair in neurodegenerative disorders and traumatic central nervous system injuries. However, much of this activity has focused on naturally occurring growth factors. Such large molecules generally cannot cross the blood-brain barrier and thus present problems in administration and delivery. One company has announced that certain of its neuroimmunophilin ligands showed positive results in stimulating nerve growth in an animal model of nerve crush, and has disclosed that it has made patent filings covering compounds and uses in connection with nerve growth promotion. This company has also announced that it has begun a phase II clinical trial for peripheral neuropathy using a neuroimmunophilin compound it originally was developing for multiple drug resistance in cancer patients. In addition, another company announced that IGF-1 showed positive results in clinical trials of a peripheral neurodegenerative disorder.

There is intense competition to develop an effective and safe neuroprotective drug or biological agent. Calcium channel antagonists, calpain inhibitors, adenosine receptor antagonists, free radical scavengers, superoxide dismutase inducers, proteoloytic enzyme inhibitors, phospholipase inhibitors and a variety of other agents are under active development by others. Glutamate or NMDA receptor antagonists are under development by several other companies.

The anesthesia/sedation field is concentrated in the United States mainly among four major companies, with several other companies doing research in the field. There are numerous products currently on the market that are accepted as relatively safe and effective anesthetic agents and sedation agents. We cannot be sure that we can successfully develop GPI-15715, our propofol pro-drug product candidate, into a safe and effective drug or that it will be cleared for marketing. Even if we do develop it into a safe and effective drug and it is cleared for marketing, the commercial prospect of GPI-15715 will heavily depend on its safety and efficacy profile relative to alternatives then available in the market.

We believe that two other companies and their affiliates, as well as some university researchers, are clinically evaluating imaging agents for dopamine neurons. In addition, a variety of radiolabeled compounds for use with Positron Emission Tomography, or “PET”, scanners have been used to image dopamine neurons successfully in patients with Parkinson’s disease. PET scanning is currently only available in a limited number of hospitals in the United States and Europe.

In the field of cocaine addiction, academic and government groups have studied most of the investigated compounds to date. Further, much of this work has been with known agents, such as carbamazepine, that are commercially available for other indications. Guilford is aware of another company that is investigating the use of butylcholinesterase as a treatment for acute cocaine overdose. We are aware of one company that is investigating an immunological approach in an attempt to develop a cocaine vaccine. We are not aware of other commercial research programs targeting specific cocaine antagonists, which do not interfere with normal dopamine neuron function.

Any product candidate that we develop and for which we gain regulatory approval, including GLIADEL® Wafer, must then compete for market acceptance and market share. For certain of our

product candidates, an important factor will be the timing of market introduction of competitive products. Accordingly, the relative speed with which we and competing companies can develop products, complete the clinical testing and approval processes, and supply commercial quantities of the products to the market is expected to be an important determinant of market success. Other competitive factors include

• the capabilities of our collaborators,

• product efficacy and safety,

• timing and scope of regulatory approval,

• product availability,

• marketing and sales capabilities,

• reimbursement coverage,

• the amount of clinical benefit of our product candidates relative to their cost, method of administration,

• price, and

• patent protection.

Our competitors may develop more effective or more affordable products or achieve earlier product development completion, patent protection, regulatory approval or product commercialization than Guilford. The achievement of any of these goals by our competitors could have a material adverse effect on our business, financial condition and results of operations.

Product Liability and Insurance

Product liability risk is inherent in the testing, manufacture, marketing and sale of Guilford’s product candidates, and there can be no assurance that Guilford will be able to avoid significant product liability exposure. While Guilford currently maintains $15 million of product liability insurance covering clinical trials and product sales, we cannot be sure that this or any future insurance coverage that we obtain will be adequate or that our insurance will cover any claims. Guilford’s insurance policies provide coverage on a claims-made basis and are subject to annual renewal. Product liability insurance varies in cost, can be difficult to obtain and may not be available to Guilford in the future on acceptable terms, or at all.

Employees

At December 31, 1999, Guilford employed 228 individuals. Of these 228 employees, 193 were employed in the areas of research and product development and in manufacturing and quality control of GLIADEL. The remaining 35 employees performed general and administrative functions, including executive, finance and administration, legal and business development. None of Guilford’s employees are currently represented by a labor union. To date, we have experienced no work stoppages related to labor issues and believe our relations with our employees are good.

All employees are required to enter into a confidentiality agreement with Guilford. Hiring and retaining qualified personnel are important factors for Guilford’s future success. We are likely to continue to add personnel particularly in the areas of research, clinical research and operations, including manufacturing. Intense competition exists for these qualified personnel from other biotechnology and biopharmaceutical companies as well as academic, research and governmental organizations. Guilford cannot be sure that it will be able to continue to hire qualified personnel and, if hired, that it will be able to retain these individuals.

Item 1A. Executive Officers and Other Significant Employees of Registrant

Craig R. Smith, M.D., age 54, joined Guilford as a Director at its inception in July 1993. Dr. Smith was elected President and Chief Executive Officer in August 1993 and was elected Chairman of the Board in January 1994. Prior to joining Guilford, Dr. Smith was Senior Vice President for Business and Market Development at Centocor, Inc., a biotechnology corporation. Dr. Smith joined Centocor in 1988 as Vice President of Clinical Research after serving on the Faculty of the Department of Medicine at Johns Hopkins Medical School for 13 years. Dr. Smith received his M.D. from the State University of New York at Buffalo in 1972 and received training in Internal Medicine at Johns Hopkins Hospital from 1972 to 1975. Dr. Smith is a member of the board of directors of CellGate, Inc.

John P. Brennan, age 57, joined Guilford as Vice President, Operations in January 1994 and became Senior Vice President, Operations in January 1997. In February 1999, Mr. Brennan was promoted to Senior Vice President, Technical Operations and General Manager, Drug Delivery Business. From 1980 to 1993, he was Vice President, Technical Operations and Manufacturing for G.D. Searle and Co., a pharmaceutical company, and was responsible for the operation of manufacturing plants in North America, Latin America and Europe and the worldwide pharmaceutical and process technology from 1980 to 1993. From 1977 to 1980, Mr. Brennan was General Manager of the E.R. Squibb & Sons, Inc. manufacturing facility in Humacao, Puerto Rico. Mr. Brennan held various technical positions at SmithKline Corporation from 1960 to 1977. Mr. Brennan has over 39 years of experience in the pharmaceutical industry. Mr. Brennan received his B.S. in Chemistry from the Philadelphia College of Pharmacy and Science in 1968 and attended the Wharton Graduate Management Program in 1976.

Andrew R. Jordan, age 52, joined Guilford as Vice President, Secretary, Treasurer and Chief Financial Officer in September 1993 and became Senior Vice President, Treasurer and Chief Financial Officer in January 1997. Prior to joining Guilford, Mr. Jordan held various positions with KPMG LLP, a public accounting firm, beginning in 1973, including partner since 1983. Mr. Jordan’s experience at KPMG LLP included advising early-stage and emerging technology companies and initial and secondary public equity and debt offerings. He received his B.A. from Rutgers College in 1969 and his MBA from Rutgers Graduate School of Business in 1973 and is a Certified Public Accountant.

Peter D. Suzdak, Ph.D., age 41, joined Guilford in March 1995 as Vice President, Research. In February 1999, Dr. Suzdak was promoted to Senior Vice President, Research & Development. Prior to joining Guilford, Dr. Suzdak was Director of Neurobiology at Novo Nordisk A/ S and was responsible for all neurobiology research from 1993 to 1995, and Department Head for Receptor Neurochemistry from 1988 to 1992 as well as a member of the drug discovery management group from 1989 to 1995. Prior thereto, Dr. Suzdak was a Pharmacology Research Associate in the Clinical Neuroscience Branch of the National Institute of Mental Health in Bethesda, Maryland from 1985 to 1988. Dr. Suzdak received his Ph.D. in Neuroscience from the University of Connecticut and a B.S. in Pharmacy from St. Johns University.

Thomas C. Seoh, age 42, joined Guilford in April 1995 as Vice President, General Counsel and Secretary. In August 1999, Mr. Seoh was promoted to Senior Vice President, General Counsel and Secretary. From 1992 to 1995, Mr. Seoh was affiliated with the ICN Pharmaceuticals, Inc. (“ICN”) group, as Vice President and Associate General Counsel of ICN from 1994 to 1995, Vice President, General Counsel and Secretary of Viratek, Inc. from 1993 to 1994 and Deputy General Counsel of SPI Pharmaceuticals, Inc. from 1992 to 1994, providing legal function support for pharmaceutical operations, research and development and corporate development. From 1990 to 1992, Mr. Seoh was General Counsel and Secretary of Consolidated Press U.S., Inc., the North American holding corporation of the Sydney, Australia-based Consolidated Press group. Prior thereto, Mr. Seoh was associated with the New York and London law offices of Lord, Day & Lord, Barrett Smith. Mr. Seoh received his J.D. and A.B. from Harvard University.

William C. Vincek, Ph.D., age 52, joined Guilford as Vice President, Corporate Quality in August 1997. From November 1993 until Dr. Vincek joined Guilford, he was Group Director, CMC & Preclinical Regulatory Affairs and Global Research and Development GMP Quality Assurance at Glaxo Wellcome, Inc. Prior thereto from 1984 until October 1993, Dr. Vincek held various positions at SmithKline Beecham Pharmaceuticals and related entities, most recently from July 1992 until October 1993 as Director, Pharmaceutical Analysis Department. Dr. Vincek received his Ph.D. in Medicinal Chemistry from the University of Kansas, where he also received an M.S. in Medicinal Chemistry. Dr. Vincek received a B.S. in Chemistry from Colorado State University.

Dana C. Hilt, M.D., age 46, joined Guilford as Vice President, Clinical Research in May 1998. As part of Guilford’s reorganization in February 1999, Dr. Hilt’s title was changed to Vice President, Clinical Research and Drug Metabolism. Prior to joining Guilford, Dr. Hilt was employed by Amgen, most recently as Director, Neuroscience from 1996 to 1998, earlier as Associate Director, Neuroscience from 1993 to 1996. While at Amgen, Dr. Hilt’s duties included overseeing aspects of basic research, clinical trials, regulatory strategy and manufacturing for certain of Amgen“s neurological product programs. Prior to joining Amgen, Dr. Hilt held a variety of positions at the University of Maryland School of Medicine and the National Institutes of Health. Dr. Hilt received his B.S. degree in Chemistry from the University of Maine, his M.D. from Tufts University School of Medicine, and received training in Internal Medicine at Harvard Medical School and Neurology at Johns Hopkins Hospital.

Nancy J. Linck, Ph.D., J.D., age 58, joined Guilford as Vice President, Intellectual Property in November 1998. From 1994 to 1998, Dr. Linck was Solicitor for the U.S. Patent and Trademark Office, where she acted as general counsel for the Commissioner of Patents and Trademarks. From 1987 to 1994, Dr. Linck worked as a patent and trademark litigator at the intellectual property law firm of Cushman, Darby & Cushman, first as an Associate from 1987 to 1990, and later as a Partner from 1991 to 1994. Since 1995, Dr. Linck has been engaged as an Adjunct Professor of Law, first at George Washington University School of Law and presently at Georgetown University Law Center. Dr. Linck received her B.S. in Chemistry from the University of California, Berkeley, her M.S. and Ph.D. in Inorganic Chemistry from the University of California, San Diego, and her J.D. from Western New England College School of Law.

Denise Battles, age 45, joined Guilford as Director of Quality Assurance in August 1994 and became Senior Director of Product Compliance in August 1997. Ms. Battles was promoted to Vice President of Corporate Quality in August 1999. Prior to joining Guilford, Ms. Battles was employed by Pharmaceutical Systems, Incorporated as the Director of Quality Assurance from 1993 to 1994. Prior thereto, Ms. Battles held various positions with Quality Control and Quality Assurance at Baxter Healthcare Corporation, including Director of Quality Assurance from 1990 to 1993. Ms. Battles received her B.S. in Biology from Fisk University in 1977 and received training at the Lake Forest Graduate School of Management.

Item 2. Properties.

In August 1994, Guilford entered into a master lease for an approximately 83,000 square foot building in Baltimore, Maryland. Guilford currently occupies 23,000 square feet for office space, 18,000 square feet for manufacturing space for GLIADEL and potentially other polymer-based products, and 42,000 square feet of research and development laboratories. Guilford added approximately 5,000 square feet to its animal handling facilities in 1998. The master lease expires in July 2005. Two five-year renewal options are available to Guilford or Guilford may exercise a purchase option any time after the ninth year of the lease for the then-current fair market value.

In February 1998, Guilford entered into an operating lease with a trust affiliated with First Union National Bank respecting the construction and occupancy of a new laboratory and office facility, consisting of approximately 73,000 square feet. Guilford began moving personnel into the facility in June 1999 and consolidated all of its operations into its current headquarters and the new facility during the third quarter of 1999. The lease expires in February 2005, at which time Guilford has an

option (1) to purchase the property or (2) to sell the property on behalf of the trust, subject to certain limitations and related obligations. In addition, Guilford may, with the consent of First Union, enter into a new lease arrangement. See Exhibit 13.01, “Management’s Discussion of Financial Condition and Results of Operations — Liquidity and Capital Resources” for a more complete description of Guilford’s arrangements with First Union.

Item 3. Legal Proceedings

We are not a party to any material legal proceedings.

Item 4. Submission of Matters to a Vote of Security Holders

None.

Item 4A. Risk Factors

An investment in our stock is very speculative and involves a high degree of risk. In addition to the other information contained in this annual report, including the reports we incorporate by reference, you should consider the following important factors carefully in evaluating our company and its business before purchasing shares of our stock.

We have a history of losses and our future profitability is uncertain.

We cannot be sure that we will be able to achieve significant and sustained revenues or realize sustained profitable operating results in the future. Guilford was founded in July 1993 and, with the sole exception of 1996, we have not earned a profit in any year since inception. Our losses stem mainly from the significant amount of money that we have spent on research and development. As of December 31, 1999, we had an accumulated deficit of approximately $83 million. We expect to have significant additional losses over the next several years.

Most of our product candidates are in research or early stages of pre-clinical and clinical development. Except for GLIADEL, none of our product candidates has been marketed and sold to the public. At this time, nearly all of our revenues have come from:

• payments from Aventis from the sale and distribution of GLIADEL® Wafer,

• one-time signing fees from our corporate partners under our collaboration agreements supporting the research, development and commercialization of our product candidates,

• one-time payments from our corporate partners upon the achievement of specified regulatory or development milestones; for example, Aventis’ payment to us in July 1999 relating to approval in France to market and sell GLIADEL for the recurrent surgery indication, and

• periodic research funding under our collaboration with Amgen.

We do not expect current and anticipated revenues from GLIADEL® Wafer to be sufficient to support all our anticipated future activities. Whether GLIADEL® Wafer sales will ever generate any significant revenues continues to remain uncertain. In addition, we do not anticipate generating revenues from the sale of our product candidates for the next several years, if ever. We will require payments from our current corporate partners, principally Aventis and Amgen, and any future corporate partners, to fund our ongoing activities.

Whether we will ever recognize significant revenues from Amgen in the form of milestone payments or royalties paid on product sales is also subject to significant risk and uncertainty. These risks are part of each of the following activities, among others:

• new product development,

• the conduct of pre-clinical animal studies and human clinical trials,

• applying for and obtaining regulatory approval to market and sell product candidates,

• scale-up of the processes for making product candidates in quantities and qualities needed for research and development purposes to commercial scale manufacture needed to support marketing and sales of new products, and

• commercialization of new products.

We discuss these and other risks in greater detail below in this “Risk Factors” section.

Whether we will ever be able to achieve sustained profitability in the future will depend on many factors, including:

• the successful marketing of GLIADEL® Wafer by Aventis,

• receipt of regulatory clearance to market and sell GLIADEL® Wafer in Europe,

• receipt of regulatory clearance to market and sell GLIADEL® Wafer for patients undergoing initial surgery for malignant glioma in the United States as well as Europe and other countries,

• the successful development and commercialization of product candidates that result from our collaboration with Amgen, and

• our ability to enter into additional collaborative arrangements and license agreements with other corporate partners for our product candidates and earlier stage technologies as we develop them.

We will need to conduct substantial additional research, development and clinical trials. We will also need to receive necessary regulatory clearances. We expect that these research, development and clinical trial activities, and regulatory clearances, together with future general and administrative activities, will result in significant expenses for the foreseeable future.

Our results of operations are likely to fluctuate.

Our revenues and expenses have fluctuated significantly in the past because of the nature of their sources. This fluctuation has in turn caused our results of operations to vary significantly from quarter to quarter and year to year. We expect the fluctuations in our revenues and expenses to continue and thus our results of operations should also continue to vary significantly. These fluctuations are due to a variety of factors, including:

• the timing and amount of sales of GLIADEL® Wafer to Aventis and Aventis’ sales to others,

• the timing and realization of milestone and other payments from our corporate partners, including Aventis and Amgen,

• the timing and amount of expenses relating to our research and development, product development, and manufacturing activities, and

• the extent and timing of costs related to our activities to obtain patents on our inventions and to extend, enforce and/or defend our patent and other rights to our intellectual property.

We are dependent on GLIADEL® Wafer and Aventis for revenues.

Our near term prospects depend to a large extent on sales by Aventis of GLIADEL® Wafer, our only commercial product to date. GLIADEL® Wafer was commercially launched in the United States in February 1997. We currently do not know whether the product will ever gain broad market acceptance or the extent of the marketing efforts necessary to achieve broad market acceptance. If GLIADEL® Wafer fails to gain market acceptance, that failure would have a material adverse effect on the likelihood of increasing the revenues that we receive from sales of GLIADEL® Wafer.

To date, we have received clearance from the FDA to market GLIADEL® Wafer in the United States for a limited subset of patients suffering from brain cancer. This clearance extends to those patients for whom surgical tumor removal, commonly referred to as “resection”, is indicated and who have recurrent forms of the brain cancer glioblastoma multiforme. A recurrent form of glioblastoma

multiforme is one in which the cancer has returned after initial surgery to remove a brain tumor. The number of patients undergoing recurrent surgery for glioblastoma multiforme is very limited, and we believe the total annual incidence of glioblastoma multiforme in the United States is less than 10,000.

In order to expand the medical uses, commonly referred to as “indications”, for which Aventis may market GLIADEL® Wafer, we and Aventis must successfully complete additional lengthy clinical trials. Thereafter, we and Aventis will have to apply to the FDA and international health regulatory authorities for clearance to market GLIADEL® Wafer for patients undergoing initial surgery for glioblastoma multiforme and potentially other brain cancers. We cannot be sure that we and Aventis will be able to successfully complete these clinical trials or receive the desired regulatory clearance. If GLIADEL® Wafer fails to receive regulatory clearance, that failure would limit Aventis’ ability to market GLIADEL® Wafer for use in patients beyond the current narrow indication and would have a material adverse effect on our business prospects.

In addition, Aventis has filed for marketing clearance for the current indication for GLIADEL® Wafer in a number of foreign countries, and as of the date of this annual report, Aventis has received international regulatory approvals to market and sell GLIADEL® Wafer in only a limited number of foreign countries, including France and Germany. Aventis may not be able to obtain any other international regulatory approvals for GLIADEL® Wafer. If Aventis fails to obtain those approvals, the geographic market for GLIADEL® Wafer would remain limited, which reduces the likelihood of increasing the revenues that we receive from sales of GLIADEL® Wafer.

We have granted Aventis exclusive worldwide (excluding Scandinavia and Japan) marketing, sales and distribution rights for GLIADEL® Wafer. However, our agreements with Aventis do not impose any minimum requirements on Aventis for the purchase of GLIADEL from us or for the sale of GLIADEL® Wafer to end-users. Therefore, we have no control over the revenues we receive from the sale and distribution of GLIADEL® Wafer, which depend completely on Aventis’ marketing efforts. In addition, prior to the February 1997 commercial launch of GLIADEL® Wafer in the United States, Aventis’ oncology sales force had no previous experience in marketing a product to neurosurgeons. We cannot be sure that Aventis will elect to continue or increase its marketing and promotional activities for GLIADEL® Wafer or that its efforts in that regard will be successful. The inability or unwillingness of Aventis to aggressively market and promote GLIADEL® Wafer would have a material adverse effect on the revenues that we receive from sales of GLIADEL® Wafer.

GLIADEL® Wafer is also a very fragile product and can easily break into many pieces if not handled with great care. Product recalls due to excessive breakage of the GLIADEL® Wafers or for other reasons could also have a material adverse effect on our business, financial condition and results of operations.

