FORM 10-K
(MARK ONE)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended June 30, 2002
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 000-26658
PHARMACYCLICS, INC.
(Exact name of Registrant as Specified in its Charter)
|
|
|
|
995 E. Arques Avenue
Sunnyvale, California 94085-4521
(Address of Principal Executive Offices including Zip Code)
(408) 774-0330
(Registrant's Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act: None
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, $.0001 Par Value
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 (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes 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.
The aggregate market value of the voting stock held by nonaffiliates of the Registrant as of August 31, 2002, was approximately $35,964,000 based on the closing price of the Common Stock of the Registrant as reported on the NASDAQ National Market on such date. The number of outstanding shares of the Registrant's Common Stock as of August 31, 2002 was 16,189,563.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the following document are incorporated by reference into Part III of this Form 10-K: the Proxy Statement for the Registrant's 2002 Annual Meeting of Stockholders scheduled to be held on December 11, 2002.
PHARMACYCLICS, INC.
ANNUAL REPORT ON FORM 10-K
FOR THE FISCAL YEAR ENDED JUNE 30, 2002
TABLE OF CONTENTS
Part I. |
|
Page |
Item 1. |
Business | |
Item 2. |
Properties | |
Item 3. |
Legal Proceedings | |
Item 4. |
Submission of Matters to a Vote of Security Holders | |
Part II. |
|
|
Item 5. |
Market for the Registrant's Common Equity and Related Stockholder Matters | |
Item 6. |
Selected Financial Data | |
Item 7. |
Management's Discussion and Analysis of Financial Condition and Results of Operations | |
Item 7a. |
Quantitative and Qualitative Disclosures About Market Risks | |
Item 8. |
Financial Statements and Supplementary Data | |
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosures | |
Part III. |
|
|
Item 10. |
Directors and Executive Officers of the Registrant | |
Item 11. |
Executive Compensation | |
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | |
Item 13. |
Certain Relationships and Related Transactions | |
Part IV. |
|
|
Item 14. |
Exhibits, Consolidated Financial Statement Schedules, Exhibits and Reports on Form 8-K | |
Signatures |
| |
Exhibits Index |
|
PHARMACYCLICS®, the "pentadentate" logo® , Xcytrin®, Antrin® and Lutrin® are registered U.S. trademarks; Optrin™ is a trademark of Pharmacyclics, Inc. Other trademarks, trade names or service marks used herein are the property of their respective owners.
Part I
Item 1. Business
We are a pharmaceutical company developing products to improve upon current therapeutic approaches to the treatment of cancer and atherosclerosis. We use our expertise in the chemistry of porphyrin-like biomolecules to develop patented compounds called texaphyrins. Texaphyrins are a new class of molecules that are rationally designed to accumulate in diseased cells and disrupt energy metabolism. When injected into the bloodstream, these molecules selectively accumulate in tumor growths and in the diseased portions of major blood vessels. When the cells are exposed to various treatments, such as radiation therapy, chemotherapy or phototherapy, texaphyrins become activated and are capable of destroying diseased tissue with minimal damage to surrounding healthy cells. Our lead texaphyrin-based product candidates are:
Our technology is based upon our expertise in developing biologically active engineered porphyrin molecules that disrupt cellular bioenergetics and are capable of being activated by energy. In nature, a class of molecules called porphyrins, including heme found in hemoglobin and chlorophyll found in plants, is found in tissues or organs responsible for energy production, metabolism or transport functions. Our texaphyrins, which are synthetic, expanded porphyrins, are designed to take advantage of two key characteristics of naturally occurring porphyrins: interaction with energy and selective accumulation in tissues with high energy demands. Texaphyrins target diseased cells and, by interfering with normal metabolism, disrupt the flow of energy in the cell. These cells become more vulnerable or responsive to various treatments such as radiation therapy and chemotherapy of cancer. Texaphyrins may be used for targeted destruction of diseased tissues.
Many diseased cells, including cancer, have metabolic derangements that distinguish them from normal cells. Texaphyrins target these metabolic disturbances and accumulate at the disease site, which generally occurs in minutes to a few hours. Following the selective accumulation of texaphyrins in diseased tissue, the appropriate treatment with radiation therapy, chemotherapy or phototherapy can be given with an increase in the therapeutic activity.
Market Overview
Cancer
Cancer results from the uncontrolled multiplication of cells which invade and interfere with the normal function of adjacent tissues and organs. Frequently, cancer cells become dislodged from their primary site and spread, or metastasize, to other places in the body. Approximately 1.2 million new cases of cancer are diagnosed annually in the United States. The appropriate cancer therapy for each patient depends on the cancer type and careful assessment of the size, location and existence of spread of the tumor using diagnostic imaging procedures. Therapy typically includes some combination of surgery, radiation therapy or chemotherapy.
Chemotherapy and radiation therapy tend to indiscriminately destroy both healthy and diseased cells and cause serious side effects. As a result, substantial cancer research has been directed toward improving the effectiveness of existing therapy while reducing toxicity. These approaches seek to identify drugs which are capable of targeting the tumor and making the cancer cells more sensitive and responsive to radiation therapy or chemotherapy. The following is a description of the market for therapies used in the treatment of cancer:
Atherosclerosis
Atherosclerosis, or hardening of the arteries, is a disease in which cholesterol, other fatty materials and inflammatory cells are deposited in the walls of blood vessels, forming a build-up known as plaque. The accumulation of plaque narrows the interior of the blood vessels, reducing blood flow. Atherosclerosis in the coronary arteries can lead to heart attack and death. In other blood vessels, atherosclerosis can lead to decreased mobility, loss of function, loss of limbs and other complications such as stroke. Atherosclerosis also can often result from the accumulation of inflammatory cells in the vessel wall. These diseased areas are vulnerable to mechanical stress and can acutely rupture causing a blood clot to form in the vessel. Heart attacks are frequently caused by rupture of a vulnerable plaque.
Current treatments for atherosclerosis include surgery and other techniques aimed at removing or relieving the plaque. Balloon angioplasty is a procedure using catheter devices inserted inside the vessels to mechanically compress or remove the obstruction. Currently, more than 600,000 patients per year in the United States undergo these procedures for treatment of atherosclerosis in the coronary arteries. These procedures require the use of anti-clotting drugs and, frequently, the use of devices inserted inside the vessels to reduce the incidence of reclosure, which results from traumatic damage to the vessel wall. Generally, these techniques have been limited to treating only short sections of the diseased vessel.
Our Business Strategy
The key elements of our business strategy include:
Status of Products Under Development
The table below summarizes our product candidates and their stage of development:
Product Targeted Disease Clinical Program Status (1) Marketing Rights - --------------------------------------------------------------------------------------------------------- CANCER THERAPY - --------------------------------------------------------------------------------------------------------- XCYTRIN Brain metastases Phase III - planned (2) Pharmacyclics Radiation Enhancer Primary brain tumor Phase II - complete Pharmacyclics Pancreatic cancer Phase I, National Cancer Institute Pharmacyclics Childhood gliomas Phase I, National Cancer Institute Pharmacyclics Lung cancer Phase I, National Cancer Institute Pharmacyclics - --------------------------------------------------------------------------------------------------------- XCYTRIN A variety of cancers Phase I with Doxorubicin Pharmacyclics Chemotherapy Enhancer XCYTRIN with Head and neck cancer Phase I Pharmacyclics Chemotherapy and Radiation therapy - --------------------------------------------------------------------------------------------------------- ATHEROSCLEROSIS THERAPY - --------------------------------------------------------------------------------------------------------- ANTRIN Peripheral Phase II Pharmacyclics Phototherapy artery disease Coronary artery disease Phase I Pharmacyclics
Cancer Therapy
Xcytrin for use in combination with Radiation Therapy
Radiation therapy destroys cancer cells through exposure to relatively high doses of externally applied radiation. While cancer cells are somewhat more sensitive to radiation exposure than healthy tissues, radiation therapy has toxic effects on healthy tissue surrounding the tumor because the radiation cannot be adequately targeted. Our preclinical studies indicate that Xcytrin both accumulates in tumors and increases the responsiveness of cancers to radiation therapy. Cancer cells have derangements in their metabolism and bioenergetics, which distinguishes tumors from normal tissues. Xcytrin's uptake in tumor cells occurs within minutes of administration and persists for hours, effectively concentrating the drug's effect in the tumor. Xcytrin has a novel mechanism of action, which is based on its affinity for the flow of electrons inside cells. By capturing electrons, Xcytrin disrupts cellular energy production by disturbing the flow of energy in cellular metabolism. The disruption of energy production weakens the tumor cells, which may render them more vulnerable to attack by radiation therapy or chemotherapy. In preclinical studies, animals receiving Xcytrin in conjunction with radiation therapy had greater tumor response rates as compared to the control groups receiving equivalent doses of radiation therapy alone. Preclinical studies further indicate that Xcytrin increases the effect of radiation therapy at the tumor site, with no increased damage to surrounding healthy tissues. An additional feature of Xcytrin is that it is detectable by magnetic resonance imaging scanning (MRI), providing a method of monitoring its distribution in patients.
For our first product, we intend to seek FDA approval of Xcytrin for treatment of patients receiving whole brain radiation therapy for non-small cell lung cancer that has spread to the brain. Patients with this problem, known as brain metastases, develop devastating complications, including severe headache, seizures, paralysis, blindness and impaired ability to think. Radiation therapy for treatment of this problem is performed on approximately 90,000 patients per year in the United States and is intended to prevent or reduce these complications. We believe that Xcytrin could eventually be used in many other tumor types and clinical situations requiring radiation therapy.
Clinical Status. We have completed a Phase I clinical trial of Xcytrin in 38 adult patients with advanced cancer who received radiation therapy. This trial was designed to determine the toxicity of a single dose of the drug. Reversible kidney toxicity was found at the highest doses of drug tested. Accumulation of Xcytrin in lung cancer, breast cancer and other tumors has been confirmed using magnetic resonance imaging. The results of this study were published in the journal Clinical Cancer Research in 1999.
We have also completed an international multicenter Phase Ib/II clinical trial in 61 patients to evaluate the safety and efficacy of Xcytrin in cancer patients receiving radiation therapy for treatment of tumors which had spread to the brain. Ten once-daily treatments were well tolerated. The maximally tolerated dose was 6.3 mg/kg. Dose limiting toxicity was found to be reversible elevation of liver function tests. The most common side effects were transient skin discoloration. Other adverse events occurring in at least ten percent of patients included nausea, vomiting, rash, headache and weakness. Xcytrin's tumor selectivity was established by MRI. The radiologic response rate was 72% in the phase II portion of the study. Death due to tumor progression in the brain was seen in 12% of Xcytrin-treated patients. After 6 months and 12 months, 41% and 25% of Xcytrin-treated patients were alive. These results were published in 2001 in the Journal of Clinical Oncology. Although there was no control group in the study, the results suggested that Xcytrin increased tumor control in the brain beyond that expected with radiation alone.
Based on the results of our Phase Ib/II trial, we conducted a randomized, controlled Phase III trial with Xcytrin for the treatment of patients with brain metastases (i.e. cancer that has spread to the brain from another part of the body) who are undergoing whole brain radiation therapy. The study was conducted at more than 50 leading cancer centers in the United States, Canada and Europe and enrolled 401 patients: 251 with lung cancer, 75 with breast cancer and 75 with other tumor types.
This study was designed to compare the safety and efficacy of standard whole brain radiation therapy (WBRT) to standard WBRT plus Xcytrin. The study had co-primary efficacy endpoints of survival and time to neurologic progression. An independent events review committee (ERC), blinded to the treatment assignment, determined neurologic progression based on prespecified criteria. The trial design also included evaluation of neurologic progression to be determined by investigator assessment.
Although the trial did not meet its primary endpoints for the entire patient population, there was a significant improvement in time to neurologic progression in the pre-specified stratum of lung cancer patients receiving Xcytrin, which represented over 60 percent of the total patients on the study. Results from the events review committee and the investigators consistently showed that the lung cancer patients had a benefit in time to neurologic progression.
By investigator neurologic assessment, treatment with Xcytrin was associated with improved time to neurologic progression in the entire 401 patient population (P=0.018) with the benefit confined to the lung cancer stratum. Neurologic progression determined by the events review committee did not show a benefit of Xcytrin in the overall study population but did show a benefit in the lung cancer stratum (P=0.048, unadjusted).
The majority of patients with brain metastases have extensive disease outside the brain and frequently die from causes unrelated to tumor growth in the brain. There was no significant difference in survival in patients who received Xcytrin (median 5.2 months) or who did not receive Xcytrin (median 4.9 months). We believe this lack of survival difference is due to death from tumor progression outside the brain, which would not be expected to be controlled by whole brain radiation therapy.
In our trial, patients with lung cancer differed substantially from patients with breast and other cancers. Lung cancer patients more often presented with brain metastases at their initial primary tumor diagnosis, had brain as the only known site of metastases, had smaller tumor volume and less prior therapy. There are several possible reasons for the observed benefit in time to neurologic progression seen in the lung cancer sub- group. We believe that less extensive extracranial disease, more rapid and reversible development of central nervous system signs and symptoms and less exposure to prior neurotoxic chemotherapies provided a greater opportunity to demonstrate a clinical benefit in this group of patients.
Neurocognitive function was one of the secondary endpoints of our study. Performance on neurocognitive tests is related to the patient's ability to manage finances, recognize safe and unsafe behaviors, and remember and comply with medication regimens. Consistent with the results of the ERC and investigator time to neurologic progression, neurocognitive testing revealed a benefit in prolonging time to neurocognitive progression in six tests of memory and executive function for lung cancer patients treated with Xcytrin.
The administration of Xcytrin was well tolerated with 97% of the intended doses delivered during the trial. Serious drug related adverse events that were noted include hypertension (5.8%), asthenia (2.6%), hyponatremia (2.1%), leukopenia (2.1%), hyperglycemia (1.6%) and vomiting (1.6%).
Based on the clinical activity seen in our Phase III trial in patients with brain metastases from lung cancer, we plan to conduct a second Phase III clinical trial to confirm the potential clinical benefits observed in patients with brain metastases from non-small cell lung cancer. We plan to enroll 550 patients in this international, randomized controlled trial. Patients will be randomized to receive either Xcytrin plus WBRT or WBRT alone. A battery of neurologic and neurocognitive assessments will be made with the goal of establishing that the function of the brain is improved with Xcytrin. Time to neurologic progression, the primary study endpoint, will be determined by a blinded events review committee. Time to neurologic progression is a clinical benefit endpoint of special importance in patients with brain metastases since the majority of patients with brain metastases experience neurologic decline despite the use of WBRT. Physicians give patients with brain metastases WBRT to help prolong the time before the neurologic progression occurs. Secondary endpoints of this trial will include survival, neurocognitive function and time to loss of functional independence.
We have reviewed our second Phase III protocol with the FDA. The FDA has indicated that the primary endpoint of the trial, time to neurologic progression, is an approvable endpoint. We are currently working with the FDA and our clinical investigator sites to finalize all the protocol elements and specific methods for scoring time to neurologic progression. We expect to begin enrolling the trial by the end of calendar 2002.
In addition to our studies in patients with tumors that have spread to the brain, the National Cancer Institute has agreed to sponsor several clinical trials with Xcytrin for additional cancer types:
TARGETED DISEASE LOCATION STATUS - ------------------------- --------------------------------------------- ------------------ Primary Brain Tumor UCLA Medical Center Phase I completed Primary Brain Tumor Ohio State University Enrolling patients Primary Brain Tumor NABTT (New Approaches to Brain Tumor Enrolling patients Therapy Consortium, comprised of ten centers) Pediatric Brain Tumors, Children's Oncology Group (COG), Enrolling patients including Childhood formerly Children's Cancer Group (CCG), Glioma a consortium of U.S. Children's Hospitals Lung Cancer Ohio State University Enrolling patients Pancreatic Cancer University of Pittsburgh Enrolling patients Pancreatic Cancer University of Wisconsin Enrolling patients Pancreatic Cancer Dartmouth University Enrolling patients
Xcytrin for Use In Combination With Chemotherapy
We are conducting preclinical studies with Xcytrin for use in combination with certain chemotherapy agents. Chemotherapy destroys cancer cells by interfering with their metabolism, protein synthesis or cell division. Because these agents are not tissue-selective, cancer chemotherapy agents produce serious or life-threatening side effects which compromise quality of life and increase medical costs for cancer patients. Preclinical studies conducted by us and our collaborators indicate that Xcytrin increases the responsiveness of tumors to treatment with certain chemotherapy agents. We believe this effect is related to Xcytrin's ability to disrupt cellular bioenergetics increasing the vulnerability of the cancer cells to cytotoxic chemotherapy. Xcytrin's uptake in tumors enhances the activity of cancer chemotherapy agents in tumor cells but not in normal tissues, thereby increasing the therapeutic margin, which is the difference between the therapeutic dose of a drug and the toxic dose of a drug. In preclinical studies, animals receiving Xcytrin and chemotherapy with either bleomycin or doxorubicin had enhanced tumor responses and survival rates as compared to control groups receiving equivalent doses of chemotherapy alone. Because of the encouraging preclinical data, we have begun a Phase I study evaluating Xcytrin in combination with doxorubicin that is currently enrolling patients. A Phase I study in head and neck cancer has also been initiated, which is evaluating Xcytrin in combination with radiation and chemotherapy.
Xcytrin for HIV
In vitro studies done in collaboration with researchers at Stanford University Medical Center and published in the Proceedings of the National Academy of Sciences in February, 2002, have shown that Xcytrin selectively localizes in and destroys HIV infected human lymphocytes. Normal lymphocytes and uninfected lymphocytes from HIV patients are not affected. These studies showed that Xcytrin inhibited viral replication in vitro. The mechanism of action of this activity was found to be related to Xcytrin's ability to generate reactive oxygen species, highly cytotoxic substances, in the infected cells. Based on the in vitro studies elucidating this novel mechanism of action, we filed an IND with the FDA to evaluate the potential use of Xcytrin in patients with HIV that is resistant to standard anti-viral drugs. FDA has notified us that additional laboratory studies will be required before we can begin this clinical trial. We plan to perform additional in vitro and animal- studies to determine whether and when to proceed with clinical trials.
Atherosclerosis Therapy
Antrin Phototherapy of Atherosclerosis.
Preclinical studies conducted by Pharmacyclics and our collaborators have demonstrated that texaphyrins also accumulate in vascular plaque caused by atherosclerosis. Preclinical studies indicated that following intravenous injection of Antrin, light delivered into the blood vessel using an optical fiber resulted in non-mechanical reduction or elimination of the plaque without damage to the lining of the vessel. Antrin Phototherapy resulted in the elimination of inflammatory cells from the diseased vessel wall. Current treatments of atherosclerosis, such as balloon angioplasty, require anti- clotting drugs and the use of devices inserted inside the vessels to reduce the incidence of reclosure. We believe that these results suggest that Antrin Phototherapy has the potential to eliminate or reduce plaque without complications such as thrombosis and reclosure. Additional preclinical studies further indicated that Antrin Phototherapy could be used to treat longer segments of blood vessels, which is not possible with other currently available techniques. Antrin's accumulation in plaque and relatively rapid clearance from blood may provide advantages over alternative treatments for atherosclerosis. Removal of inflammatory cells also suggests that Antrin may reduce or stabilize vulnerable plaque. Vulnerable plaque is rich in inflammatory cells and prone to rupture causing a sudden blood clot and closure of the vessel. Preclinical studies have shown that Antrin and other texaphyrins accumulate in the inflammatory cells within atherosclerosis and that following phototherapy the number of these cells is reduced. These data suggest that Antrin Phototherapy may be useful for the treatment or stabilization of vulnerable plaque.
