-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, UphFVu+IfAFwkTAbYu3hedvVBHN71v744a+lXMPGjJVmEkWYkdf49HRIhEMAx4vy DUH2rvSoVsEr4fhxwU7QjA== 0000004310-99-000005.txt : 19990212 0000004310-99-000005.hdr.sgml : 19990212 ACCESSION NUMBER: 0000004310-99-000005 CONFORMED SUBMISSION TYPE: 10-K405/A PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19971231 FILED AS OF DATE: 19990211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ALZA CORP CENTRAL INDEX KEY: 0000004310 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 770142070 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K405/A SEC ACT: SEC FILE NUMBER: 001-06247 FILM NUMBER: 99529311 BUSINESS ADDRESS: STREET 1: 950 PAGE MILL RD STREET 2: PO BOX 10950 CITY: PALO ALTO STATE: CA ZIP: 94303-0802 BUSINESS PHONE: 4154945000 MAIL ADDRESS: STREET 1: 950 PAGE MILL RD STREET 2: PO BOX 10950 CITY: PALO ALTO STATE: CA ZIP: 94303 10-K405/A 1 10K/A TEXT SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K/A Amendment No. 2 [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 1997 Commission File Number 1-6247 ALZA CORPORATION (Exact name of registrant as specified in its charter) Delaware 77-0142070 (State or other jurisdiction of incorporation (I.R.S. Employer Identification of organization) No.) 950 Page Mill Road, P.O. Box 10950, Palo Alto, CA 94303-0802 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (650) 494- 5000 Securities registered pursuant to Section 12(b) of the Act: Name of each exchange Title of each class on which registered Common Stock New York Stock Exchange 5 1/4% Liquid Yield Option Notes due 2014 New York Stock Exchange (Zero Coupon-Subordinated) 5% Convertible Subordinated Debentures due 2006 New York Stock Exchange Securities registered pursuant to Section 12(g) of the Act: Warrants (to purchase Common Stock at $65 per share) 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 [X] No [ ] Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.[X] State the aggregate market value of the voting stock held by non-affiliates of the registrant, as of March 16, 1998: $3,539,051,440. Indicate the number of shares outstanding of each of the registrant's classes of common stock, as of March 16, 1998: Title of Class Number of Shares Common Stock 86,052,152 DOCUMENTS INCORPORATED BY REFERENCE Part III, Items 10, 11, 12 and 13 are incorporated by reference to the definitive proxy statement for the registrant's Annual Meeting of Stockholders to be held on May 7, 1998. ALZA CORPORATION FORM 10-K/A ANNUAL REPORT FOR THE FISCAL YEAR ENDED DECEMBER 31, 1997 TABLE OF CONTENTS Page Part I Item 1. BUSINESS 3 Item 2. PROPERTIES 28 Item 3. LEGAL PROCEEDINGS 30 Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS 30 Part II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 31 Item 6. SELECTED FINANCIAL DATA 34 Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 35 Item 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 55 Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 56 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 85 Part III Item 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT 85 Item 11. EXECUTIVE COMPENSATION 85 Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 85 Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS 85 Part IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K 85 Signatures Exhibits PART I Item 1. BUSINESS Introduction ALZA Corporation ("ALZA") is an emerging pharmaceutical company with leading drug delivery technologies. ALZA applies its technologies to develop pharmaceutical products with enhanced therapeutic value for its own portfolio and for many of the world's leading pharmaceutical companies. ALZA is currently focusing its sales and marketing efforts in urology and oncology. ALZA was incorporated under the laws of the State of California on June 11, 1968, and changed its legal domicile from California to Delaware in 1987. ALZA's mailing address is 950 Page Mill Road, P.O. Box 10950, Palo Alto, California, 94303- 0802. Before the 1990s, ALZA's business consisted almost exclusively of product development activities undertaken pursuant to joint development and commercialization agreements with large pharmaceutical companies. Among the ALZA-developed products commercialized to date by client companies under these arrangements are Procardia XL-registered trademark-/Adalat CR- registered trademark- (nifedipine) for the treatment of angina and hypertension, Transderm-Nitro-registered trademark- (nitroglycerin) for the prevention and treatment of angina, NicoDerm-registered trademark- CQ-trademark- (nicotine) for use as an aid in smoking cessation, and Glucotrol XL-registered trademark- (glipizide) for the treatment of Type II diabetes. Beginning in the early 1990s and increasingly over the past several years, ALZA has embarked on a new strategy to become a fully-integrated commercial pharmaceutical company. While ALZA has continued its traditional product development arrangements with client companies, and currently has products in development with a number of major pharmaceutical companies, ALZA has expanded its commercialization capabilities and activities. In 1994, ALZA formed ALZA Pharmaceuticals, its sales and marketing division, which now has a sales force of more than 100 sales personnel. By the end of 1997, ALZA Pharmaceuticals was marketing Ethyol-registered trademark- (amifostine), Testoderm- registered trademark- (testosterone), Testoderm-registered trademark- with Adhesive, Mycelex-registered trademark- (clotrimazole) Troche, Ditropan-registered trademark- (oxybutynin), Elmiron-registered trademark- (pentosan polysulfate sodium), PolyCitra-registered trademark- (potassium citrate monohydrate), BiCitra-registered trademark- (sodium citrate dihydrate and citric acid monohydrate) and Neutra-Phos-registered trademark- (potassium and sodium phosphates), as well as ALZET- registered trademark- mini-osmotic pumps, Progestasert-registered trademark- (progesterone) intrauterine contraceptive device systems and Ocusert-registered trademark- (pilocarpine) ocular therapeutic systems, three products developed by ALZA in its early years. In March 1998, ALZA launched Testoderm-registered trademark- TTS-trademark- (testosterone) CIII, the third product in the Testoderm line. In addition, ALZA, through ALZA Pharmaceuticals, co-promotes Duragesic-registered trademark- (fentanyl), Hexalen-registered trademark- (altretamine), NeuTrexin-registered trademark- (trimetrexate glucuronate) and the ENACT AirWatch-trademark- system. A partnership of ALZA and Procter & Gamble markets the Actisite-registered trademark- (tetracycline hydrochloride) periodontal fiber for the treatment of periodontal disease in the United States. As part of its strategy to expand its commercialization activities, and in order to decrease ALZA's dependence on client companies, in 1993 ALZA formed Therapeutic Discovery Corporation ("TDC") to develop, with ALZA, a pipeline of products for commercialization by ALZA. In the third quarter of 1997, ALZA purchased all of the outstanding shares of TDC. Also in the third quarter of 1997, ALZA distributed to its stockholders and debenture holders the Class A Common Stock of Crescendo Pharmaceuticals Corporation ("Crescendo"), which was formed by ALZA to select and develop human pharmaceutical products and to commercialize those products, most likely through licensing to ALZA. ALZA and Crescendo have continued development of several products previously under development by ALZA and TDC; ALZA and Crescendo have also commenced the development or evaluation of other products. At the end of 1997, ALZA and Janssen Pharmaceutica, Inc. (together with its affiliates, "Janssen") entered into new arrangements with respect to two E-TRANS-trademark- fentanyl products - one for the treatment of acute pain and one for the treatment of chronic pain. Under these arrangements, discussed below, ALZA will have the opportunity to share in the United States operating profits from the products in exchange for making an investment in the product development programs. ALZA's 1997 activities serve as the foundation for ALZA's expanding commercial activities. Notice Concerning Forward-Looking Statements Some of the statements made in this Form 10-K are forward- looking in nature, including but not limited to ALZA's sales and marketing plans, product development activities and plans, and other statements that are not historical facts. Forward-looking statements include, but are not limited to, statements that are not historical facts, and statements including forms of the words "intend", "believe", "will", "may", "could", "expect", "anticipate", "possible", and similar terms. The occurrence of the events described, and the achievement of the intended results, are subject to the future occurrence of many events, some or all of which are not predictable or within ALZA's control; therefore, actual results may differ materially from those anticipated in any forward-looking statements. Many risks and uncertainties are inherent in the pharmaceutical industry; others are more specific to ALZA's business. Many of the significant risks related to ALZA's business are described in this Form 10-K, including risks associated with introducing and commercializing new pharmaceutical products, the risks inherent in technology and product development, risks relating to clinical development, regulatory clearance to market products and medical acceptance of products, changes in the health care marketplace, competition, patent and intellectual property matters, regulatory risks and manufacturing issues. Products Marketed and Co-Promoted by ALZA At the end of 1997, ALZA, through ALZA Pharmaceuticals, was marketing 13 pharmaceutical products and was co-promoting four additional products marketed by third parties. ALZA Pharmaceuticals has more than 100 field sales personnel. ALZA's specialty sales force has been specially trained in ALZA's two current areas of commercial focus - urology and oncology. ALZA-Marketed Products Ethyol (amifostine) - In April 1996, ALZA Pharmaceuticals began marketing Ethyol in the United States. Ethyol is a unique cytoprotective agent developed by U.S. Bioscience, Inc. ("USB"), indicated for the reduction of cumulative renal toxicity associated with repeated administration of the chemotherapeutic drug cisplatin in patients with advanced ovarian or non-small cell lung cancer. USB co-promotes the product with ALZA. ALZA has the right to market the product until mid-2001, with an option for an additional year, and will receive residual payments for a specified period after the end of ALZA's marketing term. Mycelex (clotrimazole) Troche - ALZA acquired the exclusive United States rights to this product from Bayer Corporation ("Bayer") in July 1997. Mycelex Troche is an antifungal agent for the localized treatment of oral thrush. Prior to acquiring the rights to the product, ALZA promoted the product for Bayer. Elmiron (pentosan polysulfate sodium) - In October 1997, ALZA acquired the exclusive rights in the United States and Canada to this product, indicated for the treatment of the pain and discomfort of interstitial cystitis, from IVAX Corporation and its subsidiary, Baker Norton Pharmaceuticals, Inc. (together, "IVAX"). In connection with that transaction, ALZA hired most of the IVAX personnel involved in promoting the product in the United States and Canada. The product was cleared for marketing in the United States in late 1996, and in Canada in 1993. PolyCitra (potassium citrate), BiCitra (sodium citrate and citric acid) and Neutra Phos (potassium and sodium phosphate) - - The exclusive rights to these products in the United States and Canada were acquired from IVAX in the same transaction in which the rights to Elmiron were acquired. PolyCitra and BiCitra are used in the treatment of kidney stones, and Neutra Phos is a nutritional supplement used to treat phosphorous deficiency. All three products are marketed in the United States; PolyCitra is also marketed in Canada. Ditropan (oxybutynin) - In October 1997, ALZA acquired the exclusive United States rights to the immediate release oral Ditropan product from Hoechst Marion Roussel, Inc. ("HMRI"). The product is indicated for the treatment of urge urinary incontinence. As part of the transaction, ALZA also acquired the right to use the Ditropan trademark in the United States with other products. Subject to marketing clearance by the United States Food and Drug Administration ("FDA"), and if ALZA licenses the product from Crescendo, ALZA intends to use the Ditropan trademark with the OROS-registered trademark- oxybutynin product under development by ALZA and Crescendo. The New Drug Application ("NDA") for the OROS oxybutynin product is currently on file with the FDA. Testoderm (testosterone) line of products - ALZA has developed three Testoderm products, once-daily transdermal systems for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Testoderm was introduced in 1994; Testoderm with Adhesive in 1996. Both products are worn on the scrotum. In March 1998, ALZA launched Testoderm TTS, which was developed by ALZA and TDC. This product can be worn on the arm, back or upper buttocks and is also applied once daily. In addition to the products described above, ALZA Pharmaceuticals markets the ALZET, Progestasert and Ocusert products. The Ocusert (pilocarpine) Pilo-20 and Pilo-40 ocular therapeutic systems are used for the treatment of glaucoma. The Progestasert (progesterone) intrauterine contraceptive device provides contraception for one year by releasing the natural hormone progesterone. ALZET mini-osmotic pumps are implantable, capsule-shaped units that can deliver solutions containing a wide range of agents in laboratory animals at controlled rates for up to four weeks. Product Marketing Risks Many of the products described above have been introduced by ALZA Pharmaceuticals during the last few years. Several, such as Ethyol and Elmiron, are relatively new therapies that had no established market at the time of their introduction. Others, such as the Testoderm line, are used for the treatment of conditions that may be underdiagnosed or not completely understood. There can be no assurance that ALZA Pharmaceuticals will be successful in its marketing and sales efforts. There are numerous risks associated with the marketing and sales of pharmaceutical products, including the following: Commercial Potential - In order to provide added value and gain medical and commercial acceptance, a product generally must show some performance improvement or other benefit over products incorporating the same or similar drug compounds or other products indicated for the same illness or condition. In some cases, these benefits may be difficult to establish. Competition from Other Products - Many companies have a presence in urology and oncology, in which ALZA is currently focusing its sales and marketing efforts, including companies that focus exclusively on oncology. Many competitors have far larger sales forces, and significantly greater resources and experience in marketing pharmaceutical products, than ALZA. In addition, other companies may introduce products that offer competitive advantages when compared to products marketed by ALZA. Availability of Products for In-Licensing and/or Acquisition - While ALZA has successfully acquired and in- licensed several products during the past few years, there can be no assurance of continued success in such activities. Other companies are attempting to acquire and in-license products, particularly in the oncology field, and ALZA may not be able to acquire or in-license additional products on favorable terms. Pricing and Reimbursement - As pressures for cost containment increase, particularly in the United States health care industry, there can be no assurance that the prices ALZA can charge for the products marketed by ALZA Pharmaceuticals will be as favorable as historical pharmaceutical product prices. Reimbursement by payors such as government and managed care organizations has become increasingly important, as has the listing of new products on large formularies. There can be no assurance that innovative new products such as Ethyol and Elmiron, or drug delivery products such as Testoderm TTS, will achieve reimbursement and formulary acceptance that will result in an appropriate return on ALZA's research and development efforts or investment in the acquisition of the products. Failure of one or more products to be included on formulary lists, or to be reimbursed by managed care organizations, could have a negative impact on the profitability of ALZA Pharmaceuticals. Physician and Patient Acceptance of Products - Significant efforts will be required to educate physicians and other health care practitioners, as well as patients, concerning some of ALZA's current products in order that the full potential of the products can be realized. For example, Ethyol is the first chemoprotective therapy to be cleared for marketing in the United States. Elmiron, the only oral therapy available for the pain and discomfort associated with interstitial cystitis, is used in the treatment of a disease that is often undiagnosed or misdiagnosed. The Testoderm line is used to treat testosterone deficiency in men, a condition that is not yet well understood, and which is believed to be largely undiagnosed. Dependence on Third Party Manufacturers - The products in-licensed and acquired by ALZA to date from third parties are manufactured by the third parties. ALZA is therefore dependent upon the manufacturing capabilities and capacity of the third parties for supply of those products to sell in the marketplace. Need for International Distribution Arrangements - ALZA's direct sales and marketing efforts are currently limited to the United States and Canada. ALZA will need to enter into arrangements with distributors or marketing partners outside the United States and Canada for products as to which ALZA has rights in other countries. There can be no assurance that acceptable distribution partners can be obtained, or that ALZA's return from the arrangements with international marketing partners will contribute significantly to ALZA's profits. Products Co-Promoted by ALZA Pharmaceuticals In addition to marketing the products described above, ALZA co-promotes four products with third parties. Duragesic (fentanyl) is a 72-hour system for management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be controlled by lesser means, marketed by Janssen. ALZA Pharmaceuticals has co-promoted the product in the United States since 1994. NeuTrexin (trimetrexate glucuronate) is a product developed and marketed by USB as an alternate treatment for moderate to severe pneumocystis carinii pneumonia. ALZA Pharmaceuticals has co-promoted the product in the United States since 1996. Hexalen (altretamine) is a product developed and marketed by USB for the palliative treatment of patients with persistent or recurrent ovarian cancer as second-line therapy following first-time therapy with a cisplatin and/or alkylating agent-based combination. ALZA Pharmaceuticals has co-promoted the product in the United States since 1996. The ENACT AirWatch system is a product developed by ENACT Health Management Systems for daily monitoring of asthma. ALZA Pharmaceuticals has co-promoted the product in the United States since 1995. For its co-promotion activities, ALZA receives co-promotion fees, either pursuant to a specified formula or as a percentage of sales (or incremental sales) of the product. Arrangements with Pharmaceutical Company Clients Client-Marketed Products ALZA develops products under joint development arrangements with a number of leading pharmaceutical companies. The products combine one of ALZA's drug delivery systems with a client's proprietary compound or, in some cases, a compound that is no longer patented. ALZA's technologies are discussed below under "ALZA Technologies." Under a typical arrangement with a client company, the client pays all of ALZA's costs incurred in the development of the product, and the client markets the product, making payments to ALZA based on sales of the product. The client approves the work plans for product development and clinical testing (which may be conducted by