Aventis must make designated one-time milestone payments to us upon achieving specified domestic and international regulatory approvals. By and large, Aventis is responsible for the timing and content of the applications necessary for international regulatory clearances to market and sell GLIADEL® Wafer. Thus, whether GLIADEL® Wafer will receive these clearances depends heavily on the efforts of Aventis. We cannot be sure any or all of these milestones will be satisfied in a manner so as to entitle us to receive the corresponding milestone payments from Aventis. The potential milestone payments are significant, and failure to achieve the designated regulatory objectives could have a material adverse effect on our financial condition.

The success of our Amgen collaboration is dependent on a number of
factors, most of which are outside of our control.

Regulatory and development milestone payments as well as royalty amounts on product sales payable to us under our collaboration with Amgen depend on a number of factors. Many of these factors are not within our control, including:

• the selection of one or more appropriate lead compounds,

• successful design and completion of pre-clinical and clinical development activities,

• application for and obtaining regulatory clearances to market potential products,

• commercialization of products, and

• the successful preservation and extension of the patent and other intellectual property rights licensed to Amgen.

All of these activities are subject to significant risks and uncertainties. For a description of these and other material risks related to the research, development and commercialization of the FKBP neuroimmunophilin ligand technology, you should read the following sections contained in this “Risk Factors” discussion:

• “We face technological uncertainties related to research, development and commercialization,”

• “We may be unable to protect our proprietary rights, permitting competitors to duplicate our products and services,”

• “We are dependent on licensed intellectual property,”

• “Pre-clinical and clinical trial results for our products may not be favorable,”

• “Our products use novel alternative technologies and therapeutic approaches which have not been widely studied,” and

• “Our business is dependent on our ability to keep pace with the latest technological changes.”

Moreover, under the terms of our collaboration with Amgen, we have no control over the development activities regarding the FKBP neuroimmunophilin ligand technology, which have been left to the sole discretion of Amgen. Our agreement with Amgen also does not specify a binding timetable for achieving development and commercialization goals with respect to the FKBP neuroimmunophilin ligand technology. If Amgen determines to conduct clinical trials on a product candidate resulting from our collaboration, Amgen still may not be able successfully to complete those clinical trials and then receive clearance from the FDA or foreign regulatory authorities to market and sell any such products.

The FKBP neuroimmunophilin ligand technology we have licensed to Amgen represents a new approach to the treatment of certain types of neurological and other diseases and conditions. We and Amgen have very limited experience in taking the kinds of compounds likely to result from our work and formulating them into final drug products appropriate for sale to the public. In addition, both of us have limited experience with the scale-up of such compounds from the quantity and quality needed to support research and development efforts to quantities needed to support commercial scale distribution. Also, both we and Amgen have limited experience with the manufacture of compounds of this type for commercial sale. There is a risk that Amgen will not be successful in scaling-up and manufacturing any such compounds needed for commercial sale. For a more complete description of the kinds of risks associated with product manufacture, you should read the section entitled “We have limited manufacturing capabilities” below.

If Amgen is able to obtain all regulatory approvals necessary to market a product resulting from our collaboration, our agreement does not specify any minimum sales requirements for Amgen. Thus, any royalty amounts payable to us in the future will depend entirely on the sales and marketing efforts of Amgen, an activity over which we will have no control. In addition, our agreement with

Amgen does not prevent Amgen from pursuing technologies for product candidates competitive with the FKBP neuroimmunophilin ligand technology in the future.

We have limited manufacturing capabilities.

To commercialize GLIADEL® Wafer, we must be able to manufacture this product in sufficient quantities, in compliance with regulatory requirements, and at acceptable costs. We manufacture GLIADEL® Wafer at our manufacturing facility in Baltimore, Maryland, which consists of production laboratories and redundant cleanrooms. We estimate that the facility currently has the capacity to manufacture approximately 8,000 GLIADEL® Wafer treatments per year.

Although we believe this GLIADEL® Wafer manufacturing facility meets the FDA’s current requirements for good manufacturing practices, which are commonly referred to as “cGMP”, and the FDA has inspected the facility in the past, we have manufactured only limited quantities of GLIADEL® Wafer in the facility. We cannot be sure that we will be able to continue to satisfy applicable regulatory standards, including cGMP requirements, and other requirements relating to the manufacture of GLIADEL® Wafer in the facility.

We also face risks inherent in the operation of a single facility for manufacture of GLIADEL® Wafer. These risks include:

• unforeseen plant shutdowns due to personnel, equipment or other factors, and

• the possible inability of the facility to produce GLIADEL® Wafer in quantities sufficient to meet demand.

Any delay in the manufacture of GLIADEL® Wafer could result in delays in product shipment. Delays in product shipment would have a material adverse effect on our business, financial condition and results of operations.

Currently, we have no manufacturing capabilities for our product candidates, including DOPASCAN® Injection. Consequently, in order to complete the commercialization process of any of our product candidates, we must either acquire, build or expand our internal manufacturing capabilities or rely on third parties to manufacture these product candidates. We cannot be sure that we or our corporate partners, including Amgen, will be able to (1) acquire, build or expand facilities that will meet quality, quantity and timing requirements or (2) enter into manufacturing contracts with others on acceptable terms, or at all. Our inability, or that of our corporate partners, to accomplish these tasks would impede our efforts to bring our product candidates to market, which would adversely affect our business.

Third-party manufacturers must also comply with FDA, Drug Enforcement Administration, and other regulatory requirements for their facilities, including the FDA’s cGMP regulations. In addition, manufacture of product candidates on a limited basis for investigational use in animal studies or human clinical trials does not guarantee that large-scale, commercial production is viable. Small changes in methods of manufacture can affect the safety, efficacy, controlled release or other characteristics of a product. Changes in methods of manufacture, including commercial scale-up, can, among other things, require the performance of new clinical studies. Moreover, if we decide to manufacture one or more of our product candidates ourselves, we would incur substantial start-up expenses and need to expand our facilities and hire additional personnel.

We face technological uncertainties related to research, development
and commercialization.

The research, development and commercialization of pharmaceutical drugs inherently involve significant risk. Before we or our corporate partners can be in a position to commercialize a new product (i.e., to market, distribute and sell the product), each of us will have to:

• expend substantial capital and effort to develop our product candidates further, which includes conducting extensive and expensive pre-clinical animal studies and human clinical trials,

• apply for and obtain regulatory approval to market and sell such product candidates, and

• conduct other costly activities related to preparation for product launch, among many other activities.

In some of our research programs, we are using compounds that we consider to be “prototype” compounds in the research phase of our work. By prototype compounds we mean compounds that we are using primarily to establish that a relevant scientific mechanism of biological or chemical action could have commercial application in diagnosing, treating or preventing disease. We generally do not consider our prototype compounds to be lead compounds acceptable for further development into a product(s) because of factors that render them unsuitable as drug candidates. Such factors include sub-optimal metabolic or pharmacokinetic characteristics or unfavorable patent coverage. In order to develop commercial products, we will need to conduct research using other compounds that share the key aspects of the prototype compounds but do not have the unsuitable characteristics. We cannot be sure that this will always be possible.

In addition, our product candidates are subject to the risks of failure inherent in the development of products based on new and unproved technologies. These risks include the possibility that:

• our new approaches will not result in any products that gain market acceptance;

• a product candidate will prove to be unsafe or ineffective, or will otherwise fail to receive and maintain regulatory clearances necessary for marketing,

• a product, even if found to be safe and effective, could still be difficult to manufacture on the large scale necessary for commercialization or otherwise not be economical to market,

• a product will unfavorably interact with other types of commonly used medications, thus restricting the circumstances in which it may be used,

• proprietary rights of third parties will preclude us from manufacturing or marketing a new product, or

• third parties will market superior or more cost-effective products.

As a result, our activities, either directly or through corporate partners, may not result in any commercially viable products.

We are dependent on collaborations with third parties for the development
and commercialization of our products.

Our resources are limited, particularly because we are developing our technologies for a variety of different diseases. Our business strategy requires that we enter into various arrangements with:

• corporate partners, such as Aventis and Amgen,

• academic investigators at universities, such as Johns Hopkins and others,

• licensors of technologies, such as Johns Hopkins, Massachusetts Institute of Technology and RTI,

• licensees of our technologies, such as Daiichi Radioisotope Laboratories, Ltd. and others.

Our success depends in large part upon the efforts of these parties.

Like many small biopharmaceutical companies, our business strategy includes finding larger pharmaceutical companies to collaborate with us to support the research, development and commercialization of our product candidates. In trying to attract corporate partners to collaborate with us in the research, development and commercialization process, we face serious competition from other small biopharmaceutical companies and even the in-house research and development staffs of the larger pharmaceutical companies themselves. If we are unable to enter into such arrangements with corporate partners, this failure may severely limit our ability to proceed with the research,

development, manufacture or sale of product candidates. For example, we are actively seeking corporate partners to assist in the development of DOPASCAN® Injection as well as our NAALADase and PARP inhibitor neuroprotective drug programs, but we may not find suitable corporate partners for these programs.

It is common in many corporate partnerships in our industry for the larger partner to have responsibility for conducting pre-clinical studies and human clinical trials and/or preparing and submitting applications for regulatory approval of potential pharmaceutical or other products. That is the case with some of our current corporate partnerships, including our collaboration with Amgen. It is possible that this will also be the case with future arrangements into which we may enter. If one of our collaborative partners fails to develop or commercialize successfully any of our product candidates, we would not be able to remedy this failure would and the failure could materially and adversely affect our business.

Furthermore, larger pharmaceutical companies often explore multiple technologies and products for the same medical conditions. Therefore, they are likely to enter into collaborations with our competitors for products addressing the same medical conditions targeted by our technologies. Thus our collaborators, including Amgen, may pursue alternative technologies or product candidates either on their own or in collaboration with others, including our competitors, in order to develop treatments for the diseases or disorders targeted by our collaborative arrangements. Depending on how other product candidates advance, a corporate partner may slow down or abandon its work on our product candidates or terminate its collaborative arrangement with us in order to focus on these other prospects.

We also depend to a large extent on technology license agreements with third parties, including our agreements with Johns Hopkins relating to the neuroimmunophilin ligand technology. This license agreement and others we have require that we meet a specified schedule for achieving designated research, development and regulatory milestones and that we spend minimum amounts of money to develop the technology, as well as make specified payments from proceeds from corporate partners and royalty payments. If we are unable to meet or agree upon these requirements under a license, our licensor could terminate the license and thus deprive us of access to key technology. A deprivation of this type could have a material adverse effect on our business.

We may be unable to obtain the additional capital needed to operate
and grow our business.

We will require substantial funds in order to continue our research and development programs and pre-clinical and clinical testing and to manufacture and, where applicable, market our products. We cannot be sure that we will be able to obtain any future funds that we may require on acceptable terms, or at all. Under our operating lease with a trust affiliated with First Union National Bank for our new research and development facility, we are required to hold, in the aggregate, unrestricted cash, cash equivalents and investments of $40 million at all times during the term of the lease. In addition, we are required to maintain specified amounts of cash, $19.1 million restricted at December 31, 1999, as collateral at First Union under this arrangement and other loan agreements with First Union. These requirements may limit our ability to access our capital in the future.

Our capital requirements depend on numerous factors, including:

• the progress of our research and development programs,

• the progress of pre-clinical and clinical testing,

• the time and costs involved in obtaining regulatory approvals,

• the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights,

• competing technological and market developments,

• changes in our existing research relationships with universities and others,

• our ability to establish collaborative arrangements with large pharmaceutical companies and others,

• the requirements and timing of entering into technology licensing agreements and other similar arrangements, and

• the progress of efforts to scale-up manufacturing processes.

We may use our existing resources before we may otherwise expect because of changes in our research and development and commercialization plans or other factors affecting our operating expenses or capital expenditures, including potential acquisitions of other businesses, assets or technologies.

Our ability to raise future capital on acceptable terms depends on conditions in the public and private equity markets and our performance, as well as the overall performance of other companies in the biopharmaceutical and biotechnology sectors.

Our stock price is volatile.

The market price of our stock has been and is likely to continue to be highly volatile, and an investment in our shares involves substantial risks. The market prices for shares of smaller biotechnology companies like ours have a history of being highly volatile. Furthermore, the stock market generally and the market for stocks of companies with lower market capitalizations, like us, have from time to time experienced and likely will again experience significant price and volume fluctuations that are unrelated to the operating performance of a particular company.

From time to time, stock market professionals publish research reports covering our business and our future prospects. A number of factors may limit our ability to meet the expectations of securities analysts or investors and thus may adversely affect our stock price. These factors include:

• announcements by us or our competitors of clinical results, technological innovations, product sales, new products or product candidates,

• developments or disputes concerning patent or proprietary rights,

• regulatory developments affecting our products,

• period-to-period fluctuations in the results of our operations, and

• market conditions for emerging growth companies and biopharmaceutical companies.

We may be unable to protect our proprietary rights, permitting competitors
to duplicate our products and services.

Any success that we have will depend in large part on our ability to:

• obtain, maintain and enforce intellectual property protection for our products and processes,

• license rights to patents from third parties,

• maintain trade secret protection, and

• operate without infringing upon the proprietary rights of others.

Intellectual property for our technologies and products will be a crucial factor in our ability to develop and commercialize our products. Large pharmaceutical companies consider a strong patent estate critical when they evaluate whether to enter into a collaborative arrangement to support the research, development and commercialization of a technology. Without the prospect of reasonable intellectual property protection, it would be difficult for a corporate partner, or our company for that matter, to justify the time and money that is necessary to complete the development of a product.

The rules and criteria for receiving and enforcing a patent for pharmaceutical and biotechnological inventions are in flux and are unclear in many respects. The ultimate scope of patent protection afforded these types of patents remains uncertain, and a number of our product candidates are subject to this uncertainty.

Many others, including companies, universities and other research organizations, work in the areas of our business, and we cannot be sure that the claims contained in our issued patents will be interpreted as broadly as we would like in light of the inventions of these other parties. In addition, we cannot be sure that the claims set forth in our pending patent applications will issue in the form submitted. These claims may be narrowed or stricken, and the applications may not ever ultimately result in valid and enforceable patents. Thus, we cannot be sure that our patents and patent applications will adequately protect our product candidates.

In order to protect our intellectual property position with respect to our neuroimmunophilin ligands, we filed an opposition in 1998 in an effort to prevent the final issuance of a European patent to the company we reference in the immediately preceding paragraph. While we do not believe the claims of this European patent are valid, any final issuance could result in future litigation if this company were to allege that we infringed the claims of this patent in Europe.

Furthermore, we cannot be sure that any or all of the patent applications assigned or licensed to us from third parties will be granted. We cannot offer assurances that we will develop additional products or processes that are patentable, or that any patents issued to us, or licensed by us, will provide us with any competitive advantages or adequate protection for our products. We also cannot be sure that others will not successfully challenge, circumvent or invalidate any of our existing or future patents or intellectual property.

Our policy is to control the disclosure and use of our know-how and trade secrets by entering into confidentiality agreements with our employees, consultants and third parties. There is a risk, however, that:

• these parties will not honor our confidentiality agreements,

• others will independently develop equivalent or competing technology,

• disputes will arise concerning the ownership of intellectual property or the applicability of confidentiality obligations, or

• disclosure of our trade secrets will occur regardless of these contractual protections.

In our business, we often work with consultants and research collaborators at universities and other research organizations. To the extent that any of these consultants or research collaborators uses intellectual property owned by others as part of their work with us, disputes may arise between us and these other parties as to which one of us has the rights to intellectual property related to or resulting from the work done.

We support and collaborate in research conducted in universities, such as Johns Hopkins, and in governmental research organizations, such as the National Institutes of Health. We cannot be sure that we will have or be able to acquire exclusive rights to the inventions or technical information that result from work performed by university personnel or at these organizations. Also, disputes may arise as to which party should have rights in research programs that we conduct on our own or in

collaboration with others that are derived from or related to the work performed at the university or governmental research organization. In addition, in the event of a contractual breach by us, some of our collaborative research contracts provide that we must return the technology rights, including any patents or patent applications, to the contracting university or governmental research organization.

Questions of infringement of intellectual property rights, including patent rights, may involve highly technical and subjective analyses. Some or all of our existing or future products or technologies may now or in the future infringe the rights of other parties. These other parties might initiate legal action against us to enforce their claims, and our defense of the claims might not be successful.

We may incur substantial costs if we must defend against charges of infringement of patent or proprietary rights of third parties. We may also incur substantial costs if we find it necessary to protect our own patent or proprietary rights by bringing suit against third parties, including suits involving our neurotrophic product candidates. We could also lose rights to develop or market products or be required to pay monetary damages or royalties to license proprietary rights from third parties. In response to actual or threatened litigation, we may seek licenses from third parties or attempt to redesign our products or processes to avoid infringement. We cannot be sure that we will be able to obtain licenses on acceptable terms, or at all, or successfully redesign our products or processes.

In addition to the risk that we could be a party to patent infringement litigation, the U.S. Patent and Trademark Office, or its foreign counterparts, could require us to participate in patent interference proceedings that it declares. These proceedings are often expensive and time-consuming, even if we were to prevail in such a proceeding. We may also be forced to initiate legal proceedings to protect our patent position or other proprietary rights. These proceedings typically are costly, protracted, and offer no assurance of success.

Under our collaboration, Amgen is responsible for preparing, filing, prosecuting, maintaining and defending patent applications and patents relating to the FKBP neuroimmunophilin ligand technology. We cannot be sure that Amgen will pursue these activities in the same manner or as vigorously as we would if we had that responsibility. Furthermore, Amgen has the option to take the lead in bringing actions to enforce patent rights relating to the FKBP neuroimmunophilin ligand technology and to defend against third party infringement suits regarding that technology. While Amgen and Guilford have agreed to consult with each other on such matters, in the event of disagreement, Amgen’s decisions will control.

We are dependent on licensed intellectual property.

We have licensed intellectual property, including patents, patent applications and know-how, from universities and others, including intellectual property underlying GLIADEL® Wafer, DOPASCAN® Injection and the neuroimmunophilin ligand technology. Some of our product development programs depend on our ability to maintain rights under these licenses. Under the terms of our license agreements, we are generally obligated to:

• exercise diligence in the research and development of these technologies,

• achieve specified development and regulatory milestones,

• expend minimum amounts of resources in bringing potential products to market,

• make specified royalty and milestone payments to the party from which we have licensed the technology, and

• reimburse patent costs to these parties.

In addition, these license agreements obligate us to abide by record-keeping and periodic reporting obligations. Each licensor has the power to terminate its agreement if we fail to meet our obligations under that license. We may not be able to meet our obligations under these license

agreements. Furthermore, these obligations may conflict with our obligations under other agreements that we have.

If we default under any of these license agreements, we may lose our right to market and sell any products based on the licensed technology. Losing our marketing and sales rights would have a material and adverse effect on our business, financial condition and results of operations. Our license agreements require that we pay a royalty on sales of GLIADEL® Wafer to the university that licensed us the technology underlying that product. In addition, we will have to pay milestone and/or royalty payments in connection with the successful development and commercialization of DOPASCAN® Injection and any products that result from the NIL and PARP technologies.

In the future, to support our product development efforts, we may need research materials or scientific information that researchers at universities or other organizations generate. We cannot be sure that we will be able to obtain this scientific information or research materials in a timely manner or at all.

Revenues from our products are dependent in part on reimbursement from
healthcare payors, which is uncertain.

Sales of our product candidates will depend in part on the availability of reimbursement from third-party healthcare payors, such as government insurance plans, including Medicare and Medicaid in the United States, private insurance and managed care plans. Reimbursement policies for GLIADEL® Wafer remain uncertain, both domestically and internationally. We cannot be sure that any reimbursement will be available for GLIADEL® Wafer or any of our product candidates under development. Furthermore, even if reimbursement is available, we cannot be sure that it will be available at price levels sufficient to realize an appropriate return on our investment in GLIADEL® Wafer or our other products in development.

We are dependent on one source of supply for several of our key product components.

Currently, we are able to purchase some of the key components for GLIADEL® Wafer and our product candidates only from single source suppliers. These vendors are subject to many strict regulatory requirements regarding the supply of these components. We cannot be sure that these suppliers will comply, or have complied, with applicable regulatory requirements or that they will otherwise continue to supply us with the key components we require. If suppliers are unable or refuse to supply us, or will supply us only at a prohibitive cost, we may not be able to access additional sources at acceptable prices, on a timely basis, if ever.

The current formulation of GLIADEL® Wafer utilizes the chemotherapeutic agent BCNU, which is also known as “carmustine.” Currently we have the option to procure BCNU from only two sources in the United States, and we are not aware of any supplier outside of the United States. We currently obtain BCNU from one of these two U.S. suppliers on a purchase order basis and not through any long-term supply agreement. If we fail to receive key supplies necessary for the manufacture of GLIADEL on a timely basis at a reasonable cost, delays in product shipment could result. Delays of this type would have a material adverse effect on our business.