Clinical Status. In April 1999, we completed enrollment in our Phase I study with Antrin phototherapy for patients with peripheral arterial disease. Fifty-one patients received an injection of Antrin and 47 qualified to receive phototherapy of the lower extremities. The two-part study was designed to first establish an optimum dose of Antrin by treating successive groups of patients with increasing single doses of the drug. In the second part of the study, we evaluated three doses of light at several drug dose levels. We gave Antrin intravenously and delivered light to the inside of the diseased vessel using a 0.89mm optical fiber. We evaluated patients for toxicity and local arterial responses by follow-up angiograms and intravascular ultrasound performed the day of and 28 days after phototherapy. Clinical activity was evaluated using several well-established techniques. The ankle- brachial index and the Rutherford-Becker standardized classification of clinical outcomes were measured. The ankle-brachial index is a measurement of the impact of the obstruction on blood pressure in the affected limb. The Rutherford-Becker classification scores, which are based on standards for evaluating and reporting the results of surgical or percutaneous therapy for peripheral arterial disease, measure the change in clinical symptoms due to the treatment intervention.
The results of the Phase I drug- and light-dose escalation study were published in the journal Circulation in November 2000. The results indicated that Antrin phototherapy was well tolerated. There was no evidence of dose-limiting systemic or vascular toxicities in the drug and light dose ranges tested. No skin phototoxicity or treatment-related clinical laboratory abnormalities were reported. There was no evidence of thrombus, emboli or vessel wall damage. Mild and self-limited paresthesias, or tingling, in the fingertips was observed in patients receiving higher doses of drug. Four patients reported mild and transient skin rash. Baseline and day-28 paired angiograms were available for 43 patients. Overall, these indicated improvement in minimal luminal diameter on day 28 compared to baseline. Intravascular ultrasound data also indicated no evidence of vascular damage, thrombus, or hemorrhage in the treated vessel segments. There were no deleterious effects observed in adjacent untreated segments of vessel wall. The Rutherford-Becker classification and ankle-brachial index measurements were used to evaluate clinical responses to treatment in forty-seven patients. Rutherford-Becker scores improved in sixty two percent of these patients, and ankle-brachial index measurements at day 28 improved in fifty seven percent of patients. The authors concluded that the preliminary efficacy data suggested that there was a potential role for Antrin phototherapy for the treatment of atherosclerosis.
We completed enrollment of a randomized Phase II clinical trial with Antrin for patients with peripheral arterial disease of the lower extremities. The study is designed to evaluate both prevention of restenosis following balloon angioplasty and primary treatment of atherosclerosis. 150 patients have been enrolled in this study and are being evaluated with follow up angiograms.
We also completed enrollment of a Phase I clinical trial with Antrin for the treatment of coronary artery disease in patients receiving balloon angioplasty and stents. This study is primarily designed to evaluate the safety of various doses of drug and light. Patients are receiving follow-up angiograms six months after treatment to evaluate effects of the treatment on the blood vessels. In September 2001, we reported interim results of this trial at the European Society of Cardiology and the Transcatheter Cardiovascular Therapeutics meetings, which indicate that Antrin phototherapy is safe and feasible to perform in the coronary arteries.
We believe the optimum role for Antrin phototherapy will be in the treatment or stabilization of vulnerable plaque. We currently plan to establish a corporate alliance for Antrin before performing any additional clinical development.
Other Products
Lutrin® for Photodynamic Therapy of Cancer
Photodynamic therapy is a cancer treatment based on the use of light energy to activate certain types of drugs known as photosensitizers. In this procedure, the photosensitizer, ideally one which accumulates more readily in tumor cells, is injected into the patient. The tumor site is then illuminated with visible light of a strength and wavelength that is absorbed by the photosensitizer. Once so activated, the photosensitizer causes tumor cell death.
To date, photodynamic therapy has been approved only for the treatment of superficial or small lesions because existing photosensitizers have been unable to absorb light capable of penetrating deeply into tissues. Lutrin is activated by light of 720 to 760 nanometers, wavelengths that are optimal for penetrating through tissue, blood and skin pigmentation such as melanin. After absorbing light of the wavelength, Lutrin becomes activated to its tumor cell killing state. Preclinical studies indicate that Lutrin selectively accumulates in a variety of cancer cells.
We have initially studied Lutrin for photodynamic therapy of patients with invasive surface cancers that are accessible to externally applied light, such as recurrent breast cancer to the chest wall. The National Cancer Institute is sponsoring Phase I studies of Lutrin for treatment of cancer of the prostate and cervix. We plan to continue to supply drug and light devices for the National Cancer Institute studies of Lutrin but do not plan to conduct any additional clinical studies ourselves.
Optrin™ for Treatment of Retinal Degeneration
Pharmacyclics and our collaborators have conducted preclinical studies with Optrin for treatment of degeneration of the retina caused by abnormal growth of blood vessels. These studies have indicated that Optrin selectively eliminates abnormal retinal capillaries after activation by light of an appropriate wavelength. We entered into a development agreement with Alcon, an ophthalmic products company. Under this agreement, we provided Optrin to Alcon for further preclinical and clinical development. Alcon conducted Phase I and II studies with Optrin. In 2001, Alcon terminated its rights under the development agreement and, in accordance with the development agreement, returned to us all data associated with Alcon's development of Optrin. We do not plan to do any further development of Optrin ourselves.
Citra Vu™ for Imaging the Gastrointestinal Tract.
Our oral magnetic resonance imaging contrast agent, Citra Vu, is not a texaphyrin, but is based on one of our patented compounds. Citra Vu was developed for use in imaging the gastrointestinal tract in patients undergoing MRI procedures of the abdomen or the pelvis. Citra Vu is an orange- flavored oral formulation designed to fill the bowel uniformly to improve diagnosis of abdominal or pelvic diseases.
We have granted E-Z-EM, Inc. exclusive rights to sell Citra Vu in North America and granted E-Z-EM's affiliate, E-Z-EM, Ltd., exclusive rights to sell Citra Vu in Europe. We do not expect significant revenue from this product should E-Z-EM, or its affiliate, market it in the future.
Research, Clinical Development and Marketing Collaborations
We rely on relationships with third parties to expand certain research, clinical development, process development, manufacturing, sales and marketing functions. In the photodynamic therapy field, we have used outside collaborations for development of light sources and delivery devices for use in our preclinical studies and clinical trials so that we could focus on development of our proprietary photosensitizing products.
National Cancer Institute Collaboration. In April 1997, the Decision Network Committee of the National Cancer Institute Division of Cancer Treatment, Diagnosis and Centers voted unanimously to sponsor and fund clinical development of both Xcytrin as a radiation enhancer and Lutrin as a photosensitizer for cancer treatment. Under this cooperative research and development agreement, Pharmacyclics and the National Cancer Institute jointly select clinical trials which will be conducted at leading medical centers for various types of cancer. For Xcytrin, the National Cancer Institute is conducting several separate clinical trials for treatment of brain tumors and cancers involving the lung and pancreas. For Lutrin, the National Cancer Institute is conducting clinical trials for cancer of the prostate and cervix. We believe that these National Cancer Institute-sponsored trials will supplement our own clinical development efforts for both Xcytrin and Lutrin. Although third parties will be conducting the trials, we will provide clinical supplies of our drugs and we intend to monitor the progression and results of these trials.
The University of Texas Agreements. We collaborate with and sponsor research and development programs at The University of Texas at Austin, through a group headed by Jonathan Sessler, Ph.D., Professor of Chemistry at The University of Texas at Austin. Such collaborations and programs extend our research capabilities in the field of expanded porphyrin chemistry. We have entered into two license agreements with The University of Texas at Austin that grant us the worldwide, exclusive right to patents or patent applications that relate to or result from research conducted at The University of Texas at Austin on the use, development and syntheses of expanded porphyrin molecules, and research conducted at The University of Texas at Dallas on the incorporation of paramagnetic metals into zeolites for use as MRI contrast agents. These agreements require us to pay royalties as a percentage of net sales to The University of Texas for products incorporating the licensed technology, including each of our current product candidates. In addition, we and The University of Texas at Austin have entered into sponsored research agreements which expand the products, inventions and discoveries developed by The University of Texas at Austin to which our license rights apply. In connection with The University of Texas license agreements, we also entered into a license agreement with an individual co-inventor of Citra Vu, pursuant to which we have been granted an exclusive royalty-bearing license to manufacture, use and sell certain products that fall within the scope of The University of Texas at Dallas license agreement.
Alcon Collaboration. In December 1997, we entered into an evaluation and license agreement with Alcon Pharmaceuticals, Ltd. under which Alcon acquired worldwide marketing rights to Optrin for ophthalmology uses. Alcon, a wholly-owned subsidiary of Nestlé S.A., is a global leader in the research, development, manufacturing and marketing of ophthalmic products. Under the terms of the agreement, we received an upfront fee for Alcon to evaluate Optrin for ophthalmology uses for a specified time period. Alcon completed the evaluation and paid us a milestone payment in fiscal 2000. In October 2001, Alcon terminated its rights under the agreement.
Nycomed Collaboration. In October 1997, we entered into an agreement with Nycomed, granting Nycomed exclusive sales and marketing rights to Lutrin for different types of cancer in all markets excluding the United States, Canada and Japan. In exchange for these rights, Nycomed agreed to pay us up to approximately $14.0 million in license fees and cost reimbursement, based upon an agreed budget, milestone payments and development cost subsidies related to the initial cancer uses for Lutrin to be developed by us and Nycomed. In each case, we were to reach certain development, clinical or commercialization milestones to receive payment. Nycomed agreed to bear a portion of the device and clinical development costs required for regulatory submission for product approval in the United States. We were required to supply bulk drug substance to Nycomed through our manufacturing collaborations. Nycomed was required to produce finished product for our use. In May 2001 we and Nycomed terminated this agreement. Pursuant to the termination agreement, we reacquired all our rights from Nycomed to develop and market Lutrin, and Nycomed agreed to make a non-recurring termination payment to Pharmacyclics of $2,750,000. The termination payment was recorded as revenue in the fourth quarter of fiscal 2001.
Patents and Proprietary Technology
We believe our success depends upon our ability to protect our proprietary technology. We, therefore, aggressively pursue, prosecute, protect and defend patent applications, issued patents, trade secrets, and licensed patent and trade secret rights covering certain aspects of our technology.
Our patents, patent applications, and licensed patent rights cover various compounds, pharmaceutical formulations and methods of use. We own or have license rights to:
The issued U.S. patents expire between 2009 and 2019. We also own or license 108 issued non-U.S. patents including 73 patents issued throughout Europe and 116 pending non-U.S. patent applications filed regionally under the Patent Cooperation Treaty and with the European Patent Office, and nationally in Canada, Japan, Australia and certain other countries.
We may be unsuccessful in prosecuting our patent applications or patents may not issue from our patent applications. Even if patents are issued and maintained, these patents may not be of adequate scope to benefit us, or may be held invalid and unenforceable against third parties.
We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position. We require all of our employees, consultants, advisors and collaborators to execute appropriate confidentiality and assignment-of- inventions agreements. These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances, and these agreements provide that all inventions arising out of the relationship with Pharmacyclics shall be our exclusive property.
Drug and Device Supply Agreements
We currently use third parties to manufacture various components of our products under development.
Texaphyrin-based Products. In September 1996, we entered into an agreement with Hoechst Celanese Corporation, a manufacturer of chemicals and pharmaceutical intermediates, to optimize and scale up a manufacturing process for and supply of our texaphyrin-based products. In October 1997, Hoechst Celanese assigned the agreement to Celanese, Ltd. in connection with Hoechst Celanese's corporate restructuring. This agreement granted Celanese exclusive worldwide manufacturing rights and required Celanese to supply all of our texaphyrin-based products for late-stage clinical and commercial use. As a result of the change in its business focus, Celanese requested that we pursue alternative supply sources. On August 27, 1999, we entered into an agreement to terminate the manufacturing and supply agreement with Celanese. Pursuant to that agreement, Celanese assigned to us all right, title and interest in and to the manufacturing technology and intellectual property for our texaphyrin-based products and agreed to make a cash payment of $750,000 to us. The termination agreement also relieved us of all obligations to pay Celanese for shared development costs incurred prior to termination of the agreement.
During discussions with Celanese that resulted in the termination of the manufacturing and supply agreement, we decided to change our manufacturing strategy to divide the manufacturing process for our texaphyrin- based products into three intermediates. We have entered into commercial supply agreements with three manufacturers who each manufacture a separate intermediate. In fiscal 2001, we took delivery of commercial quantities of Xcytrin drug substance.
We have entered into a development and supply agreement with Baxter Healthcare Corporation (formerly Cook Pharmaceutical Solutions) for the formulation, filling, packaging and labeling of clinical and commercial quantities of Xcytrin. Baxter also supplies us with clinical quantities of Antrin and Lutrin.
Photodynamic Therapy Light Production and Delivery Devices. In connection with our development of Lutrin and Antrin as photosensitizers, we have developed certain light sources and delivery methods, such as lasers and light emitting diodes. We have purchased light emitting diode devices capable of producing the required wavelength of light for use in photodynamic therapy with Lutrin. We have also used light emitting diode devices in preclinical animal studies and Phase I and Phase II trials. In addition, we have acquired from CardioFocus, Inc. cylindrically diffusing light fibers for animal studies and for use in our Lutrin and Antrin trials. In October 1997, we entered into a development agreement with Diomed, Inc. under which Diomed would develop a diode laser system for use in photodynamic therapy. This effort was successful and we have used Diomed lasers in our Lutrin and Antrin clinical trials. In addition, we may seek other suppliers of light delivery devices for clinical trials and commercial purposes, although we cannot be certain that any agreements will be reached with such suppliers on terms commercially reasonable to us, if at all.
Competition
We face intense competition from pharmaceutical companies, universities, governmental entities and others in the development of therapeutic and diagnostic agents for the treatment of diseases which we target.
Although the FDA has not yet approved any agents for the enhancement of radiation therapy or chemotherapy, we expect significant competition in these fields, as we believe that one or more companies, such as Allos Therapeutics, Inc., are developing and testing products which compete directly with our products under development. Allos' product is being developed for the treatment of brain metastases in conjunction with WBRT and is being tested in a Phase III clinical trial. These companies may succeed in developing technologies and products that are more effective than ours or would render our products or technologies obsolete. Moreover, certain existing chemotherapy agents also are used as radiation enhancers. See "Risk Factors - We face rapid technological change and intense competition."
We also face intense competition in the treatment of atherosclerosis, which currently includes the use of pharmaceutical agents and devices. Various drugs also have been shown to reduce or prevent atherosclerosis. Balloon angioplasty and stents are widely used and generally accepted techniques to reduce the narrowing of vessels by atherosclerosis. Treatment of in-stent stenosis with a brachytherapy (gamma radiation) system has been recently approved by the FDA.
The FDA has approved Photofrin®, a photosensitizer developed by QLT Phototherapeutics, Inc., for the treatment of specific types of cancer. We are aware of several other photosensitizers in various stages of development for a number of uses. In addition to QLT Phototherapeutics, Inc., other companies are developing products in this area. Some companies developing photodynamic therapy products are developing specialized light delivery devices for their products, which, when combined with their product offering, may give them a competitive advantage over our strategy of obtaining such devices from third-party sources.
Government Regulation
FDA Regulation and Product Approval
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign countries impose substantial requirements upon the clinical development, manufacture and marketing of pharmaceutical products. These agencies and other federal, state and local entities regulate research and development activities and the testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, advertising and promotion of our products. We believe that our products will be regulated as drugs or as a combination of drug and device, by the FDA rather than as biologics or solely devices.
The process required by the FDA before our products may be marketed in the U.S. generally involves the following:
The testing and approval process requires substantial time, effort, and financial resources and we cannot be certain that any approval will be granted on a timely basis, if at all.
Preclinical tests include laboratory evaluation of the product, its chemistry, formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product. We then submit the results of the preclinical tests, together with manufacturing information and analytical data, to the FDA as part of an IND, which must become effective before we may begin human clinical trials. The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day time period, raises concerns or questions about the conduct of the trials as outlined in the IND. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before clinical trials can begin. Our submission of an IND may not result in FDA authorization to commence clinical trials. Further, an independent Institutional Review Board at the medical center proposing to conduct the clinical trials must review and approve any clinical study.
Human clinical trials are typically conducted in three sequential phases which may overlap:
In the case of products for severe or life-threatening diseases such as cancer, the initial human testing is often conducted in patients rather than in healthy volunteers. Since these patients already have the target disease, these studies may provide initial evidence of efficacy traditionally obtained in Phase II trials and thus these trials are frequently referred to as Phase I/II trials. We cannot be certain that we will successfully complete Phase I, Phase II or Phase III testing of our product candidates within any specific time period, if at all. Furthermore, the FDA or the Institutional Review Board or the sponsor may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to an unacceptable health risk.
The results of product development, preclinical studies and clinical studies are submitted to the FDA as part of a new drug application for approval of the marketing and commercial shipment of the product. The FDA may deny a new drug application if the applicable regulatory criteria are not satisfied or may require additional clinical data. Even if such data is submitted, the FDA may ultimately decide that the new drug application does not satisfy the criteria for approval. Once issued, the FDA may withdraw product approval if compliance with regulatory standards is not maintained or if problems occur after the product reaches the market. In addition, the FDA may require testing and surveillance programs to monitor the effect of approved products which have been commercialized, and the agency has the power to prevent or limit further marketing of a product based on the results of these post- marketing programs.
On November 21, 1997, President Clinton signed into law the Food and Drug Administration Modernization Act. That act codified the FDA's policy of granting "Fast Track" approval for cancer therapies and other therapies intended to treat severe or life-threatening diseases. Previously, the FDA approved cancer therapies primarily based on patient survival rates and/or data on improved quality of life. The FDA considered evidence of partial tumor shrinkage, while often part of the data relied on for approval, insufficient by itself to warrant approval of a cancer therapy, except in limited situations. Under the FDA's new policy, which became effective on February 19, 1998, the FDA has broadened authority to consider evidence of partial tumor shrinkage or other clinical outcomes for approval. This new policy is intended to facilitate the study of cancer therapies and shorten the total time for marketing approvals.
In addition to the drug approval requirements applicable to our Lutrin product for photosensitization of certain cancers and Antrin for photoangioplasty of atherosclerosis, we will also need to obtain FDA approval for the laser and associated light delivery devices used in such treatments. To obtain approval of such devices, Pharmacyclics and the manufacturers of such devices must submit additional clinical data obtained from the use of such devices with Lutrin and Antrin, which may further delay or hinder the approval process for these photosensitizers. Manufacturers of such light delivery devices currently are under no obligation to us to file or pursue such applications, and any delay or refusal on their part to do so could have a material adverse effect on us.