ALZA, the client or both), and makes the decisions concerning product commercialization. As a result, decisions affecting the timing of product development, the clinical plan, regulatory strategy, and the level of marketing support are not within ALZA's control. Under its arrangements with client companies, ALZA undertakes the initial product development, in which ALZA performs the formulation work, research and testing necessary to incorporate the drug selected by the client (which may be a generic compound or the client's proprietary compound) into an ALZA drug delivery system. ALZA manufactures product for in vitro and human clinical studies; in other cases, the client takes this responsibility. ALZA develops pilot scale manufacturing processes and, usually, commercial manufacturing capacity. Regulatory filings to conduct clinical studies and to obtain regulatory approval may be prepared by ALZA, or by the client, as negotiated. In any case, ALZA's activities are reimbursed by the client on a cost reimbursement basis. Under the arrangements with client companies, ALZA retains the rights to, and owns, any improvements to ALZA's technologies. The client obtains the right to commercialize the specific product developed under the arrangement for an agreed upon time period, and makes payments to ALZA with respect to sales of the product. The client does not obtain the right to use ALZA technology except in the specific product covered by the arrangement. The products developed by ALZA under these joint development arrangements and currently marketed by client companies incorporate ALZA's D-TRANS-trademark- (transdermal) and OROS technologies. The D-TRANS products developed by ALZA and currently marketed by client companies include: Catapres-TTS-registered trademark- (clonidine) - Applied once-weekly for the treatment of hypertension, marketed by Boehringer Ingelheim Pharmaceuticals, Inc. ("Boehringer"). Duragesic (fentanyl) - A 72-hour system for management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be controlled by lesser means, marketed by Janssen and co-promoted in the United States by ALZA Pharmaceuticals. NicoDerm CQ/Nicoderm (nicotine) - Applied once-daily to aid in smoking cessation. NicoDerm CQ is marketed for over-the- counter use in the United States by SmithKline Beecham p.l.c. ("SKB") as part of a joint venture with HMRI, and Nicoderm is marketed as a prescription product by HMRI in some countries outside the United States. Transderm-Nitro (nitroglycerin) - Applied once-daily for the prevention and treatment of angina pectoris, marketed by Novartis Pharmaceuticals Corporation (together with its affiliates, "Novartis"). Transderm Scop-registered trademark- (scopolamine) - Applied once every three days for prevention of nausea and vomiting associated with motion sickness, marketed by Novartis in the United States and several European countries, and by Recordati Industria Chimica E Farmaceutica SPA in Italy. The OROS products developed by ALZA and currently marketed by client companies include: Covera-HS-trademark- (verapamil) - A once-daily controlled-onset-extended release (COER-24-trademark-) tablet for the treatment of hypertension and angina pectoris, marketed by G.D. Searle ("Searle"). DynaCirc CR-registered trademark- (isradipine) - A once- daily system for the treatment of hypertension, marketed by Novartis. Glucotrol XL (glipizide) - A once-daily treatment for Type II diabetes, marketed by Pfizer, Inc. ("Pfizer"). Minipress XL-registered trademark- / Alpress-registered trademark- LP (prazosin) - A once-daily formulation for the treatment of hypertension, marketed by Pfizer. Procardia XL / Adalat CR (nifedipine) - A once-daily formulation for the treatment of both angina and hypertension, marketed by Pfizer in the United States and by Bayer outside the United States. Volmax-registered trademark- (albuterol) - A twice- daily dosage form for the treatment of asthma, marketed by Muro Pharmaceutical, Inc. and Forest Laboratories, Inc. in the United States and by Glaxo Holdings p.l.c. outside the United States. In early 1998, Warner-Lambert Consumer Healthcare ("Warner- Lambert") introduced the OROS-registered trademark- pseudoephedrine product, developed by ALZA, as Sudafed-registered trademark- 24 Hour. The product is marketed by Warner-Lambert in the United States as part of its Sudafed-registered trademark- line, pursuant to semi-exclusive rights granted by ALZA. The product was previously marketed by Novartis under the Efidac- registered trademark- brand name. Other products developed by ALZA and marketed by third parties include the Actisite (tetracycline hydrochloride) periodontal fiber, designed to treat adult periodontal disease by providing rate-controlled delivery of tetracycline for ten days after placement in the periodontal pocket by a dental practitioner; the Baxter Infusor-registered trademark-, a lightweight, disposable device for intravenous therapy; and IVOMEC SR-registered trademark-, a product combining the antiparasitic agent ivermectin with ALZA's ruminal bolus technology which controls internal and external parasites in cattle for an entire grazing season following a single administration. International Activities Outside the United States and Canada, ALZA has arrangements to market several of its products through distribution arrangements with companies in designated countries. Actisite (tetracycline hydrochloride), for the treatment of periodontal disease, is distributed in several European countries by distributors, and agreements were signed during 1996 for the distribution of the product in Japan and South Korea, following regulatory approval. In December 1996, ALZA signed agreements with Ferring NV (together with its affiliate, "Ferring") granting Ferring the right to market Testoderm, Testoderm with Adhesive and Testoderm TTS in 12 European countries. ALZA has also signed distribution agreements for 17 Asian countries (excluding Japan) for Testoderm and Testoderm with Adhesive. In 1997, ALZA entered into an agreement with SKB for the commercialization by SKB of the Nicoderm (nicotine) transdermal product developed by ALZA in all countries of the world except the United States, Canada, Australia, New Zealand and Korea, where Hoechst Marion Roussel, Inc. ("HMR") has rights. (The product is marketed in the United States through a joint venture between SKB and HMR.) In order to continue the expansion of its international activities, in 1997 ALZA opened a small office in London for its subsidiary ALZA International, Inc. ("ALZA International"). This presence in Europe is intended to help ALZA identify distributors for ALZA products, to help identify new opportunities for product development programs combining ALZA technologies with compounds developed, or under development by, companies in Europe, and to identify products under development, or marketed in Europe, for potential acquisition or in-licensing by ALZA for United States and Canadian marketing. Also in 1997, ALZA expanded its sales and marketing activities into Canada when ALZA acquired the United States and Canadian rights to Elmiron, PolyCitra, BiCitra and Neutra Phos. ALZA International now has approximately 12 employees (formerly IVAX employees) located in Canada, marketing Elmiron and PolyCitra. ALZA International is doing business in Canada as ALZA Canada. Disclosed Products in Development ALZA has many products in development with Crescendo and other clients. For competitive reasons, ALZA does not disclose all of the products in development at any particular time. Products in development include: OROS oxybutynin - In December 1997, ALZA submitted a New Drug Application ("NDA") to the FDA requesting clearance to market a once-daily OROS dosage form of oxybutynin for the treatment of urge urinary incontinence. The NDA is currently on file with the FDA. Subject to FDA clearance and assuming ALZA licenses the product from Crescendo, ALZA plans to market the product under the tradename Ditropan-registered trademark- XL- trademark-. The product was initially developed by ALZA and TDC, and its development has been continued by ALZA and Crescendo. DUROS-registered trademark- leuprolide - The DUROS leuprolide product is a small osmotically-driven implantable system designed to deliver leuprolide continuously for up to 12 months to provide palliative treatment of prostate cancer. The product is currently in Phase III clinical trials with Crescendo. OROS methylphenidate - The OROS methylphenidate product is designed as a once-daily treatment for Attention Deficit Disorder/Attention Deficit Hyperactivity Disorder. The product is in Phase II clinical trials with Crescendo. OROS hydromorphone - The OROS hydromorphone product is designed as a once-daily dosage form of the opioid analgesic hydromorphone. The product is in Phase III clinical trials under ALZA's agreement with Knoll Pharmaceuticals and its parent Knoll AG (together, "Knoll"). Cereport-trademark- (bradykinin-based receptor-mediated permeabilizer) - In September 1997, ALZA entered into a clinical development and option agreement with Alkermes, Inc. ("Alkermes") relating to Cereport (previously called RMP-7-trademark-) a compound intended to facilitate the delivery of chemotherapeutic agents to the brain. Under the agreement, Alkermes is conducting additional clinical activities related to Cereport, and ALZA has the option to acquire exclusive worldwide commercialization rights to the product. E-TRANS fentanyl (acute pain) - ALZA and Janssen have entered into a modified agreement pursuant to which the companies are jointly developing an E-TRANS fentanyl product for the treatment of acute pain. Under the modified agreement, ALZA paid Janssen $21.5 million, and ALZA will receive a share of the United States operating profits from the product and royalties from sales of the product outside the United States. ALZA will have the right to co-promote the product in the United States. The product is currently in Phase III clinical trials. E-TRANS fentanyl (chronic pain) - ALZA and Crescendo are developing an E-TRANS fentanyl product for the treatment of chronic pain. Under an agreement between ALZA and Janssen, Janssen will have an option, until a specified time, to take over funding the continued development of the product and to commercialize the product worldwide. If Janssen exercises its option, ALZA will receive a share of the United States operating profits from the product and royalties from sales of the product outside the United States. ALZA will have the right to co- promote the product in the United States. If Janssen does not exercise its option, ALZA may continue the development of the product with Crescendo. The product is in early development. E-TRANS LHRH - The E-TRANS LHRH product is designed to provide a simple, effective treatment of infertility resulting from ovulation problems. The product is in early development with Crescendo. E-TRANS Macroflux-trademark- Insulin - The E-TRANS Macroflux insulin product combines ALZA's electrotransport technology and a new skin interface (Macroflux) technology to deliver insulin for the treatment of Type I and Type II diabetes. The product is in preclinical development with Crescendo. Product Development Risks All pharmaceutical products require extensive development and clinical activities before an application can be filed for regulatory clearance to market the product. There are many risks inherent in this process, and it should be expected that many of the products for which development is initiated ultimately will not become commercial products. Substantial technical, financial and human resources are required to successfully complete the development of a product. Product Circumscription - For each new product, the proper performance characteristics must be defined, and the product must be designed and developed to meet those characteristics. Every product faces significant technological hurdles as it progresses through development, and often one or more of these cannot be overcome. ALZA's DUROS, E-TRANS and Macroflux technologies, as well as some of ALZA's oral technologies, are relatively new, and none of these technologies has yet been incorporated in a commercial product. Pilot-Scale Manufacturing - Once a product is developed, it must be manufactured, on a pilot scale, for clinical testing. Pilot-scale manufacturing can be costly and time consuming, and must comply with all of the FDA's regulations concerning current Good Manufacturing Practices. Several of ALZA's drug delivery technologies, such as the D-TRANS, DUROS and E-TRANS technologies, require a series of complex manufacturing steps. For example, DUROS products require aseptic manufacturing, which ALZA has initiated in order to manufacture clinical supplies of the DUROS leuprolide product. Clinical Studies - Once a product has been successfully manufactured on a pilot scale, studies to show clinical safety and efficacy must be undertaken and completed. Clinical studies are costly, and can take many years to complete. There can be no assurance that the desired outcomes will be shown in the clinical studies. Commercial-Scale Manufacturing - Once a product has been developed, manufactured on a pilot scale and clinically tested, there are further risks in converting a pilot-scale manufacturing process to commercial scale. Due to the complexity of drug delivery technologies, this conversion can be significantly more costly than for other pharmaceutical products. Sometimes manufacturing processes must be modified in order to achieve successful commercial manufacturing and to obtain a reproducible, robust process. For products incorporating newer ALZA technologies, this commercial manufacturing scale-up can take several years and cost millions of dollars. Regulatory Risks - Obtaining regulatory clearance to market a product can take many years, and the process varies from country to country. Pricing and reimbursement approvals are also required in some countries, particularly in Europe. Any delay in the regulatory process could adversely affect the commercial potential of a product. ALZA Technologies ALZA was the pioneer, and is a recognized leader, in the development of innovative drug delivery technologies. ALZA's therapeutic systems are designed to provide controlled, predetermined rates of drug release for extended time periods. By administering drugs in preset patterns and by alternative routes, ALZA's advanced dosage forms, called therapeutic systems, can add to the medical and economic value of drug therapies by minimizing their unpleasant or harmful side effects, optimizing their beneficial actions, simplifying drug therapy, and increasing patient compliance by decreasing the frequency with which medication must be administered. ALZA's OROS and D-TRANS drug delivery systems have been incorporated into more than 20 products currently marketed in many countries of the world. D-TRANS Transdermal Systems. ALZA's D-TRANS transdermal therapeutic systems provide for the controlled delivery of drugs directly into the bloodstream through intact skin. Transdermal systems are well suited for the delivery of potent drugs that are poorly absorbed and/or extensively metabolized when administered orally. ALZA's D-TRANS products are thin, multilayer systems, in the form of small adhesive patches, that combine a drug reservoir with a polymer membrane or other mechanism to control drug release to the surface of intact skin, and then through the skin into the bloodstream. Oral Systems. ALZA has developed several therapeutic systems for oral administration. ALZA's OROS systems include the push-pull, push-stick and elementary osmotic pump systems. ALZA's OROS products resemble conventional tablets or capsules in appearance, but use an osmotic mechanism to provide pre- programmed, controlled drug delivery to the gastrointestinal tract. An OROS product comprises a polymer membrane with one or more laser-drilled holes surrounding a core containing the drug or drugs, with or without osmotic or other agents. Water from the gastrointestinal tract diffuses through the membrane at a controlled rate into the drug core, causing the drug to be released in solution or suspension at a predetermined controlled rate out of the laser-drilled hole(s). OROS systems are well suited for delivering drug compounds throughout the gastrointestinal tract in programmed delivery for local treatment or systemic absorption. ALZA's Chronset-registered trademark- therapeutic system, which may be useful for the oral delivery of compounds including proteins and peptides, provides a predetermined delay in the release of active compounds from an orally administered capsule in order to target the location or the timing of a bolus delivery. ALZA is also developing a Liquid OROS system designed for the delivery of highly insoluble liquid drug formulations or polypeptides. A delivery orifice in the outer layers of a coated capsule allows controlled release of drug, while an internal osmotic layer pushes against the drug compartment, forcing the liquid drug formulation from the system. ALZA has recently developed its RingCap-trademark- technology, a new oral controlled-release technology designed to have a low manufacturing cost and broad applicability. By incorporating several insoluble polymeric rings around a tablet, the erosion of the tablet can be controlled, modulating the release of drug in the gastrointestinal tract. RingCap systems can deliver the total dose of the selected drug evenly over an extended period. E-TRANS Systems. ALZA's E-TRANS electrotransport systems are designed to deliver drugs across intact skin through the use of an electrical potential gradient. ALZA's E-TRANS systems are small, easy-to-apply devices consisting of an adhesive, a drug reservoir, electrodes and a power source/controller. The systems are designed to deliver large molecules (including proteins and peptides) and potent drugs that are poorly absorbed or extensively metabolized in the gastrointestinal tract. DUROS Systems. ALZA's DUROS human implant technology is designed to enable the delivery of peptides, proteins and other bioactive macromolecules developed by the biotechnology industry. Products incorporating DUROS implant technology have the potential to deliver macromolecules to subcutaneous sites for systemic therapy or to specific tissues; a single miniature implant may be able to provide therapy for up to one year. Macroflux. ALZA is conducting research on a new skin interface technology designed to increase drug transport across the skin and enable delivery of larger molecular weight compounds, including proteins and peptides. This new technology may be used to enhance ALZA's existing D-TRANS transdermal and E-TRANS electrotransport technologies. Dose Sipping Technology. ALZA has recently developed its Dose Sipping Technology to provide a simple, convenient method of oral drug delivery, particularly for pediatric and geriatric patients. The simple straw-like systems can provide a pre- measured dose of the desired compound without the difficulties of swallowing a tablet or capsule. Technology Development Risks The development of ALZA's drug delivery systems requires tens of millions of dollars and many years of research and development activity. ALZA's systems can be quite complex, with many different components. There can be no assurance that any particular system will perform in the same manner when different therapeutic agents are incorporated into it. Often special materials must be fabricated for the first time for use in ALZA drug delivery systems, or materials may be used in the systems in a manner different from their customary commercial uses. Precision and reproducibility of materials can be critical to the performance of a drug delivery system, so a reliable source of a consistent supply of materials can be critical. Materials needed by ALZA may be difficult to obtain on commercially reasonable terms, particularly when relatively small quantities are required, or if the materials traditionally have not been used in pharmaceutical products. Therapeutic Discovery Corporation In June 1993, ALZA distributed a special dividend of Units to ALZA stockholders. Each Unit consisted of one share of TDC Class A Common Stock and one