The manufacture of DOPASCAN® Injection requires that a precursor compound be labeled with a radioactive isotope of iodine, known as Iodine-123, to form the final product. Only a limited number of companies worldwide are capable of performing the necessary “radioiodination” of the precursor and distribution of the final product. Currently, we do not have any arrangement for the manufacture and supply of DOPASCAN® Injection nor do we have the internal capability to manufacture DOPASCAN® Injection ourselves. Consequently, we will not be in a position to commence Phase III or other clinical trials for DOPASCAN® Injection until we locate a qualified supplier.

We have assessed the companies that we believe are currently capable of manufacturing a product like DOPASCAN® Injection. Based on this assessment, we believe a significant risk exists

that we may not be able to find a manufacturer who can meet the quality and cost requirements required to conduct the Phase III clinical trials that will be necessary to support application to the FDA for regulatory approval. Inability to come to agreement with a suitable manufacturer for the clinical and commercial supply of DOPASCAN® Injection on acceptable terms would prevent us from developing this product candidate further.

The U.S. Government holds rights which may permit it to license to third parties technology we currently hold the exclusive right to use.

The U.S. government holds rights that govern aspects of certain of the technologies licensed to us by third party licensors. These government rights in inventions conceived or reduced to practice under a government-funded program may include a non-exclusive, royalty-free, worldwide license for the government to practice or have practiced resulting inventions for any governmental purpose. In addition, the U.S. government has the right to grant to others licenses that may be exclusive under any of these inventions if the government determines that:

• adequate steps have not been taken to commercialize such inventions,

• the grant is necessary to meet public health or safety needs, or

• the grant is necessary to meet requirements for public use under federal regulations.

The U.S. government also has the right to take title to a subject invention if we fail to disclose the invention, and may elect to take title within specified time limits. The U.S. government may acquire title in any country in which we do not file a patent application within specified time limits.

Federal law requires any licensor of an invention partially funded by the federal government to obtain a commitment from any exclusive licensee, such as us, to manufacture products using the invention substantially in the United States. Further, these rights include the right of the government to use and disclose technical data relating to licensed technology that was developed in whole or in part at government expense. Our principal technology license agreements contain provisions recognizing these rights.

We have entered into a contract with the U.S. Army, funded by the Office of National Drug Control Policy, commonly referred to as the “Drug Czar”, to provide financial support for research being conducted by us on a potential cocaine inhibitor. That contract permits the U.S. government to obtain unlimited rights to data developed in the course of our performance if we do not use the data within five years after termination of the contract to conduct further laboratory investigation and/or clinical trials aimed at developing a commercial product to combat drug abuse.

Pre-clinical and clinical trial results for our products may not be favorable.

In order to obtain regulatory approval for the commercial sale of any of our product candidates, we must conduct both pre-clinical studies and human clinical trials. These studies and trials must demonstrate that the product is safe and effective for the clinical use for which we are seeking approval. Together with Aventis, we commenced a Phase III clinical trial for GLIADEL in December 1997 in patients undergoing initial surgery for the brain cancer malignant glioma. We cannot be sure that the results of this or other clinical trials we may conduct in the future will be successful. Adverse results from this or any future trial would have a material adverse effect on our business.

We also face the risk that we will not be permitted to undertake or continue clinical trials for any of our product candidates in the future. Even if we are able to conduct such trials, we may not be able to demonstrate satisfactorily that the products are safe and effective and thus qualify for the regulatory approvals needed to market and sell them. Results from pre-clinical studies and early clinical trials are often not accurate indicators of results of later-stage clinical trials that involve larger human populations.

We are subject to extensive governmental regulation, which may
change and harm our business.

Our research, pre-clinical development and clinical trials, and the manufacturing and marketing of our product candidates, are subject to extensive regulation by numerous governmental authorities in the United States and other countries, including the FDA and the DEA. Controlled drugs such as GLIADEL® Wafer and radiolabeled drugs such as DOPASCAN® Injection are subject to additional requirements. Except for GLIADEL® Wafer, none of our product candidates has received marketing clearance from the FDA. In addition, none of our product candidates has received clearance from any foreign regulatory authority for commercial sale, except with respect to GLIADEL® Wafer, which has received marketing clearance in a limited number of foreign countries.

As a condition to approval of our product candidates under development, the FDA could require additional pre-clinical, clinical or other studies. Any requirement that we perform additional pre-clinical, clinical or other studies, or purchase clinical or other data from other companies could delay, or increase the expense of, approval of our product candidates, which could have a material adverse effect on our business.

In order to obtain FDA approval of a new drug product for a specific clinical use, we must demonstrate to the satisfaction of the FDA that the product is safe and effective for its intended use. We must also demonstrate that the product is capable of being manufactured in accordance with applicable regulatory standards. Significant risks exist that:

• we will not be able to satisfy the FDA’s requirements with respect to any of our drug product candidates or with respect to the proposed expanded labeling for GLIADEL® Wafer for patients undergoing initial surgery for malignant glioma, or

• even if the FDA does approve our product candidates or expanded labeling, the FDA will approve less than the full scope of uses or labeling that we seek.

Failure to obtain regulatory drug approvals on a timely basis could have a material adverse effect on our business.

Even if we are able to obtain necessary FDA approval, the FDA may nevertheless require post-marketing testing and surveillance to monitor the approved product and continued compliance with regulatory requirements. The FDA may withdraw product approvals if we or our corporate partners, such as Aventis in the case of GLIADEL® Wafer, do not maintain compliance with regulatory requirements. The FDA may also withdraw product approvals if problems concerning safety or efficacy of the product occur following approval.

The process of obtaining FDA and other required approvals or licenses and of meeting other regulatory requirements to test and market drugs, including controlled substances and radiolabeled drugs, is rigorous and lengthy. It has required, and will continue to require, that we expend substantial resources. We will need to conduct clinical trials and other studies on all of our product candidates before we are in a position to file a new drug application for marketing and sales approval. Unsatisfactory clinical trial results and other delays in obtaining regulatory approvals or licenses would prevent the marketing of the products we are developing. Until we receive the necessary approvals or licenses and meet other regulatory requirements, we will not receive revenues or royalties related to product sales.

In addition to the requirements for product approval, before a pharmaceutical product may be marketed and sold in some foreign countries, the proposed pricing for the product must be approved as well. Products may be subject to price controls or limits on reimbursement. The requirements governing product pricing and reimbursement vary widely from country to country and can be implemented disparately at the national level. We cannot guarantee that any country which has price controls or reimbursement limitations for pharmaceuticals will allow favorable reimbursement and pricing arrangements for our products or those of our corporate partners, including Aventis and its applications for GLIADEL® Wafer outside the United States.

Where applicable, we hope to capitalize on current FDA regulations and the new provisions of the FDA Modernization Act of 1997. These regulations or provisions permit “fast track”, expedited or accelerated approval or more limited “treatment use” of, and cost recovery for, certain experimental drugs under limited circumstances. The fast track and treatment provisions, and FDA’s accelerated, expedited and treatment regulations apply generally only to:

• drug products intended to treat severely debilitating or serious or life-threatening diseases, and

• drug products that provide meaningful therapeutic benefit to patients over existing treatments, that potentially address an unmet medical need, or that are for diseases for which no satisfactory or comparable therapy exists.

The FDA Modernization Act contains provisions patterned after the accelerated approval regulations and other provisions pertaining to expanded access, i.e., treatment uses. Since some of the new statutory provisions and current FDA regulations are different from one another, it is unclear how they will apply, if at all, to our drug candidates. We cannot be sure that our drug candidates will qualify for fast track, accelerated or expedited approvals or for treatment use and cost recovery.

Because controlled drug products and radiolabeled drugs are subject to special regulations in addition to those applicable to other drugs, some of our products and product candidates, including DOPASCAN® Injection, are or may be subject to regulation by the DEA as controlled substances and by the Nuclear Regulatory Commission as radiolabeled drugs. The NRC licenses persons who use nuclear materials and establishes standards for radiological health and safety. The DEA is responsible for the control of manufacture, distribution and dispensing of controlled substances, including the equipment and raw materials used in their manufacture and packaging in order to prevent such articles from being diverted into illicit channels of commerce. Registration is required and other activities involving controlled substances are subject to a variety of record keeping and security requirements, and to permits and authorizations and other requirements. States often have requirements for controlled substances, as well. Certain exceptions are granted by the DEA from requirements for permits and authorizations to export or import materials related to or involving controlled substances. If we are unable to continue to obtain exceptions from the DEA for shipment abroad or other activities, as we have in the past, this situation could have a material adverse effect on us.

We have obtained registrations for our facilities from the DEA. We have also obtained exceptions from the DEA with respect to various of our activities involving DOPASCAN® Injection, including the shipment of specified quantities of a precursor of this product candidate to an overseas collaborative partner. However, we cannot be sure that these exceptions will be sufficient to cover our future activities or that the DEA will not revoke the exceptions. We also cannot be sure that we will be able to meet the other requirements to test, manufacture and market controlled substances or radiolabeled drugs, or that we will be able to obtain additional necessary approvals, permits, authorizations, registrations or licenses to meet state, federal and international regulatory requirements to manufacture and distribute these products. The FDA Modernization Act required the FDA to issue and finalize within one and one-half years regulations governing the approval of radiolabeled drugs. Final regulations were issued in May 1999. These cover general factors relevant to safety and effectiveness, possible indications for radiopharmaceuticals, and the evaluation criteria for safety and effectiveness. We do not know and cannot predict how these and other provisions may affect the potential for approval of DOPASCAN® Injection.

Our products use novel alternative technologies and therapeutic
approaches which have not been widely studied.

Many of our product development efforts focus on novel alternative therapeutic approaches and new technologies that have not been widely studied. Applications for these approaches and technologies include, among other things, the treatment of brain cancer, the diagnosis and monitoring of Parkinson’s disease, the promotion of nerve growth and the prevention of neuronal damage. These

approaches and technologies may not be successful. We are applying these approaches and technologies in our attempt to discover new treatments for conditions that are also the subject of research and development efforts of many other companies. Our competitors may succeed in developing technologies or products that are more effective or economical than those we are developing. Rapid technological change or developments by others may result in our technology or product candidates becoming obsolete or noncompetitive.

Our business is dependent on our ability to keep pace with the
latest technological changes.

The technological areas in which we work continue to evolve at a rapid pace. Our future success depends upon maintaining our ability to compete in the research, development and commercialization of products and technologies in our areas of focus. Competition from pharmaceutical, chemical and biotechnology companies, universities and research institutions is intense and expected to increase. Many of these competitors have substantially greater research and development capabilities and experience and manufacturing, marketing, financial and managerial resources than we do, and represent significant competition for us.

Acquisitions of competing companies by large pharmaceutical companies or other companies could enhance the financial, marketing and other resources available to these competitors. These competitors may develop products that are superior to those we are developing. We are aware of the development by other companies and research scientists of alternative approaches to:

• the treatment of malignant glioma,

• the diagnosis of Parkinson’s disease,

• the promotion of nerve growth and repair,

• the treatment and prevention of neuronal damage, and

• the treatment of cocaine addiction.

Our competitors may develop products that render our products or technologies noncompetitive or obsolete. In addition, we may not be able to keep pace with technological developments.

Our products must compete with others to gain market acceptance.

Any product candidate that we develop and for which we gain regulatory approval, including GLIADEL® Wafer, must then compete for market acceptance and market share. An important factor will be the timing of market introduction of competitive products. Accordingly, we expect that the relative speed with which we and competing companies can develop products, complete the clinical testing and approval processes, and supply commercial quantities of the products to the market will be an important element of market success.

Significant competitive factors include:

• capabilities of our collaborators,

• product efficacy and safety,

• timing and scope of regulatory approval,

• product availability,

• marketing and sale capabilities,

• reimbursement coverage from insurance companies and others,

• the amount of clinical benefit of our product candidates relative to their cost,

• the method of administering a product,

• price, and

• patent protection.

Our competitors may develop more effective or more affordable products or achieve earlier product development completion, patent protection, regulatory approval or product commercialization than we do. Our competitors’ achievement of any of these goals could have a material adverse effect on our business.

We have limited clinical and regulatory compliance capabilities.

We have limited resources in the areas of product testing and regulatory compliance. Consequently, in order to carry our products through the necessary regulatory approvals and prepare our product candidates for commercialization and marketing, we will have to:

• expend capital to acquire and expand such capabilities,

• reach collaborative arrangements with third parties to provide these capabilities, or

• contract with third parties to provide these capabilities.

We are subject to risks of product liability.

We may potentially become subject to large liability claims and significant defense costs as a result of the design, manufacture or marketing of our products, including GLIADEL® Wafer, or the conduct of clinical trials involving these products. A product liability-related claim or recall could have a material adverse effect on us. We currently maintain only $15 million of product liability insurance covering clinical trials and product sales. We cannot be sure that this existing coverage or any future insurance coverage we obtain will be adequate. Furthermore, we cannot be sure that our insurance will cover any claims made against us.

Product liability insurance varies in cost. It can be difficult to obtain, and we may not be able to purchase it in the future on terms acceptable to us, or at all. We also may not be able to otherwise protect against potential product liability claims. If this occurs, it could prevent or inhibit the clinical development and/or commercialization of any products we are developing.

We are dependent on qualified personnel and consultants.

We depend heavily on the principal members of our management and scientific staff, including Craig R. Smith, M.D., our Chief Executive Officer, and Solomon H. Snyder, M.D., who is a member of our Board of Directors and a consultant to our company. Both Dr. Smith and Dr. Snyder have extensive experience in the biotechnology industry and provide us with unique access to their contacts in the scientific community. The loss of the services of either of these individuals or other members of our senior management team could have a material adverse effect on our business.

We have entered into a consulting agreement with Dr. Snyder and an employment agreement with Dr. Smith, each of which provides protection for our proprietary rights. Nevertheless, either Dr. Snyder or Dr. Smith may terminate his relationship with us at any time. Accordingly, we cannot be sure that either of these individuals or any of our other employees or consultants will remain with us. In the future they may take jobs or consulting positions with our competitors. These employees or consultants may also choose to organize competing companies or ventures.

Our planned activities will require individuals with expertise in many areas including:

• medicinal chemistry and other research specialties,

• pre-clinical testing,

• clinical trial management,

• regulatory affairs,

• manufacturing, and

• business development.

These planned activities will require additional personnel, including management personnel, and will also require existing management personnel to develop added expertise. Recruiting and retaining qualified personnel, collaborators, advisors and consultants will be critical to our activities. We cannot be sure that we will be able to attract and retain the personnel necessary for the development of our business. Furthermore, many pharmaceutical, biotechnology and health care companies and academic and other research institutions compete intensely for experienced scientists. If we are not able to hire the necessary experienced scientists or develop the necessary expertise, this inability could have a material adverse effect on us. In addition, we also depend on the support of our collaborators at research institutions and our consultants.

We currently lack sales and marketing experience.

We currently do not have a sales force, and we have no experience in marketing or selling a product in a commercial setting. If we decide to establish an in-house sales force, our efforts may not be successful in this regard. In addition, if we succeed in bringing additional products to market, our sales force will have to compete with many other companies that currently have extensive and well-funded marketing and sales operations. We cannot be sure that our marketing and sales efforts would compete successfully against these other companies.

Our business involves using hazardous and radioactive materials and animal
testing, all of which may result in environmental liability.

Our research and development processes involve the controlled use of hazardous and radioactive materials. We and our collaborative partners are subject to international, federal, state and local laws and regulations governing the use, manufacture, storage, handling and disposal of hazardous and radioactive materials. We believe that the safety procedures relating to our in-house research and development and manufacturing efforts comply in all material respects with the standards prescribed by such laws and regulations. However, we cannot completely eliminate the risk of accidental contamination or injury from these materials. Moreover, we cannot be sure that our collaborative partners are currently complying with the governing standards. We also cannot be sure that we and our collaborative partners will be in compliance with such standards in the future. If a regulatory authority determines that we or our collaborative partners are not complying with the governing laws and regulations, that determination could have a material adverse effect on our business, operations or finances. In addition, we and/or our collaborative partners could be held liable for damages, fines or other liabilities, which could exceed our resources.

We believe that we are and will continue to be in compliance in all material respects with applicable environmental laws and regulations and currently do not expect to make material capital expenditures for environmental control facilities in the near term. However, we may have to incur significant costs to comply with environmental laws and regulations in the future. In addition, future environmental laws or regulations may have a material adverse effect on our operations, business or assets.

Many of the research and development efforts we sponsor involve the use of laboratory animals. Changes in laws, regulations or accepted clinical procedures may adversely affect these research and development efforts. Social pressures that would restrict the use of animals in testing or actions against us or our collaborators by groups or individuals opposed to testing using animals could also adversely affect these research and development efforts.

Effecting a change of control of Guilford would be difficult, which may
discourage offers for shares of our common stock.

Our certificate of incorporation and the Delaware General Corporation Law contain provisions that may delay or prevent an attempt by a third party to acquire control of us. These provisions include the requirements of Section 203 of the Delaware General Corporation Law. In general, Section 203 prohibits designated types of business combinations, including mergers, for a period of three years between us and any third party who owns 15% or more of our common stock. This provision does not apply if:

• our Board of Directors approves of the transaction before the third party acquires 15% of our stock,

• the third party acquires at least 85% of our stock at the time its ownership goes past the 15% level, or

• our Board of Directors and two-thirds of the shares of our common stock not held by the third party vote in favor of the transaction.

We have also adopted a stockholder rights plan intended to deter hostile or coercive attempts to acquire us. Under the plan, if any person or group acquires more than 20% of our common stock without approval of the Board of Directors under specified circumstances, our other stockholders have the right to purchase shares of our common stock, or shares of the acquiring company, at a substantial discount to the public market price. The plan thus makes an acquisition much more costly to a potential acquirer.

Our certificate of incorporation also authorizes us 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. We do not have to obtain stockholder approval to issue preferred stock in this manner. Issuance of these shares of preferred stock could have the effect of making it more difficult for a person or group to acquire control of us. No shares of our preferred stock are currently outstanding. While our Board of Directors has no current intentions or plans to issue any preferred stock, issuance of these shares could also be used as an anti-takeover device.

PART II

Item 5. Market for Registrant’s Common Equity and Related Stockholder Matters

We include the information set forth under the caption “Stock Description and Form 10-K” on the inside back cover of Guilford’s 1999 Annual Report to Stockholders which is included as Exhibit 13.01 to this annual report, and we incorporate by reference that portion into Part II of this report.

We have never declared or paid any cash dividends and do not intend to do so for the foreseeable future. Under our various loan and lease agreements with certain financial institutions, we may not declare, during the term of these agreements, any cash dividends on our common stock without the prior written consent of these financial institutions and, in certain cases, the Maryland Industrial Development Financing Authority.

Item 6. Selected Consolidated Financial Data

We incorporate by reference herein the information set forth under the caption “Selected Financial Data” in the 1999 Annual Report to Stockholders. We have filed this information as Exhibit 13.01 to this annual report. You should read this information in conjunction with the Consolidated Financial Statements of the Company and notes thereto.

Item 7. Management’s Discussion and Analysis of Results of
Operations and Financial Condition

We incorporate by reference herein the information set forth under the caption “Management’s Discussion and Analysis of Results of Operations and Financial Condition” in the 1999 Annual Report to Stockholders. We have filed this information as Exhibit 13.01 to this annual report.

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

We have exposure to changing interest rates. Our investment portfolio includes investment grade debt instruments. These instruments are subject to interest rate risk and are volatile to interest rate fluctuations. Due to the short duration and conservative nature of these instruments, we do not believe that we have a material exposure to interest rate risk related to our investment portfolio.

Substantially all of our financial obligations have variable rates of interest. By entering into certain interest rate swap agreements with a commercial bank (“counter party”), we have effectively fixed the interest rates for these floating rate financial obligations. In the event of non-performance by the counter party, we could be exposed to market risk related to interest rates. We describe our exposure to interest rate risk in Notes 4 and 7, “Interest Rate Swap Agreements” and “Indebtedness,” respectively, to the footnotes to our Consolidated Financial Statements. We have filed this information as Exhibit 13.01 to this annual report.

Item 8. Financial Statements and Supplementary Data

We incorporate by reference herein the consolidated financial statements and notes thereto and independent auditors’ report thereon which are included in the 1999 Annual Report to Stockholders required by this Item 8. We have filed this information as Exhibit 13.01 to this annual report.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Not Applicable.

Item 10. Directors and Executive Officers of the Registrant

The information concerning our executive officers is contained in Item 1A of Part I. The information concerning the Company’s directors and with regard to Item 405 of Regulation S-K is hereby incorporated by reference from the information to be contained under the caption “Board of Directors” and “Section 16(a) Beneficial Ownership Reporting Compliance” in our 2000 Proxy Statement, which we will file no later than 120 days following December 31, 1999.