Satisfaction of the above FDA requirements or similar requirements of state, local and foreign regulatory agencies typically takes several years and the actual time required may vary substantially, based upon the type, complexity and novelty of the pharmaceutical product. Government regulation may delay or prevent marketing of potential products for a considerable period of time and to impose costly procedures upon our activities. We cannot be certain that the FDA or any other regulatory agency will grant approval for any of our products under development on a timely basis, if at all. Success in preclinical or early stage clinical trials does not assure success in later stage clinical trials. Data obtained from preclinical and clinical activities is not always conclusive and may be susceptible to varying interpretations which could delay, limit or prevent regulatory approval. Even if a product receives regulatory approval, the approval may be significantly limited to specific indications. Further, even after regulatory approval is obtained, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Delays in obtaining, or failures to obtain regulatory approvals would have a material adverse effect on our business. Marketing our products abroad will require similar regulatory approvals and is subject to similar risks. In addition, we cannot predict what adverse governmental regulations may arise from future U.S. or foreign governmental action.
Any products manufactured or distributed by us pursuant to FDA clearances or approvals are subject to pervasive and continuing regulation by the FDA, including record-keeping requirements and reporting of adverse experiences with the drug. Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with good manufacturing practices, which impose certain procedural and documentation requirements upon us and our third party manufacturers. We cannot be certain that we or our present or future suppliers will be able to comply with the GMP regulations and other FDA regulatory requirements.
The FDA regulates drug labeling and promotion activities. The FDA has actively enforced regulations prohibiting the marketing of products for unapproved uses. Under the Modernization Act of 1997, the FDA will permit the promotion of a drug for an unapproved use in certain circumstances, but subject to very stringent requirements. We and our products are also subject to a variety of state laws and regulations in those states or localities where our products are or will be marketed. Any applicable state or local regulations may hinder our ability to market our products in those states or localities. We are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, and disposal of hazardous or potentially hazardous substances. We may incur significant costs to comply with such laws and regulations now or in the future.
The FDA's policies may change and additional government regulations may be enacted which could prevent or delay regulatory approval of our potential products. Moreover, increased attention to the containment of health care costs in the U.S. and in foreign markets could result in new government regulations which could have a material adverse effect on our business. We cannot predict the likelihood, nature or extent of adverse governmental regulation which might arise from future legislative or administrative action, either in the U.S. or abroad.
Employees
As of June 30, 2002, we had 133 employees, 3 of whom were part-time. 112 of our employees are engaged in research, development, preclinical and clinical testing, manufacturing, quality assurance and quality control and regulatory affairs and 21 in marketing, finance, administration and operations. 26 of our employees have an M.D. or Ph.D. degree. Our future performance depends in significant part upon the continued service of our key scientific, technical and senior management personnel, none of whom is bound by an employment agreement requiring service for any defined period of time. The loss of the services of one or more of our key employees could harm our business.
Our future success also depends on our continuing ability to attract, train and retain highly qualified scientific and technical personnel. Competition for these personnel is intense, particularly in the San Francisco Bay Area where we are headquartered. Due to the limited number of people available with the necessary scientific and technical skills, we can give no assurance that we can retain or attract key personnel in the future. None of our employees is represented by a labor union. We have not experienced any work stoppages and consider our relations with our employees to be good.
RISK FACTORS
This Form 10-K contains, in addition to historical information, forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from the results discussed in the forward-looking statements. Factors that could cause or contribute to such differences include those discussed in this section as well as those discussed elsewhere in this Form 10-K.
FACTORS THAT MAY AFFECT FUTURE OPERATING RESULTS
Risks Related to Pharmacyclics
All of our product candidates are in development, and we cannot be certain that any of our products under development will be commercialized
To be profitable, we must successfully research, develop, obtain regulatory approval for, manufacture, introduce, market and distribute our products under development. The time frame necessary to achieve these goals for any individual product is long and uncertain. Before we can sell any of our products under development, we must demonstrate through preclinical (animal) studies and clinical (human) trials that each product is safe and effective for human use for each targeted disease. We have conducted and plan to continue extensive and costly clinical trials to assess the safety and effectiveness of our potential products. We cannot be certain that we will be permitted to begin or continue our planned clinical trials for our potential products, or if permitted, that our potential products will prove to be safe and to produce their intended effects.
The completion rate of our clinical trials depends upon, among other factors, the rate of patient enrollment. We may fail to obtain adequate levels of patient enrollment in our clinical trials. Delays in planned patient enrollment may result in increased costs, delays or termination of clinical trials, which could have a material adverse effect on us.
Additionally, demands on our clinical staff have been increasing and we expect they will continue to increase due to our monitoring of additional clinical trials. We may fail to effectively oversee and monitor these many simultaneous clinical trials, which would result in increased costs or delays of our clinical trials. Even if these clinical trials are completed, we may fail to complete and submit a new drug application as scheduled for many reasons, including, as is the case with our Phase III trial of Xcytrin, failure to meet our primary endpoints. Even if we are able to submit a new drug application, the Food and Drug Administration may refuse to file our application or may not clear our application in a timely manner or may deny the application entirely.
Data already obtained from preclinical studies and clinical trials of our products under development do not necessarily predict the results that will be obtained from later preclinical studies and clinical trials. Moreover, data such as ours is susceptible to varying interpretations which could delay, limit or prevent regulatory approval. A number of companies in the pharmaceutical industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. The failure to adequately demonstrate the safety and effectiveness of a product under development could delay or prevent regulatory clearance of the potential product and would materially harm our business. Our clinical trials may not demonstrate the sufficient levels of safety and efficacy necessary to obtain the requisite regulatory approval or may not result in marketable products. For example, our Phase III trial of Xcytrin failed to meet its co-primary endpoints even though our Phase Ib/II trial showed a benefit for treated patients. This outcome may delay or prevent the regulatory clearance of Xcytrin as a treatment for brain metastases and may result in material harm to our business.
In December 2001, we announced the top line results of our Phase III clinical trial of Xcytrin Injection to improve the efficacy of radiation therapy of tumors that have spread to the brain resulting from a variety of cancers such as lung and breast. We did not reach statistical significance for either of the trial's endpoints, survival or time to neurologic progression. Subsequently, we decided to conduct a second Phase III trial in brain metastases patients with lung cancer, the most common cause of brain metastases. This trial is expected to start in the fourth quarter of calendar 2002.
We have a history of operating losses and we expect to continue to have losses in the future
We have incurred significant operating losses since our inception in 1991 and, as of June 30, 2002, had an accumulated deficit of approximately $158.3 million. We expect to continue to incur substantial additional operating losses until the commercialization of our products generates sufficient revenues to cover our expenses. Our achieving profitability depends upon our ability, alone or with others, to successfully complete the development of our products under development, and obtain required regulatory clearances and successfully manufacture and market our proposed products. Our lead product, Xcytrin, currently being developed for the potential treatment of brain metastases originating from non-small cell lung cancer, may receive regulatory clearance on a delayed basis or may not receive such clearance at all, which would have a material impact on our ability to become profitable. To date, we have not generated revenue from the commercial sale of our products. All revenues to date are primarily from license and milestone payments and, to a lesser extent, funding from one government research grant.
Failure to obtain product approvals or comply with ongoing governmental regulations could adversely affect our business
The manufacture and marketing of our products and our research and development activities are subject to extensive regulation for safety, efficacy and quality by numerous government authorities in the United States and abroad. Before receiving FDA clearance to market a product, we will have to demonstrate that the product is safe and effective on the patient population and for the diseases that will be treated. Clinical trials, manufacturing and marketing of products are subject to the rigorous testing and approval process of the FDA and equivalent foreign regulatory authorities. The Federal Food, Drug and Cosmetic Act and other federal, state and foreign statutes and regulations govern and influence the testing, manufacture, labeling, advertising, distribution and promotion of drugs and medical devices. As a result, clinical trials and regulatory approval can take a number of years to accomplish and require the expenditure of substantial resources. Data obtained from clinical trials are susceptible to varying interpretations which could delay, limit or prevent regulatory clearances. Data from our completed Phase III clinical trial of Xcytrin is not sufficient to obtain regulatory clearance and an additional trial will be necessary to do so. Conducting additional trials will cause significant delays in approval and consume additional resources and may not be sufficient to obtain regulatory clearance.
In addition, we may encounter delays or rejections based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review. We may encounter similar delays in foreign countries. We may be unable to obtain requisite approvals from the FDA and foreign regulatory authorities and even if obtained, such approvals may not be on a timely basis, or they may not cover the clinical uses that we specify.
Marketing or promoting a drug for an unapproved use is subject to very strict controls. Furthermore, clearance may entail ongoing requirements for post-marketing studies. The manufacture and marketing of drugs are subject to continuing FDA and foreign regulatory review and later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of the product from the market. Any of the following events, if they were to occur, could delay or preclude us from further developing, marketing or realizing full commercial use of our products, which in turn would have a material adverse effect on our business, financial condition and results of operations:
Manufacturers of drugs also must comply with the applicable FDA good manufacturing practice regulations, which include quality control and quality assurance requirements as well as the corresponding maintenance of records and documentation. Manufacturing facilities are subject to ongoing periodic inspection by the FDA and corresponding state agencies, including unannounced inspections, and must be licensed before they can be used in commercial manufacturing of our products. We or our present or future suppliers may be unable to comply with the applicable good manufacturing practice regulations and other FDA regulatory requirements. We have not been subject to a Good Manufacturing Practice inspection by the FDA or any state agency. We may be subject to delays in commercializing our products for photodynamic therapies due to delays in approvals of the third-party light sources required for these products.
Acceptance of our products in the marketplace is uncertain, and failure to achieve market acceptance will harm our business
Even if approved for marketing, our products may not achieve market acceptance. The degree of market acceptance will depend upon a number of factors, including:
Physicians, patients, payors or the medical community in general may be unwilling to accept, utilize or recommend any of our products.
We may fail to adequately protect or enforce our intellectual property rights or secure rights to third-party patents
A number of third-party patent applications have been published, and some have issued, relating to biometallic and expanded porphyrin chemistries. It is likely that competitors and other third parties have and will continue to file applications for and receive patents relating to similar or even the same compositions, methods or designs as those of our products. If any third-party patent claims are asserted against the company's products and are upheld as valid and infringed, we could be prevented from practicing the subject matter claimed in such patents, require license(s) or have to redesign our products or processes to avoid infringement. Such licenses may not be available or, if available, may not be on terms acceptable to us. Alternatively, we may be unsuccessful in any attempt to redesign our products or processes to avoid infringement. Litigation or other legal proceedings may be necessary to defend against claims of infringement, to enforce our patents, or to protect our trade secrets, and could result in substantial cost to the company, and diversion of our efforts.
We are aware of several U.S. patents owned or licensed to Schering AG that relate to pharmaceutical formulations and methods for enhancing magnetic resonance imaging. We have obtained the opinion of special patent counsel that our magnetic resonance imaging detectable compounds do not infringe the claims of such patents. Nevertheless, Schering AG may still choose to assert one or more of those patents. If any of our products were legally determined to be infringing a valid and enforceable claim of any such patents, our business could be materially adversely affected. Further, any allegation by Schering AG that we infringed their patents would likely result in significant legal costs and require the diversion of substantial management resources. Schering AG sent communications to us suggesting that our oral magnetic resonance imaging contrast agent, Citra Vu, may infringe certain of their patents. We are aware that Schering AG has asserted patent rights against at least one other company in the contrast agent imaging market and that a number of companies have entered into licensing arrangements with Schering AG with respect to one or more of such patents. We cannot be certain that we would be successful in defending a lawsuit or able to obtain a license on commercially reasonable terms from Schering AG, if required.
We also rely upon trade secrets, technical know-how and continuing technological innovation to develop and maintain our competitive position. We require our employees, consultants, advisors and collaborators to execute appropriate confidentiality and assignment-of-inventions agreements with us. These agreements typically provide that all materials and confidential information developed or made known to the individual during the course of the individual's relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances, and that all inventions arising out of the relationship with Pharmacyclics shall be our exclusive property. These agreements may be breached, and in some instances, we may not have an appropriate remedy available for breach of the agreements. Furthermore, our competitors may independently develop substantially equivalent proprietary information and techniques, reverse engineer our information and techniques, or otherwise gain access to our proprietary technology. We may be unable to meaningfully protect our rights in unpatented proprietary technology.
We rely heavily on third parties
We currently depend heavily and will depend heavily in the future on third parties for support in product development, manufacturing, marketing and distribution. We depend upon the National Cancer Institute for the sponsoring and funding of certain of the clinical trials of our Xcytrin radiation enhancer and Lutrin photosensitizer products in development. We cannot be certain that the National Cancer Institute will enlist support for all such trials or that it will continue our funding. If the National Cancer Institute did not support such trials, we may have to fund the continuation of such trials ourselves or reduce the number of disease types in our clinical trials. We cannot be certain that any of these parties will fulfill their obligations in a manner that maximizes our revenues. Any reduction or discontinuance of efforts by our partners or the termination of these alliances could have a material adverse effect on our business, financial condition and results of operations.
We may be unsuccessful in entering into additional strategic alliances for the development or commercialization of other product candidates. Even if we did enter into any such alliances, they may not be on terms favorable to us or they may ultimately be unsuccessful.
We have no expertise in the development of light sources and associated light delivery devices required for our photoangioplasty and photodynamic therapy products under development. Successful development, manufacturing, approval and distribution of our photosensitization products will require third party participation for the required light sources, associated light delivery devices and other equipment. We currently obtain lasers from Diomed, Inc. and cylindrically diffusing light fibers from CardioFocus, Inc. on a purchase order basis, and such entities are under no obligation to continue to deliver light devices on an ongoing basis. Failure to maintain such relationships may require us to develop additional supply sources which may require additional clinical trials and regulatory approvals and could materially delay commercialization of our Lutrin and Antrin products under development. We may be unable to establish or maintain relationships with other supply sources on a commercially reasonable basis, if at all, or alternatively, the enabling devices may not receive regulatory approval for use in photoangioplasty or photodynamic therapy.
We have limited manufacturing experience and thus rely heavily upon contract manufacturers
We must manufacture our products in commercial quantities, either directly or through third parties, in compliance with regulatory requirements and at an acceptable cost. We do not own manufacturing facilities necessary to provide clinical and commercial quantities of our products.
We have entered into an agreement with Baxter Healthcare Corporation (formerly Cook Pharmaceutical Solutions) to formulate, fill, package and label clinical and commercial quantities of Xcytrin. Baxter also supplies us with clinical quantities of Antrin and Lutrin. Any interruption of supply of our products from Baxter could have a material adverse affect on our business, financial condition and results of operations.
Any failure by these third parties to supply our requirements or the National Cancer Institute's requirements for clinical trial materials would jeopardize the completion of such trials and could therefore have a material adverse effect on us.
We lack marketing and sales experience
We currently have limited marketing, sales and distribution experience. We must develop a sales force with technical expertise. We have no experience in developing, training or managing a sales force. We will incur substantial additional expenses in developing, training and managing such an organization. We may be unable to build such a sales force, the cost of establishing such a sales force may exceed any product revenues, or our direct marketing and sales efforts may be unsuccessful. In addition, we compete with many other companies that currently have extensive and well-funded marketing and sales operations. Our marketing and sales efforts may be unable to compete successfully against such other companies.
Our capital requirements are uncertain and we may have difficulty raising needed capital in the future
We have expended and will continue to expend substantial funds to complete the research, development and clinical testing of our products. We will require additional funds for these purposes, to establish additional clinical-and commercial-scale manufacturing arrangements and to provide for the marketing and distribution of our products. Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable from operations or additional sources of financing, we may have to delay, reduce the scope of or eliminate one or more of our research or development programs which would materially and adversely affect our business, financial condition and operations.
We believe that our cash, cash equivalents and investments, will be adequate to satisfy our capital needs through at least calendar year 2004. However, our actual capital requirements will depend on many factors, including:
We may seek to raise any necessary additional funds through equity or debt financings, collaborative arrangements with corporate partners or other sources which may be dilutive to existing stockholders. In addition, in the event that additional funds are obtained through arrangements with collaborative partners or other sources, such arrangements may require us to relinquish rights to some of our technologies, product candidates or products under development that we would otherwise seek to develop or commercialize ourselves.
Risks Related to Our Industry
We face rapid technological change and intense competition
The pharmaceutical industry is subject to rapid and substantial technological change. Developments by others may render our products under development or technologies noncompetitive or obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competition in the industry from pharmaceutical and biotechnology companies, universities, governmental entities and others diversifying into the field is intense and is expected to increase. Many of these entities have significantly greater research and development capabilities than we do, as well as substantially more marketing, manufacturing, financial and managerial resources. These entities represent significant competition for us. Acquisitions of, or investments in, competing pharmaceutical or biotechnology companies by large corporations could increase such competitors' financial, marketing, manufacturing and other resources.
We are a relatively new enterprise and are engaged in the development of novel therapeutic technologies. As a result, our resources are limited and we may experience technical challenges inherent in such novel technologies.
Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis for competitive products. Some of these products may have an entirely different approach or means of accomplishing similar therapeutic, diagnostic and imaging effects than our products. We are aware that one of our competitors in the market for photodynamic therapy drugs has received marketing approval of a product for certain uses in the United States and other countries. Our competitors may develop products that are safer, more effective or less costly than our products and, therefore, present a serious competitive threat to our product offerings.
The widespread acceptance of therapies that are alternatives to ours may limit market acceptance of our products even if commercialized. The diseases for which we are developing our therapeutic products can also be treated, in the case of cancer, by surgery, radiation and chemotherapy, and in the case of atherosclerosis, by surgery, angioplasty, drug therapy and the use of devices to maintain and open blood vessels. These treatments are widely accepted in the medical community and have a long history of use. The established use of these competitive products may limit the potential for our products to receive widespread acceptance if commercialized.
The price of our common stock may be volatile
The market prices for securities of small capitalization biotechnology companies, including ours, have historically been highly volatile. The market has from time to time experienced significant price and volume fluctuations unrelated to the operating performance of particular companies. The market price of our common stock may fluctuate significantly due to a variety of factors, including:
In addition, if any of the risks described in these "Risk Factors" actually occurred, it could have a dramatic and material adverse impact on the market price of our common stock.
We are subject to uncertainties regarding health care reimbursement and reform
The continuing efforts of government and insurance companies, health maintenance organizations and other payors of healthcare costs to contain or reduce costs of health care may affect our future revenues and profitability, and the future revenues and profitability of our potential customers, suppliers and collaborative partners and the availability of capital. For example, in certain foreign markets, pricing or profitability of prescription pharmaceuticals is subject to government control. In the United States, given recent federal and state government initiatives directed at lowering the total cost of health care, the U.S. Congress and state legislatures will likely continue to focus on health care reform, the cost of prescription pharmaceuticals and on the reform of the Medicare and Medicaid systems. While we cannot predict whether any such legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could have a material adverse effect on our business, financial condition and results of operations.
Our ability to commercialize our products successfully will depend in part on the extent to which appropriate reimbursement levels for the cost of our products and related treatment are obtained from governmental authorities, private health insurers and other organizations, such as HMOs. Third-party payors are increasingly challenging the prices charged for medical products and services. Also, the trend toward managed health care in the United States and the concurrent growth of organizations such as HMOs, which could control or significantly influence the purchase of health care services and products, as well as legislative proposals to reform health care or reduce government insurance programs, may all result in lower prices for or rejection of our products. The cost containment measures that health care payors and providers are instituting and the effect of any health care reform could materially adversely affect our ability to operate profitably.