warrant to purchase one-eighth of one share of ALZA Common Stock. TDC was formed by ALZA for the purpose of selecting and developing new human pharmaceutical products combining ALZA's proprietary drug delivery technologies with various drug compounds, and commercializing such products, most likely through licensing to ALZA. Prior to the distribution of Units to stockholders, ALZA contributed $250 million to fund TDC. ALZA and TDC had a development agreement pursuant to which ALZA conducted research and development activities on behalf of TDC. ALZA had an option to license all of the products developed by TDC, on a product-by-product and country-by-country basis. ALZA also had an option, exercisable at ALZA's sole discretion, to purchase, according to a predetermined formula, all of the outstanding shares of TDC Class A Common Stock. In September 1997, ALZA exercised its purchase option and paid $100 million in cash for all of the shares of Class A Common Stock of TDC; TDC is now a wholly-owned subsidiary of ALZA. The ALZA warrants issued as part of the Units remain outstanding and are exercisable at a price of $65 per share until December 31, 1999. See "Crescendo Pharmaceuticals Corporation" below for the background concerning the formation of TDC. Crescendo Pharmaceuticals Corporation In 1993, ALZA determined to pursue the business of commercialization of products by ALZA, in addition to its business of developing products for commercialization by client companies resulting in payments to ALZA based on sales of the resulting products. To that end, ALZA formed ALZA Pharmaceuticals, its sales and marketing division, to commercialize products. In addition, at that time ALZA formed TDC to develop products for commercialization by ALZA Pharmaceuticals. ALZA has made significant progress in the establishment and expansion of its product commercialization business. ALZA's growing product commercialization business offers the potential rewards inherent in the direct commercialization of pharmaceutical products; however, the development of products for commercialization by ALZA requires the investment by ALZA of substantial resources in product selection and development, including clinical evaluation and regulatory activities. When ALZA develops products for commercialization by ALZA, ALZA must bear most or all of the risk and expenses of product development and has the opportunity to retain all or most of any gross margin resulting from sales of the product. Therefore, the risk/reward profile is significantly different from that of ALZA's traditional client-sponsored/royalty-based business, in which ALZA's clients bear most of the expenses and risks associated with product development and commercialization activities, and make payments to ALZA based on their sales of the products developed jointly with ALZA. Such payments to ALZA generally represent a relatively small portion of the total gross margin. The formation of TDC, and later Crescendo, to fund the development of products for commercialization by ALZA provides ALZA with the opportunity to continue to pursue and expand, more quickly than would otherwise be possible, its product commercialization business. In September 1997, ALZA contributed $300 million to Crescendo and distributed the shares of Class A Common Stock of Crescendo (the "Crescendo Shares") to ALZA's stockholders and debenture holders. Crescendo was formed by ALZA for the purpose of selecting and developing human pharmaceutical products and commercializing such products, most likely through licensing to ALZA. The products may, but are not required to, incorporate ALZA drug delivery technologies. ALZA and Crescendo have entered into a Development Agreement (the "Development Agreement") pursuant to which ALZA conducts product development and related activities on behalf of Crescendo under work plans and cost estimates which have been proposed by ALZA and approved by Crescendo. Development Costs are billed to Crescendo on a product by product basis under terms consistent with arrangements with other client companies. Crescendo is required to spend all of the funds contributed to Crescendo, plus interest earned thereon, less Crescendo's reasonable administrative costs, the Technology Fee (described below) paid to ALZA, and reserves of up to $2 million (the "Available Funds"), to conduct activities under the Development Agreement. Under the Development Agreement, Crescendo agreed to fund the development of seven products (the "Initial Products"), the development of which was commenced by ALZA and TDC, from August 25, 1997, the date on which TDC ceased funding such products, through October 31, 1997. Continuation of development of the Initial Products after October 31, 1997 was subject to ALZA proposing, and Crescendo's Board of Directors accepting, work plans and cost estimates for the products. As of the date hereof, five of the seven Initial Products are continuing in active development. The five Initial Products currently in active development are: OROS oxybutynin (Ditropan XL) DUROS leuprolide OROS methylphenidate E-TRANS Macroflux insulin E-TRANS LHRH Two of the Initial Products (the IUTS progesterone and D-TRANS testosterone matrix products), are no longer under active development. Crescendo ceased funding the development of these products on ALZA's recommendation. Crescendo makes the determination, independent of ALZA, as to whether or not Crescendo will continue the funding of any particular product. ALZA may make recommendations to Crescendo as to the continuation (or discontinuation) of the development of a particular product, but Crescendo has no obligation to follow ALZA's recommendation. ALZA and Crescendo have entered into a Technology License Agreement pursuant to which ALZA has granted to Crescendo a worldwide license to use ALZA technology solely to select and develop Crescendo products, to conduct related activities, and to commercialize such products. In exchange for the license to use existing ALZA technology relating to the Initial Products, Crescendo pays ALZA a Technology Fee, payable monthly over a period of three years, in the amount of $1 million per month for the first 12 months following the distribution of Crescendo Shares, $667,000 per month for the following 12 months and $333,000 per month for the next 12 months. The Technology Fee will no longer be payable at such time as fewer than two of the Initial Products are being developed by Crescendo and/or have been licensed by ALZA pursuant to the license option described below. In the License Option Agreement (the "License Option Agreement") entered into by ALZA and Crescendo, Crescendo has granted ALZA an option to acquire a license to each product developed under the Development Agreement, including the Initial Products. The license option for any such Crescendo product is exercisable on a country-by-country basis at any time until (i) with respect to the United States, 30 days after clearance by the FDA to market such Crescendo product in the United States and (ii) with respect to any other country, 90 days after the earlier of (a) clearance by the appropriate regulatory agency to market the Crescendo product in such country and (b) clearance by the FDA to market the Crescendo product in the United States. The license option will expire, to the extent not previously exercised, 30 days after the expiration of ALZA's option to purchase all of the outstanding Crescendo Shares, described below. If and to the extent the license option is exercised as to any Crescendo product, ALZA will acquire a perpetual, exclusive license (with the right to sublicense) to develop, make, have made and use the licensed product, and to sell and have sold the licensed product in the country or countries as to which the license option is exercised. Under the License Agreement for each licensed product, a form of which is attached to the License Option Agreement (a "License Agreement"), ALZA will make payments to Crescendo with respect to the licensed product equal to 1% of net sales of the licensed product by ALZA and its sublicensees, distributors and marketing partners, plus an additional 0.1% of such net sales for each full $1 million of development costs of the licensed product that have been paid by Crescendo; provided, however, that such total payments will not exceed 2.5% of net sales in the first four quarters a licensed product is sold in a major market country, and will not exceed 3% for the following two years. ALZA has the right to buy out Crescendo's right to receive payments for licensed products on a country-by-country or global basis. A country-by-country buy-out option may be exercised for any Crescendo product in any country at any time after the end of the twelfth calendar quarter during which the product was commercially sold in such country. The buy-out price will be 15 times the payments made by or due from ALZA to Crescendo with respect to sales of such product in such country for the four calendar quarters immediately preceding the quarter in which the buy-out option is exercised (plus 15 times such additional product payments as would have been made by ALZA to Crescendo for such period but for the 2.5% and 3% limits described above.) The global buy-out option may be exercised for any Crescendo product, at any time after the end of the twelfth calendar quarter during which the product was commercially sold in either the United States or two other major market countries. The global buy-out price will be (i) 20 times (a) the payments made by or due from ALZA to Crescendo for the relevant product, plus (b) such payments as would have been made by or due from ALZA to Crescendo if ALZA had not exercised any country-specific buy-out option with respect to such product, plus (c) such additional product payments as would have been made by ALZA to Crescendo but for the 2.5% and 3% limits described above, in each case for the four calendar quarters immediately preceding the quarter in which the global buy-out option is exercised, less (ii) any amounts previously paid to exercise any country-specific buy-out option with respect to such product. Pursuant to Crescendo's Restated Certificate of Incorporation, ALZA has the right to purchase all (but not less than all) of the Crescendo Shares (the "Purchase Option"). The Purchase Option will be exercisable by written notice to Crescendo at any time until January 31, 2002, provided that such date will be extended for successive six month periods if, as of any July 31 or January 31 beginning with July 31, 2001, Crescendo has not paid (or accrued expenses for) at least 95% of Available Funds pursuant to the Development Agreement. In any event, the Purchase Option will terminate on the 60th day after Crescendo provides ALZA with a statement that, as of the end of any calendar month, there are less than $2.5 million of Available Funds remaining, accompanied by a report of Crescendo's independent auditors. If the Purchase Option is exercised, the exercise price will be the greatest of: (a)(i) 25 times the actual payments made by or due from ALZA to Crescendo under the Development Agreement and the License Agreement with respect to any product (and, in addition, such payments as would have been made by or due from ALZA to Crescendo if ALZA had not previously exercised its payment buy-out option with respect to any such payments) for the four calendar quarters immediately preceding the quarter in which the Purchase Option is exercised (provided, however, that for any product which has not been commercially sold during each of such four calendar quarters, the portion of the exercise price for such product will be 100 times the average of the quarterly payments made by or due from ALZA to Crescendo for each of such calendar quarters during which such product was commercially sold) less (ii) any amounts previously paid to exercise any payment buy-out option; (b) the fair market value of one million shares of ALZA Common Stock; (c) $325 million less all amounts paid by or due from Crescendo under the Development Agreement to the date the Purchase Option is exercised; and (d) $100 million. In each case, the amount payable as the Purchase Option exercise price will be reduced to the extent, if any, that Crescendo's liabilities at the time of exercise (other than liabilities under the Development Agreement, the Technology License Agreement and the Services Agreement, described below) exceed Crescendo's cash and cash equivalents and short-term and long-term investments (excluding the amount of Available Funds remaining at such time). ALZA may pay the exercise price in cash, in ALZA Common Stock or in any combination of cash and ALZA Common Stock. ALZA and Crescendo have entered into a Services Agreement pursuant to which ALZA has agreed to provide Crescendo with administrative services, including accounting and legal services, on a fully-burdened cost reimbursement basis. The Services Agreement has a one year term and will be renewed automatically for successive one year terms during the term of the Development Agreement unless terminated by Crescendo at any time upon 60 days' written notice. Crescendo has a six person Board of Directors, none of whom is affiliated with ALZA, with many years of experience in different aspects of the pharmaceutical industry. Crescendo has a Chief Executive Officer (who is also a director) with more than 30 years of pharmaceutical industry experience, who is the sole employee of Crescendo. The Crescendo Board of Directors meets frequently, and reviews in detail all of the activities conducted by ALZA under the Development Agreement. The Chief Executive Officer of Crescendo holds regular meetings with the leaders of the ALZA development teams working on Crescendo products and provides advice to them on an ongoing basis, as well as providing regular reports to the Crescendo Board of Directors. Crescendo approves or disapproves all work plans and cost estimates proposed by ALZA for activities with respect to Crescendo products. Crescendo makes the determination as to whether a product will initially be accepted as a product, and the amount of Crescendo funding to be allocated for the development of the product. Work plans are generally approved by Crescendo on a milestone basis - once a milestone is achieved, Crescendo reviews the program and the proposed work plan and cost estimate for the next stage of development to determine whether to continue funding the product. ALZA may not continue the development of a product with Crescendo funding unless the work plan is approved by the Crescendo Board. If Crescendo determines to stop funding the development of a product, which decision is in Crescendo's sole discretion, the product remains a Crescendo product and development cannot continue, unless ALZA exercises its license option for the product. Crescendo funding and product decisions are made by the Crescendo Board of Directors without any ALZA participation. ALZA performs, or engages subcontractors such as clinical investigators, contract research organizations (for clinical studies) an analytical laboratories to perform the activities under work plans approved by Crescendo. ALZA charges Crescendo for these activities pursuant to a formula set forth in the Development Agreement, which formula is intended to reimburse ALZA for its fully-burdened costs of performing the activities. Amounts paid to third parties are billed to Crescendo at cost, with no mark-up by ALZA. The formula under which ALZA charges Crescendo for activities under the Development Agreement is the same formula used by ALZA in charging its pharmaceutical company clients under ALZA's product development arrangements with them. As discussed above, the formation of Crescendo (and previously, TDC) has enabled ALZA to pursue the development of products for commercialization by ALZA more quickly than otherwise would have been possible. Had ALZA not formed Crescendo (or TDC), any research and development activities that ALZA might nonetheless have decided to undertake would have been research and development expenses of ALZA, without corresponding research revenues. Under those circumstances, ALZA might have determined not to proceed as rapidly with the development of products for commercialization by ALZA Pharmaceuticals, or could have reduced the number of such products, because of the potentially negative impact on ALZA's operating profits. ALZA TTS Research Partners, Ltd. ALZA developed the Duragesic product and the original Testoderm product on behalf of ALZA TTS Research Partners, Ltd. (the "Transdermal Partnership"), a limited partnership funded in 1983 from which ALZA licensed those products. The Transdermal Partnership receives payments from ALZA equal to 4% of Janssen's sales of Duragesic and 4% of ALZA's sales of Testoderm and Testoderm with Adhesive. The Transdermal Partnership did not fund the development of, and will not receive payments on sales of, Testoderm TTS. ALZA's license from the Transdermal Partnership for Testoderm will become nonexclusive on July 26, 1998, and ALZA's license from the Transdermal Partnership for Duragesic will become nonexclusive on December 4, 1998. Once ALZA's licenses become nonexclusive, the Transdermal Partnership will need to determine whether to grant nonexclusive licenses to third parties. Under ALZA's distribution agreement with Janssen for the Duragesic product, if ALZA's license from the Transdermal Partnership becomes nonexclusive, if the Transdermal Partnership licenses the product to a third party and if the third party introduces the product, Janssen's royalty payable to ALZA will drop significantly; however, ALZA will continue to owe the Transdermal Partnership 4% of Janssen's net sales. ALZA has an option to purchase all of the interests in the Transdermal Partnership for $120 million cash, less amounts paid by ALZA to the Transdermal Partnership under its licenses prior to the date the option is exercised. As of December 31, 1997, ALZA had paid the Transdermal Partnership $27.3 million under these licenses. Research and Development Expenditures ALZA spent $126.3 million on client-sponsored product development activities during 1997 ($114.8 million and $85.8 million in 1996 and 1995, respectively); such amounts exclude reimbursable general and administrative costs. ALZA spent $30.6 million on ALZA-sponsored research and development activities during 1997 ($26.8 million and $17.6 million in 1996 and 1995, respectively), also excluding allocable general and administrative costs. Research and development costs are expensed as incurred. ALZA had research and development revenue of $135.0 million during 1997, $131.2 million during 1996 and $104.0 million during 1995, from clients with which ALZA has joint product development agreements. These amounts included $67.8 million from TDC and $29.7 million from Crescendo in 1997, and $100.7 million and $70.1 million from TDC in 1996 and 1995, respectively. The payments by TDC and Crescendo were made from funds contributed by ALZA to TDC and Crescendo at the time of their respective formation. ALZA's client-sponsored research and development revenue generally represents clients' reimbursement of costs, including a portion of general and administrative expenses. Therefore, product development activities do not contribute significantly to operating results. Governmental Regulation Under the United States Food, Drug and Cosmetic Act, "new drugs" must obtain clearance from the FDA before they lawfully can be marketed in the United States. Applications for marketing clearance must be based on extensive clinical and other testing, the cost of which is very substantial. Approvals (sometimes including pricing approvals) are required from health regulatory authorities in foreign countries before marketing of pharmaceutical products may commence in those countries. Requirements for approval may differ from country to country, and can involve additional testing. There can be substantial delays in obtaining required clearances from both the FDA and foreign regulatory authorities after applications are filed. Even after clearances are obtained, further delays may be encountered before the products become commercially available in countries requiring pricing approvals. Product