PART III

Item 11. Executive Compensation

The information required by this item is hereby incorporated by reference from the information to be contained under the caption “Executive Compensation” in our 2000 Proxy Statement, which we will file no later than 120 days following December 31, 1999.

Item 12. Security Ownership of Certain Beneficial Owners and Management

The information required by this item is hereby incorporated by reference from the information to be contained under the caption “Beneficial Ownership of Common Stock” in our 2000 Proxy Statement, which we will file no later than 120 days following December 31, 1999.

Item 13. Certain Relationships and Related Transactions

The information required by this item is hereby incorporated by reference from the information to be contained under the caption “Beneficial Ownership of Common Stock” and “Certain Relationships and Related Party Transactions” in our 2000 Proxy Statement, which we will file no later than 120 days following December 31, 1999.

PART IV

Item 14. Exhibits, Financial Statement Schedules, and Reports on Form 8-K

(a)(1) Financial Statements

The following Consolidated Financial Statements of Guilford and Independent Auditors’ Report beginning on page 41 in Guilford’s 1999 Annual Report to Stockholders are included in Exhibit 13.01 to this report and are incorporated into Item 8 of this report:

Independent Auditors’ Report

Consolidated Balance Sheets as of December 31, 1999 and 1998

Consolidated Statements of Operations for the Years Ended December 31, 1999, 1998 and 1997

Consolidated Statements of Changes in Stockholders’ Equity for the Years Ended December 31, 1999, 1998 and 1997

Consolidated Statements of Cash Flows for the Years Ended December 31, 1999, 1998 and 1997

Notes to Consolidated Financial Statements

(a)(2) Financial Statement Schedules

Independent Auditors’ Report

Schedule II — Valuation and Qualifying Accounts

Independent Auditors’ Report

The Board of Directors and Stockholders
Guilford Pharmaceuticals Inc.:

Under date of February 11, 2000, we reported on the consolidated balance sheets of Guilford Pharmaceuticals Inc. and subsidiaries as of December 31, 1999 and 1998, and the related consolidated statements of operations, changes in stockholders’ equity, and cash flows for each of the years in the three-year period ended December 31, 1999, which are included in the Form 10-K. In connection with our audits of the aforementioned consolidated financial statements, we also audited the related consolidated financial statement schedule as listed in the accompanying index. This financial statement schedule is the responsibility of the Company’s management. Our responsibility is to express an opinion on this financial statement schedule based on our audits.

In our opinion, such financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents fairly, in all material respects, the information set forth therein.

/s/ KPMG LLP

Philadelphia, Pennsylvania
February 11, 2000

GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES

VALUATION AND QUALIFYING ACCOUNTS AND RESERVES

SCHEDULE II

(in thousands)


	Balance		Charged to				Balance
Classification	@ 12/31/96		Costs and Expenses		Deductions		@ 12/31/97

Inventory Reserve	$	—	$	257	$	—	$	257


	Balance		Charged to				Balance
Classification	@ 12/31/97		Costs and Expenses		Deductions		@ 12/31/98

Inventory Reserve	$	257	$	—	$	—	$	257


	Balance		Charged to				Balance
Classification	@ 12/31/98		Costs and Expenses		Deductions		@ 12/31/99

Inventory Reserve	$	257	$	—	$	—	$	257

All other schedules are omitted because they are not applicable or the required information is included in the Consolidated Financial Statements or notes thereto.

(a)(3) Exhibits

The following exhibits are filed with this Form 10-K or incorporated herein by reference to the document set forth next to the exhibit listed below:


Exhibit
Number*		Description

	3.01A	Amended and Restated Certificate of Incorporation of the Company.
	3.01B	Certificate of Amendment to Amended and Restated Certificate of Incorporation.
	3.02A	Amended and Restated By-laws of the Company.
	3.02B	Amendments to Amended and Restated By-laws of the Company (incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 1998 and the Registrant’s Annual Report on Form 10-K for the year ended December 31, 1998).
	4.01	Specimen Stock Certificate.
	4.02A	Stockholder Rights Agreement dated September 26, 1995.
	4.02B	Form of Amendment No. 1 to Stockholder Rights Agreement (incorporated by reference to Form 8-K, filed October 20, 1998).
	10.01A	1993 Employee Share Option and Restricted Share Plan (“1993 Option Plan”).
	10.01B	Amendments to 1993 Option Plan.
	10.01C	1998 Employee Share Option and Restricted Share Plan as amended (“1998 Option Plan”) (incorporated by reference to Form S-8, filed on February 22, 2000).
	10.01D	Amendment to 1998 Option Plan (incorporated by reference to Form 10-K filed on March 30, 1999).
	10.02A	Series A Preferred Stock Purchase Agreement, dated September 30, 1993, as amended between the Company and holders of its Series A Preferred Stock (“Series A Agreement”).
	10.02B	Amendment, dated August 25, 1994, to Series A Agreement.
	10.02C	Amendment, dated February 15, 1995, to Series A Agreement.
	10.03A†	License Agreement, effective March 18, 1994, between the Company and Research Triangle Institute, a not-for-profit Corporation existing under the laws of North Carolina.
	10.03B	Appendix A to Exhibit 10.04.
	10.04†	License Agreement, dated March 15, 1994, between the Company and Scios Nova.
	10.05	Employment Agreement between the Company and Craig R. Smith, M.D.
	10.06	Employment Agreement between the Company and Andrew R. Jordan.
	10.07	Employment Agreement between the Company and John P. Brennan.
	10.08	(Intentionally Omitted)
	10.09	Employment Agreement between the Company and William C. Vincek, Ph.D.
	10.10	Employment Agreement between the Company and Peter D. Suzdak.
	10.11	Employment Agreement between the Company and Nicholas Landekic.
	10.12	Employment Agreement between the Company and Thomas C. Seoh.
	10.13A	Amendments to certain executive officer employment letter Agreements.
	10.13B	Form of Change in Control Severance Agreement (incorporated be reference to the Form 10-Q for the quarter ended September 30, 1998).
	10.13C	Severance Provisions from Employment Letter Agreement, effective September 21, 1998, with Nancy J. Linck (incorporated be reference to the Form 10-Q for the quarter ended September 30, 1998).
	10.14	(Intentionally Omitted)
	10.15A	Consulting Agreement, dated August 1, 1993, as amended on February 28, 1994, between the Company and Solomon H. Snyder, M.D (the “Snyder Consulting Agreement”).
	10.15B	September 1, 1995 amendment to Snyder Consulting Agreement.


Exhibit
Number*		Description

	10.15C	November 19, 1997 amendment to Snyder Consulting Agreement.
	10.15D	September 1, 1998 and January 1, 1999 amendments to Snyder Consulting Agreement (incorporated by reference to Form 10-K filed March 30, 1999).
	10.16A†	License Agreement, dated December 20, 1993, between the Company and The Johns Hopkins University (“JHU Agreement”).
	10.16B	Appendix B to JHU Agreement.
	10.16C†	Amended and Restated License Agreement, effective November 25, 1998, between the Company and Johns Hopkins (incorporated by reference to Form 10-K filed March 30, 1999).
	10.17	Form of Director and Officer Indemnification Agreement.
	10.18	Form of Tax Indemnity Agreement.
	10.19A	Guilford Pharmaceuticals Inc. Directors’ Stock Option Plan.
	10.19B	Amendments to Directors’ Stock Option Plan (incorporated by reference to Form 10-K filed on March 30, 1999).
	10.19C	Amendment to Form of Directors’ Stock Option Agreement (incorporated by reference to Form 10-K filed March 30, 1999).
	10.20	Lease Agreement, dated August 30, 1994, between Crown Royal, L.P. and the Company.
	10.21A	Lease Agreement, dated June 9, 1997 between SN Properties, Inc. and the Company (“Freeport Lease”).
	10.21B	Amendment, dated February 10, 1998, to Freeport Lease.
	10.22(1)	Employment Letter Agreement, effective March 8, 1998, between the Company and Gregory M. Hockel, Ph.D.
	10.23(1)	Employment Letter Agreement, effective January 27, 1998, between the Company and Dana C. Hilt, M.D.
	10.24	Exchange and Registration Rights Agreement, dated February 17, 1995, among the Company and the Abell Foundation, Inc., and the several holders named in Appendix I.
	10.25A	Loan and Financing Agreement between the Maryland Economic Development Corporation (“MEDCO”), the Company and Signet Bank/ Maryland (“Signet”) (“L&F Agreement”).
	10.25B	Amendment No. 1, dated June 30, 1998, to L&F Agreement (incorporated be reference to the Form 10-Q for the quarter ended June 30, 1998).
	10.26	Leasehold Deed of Trust by and between the Company and Janice E. Godwin and Ross Chaffin (as trustees) for the benefit of MEDCO and Signet.
	10.27A	Insurance Agreement between the Maryland Industrial Development Financing Authority and Signet (“Insurance Agreement”).
	10.27B	Letter, dated April 2, 1996, amending Insurance Agreement.
	10.27C	Amendment No. 2, dated June 29, 1998, to Insurance Agreement (incorporated by reference to the Form 10-Q for the quarter ended June 30, 1998).
	10.28†	License Agreement, dated December 9, 1995, by and between the Company and Daiichi Radioisotope Laboratories, Ltd.
	10.29†	License and Distribution Agreement, dated October 13, 1995, by and between the Company and Orion Corporation Farmos.
	10.30	Employment Letter Agreement, effective June 10, 1998, between the Company and David H. Bergstrom, Ph.D.
	10.31	Master Lease Agreement, dated March 19, 1998, by and between Comdisco Laboratory and Scientific Group, a Division of Comdisco Healthcare Group, Inc., and the Company (incorporated by reference to Form 10-Q for the quarter ended March 31, 1998).


Exhibit
Number*		Description

	10.32†	Bulk Pharmaceutical Sales Contract, dated September 23, 1994, between the Company and Aerojet-General Corporation.
	10.33	Equipment Lease, dated September 18, 1996, between the Company and General Electric Capital Corporation.
	10.34	Term Loan, dated April 30, 1996, as amended on December 6, 1996, by and between the Company and Signet Bank.
	10.35A	Marketing, Sales and Distribution Rights Agreement between Aventis S.A (formerly known as Rhône-Poulenc Rorer Pharmaceuticals Inc.) (“Aventis”), the Company and GPI Holdings, Inc., dated June 13, 1996 (“MSDA”).
	10.35B†	Amendment No. 1 to MDSA, dated September 25, 1998 (incorporated by reference to Form 8-K, filed October 2, 1998).
	10.36	Manufacturing and Supply Agreement between Aventis and the Company, dated June 13, 1996.
	10.37A	Stock Purchase Agreement between the Company and Aventis, dated June 13, 1996 (“Aventis Stock Purchase Agreement”).
	10.37B	Amendment No. 1 to Aventis Stock Purchase Agreement, dated September 25, 1998 (incorporated by reference to Form 8-K, filed October 2, 1998).
	10.38	Loan Agreement between the Company and Aventis Inc., dated June 13, 1996.
	10.39	(Intentionally Omitted)
	10.40†	Collaboration and License Agreement, dated December 15, 1997 and effective as of August 20, 1997, between Amgen Inc. (“Amgen”), GPI NIL Holdings, Inc. and the Company.
	10.41	Stock and Warrant Purchase Agreement, dated October 1, 1997, between Amgen and the Company.
	10.42	Registration Rights Agreement, dated October 1, 1997, between Amgen and the Company.
	10.43	Warrant, dated October 1, 1997 issued to Amgen.
	10.44	Security Agreement, dated as of February 5, 1998, between First Security Bank, National Association (“First Security”), not individually, but solely as the Owner Trustee under the Guilford Real Estate Trust 1998-1 (the “Trust”) and First Union.
	10.45	Amended and Restated Trust Agreement, dated as of February 5, 1998 between the Several Holders from time to time parties thereto and the Trust.
	10.46	Agency Agreement, dated as of February 5, 1998, between the Company and the Trust.
	10.47	Credit Agreement, dated as of February 5, 1998, among the Trust, the Several Holders from time to time parties thereto and First Union.
	10.48	Participation Agreement, dated as of February 5, 1998, among the Company, the Trust, the various and other lending institutions which are parties hereto from time to time, as Holders, the various and other lending institutions which are parties hereto from time to time, as Lenders, and First Union.
	10.49	Lease Agreement, dated as of February 5, 1998, between the Trust and the Company.
	10.50	MIDFA Agreement, dated June 29, 1998, by and between MIDFA, First Security, the Company and First Union (incorporated by reference to Form 10-Q for the quarter ended June 30, 1998).
	10.51	Insurance Agreement, dated June 29, 1998, by and between MIDFA and First Union (incorporated by reference to Form 10-Q for the quarter ended June 30, 1998).
	10.52	April 1, 1999 amendment to Consulting Agreement, dated August 1, 1993, as amended, between the Company and Solomon H. Snyder, M.D. (incorporated by reference to Form 10-Q for the quarter ended March 31, 1999).


Exhibit
Number*		Description

	10.53	Amendment to Directors’ Stock Option Plan (incorporated by reference to Form 10-Q for the quarter ended March 31, 1999).
	10.54	Amendment to Form of Stock Option Agreement under the Company’s 1993 and 1998 Employee Share Option and Restricted Share Plans (incorporated by reference to Form 10-Q for the quarter ended March 31, 1999).
	10.55	Amendment to Form of Directors’ Stock Option Agreement, effective May 18, 1999 (incorporated by reference to Form 10-Q for the quarter ended June 30, 1999).
	10.56	July 1, 1999 amendment to Consulting Agreement, dated August 1, 1993 between the Company and Solomon H. Snyder, M.D. (incorporated by reference to Form 10-Q for the quarter ended June 30, 1999).
	10.57	Consulting Agreement, dated July 23, 1999, between the Company and Solomon H. Snyder, M.D. (incorporated by reference to Form 10-Q for the quarter ended June 30, 1999).
	10.58	Form of Severance Agreement (incorporated by reference to Form 10-Q for the quarter ended September 30, 1999).
	10.59	Form of Change in Control Severance Agreement (incorporated by reference to Form 10-Q for the quarter ended September 30, 1999).
	11.01	Statement re: Computation of Per Share Earnings (See Notes to Consolidated Financial Statements).
	13.01	Portions of the Company’s 1999 Annual Report to Stockholders (filed herewith).
	21.01	Subsidiaries of Registrant (filed herewith).
	23.01	Consent of KPMG LLP (filed herewith).
	24.01	Power of Attorney (contained in signature page).
	27.01	Financial Data Schedule (filed herewith).


*	Unless otherwise noted above, all exhibits referenced above are incorporated by reference to Guilford’s Annual Report on Form 10-K for the year ended December 31, 1997.

† Confidential treatment of certain portions of these agreements has been granted by the Securities and Exchange Commission.

(b) Reports on 8-K:

None.

Signatures and Power of Attorney

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

March 30, 2000

GUILFORD PHARMACEUTICALS INC.

By: /s/ CRAIG R. SMITH, M.D.

Craig R. Smith, M.D.

President and Chief Executive Officer

KNOW ALL PERSONS BY THESE PRESENT, that each person whose signature appears below constitutes and appoints, Craig R. Smith, M.D., Andrew R. Jordan, Thomas C. Seoh, Stephen H. McElhennon and Michael J. Silver, and each of them, his or her true and lawful attorney-in-fact and agents, with full power of substitution and resubstitution, from such person and in each person’s name, place and stead, in any and all capacities, to sign the report and any and all amendments to this report, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, full power and authority to do and perform each and every act and thing requisite and necessary to be done as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, and any of them, may lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed by the following persons in the capacities and on the date indicated.


Signature	Title	Date

/s/ CRAIG R. SMITH, M.D. Craig R. Smith, M.D.	Chief Executive Officer, President and Director (Principal Executive Officer)	March 30, 2000
/s/ ANDREW R. JORDAN Andrew R. Jordan	Sr. Vice President, Chief Financial Officer, and Treasurer (Principal Financial Officer and Principal Accounting Officer)	March 30, 2000
/s/ SOLOMON H. SNYDER, M.D. Solomon H. Snyder, M.D.	Director	March 30, 2000
/s/ RICHARD L. CASEY Richard L. Casey	Director	March 30, 2000
/s/ GEORGE L. BUNTING, JR. George L. Bunting, Jr.	Director	March 30, 2000
/s/ W. LEIGH THOMPSON, M.D., PH.D. W. Leigh Thompson, M.D., Ph.D.	Director	March 30, 2000
/s/ ELIZABETH M. GREETHAM Elizabeth M. Greetham	Director	March 30, 2000
/s/ JOSEPH KLEIN, III Joseph Klein, III	Director	March 30, 2000

52 EX-13.01 2 1999 ANNUAL REPORT 1 Exhibit 13.01 SELECTED FINANCIAL DATA The following selected consolidated financial data of our company for each of the years in the five-year period ended December 31, 1999 have been derived from our Consolidated Financial Statements, which have been audited by KPMG LLP, our independent auditors. Our Consolidated Financial Statements as of December 31, 1999 and 1998, and for each of the years in the three-year period ended December 31, 1999, including the footnotes to these financial statements, are included elsewhere in this annual report, beginning on page 42. The information set forth below should be read in conjunction with our Consolidated Financial Statements and the related footnotes, as well as "Management's Discussion and Analysis of Financial Condition and Results of Operations," beginning on page 34 of this annual report.
YEARS ENDED DECEMBER 31 ------------------------------------------------------------- 1995 1996 1997 1998 1999 -------- -------- --------- --------- --------- (in thousands, except per share data) STATEMENT OF OPERATIONS DATA: Total revenues $ 586 $28,020 $ 23,828 $ 12,483 $ 21,561 Costs and expenses: Cost of sales -- -- 2,585 2,036 2,308 Research and development 9,688 18,761 30,293 37,722 41,922 General and administrative 4,367 6,736 9,076 10,546 11,281 -------- ------- -------- -------- -------- Total costs and expenses 14,055 25,497 41,954 50,304 55,511 -------- ------- -------- -------- -------- Operating income (loss) (13,469) 2,523 (18,126) (37,821) (33,950) Other income, net 832 2,550 6,689 8,123 7,082 -------- ------- -------- -------- -------- Net income (loss) $(12,637) $ 5,073 $(11,437) $(29,698) $(26,868) ======== ======= ======== ======== ======== Basic earnings (loss) per common share(1) $ (1.72) $ 0.39 $ (0.65) $ (1.52) $ (1.31) Average common shares outstanding(1) 7,354 13,001 17,570 19,479 20,475 Diluted earnings (loss) per common share(1) $ (1.72) $ 0.35 $ (0.65) $ (1.52) $ (1.31) Average common and dilutive equivalent shares outstanding(1) 7,354 14,634 17,570 19,479 20,475