Our business exposes us to product liability claims
The testing, manufacture, marketing and sale of our products involve an inherent risk that product liability claims will be asserted against us. Although we are insured against such risks up to a $10,000,000 annual aggregate limit in connection with clinical trials and commercial sales of our products, our present product liability insurance may be inadequate. A successful product liability claim in excess of our insurance coverage could have a material adverse effect on our business, financial condition and results of operations. Any successful product liability claim may prevent us from obtaining adequate product liability insurance in the future on commercially desirable or reasonable terms. In addition, product liability coverage may cease to be available in sufficient amounts or at an acceptable cost. An inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of our pharmaceutical products. A product liability claim or recall would have a material adverse effect on our reputation, business, financial condition and results of operations.
Our business involves environmental risks
In connection with our research and development activities and our manufacture of materials and products, we are subject to federal, state and local laws, rules, regulations and policies governing the use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. Although we believe that we have complied with the applicable laws, regulations and policies in all material respects and have not been required to correct any material noncompliance, we may be required to incur significant costs to comply with environmental and health and safety regulations in the future. Our research and development involves the controlled use of hazardous materials, including but not limited to certain hazardous chemicals and radioactive materials. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an occurrence, we could be held liable for any damages that result and any such liability could exceed our resources.
Executive Officers and Directors
Executive officers and directors of the Company, and their ages as of August 31, 2002, are as follows:
Name |
Age |
Position |
Richard A. Miller, M.D. |
51 |
President, Chief Executive Officer and Director |
Cynthia J. Ladd |
47 |
Senior Vice President, General Counsel and Secretary |
Marc L. Steuer |
55 |
Senior Vice President, Business Development |
Timothy G. Whitten |
45 |
Senior Vice President, Commercial Operations |
Leiv Lea |
48 |
Vice President, Finance and Administration and Chief Financial Officer |
Daniel C. Adelman, M.D. |
45 |
Vice President, Clinical Operations |
Hugo Madden, Ph.D. |
53 |
Vice President, Chemical Operations |
Markus F. Renschler, M.D. |
41 |
Vice President, Oncology Clinical Development |
Miles R. Gilburne(2) |
51 |
Director |
Loretta M. Itri, M.D.(2) |
53 |
Director |
Richard M. Levy, Ph.D.(1) |
64 |
Director |
William R. Rohn(1) |
59 |
Director |
Craig C. Taylor(1)(2) |
52 |
Director |
__________
(1) Member of Compensation Committee.
(2) Member of Audit Committee.
Dr. Miller has served as President, Chief Executive Officer and a Director since he co-founded the company in April 1991. Dr. Miller was a co-founder of IDEC Pharmaceuticals Corporation and from 1984 to February 1992 served as Vice President and a Director. Dr. Miller also is a Clinical Professor of Medicine (Oncology) at Stanford University Medical Center. Dr. Miller received his M.D. from the State University of New York Medical School and is board certified in both Internal Medicine and Medical Oncology.
Ms. Ladd has served as Senior Vice President, General Counsel and Secretary since May 2000. From 1989 to April 2000, she served in various legal and executive management positions with Genentech, Inc., most recently as Vice President, Corporate Law. Ms. Ladd received a B.S. degree in Animal Science from the Pennsylvania State University, an M.S. degree in animal nutrition/biochemistry from Cornell University and a law degree from Stanford University.
Mr. Steuer has served as Senior Vice President, Business Development since December 1998. Prior to that, Mr. Steuer served as Senior Vice President, Business Development and Chief Financial Officer from May 1998 to December 1998. Prior to that, Mr. Steuer served as Vice President, Business Development and Chief Financial Officer from November 1994 to May 1998. From April 1992 to November 1994, he was Executive Vice President, Business Development and Commercial Affairs for SciClone Pharmaceuticals, Inc. and also served as its Chief Financial Officer. From 1985 to 1992, Mr. Steuer served in a variety of roles in the Pilkington Visioncare Group ("PVG"), which developed, manufactured and distributed medical devices, pharmaceuticals and equipment for the ophthalmic field. Mr. Steuer received both B.S. and M.S. degrees in Electrical Engineering from Columbia University and an M.B.A. from New York University.
Mr. Whitten has served as Senior Vice President, Commercial Operations since September 2001. From 1985 through 2001, Mr. Whitten served in a variety of positions at Bristol-Myers Squibb, most recently as: Vice President, Global Marketing, Oncology, from February 2000 to September 2001; Vice President Global Marketing, Oncology and Immunology from February 1999 to February 2000; Vice President, Pravastatin Initiative, from November 1997 to February 1999; Vice President, Marketing, Oncology and Immunology for the U.S. Business Unit, from April 1996 to October 1997. Mr. Whitten received his B.S. in Pharmacy from West Virginia University and an M.B.A. from the University of Virginia.
Mr. Lea has served as Vice President, Finance and Administration and Chief Financial Officer since December 1998. Prior to that, Mr. Lea served as Vice President, Finance and Administration from December 1997 to December 1998. From September 1996 through November 1997, he served as a financial consultant for high technology companies and was Acting Chief Financial Officer for Global Village Communications, Inc. From 1987 through June 1996 he served as Vice President and Chief Financial Officer of Margaux, Inc., a public company that manufactured refrigeration equipment. Mr. Lea received a B.S. degree in Agricultural Economics from the University of California, Davis and an M.B.A. from the University of California, Los Angeles.
Dr. Adelman has served as Vice President, Clinical Operations since June 2002. Prior to that, Dr. Adelman served as Senior Director of Clinical Development from April 1998 to June 2002. From December 1994 to April 1998, Dr. Adelman was a Clinical Scientist at Genentech, Inc., and from 1989 to 1994 he was Director of Clinical Immunology and Allergy and an Assistant Professor of Clinical Medicine at the University of California, San Francisco. Dr. Adelman is an Associate Adjunct Professor of Medicine at UCSF and board certified in Medicine and Allergy and Immunology. Dr. Adelman received his M.D. from the University of California, Davis and a B.A. degree in Biological Sciences from the University of California, Berkeley.
Dr. Madden has served as Vice President, Chemical Operations since June 1998. From 1995 to June 1998, he served as Plant Manager and as Director of Process Development at Catalytica Pharmaceuticals, Inc., a contract pharmaceutical manufacturer. From 1977 to 1995, Dr. Madden served in a variety of positions with Syntex Corporation, a pharmaceutical company. His positions at Syntex included Technical Director at the Bahamas Chemical Division and Manager of Process Development and Engineering at the Technology Center in Boulder, Colorado. Dr. Madden received a B.A. degree in Chemistry from the University of Oxford and a Ph.D. from the University of London.
Dr. Renschler has served as Vice President, Oncology Clinical Development since May 2001. Prior to that, Dr. Renschler served as Senior Director of Clinical Development from May 1998 to May 2001. Prior to that, Dr. Renschler served as Director of Clinical Development from January 1996 to May 1998. Dr. Renschler is also a Clinical Assistant Professor of Medicine/Oncology at Stanford University School of Medicine. He is board certified both in Medical Oncology and Internal Medicine. Dr. Renschler received his M.D. from Stanford University and a B.A. degree in Public and International Affairs from Princeton University.
Mr. Gilburne was elected as a Director of the Company in March 2000. Mr. Gilburne has been a managing member of ZG Ventures, a venture capital and investment company since 2000. From February 1995 through December 1999, he was Senior Vice President, Corporate Development for America Online, Inc., an internet services company. He is currently a member of the board of directors of AOL Time Warner Inc. Prior to joining America Online, Mr. Gilburne was a founding partner of the Silicon Valley office of the law firm of Weil, Gotshal and Manges and a founding partner of the Cole Gilburne Fund, an early stage venture capital fund focused on information technology. Mr. Gilburne received an A.B. degree from Princeton University and a law degree from the Harvard Law School.
Dr. Itri was elected as a Director of the Company in July 2001. Dr. Itri is currently the Executive Vice President, Pharmaceutical Research and Development, and Chief Medical Officer of Genta Incorporated, a biopharmaceutical company which she joined in March 2001. From November 1990 to January 2000 she was Senior Vice President, Worldwide Clinical Affairs, and Chief Medical Officer at Ortho Biotech Inc., a Johnson & Johnson company. Dr. Itri earned her M.D. from New York Medical College, and is Board certified in Internal Medicine. She completed a fellowship in Medical Oncology at Memorial Sloan-Kettering Cancer Center.
Dr. Levy was elected as a Director of the Company in June 2000. He has served as President and Chief Executive Officer and a director of Varian Medical Systems, Inc., a medical equipment company, since April 1999, and as Executive Vice President of Varian Associates, Inc., the predecessor company from which Varian Medical Systems, Inc. was spun out, since 1992. Dr. Levy holds a B.A. degree from Dartmouth College and a Ph.D. in nuclear chemistry from the University of California at Berkeley.
Mr. Rohn was elected as a Director of the Company in March 2000. He has served as the President and Chief Operating Officer of IDEC Pharmaceuticals Corporation, a biopharmaceutical company, since May 1998. He joined IDEC in August 1993 as Senior Vice President, Commercial and Corporate Development and was appointed Senior Vice President, Commercial Operations in April 1996 and Chief Operating Officer in May 1998. From 1984 to 1993, he was employed by Adria Laboratories, most recently as Senior Vice President of Sales and Marketing. Mr. Rohn is currently a Director of Cerus Corporation. Mr. Rohn received a B.A. in Marketing from Michigan State University.
Mr. Taylor was elected as a Director of the Company in June 1991. Mr. Taylor is a General Partner of AMC Partners 89, L.P., and the General Partner of Asset Management Associates 1989, L.P., a private venture capital partnership. Mr. Taylor has been a General Partner of Alloy Ventures, Inc., a venture management firm which succeeded Asset Management Company, the prior management firm for the Asset Management funds, since 1998. Mr. Taylor had been with Asset Management Company from 1977 to 1998, as General Partner since 1982. Mr. Taylor is a Director of Lynx Therapeutics, Inc. and several private companies. Mr. Taylor holds B.S. and M.S. degrees in Physics from Brown University and an M.B.A. from Stanford University.
Item 2. Properties
Our corporate offices are located in Sunnyvale, California, where we lease approximately 105,000 square feet under two leases that expire in December 2003 and January 2004. We have subleased 18,000 square feet of this space through January 2003. These facilities include administrative and research and development space. Both leases are non-cancelable operating leases. We believe that our existing facilities are adequate to meet our current and foreseeable needs or that suitable additional space will be available as needed.
Item 3. Legal Proceedings
None.
Item 4. Submission of Matters to a Vote of Security Holders
None.
PART II
Item 5. Market for Registrant's Common Equity and Related Stockholder Matters
Our common stock began trading publicly on the Nasdaq National Market on October 24, 1995 and is traded under the symbol "PCYC." Prior to that date, there was no public market for our common stock. The following table sets forth for the periods indicated the high and low sales prices of the common stock.
|
HIGH |
LOW |
FISCAL YEAR ENDED JUNE 30, 2001
|
|
|
FISCAL YEAR ENDED JUNE 30, 2002
|
|
|
As of June 30, 2002, there were 163 holders of record of our common stock. We currently anticipate that we will retain all future earnings for use in our business and do not anticipate paying any cash dividends in the foreseeable future.
Item 6. Selected Financial Data
The data set forth below should be read in conjunction with Management's Discussion and Analysis of Financial Condition and Results of Operations and the financial statements and related notes included elsewhere herein.
Period from Inception (April 1991) Years Ended June 30, through ----------------------------------------------------- June 30, 2002 2001 2000 1999 1998 2002 --------- --------- --------- --------- --------- --------- (in thousands, except per share amounts) STATEMENT OF OPERATIONS DATA: Revenues: License, milestone and grant revenues ............................ $ -- $ -- $ 1,000 $ 750 $ 2,700 $ 7,855 Contract revenues ..................... -- 3,121 604 1,291 831 5,847 --------- --------- --------- --------- --------- --------- Total revenues .................... -- 3,121 1,604 2,041 3,531 13,702 --------- --------- --------- --------- --------- --------- Operating expenses: Research and development .............. 33,981 37,974 28,590 21,889 13,973 173,567 Marketing, general and administrative . 7,791 6,548 4,409 2,762 1,987 29,572 --------- --------- --------- --------- --------- --------- Total operating expenses .......... 41,772 44,522 32,999 24,651 15,960 203,139 --------- --------- --------- --------- --------- --------- Loss from operations .................... (41,772) (41,401) (31,395) (22,610) (12,429) (189,437) Interest income ......................... 5,152 10,604 7,778 3,398 2,826 32,699 Interest expense and other income (expense), net ................ 45 (128) (13) (34) (72) (1,529) --------- --------- --------- --------- --------- --------- Net loss................................. $ (36,575) $ (30,925) $ (23,630) $ (19,246) $ (9,675) $(158,267) ========= ========= ========= ========= ========= ========= Basic and diluted net loss per share(1)..................... $ (2.27) $ (1.92) $ (1.60) $ (1.55) $ (0.87) ========= ========= ========= ========= ========= Shares used to compute basic and diluted net loss per share(1) ......... 16,143 16,075 14,723 12,378 11,061 ========= ========= ========= ========= ========= June 30, ----------------------------------------------------- 2002 2001 2000 1999 1998 --------- --------- --------- --------- --------- (in thousands) BALANCE SHEET DATA: Cash, cash equivalents and marketable securities ............................ $ 114,918 $ 152,782 $ 178,247 $ 50,005 $ 70,381 Total assets ............................ 121,012 160,973 185,123 55,557 73,019 Capital lease obligations ............... -- -- 59 275 530 Deficit accumulated during development stage ..................... (158,267) (121,692) (90,767) (67,137) (47,891) Total stockholders' equity .............. 117,608 154,355 181,414 49,957 68,641
__________
(1) See Note 1 to the financial statements for a description of the computation of basic and diluted net loss per share.
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
In addition to historical information, this report contains predictions, estimates and other forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Actual results could differ materially from any future performance suggested in this report as a result of the factors, including those discussed in "Risk Factors," elsewhere in this report.
Overview
Pharmacyclics is a pharmaceutical company focused on the development of products that improve existing therapeutic approaches to cancer and atherosclerosis. To date we have devoted substantially all of our resources to the research and development of our products and have not derived any commercial revenues from the sale of our products. We have two primary drug products, or research and development programs, for which we are currently focusing our efforts: Xcytrin® and Antrin®.
In December 2001, we announced the top line results of our Phase III clinical trial of Xcytrin Injection to improve the efficacy of radiation therapy of tumors that have spread to the brain resulting from a variety of cancers such as lung and breast or brain metastases. We did not reach statistical significance for either of the trial's endpoints, survival or time to neurologic progression. However, additional analysis of the data indicated that brain metastases patients with lung cancer who received Xcytrin demonstrated significant improvement in time to neurologic progression. Based on our discussions with the FDA, we believe the best course of action is to conduct a confirmatory trial in brain metastases patients with lung cancer, the most common cause of brain metastases. This confirmatory trial is expected to start in the fourth quarter of calendar 2002.
We have completed patient enrollment in a multicenter Phase II trial with Xcytrin for the treatment of glioblastoma multiforme, a malignant primary brain tumor. We also have begun enrollment in a Phase I clinical trials for head and neck cancer and the use of Xcytrin with chemotherapy. Through our Cooperative Research and Development Agreement, the National Cancer Institute is conducting Phase I trials of Xcytrin for treatment of both primary adult and pediatric brain tumors, pancreatic cancer and lung cancer.
We completed enrollment of a randomized Phase II clinical trial with Antrin for patients with peripheral arterial disease of the lower extremities. The study is designed to evaluate both prevention of restenosis following balloon angioplasty and primary treatment of atherosclerosis. 150 patients have been enrolled in this study and are being evaluated with follow up angiograms.
We also completed enrollment of a Phase I clinical trial with Antrin for the treatment of coronary artery disease in patients receiving balloon angioplasty and stents. This study is primarily designed to evaluate the safety of various doses of drug and light. Patients are receiving follow-up angiograms six months after treatment to evaluate effects of the treatment on the blood vessels. In September 2001, we reported interim results of this trial at the European Society of Cardiology and the Transcatheter Cardiovascular Therapeutics meetings, which indicate that Antrin phototherapy is safe and feasible to perform in the coronary arteries.
We currently plan to establish a corporate alliance for Antrin before performing any additional clinical development.
We have initially studied Lutrin for photodynamic therapy of patients with invasive surface cancers that are accessible to externally applied light, such as recurrent breast cancer to the chest wall. The National Cancer Institute is sponsoring Phase I studies of Lutrin for treatment of cancer of the prostate and cervix. We plan to continue to supply drug and light devices for the National Cancer Institute studies of Lutrin but do not plan to conduct any additional clinical studies ourselves.
We have incurred significant operating losses since our inception in 1991, and as of June 30, 2002, had an accumulated deficit of approximately $158.3 million. We expect to continue to incur significant operating losses until the commercialization of our products generates sufficient revenues to cover our expenses. We expect that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial. Our achieving profitability depends upon our ability, alone or with others, to successfully complete the development of our products under development, and obtain required regulatory clearances and successfully manufacture and market our products. See "Risk Factors - All of our product candidates are in development and we cannot be certain that any of our products under development will be commercialized," "- Acceptance of our products in the marketplace is uncertain and failure to achieve market acceptance will harm our business," "- We have a history of operating losses and we expect to continue to have losses in the future," "- Failure to obtain product approvals or comply with ongoing governmental regulations could adversely affect our business" and "- our capital requirements are uncertain and we may have difficulty raising needed capital in the future."
Results of Operations
Comparison of Years Ended June 30, 2002, 2001 and 2000
Revenues. Our revenues for
the years ended June 30, 2002, 2001 and 2000 were nil, $3,121,000 and $1,604,000, respectively. Revenues for the year ended June 30, 2001 resulted primarily from a non-recurring fee paid by Nycomed to terminate their collaboration agreement to sell and market Lutrin outside the United States, Canada and Japan and contract revenue received from Nycomed prior to the termination of the agreement. Revenues for the year ended June 30, 2000 resulted from a milestone payment from Alcon and contract revenue from Nycomed.Research and Development Expenses. Research and development expenses were $33,981,000, $37,974,000 and $28,590,000 for the years ended June 30, 2002, 2001, and 2000, respectively. The $3,993,000 decrease from 2001 to 2002 was primarily due to decreased expenses with our Antrin and Lutrin programs. The $9,384,000 increase in fiscal 2001 from fiscal 2000 was the result of increased expense associated with our Xcytrin program and the impact of recognizing a credit of $3,540,000 in fiscal 2000 associated with the termination of our manufacturing and supply agreement with Celanese Ltd. Research and development expenses are comprised of direct and indirect costs. Direct costs consist of personnel costs directly associated with a program, preclinical study costs, clinical trial costs, and related clinical drug and device development and manufacturing costs, drug formulation costs, contract services and other research expenditures. Indirect costs consist of personnel costs not directly associated with a program, overhead and facility costs and other support service expenses.