development generally involves all of the following steps which are required by the regulatory process: preclinical development and testing, during which laboratory development and in vitro and in vivo testing takes place; submission to the FDA of an investigational new drug application, which must become effective before human clinical studies may begin; adequate and well-controlled human clinical trials (Phase I, II and III studies) to establish the safety and efficacy of the product; submission of an NDA to the FDA (and comparable filings to regulatory agencies outside the United States) requesting clearance to market the product; and the FDA (and foreign regulatory agencies) must clear the product for marketing. All of these steps can take several years and cost tens of millions of dollars. The products sold by ALZA and its client companies in the United States, and/or exported to other countries, are subject to extensive regulation by the FDA and comparable agencies in other countries where the products are distributed. Regulations govern a range of activities including manufacturing, quality assurance, advertising and record-keeping. The continuing trend of stringent FDA oversight in product clearance and enforcement has caused more uncertainty, greater risks and higher costs of obtaining clearance to market a product, and sometimes longer clearance cycles. Failure to obtain, or delays in obtaining, regulatory clearance to market new products, as well as other regulatory actions and recalls, could adversely affect ALZA's financial results. The packaging, labeling and advertising of pharmaceutical products are also subject to government regulation. The FDA recommends preclearing advertising materials prior to the launch of a product, and the launch materials for products receiving an accelerated FDA clearance must be precleared by the FDA. With an accelerated FDA clearance (such as was obtained by USB for Ethyol), all labeling and advertising must be submitted to the FDA 30 days prior to use, unless the FDA determines otherwise. In addition, the FDA may require that additional clinical studies- Phase IV studies-be completed after clearance to market a product has been granted. If these studies are not completed, or if the expected outcomes are not achieved, a product could be withdrawn from the market. Manufacturing ALZA manufactures products marketed by its client companies, and certain products marketed by ALZA, in ALZA's Vacaville, California commercial manufacturing facility. The Vacaville facility is the sole manufacturing site for several products, although some lower-volume products are manufactured in ALZA's Mountain View and Palo Alto, California research and development facilities. These facilities were not designed for high volume commercial manufacturing. The products acquired and in-licensed by ALZA are manufactured by the third parties from whom ALZA acquired or in-licensed the products. Generally these products are also manufactured at only one site. A shut down in one of these facilities, or in ALZA's Vacaville facility, resulting in an interruption in supply of one or more of the products, could have an adverse impact on ALZA's financial results. Some of the critical materials and components used in ALZA's products are sourced from one single supplier. An interruption in supply from a vendor of a key material could significantly delay the manufacturing of one or more ALZA products. Because the vendors of key components and materials must be named in the NDA for the relevant product, significant delays can occur if the qualification of a new vendor is required. Significant delays or an interruption in product supply could occur if a supplement to the NDA must be filed and approved before materials obtained from the new vendor can be used to manufacture a product. The manufacturing process for pharmaceutical products is highly regulated. Periodic inspections are conducted by the FDA and regulatory agencies from other countries. The FDA's current Good Manufacturing Practices are extensive regulations governing the manufacturing process, stability testing, record-keeping and quality standards. Similar, but not identical, regulations are in effect in other countries. The cost of complying with these regulations is substantial. Environmental regulations may also affect the manufacturing process. As a pharmaceutical company, ALZA uses chemicals and materials which may be classified as hazardous or toxic, and which require special handling and disposal. ALZA undertakes to minimize releases to the environment and exposure of its employees and the public to such materials. The costs of these activities have increased substantially in recent years, and it is possible that such costs may continue to increase significantly in the future. Patents and Patent Applications As of December 31, 1997, ALZA held approximately 540 United States patents and had approximately 200 pending United States patent applications relating to its products and other technologies. ALZA has in excess of 1,500 foreign patents and 770 pending foreign patent applications covering its various technologies and products. Patents have been issued, or are expected to be issued, covering ALZA's current technologies and products, as well as technologies and products under development. Patent protection generally has been important in the pharmaceutical industry. ALZA believes that its current patents, and patents that may be obtained in the future, are important to current and future operations. ALZA technologies and products are generally covered by multiple patents. However, there can be no assurance that ALZA's existing patents will cover future products, that additional patents will be issued, or that any patents now or hereafter issued will be of commercial benefit. In the United States, patents are granted for specified periods of time. Some of ALZA's earlier patents covering various aspects of certain OROS and D-TRANS dosage forms have expired, or will expire, over the next several years. In 2003, certain significant ALZA patents are due to expire that relate to ALZA's OROS systems and the Procardia XL (nifedipine) product developed by ALZA and marketed by Pfizer (which uses the OROS delivery system). Other forms of sustained release nifedipine using different delivery systems are reported to be in various stages of development by other companies, and two companies (Mylan Laboratories, Inc. and Biovail, Inc.) have filed Abbreviated New Drug Applications ("ANDAs") with the FDA requesting clearance to market generic sustained release nifedipine products. Pfizer has filed suit against Mylan for infringement of a patent relating to nifedipine particles, and is also involved in litigation with the FDA and Mylan concerning the regulatory status of Mylan's product. The Biovail application was filed in late February 1998, and ALZA and Pfizer are reviewing information concerning the Biovail product to determine what actions may be taken. It is not possible to predict the timing and amount of the negative impact on sales of Procardia XL that will result from competition from these or other potential generic sustained release nifedipine products. ALZA commercializes several products it has acquired or in-licensed from third parties. The extent to which such products are protected by patent rights varies significantly from product to product. Ditropan and Mycelex Troche have been sold for many years and are not covered by patents. The chemical compounds constituting the active ingredients of Ethyol and Elmiron are not covered by patents. However, patents have issued or are pending relating to significant developments in uses and the formulation of Ethyol, and for certain uses of Elmiron. ALZA anticipates that additional patents may issue relating to these products; however, there can be no assurance that any such patent coverage will be obtained, or if obtained will provide significant proprietary protection for the products. Although a patent has a statutory presumption of validity in the United States, the issuance of a patent is not conclusive as to such validity or as to the enforceable scope of the claims of the patent. There can be no assurance that patents of ALZA will not be successfully challenged in the future. In some cases, third parties have initiated reexamination by the Patent and Trademark Office of patents issued to ALZA, and have opposed ALZA patents in other jurisdictions. The validity or enforceability of ALZA patents after their issuance have also been challenged in litigation. If the outcome of such litigation is adverse to ALZA, third parties may then be able to use the invention covered by the patent, in some cases without payment. There can be no assurance that ALZA patents will not be infringed or successfully avoided through design innovation. It is also possible that third parties may obtain patent or other proprietary rights that may be necessary or useful to ALZA. With numerous other companies engaged in developing new chemical entities and competitive drug delivery technologies, it can be expected that other parties may in some circumstances file patent applications or obtain patents that compete in priority with ALZA's patent applications. Such competition may result in adversarial proceedings such as patent interferences and oppositions, which can increase the uncertainty of patent coverage. In cases where third parties are first to invent a particular product or technology, it is possible that those parties will obtain patents that will be sufficiently broad so as to prevent ALZA from using certain technology or from further developing or commercializing certain products. As ALZA expands its direct marketing of products, ALZA may attempt to in-license additional products, or compounds or technologies for use in products. In each of these cases, if licenses from third parties are necessary but cannot be obtained, commercialization of the products would be delayed or prevented. In addition, ALZA utilizes significant unpatented proprietary technology, and there can be no assurance that others will not develop similar technology. Competition It can be expected that all or most of the products commercialized by ALZA will face competition at the time of introduction, or later in their life cycles, from different chemical or other agents intended for treatment of the same indications. All of ALZA's current and future drug delivery products are likely to face competition both from traditional forms of drug delivery and from advanced delivery systems being developed by others. ALZA's competition potentially includes all of the pharmaceutical companies in the world, including current ALZA clients. Many of these pharmaceutical companies have greater financial resources, technical staff and manufacturing and marketing capabilities than ALZA. A large number of companies are developing drug delivery technologies. To the extent that ALZA develops or markets products incorporating drugs that are off-patent, or are being developed by multiple companies, ALZA will face competition from other companies developing and marketing similar products. As the pharmaceutical industry continues to consolidate, and as pressures increase for cost-effective research and development, some pharmaceutical companies have reduced, and may continue to reduce, their funding of research and development. Competition for limited client dollars may therefore increase, and this competition could include the clients' internal research and development programs, other drug delivery programs and other technologies and products of third parties. Similarly, as pharmaceutical companies search to fill gaps in their product pipelines with in-licensed or acquired products, ALZA will be competing for product in-licensing and acquisition opportunities with companies with far greater financial and other resources than ALZA. Competition among pharmaceutical products is generally based on performance characteristics and price. Acceptance by hospitals, physicians and patients is crucial to the success of a product. Health care reimbursement policies of managed care organizations, insurers and government agencies will continue to exert pressure on pricing, and various federal and state agencies have enacted regulations requiring rebates of a portion of the purchase price of many pharmaceutical products. Cost- effectiveness, although often difficult to measure, is becoming increasingly critical to the commercial success of a new product. A major challenge faced by ALZA and other pharmaceutical companies is competition from generic pharmaceutical manufacturers. Generic competitors generally are able to obtain regulatory approval for off-patent drugs without investing in costly and time-consuming clinical trials, and need only demonstrate bioequivalence to the drug they wish to copy. Because of their substantially reduced development costs, generic companies are often able to charge much lower prices for their products than the originator of a new product. A number of ALZA- developed products incorporate chemical entities that are not covered by patents. These products therefore may be subject to potential generic competition to the extent that competitors can demonstrate bioequivalence without infringing ALZA patents relating to its drug delivery technologies. Two companies have filed ANDAs with the FDA requesting clearance to market generic versions of Procardia XL (see "Patents and Patent Applications" above). The health care industry has continued to change rapidly as the public, government, medical practitioners and the pharmaceutical industry focus on ways to expand medical coverage while controlling the growth in health care costs. The growth of managed care organizations and the resulting pressures for cost-containment in the United States health care system are expected to continue to put pressures on the prices charged for pharmaceutical products. Prescription drug reimbursement practices and the growth of large managed care organizations, as well as generic and therapeutic substitution (substitution of a different product for the same indication), will significantly affect ALZA's business. While ALZA believes the changing health care environment may increase the value of ALZA's drug delivery products over the long term, it is impossible to predict accurately the impact these changes may have on ALZA. Revenues In 1997, ALZA received royalty revenue based on sales of approximately 16 products. Sales of Procardia XL in the United States by Pfizer accounted for approximately 29% of ALZA's royalties and fees in 1997 (approximately 40% in 1996 and more than 40% in 1995). ALZA's net sales in 1997 consisted of direct sales of products in the marketplace and sales to client companies of products manufactured by ALZA. ALZA's net sales of ALZA-marketed products were approximately $52.9 million in 1997. Research and development revenues consist of reimbursement by client companies, including Crescendo (and previously, TDC), of research and development expenses incurred by ALZA in developing products on behalf of the client companies. Information about ALZA's revenues is presented below: 1997 1996 1995 (in millions) Royalties, fees and other $ 183.3 173.3 $ 143.7 Net sales 146.1 108.6 76.9 Research and development 135.0 131.2 104.0 Total revenues $ 464.4 $ 413.1 $ 324.6 Pfizer accounted for 17% of ALZA's total revenues in 1997, 22% in 1996, and 26% in 1995; TDC accounted for 15% of ALZA's total revenues in 1997, 24% in 1996, and 22% in 1995; Janssen accounted for 15% of ALZA's total revenues in 1997, 14% in 1996, and 13% in 1995; and HMRI accounted for 10% of ALZA's total revenues in 1997, and 11% in both 1996 and 1995. The loss of revenues from one or more of these clients would have a material adverse effect on ALZA's profitability. Product Returns; Payment Terms For products marketed by ALZA, payment terms are generally net 30 days. From time to time, ALZA has extended its customary payment terms, for example in the case of new product introduction and in anticipation of a holiday shut down. ALZA generally accepts returns of unopened product for full credit. Industry Segments; Exports ALZA's business comprises one industry segment. Export sales were $31.5 million in 1997, $23.0 million in 1996, and $20.1 million in 1995, principally to distributors and client companies in Europe. Employees On December 31, 1997, ALZA had 1,532 employees, of whom approximately 670 were engaged in research and development activities, approximately 493 were engaged in manufacturing activities, approximately 126 were engaged in sales and marketing activities and the remainder were working in general and administrative areas. Item 2. PROPERTIES ALZA's corporate offices are located in Palo Alto, California, and its two primary research and development campuses are in Palo Alto and Mountain View, California. Most of the facilities in Palo Alto are held under prepaid ground leases from Stanford University expiring in approximately 17 to 60 years. One Palo Alto facility is subleased to ALZA; there are three years remaining on the sublease and ALZA has an option for an additional three years. ALZA owns all of its significant Mountain View facilities, except as described below. ALZA also occupies a research facility in Spring Lake Park, Minnesota which is leased from a third party until the year 2000. ALZA's large-scale commercial manufacturing facility, which is owned by ALZA, is located in Vacaville, California. Some smaller scale manufacturing also takes place in the Palo Alto and Mountain View facilities. While ALZA believes that its facilities and equipment are sufficient to meet its current operating requirements, ALZA is actively planning to expand its facilities and equipment to support its long-term requirements, in particular in Mountain View, California. In late 1997, ALZA acquired a 50% interest in a real estate joint venture, formed as a limited liability company, for the development of a 13-acre parcel of land in Mountain View, California. ALZA invested $36.2 million in the joint venture, which will be applied to the construction of three buildings on the parcel. ALZA is also obligated to make improvements to the buildings, the total cost of which is estimated to be between $60.0 million and $100.0 million. The joint venture will lease the buildings to ALZA upon completion of construction. The lease payments due on the Mountain View facility, which begin in May 1999, are based upon the final square footage of the buildings (which is estimated to be approximately 120,000 square feet per building). Those lease payments are currently estimated to be approximately $225,000 per month per building for the first year and escalate $0.05 per square foot per year for the remainder of the initial term of the lease. ALZA currently plans to occupy two of the buildings upon completion, and sublease the third building for several years. The leases provide for an initial term of 15 years, with options to extend for approximately 20 additional years, and with scheduled annual rent increases during the extended term based upon the Consumer Price Index. ALZA will receive 50% of the joint venture's income (rent less management fees). ALZA has also entered into a ground lease agreement for an adjacent seven-acre parcel of land on which it plans to construct a pilot plant, laboratories and other technical facilities. The term of the ground lease is approximately 33 years and includes options for ALZA to purchase, or to be required to purchase, the property. Groundlease payments are approximately $140,000 per month. Under the groundlease for the seven-acre parcel, ALZA's option to acquire the property may be exercised at any time after August 31, 2000 and prior to expiration of the lease, and the landlord may exercise its option to sell the property to ALZA at any time before August 31, 2000. For a purchase on or before September 30, 2002, the purchase price is approximately $17 million; thereafter the purchase price is adjusted for inflation. If neither ALZA nor the landlord exercises its option, then any improvements constructed by ALZA on the parcel would be the property of the landlord on termination of the lease. Item 3. LEGAL PROCEEDINGS Product liability suits have been filed against Janssen and ALZA from time to time relating to the Duragesic product. Janssen is managing the defense of these suits in consultation with ALZA under an agreement between the parties. Pursuant to a Remedial Action Order No. HSA 88/89-016 issued by the California Department of Toxic Substances Control ("DTSC"), ALZA has been named as one of a number of potentially responsible parties in connection with the cleanup and environmental remediation of the Hillview-Porter Regional Site Project near ALZA's Palo Alto facilities. The purpose of the DTSC action is, in part, to apportion responsibility for cleanup costs among the parties involved. Estimates of cleanup costs for the entire region are approximately $16 million. ALZA believes that it did not discharge any of the chemicals of concern at the site in question. ALZA does not believe that its liability in this matter, if any, will be material. However, the courts have not determined whether individual parties may be jointly and severally liable in such matters. Because the action involves many parties and multiple regulatory authorities, and the cleanup and allocation of financial responsibility may not be resolved for several years, it is impossible to predict the timing or amount of ALZA's potential liability. Historically, the cost of resolution of liability claims against ALZA (including product liability claims) has not been significant, and ALZA is not aware of any asserted or unasserted claims pending against it, including the suits mentioned above, the resolution of which would have a material adverse impact on the operations or financial position of ALZA. Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS None. EXECUTIVE OFFICERS OF THE REGISTRANT Principal Occupations for Name Age Past Five Years Dr. Ernest Mario 59 Chairman of the Board and Chief Executive Officer of ALZA (since 1993); Chief Executive of Glaxo Holdings, p.l.c., a pharmaceutical company (1989-1993). Dr. Felix Theeuwes 60 President, New Ventures of ALZA (since 1997) and Chief Scientist (since 1982); President, Research and Development (1995-1997); President, ATI (1994-1995); Executive Vice President, Research and Development (1991-1994). James Butler 57 Senior Vice President, Sales and Marketing of ALZA (since 1997); Vice President, Sales and Marketing (1993-1996); Vice President and General Manager of the corporate division of Glaxo, Inc., a pharmaceutical company (1987-1993). Bruce C. Cozadd 34 Senior Vice President and Chief Financial Officer of ALZA (since 1997); Vice President and Chief Financial Officer (1994-1996); Vice President, Corporate Planning and Analysis (1993); Manager, Strategic Projects (1991-1993). Harold Fethe 53 Vice President, Human Resources of ALZA (since 1991). Dr. Gary V. Fulscher 54 Senior Vice President, Commercial Services of ALZA (since 1998); Senior Vice President, Operations (1994-1997); Vice President, Administration (1987-1994). Dr. Samuel R. Saks 43 Senior Vice President, Medical Affairs of ALZA (since 1994); Vice President, Medical Affairs (1992-1994); Vice President, Clinical Research, Oncology, Schering Plough Corporation, a pharmaceutical company(1991-1992). Peter D. Staple 46 Senior Vice President and General Counsel of ALZA (since 1997); Vice President and General Counsel (1994- 1996); Vice President and Associate General Counsel of Chiron Corporation, a biotechnology company (1992-1994). Janne Wissel 42 Senior Vice President, Operations of ALZA (since 1998); Vice President Regulatory and Quality Management(1995 to 1997); Vice President, Quality Management (1994-1995); Senior Director, Regulatory Affairs (1993 to 1994). Dr. James W. Young 53 Senior Vice President, Research and Development of ALZA (since 1997); Senior Vice President, Commercial Development (1995-1997); Vice President and Managing Director of ALZA Technology Institute (June 1995- September 1995); President, Pharmaceuticals Division, Affymax N.V., a biotechnology company (1992-1995). PART II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS ALZA common stock (symbol AZA) is listed for trading on the New York Stock Exchange and, as of December 31, 1997, there were 8,242 holders of record. ALZA has never paid cash dividends on its common stock and has no plan to do so in the near term. The quarterly high and low sales prices of ALZA common stock for 1997 and 1996, as reported on the composite tape are shown below: ALZA COMMON STOCK _________________________________________________________________ 1997 1996 _________________________________________________________________ High Low High Low First quarter $31 3/8 $24 7/8 $34 7/8 $24 3/8 Second quarter 31 3/8 25 1/2 32 1/2 26 3/8 Third quarter 32 1/2 28 1/16 27 3/4 24 Fourth quarter 31 13/16 24 7/8 29 25 1/8 Item 6. SELECTED FINANCIAL DATA (In millions, except per share amounts) 1997 1996 1995 1994 1993 __________________________________________________________________ Total revenues $ 464.4 $413.1 $324.6 $ 261.2 $ 214.6 Net income (loss) (261.1)(1) 92.4 72.4 58.1 45.6(2) Earnings (loss) per share, Basic (3.07) 1.10 0.88 0.71 0.59 Diluted (3.07) 1.08 0.88 0.71 0.57 Cash and investments 535.8 999.8 419.1 344.9 257.5(3) Total assets 1,369.2 1,613.7 937.2 806.3 621.8(3) Total long-term liabilities 963.4 949.8 414.7 385.8 29.0(4) Total stockholders' equity 301.2 596.7 454.6 364.5 306.7(3) __________________________________________________________________ 1 Reflects a total of $368.7 million (or $4.30 per share, diluted) of charges, including a $247.0 million charge and $8.0 million of interest expense related to ALZA's distribution of shares of Crescendo, $108.5 million for acquired in-process research and development, an asset write- down of $11.5 million and costs of $1.8 million related to a workforce reduction, less a tax benefit of $8.1 million. 2 Includes pre-tax charges and allowances of $28.1 million ($0.23 per share, diluted) related primarily to manufacturing activities. Also includes $6.6 million ($0.08 per share, diluted) in one-time benefits resulting from the adoption of SFAS No. 109, "Accounting for Income Taxes", and a $3.8 million ($0.05 per share, diluted) extraordinary charge relating to the redemption of ALZA's 7 1/2% zero coupon convertible subordinated debentures. 3 Includes the effect of the $250.0 million contribution to Therapeutic Discovery Corporation and the related special dividend of shares of Therapeutic Discovery Corporation to ALZA stockholders. 4 Approximately $249.5 million of commercial paper (including accrued interest) was outstanding. Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 1997 EVENTS The following 1997 events are important to understanding the business and operating results of ALZA Corporation ("ALZA" or the "Company"). In 1997, ALZA: Purchased the Class A Common Stock of Therapeutic Discovery Corporation ("TDC") for $100.0 million. The purchase resulted in a charge of $77.0 million to acquisition of in-process research and development. Approximately $23.0 million of the purchase price was allocated to a deferred tax asset arising from TDC's net operating loss carryforward and capitalized research and development expense. Contributed $300.0 million to Crescendo Pharmaceuticals Corporation ("Crescendo") and distributed its shares to ALZA stockholders and debenture holders. ALZA recorded a charge of $247.0 million (including expenses of $4.0 million) and interest expense of $8.0 million related to ALZA's contribution to Crescendo and the distribution to stockholders and debenture holders, respectively. ALZA also recorded a dividend of $49.1 million to ALZA stockholders in connection with the distribution of the Crescendo Shares. Acquired exclusive rights to Mycelex-registered trademark- (clotrimazole) Troche in the United States from Bayer Corporation ("Bayer"). Under the terms of the agreement, ALZA made a $50.0 million upfront payment to Bayer, which was capitalized, and will make an additional payment if net sales of the product during a certain period are above a specified level. Bayer manufactures Mycelex-registered trademark- Troche for ALZA, and receives payments from ALZA based on sales of the product. Acquired the exclusive rights in the United States and Canada to Elmiron-registered trademark- (pentosan polysulfate sodium) and three additional urology products, BiCitra-registered trademark-(sodium citrate and citric acid), PolyCitra-registered trademark-(potassium citrate) and Neutra-Phos-registered trademark-(potassium and sodium phosphate), from Baker Norton Pharmaceuticals, Inc. and its parent, IVAX Corporation (together, "IVAX"). Under the terms of the agreement, ALZA paid a $75.0 million upfront fee to IVAX, which was capitalized, and will pay additional fees if specified Elmiron-registered trademark- sales levels are achieved during the next five years. Acquired the rights in the United States to the immediate- release Ditropan-registered trademark- (oxybutynin chloride) product and trademark from Hoechst Marion Roussel, Inc. ("HMRI"). Under the terms of the agreement, ALZA made an upfront payment to HMRI, which was capitalized, and will make additional payments if specified sales levels of Ditropan-registered trademark- are achieved. HMRI manufactures the product for ALZA for a price based upon net sales. ALZA has the right to market other products in the United States under the Ditropan-registered trademark- trademark, and HMRI will receive royalty payments from ALZA if the trademark is used by ALZA with other products. Acquired an option to develop and commercialize the Cereport- trademark- (RMP-7-trademark-) product, a compound intended to facilitate the delivery of chemotherapeutic agents to the brain. Under the terms of the agreement, ALZA paid Alkermes $10.0 million, which was charged to acquisition of in-process research and development. Under the agreement, Alkermes is conducting additional clinical activities related to Cereport-trademark-, and ALZA has the option to acquire exclusive worldwide commercialization rights to the product. Modified its arrangements with Janssen Pharmaceutica, Inc. (together with its affiliates "Janssen") covering E-TRANS- trademark- fentanyl products for the treatment of acute and chronic pain. In connection with the modified arrangements, ALZA made a one-time payment of $21.5 million to Janssen, which was charged to acquisition of in-process research and development. ALZA will receive a share of the U.S. operating profits from the product and royalties from sales of the product outside the United States. RESULTS OF OPERATIONS SUMMARY (In millions, except per share amounts) 1997 1996 1995 _________________________________________________________________ Revenues $464.4 $413.1 $324.6 _________________________________________________________________ Operating Income (Loss) (204.0) 139.2 114.7 _________________________________________________________________ Net Income (Loss) (261.1) 92.4 72.4 _________________________________________________________________ Earnings (Loss) per Share (diluted) (3.07) 1.08 0.88 _________________________________________________________________ ALZA's net loss for 1997 was $261.1 million compared with net income of $92.4 million in 1996 and $72.4 million in 1995. The 1997 loss was due in part to: Acquisitions of in-process research and development, which consisted of $77.0 million related to the purchase of the Class A Common Stock of TDC, a $10.0 million charge in connection with a development and option agreement for Cereport-trademark- between ALZA and Alkermes, and $21.5 million related to a development and commercialization agreement between ALZA and Janssen for an E-TRANS-trademark- fentanyl product for the treatment of acute pain; A charge of $247.0 million and interest expense of $8.0 million related to ALZA's contribution to Crescendo and distribution of shares to stockholders and debenture holders, respectively; A write-down of excess manufacturing equipment of $11.5 million; $1.8 million in costs related to a workforce reduction ($1.4 million included in research and development expenses, and $0.4 million included in selling, general and administrative expenses). Net income for 1996 included: A $7.1 million benefit from the reversal of a reserve related to Procardia XL-registered trademark- royalties; A $6.4 million benefit from the settlement of litigation related to patent disputes concerning transdermal nicotine patches; A $4.0 million charge for the unamortized portion of a partnership acquisition prepayment; A $1.9 million charge related to a limited recall of two lots of Duragesic-registered trademark-, and other joint venture, partnership and product reserves. Net income for 1995 included: A benefit of $7.4 million resulting from the partial reversal of a reserve established in connection with a patent dispute concerning transdermal nicotine patches; A reserve of $9.0 million established to account for a potential reduction of the royalties from Pfizer on sales of Procardia XL-registered trademark-; A charge of $6.7 million for a portion of the initial payment by ALZA to USB under the marketing and distribution agreement for Ethyol-registered trademark-. On a comparable basis, excluding the impact of the 1997 items mentioned above, ALZA's 1997 net income was $107.6 million, or $1.23 per diluted share, compared with $90.1 million, or 1.06 per diluted share, for 1996 excluding the items mentioned above, an increase of 19%. This increase resulted primarily from higher net sales of ALZA-marketed products, which more than doubled in 1997 compared with 1996. Also contributing to the increase in 1997 net income were higher royalties, fees and other revenues and a lower effective income tax rate. Partially offsetting these contributions to net income in 1997 were increases in research and development expenses and sales and marketing expenses, and the amortization of product acquisition costs, as well as decreased net interest income. ALZA's net income increased 16% in 1996 compared to 1995, on a comparable basis excluding the 1996 and 1995 items mentioned above. This increase primarily resulted from higher royalties, fees and other revenues in 1996 compared to 1995, as well as increases in net sales, research and development revenues and net interest income. These increases were partially offset by higher research and development expenses, and increased selling, general and administrative expenses in 1996 compared with 1995. (Presented graphically in paper format annual report) REVENUES (In millions of dollars) 1997 1996 1995 1994 1993 _________________________________________________________________ Royalties and fees 183 173 144 123 114 Net sales 146 109 77 69 54 Research and development 135 131 104 69 47 _________________________________________________________________ TOTAL REVENUES 464 413 325 261 215 (Presented graphically in paper format annual report) OPERATING INCOME (LOSS) (In millions of dollars) 1997 1996 1995 1994 1993 _________________________________________________________________ (204) 139 115 95 66 ROYALTIES, FEES AND OTHER REVENUES (Dollars in millions) 1997 1996 1995 _________________________________________________________________ Royalties, fees and other revenues $183.3 $173.3 $143.7 Percentage of total revenues 39% 42% 44% _________________________________________________________________ Royalties, fees and other revenues increased 6% in 1997 compared to 1996, primarily as a result of increased royalties due to higher sales of Glucotrol XL-registered trademark- (glipizide) by Pfizer Inc. ("Pfizer"), Duragesic-registered trademark- (fentanyl) by Janssen, Nicoderm-registered trademark- and NicoDerm-registered trademark- CQ-trademark- (nicotine) by HMRI and SmithKline Beecham ("SmithKline"), respectively, and Catapres-TTS-registered trademark- (clonidine) by Boehringer Ingelheim Pharmaceuticals,Inc. These increases were partially offset by decreased royalties on sales of Procardia XL-registered trademark-(nifedipine) by Pfizer. Royalties, fees and other revenues for 1996 included a net benefit of $10.5 million from the reversal of a reserve related to Procardia XL-registered trademark- royalties and settlement of litigation related to patent disputes concerning transdermal nicotine patches, partially offset by a charge for the unamortized portion of a partnership acquisition prepayment. On a comparable basis, excluding this net benefit, royalties, fees and other revenues increased 13% in 1997 compared with 1996. Commercialization and licensing fees also contributed to the increase in royalties, fees and other revenues in 1997 compared with 1996. Fees for 1997 included upfront payments from Knoll Pharmaceutical Company in connection with an agreement for continued development and worldwide commercialization of the OROS- registered trademark- hydromorphone product, from SmithKline in connection with the agreement for the commercialization of the Nicoderm-registered trademark- transdermal nicotine product in numerous international markets, and from Pfizer for the rights to commercialize the OROS-registered trademark- pseudoephedrine product in certain countries outside the U.S., and technology fee revenue of $4.0 million from Crescendo. Sales of Procardia XL-registered trademark-, as reported by Pfizer, decreased 18% in 1997 from 1996, and decreased 11% in 1996 from 1995. Royalties from Procardia XL-registered trademark- accounted for approximately 29% of royalties, fees and other revenues in 1997, compared with 42% in 1996. In 1997, Mylan Laboratories Inc. ("Mylan") filed an Abbreviated New Drug Application ("ANDA") with the United States Food and Drug Administration ("FDA") requesting clearance to market a controlled-release nifedipine tablet as a generic alternative to Procardia XL-registered trademark-. Pfizer subsequently commenced separate legal proceedings challenging Mylan's product based on regulatory and patent issues. Under applicable law, Pfizer's suits may have the effect of delaying FDA clearance of Mylan's ANDA. However, it is not possible to predict the outcome of such litigation, nor is it possible to predict the impact Mylan's product, if cleared for marketing, may ultimately have on sales of Procardia XL-registered trademark- and the resulting royalties to ALZA. The growth in royalties, fees and other revenues in 1996 compared with 1995 was due in part to the $10.5 million in net benefits recognized in 1996, as discussed above, and to increased sales of Adalat CR-registered trademark- (nifedipine) by Bayer AG, Catapres-TTS-registered trademark-, Duragesic-registered trademark-, Glucotrol XL-registered trademark-, and NicoDerm- registered trademark- CQ-trademark- following its introduction in the third quarter of 1996. In addition, despite lower sales of Procardia XL-registered trademark- in 1996, royalties from this product increased due to a higher effective royalty rate. Reducing royalties and fees in 1996 were lower royalties on sales of Transderm-Nitro-registered trademark- (nitroglycerin) by Novartis Pharmaceuticals Corporation. NET SALES AND COSTS OF PRODUCTS SHIPPED Net Sales (Dollars in millions) 1997 1996 1995 _________________________________________________________________ ALZA-marketed products Ethyol-registered trademark- $20.6 $9.4 - Mycelex-registered trademark- Troche 10.8 - - Testoderm-registered trademark- 6.3 6.7 6.8 Elmiron-registered trademark- 4.8 - - Other 10.4 7.1 6.8 _________________________________________________________________ Total ALZA-marketed products 52.9 23.2 13.6 Contract manufacturing 93.2 85.4 63.3 _________________________________________________________________ Total net sales $146.1 $ 108.6 $ 76.9 ================================================================= Percentage of total revenues 31% 26% 24% ALZA-marketed products as a percentage of net sales 36% 21% 18% _________________________________________________________________ Included in net sales are sales of products marketed directly by ALZA and through distributors, and sales generated from contract manufacturing activities for ALZA's client companies. In 1997, net sales increased 35% from 1996, primarily due to a substantial increase in sales of ALZA-marketed products, the rights to many of which were acquired by ALZA during 1997. Sales