DECEMBER 31 ------------------------------------------------------------- 1995 1996 1997 1998 1999 ------- ------- -------- -------- -------- (in thousands) BALANCE SHEET DATA: Cash, cash equivalents and investments(2) $19,454 $77,439 $160,219 $128,261 $144,718 Total assets(2) 26,048 93,659 180,081 150,959 164,242 Long-term debt 4,696 10,905 10,926 8,766 7,152 Total stockholders' equity 17,773 75,877 158,294 130,379 144,980
- ---------- (1) For information concerning the calculation of earnings (loss) per share, see Note 16, "Earnings (loss) per share," to the footnotes to our Consolidated Financial Statements on page 53. (2) Includes restricted investments of $3.6 million, $10.1 million, $12.1 million, $16.5 million and $21.4 million at December 31, 1995, 1996, 1997, 1998 and 1999, respectively. See Notes 7 and 8, "Indebtedness" and "Leases," to the footnotes to our Consolidated Financial Statements on page 49. 2 MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION CAUTIONARY NOTE From time to time in this annual report we may make statements that reflect our current expectations regarding our future results of operations, economic performance, and financial condition, as well as other matters that may affect our business. In general, we try to identify these forward-looking statements by using words such as: - "anticipate," - "believe," - "expect," - "estimate," and similar expressions. While these statements reflect our current plans and expectations, and we base the statements on information currently available to us, we cannot be sure that we will be able to implement these plans successfully. We may not realize our expectations in whole or in part in the future. The forward-looking statements contained in this annual report may cover, but are not necessarily limited to, the following topics: - our efforts in conjunction with Aventis S.A. (successor by merger between Rhone-Poulenc Rorer Pharmaceuticals Inc. and Hoechst AG in December 1999) ("Aventis") to obtain additional international regulatory clearances to market and sell GLIADEL(R) Wafer and to increase end-user sales of GLIADEL(R) Wafer; - our efforts in conjunction with Aventis to expand the labeled uses for GLIADEL(R) Wafer; - our efforts to develop polymer drug delivery product line extensions and new polymer drug delivery products; - conducting and completing research programs related to our FKBP neuroimmunophilin ligand technology partnered with Amgen Inc. ("Amgen"), as well as our NAALADase inhibition, PARP inhibition, polymer drug delivery and other technologies; - clinical development activities, including commencing and conducting clinical trials, related to our polymer-based drug delivery products and product candidates (including GLIADEL(R) Wafer and PACLIMER(TM) Microspheres) and our pharmaceutical product candidates (including lead compounds in our 3 FKBP neuroimmunophilin ligand program and any future lead compounds in our NAALADase and PARP programs); - our efforts to scale-up product candidates from laboratory bench quantities to commercial quantities; - our efforts to secure adequate supply of the active pharmaceutical ingredients for the clinical development and commercialization of our polymer-based and other drug candidates; - our efforts to manufacture drug candidates for clinical development and eventual commercial supply; - our strategic plans; and - anticipated expenditures and the potential need for additional funds. All of these items involve significant risks and uncertainties. Any of the statements we make in this annual report that are forward-looking are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. We wish to caution you that our actual results may differ significantly from the results we discuss in the forward-looking statements. We discuss factors that could cause or contribute to such differences elsewhere in this annual report, as well as in our filings with the Securities and Exchange Commission ("SEC"). Our SEC filings include the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 1999. For convenience we refer to this document as the "1999 Form 10-K" in the discussion set forth below. In addition, any forward-looking statements we make in this document speak only as of the date of this document, and we do not intend to update any such forward-looking statements to reflect events or circumstances that occur after that date. INTRODUCTION In the following sections of this Management's Discussion and Analysis of Financial Condition and Results of Operations ("Management's Discussion and Analysis"), we explain the general financial condition and the results of operations for Guilford and its subsidiaries, including: - what factors affect our business; - what our losses and costs were in 1999, 1998, and 1997; - for 1999 and 1998, why losses and costs changed from the year before; 4 - where our revenues came from; - how all of the foregoing affect our overall financial condition; and - what our expenditures for capital projects were in 1999, 1998 and 1997 and a description of our capital requirements. As you read this Management's Discussion and Analysis, you may find it helpful to refer to our Consolidated Financial Statements beginning on page 42 of this annual report. These Consolidated Financial Statements present the results of our operations for 1999, 1998, and 1997 as well as our financial position at December 31, 1999 and 1998. We analyze and explain the annual changes in the specific line items set forth in the section of our Consolidated Financial Statements titled "Consolidated Statements of Operations." Our analysis may be important to you in making decisions about your investment in Guilford. In 1998 the SEC adopted new rules requiring public companies like us to write certain documents in plain English. Even though the SEC does not require us to present our Management's Discussion and Analysis in plain English, we have decided voluntarily to apply these rules to the following discussion. Our goal is to describe and analyze our financial condition in language that may be easier for our stockholders to understand. GENERAL Guilford is a biopharmaceutical company engaged in the development and commercialization of novel products in two principal areas: - targeted and controlled drug delivery products using proprietary biodegradable polymers for the treatment of cancer and other diseases or conditions, and - therapeutic and diagnostic products for neurological diseases and conditions. In February 1997, we commercially launched our first product, GLIADEL(R) Wafer, in the United States through Aventis. GLIADEL(R) Wafer is a proprietary polymer product for the treatment of certain types of brain cancer. This product dissolves over time and releases an anti-cancer drug known as "BCNU" (or carmustine) directly to the tumor site. Aventis is our exclusive worldwide marketing partner for GLIADEL(R) Wafer, except in Japan and Scandinavia. Orion Corporation Pharma (formerly Orion Corporation Farmos) is our marketing partner for GLIADEL(R) Wafer in Scandinavia. We have also licensed from others and internally developed on our own: 5 - technologies that may be useful in preventing and treating certain neurological diseases and conditions, and - a new class of biodegradable polymers different from the type used in GLIADEL(R) Wafer, including PACLIMER(TM) Microspheres, which we are using for the targeted and controlled delivery of cancer chemotherapeutics. In addition, in 1999 we continued to increase our investment in research and development activities with respect to certain of these technologies. We anticipate that our revenues in 2000 will come primarily from the following sources: - sales of our manufactured products to our marketing partners, which currently consist of sales of GLIADEL(R) Wafer; - royalties from our marketing partners related to their sales of our products to third parties, such as Aventis' sales of GLIADEL(R) Wafer to hospitals; and/or - one-time rights, milestone, and other payments from corporate partners under our current collaborative agreements and new ones that we may enter into with others in the future. As we discuss in greater detail below, if we or our corporate collaborators, Aventis and Amgen, attain certain regulatory and/or development objectives, we are eligible to receive certain milestone and other payments from these companies. We view these potential payments as significant future revenue and/or capital raising opportunities. As we discuss in the 1999 Form 10-K, we cannot be sure that our corporate collaborators will achieve the designated milestones and that we will receive any or all of the milestone payments for which we are eligible under our existing or any future collaborations. We also cannot be sure that we will be able to enter into collaborations in the future with others for the research, development, and/or commercialization of our technologies. Since the commercial launch of GLIADEL(R) Wafer in the United States in February 1997 through December 31, 1999, we have recognized an aggregate of $20.6 million in product sales and royalties. Of this amount, $14.0 million represents revenues from sales of GLIADEL(R) Wafer to both Aventis and Orion Corporation Pharma. The additional $6.6 million are royalties paid to us from Aventis on its sales of GLIADEL(R) Wafer to third parties, such as hospitals. Under the terms of our agreements with Aventis, if Aventis is able to achieve certain specified regulatory objectives, then Aventis is obligated to pay us up to an additional $30.5 million in milestone payments and payments for the purchase of shares of our common stock. These regulatory objectives include obtaining additional approvals to market GLIADEL(R) Wafer in certain foreign countries and 6 expanding the clinical uses of GLIADEL(R) Wafer. In July and August 1999, we received an aggregate of $4.5 million in non-refundable milestone payments from Aventis. These milestone payments were paid upon Aventis' receipt of specified regulatory approvals to market and sell GLIADEL(R) Wafer for the recurrent surgery indication in France and Germany. As we discuss below and in greater detail in the 1999 Form 10-K, a number of factors subject our future sales of GLIADEL(R) Wafer to significant risk and uncertainty. We cannot be sure that our sales of GLIADEL(R) Wafer to Aventis and Aventis' sales of GLIADEL(R) Wafer to third parties will increase over time or even continue at the current rate. The milestone payments and other amounts payable by Aventis are contingent upon: - making certain international regulatory filings and obtaining clearances to market GLIADEL(R) Wafer for the recurrent surgery indication pursuant to such filings; - obtaining authorization from the U.S. Food and Drug Administration ("FDA") and international health regulatory authorities to expand the description of the clinical uses for GLIADEL(R) Wafer that we can put on its label to include use of the product in first surgeries; and - obtaining permission to sell GLIADEL(R) Wafer in certain countries at prices that are acceptable to Aventis and us. We cannot control the timing and extent of governmental clearances. We also cannot be sure that we and Aventis will attain any of these regulatory objectives. Except for GLIADEL(R) Wafer, we do not expect to sell other products for at least the next several years if ever. In August 1997, we entered into a collaboration with Amgen to research, develop, and commercialize our FKBP neuroimmunophilin compound technology. Under our agreement with Amgen, Amgen paid us $35 million in 1997. Of this amount, Amgen paid $15 million in the form of a one-time, non-refundable rights fee upon signing the agreement. Amgen paid us the remaining $20 million for the purchase of 640,095 shares of our common stock and warrants to purchase up to an additional 700,000 shares of our common stock. These warrants are exercisable for five years and have an exercise price of $35.15 per share. We also granted to Amgen certain rights to register shares of our common stock with the SEC for sale in the public markets. In December 1999, we received a one-time, non-refundable $5.0 million milestone payment from Amgen when Amgen filed an Investigational New Drug application for its Phase I study. As part of this collaboration, Amgen agreed to fund up to a total of $13.5 million to support Guilford's research relating to the FKBP neuroimmunophilin ligand 7 technology. This research funding began on October 1, 1997 and is payable quarterly over three years, with the last quarterly payment due July 1, 2000. As of December 31, 1999, we had recognized an aggregate of approximately $10.1 million in research support from Amgen under our collaboration arrangement. Amgen also has the option to fund a fourth year of research. Our agreement also requires that Amgen make milestone payments to us if Amgen achieves specified regulatory and product development milestones. If Amgen is able to meet all of these milestones for each of 10 different specified clinical indications (i.e., uses), then these payments could total up to $392 million in the aggregate. Amgen is also required to pay us royalties on its sales to third parties of any product(s) that result from our collaboration. As we discuss below and in greater detail in the 1999 Form 10-K, we cannot be sure that Amgen will be successful in its efforts to develop one or more FKBP neuroimmunophilin compounds into products that the FDA and international regulatory authorities will approve as safe and effective drugs for neurological or other uses. Consequently, we cannot be sure that we will earn any of the milestone payments related to these regulatory and product development activities. In addition to revenues related to net product sales and royalties from GLIADEL(R) Wafer, the only other significant revenues we recognized in 1999 consisted of: - $5 million in a milestone payment from Amgen; - $4.5 million in milestone payments from Aventis; and - $4.5 million relating to research support for the FKBP neuroimmunophilin ligand technology from Amgen. As we discuss below, whether Amgen will ever make milestone or royalty payments to us in the future is subject to significant risk and uncertainty. We cannot be sure that we will recognize any significant revenues from Amgen in the future. For the year ended December 31, 1999, we incurred a net loss of $26.9 million. Since inception through December 31, 1999, we had an accumulated deficit of $82.9 million. Our accumulated deficit is equal to the sum of our cumulative profits and losses since inception in July 1993. We do not expect 2000 to be profitable. We cannot be sure that we will ever achieve or sustain profitability in the future. Furthermore, our revenues and expenses have fluctuated significantly in the past because of the nature and timing of their sources. We expect fluctuations in our revenues and expenses to continue, 8 and thus our operating results should also vary significantly from quarter-to-quarter and year-to-year. A variety of factors cause these fluctuations, including: - the timing and amount of sales of GLIADEL(R) Wafer to Aventis and Aventis' sales to end-customers; - the timing and realization of milestone and other payments from our corporate partners, including Aventis and Amgen; - the timing and amount of expenses relating to our research, development, and manufacturing activities; and - the extent and timing of costs related to our activities to obtain, extend, enforce and/or defend our patent and other rights to our intellectual property. We expect that expenses in all areas of our business will continue to increase. These areas include research and product development, pre-clinical testing, human clinical trials, regulatory affairs, operations, manufacturing, and general and administrative activities. In addition, we expect the number of employees working at our company to continue to increase. At December 31, 1999, we had 228 full-time employees, which compares to 218 and 198 at December 31, 1998 and 1997, respectively. Our ability to achieve consistent profitability in the future will depend on many factors, including: - the level of future sales of GLIADEL(R) Wafer; - our ability, either alone or with others, to develop our product candidates successfully, including NIL-A with Amgen, PACLIMER(TM) Microspheres and any other product candidates or to acquire product candidates; - the extent of any human clinical trials and related costs necessary to develop our product candidates; - our ability, either alone or with others, to obtain required regulatory approvals to market our product candidates; - our ability and that of our corporate partners to manufacture products at reasonable cost; - our ability and that of our collaborators to market and distribute products successfully; - our ability to enter into acceptable collaborative arrangements for our technologies and license agreements for new technologies of others in the future; and 9 - our ability to invent or acquire new technologies and/or in-license new technologies from others and to obtain, acquire, defend, and/or enforce patents on new and existing technologies. For a discussion of these and other risks, you should read the "Risk Factors" section, particularly those paragraphs specifically addressing the risks we note above. Future product sales of GLIADEL(R) Wafer are subject to certain risks and uncertainties. These risks include the following, among others: - Aventis is not obligated to purchase any minimum amounts of GLIADEL(R) Wafer from us, and so our revenues from the sale and distribution of GLIADEL(R) Wafer are entirely dependent on the level of Aventis' sales to end-users. - Aventis may not be successful in its efforts to market and sell GLIADEL(R) Wafer. - Neurosurgeons and their patients may not accept GLIADEL(R) Wafer for a number of reasons, including the fact that GLIADEL(R) Wafer represents a new and unfamiliar approach to the treatment of brain cancer and their assessment that benefits of this therapy do not outweigh its costs. - Aventis may not be successful in its attempts to obtain any additional regulatory and marketing approvals to market GLIADEL(R) Wafer and sell GLIADEL(R) Wafer at acceptable prices. - BCNU, the chemotherapeutic agent we use in GLIADEL(R) Wafer, is currently only available from two suppliers, and thus this material may not be available for GLIADEL(R) Wafer manufacture. - The Company's current manufacturing plant for GLIADEL(R) Wafer and a recently completed second manufacturing facility are both located in the same building at our headquarters in Baltimore, Maryland, and thus, are subject to the risk that natural disasters or other factors may adversely affect their operation and interrupt GLIADEL(R) Wafer manufacture. As we note in the section captioned "Risk Factors," there is no guarantee that we or Amgen will be able to successfully develop any FKBP neuroimmunophilin compounds or other product candidates into safe and effective drug(s) for neurological or other uses. Consequently, we may not earn additional milestone payments related to Amgen's development activities or revenues related to product sales. In particular, the research, development, and commercialization of early-stage technology, like the FKBP neuroimmunophilin ligand technology, are subject 10 to significant risks and uncertainty. These risks involve those relating to, among other things: - selection of appropriate lead compounds; - successful completion of pre-clinical and clinical development activities; - the need to obtain regulatory clearances in the United States and elsewhere to market and sell drug products; - formulation of final product dosage forms; - scale-up from laboratory bench quantities to commercial quantities at a reasonable cost; - successful manufacture of drug products at an acceptable cost; - successful commercialization of such products at an acceptable price; and - the successful prosecution, enforcement, and defense of patent and other intellectual property rights. For a discussion of these and other risks, you should read the "Risk Factors" section, particularly those paragraphs specifically addressing the risks we note above. RESULTS OF OPERATIONS In this section we discuss our 1999, 1998, and 1997 revenues, costs and expenses, and other income and expenses, as well as the factors affecting each of them. REVENUES In 1999, 1998, and 1997 our revenues primarily came from the following sources: - net product sales of GLIADEL(R) Wafer to our marketing and distribution partners, Aventis (for the entire world, except Scandinavia and Japan) and Orion Corporation Pharma (for Scandinavia only); - royalty payments from Aventis on its sales of GLIADEL(R) Wafer to others, primarily hospitals; - one-time rights or milestone payments from Aventis and Amgen; - quarterly research funding from Amgen; and 11 - amounts Aventis reimbursed to us for costs related to our efforts to develop a high-dose GLIADEL(R) Wafer product. In 1999, 1998, and 1997, we recognized net revenues of $21.6 million, $12.5 million, and $23.8 million, respectively. These revenues consisted primarily of the following:
1999 1998 1997 ---- ---- ---- (in millions) REVENUES RELATED TO GLIADEL(R) WAFER: Net product sales $4.4 $3.9 $ 5.7 License fees and royalties 2.4 2.7 1.6 Non-recurring rights and milestone payments 4.5 -- -- REVENUES FROM AMGEN: Non-recurring rights and milestone payments 5.0 1.0 15.0 Research funding under collaborative agreements 4.5 4.5 1.1
GLIADEL(R) Wafer Product Sales We earned $4.4 million, $3.9 million and $5.7 million for the years ended December 31, 1999, 1998, and 1997, respectively, from the net product sales of GLIADEL(R) Wafer to our marketing and distribution partners, Aventis (for the entire world, except Scandinavia and Japan) and Orion Corporation Pharma (for Scandinavia only). The increase in revenues attributable to sales of GLIADEL(R) Wafer to Aventis in 1999 compared to 1998 is due to the build-up of inventory of the product to support the anticipated launch in France, Germany, and other countries in Europe and elsewhere around the world. We cannot guarantee, however, that Aventis will obtain all necessary regulatory approvals to launch the product in additional European countries or elsewhere to market and sell GLIADEL(R) Wafer. In addition, we cannot be sure that, even if Aventis does obtain these approvals in one or more European or other countries, GLIADEL(R) Wafer will be launched in these countries in 2000 or thereafter, or that sales in those countries, if any, including France and Germany, will be significant. The decrease in revenues attributable to product sales of GLIADEL(R) Wafer to Aventis in 1998 compared to 1997 is because our product sales to Aventis in 1997 included Aventis' initial build-up of inventory to support commercial launch. 12 Royalties on GLIADEL(R) Wafer Sales to Third Parties Net royalty revenues on Aventis' sales of GLIADEL(R) Wafer to third parties were $2.4 million, $2.6 million, and $1.6 million for the years ended December 31, 1999, 1998, and 1997, respectively. We believe Aventis' sales of GLIADEL(R) Wafer to third parties decreased in 1999 as compared to 1998 because the sales force at Aventis was restructured in 1999, and thus, the new personnel needed to gain familiarity and experience selling GLIADEL(R) Wafer. We believe Aventis' sales of GLIADEL(R) Wafer to third parties increased in 1998 as compared to 1997, because: - awareness about GLIADEL(R) Wafer increased among neurosurgeons, the physician group that uses GLIADEL(R) Wafer and makes treatment recommendations to brain cancer patients; - neurosurgeons had gained familiarity and experience in using GLIADEL(R) Wafer; and - GLIADEL(R) Wafer sales commenced in late February 1997 and, thus, were made only for approximately 10 months in 1997 as compared to 12 months in 1998 and thereafter. A number of factors subject our future sales of GLIADEL(R) Wafer to significant risk and uncertainty. We cannot be sure that GLIADEL(R) Wafer sales will increase from, or even remain at, current levels or will ever generate significant revenues for us in the future. COST OF SALES Our cost of sales for the years ended December 31, 1999, 1998, and 1997 were $2.3 million, $2.0 million, and $2.6 million, respectively. Included in these amounts are approximately $180,000, $159,000, and $281,000, respectively, representing: - royalty payments made to the university from which we have licensed certain technology related to GLIADEL(R) Wafer and - with respect to 1997 only, certain additional costs specifically related to the commercial product launch of GLIADEL(R) Wafer in the United States. In 1999, the cost of product sales as a percentage of net product sales revenue was unchanged from 1998. In 1997, cost of product sales was 45% of net product sales revenue. The increase in cost of product sales as a percentage of net product sales revenue during 1998 when compared to 1997, reflects a reduction in the number of units of GLIADEL(R) Wafer manufactured for sale to Aventis during 1998. The cost to manufacture GLIADEL(R) Wafer at current production levels can vary materially with the production volume. Production volume in turn is dependent 13 upon purchase orders. To the extent that GLIADEL(R) Wafer production levels increase in the future, we anticipate that the unit cost to manufacture GLIADEL(R) Wafer may decrease, although we cannot be sure that GLIADEL(R) Wafer product sales will ever reach levels necessary for us to realize such a reduction in the per unit cost of manufacturing GLIADEL(R) Wafer. To the extent that GLIADEL(R) Wafer production levels decrease, we anticipate that the unit cost to manufacture GLIADEL(R) Wafer will increase. Based on our experience to date, we would expect the cost of product sales of GLIADEL(R) Wafer to fluctuate from quarter to quarter, based on production volumes. RESEARCH AND DEVELOPMENT EXPENSES Our research and development expenses increased to $41.9 million in 1999 from $37.7 million and $30.3 million in 1998 and 1997, respectively. During 1999, we continued to increase our research and product development efforts, particularly with respect to our NAALADase inhibitor and PARP inhibitor neuroprotectant programs, our FKBP neuroimmunophilin compound program, and our polymer development program, including our polymer oncology candidate, PACLIMER(TM) Microspheres. In addition, we continued to provide financial support for Aventis' Phase III clinical trial program in support of a first surgery indication for GLIADEL(R) Wafer. During 1998, we increased our research and product development efforts, particularly with respect to our NAALADase inhibitor and PARP inhibitor neuroprotectant programs, our FKBP neuroimmunophilin compound program, and our polymer development program. We funded development activities at a third-party manufacturer of the clinical supply of DOPASCAN(R) Injection. Additionally, we incurred certain costs not reimbursed to us by Aventis for Phase I clinical trials for a high-dose formulation of GLIADEL(R) Wafer and shared financial support for Aventis' Phase III clinical trial program in support of a first surgery indication for GLIADEL(R) Wafer. At December 31, 1999, we employed 193 individuals on a full-time basis in the areas of research, development, and manufacturing. We employed 185 individuals and 167 individuals in these areas at December 31, 1998 and 1997, respectively. GENERAL AND ADMINISTRATIVE EXPENSES Our general and administrative expenses were $11.3 million, $10.5 million, and $9.1 million for the years ended December 31, 1999, 1998, and 1997, respectively. We attribute the increases in general and administrative expenses of $735,000 from 1998 to 1999 and $1.5 million from 1997 to 1998, in part, because of an increase in 14 the activities necessary to support our research, product development, and commercialization efforts. We include the costs to prepare, file, and prosecute domestic and international patent applications and for other activities to establish and preserve our intellectual property rights in our general and administrative expenses. These costs also increased from 1997 through 1999. We anticipate that our general and administrative expenses will continue to increase in future periods. At December 31, 1999, we employed 35 individuals on a full-time basis in general and administrative areas compared to 33 and 31 at December 31, 1998 and 1997, respectively. OTHER INCOME AND EXPENSE Other income and expense consists primarily of investment income on our monetary investments and interest expense on our debt and other financial obligations. Our investment income was $7.7 million, $8.9 million, and $7.5 million for the years ended December 31, 1999, 1998, and 1997, respectively. The decrease in 1999 compared to 1998 was primarily due to lower average amounts invested during the course of the year. Invested capital increased in the fourth quarter of 1999 primarily because of the receipt of: - $42.4 million in net proceeds from the private sale of approximately 3.4 million shares of our common stock in September 1999 and - a milestone payment from Amgen for $5 million in December 1999. Increases in 1999 and 1998 compared to 1997 were primarily due to an increase in the average amount of money we invested each year as compared to the prior year and, to a lesser extent, a higher average yield on our investment portfolio. We incurred interest expense of $640,000, $768,000, and $837,000 for the years ended December 31, 1999, 1998, and 1997, respectively. These expenses resulted from loans from a commercial bank that helped fund the construction of our manufacturing, administrative, and research and development facilities and the purchase of certain furniture and equipment. Because we continued to repay these loans, resulting in a lower average principal balance during 1999, interest expense decreased in 1999 as compared to 1998 and 1997. We describe these interest expenses in Notes 4 and 7, "Interest Rate Swap Agreements" and "Indebtedness," to the footnotes to our Consolidated Financial Statements on pages 48 and 49, respectively. 