Research and development costs are identified as either directly attributed to one of our research and development programs or as an indirect cost, with only direct costs being tracked by specific program. Prior to 1999, we did not track our historical research and development costs by specific program. For this reason we cannot accurately estimate our total historical costs on a specific program basis. Direct costs by program and indirect costs are as follows:
Program 2002 2001 2000 - ------------------------------------- ----------- ----------- ----------- Direct costs: Xcytrin........................... $16,026,000 $16,831,000 $13,125,000 Antrin............................ 3,968,000 8,437,000 7,419,000 Lutrin............................ 730,000 2,537,000 2,499,000 ----------- ----------- ----------- Total direct costs................... 20,724,000 27,805,000 23,043,000 Indirect costs....................... 13,257,000 10,169,000 5,547,000 ----------- ----------- ----------- Total research and development costs................. $33,981,000 $37,974,000 $28,590,000 =========== =========== ===========
Xcytrin
Xcytrin direct costs were $16,026,000, $16,831,000 and $13,125,000 for the years ended June 30, 2002, 2001 and 2000, respectively. The decrease of $805,000 in fiscal 2002 compared to fiscal 2001 was primarily due to lower clinical trial costs ($2,317,000) as our Phase III trial was completed in fiscal 2002 and lower drug manufacturing costs ($1,461,000) due to the timing of the manufacturing of Xcytrin. It is our policy to expense all costs related to the manufacturing of our drug products when incurred until commercial viability of such products have been demonstrated and the necessary regulatory approvals are received. These decreases were partially offset by the increase in employee costs ($2,800,000) as we increased staffing to support the potential regulatory filings related to our Phase III clinical trial of Xcytrin.
The increase of $3,706,000 in fiscal 2001 as compared to fiscal 2000 was primarily due to higher personnel ($2,188,000) and consulting costs ($570,000) to support our on-going Phase III trial.
Antrin
Antrin direct costs were $3,968,000, $8,437,000 and $7,419,000 for the years ended June 30, 2002, 2001 and 2000, respectively. The decrease of $4,469,000 in fiscal 2002 compared to fiscal 2001 was primarily due to focusing our resources on our Xcytrin product. This resulted in lower pre- clinical studies costs ($1,427,000), lower employee costs ($751,000) and lower device expenditures ($595,000). Antrin direct costs were also affected by lower drug manufacturing costs ($998,000).
The increase in fiscal 2001 of $1,018,000 as compared to fiscal 2000 was primarily due to higher third party clinical trial costs ($829,000) due to higher clinical trial activity, higher personnel costs ($864,000) to support these trials, as well as higher pre-clinical studies ($778,000). These costs were partially offset by lower device costs ($904,000) and lower third party research expenses ($369,000).
Lutrin
Lutrin direct costs were $730,000, $2,537,000 and $2,499,000 for the years ended June 30, 2002, 2001 and 2000, respectively. The decrease of $1,807,000 in fiscal 2002 was primarily due to focusing our resources on our Xcytrin product. The change in focus resulted in lower employee ($416,000) and pre-clinical studies costs ($111,000). Lutrin was also affected by lower drug manufacturing costs ($943,000) due to the timing of the manufacture of Lutrin.
Lutrin direct costs remained relatively consistent in fiscal 2001 as compared to fiscal 2000.
Indirect Costs
Indirect costs were $13,257,000, $10,169,000 and $5,547,000 for the years ended June 30, 2002, 2001 and 2000, respectively. The increase of $3,088,000 in fiscal 2002 as compared to fiscal 2001 was primarily due to the increase in facility and IT support costs ($2,501,000) to support the growth in personnel and higher employee costs ($885,000) as we increased headcount to support our research and development efforts, partially offset by lower consulting costs ($253,000).
The increase of $4,622,000 in fiscal 2001 as compared to fiscal 2000 was primarily due to recognizing a credit of $3,540,000 in fiscal 2000 associated with the termination of our manufacturing development and supply agreement with Celanese, Ltd.
Marketing, General and Administrative Expenses. Marketing, general and administrative expenses for the years ended June 30, 2002, 2001, and 2000 were $7,791,000, $6,548,000, and $4,409,000, respectively. The $1,243,000 increase in fiscal 2002 compared to fiscal 2001 primarily resulted from higher personnel costs ($624,000) and higher facilities and IT support costs ($627,000) to support expected increases in operations. The $2,139,000 increase in fiscal 2001 compared to fiscal 2000 primarily resulted from higher personnel costs related to increased headcount to support greater clinical development activities ($650,000), and increased marketing efforts to promote awareness of the company's products ($1,070,000).
Interest and Other, Net. Interest and other, net, was $5,197,000, $10,476,000 and $7,765,000 for the years ended June 30, 2002, 2001 and 2000, respectively. The decrease in fiscal 2002 was primarily due to lower interest rates being earned on reduced balances of cash, cash equivalents and marketable securities. The increase in fiscal 2001 was primarily the result of interest earned on higher average cash balances from sales of common stock in the third quarter of fiscal 2000. Our cash equivalents and marketable securities consist primarily of fixed rate instruments.
Income Taxes. At June 30, 2002, we had net operating loss carryforwards of approximately $159.3 million for federal income tax reporting purposes and tax credit carryforwards of approximately $6.6 million for federal reporting purposes. These amounts expire at various times through 2022. As a result of ownership changes that have occurred in the past, we believe that utilization of our net operating loss and tax credit carryforwards is subject to annual limitations. A full valuation allowance has been established for the company's deferred tax assets since realization of such assets through the generation of future taxable income is uncertain. See Note 5 of "Notes to Financial Statements."
Liquidity and Capital Resources
Our principal sources of working capital have been private and public equity financings and proceeds from collaborative research and development agreements, as well as grant and contract revenues and interest income. Since inception, we have used approximately $146,054,000 of cash for operating activities and approximately $14,120,000 of cash for the purchase of laboratory and office equipment and payments under capital lease agreements.
As of June 30, 2002, we had approximately $114,918,000 in cash, cash equivalents and marketable securities. Net cash used in operating activities was $36,324,000, $25,746,000 and $24,767,000 for the years ended June 30, 2002, 2001 and 2000, respectively, and resulted primarily from operating losses adjusted for non-cash expenses and changes in accounts payable, accrued liabilities, and prepaid expenses and other assets.
Net cash provided by investing activities of $73,590,000 and $31,719,000 in the years ended June 30, 2002 and 2001, respectively, consisted primarily of proceeds of maturities and sales of marketable securities, net of purchases of marketable securities, partially offset by purchases of property and equipment. Net cash used in investing activities was $90,831,000 in the year ended June 30, 2000 and consisted primarily of purchases of marketable securities and property and equipment, partially offset by proceeds from maturities of marketable securities.
In March 2000, we sold 820,000 shares of our common stock through a private placement at a price of $73.25 per share resulting in net cash proceeds to us of approximately $57,600,000. In September and October 1999, we sold a total of 2,645,000 shares of our common stock at $38.75 per share resulting in net cash proceeds to us of approximately $96,100,000.
The company leases its facilities under non-cancelable operating leases that expire in fiscal 2004. Future minimum lease payments and sublease income under non-cancelable operating leases as of June 30, 2002 are as follows:
Operating Operating Lease Sublease Commitments Income ----------- ----------- Fiscal 2003.......................... $ 3,720,000 $ (233,000) Fiscal 2004.......................... 2,163,000 -- ----------- ----------- Total minimum lease payments and operating lease income ..... $ 5,883,000 $ (233,000) =========== ===========
Based upon the current status of our product development and commercialization plans, we believe that our existing cash, cash equivalents and investments, will be adequate to satisfy our capital needs through at least calendar year 2004. However, our actual capital requirements will depend on many factors, including the status of product development; the time and cost involved in conducting clinical trials and obtaining regulatory approvals; filing, prosecuting and enforcing patent claims; competing technological and market developments; and our ability to market and distribute our products and establish new collaborative and licensing arrangements.
Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward- looking statement that involves risks and uncertainties, and actual results could vary materially. The factors described above will impact our future capital requirements and the adequacy of our available funds. We may be required to raise additional funds through public or private financings, collaborative relationships or other arrangements. We cannot be certain that such additional funding, if needed, will be available on terms attractive to us, or at all. Furthermore, any additional equity financing may be dilutive to existing stockholders and debt financing, if available, may involve restrictive covenants. Collaborative arrangements, if necessary to raise additional funds, may require us to relinquish rights to certain of our technologies, products or marketing territories. Our failure to raise capital when needed could have a material adverse effect on our business, financial condition and results of operations. See "Risk Factors - Risks Related to Pharmacyclics - Our capital requirements are uncertain and we may have difficulty raising capital in the future."
Critical Accounting Policies
Critical accounting policies are defined by the SEC as those that are most important to the portrayal of a company's financial condition and results, and that require management's most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effects of matters that are inherently uncertain. We have identified the following critical accounting policies used in the preparation of our financial statements and accompanying notes.
Revenue Recognition
Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable and collectibility is reasonably assured. License and milestone fees are recognized as revenue when earned over the period of the arrangement, as evidenced by achievement of the specified milestones and the absence of any on-going obligation. Contract revenue is recognized as earned, primarily based on costs incurred to total estimated costs at completion, pursuant to the terms of each agreement. License, milestone, contract and grant revenues are not subject to repayment. Any amounts received in advance of performance are recorded as deferred revenue.
Cash Equivalents and Marketable Securities
We maintain investment portfolio holdings of various issuers, types and maturities. We consider all highly liquid investments purchased with original maturities of three months or less to be cash equivalents. At June 30, 2002, these investment securities are classified as available-for-sale and consequently are recorded on the balance sheet at fair value with unrealized gains and losses reported as a separate component of accumulated other comprehensive income. Management assesses whether declines in the fair value of investment securities are other than temporary. If the decline in fair value is judged to be other than temporary, the cost basis of the individual security is written down to fair value and the amount of the write down is included in earnings. In determining whether a decline is other than temporary, management considers the following factors:
Recent Accounting Pronouncements
In October 2001, the FASB issued Statement of Financial Accounting Standards ("SFAS") No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" ("SFAS 144"). SFAS 144 establishes a single accounting model, based on the framework established in Statement of Financial Accounting Standards No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of" ("SFAS 121"), for long-lived assets to be disposed of by sale, and resolves implementation issues related to SFAS 121. The Company is required to adopt SFAS 144 no later than the first quarter of fiscal 2003. The Company believes that the adoption of this standard will have no impact on its financial statements.
In May 2002, the FASB issued SFAS No. 145, "Rescission of SFAS Nos. 4, 44, and 64, Amendment of SFAS No. 13, and Technical Corrections" ("SFAS 145"). Among other things, SFAS 145 rescinds various pronouncements regarding early extinguishment of debt and allows extraordinary accounting treatment for early extinguishment only when the provisions of Accounting Principles Board Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions" are met. SFAS 145 provisions regarding early extinguishment of debt are generally effective for fiscal years beginning after May 15, 2002. The Company believes that the adoption of this standard will have no impact on its financial statements.
In July 2002, the FASB issued SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal Activities" ("SFAS 146"). This Statement addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring)." This Statement requires that a liability for costs associated with an exit or disposal activity be recognized and measured initially at fair value only when the liability is incurred. The provisions of this Statement are effective for exit or disposal activities that are initiated after December 31, 2002. The Company believes that the adoption of this standard will have no impact on its financial statements.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Our exposure to interest rate risk relates primarily to our investment portfolio. Fixed rate securities may have their fair market value adversely impacted due to fluctuations in interest rates, while floating rate securities may produce less income than expected if interest rates fall. Due in part to these factors, our future investment income may fall short of expectations due to changes in interest rates or we may suffer losses in principal if forced to sell securities which have declined in market value due to changes in interest rates. The primary objective of our investment activities is to preserve principal while at the same time maximize yields without significantly increasing risk. To achieve this objective, we invest in debt instruments of the U.S. Government and its agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits. To minimize the exposure due to adverse shifts in interest rates, we maintain investments at an average maturity of generally less than two years. Assuming a hypothetical increase in interest rates of one percentage point, the fair value of our total investment portfolio as of June 30, 2001 would have potentially declined by $634,000.
One of our cancelable drug supply agreements is denominated in a foreign currency. We have not entered into any agreements or transactions to hedge the risk associated with potential fluctuations in currencies; accordingly, we are subject to foreign currency exchange risk related to this contract. While we may enter into hedge or other agreements in the future to actively manage this risk, we do not believe this risk is material to our financial statements.
Item 8. Financial Statements and Supplementary Data
INDEX TO FINANCIAL STATEMENTS
|
Page |
Report of Independent Accountants |
37 |
Balance Sheets |
38 |
Statements of Operations |
39 |
Statements of Cash Flows |
40 |
Statements of Stockholders' Equity (Deficit) |
41 |
Notes to Financial Statements |
45 |
REPORT OF INDEPENDENT ACCOUNTANTS
To the Board of Directors
and Stockholders of Pharmacyclics, Inc.;
In our opinion, the accompanying balance sheets and the related statements of operations, of cash flows and of stockholders' equity (deficit) present fairly, in all material respects, the financial position of Pharmacyclics, Inc. (a development stage enterprise) at June 30, 2002 and 2001, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2002, and, cumulatively, for the period from inception (April 1991) through June 30, 2002, in conformity with accounting principles generally accepted in the United States of America. These financial statements are the responsibility of the Company's management; our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits of these statements in accordance with auditing standards generally accepted in the United States of America which 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, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
San Jose, California
August 9, 2002
PHARMACYCLICS, INC.
(a development stage enterprise)
BALANCE SHEETS
(in thousands, except share and per share amounts)
June 30, -------------------- 2002 2001 --------- --------- ASSETS Current assets: Cash and cash equivalents ................................ $ 89,324 $ 51,391 Marketable securities .................................... 25,594 101,391 Prepaid expenses and other current assets ................ 1,182 2,265 --------- --------- Total current assets ............................. 116,100 155,047 Property and equipment, net ................................ 4,156 5,174 Other assets ............................................... 756 752 --------- --------- $ 121,012 $ 160,973 ========= ========= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable ......................................... $ 1,784 $ 4,599 Accrued liabilities ...................................... 1,386 1,861 --------- --------- Total current liabilities ........................ 3,170 6,460 Deferred rent .............................................. 234 158 --------- --------- Total liabilities ................................ 3,404 6,618 --------- --------- Commitments (Note 6) Stockholders' equity: Preferred stock, $0.0001 par value; 1,000,000 shares authorized at June 30, 2002 and 2001; no shares issued and outstanding ........................................ -- -- Common stock, $0.0001 par value; 49,000,000 and 24,000,000 authorized at June 30, 2002 and 2001; shares issued and outstanding -- 16,187,796 at June 30, 2002 and 16,116,370 at June 30, 2 2 2 Additional paid-in capital ............................... 275,710 274,952 Accumulated other comprehensive income ................... 163 1,093 Deficit accumulated during development stage ............. (158,267) (121,692) --------- --------- Total stockholders' equity ....................... 117,608 154,355 --------- --------- $ 121,012 $ 160,973 ========= =========
The accompanying notes are an integral part of these financial statements.
PHARMACYCLICS, INC.
(a development stage enterprise)
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Period from Inception (April 1991) Year Ended June 30, through ------------------------------- June 30, 2002 2001 2000 2002 --------- --------- --------- ---------- Revenues: License and milestone revenues....... $ -- $ -- $ 1,000 $ 7,855 Contract revenues ................... -- 3,121 604 5,847 --------- --------- --------- ---------- Total revenues .............. -- 3,121 1,604 13,702 --------- --------- --------- ---------- Operating expenses: Research and development ............ 33,981 37,974 28,590 173,567 Marketing, general and administrative 7,791 6,548 4,409 29,572 --------- --------- --------- ---------- Total operating expenses .... 41,772 44,522 32,999 203,139 --------- --------- --------- ---------- Loss from operations ................. (41,772) (41,401) (31,395) (189,437) Interest income ....................... 5,152 10,604 7,778 32,699 Interest expense and other income (expense), net .............. 45 (128) (13) (1,529) --------- --------- --------- ---------- Net loss .............................. $ (36,575) $ (30,925) $ (23,630) $ (158,267) ========= ========= ========= ========== Basic and diluted net loss per share .. $ (2.27) $ (1.92) $ (1.60) ========= ========= ========= Shares used to compute basic and diluted net loss per share ........ 16,143 16,075 14,723 ========= ========= =========
The accompanying notes are an integral part of these financial statements.
PHARMACYCLICS, INC.
(a development stage enterprise)
STATEMENTS OF CASH FLOWS
(in thousands)
Period from Inception (April 1991) Year Ended June 30, through ------------------------------- June 30, 2002 2001 2000 2002 --------- --------- --------- ---------- Cash flows from operating activities: Net loss ........................................................... $ (36,575) $ (30,925) $ (23,630) $ (158,267) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization ................................... 2,299 1,697 1,194 9,471 Stock compensation expense ...................................... 91 326 88 837 Loss (gain) on sale of marketable securities .................... (20) 78 -- 58 Write-down of fixed assets ...................................... 16 47 12 381 Changes in assets and liabilities: Accounts and other receivables ................................ -- -- 294 -- Prepaid expenses and other assets ............................. 1,079 63 (1,050) (1,938) Accounts payable .............................................. (2,815) 1,748 (1,712) 1,784 Accrued liabilities ........................................... (475) 1,097 17 1,386 Deferred rent ................................................. 76 123 20 234 --------- --------- --------- ---------- Net cash used in operating activities ...................... (36,324) (25,746) (24,767) (146,054) --------- --------- --------- ---------- Cash flows from investing activities: Purchase of property and equipment ................................. (1,297) (3,122) (1,774) (10,239) Proceeds from sale of property and equipment ....................... -- -- -- 112 Purchases of marketable securities ................................. (49,059) (43,208) (145,808) (345,989) Proceeds from sales of marketable securities ....................... 8,517 8,795 -- 17,312 Proceeds from maturities of marketable securities .................. 115,429 69,254 56,751 303,188 --------- --------- --------- ---------- Net cash provided by (used in) investing activities ...... 73,590 31,719 (90,831) (35,616) --------- --------- --------- ---------- Cash flows from financing activities: Issuance of common stock, net of issuance costs .................... 667 1,941 155,420 251,361 Proceeds from notes payable ........................................ -- -- -- 3,000 Issuance of convertible preferred stock, net of issuance costs ..... -- -- -- 20,514 Payments under capital lease obligations ........................... -- (59) (216) (3,881) --------- --------- --------- ---------- Net cash provided by financing activities ................ 667 1,882 155,204 270,994 --------- --------- --------- ---------- Increase in cash and cash equivalents ................................ 37,933 7,855 39,606 89,324 Cash and cash equivalents at beginning of period ..................... 51,391 43,536 3,930 -- --------- --------- --------- ---------- Cash and cash equivalents at end of period ........................... $ 89,324 $ 51,391 $ 43,536 $ 89,324 ========= ========= ========= ========== Supplemental Disclosures of Cash Flow Information: Interest paid ...................................................... $ $ 6 $ 13 $ 1,269 Supplemental Disclosure of Non-Cash Investing and Financing Activities Property and equipment acquired under capital lease obligations .... -- -- -- 3,881 Warrants issued .................................................... -- -- -- 49 Conversion of notes payable and accrued interest into convertible preferred stock ................................. -- -- -- 3,051
The accompanying notes are an integral part of these financial statements.
PHARMACYCLICS, INC.