of Ethyol-registered trademark- (amifostine), which was launched in April 1996, contributed to the increase in sales of ALZA-marketed products in 1997, together with sales of Mycelex- registered trademark- Troche, the U.S. rights to which were acquired in July 1997, and sales of Elmiron-registered trademark- , the U.S. and Canadian rights to which were acquired in October 1997. Net sales from contract manufacturing increased 9% in 1997 compared with 1996 primarily due to a 27% increase in ALZA shipments of Nicoderm-registered trademark- and NicoDerm- registered trademark- CQ-trademark-, and a 14% increase in ALZA shipments of Duragesic-registered trademark-. In July 1997, ALZA acquired exclusive rights to Mycelex- registered trademark- (clotrimazole) Troche in the United States from Bayer Corporation ("Bayer"). Under the terms of the agreement, ALZA made a $50.0 million upfront payment to Bayer, which was capitalized, and will make an additional payment if net sales of the product during a certain period are above a specified level. Bayer manufactures Mycelex-registered trademark- Troche for ALZA, and receives payments from ALZA based on sales of the product. In October 1997, ALZA acquired the exclusive rights in the United States and Canada to Elmiron-registered trademark- (pentosan polysulfate sodium) and three additional urology products, BiCitra-registered trademark-(sodium citrate and citric acid), PolyCitra-registered trademark-(potassium citrate) and Neutra-Phos-registered trademark-(potassium and sodium phosphate), from Baker Norton Pharmaceuticals, Inc. and its parent, IVAX Corporation (together, "IVAX"). Under the terms of the agreement, ALZA paid a $75.0 million upfront fee to IVAX, which was capitalized, and will pay additional fees if specified Elmiron-registered trademark- sales levels are achieved during the next five years. IVAX manufactures the products for ALZA and receives payments from ALZA based on sales of the products. In October 1997, ALZA acquired the rights in the United States to the immediate-release Ditropan-registered trademark- (oxybutynin chloride) product and trademark from Hoechst Marion Roussel, Inc. ("HMRI"). Under the terms of the agreement, ALZA made an upfront payment to HMRI, which was capitalized, and will make additional payments if specified sales levels of Ditropan- registered trademark- are achieved. HMRI manufactures the product for ALZA for a price based upon net sales. ALZA has the right to market other products in the United States under the Ditropan-registered trademark- trademark, and HMRI will receive royalty payments from ALZA if the trademark is used by ALZA with other products. Net sales increased 41% in 1996 compared to 1995, primarily due to sales of Ethyol-registered trademark- beginning in April 1996, and increased sales from shipments to client companies of launch quantities of NicoDerm-registered trademark- CQ-trademark- and Covera-HS-trademark-. (Presented graphically in paper format annual report) NET SALES (In millions of dollars) 1997 1996 1995 1994 1993 _________________________________________________________________ ALZA-marketed products 53 23 14 11 7 Contract manufacturing 93 86 63 58 47 _________________________________________________________________ TOTAL NET SALES 146 109 77 69 54 _________________________________________________________________ Net sales of ALZA-marketed products can be expected to vary from quarter to quarter, particularly in the first years after launch of a new product. Rights to several of the ALZA-marketed products were acquired by ALZA during 1997. Both Ethyol- registered trademark- and Elmiron-registered trademark- were cleared for marketing during the past few years and have not yet achieved their steady-state sales levels. Wholesaler stocking patterns, managed care and formulary acceptance, the introduction of competitive products and acceptance by patients and physicians will affect future sales of these products. ALZA's contract manufacturing activities are undertaken pursuant to ALZA's client-funded product development arrangements. Under the third party arrangements, ALZA is reimbursed for its costs of developing the products; ALZA often manufactures the product for the client, generally for a supply price intended to cover ALZA's costs to manufacture the product plus a small margin; and ALZA receives royalties based on the client's sales of the products. As a result, ALZA's gross margin on its contract manufacturing sales is considerably lower than its gross margin on ALZA-marketed products, since the royalties received from the client companies for the product are reported as royalties, fees and other revenue, and are not included in the gross margin. The timing and quantities of orders for products marketed by client companies are not within ALZA's control. Net sales to client companies can be expected to fluctuate from period to period, sometimes significantly, depending on the volume, mix and timing of orders of products shipped to client companies, and in some quarters, due to the shipment of launch quantities of products to the clients. Costs of products shipped increased 9% to $92.8 million in 1997 compared to 1996, and 30% to $85.2 million in 1996 compared with 1995, reflecting the increase in net sales. Costs of products shipped in 1996 included a charge related to costs associated with a limited recall of two lots of the Duragesic- registered trademark- product. Costs of products shipped increased 12% in 1997 and 27% in 1996 excluding this charge. 1997 1996 1995 _________________________________________________________________ Gross margin as a percentage of net sales (1) 36% 21% 15% _________________________________________________________________ (1) Gross margin is net sales less costs of products shipped The increase in ALZA's gross margin in 1997 compared to 1996 was due to increased sales of higher-margin ALZA-marketed products and increased margins on products shipped to client companies. ALZA expects its gross margin on net sales to increase from historical rates over the longer term, although quarter-to-quarter fluctuations, even significant ones, can be expected to continue to occur for the reasons discussed above. A trend of higher gross margins may be achieved through a proportionate increase in the sales of ALZA-marketed products in relation to contract manufacturing activities, increased utilization of capacity, and greater operating efficiencies. RESEARCH AND DEVELOPMENT Therapeutic Discovery Corporation On September 29, 1997, ALZA purchased all of the outstanding shares of TDC Class A Common Stock for $100.0 million in cash. The purchase resulted in a charge of $77.0 million to acquisition of in-process research and development. Approximately $23.0 million of the purchase price was allocated to a deferred tax asset arising from TDC's net operating loss carryforwards and capitalized research and development expense. TDC was formed by ALZA in 1993 to develop and commercialize products incorporating ALZA's drug delivery technologies. At the time of its purchase by ALZA, TDC had a broad range of products in development, although none of these products had received regulatory approval for marketing. A significant portion of the purchase price was charged to the acquisition of in-process research and development because the TDC products were under development and had not been approved by the FDA. In addition, because TDC had rights only to specific products, and not technology, the products acquired had no alternative future uses. Crescendo Pharmaceuticals Corporation On September 29, 1997, ALZA contributed $300.0 million in cash to Crescendo for Crescendo's Class A Common Stock (the "Crescendo Shares"). On September 30, 1997, the Crescendo Shares were distributed to holders of ALZA common stock and ALZA's outstanding convertible subordinated debentures. ALZA recorded a charge of $247.0 million (including expenses of $4.0 million) and interest expense of $8.0 million related to ALZA's contribution to Crescendo and the distribution to stockholders and debenture holders, respectively. ALZA also recorded a dividend of $49.1 million to ALZA stockholders in connection with the distribution of the Crescendo Shares. ALZA's total cash outlay in connection with establishing Crescendo consisted of the $300 million contribution and approximately $4 million in expenses. Under a Development Agreement between ALZA and Crescendo, Crescendo is funding the development of human pharmaceutical products proposed by ALZA and accepted by Crescendo. The development of certain specified products was funded by Crescendo beginning August 25, 1997, the date on which TDC ceased funding the development of such products. Under a Technology License Agreement between ALZA and Crescendo, ALZA has granted to Crescendo a worldwide license to use ALZA technology solely to select and develop Crescendo products, to conduct related activities, and to commercialize Crescendo products. In exchange for the license to use existing ALZA technology relating to the products initially under development by ALZA and Crescendo, Crescendo pays a technology fee to ALZA, payable monthly over a period of three years, in the amount of $1.0 million per month for the 12 months following the distribution of Crescendo Shares, $667,000 per month for the following 12 months and $333,000 per month for the following 12 months. The technology fee will no longer be payable at such time as fewer than two of the seven initial products under development by ALZA and Crescendo are being developed by Crescendo and/or have been licensed by ALZA pursuant to the option, granted to it by Crescendo, to license any or all Crescendo products. ALZA recorded technology fee revenue from Crescendo of $4.0 million for 1997. Five of the seven initial products were in development at January 31, 1998. ALZA has an option to acquire an exclusive, royalty-bearing license to each product developed by Crescendo under the Development Agreement. The option is exercisable on a product-by- product, country-by-country, basis. In addition, under Crescendo's Restated Certificate of Incorporation, ALZA has the right to purchase all (but not less than all) of the Crescendo Shares at a price based upon a pre-established formula (the "Purchase Option"). The Purchase Option price will be determined as the greater of the following: (a)(i) 25 times the actual payments made by or due from ALZA to Crescendo under the Development Agreement and the License Agreement with respect to any product (and, in addition, such payments as would have been made by or due from ALZA to Crescendo if ALZA had not previously exercised its payment buy-out option with respect to any such payments) for the four calendar quarters immediately preceding the quarter in which the Purchase Option is exercised (provided, however, that for any product which has not been commercially sold during each of such four calendar quarters, the portion of the exercise price for such product will be 100 times the average of the quarterly payments made by or due from ALZA to Crescendo for each of such calendar quarters during which such product was commercially sold) less (ii) any amounts previously paid to exercise any payment buy-out option; (b) the fair market value of one million shares of ALZA Common Stock; (c) $325 million less all amounts paid by or due from Crescendo under the Development Agreement to the date the Purchase Option is exercised; and (d) $100 million. In each case, the amount payable as the Purchase Option exercise price will be reduced to the extent, if any, that Crescendo's liabilities at the time of exercise (other than liabilities under the Development Agreement, the Technology License Agreement and the Services Agreement) exceed Crescendo's cash and cash equivalents and short-term and long-term investments (excluding the amount of Available Funds remaining at such time). ALZA may pay the exercise price in cash, in ALZA Common Stock or in any combination of cash and ALZA Common Stock. The Purchase Option structure is intended to eliminate any possibility of a bargain purchase by ALZA. The first price option is intended to provide a fair value buy-out option price since Crescendo's principal source of future earnings will be product payments and royalties. The remaining three price options are intended to be minimum amounts to avoid the possibility of a bargain purchase. Development and Option Agreements In September 1997, ALZA entered into a clinical development and option agreement with Alkermes, Inc. ("Alkermes") relating to Cereport-trademark-, a compound intended to facilitate the delivery of chemotherapeutic agents to the brain. Under the terms of the agreement, ALZA paid Alkermes $10.0 million. As the product was not approved for development and has no alternative future use, the payment was charged to acquisition of in-process research and development. Under the agreement, Alkermes is conducting additional clinical activities related to Cereport- trademark-, and ALZA has the option to acquire exclusive worldwide commercialization rights to the product. ALZA entered into two agreements with Janssen, effective December 31, 1997, modifying the previous arrangements between the parties relating to two E-TRANS-trademark- fentanyl products. Under a development and commercialization agreement, ALZA and Janssen modified the agreement pursuant to which the companies were jointly developing an E-TRANS-trademark- fentanyl product for the treatment of acute pain. In connection with this modified agreement, ALZA made a one-time payment of $21.5 million to Janssen. As the product was not approved for development and has no alternative future use, the payment was charged to acquisition of in-process research and development. ALZA will receive a share of the U.S. operating profits from the product and royalties from sales of the product outside the United States. The product is currently in Phase III clinical trials. Under the second agreement, ALZA will continue the development of an E-TRANS-trademark- fentanyl product for the treatment of chronic pain. Janssen will have an option, exercisable until 90 days after ALZA has spent $30 million on the product, to take over funding the continued development of the product and to commercialize the product worldwide. If Janssen exercises its option, ALZA will receive a share of the U.S. operating profits from the product and royalties from sales of the product outside the United States. If Janssen does not exercise its option, ALZA may continue the development of the product, which is currently under development with Crescendo, and which ALZA did not have the right to develop independent of Janssen prior to the modification of the arrangements. Prior to the modifications described above, the agreement with Janssen for E-TRANS-trademark- fentanyl was a typical client arrangement under which Janssen paid all development costs of the acute pain product, and ALZA would receive a royalty based on sales of the product, if it were successfully developed. Research and Development Revenues (Dollars in millions) 1997 1996 1995 _________________________________________________________________ TDC $ 67.8 $ 100.7 $ 70.1 Crescendo 29.7 - - Other clients 37.5 30.5 33.9 _________________________________________________________________ Total research and development revenues $ 135.0 $ 131.2 $ 104.0 ================================================================= Percentage of total revenues 29% 32% 32% _________________________________________________________________ The increase in research and development revenues in 1997 compared to 1996, and in 1996 compared with 1995, was due to product development activities undertaken on behalf of client companies, including TDC and Crescendo. In the third quarter of 1997, TDC ceased funding products under development. Crescendo commenced operations in the third quarter of 1997, and began funding certain of the products previously under development by ALZA and TDC. The 1996 research and development revenues included charges related to a credit from ALZA to TDC and a write- off of potentially uncollectible receivables totaling $2.1 million. Research and development revenues from other clients increased 23% in 1997 compared to 1996, reflecting an increase in product development activities under ALZA's agreements with these companies. ALZA's research and development revenues generally represent client reimbursement of costs, including a portion of general and administrative expenses. Therefore, product development activities do not contribute significantly to operating results. Research and Development Expenses (Dollars in millions) 1997 1996 1995 _________________________________________________________________ Research and development expenses $ 156.8 $ 141.6 $ 103.4 As a percentage of total revenues 34% 34% 32% _________________________________________________________________ The increase in research and development expenses in 1997 compared to 1996 reflects the increased activity for client companies, including TDC and Crescendo. Research and development expenses in 1997 include $1.4 million in costs related to workforce reductions. Research and development expenses increased in 1996 compared to 1995 as a result of increased activity for TDC. (Presented graphically in paper format annual report) RESEARCH AND DEVELOPMENT EXPENSES (In millions of dollars) 1997 1996 1995 1994 1993 _________________________________________________________________ Research and Development Expenses 157 142 103 76 53 SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (Dollars in millions) 1997 1996 1995 _________________________________________________________________ Sales and marketing expenses $28.8 $24.2 $ 23.8 General and administrative expenses 19.0 20.7 17.3 Amortization of product acquisition payments 4.0 2.2 - _________________________________________________________________ Total selling, general and administrative expenses $51.8 $47.1 $ 41.1 ================================================================= As a percentage of total revenues 11% 11% 13% _________________________________________________________________ Selling, general and administrative expenses increased 10% in 1997 compared with 1996 as a result of increased sales and marketing expenses, and amortization of product acquisition payments primarily related to products acquired in 1997. Higher sales and marketing expenses in 1997 compared with 1996 resulted from the expansion of ALZA's sales force and increased marketing costs in support of Ethyol-registered trademark-, Mycelex- registered trademark- Troche and Elmiron-registered trademark-. General and administrative expenses declined 8% in 1997 compared to 1996. While corporate administrative costs increased 7% in 1997 compared with 1996, including $0.4 million in costs related to workforce reductions, this increase was offset by an increase in the cash surrender value of life insurance policies. Selling, general and administrative expenses increased 15% in 1996 compared to 1995 due primarily to sales and marketing expenses related to the launch of Ethyol-registered trademark-, the amortization of the upfront payment to U.S. Bioscience, Inc. ("USB") for Ethyol-registered trademark-, and an increase in overall general and administrative expenses in support of increased corporate activities. Included in 1995 selling, general and administrative expenses was $6.7 million for a portion of the initial payment by ALZA to USB under the marketing and distribution agreement for Ethyol-registered trademark. Excluding this charge, selling, general and administrative expenses increased 36% in 1996 compared with 1995. ASSET WRITE-DOWN In 1997, ALZA wrote down approximately $11.5 million of fixed assets, $3.7 million of which related to excess manufacturing equipment. Lower than expected production requirements under a supply agreement with G.D. Searle & Co. for Covera-HS-trademark- (verapamil) contributed to the excess capacity of manufacturing equipment. Such equipment was written down to its fair market value, which was determined based upon estimates of current market prices. ALZA has not yet determined the ultimate disposition of these assets. The remaining $7.8 million of the