15 LIQUIDITY AND CAPITAL RESOURCES Our cash, cash equivalents, and investments were approximately $144.7 million at December 31, 1999. Of this amount, we pledged $21.4 million as collateral for certain of our loans and other financial lease obligations. In addition to these restricted investments, the Company is required to maintain, in the aggregate, unrestricted cash, cash equivalents, and investments of $40 million at all times under the terms of certain of its financial obligations. Our total debt decreased to $9.4 million at December 31, 1999 compared to $10.9 million at December 31, 1998. This decrease resulted primarily because of our continued repayment of principal under our loans with a commercial bank. We incurred net capital expenditures of $1.9 million, $5.1 million, and $6.4 million for the years ended December 31, 1999, 1998, and 1997, respectively. These capital expenditures resulted from the purchase of equipment to support our ongoing research and development and production activities. In March 1998, we entered into arrangements with certain equipment leasing companies that permit us to lease up to $10.8 million in equipment, including computer hardware and software, and furniture and fixtures. We leased approximately $6.4 million in equipment under these arrangements in 1999. Depending on the type of equipment covered and certain other factors, the term of any lease we enter under these arrangements can range from two to four years. At December 31, 1999, $4.4 million was available under these arrangements to lease additional equipment. Substantially all of the unused portion of these lines has been extended to December 31, 2000. We expect our existing financing arrangements, our internal capital resources, and potential external sources of funds to provide for our current equipment needs at least through the end of 2000. If we decide to expand our research and development programs beyond current expectations or if we engage in acquisitions, our capital equipment requirements could increase, and thus, we may require additional capital funding. In order to meet our anticipated future facilities needs, in 1997 we initiated a project to design, construct, and lease a new research and development facility. To accomplish this task, in February 1998 we entered into an operating lease and other related agreements with a commercial bank and related entities in connection with such a facility. This new facility, which was substantially completed in June 1999, was constructed adjacent to our current headquarters in Baltimore, Maryland. This facility is owned by a trust affiliated with a commercial bank (the "Trust") and provides approximately 73,000 square feet of research and development capacity. The initial lease term expires in February 2005. At the end of the initial lease term, the Company may re-lease the facility, purchase the building, or arrange for the 16 sale of the building to a third party. In the event the building is sold to a third party, the Company will be obligated to pay the lessor any shortfall between the sales price and 83% of the lessor's net investment in the facility. We describe these arrangements with the Trust in Note 8, "Leases," of the footnotes to our Consolidated Financial Statements on page 49. We anticipate that this new research and development facility, along with our headquarters facility, will support our research, development, commercialization, and administrative activities through at least the end of 2000. Under a loan agreement we executed with Aventis in 1996, Aventis has extended to us a $7.5 million line of credit to support expansion of our GLIADEL(R) Wafer and polymer manufacturing capacity, of which $4.0 million is currently available to us. The remaining $3.5 million becomes available no earlier than 12 months nor later than 18 months following funding of the initial portion. Any principal amounts we borrow are due five years from the date borrowed. These amounts will carry an interest rate equal to the lowest rate Aventis pays from time to time on its most senior debt. We have not borrowed any amounts under this credit facility as of December 31, 1999. During 1998, we entered into a series of interest rate swap transactions with a commercial bank covering $20 million in financial obligations under our lease with the Trust. In January 1999, we entered into additional interest rate swap agreements with the commercial bank covering $10 million of our floating rate debt. As a result, we fixed the interest rates on our financial lease obligations and debt at approximately 6% in the aggregate. The interest rate swap agreements provide the commercial bank with a call provision exercisable on the fifth anniversary of each interest rate swap agreement. We describe these interest rate swap transactions with the commercial bank in Note 4, "Interest Rate Swap Agreements," of the footnotes to our Consolidated Financial Statements on page 48. In the fourth quarter of 1998, we established an unsecured, revolving line of credit for $5 million with a commercial bank. Borrowings under this line of credit carry an interest rate of LIBOR plus 0.55% and are available on demand. We may draw on this line of credit from time to time to meet our short-term working capital needs. No amounts were drawn under this line of credit in 1999 or 1998. In 1998, our Board of Directors approved a program to purchase up to 1,000,000 shares of our common stock in the open market from time to time at our discretion. In August 1999, the Company terminated this share repurchase program. We repurchased a total of 252,500 of our shares under this program for an aggregate cash outlay of $2.7 million. We expect to need significantly greater capital to continue our research and product development programs and pre-clinical and clinical testing and to manufacture and possibly market our products. We will also need additional funds 17 to meet our future facility expansion needs if necessary. Our capital requirements depend on a number of factors, including: - the progress of our research and development programs; - the progress of pre-clinical and clinical testing; - the time and costs involved in obtaining regulatory approvals; - the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; - competing technological and market developments; - changes in our existing research relationships; - our ability to establish collaborative arrangements; - our ability to enter into licensing agreements and contractual arrangements with others; and - the progress of efforts to scale-up manufacturing processes. We believe that our existing resources will be sufficient to fund our activities through at least December 31, 2001. We may, however, expend these resources before that time for a number of reasons, including, among others: - changes in our research, product development, and commercialization plans; - other factors that increase our expenses or capital expenditures, including potential acquisitions of other companies, assets, products, or in-licensing of drug candidates, or technologies; and - unanticipated capital expenditures. RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS In December 1999, the staff of the SEC issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements" ("SAB 101"). SAB 101 summarizes certain of the staff's views in applying Generally Accepted Accounting Principles to revenue recognition in financial statements, including recognition of non-refundable fees received upon entering into arrangements. We are in the process of evaluating SAB 101 and the effect it will have on our Consolidated Financial Statements and current revenue recognition policy. In June 1998, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities" ("SFAS 133"). SFAS 133 establishes accounting and reporting standards for derivative instruments, including certain derivative instruments embedded in other contracts, and for hedging activities. It requires companies to recognize all derivatives as either assets or liabilities on the balance sheet and measure those instruments at fair value. Gains or losses resulting from changes in the values of those derivatives would be accounted for, depending on the use of the derivative and whether it qualifies for hedge accounting under SFAS 133. Prospective application of SFAS 133, as amended, is required commencing with the first quarter of the fiscal year beginning after June 15, 2000; however, earlier application is permitted. We do not expect the impact of SFAS 133 to be material to our financial position and results of operations. YEAR 2000 We dedicated resources during 1999 to address the potential hardware, software, and other computer and technology issues and related concerns associated with the transition to the Year 2000 and to confirm that our service providers took appropriate measures. As a result of those efforts, we have not experienced any material disruptions in our operation in connection with, or following, the transition to the Year 2000. As of December 31, 1999, the total costs of our Year 2000 compliance program have not been significant, and we currently estimate that any additional Year 2000 costs will not be significant. Most of our costs relative to the Year 2000 issue have been internal personnel costs. We currently estimate that our Year 2000 costs will total approximately $157,000. 18 INDEPENDENT AUDITORS' REPORT The Board of Directors and Stockholders of Guilford Pharmaceuticals Inc.: We have audited the accompanying consolidated balance sheets of Guilford Pharmaceuticals Inc. and subsidiaries as of December 31, 1999 and 1998, and the related consolidated statements of operations, changes in stockholders' equity and cash flows for each of the years in the three-year period ended December 31, 1999. These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We conducted our audits in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Guilford Pharmaceuticals Inc. and subsidiaries as of December 31, 1999 and 1998, and the results of their operations and their cash flows for each of the years in the three-year period ended December 31, 1999, in conformity with generally accepted accounting principles. /s/ KPMG LLP Philadelphia, Pennsylvania February 11, 2000 19 GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31 (IN THOUSANDS, EXCEPT SHARE DATA)
1999 1998 -------- -------- ASSETS Current assets: Cash and cash equivalents $ 14,336 $ 8,480 Investments 108,997 103,281 Accounts receivable 1,020 1,172 Inventories 1,348 1,291 Other current assets 752 709 -------- -------- Total current assets 126,453 114,933 Investments -- restricted 21,385 16,500 Property and equipment, net 15,793 18,790 Other assets 611 736 -------- -------- $164,242 $150,959 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 3,085 $ 3,265 Current portion of long-term debt 2,214 2,159 Accrued payroll related costs 2,070 2,279 Accrued contracted services 2,066 2,095 Accrued expenses and other current liabilities 1,550 891 Deferred income 1,125 1,125 -------- -------- Total current liabilities 12,110 11,814 Long-term debt, net of current portion 7,152 8,766 -------- -------- Total liabilities 19,262 20,580 -------- -------- Stockholders' equity: Preferred stock, par value $0.01 per share; authorized 4,700,000 shares, none issued -- -- Series A junior participating preferred stock, par value $0.01 per share; authorized 300,000 shares, none issued -- -- Common stock, par value $0.01 per share; authorized 75,000,000 shares, 23,328,313 and 19,594,316 issued at December 31, 1999 and 1998, respectively 233 196 Additional paid-in capital 232,913 187,139 Accumulated deficit (82,877) (56,009) Accumulated other comprehensive income (loss) (1,838) 876 Note receivable from officer (60) (60) Treasury stock, at cost 274,880 and 77,224 shares at December 31, 1999 and 1998, respectively (3,284) (1,399) Deferred compensation (107) (364) -------- -------- Total stockholders' equity 144,980 130,379 -------- -------- $164,242 $150,959 ======== ========
See accompanying notes to consolidated financial statements. 20 GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS YEARS ENDED DECEMBER 31 (IN THOUSANDS, EXCEPT PER SHARE DATA)
1999 1998 1997 -------- -------- -------- Revenues: Contract revenues $ 9,500 $ 1,000 $ 15,000 Net product sales 4,371 3,860 5,741 License fees and royalties 2,427 2,713 1,628 Revenues under collaborative agreements 5,263 4,910 1,459 -------- -------- -------- Total revenues 21,561 12,483 23,828 Costs and expenses: Cost of sales 2,308 2,036 2,585 Research and development 41,922 37,722 30,293 General and administrative 11,281 10,546 9,076 -------- -------- -------- Total costs and expenses 55,511 50,304 41,954 -------- -------- -------- Operating loss (33,950) (37,821) (18,126) Other income (expense): Investment income 7,671 8,855 7,477 Interest expense (640) (768) (837) Other income 51 36 49 -------- -------- -------- Net loss $(26,868) $(29,698) $(11,437) ======== ======== ======== Basic and diluted loss per share $ (1.31) $ (1.52) $ (0.65) ======== ======== ======== Weighted average shares outstanding to compute basic and diluted loss per share 20,475 19,479 17,570 ======== ======== ========
See accompanying notes to consolidated financial statements. 21 GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (IN THOUSANDS, EXCEPT SHARE DATA)
COMMON STOCK ACCUMULATED NOTE -------------------- ADDITIONAL OTHER RECEIVABLE NUMBER PAID-IN ACCUMULATED COMPREHENSIVE FROM OF SHARES AMOUNT CAPITAL DEFICIT INCOME (LOSS) OFFICER ----------- ------ ---------- ----------- ------------- ---------- Balance, January 1, 1997 13,979,490 $140 $ 90,880 $(14,874) $ 62 $(129) Comprehensive loss Net loss for the year (11,437) Other comprehensive income: Unrealized gain on available-for- sale securities 364 Total comprehensive loss Issuance of common stock in follow-on public offering at $20.00 per share, net of offering costs 3,737,500 37 70,429 Other issuances of common stock 1,670,956 17 22,911 Purchase of 35,547 shares of common stock Stock option compensation 985 Amortization of deferred compensation Reduction in notes receivable on common stock 69 ----------- ---- -------- -------- -------- ---- Balance, December 31, 1997 19,387,946 $194 $185,205 $(26,311) $ 426 $(60) Comprehensive loss Net loss for the year (29,698) Other comprehensive income: Unrealized gain on available-for-sale securities 450 Total comprehensive loss Issuances of common stock 206,370 2 1,485 Purchase of 41,677 shares of common stock Stock option compensation 449 Amortization of deferred compensation ----------- ---- -------- -------- -------- ---- Balance, December 31, 1998 19,594,316 $196 $187,139 $(56,009) $ 876 $(60) Comprehensive loss Net loss for the period (26,868) Other comprehensive loss: Unrealized loss on available-for-sale securities (2,714) Total comprehensive loss Issuance of common stock in private placement at $13.50 per share, net of offering costs 3,360,000 34 42,374 Other issuances of common stock 373,997 3 2,601 Purchase of 224,150 shares of common stock Distribution of 26,494 shares of treasury stock to 401(k) plan 28 Stock option compensation 947 Amortization of deferred compensation Forfeiture of unvested restricted stock (176) ----------- ---- -------- -------- -------- ---- Balance, December 31, 1999 23,328,313 $233 $232,913 $(82,877) $ (1,838) $(60) =========== ==== ======== ======== ======== ====
See accompanying notes to financial statements. 22
TOTAL TREASURY DEFERRED STOCKHOLDERS' STOCK AT COST COMPENSATION EQUITY ------------- ------------ ------------- Balance January 1, 1997 $ -- $ (202) $ 75,877 Comprehensive loss Net loss for the year (11,437) Other comprehensive income Unrealized gain on available-for- sale securities 364 -------- Total comprehensive loss $(11,073) -------- Issuance of common stock in follow-on public offering at $20.00 per share, net of offering costs 70,466 Other issuances of common stock (331) 22,597 Purchase of 35,547 shares of common stock (878) (878) Stock option compensation 985 Amortization of deferred compensation 251 251 Reduction in notes receivable on common stock 69 ------- ------- -------- Balance, December 31, 1997 $ (878) $ (282) $158,294 Comprehensive loss Net loss for the year (29,698) Other comprehensive income: Unrealized gain on available-for-sale securities 450 -------- Total comprehensive loss $(29,248) -------- Issuances of common stock (191) 1,296 Purchase of 41,677 shares of common stock (521) (521) Stock option compensation 449 Amortization of deferred compensation 109 109 ------- ------- -------- Balance, December 31, 1998 $(1,399) $ (364) $130,379 Comprehensive loss Net loss for the period (26,868) Other comprehensive loss: Unrealized loss on available-for-sale securities (2,714) -------- Total comprehensive loss $(29,582) -------- Issuance of common stock in private placement at $13.50 per share, net of offering costs 42,408 Other issuances of common stock 2,604 Purchase of 224,150 shares of common stock (2,209) (2,209) Distribution of 26,494 shares of treasury stock to 401(k) plan 324 352 Stock option compensation 947 Amortization of deferred compensation 81 81 Forfeiture of unvested restricted stock 176 -- ------- ------- -------- Balance, December 31, 1999 $(3,284) $ (107) $144,980 ======= ======= ========
See accompanying notes to financial statements. 23 GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS YEARS ENDED DECEMBER 31 (IN THOUSANDS)
1999 1998 1997 --------- -------- --------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (26,868) $(29,698) $ (11,437) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 5,118 3,601 2,735 Non-cash compensation expense 866 558 1,236 Changes in assets and liabilities: Accounts receivable, other current assets, and other assets (37) (1,270) (17) Inventories (57) 51 191 Accounts payable and other current liabilities 247 839 3,188 --------- -------- --------- Net cash used in operating activities (20,731) (25,919) (4,104) --------- -------- --------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of property and equipment, net (1,850) (5,104) (6,433) Sale and maturities of marketable securities 166,348 100,130 100,457 Purchases of marketable securities (179,155) (84,222) (174,453) --------- -------- --------- Net cash provided by (used in) investing activities (14,657) 10,804 (80,429) --------- -------- --------- CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuances of common stock 45,012 1,296 93,063 Purchase of treasury stock (2,209) (521) (878) Proceeds from loans 600 -- 1,843 Payment of notes receivable on common stock -- -- 69 Principal payments on bond and term loan payable (2,159) (2,160) (1,144) --------- -------- --------- Net cash provided by (used in) financing activities 41,244 (1,385) 92,953 --------- -------- --------- Net increase (decrease) in cash and cash equivalents 5,856 (16,500) 8,420 CASH AND CASH EQUIVALENTS AT THE BEGINNING OF YEAR 8,480 24,980 16,560 --------- -------- --------- CASH AND CASH EQUIVALENTS AT THE END OF YEAR $ 14,336 $ 8,480 $ 24,980 ========= ======== ========= Supplemental disclosures of cash flow information: Net interest paid $ 590 $ 784 $ 828 ========= ======== =========
See accompanying notes to consolidated financial statements. 24 GUILFORD PHARMACEUTICALS INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (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 AND PRACTICES Principles of Consolidation The consolidated financial statements include the financial statements of Guilford Pharmaceuticals Inc. and its subsidiaries, all of which are wholly owned. All significant intercompany balances and transactions have been eliminated in consolidation. Segment Information The Company operates primarily in one industry segment, which includes the development, and commercialization of novel products for the healthcare industry. The Company is managed and operated as one business. The entire business is comprehensively managed by a single management team that reports to the Chief Executive Officer. The Company does not operate separate lines of business or separate business entities with respect to its product or product candidates. In addition, the Company operates primarily from its corporate headquarters located in the United States. Accordingly, the Company does not prepare discrete financial information with respect to separate product areas or by location and does not have separately reportable segments as defined by Statement of Financial Accounting Standards ("SFAS") No. 131, "Disclosure About Segments of an Enterprise and Related Information." Cash Equivalents Cash equivalents of $10.4 million and $6.7 million at December 31, 1999 and 1998, respectively, consist of overnight investments and money market funds. The Company classifies all highly liquid investments with an original maturity of three months or less at the time of purchase as cash equivalents. Investments Investment securities consist of direct obligations of the U.S. government and U.S. government agencies, asset backed securities and corporate debt securities. The Company classifies investments at the time of purchase as either available-for-sale or held-to-maturity. Investments in securities that are classified as available-for-sale are carried at their fair values. Unrealized holding gains and losses on available-for-sale securities are excluded from current earnings and are reported as a separate component of stockholders' equity as "Accumulated other comprehensive income (loss)." Realized gains and losses on available-for-sale securities are determined on a specific identification basis. Held-to-maturity securities are those securities in which the Company has the ability and intent to hold the security until maturity. Held-to-maturity securities are carried at cost, adjusted for the amortized discount or premium. 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 that would result in a reduction in the carrying amount to fair value. Such impairment, if any, is charged to current earnings, and an adjusted cost basis for the security is established. Dividends and interest income are recognized when earned. 25 Inventories Inventories are stated at the lower of cost or market. Cost is determined using a weighted-average approach, which approximates the first-in, first-out method. Property and Equipment Property and equipment are stated at cost. Depreciation and amortization are calculated on the straight-line method over the estimated useful lives of the assets, generally three to seven years for furniture and equipment, and over the shorter of the estimated useful life of leasehold improvements or the related lease term for such improvements. Upon the disposition of assets, the cost and related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in the Consolidated Statements of Operations. Expenditures for repairs and maintenance are expensed as incurred. Revenue Recognition Product sales are recognized at the time the product has received a "certificate of analysis" and has been shipped. Sales are reported net of estimated discounts, rebates, chargebacks, and product returns. Royalty revenue is recognized at such time as the Company's sales, marketing, and distribution partner sells the product. Collaborative research revenue is recognized, up to the contractual limits, when the Company meets its performance obligations under the respective agreements. Non-refundable contract fees for which no further performance obligation exists are recognized when payments are received or when collection is assured. Payments received that relate to future performance are deferred and recognized as revenue at the time such future performance has been accomplished. In December 1999, the staff of the Securities and Exchange Commission ("SEC") issued Staff Accounting Bulletin No. 101, "Revenue Recognition in Financial Statements" ("SAB 101"). SAB 101 summarizes certain of the staff's views in applying Generally Accepted Accounting Principles to revenue recognition in financial statements, including the recognition of non-refundable fees received upon entering into arrangements. The Company is in the process of evaluating SAB 101 and the effect it will have on its consolidated financial statements and current revenue recognition policy. Research and Development, Patent, and Royalty Costs Research and development, patent, and royalty costs are expensed as incurred. Royalty expense related to product sales is recognized concurrently with the recognition of product revenue and included as part of cost of sales. Royalty expense from third-party sales is expensed as incurred and is offset against royalty revenue related to third-party sales. Accounting for Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The measurement of deferred tax assets is reduced, if necessary, by a valuation allowance for any tax benefits, which are not expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that such tax rate changes are enacted. Stock-Based Compensation The Company applies the intrinsic value-based method of accounting prescribed by Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," ("APB 25"), and related interpretations, in accounting for the Company's employee share option plans. As such, compensation expense would be recorded on the date of grant only if the fair value of the underlying stock exceeded the exercise price. Under the Company's employee share option plans, share options are granted at an exercise price that equals the current fair value at the date of grant, and based on the provisions set forth under APB 25, no compensation expense is recorded. SFAS 123, 26 "Accounting for Stock-Based Compensation," ("SFAS 123"), established accounting and disclosure requirements using a fair value-based method of accounting for stock-based employee compensation plans. As allowed by SFAS 123, the Company has elected to continue to apply the intrinsic value-based method of accounting (APB 25) as described above and has adopted the disclosure requirements of SFAS 123. Stock-based awards issued to non-employees are accounted for under the fair value-based method as defined in SFAS 123. Comprehensive Income (Loss) Under SFAS No. 130, "Reporting Comprehensive Income," the Company is required to display comprehensive income (loss) and its components as part of the Company's full set of financial statements. The purpose of reporting comprehensive income (loss) is to report a measure of all changes in equity of an enterprise that result from recognized transactions and other economic events of the period, except those resulting from investments by owners and distributions to owners. The measurement and presentation of net income (loss) did not change. Comprehensive income (loss) comprises net income (loss) and other comprehensive income (loss). Other comprehensive income (loss) includes certain changes in equity of the Company that are excluded from net income (loss). Comprehensive income (loss) for years ended December 31, 1999, 1998, and 1997 has been reflected in the Consolidated Statements of Changes in Stockholders' Equity. Earnings (Loss) Per Share Basic earnings (loss) per share ("EPS") is computed by dividing earnings (loss) by the weighted-average number of shares outstanding for the period. The computation of Diluted EPS is similar to Basic EPS except that the weighted-average number of shares outstanding for the period is increased to include the number of additional shares that would have been outstanding if the dilutive potential shares had been issued. Potential common shares are excluded if the effect on earnings (loss) per share is antidilutive. Impairment of Long-Lived Assets The Company reviews its long-lived assets for impairment when events or changes in circumstances indicate that the carrying amount of a long-lived asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less cost to sell. Interest Rate Swap Agreements As a hedge against fluctuations in interest rates, the Company has entered into interest rate swap agreements to exchange a portion of its variable rate interest obligations for fixed rates. The Company does not speculate on the future direction of interest rates nor does the Company use these derivative financial instruments for trading purposes. The differential to be paid or received as interest rates change is accrued and recognized as an adjustment of interest expense related to the financial obligation. Fair Value of Financial Instruments The fair value of financial instruments is determined by reference to various market data and other valuation techniques, as appropriate. The fair values of financial instruments approximate their recorded value. Concentration of Credit Risk The Company invests excess cash in accordance with a policy objective that seeks to preserve both liquidity and safety of principal. The policy limits investments to certain instruments issued by institutions with strong investment grade credit ratings at the time of purchase and places restrictions on their terms and concentrations by type and issuer. Uncertainties The Company is subject to various risks common to companies within the biotechnology industry. These include, but are not limited to, development by competitors of new technological innovations; dependence on key personnel; protection of proprietary technology; 27 estimation by the Company of the size and characteristics of the market for the Company's product(s); acceptance of the Company's product(s) by the various countries' regulatory agencies in which the Company may choose to sell its products, as well as the end customer; healthcare cost containment initiatives; and product liability and compliance with government regulations and agencies, including the U.S. Food and Drug Administration ("FDA"). Use of Estimates The preparation of the Company's financial statements, in conformity with generally accepted accounting principles, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, revenues and expenses, and disclosures of contingent assets and liabilities at the date of the financial statements. Actual results could differ from those estimates. Significant Customer and Product The Company sells only one product, GLIADEL(R) Wafer, a novel treatment for recurrent malignant gliablastoma multiforme, the most fatal form of brain cancer. The Company markets, sells, and distributes its product through one of its partners Aventis, S.A. ("Aventis") (successor by merger between Rhone-Poulenc Rorer Pharmaceuticals Inc. and Hoechst AG in December 1999). Substantially all net product sales and license fees and royalties were with Aventis for years ended December 31, 1999, 1998, and 1997. The Company expects that future sales will also be derived largely from the same customer and will be relying upon that customer's ability to obtain regulatory clearance where necessary and then market, sell, and distribute the product. Reclassifications Certain prior year amounts have been reclassified to conform to the current year presentation. (3) INVESTMENTS Investments in marketable securities as of December 31, 1999 and 1998 are as follows: 28