(a development stage enterprise)
STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)
For the period from inception (April 1991) through June 30, 2002
(in thousands, except share and per share amounts)
Deficit Convertible Accumulated Accumulated Preferred Stock Common Stock Additional other During --------------------- ---------------------- Paid-in Comprehensive Development Shares Amount Shares Amount Capital Income/(Loss) Stage Total ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Issuance of common stock for cash at $0.02 per share ........................ -- $ -- 400,000 $ -- $ 6 $ -- $ -- $ 6 ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1991 ................. -- -- 400,000 -- 6 -- -- 6 Issuance of common stock for cash at an average price of $0.02 per share ....... -- -- 97,111 -- 2 -- -- 2 Issuance of convertible preferred stock for cash, net of issuance costs, at an average price of $1.32 per share .... 2,040,784 -- -- -- 2,667 -- -- 2,667 Net loss ................................. -- -- -- -- -- -- (523) (523) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1992 ................. 2,040,784 -- 497,111 -- 2,675 -- (523) 2,152 Issuance of common stock for cash at an average price of $0.06 per share ....... -- -- 49,000 -- 3 -- -- 3 Issuance of convertible preferred stock for cash, net of issuance costs, at $4.88 per share ........................ 1,580,095 -- -- -- 7,674 -- -- 7,674 Net loss ................................. -- -- -- -- -- -- (3,580) (3,580) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1993 ................. 3,620,879 -- 546,111 -- 10,352 -- (4,103) 6,249 Issuance of common stock upon exercise of stock options at an average price of $0.12 per share ..................... -- -- 324,188 -- 38 -- -- 38 Issuance of convertible preferred stock for cash, net of issuance costs, at an average price of $8.63 per share .... 886,960 -- -- -- 7,623 -- -- 7,623 Net loss ................................. -- -- -- -- -- -- (5,141) (5,141) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1994 ................. 4,507,839 -- 870,299 -- 18,013 -- (9,244) 8,769 Issuance of common stock upon exercise of stock options at an average price of $0.24 per share ..................... -- -- 38,403 -- 9 -- -- 9 Issuance of warrants ..................... -- -- -- -- 49 -- -- 49 Net loss ................................. -- -- -- -- -- -- (10,479) (10,479) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1995 ................. 4,507,839 -- 908,702 -- 18,071 -- (19,723) (1,652) Issuance of convertible preferred stock for notes payable and accrued interest at an average of $8.63 per share ....... 353,483 -- -- -- 3,051 -- -- 3,051 Issuance of convertible preferred stock for cash, net of issuance costs, at an average price of $8.63 per share ....... 295,649 -- -- -- 2,550 -- -- 2,550 Issuance of common stock upon initial public offering, net of issuance costs, for cash at $12 per share ....... -- -- 2,383,450 1 26,042 -- -- 26,043 Conversion of convertible preferred stock into common stock ...................... (5,156,971) -- 5,156,971 -- -- -- -- -- Issuance of common stock upon exercise of stock options at an average exercise price of $1.33 per share ............... -- -- 91,922 -- 122 -- -- 122 Issuance of common stock upon exercise of purchase rights at an exercise price of $10.20 per share .................................. -- -- 8,379 -- 86 -- -- 86 Stock compensation expense ............... -- -- -- -- 26 -- -- 26 Net loss ................................. -- -- -- -- -- -- (8,235) (8,235) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1996 ................. -- -- 8,549,424 1 49,948 -- (27,958) 21,991 Issuance of common stock, net of issuance costs, for cash at an average price of $16.93 per share ...... -- -- 1,442,190 -- 24,420 -- -- 24,420 Issuance of common stock upon exercise of stock options at an average price of $2.74 per share ..................... -- -- 96,283 -- 264 -- -- 264 Issuance of common stock upon exercise of purchase rights at an exercise price of $10.51 per share .............. -- -- 14,557 -- 153 -- -- 153 Stock compensation expense ............... -- -- -- -- 126 -- -- 126 Net loss ................................. -- -- -- -- -- -- (10,258) (10,258) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1997 ................. -- -- 10,102,454 1 74,911 -- (38,216) 36,696 Issuance of common stock, net of issuance costs, for cash at $21.75 per share .............................. -- -- 2,012,500 -- 40,796 -- -- 40,796 Issuance of common stock upon exercise of stock options at an average price of $6.57 per share ............... -- -- 88,933 -- 584 -- -- 584 Issuance of common stock upon exercise of purchase rights at an exercise price of $14.36 per share .............. -- -- 10,372 -- 149 -- -- 149 Issuance of common stock upon exercise of warrants ............................ -- -- 80,033 -- -- -- -- -- Stock compensation expense ............... -- -- -- -- 91 -- -- 91 Net loss ................................. -- -- -- -- -- -- (9,675) (9,675) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1998 ................. -- -- 12,294,292 1 116,531 -- (47,891) 68,641 Issuance of common stock upon exercise of stock options at an average price of $5.10 per share ..................... -- -- 75,275 -- 384 -- -- 384 Issuance of common stock upon exercise of purchase rights at an exercise price of $12.77 per share .............. -- -- 13,643 -- 174 -- -- 174 Issuance of common stock upon exercise of warrants ............................ -- -- 45,661 -- -- -- -- -- Stock compensation expense ............... -- -- -- -- 89 -- -- 89 Comprehensive (loss): Change in unrealized loss on marketable securities .................. -- -- -- -- -- (85) -- (85) Net loss ................................. -- -- -- -- -- -- (19,246) (19,246) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 1999 ................. -- -- 12,428,871 1 117,178 (85) (67,137) 49,957 Issuance of common stock upon exercise of stock options at an average price of $13.88 per share .................... -- -- 102,372 -- 1,421 -- -- 1,421 Issuance of common stock upon exercise of purchase rights at an exercise price of $25.62 per share .............. -- -- 11,213 -- 287 -- -- 287 Issuance of common stock, net of issuance costs, for cash at an average price of $44.36 per share ...... -- -- 3,465,000 1 153,711 -- -- 153,712 Stock compensation expense ............... -- -- -- -- 88 -- -- 88 Comprehensive (loss): Change in unrealized loss on marketable securities ................ -- -- -- -- -- (421) -- (421) Net loss ................................. -- -- -- -- -- -- (23,630) (23,630) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 2000 ................. -- -- 16,007,456 2 272,685 (506) (90,767) 181,414 Issuance of common stock upon exercise of stock options at an average price of $16.17 per share .................... -- -- 93,528 -- 1,512 -- -- 1,512 Issuance of common stock upon exercise of purchase rights at an exercise price of $27.89 per share .............. -- -- 15,386 -- 429 -- -- 429 Stock compensation expense ............... -- -- -- -- 326 -- -- 326 Comprehensive income: Change in unrealized gain on marketable securities ................ -- -- -- -- -- 1,599 -- 1,599 Net loss ................................. -- -- -- -- -- -- (30,925) (30,925) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 2001 ................. -- -- 16,116,370 2 274,952 1,093 (121,692) 154,355 Issuance of common stock upon exercise of stock options at an average price of $13.93 per share .................... -- -- 13,257 -- 183 -- -- 183 Issuance of common stock upon exercise of purchase rights at an exercise price of $8.32 per share ............... -- -- 58,169 -- 484 -- -- 484 Stock compensation expense ............... -- -- -- -- 91 -- -- 91 Comprehensive loss: Change in unrealized gain on marketable securities ................ -- -- -- -- -- (930) -- (930) Net loss ................................. -- -- -- -- -- -- (36,575) (36,575) ----------- -------- ------------ -------- ---------- --------------- ----------- ---------- Balance at June 30, 2002 ................. -- $ -- 16,187,796 $ 2 $ 275,710 $ 163 $ (158,267) $ 117,608 =========== ======== ============ ======== ========== =============== =========== ==========
The accompanying notes are an integral part of these financial statements.
PHARMACYCLICS, INC.
(a development stage enterprise)
NOTES TO FINANCIAL STATEMENTS
Note 1 - The Company and Significant Accounting Policies:
Description of the company
Pharmacyclics, Inc. (the "company") was incorporated in Delaware in 1991 and commenced operations during 1992 to develop and market pharmaceutical products to improve upon current therapeutic approaches to the treatment of cancer and atherosclerosis. Since inception, the company has been in the development stage, principally involved in research and development and other business planning activities, with no commercial revenues from product sales. Successful future operations depend upon the company's ability to develop, to obtain regulatory approval for, and to commercialize its products. The company operates in one business segment.
Management's use of estimates and assumptions
The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reported period. Actual results could differ from those estimates.
Basic and diluted net loss per share
Basic earnings per share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the weighted average number of common and potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon conversion of outstanding convertible preferred stock (using the if-converted method) and shares issuable upon the exercise of stock options (using the treasury stock method). Options to purchase 4,268,687, 3,272,936 and 2,548,634 shares of common stock were outstanding at June 30, 2002, 2001 and 2000, respectively, but have been excluded from the computation of diluted net loss per share because their effect was anti-dilutive.
Cash and cash equivalents
All highly liquid investments purchased with an original maturity date of three months or less that are readily convertible into cash and have insignificant interest rate risk are considered to be cash equivalents. All other investments are reported as available-for-sale marketable securities.
Marketable securities - available-for-sale
The company has classified all its marketable securities as "available-for-sale." Unrealized gains and losses on available-for-sale securities are included in other comprehensive income (loss). The amortized cost of debt securities in this category is adjusted for amortization of premiums and accretions of discounts to maturity. Such amortization is included in interest income. Gains and losses on securities sold are recorded based on the specific identification method and are included in interest expense and other income (expense), net in the statement of operations.
The company's marketable securities consisted of the following (in thousands):
Net Estimated Amortized Unrealized Fair Cost Gains Value --------- --------- --------- June 30, 2002 Debt (state or political subdivision)... $ 10,459 $ 22 $ 10,481 Debt (corporate)........................ 14,972 141 15,113 --------- --------- --------- $ 25,431 $ 163 $ 25,594 ========= ========= ========= June 30, 2001 Debt (state or political subdivision)... $ 3,975 $ 4 $ 3,979 Debt (corporate)........................ 96,323 1,089 97,412 --------- --------- --------- $ 100,298 $ 1,093 $ 101,391 ========= ========= =========
At June 30, 2002 and 2001, all of the company's debt investments are classified as short-term, as the company may choose not to hold its investments until maturity in order to take advantage of market conditions. Unrealized losses in 2002 and 2001 were not material and have therefore been netted against unrealized gains and losses, respectively. At June 30, 2002, the company's marketable securities had the following maturities (in thousands):
Estimated Amortized Fair Cost Value --------- --------- Less than one year...................... $ 14,853 14,939 Between one and two years............... 10,578 10,655 --------- --------- $ 25,431 $ 25,594 ========= =========
Concentration of credit risk
Financial instruments that potentially subject the company to credit risk consist principally of cash, cash equivalents and marketable securities. The company places its cash, cash equivalents and marketable securities with high-credit quality financial institutions and invests in debt instruments of financial institutions, corporations and government entities with strong credit ratings. Management of the company believes it has established guidelines relative to diversification and maturities that maintain safety and liquidity.
Property and equipment
Property and equipment are stated at cost. Depreciation is computed using the straight-line method over the shorter of the estimated useful lives of the assets, generally three to five years, or the lease term of the respective assets, if applicable. Amortization of leasehold improvements is computed using the straight-line method over the shorter of their estimated useful lives or lease terms.
Long-lived assets
The company identifies and records impairment losses on long-lived assets when events and circumstances indicate that the assets might be impaired. No significant impairment losses have been recorded to date with respect to the company's long-lived assets, which consist primarily of property and equipment and leasehold improvements.
Revenue recognition
Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed and determinable and collectibility is reasonably assured. License and milestone fees are recognized as revenue when earned over the period of the arrangement, as evidenced by achievement of the specified milestones and the absence of any on-going performance obligation. Contract revenue is recognized as earned, primarily based on costs incurred to total estimated costs at completion, pursuant to the terms of each agreement. License, milestone, contract and grant revenues are not subject to repayment. Any amounts received in advance of performance are recorded as deferred revenue.
Recent accounting pronouncements
In October 2001, the FASB issued Statement of Financial Accounting Standards ("SFAS") No. 144, "Accounting for the Impairment or Disposal of Long-Lived Assets" ("SFAS 144"). SFAS 144 establishes a single accounting model, based on the framework established in Statement of Financial Accounting Standards No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of" ("SFAS 121"), for long-lived assets to be disposed of by sale, and resolves implementation issues related to SFAS 121. The Company is required to adopt SFAS 144 no later than the first quarter of fiscal 2003. The Company believes that the adoption of this standard will have no impact on its financial statements.
In May 2002, the FASB issued SFAS No. 145, "Rescission of SFAS Nos. 4, 44, and 64, Amendment of SFAS No. 13, and Technical Corrections" ("SFAS 145"). Among other things, SFAS 145 rescinds various pronouncements regarding early extinguishment of debt and allows extraordinary accounting treatment for early extinguishment only when the provisions of Accounting Principles Board Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions" are met. SFAS 145 provisions regarding early extinguishment of debt are generally effective for fiscal years beginning after May 15, 2002. The Company believes that the adoption of this standard will have no impact on its financial statements.
In July 2002, the FASB issued SFAS No. 146, "Accounting for Costs Associated with Exit or Disposal Activities" ("SFAS 146"). This Statement addresses financial accounting and reporting for costs associated with exit or disposal activities and nullifies Emerging Issues Task Force (EITF) Issue No. 94-3, "Liability Recognition for Certain Employee Termination Benefits and Other Costs to Exit an Activity (including Certain Costs Incurred in a Restructuring)." This Statement requires that a liability for costs associated with an exit or disposal activity be recognized and measured initially at fair value only when the liability is incurred. The provisions of this Statement are effective for exit or disposal activities that are initiated after December 31, 2002. The Company believes that the adoption of this standard will have no impact on its financial statements.
Inventories
The company has purchased quantities of its texaphyrin-based drug substance that are expected to be available in the future to support the commercial launch of its products currently under development. Until the commercial viability of such products has been demonstrated and the necessary regulatory approvals received, the company will continue to charge all such amounts to research and development expense.
Research and development
Research and development activities are expensed as incurred and include costs associated with company's internal programs, as well as costs incurred in connection with contract research performed pursuant to collaborative agreements. Research and development costs consist of direct and indirect internal costs related to specific projects as well as fees paid to other entities which conduct certain research activities on behalf of the company. Research and development expenses incurred in connection with research contracts were zero, $0.9 million and $1.7 million for the years ended June 30, 2002, 2001and 2000, respectively.
Income taxes
The company provides for income taxes using the liability method. This method requires that deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the tax bases of assets and liabilities and their financial statement reported amounts. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
Fair value of financial instruments
The carrying value of the company's financial instruments including cash and cash equivalents, marketable securities and accrued liabilities, approximate fair value due to their short maturities.
Stock-based compensation
The company accounts for employee stock-based compensation using the intrinsic value method prescribed in Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations. The Company provides additional pro forma disclosures as required under Statement of Financial Accounting Standards No. 123 ("SFAS 123"), "Accounting for Stock-Based Compensation."
The company accounts for equity instruments issued to non- employees in accordance with the provisions of SFAS 123 and Emerging Issues Task Force No. 96-18, "Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services." Stock compensation expense related to stock options granted to non-employees is recognized as the stock options are earned in accordance with the provisions of SFAS 123 and Financial Accounting Standards Board No. Interpretation 28, "Accounting for Stock Appreciation Rights and Other Variable Stock Option or Award Plans."
Note 2 - Agreements:
University of Texas License. The company has entered into two exclusive patent license agreements with The University of Texas which permit the company to exclusively manufacture, use and sell products covered by patents that result from certain research conducted by The University of Texas. Each agreement requires the company to pay royalties to The University of Texas. The company paid $50,000 and $100,000 of royalties in the years ended June 30, 2002 and 2001, respectively, and paid no royalties in the year ended June 30, 2000.
Alcon Collaboration. In December 1997, the company entered into an evaluation and license agreement with Alcon Pharmaceuticals Ltd., under which Alcon acquired worldwide marketing rights to Optrin™ photosensitizer for ophthalmology uses. Optrin is a lutetium texaphyrin molecule which was being developed as a photosensitizer for the use in photodynamic therapy of retinal degeneration. Alcon conducted and was responsible for all costs associated with its worldwide development and regulatory submissions for ophthalmology uses of Optrin. In accordance with the terms of this agreement, the company received a non-refundable, up-front payment. In October 2001, Alcon terminated this agreement.
Nycomed Collaboration. In October 1997, the company entered into an agreement with Nycomed Imaging A/S, in which Nycomed acquired exclusive sales and marketing rights to Lutrin™ photosensitizer for cancer treatments in all markets of the world excluding the United States, Canada and Japan. Lutrin is a lutetium texaphyrin molecule being developed as a photosensitizer for use in the photodynamic therapy of cancer. In May 2001, the company and Nycomed terminated this agreement. Pursuant to the termination agreement, Pharmacyclics reacquired all its rights from Nycomed to develop and market Lutrin and Nycomed agreed to make a non-recurring termination payment to Pharmacyclics of $2,750,000. The termination payment was recorded as revenue in the fourth quarter of fiscal 2001 as the company had no further performance obligation under the termination agreement.
Note 3 - Balance Sheet Components:
Property and equipment consists of the following (in thousands):
June 30, -------------------- 2002 2001 --------- --------- Equipment ........................................ $ 7,165 $ 6,355 Leasehold improvements ........................... 4,044 3,870 Furniture and fixtures ........................... 1,193 1,100 --------- --------- 12,402 11,325 Less accumulated depreciation and amortization ... (8,246) (6,151) --------- --------- $ 4,156 $ 5,174 ========= =========
Accrued liabilities consist of the following (in thousands):
June 30, -------------------- 2002 2001 --------- --------- Employee compensation ............................ $ 1,319 $ 1,788 Other ............................................ 67 73 --------- --------- $ 1,386 $ 1,861 ========= =========
Note 4 - Stockholders' Equity:
Common stock
In September and October 1999, the company sold a total of 2,645,000 shares of its common stock at $38.75 per share resulting in net cash proceeds of approximately $96.1 million. In March 2000, the company sold 820,000 shares of unregistered common stock to four purchasers in a private placement. The shares were sold at $73.25 per share, which resulted in net proceeds of approximately $57.6 million. The company filed a registration statement on Form S-3 related to these shares, which was declared effective on April 11, 2000.
Preferred stock
As amended, the company's Certificate of Incorporation authorizes 1,000,000 shares of preferred stock, par value $0.0001 per share. The Board of Directors is authorized to issue the preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions thereof, including dividend rights, dividend rates, conversion rights, voting rights, terms of redemption, redemption prices, liquidation preferences and the number of shares constituting any series or the designation of such series, without further vote or action by the stockholders.
The ability of the company's Board of Directors to issue shares of preferred stock without stockholder approval, and the adoption of a stockholder rights plan, may alone or in combination have certain anti-takeover effects. The company is also subject to provisions of the Delaware General Corporation Law, which may make certain business combinations more difficult.
Shareholder rights plan
In April 1997, the Board of Directors approved a shareholder rights plan (the "Plan") under which stockholders of record on May 1, 1997 received a right to purchase (a "Right") one one-hundredth of a share of Series A Junior Participating Preferred Stock, par value $.001 per share (the "Series A Preferred Stock"), at an exercise price of $125 per one one-hundredth of a share, subject to adjustment. The Rights will separate from the common stock and Rights certificates will be issued and will become exercisable upon the earlier of (i) 10 business days following a public announcement that a person or group of affiliated or associated persons has acquired, or obtained the right to acquire, beneficial ownership of 15% or more of the company's outstanding common stock or (ii) 10 business days or such later date as may be determined by a majority of the Board of Directors following the commencement of, or announcement of, an intention to make a tender offer or exchange offer, the consummation of which would result in the beneficial ownership by a person or group of 15% or more of the outstanding common stock of the Company. The Rights expire at the close of business on April 30, 2007. The company has designated 120,000 shares of its preferred stock as Series A Junior Participating Preferred Stock in connection with this plan. In December 2001, the Board of Directors approved an amendment to the Plan so that each Right entitles the holder to purchase one one-thousandth of a share of Series A Preferred Stock at a price of $125 per one one-thousandth of a share, subject to adjustment.