write-down is related primarily to custom-designed manufacturing and research and development equipment that was determined to have limited or no future use based upon changes in production volumes or product formulations. ALZA intends to use this equipment to the extent possible or return or otherwise dispose of equipment with no alternative future use. NET INTEREST (In millions) 1997 1996 1995 _________________________________________________________________ Interest and other income $ (55.6) $ (52.9) $ (26.0) Distribution to debenture holders 8.0 - - Interest expense 55.0 43.0 23.9 _________________________________________________________________ Net interest and other expense (income) $ 7.4 $ (9.9) $ (2.1) _________________________________________________________________ Interest and other income increased 5% in 1997 compared to 1996, primarily due to higher average invested cash balances during 1997 following ALZA's issuance of $500.0 million of 5% convertible subordinated debentures due 2006 (the "5% Debentures") in April 1996. Partially offsetting the higher interest income were lower realized gains on the sales of investments in 1997 compared with 1996. The increase in interest and other income in 1996 compared to 1995 was primarily due to higher average invested cash balances following the issuance of the 5% Debentures. Also contributing to the increase in interest and other income in 1996 were net realized gains of $8.4 million on sales of investments in 1996, compared with $1.0 million of such gains in 1995. Interest expense increased 28% in 1997 compared to 1996, as the 5% Debentures were outstanding for all of 1997. Also contributing to the increase were lower amounts of capitalized interest on construction projects and higher interest on the 5 1/4% zero coupon convertible subordinated debentures due 2014 (the "5 1/4% Debentures"). The 1997 distribution to debenture holders is related to the Crescendo transaction and discussed under "Crescendo Pharmaceuticals Corporation" above. The increase in interest expense in 1996 compared to 1995 reflects the interest expense on the 5% Debentures and higher interest on the 5 1/4 % debentures. EFFECTIVE TAX RATE In 1997, ALZA recorded income tax expense of $49.7 million despite ALZA's pretax loss, as certain charges recognized in 1997 are generally not deductible for income tax purposes. Excluding such items, ALZA's 1997 effective income tax rate was 35% compared to 38% in 1996 and 1995. The rate declined in 1997 from prior years primarily due to increased investment and research tax credits in 1997. LIQUIDITY AND CAPITAL RESOURCES (In millions) 1997 1996 1995 _________________________________________________________________ Working capital $ 253.4 $ 494.8 $ 273.2 Cash and investments 535.8 999.8 419.1 Total assets 1,369.2 1,613.7 937.2 Long-term debt 902.6 882.3 362.9 Net cash provided by (used in) operating activities (185.9) 123.3 111.4 Capital expenditures 38.8 48.6 46.3 Product acquisition payments 140.1 - 13.3 _________________________________________________________________ During 1997, ALZA paid $100.0 million in cash for the purchase of all of the shares of TDC, and contributed $300.0 million in cash to Crescendo. Also in 1997, ALZA paid Bayer a $50.0 million upfront fee for the United States rights to Mycelex- registered trademark- Troche, made a $10.0 million payment to USB related to Ethyol-registered trademark- and made an upfront payment of $75.0 million to IVAX for the United States and Canadian rights to Elmiron-registered trademark- and three additional urology products. ALZA also paid $10.0 million to Alkermes under the agreement related to Cereport-trademark-. Cash provided by operating activities in 1997 excluding the items discussed above was $149.8 million. During 1997, ALZA also made a $36.2 million investment in a real estate joint venture, described below. Cash for these transactions was provided from the sales and maturities of short- and long-term investments, as well as from cash and cash equivalents. (Presented graphically in paper format annual report) NET CASH PROVIDED BY OPERATING ACTIVITIES (In millions of dollars) 1997 1996 1995 1994 1993 _________________________________________________________________ Net Cash Provided by (Used in)Operating activities (186) 123 111 74 76 In late 1997, ALZA acquired a 50% interest in a real estate joint venture for the development of a 13-acre parcel of land in Mountain View, California. ALZA invested $36.2 million in the joint venture, which will be applied to the construction of buildings on the parcel. ALZA is also obligated to make improvements to the buildings, the total cost of which is estimated to be between $60.0 million and $100.0 million. The improvements are currently expected to be completed during the fourth quarter of 1999. The joint venture will lease the buildings to ALZA upon completion of construction, currently scheduled for 1999. The leases provide for an initial term of 15 years with scheduled annual rent increases, followed by two 10- year extension periods with rent increases based upon the Consumer Price Index. ALZA will receive 50% of the joint venture's income. ALZA has also entered into a ground lease agreement for an adjacent seven-acre parcel of land on which it plans to construct a pilot plant, laboratories and other technical facilities. The term of the ground lease is approximately 33 years and includes options for ALZA to purchase, or to be required to purchase, the property. ALZA's capital spending for 1997 was $38.8 million for additions to property, plant and equipment to support its expanding research, development and manufacturing activities, compared to capital spending of $48.6 million in 1996 and $46.3 million in 1995. While ALZA believes its current facilities and equipment are sufficient to meet its current operating requirements, ALZA is expanding its facilities and equipment to support its medium-term and long-term requirements. Capital expenditures in 1998 are currently expected to increase over 1997 levels due primarily to expenditures related to improvements to the buildings discussed above. ALZA believes that its existing cash and investment balances are adequate to fund its cash needs for 1998 and beyond. In addition, should the need arise, ALZA believes it would be able to borrow additional funds or otherwise raise additional capital. ALZA may consider using its capital to make strategic investments or to acquire or license technology or products. ALZA may also enter into strategic alliances with third parties that could provide access to additional capital. OUTLOOK Notice Concerning Forward-Looking Statements The following is intended to provide an outlook for 1998 and beyond. To the extent any statements made in this Annual Report to Stockholders, including this section, deal with information that is not historical, these statements are forward-looking. Such statements include, without limitation, plans concerning the commercialization of products, statements concerning potential product sales, future costs of products shipped (and gross margins), associated sales and marketing expenses, plans concerning development of products and other statements that are not historical facts. The occurrence of the events described, and the achievement of the intended results, are subject to various risk factors that could cause ALZA's actual results to be materially different from those presented in this outlook, some or all of which are not predictable or within ALZA's control. Many risks and uncertainties are inherent in the pharmaceutical industry; others are more specific to ALZA's business. Many of the significant risks related to ALZA's business are described in ALZA's Annual Report on Form 10-K and discussed below. ROYALTIES, FEES AND OTHER REVENUES ALZA expects royalties, fees and other revenues to continue to increase in 1998 as a result of growth in sales of products currently marketed by client companies and, to a lesser extent, products which are awaiting approval by regulatory authorities outside of the United States. Sales of Procardia XL-registered trademark-, and therefore ALZA's royalties from this product, are expected to continue to decline in 1998. Royalties, fees and other revenues, which are derived largely from sales by client companies of products developed jointly with ALZA, vary from quarter to quarter as a result of changing levels of product sales by client companies and, occasionally, the receipt by ALZA of certain one-time fees. Because ALZA's clients generally take responsibility for obtaining necessary regulatory approvals and make all marketing and commercialization decisions regarding such products, most of the variables that affect ALZA's royalties, fees and other revenues are not directly within ALZA's control. Sales of products from which ALZA derives royalties and fees are affected by the clients' marketing efforts and the introduction and marketing of competing products, among other factors. Fees are one-time in nature and will vary year to year and quarter to quarter. Royalties and fees for 1998 are expected to include $10.7 million in technology fees from Crescendo and may include upfront fees from third parties in connection with arrangements for the commercialization of Crescendo products. During the next several years, ALZA intends to continue reducing its dependence on royalties and fees by further expanding ALZA's sales and marketing activities and by directly marketing and selling more products, including products developed with Crescendo. However, there can be no assurance that ALZA will be successful in undertaking this expansion, or that any expanded sales and marketing activities will be successful, due to factors such as the risks associated with developing, clinically testing and obtaining regulatory clearance of products for ALZA marketing, the difficulties and costs associated with acquiring from third parties products for ALZA to market, the length of the regulatory approval process, the uncertainties surrounding the acceptance of new products by the intended markets, the marketing of competitive products, risks relating to patents and proprietary rights and the current health care cost containment environment. ALZA expects that, in the near term, royalties on sales by clients of currently marketed products will continue to be a substantial contributor to net income. NET SALES Net sales of ALZA-marketed products are expected to increase significantly in 1998, as the products acquired in 1997 contribute a full year of sales. Wholesaler stocking patterns, managed care and formulary acceptance, the introduction of competitive products, and acceptance by patients and physicians will affect future sales of these products. ALZA expects that 1998 contract manufacturing revenues will remain approximately at 1997 levels. Because many factors affecting contract manufacturing activities are not within ALZA's control, revenues will fluctuate from period to period depending on the volume, mix and timing of orders received from client companies. ALZA also expects that gross margins, as a percentage of net sales, will continue to increase over the longer term, although quarter-to-quarter fluctuations will continue to occur. Higher gross margins may be achieved through continuing the proportionate increase in the sales of ALZA-marketed products (as compared with sales from contract manufacturing), increased utilization of capacity and greater operating efficiencies. RESEARCH AND DEVELOPMENT Crescendo Pharmaceuticals Corporation ALZA expects that Crescendo will expend its available funds over the next three to four years. The rate of expenditure by Crescendo will depend upon the continued development of products currently under development by ALZA and Crescendo, and new products proposed by ALZA and accepted by Crescendo for development. Pharmaceutical Company Clients To maintain or increase 1997 product development revenue levels, ALZA will need to enter into new arrangements with client companies to replace revenues lost when programs terminate or products are submitted for regulatory clearance or cleared for marketing. Development agreements with client companies are generally terminable by the clients on short notice and may be terminated for many reasons, including technical issues, marketing concerns, reallocation of client resources, and changes in client priorities. In addition, revenues from any particular client program could decrease dramatically once the New Drug Application for the product has been filed, and could decrease earlier if the client, rather than ALZA, were to undertake the clinical development of a product. ALZA Technology Institute In 1998, ALZA expects to continue its current level of internal technology research in order to continue strengthening ALZA's leadership in the drug delivery field. These activities consist largely of extending and improving existing drug delivery technologies, and conducting research and development of new technologies, as well as some early stage product development activities. SELLING, GENERAL AND ADMINISTRATIVE EXPENSES Sales and marketing expenses are expected to continue to increase in 1998 primarily due to growth in marketing efforts resulting from the acquisition of new products and the introduction of products developed by ALZA. The increase in the size of ALZA's sales force in late 1997 will increase sales and marketing expenses in 1998 compared with 1997. In December 1997, ALZA received clearance from the FDA to market Testoderm- registered trademark- TTS (testosterone transdermal system) CIII for men with testosterone deficiency. Sales and marketing efforts will expand as Testoderm-registered trademark- TTS is introduced in March 1998. Sales and marketing expenses are also expected to increase in anticipation of the launch of Ditropan- registered trademark- XL-trademark-, which may occur in early 1999, and as ALZA increases its activities for recently acquired products. Selling, general and administrative expenses in 1998 will include amortization of product acquisition fees relating to products acquired in prior years. INTEREST AND OTHER INCOME Interest and other income is expected to be lower in 1998 as a result of the significant reduction of cash and investment balances in 1997. INCOME TAX RATE ALZA currently expects its combined federal and state 1998 effective income tax rate to be approximately 35%. The actual effective income tax rate will depend upon the level of actual earnings, changes in the tax laws, and the amount of investment and research credits available and ALZA's ability to utilize such credits. YEAR 2000 The majority of ALZA's significant operating and accounting systems are year 2000 compliant. The systems that are not currently year 2000 compliant are in the process of being upgraded or replaced. ALZA does not have a comprehensive program for monitoring whether its suppliers' and vendors' systems are year 2000 compliant. However, for material new agreements, ALZA requests assurances of year 2000 compliance. ALZA does not expect its financial condition or results of operations to be materially adversely affected by its year 2000 issues. ALZA TTS RESEARCH PARTNERS, LTD. ALZA developed the Duragesic-registered trademark- and Testoderm-registered trademark- products on behalf of the ALZA TTS Research Partners, Ltd. (the "TTS Partnership"), a limited partnership from which ALZA licensed the products. The TTS Partnership receives payments from ALZA equal to 4% of Janssen's net sales of Duragesic-registered trademark- and 4% of ALZA's sales of Testoderm-registered trademark-. ALZA's license from the TTS Partnership for Testoderm- registered trademark- will become nonexclusive on July 26, 1998; ALZA's license for Duragesic-registered trademark- will become nonexclusive on December 4, 1998. Once ALZA's licenses become nonexclusive, the TTS Partnership will need to determine whether to grant nonexclusive licenses to third parties. Under ALZA's distribution agreement with Janssen for the Duragesic-registered trademark- product, if ALZA's license from the TTS Partnership becomes nonexclusive, if the TTS Partnership licenses the product to a third party and if the third party introduces the product, Janssen's royalty payable to ALZA will drop significantly; however, ALZA will continue to owe the TTS Partnership 4% of Janssen's net sales. ALZA has an option to purchase all of the interests in the TTS Partnership for $120 million in cash less amounts paid by ALZA to the TTS Partnership under its licenses prior to the date the option is exercised. As of December 31, 1997, ALZA had paid the Partnership $27.3 million under these licenses. Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK This Item is not applicable to ALZA for this reporting period. Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA ALZA Corporation CONSOLIDATED STATEMENT OF OPERATIONS Years ended December 31, (In millions, except per share amounts) 1997 1996 1995 _________________________________________________________________ REVENUES Royalties, fees and other $ 183.3 $ 173.3 $ 143.7 Net sales 146.1 108.6 76.9 Research and development, including amounts from TDC, a related party (1997-$67.8,1996-$100.7, 1995-$70.1) and Crescendo, a related party (1997-$29.7) 135.0 131.2 104.0 _________________________________________________________________ Total revenues 464.4 413.1 324.6 COSTS AND EXPENSES Costs of products shipped 92.8 85.2 65.4 Research and development 156.8 141.6 103.4 Selling, general and administrative 51.8 47.1 41.1 Acquisitions of in-process research and development 108.5 - - Contribution to Crescendo, a related party 247.0 - - Asset write-down 11.5 - - _________________________________________________________________ Total costs and expenses 668.4 273.9 209.9 _________________________________________________________________ Operating income (loss) (204.0) 139.2 114.7 Interest expense 55.0 43.0 23.9 Distribution to debenture holders 8.0 - - Interest and other income (55.6) (52.9) (26.0) _________________________________________________________________ Net interest and other expense (income) 7.4 (9.9) (2.1) _________________________________________________________________ Income (loss) before income taxes (211.4) 149.1 116.8 Provision for income taxes 49.7 56.7 44.4 _________________________________________________________________ Net income (loss) $(261.1) $ 92.4 $ 72.4 ================================================================= Earnings (loss) per share Basic $ (3.07) $ 1.10 $ 0.88 ================================================================= Diluted $ (3.07) $ 1.08 $ 0.88 ================================================================= See accompanying notes. ALZA Corporation CONSOLIDATED BALANCE SHEET December 31, (In millions, except per share amounts) 1997 1996 _________________________________________________________________ ASSETS CURRENT ASSETS Cash and cash equivalents $ 65.0 $187.7 Short-term investments 109.2 199.3 Receivables, net of allowance for doubtful accounts(1997-$0.8; 1996-$0.6) 119.2 116.6 Inventories 37.8 39.2 Prepaid expenses and other current assets 26.8 19.2 _________________________________________________________________ Total current assets 358.0 562.0 PROPERTY, PLANT AND EQUIPMENT Buildings and leasehold improvements 209.6 228.7 Equipment 145.0 144.2 Construction in progress 22.9 18.1 Land and prepaid land leases 24.3 17.1 _________________________________________________________________ 401.8 408.1 Less accumulated depreciation and amortization (91.4) (100.3) _________________________________________________________________ Net property, plant and equipment 310.4 307.8 Investments in long-term securities 361.6 612.8 Deferred product acquisition payments 147.2 11.1 Other assets 192.0 120.0 _________________________________________________________________ TOTAL ASSETS $1,369.2 $1,613.7 ================================================================= LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES Accounts payable $ 56.9 $ 28.7 Accrued liabilities 45.9 37.6 Current portion of long-term debt 1.8 0.9 _________________________________________________________________ Total current liabilities 104.6 67.2 5% convertible subordinated debentures 500.0 