GROSS GROSS UNREALIZED UNREALIZED 1999 COST HOLDING GAINS HOLDING LOSSES FAIR VALUE - ---- -------- ------------- -------------- ---------- (IN THOUSANDS) Available-for-sale: U.S. Treasury securities $ 44,335 $ -- $ (595) $ 43,740 Corporate debt securities 68,624 -- (872) 67,752 Other debt securities 18,751 -- (371) 18,380 -------- ---- ------- -------- 131,710 -- (1,838) 129,872 -------- ---- -------- -------- Held-to-maturity: U.S. Treasury securities 510 -- -- 510 -------- ---- ------- -------- 510 -- -- 510 -------- ---- ------- -------- $132,220 $ -- $(1,838) $130,382 ======== ==== ======= ======== 1998 - ---- Available-for-sale: U.S. Treasury securities $ 89,399 $689 $ -- $ 90,088 Corporate debt securities 15,900 36 -- 15,936 Other debt securities 11,073 151 -- 11,224 -------- ---- ------- -------- 116,372 876 -- 117,248 -------- ---- ------- -------- Held-to-maturity: U.S. Treasury securities 2,023 16 -- 2,039 Corporate debt securities 510 -- -- 510 -------- ---- ------- -------- 2,533 16 -- 2,549 -------- ---- ------- -------- $118,905 $892 $ -- $119,797 ======== ==== ======= ========
At December 31, 1999 and 1998, investments of $21.4 million and $16.5 million, respectively, are classified as "Investments-restricted" in the accompanying Consolidated Balance Sheets (see Notes 7 and 8). Maturities of investments in marketable securities classified as available-for-sale and held-to-maturity were as follows at December 31, 1999:
AMORTIZED FAIR COST VALUE --------- -------- (IN THOUSANDS) Available-for-sale: Due in 1 year or less $ 62,734 $ 61,858 Due in 1-5 years 68,976 68,014 -------- -------- 131,710 129,872 -------- -------- Held-to-maturity: Due in 1 year or less 510 510 -------- -------- 510 510 -------- -------- $132,220 $130,382 ======== ========
(4) INTEREST RATE SWAP AGREEMENTS The Company entered into interest rate swap agreements with a commercial bank ("counter party") to reduce the impact of changes in interest rates on certain financial obligations (see Notes 7 and 8). These agreements have a total notional principal amount of approximately $29 million as of December 31, 1999. The Company has effectively fixed the interest rates on certain financial lease obligations and debt to an annual rate of approximately 6% in the aggregate. These interest rate swap agreements have approximately the 29 same maturity as the financial obligations and expire on various dates through February 2005. The commercial bank has the right to terminate the agreements on the fifth anniversary of each interest rate swap agreement. In the event of non-performance by the counter party, the Company could be exposed to market risk related to interest rates. The fair value of interest rate swap agreements were approximately $1 million at December 31, 1999. Current market pricing models were used to estimate fair values of interest rate swap agreements. (5) INVENTORIES Inventories consist of the following:
DECEMBER 31, -------------------- 1999 1998 ------ ------ (IN THOUSANDS) Raw materials $ 280 $ 283 Work in process 416 371 Finished goods 652 637 ------ ------ $1,348 $1,291 ------ ------
Inventories are net of applicable reserves. Inventories include finished goods and raw materials that may be either available for sale, consumed in production, or consumed internally in the Company's 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:
DECEMBER 31, ------------------------ 1999 1998 -------- ------- (IN THOUSANDS) Laboratory equipment $ 4,789 $ 4,055 Manufacturing equipment 2,794 2,544 Computer and office equipment 4,758 4,106 Leasehold improvements 16,052 15,838 -------- ------- 28,393 26,543 Less accumulated depreciation and amortization (12,600) (7,753) -------- ------- $ 15,793 $18,790 ======== =======
30 (7) INDEBTEDNESS Long-term debt consists of the following:
DECEMBER 31, ------------------------ 1999 1998 ------- ------- (IN THOUSANDS) Borrowings under bond financing arrangement,** payable in monthly installments of $78, plus interest at LIBOR + 0.75% (7.101% at December 31,1999*), with final payment due December 2004 $ 4,706 $ 5,647 Borrowings under term loan,** payable in monthly installments of $101, plus interest at LIBOR + 0.625% (7.101% at December 31, 1999*), with final payment due April 2003 4,060 5,278 Note payable to the City of Baltimore, interest at 2%, payable in monthly installments of approximately $5, including principal and interest, commencing January 2000 with final payment due December 2009 600 -- -------- ------- Total long-term debt 9,366 10,925 Less current portion of long-term debt (2,214) (2,159) ------- ------- Long-term debt, net of current portion $ 7,152 $ 8,766 ======= =======
---------- * See Note 4- "Interest Rate Swap Agreements". ** Secured by equipment and leasehold improvements. Aggregate maturities of long-term debt for each of the five years subsequent to December 31, 1999 and thereafter are approximately: 2000, $2.2 million; 2001, $2.2 million; 2002, $2.2 million; 2003, $1.4 million; 2004, $1.0 million; and 2005 and thereafter, $0.4 million. Bond Financing Arrangement In 1994, the Company entered into an $8 million bond financing arrangement with a commercial bank. The bond was issued by the Maryland Economic Development Corporation, and 50% of the outstanding borrowings were guaranteed by the Maryland Industrial Development Financing Authority ("MIDFA"). Effective June 1998, MIDFA increased its guarantee from 50% to 81.73% of the outstanding borrowings. Restrictive Covenants The aforementioned debt agreements contain restrictions, that require the Company to meet certain financial covenants. Under the bond financing arrangement, the Company maintained $0.7 million and $0.9 million at December 31, 1999 and 1998, respectively, as collateral (approximately 18.27% of the outstanding principal balance). In accordance with the term loan agreement, the Company is required to maintain $4.1 million and $5.3 million at December 31, 1999 and 1998, respectively (equal to 100% of the outstanding principal balance). Total collateral is included in the accompanying Consolidated Balance Sheets as "Investments-restricted." Other covenants preclude the Company from declaring any cash dividends on its common stock without prior written consent. 31 Revolving Line of Credit In 1998, the Company entered into a revolving line of credit agreement renewable annually with a commercial bank for $5 million. Borrowings under the line of credit, if any, require interest at LIBOR plus 0.55% and are payable on demand. Under the terms of the agreement, the Company is required to maintain unrestricted cash, cash equivalents, and investments in the aggregate equal to $40 million with the bank or any financial institution acceptable to the bank. There were no amounts drawn under the line of credit during 1999 or 1998. (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 research and development facility. The facility, which is approximately 73,000 square feet, is located adjacent to the Company's corporate headquarters in Baltimore, Maryland. Construction of this facility was completed during 1999 for a total cost of approximately $19.5 million. The initial lease term is for a period of 84 months (including the construction period) and expires in February 2005. The Company has the option to purchase the facility beginning in February 2001 and annually thereafter. In addition, the Company has an option to sell the facility to a third party in the third and fourth year or at the expiration date. In the event the building is sold to a third party, the Company will be obligated to pay the lessor any shortfall between the sales price and 83% of the lessor's net investment in the facility. Annual lease payments under this operating lease agreement are approximately $1.4 million during the initial lease term. The Company is required to maintain collateral equal to 83% of the remaining balance of the lessor's net investment in the facility less guarantees. The Company maintained collateral of $14.3 million and $8.1 million as of December 31, 1999 and 1998, respectively. The collateral is included in the accompanying Consolidated Balance Sheets as "Investments-restricted." In addition to its collateral requirements, 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. In March 1998, the Company entered into certain Master Lease Agreements, as amended, to provide up to $10.8 million for computer and equipment financing. The Company's ability to draw on these Master Lease Agreements expires on December 31, 2000. The term of each operating lease may vary from 24 to 48 months, based upon the type of equipment being leased. As of December 31, 1999, the Company had leased approximately $6.4 million in computers and equipment under these agreements. Previously, the Company entered into a Master Lease Arrangement related to the land and building that it occupies as its corporate headquarters. The term of the lease is for 10 years and expires July 2004, with options to renew for two five-year periods. The Company has the option to purchase the building after the ninth year for its then current fair market value (excluding improvements). The Company's future minimum lease payments under these non-cancelable operating leases for years subsequent to December 31, 1999 are as follows:
AMOUNT YEAR (IN THOUSANDS) ----------- -------------- 2000 $ 4,163 2001 3,383 2002 2,670 2003 1,941 2004 1,681 Beyond 2004 226 ------- $14,064 =======
Rent expense for operating leases was approximately $4.2 million, $2.7 million, and $1.5 million for the years ended December 31, 1999, 1998, and 1997, respectively. (9) INCOME TAXES As of December 31, 1999, the Company had net operating loss ("NOL") carryforwards available for federal income tax purposes of 32 approximately $74 million, which expire at various dates between 2010 to 2019. 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, 1999, the Company had tax credit carryforwards of approximately $5.6 million expiring between 2010 and 2019. Actual income tax expense differs from the expected income tax expense computed at the effective federal rate as follows:
1999 1998 1997 -------- -------- ------- (IN THOUSANDS) Computed "expected" tax benefit at statutory rate $ (9,135) $(10,097) $(3,889) State income tax, net of federal benefit (1,867) (1,965) (515) General business credit generated (1,631) (1,610) (1,245) Compensatory stock awards -- -- (373) Other, net 62 (546) 43 Change in valuation allowance 12,571 14,218 5,979 -------- -------- ------- $ -- $ -- $ -- ======== ======== =======
Realization of net deferred tax assets related to the Company's 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 that may not be realized in the future, resulting in net deferred tax assets of approximately $138,000 at December 31, 1999 and 1998. The change in the valuation allowance was an increase of approximately $12.6 million in 1999 and an increase of approximately $14.2 million in 1998. Significant components of the Company's deferred tax assets and liabilities as of December 31, 1999 and 1998 are shown below.
DECEMBER 31, ---------------------------- 1999 1998 -------- -------- (IN THOUSANDS) Deferred tax assets: Net operating loss carryforwards $ 30,021 $ 20,771 Research and experimentation credits 5,446 3,815 Compensatory stock grants 2,156 1,599 Depreciation 1,617 -- Alternative minimum tax credit carryforwards 138 138 Contribution carryover and capitalized start-up costs 101 88 Other 1,269 1,502 -------- -------- 40,748 27,913 Deferred tax liabilities: Prepaid expenses and deferred compensation (530) (266) -------- -------- Net deferred tax assets 40,218 27,647 Valuation allowance (40,080) (27,509) -------- -------- Net deferred tax assets $ 138 $ 138 ======== ========
(10) CAPITAL TRANSACTIONS In September 1999, the Company completed a private placement of approximately 3.4 million shares of its common stock to certain institutional and other accredited investors, resulting in net proceeds to the Company of approximately $42.4 million. In June 1999, the Company issued 312,993 shares of common stock upon exercise of a warrant by Bear, Stearns Securities Corp. as partial compensation for underwriting services. In exchange, the Company received approximately $2.25 million. The Company repurchased 224,150 and 41,677 shares of its common stock at an aggregate cost of approximately $2.2 million and 33 $521,000 during the years ended December 31, 1999 and 1998, respectively, of which 212,900 and 39,600 shares were purchased pursuant to the stock repurchase program approved by the Company's Board of Directors in September 1998. In August 1999, this stock repurchase program was terminated. On October 1, 1997, the Company sold 640,095 shares of common stock to Amgen Inc. ("Amgen") for $15 million. In addition, the Company received $5 million in exchange for warrants, exercisable for five years, to purchase up to 700,000 shares of the Company's common stock at an exercise price of $35.15 per share (see Note 14). 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 Company's 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. 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 were no shares of this preferred stock outstanding at December 31, 1999 or 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, 1999, the Rights were neither exercisable nor traded separately from the Company's common stock and become exercisable only if a person or group becomes the beneficial owner of 20% or more of the Company's common stock or announces a tender or exchange offer that would result in its ownership of 20% or more of the Company's common stock without the approval of the Board of Directors. 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 if 50% or more of the Company's assets are sold in one or more related transactions, then 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 The Company adopted Employee Share Option and Restricted Share Plans (the "Plans") in 1998 and 1993. The Plans were established to provide eligible individuals with an opportunity to acquire or increase an equity interest in the Company and to encourage such individuals to continue in the employment of the Company. Share options are granted at the fair market value of the stock on the day immediately preceding the date of grant or date of initial employment if later. Share options are exercisable for a period not to exceed 10 years from the date of grant. In general, share options vest over four years. 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, 1999, the maximum share options issuable under the Plans were 4,535,000, of which up to 400,000 shares may be issued under the restricted share provisions. At December 31, 1999, there were 1,451,913 share options or restricted shares (subject to 34 the above limitation) available for grant under the Plans. The Directors' Plan The Directors' Stock Option Plan (the "Directors' Plan") was established to provide non-employee directors with an opportunity to acquire or increase an equity interest in the Company. Under the Directors' Plan, 300,000 shares of common stock are reserved for issuance at an exercise price not less than fair value of the Company's common stock on the day immediately preceding the date of grant. Such share options vest 50% at the end of year one and 100% at the end of year two. Under the Directors' Plan 22,500, 52,500, and 22,500 share options were granted during 1999, 1998, and 1997, respectively. As of December 31, 1999, 195,000 share options were outstanding under the Directors' Plan, of which 146,250 are exercisable as of December 31, 1999. At December 31, 1999, there were 105,000 share options available for grant under the Directors' Plan. If the above Directors' Plan has reached its limit of grants per individual director, those non-employee directors eligible to receive annual share option grants under the above Directors' Plan may instead receive annual grants of non-qualified stock options to purchase 7,500 shares under the terms of the Company's 1998 Employee Share Option and Restricted Share Plan, as amended. Such options are to be for a term of 10 years and are exercisable 50% at the end of year one and 100% at the end of year two. In 1999, two non-employee directors were granted 15,000 share options in the aggregate with an exercise price equal to fair value at date of grant. These share options were not exercisable as of December 31, 1999. Consultants Prior to 1997, the Company granted share options to each of two consultants to purchase up to 225,000 shares of the Company's common stock, valid for 10 years from issuance, with varying exercise prices. Vesting periods are based on either the passage of time or upon the achievement of certain milestones. Of the aforementioned share options, 215,300 were exercisable as of December 31, 1999. The Company recognized $439,000, $439,000, and $985,000 in non-cash compensation expense, in accordance with SFAS 123, relating to the value of such share options (as determined using the Black-Scholes option pricing model) for the years ended December 31, 1999, 1998, and 1997, respectively. The Company expects to charge up to an additional $311,000 of non-cash compensation expense to operations through 2001 relating to such agreements. The following is a summary of the Company's share option activity and balances as of and for the years ended December 31, 1999, 1998, and 1997:
WEIGHTED- SHARE AVERAGE OPTIONS EXERCISE PRICE --------- -------------- Balance, January 1, 1997 2,503,756 $12.04 Granted 337,600 25.20 Exercised (262,925) 6.58 Canceled (156,942) 13.36 --------- ------ Balance, December 31, 1997 2,421,489 14.38 Granted 867,403 19.31 Exercised (178,678) 5.91 Canceled (197,984) 20.62 --------- ------ Balance, December 31, 1998 2,912,230 15.94 Granted 752,719 12.89 Exercised (61,064) 5.81 Canceled (378,231) 18.84 --------- ------ Balance, December 31, 1999 3,225,654 $15.08 ========= ======
35 Share options outstanding and exercisable by price range are as follows:
OPTIONS OUTSTANDING OPTIONS EXERCISABLE - ------------------------------------------------------------------------------------- ------------------------------------ WEIGHTED-AVERAGE WEIGHTED- WEIGHTED- RANGE OF OUTSTANDING AS OF REMAINING AVERAGE EXERCISABLE AS OF AVERAGE EXERCISE PRICES DECEMBER 31, 1999 CONTRACTUAL LIFE EXERCISE PRICE DECEMBER 31, 1999 EXERCISE PRICE - --------------- ----------------- ---------------- -------------- ----------------- -------------- $ 0.00 - $10.00 387,272 5.6 $ 5.52 387,272 $ 5.52 $10.01 - $20.00 2,667,681 7.2 15.85 1,089,920 16.17 $20.01 - $30.00 163,201 6.6 24.54 117,551 24.10 $30.01 - $40.00 7,500 7.7 30.63 7,500 30.63 --------- ---- ------ --------- ------ 3,225,654 7.0 $15.08 1,602,243 $14.25 ========= ==== ====== ========= ======
36 Pro Forma Option Information The per share weighted-average fair value of all share options granted during 1999, 1998, and 1997 was $7.76, $10.00, and $10.00, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions.
1999 1998 1997 ---- ---- ---- Expected dividend yield 0% 0% 0% Risk-free interest rate 5.9% 4.7% 6.2% Volatility 57.3% 62.5% 40.0% Expected life in years 4 4 4
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 SFAS 123, (using the Black-Scholes option pricing model), the Company's net loss would have been increased to the pro forma amounts indicated below:
YEARS ENDED DECEMBER 31, ---------------------------------------- 1999 1998 1997 -------- -------- -------- (in thousands, except per share data) Net loss As reported $(26,868) $(29,698) $(11,437) Pro forma $(32,903) $(32,827) $(12,532) Basic and diluted loss per share As reported $ (1.31) $ (1.52) $ (0.65) Pro forma $ (1.61) $ (1.69) $ (0.71)
(13) 401(k) PROFIT SHARING PLAN The Company has a 401(k) Profit Sharing Plan ("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 participant's contribution or may contribute a discretionary amount to the 401(k) Plan. Effective January 1997, the Company elected to make "matching contributions" of the Company's common stock equal to 50% of the first 6% of an employee's salary contributed to such employee's 401(k) Plan account. Such amounts vest 25% per year, based on a participant's years of service with the Company. The Company has made "matching contributions" of approximately $348,000, $308,000, and $241,000 for the years ended December 31, 1999, 1998, and 1997, respectively. (14) SIGNIFICANT CONTRACTS AND LICENSING AGREEMENTS Agreements with Amgen Inc. In August 1997, the Company entered into an agreement with Amgen (the "Agreement") relating to the research, development, and commercialization of the Company's FKBP-based neuroimmunophilin ligand technology ("FKBP Neuroimmunophilin Technology") for all human therapeutic and diagnostic applications. Pursuant to the terms of the Agreement, the Company received an aggregate of $35 million, consisting of a one-time non-refundable payment of $15 million upon the signing of the Agreement and $20 million for 640,095 37 shares of the Company's common stock and warrants, exercisable for five years, to purchase up to an additional 700,000 shares of the Company's common stock at $35.15 per share. In connection with the sale of these securities, the Company granted Amgen certain demand and "piggyback" registration rights under applicable securities laws. Under the terms of the Agreement, Amgen agreed to provide the Company with 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 recognized $4.5 million, $4.5 million, and $1.1 million in research support for the years ended December 31, 1999, 1998, and 1997, respectively. As of December 31, 1999, the Company has recognized in total approximately $10.1 million in research support. Additionally, the Agreement provides for certain milestone payments to the Company, in up to 10 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. As of December 31, 1999, the Company has received $6 million in milestone payments related to certain development milestones. Agreements with Aventis S.A. (formerly Rhone-Poulenc Rorer Pharmaceuticals Inc.) In June 1996, the Company entered into a Marketing, Sales, and Distribution Rights Agreement (together with related agreements, the "Aventis Agreements") with Aventis. Under the Aventis Agreements, Aventis has worldwide marketing rights (excluding Scandinavia and Japan) for GLIADEL(R) Wafer. The Company received $15 million upon the signing of these agreements ($7.5 million as an equity investment and $7.5 million as a non-refundable rights payment). On September 23, 1996, the Company obtained clearance from the FDA to market GLIADEL(R) Wafer for recurrent glioblastoma multiforme where surgical tumor removal is indicated and, accordingly, received a $20 million non-refundable milestone payment from Aventis. During 1999, the Company received $4.5 million in milestone payments for obtaining certain international regulatory approvals. Aventis is obligated to make up to $30.5 million (as amended in September 1998) in additional milestone payments, including $7.5 million in the form of an equity investment, only if the Company achieves certain domestic and international regulatory approvals. In addition, Aventis may also fund up to approximately $17 million for the development of a high-dose GLIADEL(R) Wafer product and fund certain additional clinical studies, if any, related to GLIADEL(R) Wafer. The Company manufactures and supplies GLIADEL(R) Wafer to Aventis and receives revenue from net product sales and royalties based on sales. Under the Aventis Agreements, the Company has the right to borrow up to an aggregate of $7.5 million under certain conditions, including $4 million that became available January 2, 1997, and the remainder no earlier than 12 months nor later than 18 months following funding of the initial $4 million. The loan proceeds are available to fund the expansion of the Company's facility supporting the production of GLIADEL(R) Wafer, and the construction of a second facility for the scale-up and production of GLIADEL(R) Wafer 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 Aventis on its most senior indebtedness. Both the principal and interest due under this agreement may, at the Company's election, be repaid by offsetting certain amounts due to the Company under the Aventis Agreements. The Company has not drawn down any of the available funds under the Aventis Agreements. In September 1998, the Company and Aventis amended its Aventis Agreements. Under the original Marketing, Sales, and Distribution Rights Agreement and related agreements, the Company was to conduct and pay for a U.S. Phase III clinical trial for first surgery indication for GLIADEL(R) Wafer. Independently, Aventis was already conducting and paying for an international Phase III clinical trial to support the first surgery indication for GLIADEL(R) Wafer, which included clinical sites in the United States. One of the principal amendments to the agreement now provides for the Company and Aventis to share the costs (subject to an aggregate cap of $3 million for the Company) of a single, multinational Phase III clinical trial. A second principal amendment provides for an equal splitting of the previously determined international regulatory milestones between first and recurrent surgery for market clearances of GLIADEL(R) Wafer 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 $24.0 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 Aventis' right of first offer, from six months on all new polymer oncology products, to 90 days and only on products being developed directly by Guilford specifically for brain cancer; elimination of Aventis' right to a seat on Guilford's Board of Directors at the time Aventis subscribes to $7.5 million in the Company's common stock upon any market clearance in the United States of GLIADEL(R) Wafer for first surgery; a clarification of the allocation of certain costs; and an acknowledgment that rights to 38 GLIADEL(R) Wafer 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 entered into licensing, technology transfer, and development agreements with The Johns Hopkins University under which it is required to make certain payments for patent maintenance costs, processing fees, license payments, and development payments. The Company has also agreed to spend approximately $800,000 per year through 2016 with respect to internal research and development activities to develop such technologies and may be required to make certain payments, as defined, to The Johns Hopkins University should agreed-upon milestones be attained. 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 (as defined) of payments received by the Company from sublicensees if any. The Company has also entered into various other licensing, research, and development agreements that 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 $2.9 million in the aggregate through 2005. 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 until February 1999, has billed the Company for facility rents related to the Company's research and development activities, aggregating approximately $334,000, $883,000, and $341,000 in 1999, 1998, and 1997, respectively. (16) EARNINGS (LOSS) PER SHARE The following table presents the computations of basic and diluted EPS:
1999 1998 1997 -------- -------- -------- (in thousands, except per share data) Net loss applicable to common stockholders $(26,868) $(29,698) $(11,437) ======== ======== ======== Weighted-average shares outstanding 20,475 19,479 17,570 -------- -------- -------- Total weighted-average diluted shares(1) 20,475 19,479 17,570 ======== ======== ======== Basic and diluted EPS $ (1.31) $ (1.52) $ (0.65) ======== ======== ========
(1) At December 31, 1999, 1998, and 1997, there were approximately 246,000, 652,000, and 1,293,000 instruments, respectively, that were considered antidilutive and, accordingly, excluded in the above calculation. (17) CONTINGENCIES The Company from time to time is involved in routine legal matters and contractual disputes incidental to its normal operations. In management's opinion, the resolution of such matters will not have a material adverse effect on the Company's consolidated financial condition, results of operations, or liquidity. 39 Stock Description and Form 10-K Our common stock is listed on the Nasdaq(R) National Market under the symbol "GLFD". As of March 10, 2000, we had approximately 236 holders of record of our common stock and in excess of 6,000 beneficial holders. We have never declared or paid any cash dividends and do not intend to do so for the foreseeable future. The following table sets forth the range of high and low sale prices for our common stock as reported on the Nasdaq(R) National Market for the periods indicated below.
High Low 1997 First Quarter $ 30.25 $ 20.50 Second Quarter 27.75 19.75 Third Quarter 31.63 20.50 Fourth Quarter 32.25 17.88 1998 First Quarter $ 24.88 $ 17.50 Second Quarter 24.00 17.00 Third Quarter 18.25 11.63 Fourth Quarter 18.88 11.19 1999 First Quarter $ 15.13 $ 9.75 Second Quarter 13.00 9.63 Third Quarter 17.50 12.00 Fourth Quarter 17.50 13.13 2000 First Quarter $ 38.25 $ 16.25 (through 3/10/00)
Shareholder Inquiries: Information about the Company can be obtained by contacting Guilford's investor relations department at (410) 631-5022 or through our website at www.guilfordpharm.com. Stockholders may obtain, at no charge, a copy of the Guilford Pharmaceuticals Inc. Form 10-K, filed with the Securities and Exchange Commission, by writing to: Guilford Pharmaceuticals Inc. Attn: Investor Relations 6611 Tributary Street Baltimore, Maryland 21224 EX-21.01 3 SUBSIDIARIES OF REGISTRANT 1 EXHIBIT 21.01 SUBSIDIARIES OF GUILFORD PHARMACEUTICALS INC. Below is a list of direct and indirect subsidiaries of the Corporation. All subsidiaries are wholly-owned. 1. GPI Holdings, Inc., a Delaware corporation 2. Gell Pharmaceuticals, Inc., a Delaware corporation 3. Holabird Holdings N.V., a Netherlands corporation 4. GPI Polymer Holdings, Inc., a Delaware corporation 5. GPI NIL Holdings, Inc., a Delaware corporation EX-23.01 4 CONSENT OF KPMG LLP 1 EXHIBIT 23.01 CONSENT OF INDEPENDENT AUDITORS The Board of Directors of Guilford Pharmaceuticals Inc.: We consent to incorporation by reference in the registration statements (No. 33-90828, No. 333-17833, No. 333-72319 and No. 333-30814) on Form S-8 and registration statements (No. 333-35415, No. 333-23001, No. 333-82397 and No. 333-87091) on Form S-3 of Guilford Pharmaceuticals Inc. of our reports dated February 11, 2000, relating to the consolidated balance sheets of Guilford Pharmaceuticals Inc. and subsidiaries as of December 31, 1999 and 1998, and the related consolidated statements of operations, changes in stockholders' equity and cash flows for each of the years in the three-year period ended December 31, 1999, and the related consolidated financial statement schedule, which reports appear in the December 31, 1999 annual report on Form 10-K of Guilford Pharmaceuticals Inc. /s/KPMG LLP Philadelphia, Pennsylvania March 28, 2000 EX-27.01 5 FINANCIAL DATA SCHEDULE
5 1,000 12-MOS DEC-31-1999 JAN-01-1999 DEC-31-1999 14,336 130,382 1,020 0 1,348 126,453 28,393 12,600 164,242 12,110 7,152 0 0 233 144,747 164,242 4,371 21,561 2,308 0 53,203 0 640 (26,868) 0 (26,868) 0 0 0 (26,868) (1.31) (1.31)