Warrants
In connection with the company's initial public offering during 1995, outstanding warrants to purchase shares of preferred stock were converted into warrants to purchase shares of common stock. In fiscal 1998, holders of all of the warrants granted in July 1995 elected "net issue exercises" at an average market price of $24.15 per share, resulting in the issuance of 80,033 shares of common stock and the cancellation of warrants to purchase 44,465 shares of common stock. In fiscal 1999, warrants for 45,661 shares were exercised. At June 30, 2002 and 2001, there were no outstanding warrants.
Stock option plans
1992 Stock Option Plan. The 1992 Stock Option Plan (the "1992 Plan"), as amended, authorizes the Board of Directors to grant incentive stock options and non-statutory stock options to employees, directors and consultants to purchase up to 1,233,334 shares of common stock. Under the 1992 Plan, incentive stock options are granted at a price not less than 100% of the estimated fair value of the stock on the date of grant, as determined by the Board of Directors. Nonqualified stock options are granted at a price not less than 85% of the estimated fair value of the stock on the date of grant, as determined by the Board of Directors. To date, all options granted under the 1992 Plan have been granted at 100% of the estimated fair value of the common stock as determined by the Board of Directors. Options are exercisable for a period of ten years.
1995 Stock Option Plan. The company's 1995 Stock Option Plan (the "1995 Plan") was adopted by the Board of Directors in August 1995. The 1995 Plan authorizes for issuance 4,185,676 shares of common stock. Beginning on January 1, 1996, the 1995 Plan also allows for an annual increase to the number of shares available for issuance equal to 1% of the number of shares of common stock outstanding on the last day of the preceding calendar year, not to exceed 500,000 shares per year. Shares of common stock subject to outstanding options that expire or terminate prior to exercise will be available for future issuance under the 1995 Plan.
Under the 1995 Plan, employees, non-employee members of the Board of Directors (other than those serving as members of the Compensation Committee) and independent consultants may, at the discretion of the plan administrator, be granted options to purchase shares of common stock at an exercise price not less than 85% of the fair market value of such shares on the grant date. Non-employee members of the Board of Directors will also be eligible for automatic option grants under the company's 1995 Non-Employee Directors Stock Option Plan. Generally, shares subject to options under the 1995 Plan vest over a four to five-year period and are exercisable for a period of ten years.
In the event the company is acquired by merger, consolidation or asset sale, options outstanding under the 1995 Plan will immediately vest in full, except to the extent the options are assumed by the acquiring entity. Any assumed options will accelerate upon the optionee's involuntary termination within 18 months following the acquisition. The Compensation Committee also has discretion to provide for the acceleration of one or more outstanding options under the 1995 Plan and the vesting of shares subject to outstanding options upon the occurrence of certain hostile tender offers. Such accelerated vesting may be conditioned upon the subsequent termination of the affected optionee's service. The Board may amend or modify the 1995 Plan at any time. The 1995 Plan will terminate on August 1, 2005, unless terminated earlier by the Board.
1995 Non-Employee Directors Stock Option Plan. The Company's 1995 Non-Employee Directors Stock Option Plan (the "Directors Plan"), was adopted by the Board of Directors on August 2, 1995. Automatic option grants are made at periodic intervals to eligible non-employee Board members under the Directors Plan. The Directors Plan became effective as of the effective date of the Company's initial public offering. A total of 246,667 shares of common stock have been reserved for issuance under the Directors Plan.
Each individual first elected or appointed as a non-employee Board member will automatically be granted, on the date of such election or appointment, a non-statutory option to purchase 10,000 shares of common stock vesting over five years. In addition, on the date of each annual stockholders meeting each individual who is to continue to serve as a non-employee Board member after that annual meeting and has been a member of the Board for at least six months will automatically be granted a non-statutory option to purchase 5,000 shares of common stock, vesting in equal monthly installments for one year after the grant date. There will be no limit on the number of such annual 5,000- share option grants any one non-employee Board member may receive over his or her period of continued Board service. The exercise price per share of each automatic option grant will be equal to the fair market value of the common stock on the automatic grant date. Each automatic option will be immediately exercisable; however, any shares purchased upon exercise of the option will be subject to repurchase should the optionee's service as a non-employee Board member cease prior to vesting in the shares. Each 10,000-share grant will vest in five equal and successive annual installments over the optionee's period of Board service. Each 5,000-share grant will vest in twelve equal and successive monthly installment over the optionee's period of Board service.
In the event of the Board member's death or permanent disability or in the event the company is acquired by a merger or asset sale and in the event of certain hostile tender offers, each outstanding option will become fully vested. Upon the acquisition of 50% or more of the company's outstanding voting stock pursuant to a hostile tender offer, each automatic option grant outstanding for at least six months may be surrendered automatically or be cancelled in exchange for cash distribution to the Board member based upon the tender offer price. The Directors Plan will terminate on August 1, 2005.
The following table summarizes activity under the company's stock option plans (in thousands, except per share amounts):
Options Outstanding --------------------- Weighted Average Exercise Shares Price Available Per for Grant Number Share ----------- ---------- --------- Authorized ..................... 1,000 -- $ -- Granted ........................ (480) 480 0.19 ----------- ---------- Balance at June 30, 1993 ....... 520 480 0.19 Exercised ...................... -- (324) 0.12 Granted ........................ (167) 167 2.22 Canceled ....................... 8 (8) 0.11 ----------- ---------- Balance at June 30, 1994 ....... 361 315 1.37 Exercised ...................... -- (39) 0.24 Granted ........................ (193) 193 3.75 Canceled ....................... 38 (38) 1.82 ----------- ---------- Balance at June 30, 1995 ....... 206 431 2.50 Authorized ..................... 485 -- -- Exercised ...................... -- (92) 3.09 Granted ........................ (492) 492 10.03 Canceled ....................... 11 (11) 6.11 ----------- ---------- Balance at June 30, 1996 ....... 210 820 9.20 Authorized ..................... 842 -- -- Exercised ...................... -- (96) 2.74 Granted ........................ (569) 569 16.69 Canceled ....................... 31 (31) 12.21 ----------- ---------- Balance at June 30, 1997 ....... 514 1,262 11.58 Authorized ..................... 602 -- -- Exercised ...................... -- (89) 6.57 Granted ........................ (577) 577 25.33 Canceled ....................... 158 (158) 15.41 ----------- ---------- Balance at June 30, 1998 ....... 697 1,592 16.43 Authorized ..................... 524 -- -- Exercised ...................... -- (75) 5.10 Granted ........................ (671) 671 19.25 Canceled ....................... 221 (221) 20.37 ----------- ---------- Balance at June 30, 1999 ....... 771 1,967 17.38 Authorized ..................... 681 -- -- Exercised ...................... -- (103) 13.88 Granted ........................ (723) 723 56.97 Canceled ....................... 53 (53) 23.38 ----------- ---------- Balance at June 30, 2000 ....... 782 2,534 28.70 Authorized ..................... 811 -- -- Exercised ...................... -- (94) 16.17 Granted ........................ (947) 947 36.80 Canceled ....................... 114 (114) 45.70 ----------- ---------- Balance at June 30, 2001 ....... 760 3,273 29.78 Authorized ..................... 747 -- Exercised ...................... -- (13) 13.93 Granted ........................ (1,634) 1,634 8.76 Canceled ....................... 625 (625) 27.83 ----------- ---------- Balance at June 30, 2002 ....... 498 4,269 21.82 =========== ==========
A summary of outstanding and vested stock options as of June 30, 2002 is as follows:
Options Outstanding Options Vested --------------------------------- --------------------- Weighted Weighted Weighted Average Average Average Exercise Exercise Number Remaining Price Number Price Range of of Contractual Per of Per Exercise Prices Shares Life Share Shares Share - ------------------- ---------- ----------- --------- ---------- --------- $0.075 - 4.25 ..... 654,469 8.71 $ 4.14 104,919 $ 3.57 7.39 - 7.39....... 616,277 9.61 7.39 57,115 7.39 7.50 - 16.00...... 459,639 4.15 11.72 419,348 11.50 16.88 - 18.07...... 627,366 6.81 17.82 319,044 17.70 18.25 - 27.00...... 607,314 6.18 23.27 479,562 23.22 27.50 - 38.13...... 627,409 8.72 28.56 123,317 30.64 38.25 - 58.06...... 616,124 8.10 53.01 252,651 53.48 66.13 - 78.125..... 60,089 7.69 76.39 26,524 76.43 ---------- ---------- 4,268,687 7.61 21.82 1,782,480 23.41 ========== ==========
The Company has outstanding exercisable options to purchase 3,774,694, 3,081,532, and 2,313,942 shares of common stock with a weighted average exercise price of $22.78, $28.84, and $27.57 at June 30, 2002, 2001, and 2000, respectively.
Employee Stock Purchase Plan. The company adopted an Employee Stock Purchase Plan (the "Purchase Plan") in August 1995. Qualified employees may elect to have a certain percentage of their salary withheld to purchase shares of the company's common stock under the Purchase Plan. The purchase price per share is equal to 85% of the fair market value of the stock on specified dates. Sales under the Purchase Plan in fiscal 2002, 2001and 2000 were 58,169, 15,386 and 11,213 shares of common stock at an average price of $8.32, $27.89 and $25.62 per share, respectively. Shares available for future purchase under the Purchase Plan are 168,281 at June 30, 2002. The Purchase Plan will terminate in October 2005.
Pro forma disclosure
The weighted average estimated grant date fair value, as defined by SFAS 123, for options granted under the company's stock option plans during fiscal 2002, 2001 and 2000 was $6.50, $23.43 and $40.84 per share, respectively. The weighted average estimated grant date fair value of purchase awards under the company's Purchase Plan during fiscal 2002, 2001and 2000 was $15.74, $21.09 and $18.06, respectively. The estimated grant date fair values were calculated using the Black-Scholes valuation model.
The following assumptions are included in the estimated grant date fair value calculations for the company's stock option and purchase awards:
Year Ended June 30, ------------------------------- 2002 2001 2000 ---------- --------- -------- Stock option plans: Expected dividend yield ............ 0 % 0 % 0 % Expected stock price volatility .... 89 % 84 % 81 % Risk free interest rate ............ 4.72 % 5.21 % 6.37 % Expected life (years) .............. 5.65 5.65 5.61 Stock purchase plan: Expected dividend yield ............ 0 % 0 % 0 % Expected stock price volatility .... 96 % 81 % 81 % Risk free interest rate ............ 2.94 % 6.42 % 6.25 % Expected life (years) .............. 2.00 2.00 2.00
Pro forma net loss and net loss per share
Had the company recorded stock compensation cost based on the estimated grant date fair value, as defined by SFAS 123, for awards granted under its stock option plans and stock purchase plan, the company's net loss and net loss per share would have been increased to the pro forma amounts below (in thousands, except per share amounts):
Year Ended June 30, ------------------------------- 2002 2001 2000 ---------- --------- -------- Net loss: As reported ........................ $ (36,575) $ (30,925) $(23,630) Pro forma .......................... (48,971) (41,678) (29,060) Net loss per share: As reported ........................ $ (2.27) $ (1.92) $ (1.60) Pro forma .......................... (3.03) (2.59) (1.97)
Such pro forma disclosures may not be representative of the pro forma effect in future years because options vest over several years and additional grants may be made each year.
Note 5 - Income Taxes:
Deferred tax assets are summarized as follows (in thousands):
June 30, --------------------- 2002 2001 ---------- --------- Net operating loss carryforwards ..... $ 56,981 $ 43,297 Tax credit carryforwards ............. 9,461 7,586 Capitalized start-up and R&D costs ... 3,560 1,937 Depreciation and amortization......... 847 529 Reserves and accruals................. 418 2,172 ---------- --------- Gross deferred tax assets ............ 71,267 55,521 Less valuation allowance ............. (71,267) (55,521) ---------- --------- Net deferred tax assets .............. $ -- $ -- ========== =========
A full valuation allowance has been established for the company's deferred tax assets at June 30, 2002 and 2001 since realization of such assets through the generation of future taxable income is uncertain.
The provision for income taxes differs from the amount determined by applying the U.S. statutory income tax rate to the loss before income taxes as summarized below (in thousands):
Year Ended June 30, ------------------------------- 2002 2001 2000 ---------- --------- -------- Tax benefit at statutory rate ........ $ 12,801 $ 10,824 $ 8,271 Net operating loss carryforward for which no benefit was available...... (12,801) (10,824) (8,271) ---------- --------- -------- $ -- $ -- $ -- ========== ========= ========
At June 30, 2002, the company had federal and state net operating loss carryforwards of approximately $159.3 million and $48.1 million, respectively, and federal and state tax credit carryforwards of $6.6 million and $4.4 million, respectively, available to offset future taxable income. These amounts expire at various times through 2022.
Under the Tax Reform Act of 1986, the amounts of and the benefit from net operating losses and tax credit carryforwards that can be carried forward may be impaired or limited in certain circumstances. These circumstances include, but are not limited to, a cumulative stock ownership change of greater than 50%, as defined, over a three year period. As a result of ownership changes that have occurred in the past, management believes that utilization of the company's net operating loss and tax credit carryforwards is subject to certain annual limitations.
Note 6 - Commitments:
The company leases its facilities under non-cancelable operating leases that expire in fiscal 2004. Future minimum lease payments under non-cancelable operating leases are as follows (in thousands):
Operating Operating Lease Sublease Commitments Income ---------- --------- Year Ending June 30, - -------------------------------------- $ 3,720 $ (233) 2003.................................. 2,163 -- 2004.................................. ---------- --------- Total minimum lease payments and operating lease income ...... $ 5,883 $ (233) ========== =========
Rent expense for the years ended June 30, 2002, 2001 and 2000 was $2,961,000, $1,174,000 and $731,000, respectively, and $7,135,000 for the period from inception (April 1991) through June 30, 2002. Sublease income was $486,000 for the year ended June 30, 2002 and from the period from inception (April 1991) through June 30, 2002. The terms of one facility lease provides for rental payments on a graduated scale. The company recognizes rent expense on a straight-line basis over the lease period and has accrued for rent expense incurred but not paid at June 30, 2002.
Note 7 - Quarterly Results (Unaudited)
The following table is in thousands, except per share amounts:
Quarter Ended -------------------------------------------------------- September 30, December 31, March 31, June 30, ------------ ------------ ------------ ------------ Fiscal 2002 Revenues ............................. $ -- $ -- $ -- $ -- Loss from operations ................. (11,657) (13,105) (8,952) (8,058) Net loss ............................. (9,702) (11,724) (7,896) (7,253) Basic and diluted net loss per share . $ (0.60) $ (0.73) $ (0.49) $ (0.45) Shares used in computation of basic and diluted net loss per share .... 16,124 16,134 16,141 16,173 Quarter Ended -------------------------------------------------------- September 30, December 31, March 31, June 30, ------------ ------------ ------------ ------------ Fiscal 2001 Revenues ............................. $ 110 $ 229 $ 70 $ 2,712 Loss from operations ................. (11,163) (10,556) (9,233) (10,449) Net loss ............................. (8,215) (7,877) (6,639) (8,194) Basic and diluted net loss per share . $ (0.51) $ (0.49) $ (0.41) $ (0.51) Shares used in computation of basic and diluted net loss per share .... 16,031 16,062 16,093 16,116
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Not Applicable.
PART III
Item 10. Directors and Executive Officers of the Registrant
The information required by this Item 10 (with respect to Directors) is hereby incorporated by reference from the information under the caption "Election of Directors" contained in the Company's definitive proxy statement to be filed with the Securities and Exchange Commission no later than 120 days from the end of the Company's last fiscal year in connection with the solicitation of proxies for its Annual Meeting of Stockholders to be held on December 11, 2002, (the "Proxy Statement"). The required information concerning MANAGEMENT - Directors and Executive Officers is contained in Item 1, Part 1, of this Form 10-K under the caption "Executive Officers and Directors" on pages 23 through 25.
The information required by Section 16(a) is hereby incorporated by reference from the information under the caption "Compliance with Section 16(a) of the Securities Exchange Act of 1934" in the Proxy Statement.
Item 11. Executive Compensation
The information required by this Item 11 is incorporated by reference from the information under the caption "Election of Directors, Summary of Cash and Certain Other Compensation, Stock Options, Exercises and Holdings" in the Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Equity Compensation Plan Information
As of June 30, 2002
Number of securities remaining available Number of securities for future issuance to be issued Weighted-average under equity upon exercise of exercise price of compensation plans outstanding options, outstanding options, (excluding securities warrants and rights warrants and rights reflected in column (a)) Plan Category (a) (b) (c) - ---------------------------------- -------------------- ------------------- ----------------------- Equity compensation plans approved by security holders (1) 4,268,687 $ 21.82 666,120 Equity compensation plans not approved by security holders.... -- -- -- -------------------- ------------------- ----------------------- Total 4,268,687 $ 21.82 666,120 ==================== =================== =======================
(1) Includes our 1992 Stock Option Plan, 1995 Stock Option Plan, 1995 Non-employee Directors Stock Option Plan, and Employee Stock Purchase Plan
The other information required by this Item 12 is incorporated by reference from the information under the caption "Stock Ownership of Management and Certain Beneficial Owners" in the Proxy Statement.
Item 13. Certain Relationships and Related Transactions
The information required by this Item 13 is incorporated by reference from the information under the caption "Certain Relationships and Related Transactions" in the Proxy Statement.
PART IV
Item 14. Financial Statements, Financial Statement Schedules, Exhibits and Reports on Form 8-K
(a) 1. Financial Statements
See Index to Financial Statements under Item 8 on page 36.
(a) 2. Financial Statement Schedules
All schedules are omitted because they are not applicable or are not required or the information required to be set forth therein is included in the consolidated financial statement or notes thereto.
(b) Reports on Form 8-K
None.
(c) Exhibits
The following documents are referenced or included in this report.
Exhibit Number |
Description |
3.1 |
Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference to exhibit of the same number to Form 8-A12G/A filed on May 21, 2002) |
3.2 |
Amended and Restated Bylaws of the Company (Incorporated by reference to exhibit of the same number to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2001 |
3.3 |
Certificate of Designation of Series A Junior Participating Preferred Stock of the Company (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the fiscal year ended June 30, 1997) |
4.1 |
Amended and Restated Rights Agreement, dated as of February 15, 2002 (Incorporated by reference to Exhibit 3.2 to Form 8-A12G/A filed on May 21, 2002) |
4.2 |
Specimen Certificate of the Company's Common Stock (Incorporated by reference to Exhibit 4.2 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.1 |
Form of Indemnification Agreement between the Company and its directors and executive officers (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.2 |
Series C Stock Purchase Agreement dated as of June 13, 1994, between the Company and the investors specified therein (Incorporated by reference to Exhibit 10.4 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.3 |
Investment Agreement dated as of July 31, 1995, between the Company and the investors specified therein (Incorporated by reference to Exhibit 10.5 to the Company's Registrati Statement on Form S-1, Commission File No. 33-96048) |
10.4 |
Form of Series C Preferred Stock Purchase Warrant dated as of July 31, 1995, issued by the Company to the investors listed on Schedule A thereto (Incorporated by reference to Exhibit 10.6 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.5 |
Master Lease and Warrant Agreements entered into between the Company and Comdisco, Inc., dated as of July 22, 1992, July 30, 1992, March 31, 1993, June 24, 1993, October 3, 1994, respectively (Incorporated by reference to Exhibit 10.7 to the Company' Registration Statement on Form S-1, Commission File No. 33-96048) |
10.6* |
Patent License Agreement entered into between the Company and The University of Texas, Austin dated entered into on or about July 1, 1991 (Incorporated by reference to Exhibit 10.8 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.7* |
Patent License Agreement entered into between the Company and The University of Texas, Dallas dated as of July 1, 1992, as amended by the Patent License Agreement dated May 27, 1993 (Incorporated by reference to Exhibit 10.9 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.8* |
Patent License Agreement entered into between the Company and Stuart W. Young dated as of October 15, 1992 (Incorporated by reference to Exhibit 10.10 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.9 |
Lease Agreement entered into between the Company and New England Mutual Life Insurance Company dated as of June 17, 1993, as amended on July 22, 1993, and as further amended on March 1, 1994 (Incorporated by reference to Exhibit 10.11 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.10 |
Supply Agreement entered into between the Company and Glaxo Wellcome Company. (f/k/a Burroughs Wellcome Co.) dated as of March 1, 1995 (Incorporated by reference to Exhibit 10.14 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.11* |
License Agreement entered into between the Company and Cook, Incorporated, dated as of April 4, 1995 (Incorporated by reference to Exhibit 10.13 to the Company's Registrati Statement on Form S-1, Commission File No. 33-96048) |
10.12* |
License and Supply Agreement entered into between the Company and E-Z-EM, Inc. dated as of August 7, 1995 (Incorporated by reference to Exhibit 10.14 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.13 |
The Company's 1995 Stock Option Plan (Incorporated by reference to Exhibit 99.1 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.14 |
The Company's 1995 Non-Employee Directors' Stock Option Plan (Incorporated by reference to Exhibit 99.7 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.15 |
The Company's Employee Stock Purchase Plan (Incorporated by reference to Exhibit 99.7 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.16 |
Employment Agreement entered into between the Company and Richard A. Miller, M.D. dated as of June 10, 1992 (Incorporated by reference to Exhibit 10.19 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.17 |
Employment Agreement entered into between the Company and Marc L. Steuer dated as of October 31, 1994 (Incorporated by reference to Exhibit 10.20 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.18 |
Employment Agreement entered into between the Company and William C. Dow, Ph.D., dated as of May 20, 1992, as amended by a letter agreement dated July 8, 1992 (Incorporated by reference to Exhibit 10.21 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.19 |
Employment Agreement entered into between the Company and Stuart W. Young, M.D. dated as of April 19, 1993 (Incorporated by reference to Exhibit 10.22 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.20 |
Promissory Notes issued by the Company to Stuart W. Young, M.D. dated as of September 1994 and April 1995, in the amounts of $65,000 and $30,000, respectively (Incorporated b reference to Exhibit 10.24 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.21* |
Master Process Development and Supply Agreement dated September 6, 1996 entered into between the Company and Hoechst Celanese Corporation (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the fiscal year ended June 30, 1996) |
10.22 |
Form of Notice of Grant of Stock Option generally to be used under the 1995 Stock Option Plan (Incorporated by reference to Exhibit 99.2 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.23 |
Form of Stock Option Agreement (Incorporated by reference to Exhibit 99.3 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.24 |
Form of Addendum to Stock Option Agreement (Limited Stock Appreciate Right) (Incorporated by reference to Exhibit 99.4 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.25 |
Form of Addendum to Stock Option Agreement (Special Tax Election) (Incorporated by reference to Exhibit 99.5 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.26 |
Form of Addendum to Stock Option Agreement (Involuntary Termination following Change in Control) (Incorporated by reference to Exhibit 99.6 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.27 |
Form of Notice of Grant of Automatic Stock Option (Initial Grant) (Incorporated by reference to Exhibit 99.8 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.28 |
Form of Notice of Grant of Automatic Stock Option (Annual Grant) (Incorporated by reference to Exhibit 99.9 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.29 |
Form of Non-Employee Director Stock Option Agreement (Incorporated by reference to Exhibit 99.10 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.30 |
Form of Employee Stock Purchase Plan Enrollment/Change Form (Incorporated by reference to Exhibit 99.12 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.31 |
Form of Stock Purchase Agreement (Incorporated by reference to Exhibit 99.13 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.32 |
Form of Special Officer Participation Form (Incorporated by reference to Exhibit 99.14 t the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.33 |
Common Stock Purchase Agreement dated November 11,1996, by and among the Company and the persons listed on Schedule 1 thereto (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 333-22747) |
10.34 |
Common Stock Purchase Agreement dated February 21, 1997, by and among the Company and the persons listed on Schedule 1 thereto (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 333-22747) |
10.35 |
Form of Severance Agreement between the Company and certain executive officers (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.36* |
Development, License and Commercialization Agreement, dated October 17, 1997, by and between the Company and Nycomed Imaging AS (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.37 |
Employment Agreement, dated October 14, 1997, by and between the Company and Michael J. Hensley, M.D. (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.38 |
Employment Agreement, dated December 18, 1997, by and between the Company and Leiv Lea (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended March 31, 1998) |
10.39* |
Evaluation and License Agreement, dated December 16, 1997, by and between Alcon Laboratories, Inc. (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-3, Commission File No. 333-43621) |
10.40 |
Employment agreement, dated March 11, 1998, by and between the Company and David A. Lowin (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.41 |
Employment agreement, dated May 28, 1998, by and between the Company and Hugo Madden (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.42* |
Development and Supply Agreement dated June 16, 1998 entered into between the Company and Abbott Laboratories Inc (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.43 |
Termination Agreement, dated as of August 27, 1999, by and between Registrant and Celanese, Ltd. (Incorporated by reference to Exhibit 10.1 to an 8-K filed on September 3 1999) |
10.44* |
Master Development and Supply Agreement, dated March 20, 2000 by and between Cook Imaging Corporation, D.B.A. Cook Pharmaceutical Solutions, and the Registrant (Incorporated by reference to Exhibit 10.1 to the Quarterly report on Form 10-Q for the quarter ended March 31, 2000) |
10.45 |
Employment agreement, dated March 23, 2000 by and between the Company and Cynthia J. Ladd (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 2000) |
10.46 |
Employment agreement, dated July 10, 2000, by and between the Company and Jon R. Wallace (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2000) |
10.47* |
Supply Agreement, dated December 11, 2000 by and between Dixie Chemical Company and the Registrant (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2000) |
10.48* |
Supply Agreement, dated December 18, 2000 by and between Lonza, AG and the Registrant (Incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2000) |
10.49 |
Lease and Lease Terminatin Agreement dated June 14, 2000 by and between the Registrant and Metropolitan Life Insurance Company |
10.50 |
First Amendment to New Lease dated April 10, 2001 by and between the Registrant and Metropolitan Life Insurance Company |
10.51 |
Second Amendment to New Lease dated June 29, 2001 by and between the Registrant Metropolitan Life Insurance Company |
10.52 |
Employment agreement, dated August 14, 2001, by and between the Company and Timothy G. Whitten (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2001) |
23.1 |
Consent of Independent Accountants |
24.1 |
Power of Attorney (see page 66) |
99.1 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
99.2 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
__________
* Confidential treatment has been granted as to certain portions of this agreement.
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, (the "Exchange Act") the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Dated: September 17, 2002
PHARMACYCLICS, INC. |
By: | /s/ RICHARD A. MILLER, M.D. |
| |
Richard A. Miller, M.D. | |
President and Chief Executive Officer |
POWER OF ATTORNEY KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints jointly and severally, Richard A. Miller and Leiv Lea, or either of them as his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Report on Form 10-K, 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, and each of them, full power and authority to do and perform each and very act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
IN WITNESS WHEREOF, each of the undersigned has executed this Power of Attorney as of the date indicated.
Pursuant to the requirements of the Exchange Act, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
Signature |
Title |
Date |
/s/ RICHARD A. MILLER, M.D.
Richard A. Miller, M.D. |
President and Chief Executive Officer and Director (Principal Executive Officer) | September 17, 2002 |
/s/ LEIV LEA
Leiv Lea |
Vice President, Finance and Administration and Chief Financial Officer (Principal Financial and Accounting Officer) | September 17, 2002 |
/s/ MILES R. GILBURNE
Miles R. Gilburne |
Director | September 17, 2002 |
/s/ LORETTA M. ITRI, M.D.
Loretta M. Itri, M.D. |
Director | September 17, 2002 |
/s/ RICHARD M. LEVY, PH.D.
Richard M. Levy, Ph.D. |
Director | September 17, 2002 |
/s/ WILLIAM R. ROHN
William R. Rohn |
Director | September 18, 2002 |
/s/ CRAIG C. TAYLOR
Craig C. Taylor |
Director | September 17, 2002 |
I, Richard A. Miller, M.D., certify that:
1. I have reviewed this annual report on Form 10-K of Pharmacyclics, Inc.;
2. Based on my knowledge, this annual report does not contain any untrue
statement of a material fact or omit
to state a material fact necessary to make
the statements made, in light of the circumstances under which such
statements
were made, not misleading with respect to the period covered by this annual
report; and
3. Based on my knowledge, the financial statements, and other financial
information included in this annual
report, fairly present in all material
respects the financial condition, results of operations and cash flows of
the
registrant as of, and for, the periods presented in this annual report.
Date: September 17, 2002
/S/ RICHARD A. MILLER, M.D.
Richard A. Miller, M.D.
President and Chief Executive Officer
I, Leiv Lea, certify that:
1. I have reviewed this annual report on Form 10-K of Pharmacyclics, Inc.;
2. Based on my knowledge, this annual report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this annual report; and
3. Based on my knowledge, the financial statements, and other financial information included in this annual report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this annual report.
Date: September 17, 2002
/S/ LEIV LEA
Leiv Lea
Vice President, Finance and Administration and Chief Financial Officer
EXHIBITS INDEX
Exhibit Number |
Description |
3.1 |
Amended and Restated Certificate of Incorporation of the Company (Incorporated by reference to exhibit of the same number to Form 8-A12G/A filed on May 21, 2002) |
3.2 |
Amended and Restated Bylaws of the Company (Incorporated by reference to exhibit of the same number to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2001 |
3.3 |
Certificate of Designation of Series A Junior Participating Preferred Stock of the Company (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the fiscal year ended June 30, 1997) |
4.1 |
Amended and Restated Rights Agreement, dated as of February 15, 2002 (Incorporated by reference to Exhibit 3.2 to Form 8-A12G/A filed on May 21, 2002) |
4.2 |
Specimen Certificate of the Company's Common Stock (Incorporated by reference to Exhibit 4.2 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.1 |
Form of Indemnification Agreement between the Company and its directors and executive officers (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.2 |
Series C Stock Purchase Agreement dated as of June 13, 1994, between the Company and the investors specified therein (Incorporated by reference to Exhibit 10.4 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.3 |
Investment Agreement dated as of July 31, 1995, between the Company and the investors specified therein (Incorporated by reference to Exhibit 10.5 to the Company's Registrati Statement on Form S-1, Commission File No. 33-96048) |
10.4 |
Form of Series C Preferred Stock Purchase Warrant dated as of July 31, 1995, issued by the Company to the investors listed on Schedule A thereto (Incorporated by reference to Exhibit 10.6 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.5 |
Master Lease and Warrant Agreements entered into between the Company and Comdisco, Inc., dated as of July 22, 1992, July 30, 1992, March 31, 1993, June 24, 1993, October 3, 1994, respectively (Incorporated by reference to Exhibit 10.7 to the Company' Registration Statement on Form S-1, Commission File No. 33-96048) |
10.6* |
Patent License Agreement entered into between the Company and The University of Texas, Austin dated entered into on or about July 1, 1991 (Incorporated by reference to Exhibit 10.8 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.7* |
Patent License Agreement entered into between the Company and The University of Texas, Dallas dated as of July 1, 1992, as amended by the Patent License Agreement dated May 27, 1993 (Incorporated by reference to Exhibit 10.9 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.8* |
Patent License Agreement entered into between the Company and Stuart W. Young dated as of October 15, 1992 (Incorporated by reference to Exhibit 10.10 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.9 |
Lease Agreement entered into between the Company and New England Mutual Life Insurance Company dated as of June 17, 1993, as amended on July 22, 1993, and as further amended on March 1, 1994 (Incorporated by reference to Exhibit 10.11 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.10 |
Supply Agreement entered into between the Company and Glaxo Wellcome Company. (f/k/a Burroughs Wellcome Co.) dated as of March 1, 1995 (Incorporated by reference to Exhibit 10.14 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.11* |
License Agreement entered into between the Company and Cook, Incorporated, dated as of April 4, 1995 (Incorporated by reference to Exhibit 10.13 to the Company's Registrati Statement on Form S-1, Commission File No. 33-96048) |
10.12* |
License and Supply Agreement entered into between the Company and E-Z-EM, Inc. dated as of August 7, 1995 (Incorporated by reference to Exhibit 10.14 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.13 |
The Company's 1995 Stock Option Plan (Incorporated by reference to Exhibit 99.1 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.14 |
The Company's 1995 Non-Employee Directors' Stock Option Plan (Incorporated by reference to Exhibit 99.7 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.15 |
The Company's Employee Stock Purchase Plan (Incorporated by reference to Exhibit 99.7 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.16 |
Employment Agreement entered into between the Company and Richard A. Miller, M.D. dated as of June 10, 1992 (Incorporated by reference to Exhibit 10.19 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.17 |
Employment Agreement entered into between the Company and Marc L. Steuer dated as of October 31, 1994 (Incorporated by reference to Exhibit 10.20 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.18 |
Employment Agreement entered into between the Company and William C. Dow, Ph.D., dated as of May 20, 1992, as amended by a letter agreement dated July 8, 1992 (Incorporated by reference to Exhibit 10.21 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.19 |
Employment Agreement entered into between the Company and Stuart W. Young, M.D. dated as of April 19, 1993 (Incorporated by reference to Exhibit 10.22 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.20 |
Promissory Notes issued by the Company to Stuart W. Young, M.D. dated as of September 1994 and April 1995, in the amounts of $65,000 and $30,000, respectively (Incorporated b reference to Exhibit 10.24 to the Company's Registration Statement on Form S-1, Commission File No. 33-96048) |
10.21* |
Master Process Development and Supply Agreement dated September 6, 1996 entered into between the Company and Hoechst Celanese Corporation (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the fiscal year ended June 30, 1996) |
10.22 |
Form of Notice of Grant of Stock Option generally to be used under the 1995 Stock Option Plan (Incorporated by reference to Exhibit 99.2 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.23 |
Form of Stock Option Agreement (Incorporated by reference to Exhibit 99.3 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.24 |
Form of Addendum to Stock Option Agreement (Limited Stock Appreciate Right) (Incorporated by reference to Exhibit 99.4 to the Company's Registration Statement on Form S-8, Commission File No. 333-52881) |
10.25 |
Form of Addendum to Stock Option Agreement (Special Tax Election) (Incorporated by reference to Exhibit 99.5 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.26 |
Form of Addendum to Stock Option Agreement (Involuntary Termination following Change in Control) (Incorporated by reference to Exhibit 99.6 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.27 |
Form of Notice of Grant of Automatic Stock Option (Initial Grant) (Incorporated by reference to Exhibit 99.8 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.28 |
Form of Notice of Grant of Automatic Stock Option (Annual Grant) (Incorporated by reference to Exhibit 99.9 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.29 |
Form of Non-Employee Director Stock Option Agreement (Incorporated by reference to Exhibit 99.10 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.30 |
Form of Employee Stock Purchase Plan Enrollment/Change Form (Incorporated by reference to Exhibit 99.12 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.31 |
Form of Stock Purchase Agreement (Incorporated by reference to Exhibit 99.13 to the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.32 |
Form of Special Officer Participation Form (Incorporated by reference to Exhibit 99.14 t the Company's Registration Statement on Form S-8, Commission File No. 33-98514) |
10.33 |
Common Stock Purchase Agreement dated November 11,1996, by and among the Company and the persons listed on Schedule 1 thereto (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 333-22747) |
10.34 |
Common Stock Purchase Agreement dated February 21, 1997, by and among the Company and the persons listed on Schedule 1 thereto (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-1, Commission File No. 333-22747) |
10.35 |
Form of Severance Agreement between the Company and certain executive officers (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.36* |
Development, License and Commercialization Agreement, dated October 17, 1997, by and between the Company and Nycomed Imaging AS (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.37 |
Employment Agreement, dated October 14, 1997, by and between the Company and Michael J. Hensley, M.D. (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended September 30, 1997) |
10.38 |
Employment Agreement, dated December 18, 1997, by and between the Company and Leiv Lea (Incorporated by reference to exhibit of the same number to the Quarterly report on Form 10-Q for the quarter ended March 31, 1998) |
10.39* |
Evaluation and License Agreement, dated December 16, 1997, by and between Alcon Laboratories, Inc. (Incorporated by reference to Exhibit 10.1 to the Company's Registration Statement on Form S-3, Commission File No. 333-43621) |
10.40 |
Employment agreement, dated March 11, 1998, by and between the Company and David A. Lowin (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.41 |
Employment agreement, dated May 28, 1998, by and between the Company and Hugo Madden (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.42* |
Development and Supply Agreement dated June 16, 1998 entered into between the Company and Abbott Laboratories Inc (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 1999) |
10.43 |
Termination Agreement, dated as of August 27, 1999, by and between Registrant and Celanese, Ltd. (Incorporated by reference to Exhibit 10.1 to an 8-K filed on September 3 1999) |
10.44* |
Master Development and Supply Agreement, dated March 20, 2000 by and between Cook Imaging Corporation, D.B.A. Cook Pharmaceutical Solutions, and the Registrant (Incorporated by reference to Exhibit 10.1 to the Quarterly report on Form 10-Q for the quarter ended March 31, 2000) |
10.45 |
Employment agreement, dated March 23, 2000 by and between the Company and Cynthia J. Ladd (Incorporated by reference to exhibit of the same number to the Annual Report on Form 10-K for the year ended June 30, 2000) |
10.46 |
Employment agreement, dated July 10, 2000, by and between the Company and Jon R. Wallace (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2000) |
10.47* |
Supply Agreement, dated December 11, 2000 by and between Dixie Chemical Company and the Registrant (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2000) |
10.48* |
Supply Agreement, dated December 18, 2000 by and between Lonza, AG and the Registrant (Incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q for the quarter ended December 31, 2000) |
10.49 |
Lease and Lease Terminatin Agreement dated June 14, 2000 by and between the Registrant and Metropolitan Life Insurance Company |
10.50 |
First Amendment to New Lease dated April 10, 2001 by and between the Registrant and Metropolitan Life Insurance Company |
10.51 |
Second Amendment to New Lease dated June 29, 2001 by and between the Registrant Metropolitan Life Insurance Company |
10.52 |
Employment agreement, dated August 14, 2001, by and between the Company and Timothy G. Whitten (Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q for the quarter ended September 30, 2001) |
23.1 |
Consent of Independent Accountants |
24.1 |
Power of Attorney (see page 66) |
99.1 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
99.2 |
Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of Sarbanes-Oxley Act of 2002. |
__________
* Confidential treatment has been granted as to certain portions of this agreement.