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(3)	Orion Corporation Pharma, which was formerly Orion Corporation Farmos, is our corporate partner for GLIADEL® Wafer in Scandinavia.

(4)	Orion Corporation Pharma has certain rights of first refusal for a high-dose GLIADEL® Wafer product in Scandinavia.

(5)	Daiichi Radioisotope Laboratories, Ltd. is our corporate partner for DOPASCAN® Injection in Japan, Korea and Taiwan.


	(1)	conducting appropriate preclinical laboratory and animal tests;

	(2)	submitting to the FDA an application for an IND, which must become effective before clinical trials may commence;

	(3)	conducting well-controlled human clinical trials that establish the safety and efficacy of the drug product;

	(4)	filing with the FDA a New Drug Application, or “NDA”, for non-biological drugs; and

	(5)	obtaining FDA approval of the NDA prior to any commercial sale or shipment of the non-biological drug.


	•	product efficacy and safety,

	•	timing and scope of regulatory approval,

	•	product availability,

	•	marketing and sales capabilities,

	•	reimbursement coverage,

	•	the amount of clinical benefit of our product candidates relative to their cost, method of administration,

	•	price, and

	•	patent protection.


	•	payments from Aventis from the sale and distribution of GLIADEL® Wafer,

	•	one-time signing fees from our corporate partners under our collaboration agreements supporting the research, development and commercialization of our product candidates,

	•	one-time payments from our corporate partners upon the achievement of specified regulatory or development milestones; for example, Aventis’ payment to us in July 1999 relating to approval in France to market and sell GLIADEL for the recurrent surgery indication, and

	•	periodic research funding under our collaboration with Amgen.


	•	new product development,

	•	the conduct of pre-clinical animal studies and human clinical trials,

	•	applying for and obtaining regulatory approval to market and sell product candidates,


	•	scale-up of the processes for making product candidates in quantities and qualities needed for research and development purposes to commercial scale manufacture needed to support marketing and sales of new products, and

	•	commercialization of new products.


	•	the successful marketing of GLIADEL® Wafer by Aventis,

	•	receipt of regulatory clearance to market and sell GLIADEL® Wafer in Europe,

	•	receipt of regulatory clearance to market and sell GLIADEL® Wafer for patients undergoing initial surgery for malignant glioma in the United States as well as Europe and other countries,

	•	the successful development and commercialization of product candidates that result from our collaboration with Amgen, and

	•	our ability to enter into additional collaborative arrangements and license agreements with other corporate partners for our product candidates and earlier stage technologies as we develop them.


	•	the timing and amount of sales of GLIADEL® Wafer to Aventis and Aventis’ sales to others,

	•	the timing and realization of milestone and other payments from our corporate partners, including Aventis and Amgen,

	•	the timing and amount of expenses relating to our research and development, product development, and manufacturing activities, and

	•	the extent and timing of costs related to our activities to obtain patents on our inventions and to extend, enforce and/or defend our patent and other rights to our intellectual property.


	•	the selection of one or more appropriate lead compounds,

	•	successful design and completion of pre-clinical and clinical development activities,

	•	application for and obtaining regulatory clearances to market potential products,

	•	commercialization of products, and

	•	the successful preservation and extension of the patent and other intellectual property rights licensed to Amgen.


	•	“We face technological uncertainties related to research, development and commercialization,”

	•	“We may be unable to protect our proprietary rights, permitting competitors to duplicate our products and services,”

	•	“We are dependent on licensed intellectual property,”

	•	“Pre-clinical and clinical trial results for our products may not be favorable,”

	•	“Our products use novel alternative technologies and therapeutic approaches which have not been widely studied,” and

	•	“Our business is dependent on our ability to keep pace with the latest technological changes.”


	•	unforeseen plant shutdowns due to personnel, equipment or other factors, and

	•	the possible inability of the facility to produce GLIADEL® Wafer in quantities sufficient to meet demand.


	•	expend substantial capital and effort to develop our product candidates further, which includes conducting extensive and expensive pre-clinical animal studies and human clinical trials,


	•	apply for and obtain regulatory approval to market and sell such product candidates, and

	•	conduct other costly activities related to preparation for product launch, among many other activities.


	•	our new approaches will not result in any products that gain market acceptance;

	•	a product candidate will prove to be unsafe or ineffective, or will otherwise fail to receive and maintain regulatory clearances necessary for marketing,

	•	a product, even if found to be safe and effective, could still be difficult to manufacture on the large scale necessary for commercialization or otherwise not be economical to market,

	•	a product will unfavorably interact with other types of commonly used medications, thus restricting the circumstances in which it may be used,

	•	proprietary rights of third parties will preclude us from manufacturing or marketing a new product, or

	•	third parties will market superior or more cost-effective products.


	•	corporate partners, such as Aventis and Amgen,

	•	academic investigators at universities, such as Johns Hopkins and others,

	•	licensors of technologies, such as Johns Hopkins, Massachusetts Institute of Technology and RTI,

	•	licensees of our technologies, such as Daiichi Radioisotope Laboratories, Ltd. and others.


	•	the progress of our research and development programs,

	•	the progress of pre-clinical and clinical testing,

	•	the time and costs involved in obtaining regulatory approvals,

	•	the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights,

	•	competing technological and market developments,


	•	changes in our existing research relationships with universities and others,

	•	our ability to establish collaborative arrangements with large pharmaceutical companies and others,

	•	the requirements and timing of entering into technology licensing agreements and other similar arrangements, and

	•	the progress of efforts to scale-up manufacturing processes.


	•	announcements by us or our competitors of clinical results, technological innovations, product sales, new products or product candidates,

	•	developments or disputes concerning patent or proprietary rights,

	•	regulatory developments affecting our products,

	•	period-to-period fluctuations in the results of our operations, and

	•	market conditions for emerging growth companies and biopharmaceutical companies.


	•	obtain, maintain and enforce intellectual property protection for our products and processes,

	•	license rights to patents from third parties,

	•	maintain trade secret protection, and

	•	operate without infringing upon the proprietary rights of others.


	•	these parties will not honor our confidentiality agreements,

	•	others will independently develop equivalent or competing technology,

	•	disputes will arise concerning the ownership of intellectual property or the applicability of confidentiality obligations, or

	•	disclosure of our trade secrets will occur regardless of these contractual protections.


	•	exercise diligence in the research and development of these technologies,

	•	achieve specified development and regulatory milestones,

	•	expend minimum amounts of resources in bringing potential products to market,

	•	make specified royalty and milestone payments to the party from which we have licensed the technology, and

	•	reimburse patent costs to these parties.


	•	adequate steps have not been taken to commercialize such inventions,

	•	the grant is necessary to meet public health or safety needs, or

	•	the grant is necessary to meet requirements for public use under federal regulations.


	•	we will not be able to satisfy the FDA’s requirements with respect to any of our drug product candidates or with respect to the proposed expanded labeling for GLIADEL® Wafer for patients undergoing initial surgery for malignant glioma, or

	•	even if the FDA does approve our product candidates or expanded labeling, the FDA will approve less than the full scope of uses or labeling that we seek.


	•	drug products intended to treat severely debilitating or serious or life-threatening diseases, and

	•	drug products that provide meaningful therapeutic benefit to patients over existing treatments, that potentially address an unmet medical need, or that are for diseases for which no satisfactory or comparable therapy exists.


	•	the treatment of malignant glioma,

	•	the diagnosis of Parkinson’s disease,

	•	the promotion of nerve growth and repair,

	•	the treatment and prevention of neuronal damage, and

	•	the treatment of cocaine addiction.


	•	capabilities of our collaborators,

	•	product efficacy and safety,

	•	timing and scope of regulatory approval,

	•	product availability,

	•	marketing and sale capabilities,

	•	reimbursement coverage from insurance companies and others,

	•	the amount of clinical benefit of our product candidates relative to their cost,

	•	the method of administering a product,


	•	expend capital to acquire and expand such capabilities,

	•	reach collaborative arrangements with third parties to provide these capabilities, or

	•	contract with third parties to provide these capabilities.


	•	medicinal chemistry and other research specialties,

	•	pre-clinical testing,

	•	clinical trial management,

	•	regulatory affairs,


	•	our Board of Directors approves of the transaction before the third party acquires 15% of our stock,

	•	the third party acquires at least 85% of our stock at the time its ownership goes past the 15% level, or

	•	our Board of Directors and two-thirds of the shares of our common stock not held by the third party vote in favor of the transaction.


†	Confidential treatment of certain portions of these agreements has been granted by the Securities and Exchange Commission.