500.0 5 1/4% zero coupon convertible subordinated debentures 402.6 382.3 Other long-term liabilities 60.8 67.5 Commitments and contingencies STOCKHOLDERS' EQUITY Common stock, $.01 par value,300.0 shares authorized; 85.5 and 84.6 shares issued and outstanding at December 31, 1997 and 1996, respectively 0.9 0.8 Additional paid-in capital 381.5 362.2 Unrealized losses on available-for-sale securities, net of tax effect (4.8) (0.1) Retained earnings (deficit) (76.4) 233.8 _________________________________________________________________ Total stockholders' equity 301.2 596.7 _________________________________________________________________ TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 1,369.2 $ 1,613.7 ================================================================= See accompanying notes. ALZA Corporation CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY Years ended December 31, 1997, 1996 and 1995 (In millions) GAINS (UNREALIZED LOSSES) TOTAL ADDITIONALON AVAILABLE- RETAINED STOCK- COMMON PAID-IN FOR-SALE EARNINGS HOLDERS' STOCK CAPITAL SECURITIES (DEFICIT) EQUITY ___________________________________________________________________________ Balance, December 31, 1994 $ 0.8 $302.2 $ (7.5) $ 69.0 $ 364.5 Common stock issued - 8.3 - - 8.3 Unrealized gains on available-for-sale securities, net of tax effect - - 9.4 - 9.4 Net income - - - 72.4 72.4 ________________________________________________________________________ Balance, December 31, 1995 0.8 310.5 1.9 141.4 454.6 Common stock issued - 51.7 - - 51.7 Unrealized losses on available-for-sale securities, net of tax effect - - (2.0) - (2.0) Net income - - - 92.4 92.4 ________________________________________________________________________ Balance, December 31, 1996 0.8 362.2 (0.1) 233.8 596.7 Common stock issued 0.1 19.3 - - 19.4 Distribution of Crescendo Shares - - - (49.1) (49.1) Unrealized losses on available-for-sale sec- urities, net of tax effect - - (4.7) - (4.7) Net loss - - - (261.1) (261.1) ________________________________________________________________________ Balance, December 31, 1997 $ 0.9 $381.5 $ (4.8) $(76.4) $301.2 ======================================================================== See accompanying notes. ALZA Corporation CONSOLIDATED STATEMENT OF CASH FLOWS (In millions) Years ended December 31, 1997 1996 1995 __________________________________________________________________ CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss) $(261.1) $92.4 $72.4 Non-cash adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation and amortization 29.3 19.8 15.3 Amortization of product acquisition payments 4.0 2.2 - Interest on 5 1/4% zero coupon convertible subordinated debentures 20.3 19.3 18.4 Decrease (increase) in assets: Receivables (2.6) (8.6) (23.1) Inventories 1.5 (4.7) (1.1) Prepaid expenses and other current assets (4.4) (1.2) 6.2 Increase (decrease) in liabilities: Accounts payable 28.1 8.7 - Accrued liabilities 8.7 7.8 10.6 Deferred revenue (0.4) (17.2) 1.3 Other long-term liabilities (20.8) 4.8 11.4 Asset write-down 11.5 - - __________________________________________________________________ Total adjustments 75.2 30.9 39.0 __________________________________________________________________ Net cash provided by (used in) operating activities (185.9) 123.3 111.4 CASH FLOWS FROM INVESTING ACTIVITIES: Product acquisition payments (140.1) - (13.3) Capital expenditures (38.8) (48.6) (46.3) Investment in real estate joint venture (36.2) - - Purchase of TDC deferred tax asset (23.0) - - Purchases of available-for-sale securities (370.8) (1,125.2) (205.2) Sales of available-for-sale securities 680.9 542.6 134.1 Maturities of available-for-sale securities 23.3 98.1 12.0 Increase in cash surrender value-life insurance and prepaid premiums (12.8) (20.3) (4.1) Decrease (increase) in other assets 12.4 (9.6) 3.1 __________________________________________________________________ Net cash provided by (used in) investing activities 94.9 (563.0) (119.7) CASH FLOWS FROM FINANCING ACTIVITIES: Distribution of Crescendo Pharmaceuticals Corporation shares to ALZA stockholders (49.1) - - Net proceeds from 5% convertible subordinated debentures - 488.8 - Issuances of common stock 19.4 51.7 8.3 Principal payments on long-term debt (2.0) (1.1) (0.8) __________________________________________________________________ Net cash provided by (used in) financing activities (31.7) 539.4 7.5 __________________________________________________________________ Net increase (decrease) in cash and cash equivalents (122.7) 99.7 (0.8) Cash and cash equivalents at the beginning of year 187.7 88.0 88.8 __________________________________________________________________ Cash and cash equivalents at the end of year $ 65.0 $187.7 $88.0 ================================================================== See accompanying notes. ALZA Corporation NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NOTE 1. BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES ALZA Corporation is an emerging pharmaceutical company with leading drug delivery technologies. ALZA applies its delivery technologies to develop pharmaceutical products with enhanced therapeutic value for its own portfolio and for many of the world's leading pharmaceutical companies. ALZA is currently focusing its sales and marketing efforts in urology and oncology. Nature of Operations Royalties, fees and other revenues include royalty revenue and other payments based on sales by ALZA's client companies of products developed under joint development and commercialization agreements, and certain one-time or infrequent fees or similar payments under such agreements. Included in royalties, fees and other revenues are revenues from ALZA's promotion and copromotion of certain products, some of which are contingent on sales. Royalties, fees and other revenues are recognized as earned. ALZA recognizes upfront fee revenues on or after the effective date of the licensing, copromotion or other agreement, when there are no contingencies or conditions to ALZA's receipt of the payments. ALZA recognizes milestone fee revenues when all of the conditions to payment have been met and there are no further contingencies or conditions to ALZA's receipt of payment. Such fees, when recognized, are not refundable, and do not require any future performance by ALZA in order to retain them. Net sales includes sales of products marketed directly by ALZA and through distributors, and sales generated from contract manufacturing activities for ALZA's client companies. ALZA recognizes sales revenues at the time of product shipment, net of discounts, rebates and allowances. Export sales, principally to distributors and client companies in Europe, were $31.5 million, $23.0 million and $20.1 million in 1997, 1996 and 1995, respectively. Revenues from research and development activities with client companies, including Crescendo, are reported as research and development revenues, and are recognized as earned. ALZA's research and development revenues represent clients' reimbursement to ALZA of costs incurred in product development and clinical evaluation, including a portion of general and administrative expenses, and therefore do not contribute significantly to operating results. Research and development revenues are recognized when billable in accordance with the terms prescribed in each respective client development agreement (billed based upon labor and other costs incurred during the period). Such revenues are not refundable. ALZA's policy is to expense all costs of research and product development related both to costs incurred on its own behalf and on behalf of its clients. Credit and Investment Risks Royalties, fees and other revenues and research and development revenues are derived from agreements with major pharmaceutical company clients and Crescendo, all of which have significant cash resources. Therefore, ALZA considers its credit risk related to these transactions to be minimal. ALZA's net sales result from sales of ALZA-marketed products primarily to major pharmaceutical distributors, and sales from contract manufacturing for ALZA's client companies. If the financial condition or operations of any of the pharmaceutical distributors were to deteriorate substantially, ALZA's operating results could be adversely affected. ALZA generally invests excess cash in securities of banks and companies from a variety of industries with strong credit ratings, and in U.S. government obligations. These securities typically bear minimal risk and ALZA has not experienced any losses on its investments due to institutional failure or bankruptcy. ALZA's investment policy is designed to limit exposure with any one institution. Pfizer accounted for 17% of ALZA's total revenues in 1997, 22% in 1996 and 26% in 1995. TDC accounted for 15% of ALZA's total revenues in 1997, 24% in 1996 and 22% in 1995. Janssen accounted for 15% of ALZA's total revenues in 1997, 14% in 1996 and 13% in 1995. HMRI accounted for 10% of ALZA's total revenues in 1997 and 11% in both 1996 and 1995. Principles of Consolidation The consolidated financial statements include the accounts of ALZA and its wholly-owned subsidiaries, ALZA Development Corporation, ALZA International, Inc., ALZA Land Management, Inc., ALZA Limited and, since its acquisition in September 1997, TDC. All significant intercompany accounts and transactions have been eliminated. Use of Estimates The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Restatements In 1997, ALZA changed the presentation of its consolidated statement of operations and consolidated balance sheet. In the consolidated statement of operations, royalties, fees and other revenue now include items related to operations that were previously reflected in interest and other income. Interest expense and income are now shown separately after operating income (loss). On the consolidated balance sheet, ALZA has reclassified securities which have maturities of one year or more as investments in long-term securities; these securities were previously treated as current assets. Prior year amounts have been changed to conform with the current year presentation. Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents include cash balances and investments with maturities of three months or less at the time of purchase. Short-term investments include commercial paper and other highly liquid investments with maturities less than one year. The carrying amount reported on the balance sheet for cash, cash equivalents and short-term investments approximates their fair value. Inventories Raw materials, work in-process and finished goods inventories are stated at the lower of standard cost (which approximates actual costs on a first-in, first-out cost method) or market value. Inventories consist of the following (in millions): 1997 1996 _________________________________________________________________ Raw materials $ 16.5 $17.7 Work in-process 8.5 18.0 Finished goods 12.8 3.5 _________________________________________________________________ Total inventories $ 37.8 $39.2 ================================================================= Property, Plant and Equipment Property, plant and equipment are stated at cost, including interest capitalized of $0.7 million in 1997, $2.2 million in 1996 and $1.3 million in 1995. Maintenance and repairs are expensed as incurred. Depreciation and amortization are generally computed on the straight-line method, over estimated useful lives, as follows: Classification Estimated Useful Life _________________________________________________________________ Buildings 30 to 40 years Leasehold improvements Terms of the leases (1 to 5 years) Equipment 3 to 9 years Prepaid land leases Remaining terms of the leases (17 to 60 years) Depreciation and amortization expense for property, plant and equipment was $24.7 million, $17.8 million and $14.8 million for 1997, 1996 and 1995, respectively. Prepaid land leases represent ALZA's total cost, paid in advance, of leasehold rights to land upon which certain of ALZA's buildings in Palo Alto, California are situated. Included in construction in progress are payments made in connection with facilities being constructed or modified, and the installation of related equipment in Palo Alto and Mountain View, California (primarily research and development) and Vacaville, California (primarily commercial manufacturing). ALZA routinely evaluates the carrying value of its long- lived assets. ALZA records impairment losses on long-lived assets used in operations when events and circumstances indicate that assets may be impaired and the undiscounted cash flows estimated to be generated by the assets are less than the carrying amount of those assets. In 1997, ALZA wrote down approximately $11.5 million of fixed assets, $3.7 million of which related to excess manufacturing equipment. Lower than expected production requirements under a supply agreement with G.D. Searle & Co. for Covera-HS-trademark- (verapamil) contributed to the excess capacity of manufacturing equipment. Such equipment was written down to its fair market value, which was determined based upon estimates of current market prices. ALZA has not yet determined the ultimate disposition of these assets. The remaining $7.8 million of the write-down is related primarily to custom-designed manufacturing and research and development equipment that was determined to have limited or no future use based upon changes in production volumes or product formulations. ALZA intends to use this equipment to the extent possible or return or otherwise dispose of equipment with no alternative future use. Deferred Product Acquisition Costs and Acquisition of In-process Research and Development Initial payments and distribution fees for the acquisition of products that, at the time of acquisition by ALZA, are already marketed or are approved by the FDA for marketing (or such approval is imminent) are capitalized and amortized over the estimated life cycle of the products, which range from 10 to 20 years. At the time of acquisition, the product life cycle is estimated by ALZA based upon the term of the agreement, the patent life of the product and, for products that are no longer covered by patents, the product's historical profitability trend since it has been off-patent and management's assessment of future sales and profitability of the product. This estimate is assessed regularly during the amortization period and the asset value is reduced when appropriate. Accumulated amortization of these costs was $6.2 million and $2.2 million at December 31, 1997 and 1996, respectively. Payments for rights to products acquired by ALZA when they are in development and not yet approved by the FDA (and which have no alternative future use) are recognized as charges to acquisitions of in-process research and development. Charges to in-process research and development were $108.5 million in 1997. Accrued Liabilities Accrued liabilities are as follows(in millions): 1997 1996 _________________________________________________________________ Accrued compensation $ 17.7 $15.4 Accrued income taxes 9.7 7.3 Other accrued liabilities 18.5 14.9 _________________________________________________________________ Total accrued liabilities $ 45.9 $37.6 ================================================================= Advertising Costs Advertising costs are accounted for as expenses in the period in which they are incurred. Advertising expense for 1997, 1996 and 1995 was $6.4 million, $4.4 million and $3.3 million, respectively. Supplemental Disclosures of Cash Flow Information (in millions) Cash paid during the year for: 1997 1996 1995 _________________________________________________________________ Income taxes $ 59.5 $ 42.2 $ 37.0 Interest, net of amount capitalized 36.6 16.3 2.6 Noncash investing and financing activities: 1997 1996 1995 _________________________________________________________________ Net unrealized gains (losses) on available-for-sale securities, net of tax effect $(4.7) $(2.0) $ 9.4 Deferred issuance costs for 5% Debentures - 11.2 - Investment in low-income housing in exchange for long term debt 17.1 11.9 - Recently Issued Accounting Pronouncements In June 1997, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards ("SFAS") No. 130, "Reporting Comprehensive Income" ("SFAS 130") and SFAS No. 131 ("SFAS 131"), "Disclosures about Segments of an Enterprise and Related Information". SFAS 130 establishes standards for reporting comprehensive income and is effective in 1998. SFAS 131 establishes standards for annual and interim disclosures of operating segments, products and services, geographic areas and major customers, and is also effective in 1998. ALZA is in the process of evaluating the disclosure requirements of the new standards, the adoption of which will have no impact on ALZA's results of operations or financial condition. Note 2. INVESTMENTS ALZA has classified its entire investment portfolio, including cash equivalents of $64.1 million and $185.2 million at December 31, 1997 and 1996, respectively, as available-for-sale. Investments in the available-for-sale category are generally carried at fair value with unrealized gains and losses recorded as a separate component of stockholders' equity. At December 31, 1997, net unrealized losses on available-for-sale securities were $4.8 million, net of $3.4 million tax effect. At December 31, 1996, net unrealized losses on available-for-sale securities were $0.1 million, net of $0.1 million tax effect. The cost of securities when sold is based upon specific identification. Realized gains and losses for the year ended December 31, 1997 were $7.6 million and $1.5 million, respectively. Realized gains and losses for the year ended December 31, 1996 were $9.1 million and $0.7 million, respectively. The following is a summary of ALZA's investment portfolio: (in millions) December 31, 1997 __________________________________________________________________ Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value __________________________________________________________________ U.S. Treasury securities and obligations of U.S. government agencies $ 143.2 $ 0.4 $ (0.3) $ 143.3 Collateralized mortgage obligations and asset backed securities 70.9 0.3 (0.2) 71.0 Corporate securities (primarily corporate notes and commercial paper) 329.1 2.0 (10.4) 320.7 __________________________________________________________________ Total $ 543.2 $ 2.7 $ (10.9) $ 535.0 ================================================================== December 31, 1996 __________________________________________________________________ Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value __________________________________________________________________ U.S. Treasury securities and obligations of U.S. government agencies $ 434.1 $ 1.0 $ (1.8) $ 433.3 Collateralized mortgage obligations and asset backed securities 112.8 0.3 (0.4) 112.7 Corporate securities (primarily corporate notes and commercial paper) 450.6 1.9 (1.2) 451.3 __________________________________________________________________ Total $ 997.5 $ 3.2 $ (3.4) $ 997.3 ================================================================== The amortized cost and estimated fair value of debt securities at December 31, 1997 and 1996, by contractual maturity, are shown below (in millions). Expected maturities will differ from contractual maturities because the issuers of the securities may have the right to prepay certain of the obligations without prepayment penalties. December 31, 1997 1996 __________________________________________________________________ Estimated Estimated Amortized Fair Amortized Fair Cost Value Cost Value __________________________________________________________________ Due in one year or less $173.5 $173.4 $384.5 $384.5 Due after one year through four years 235.1 235.6 428.1 427.8 Due after four years through eight years 134.6 126.0 184.9 185.0 __________________________________________________________________ Total $543.2 $535.0 $997.5 $997.3 ================================================================== In early 1997, ALZA purchased approximately 1.2 million common shares of USB (4.9% of the outstanding common shares) at a price of $18.256 per share, for an aggregate investment of $21.5 million. ALZA may not dispose of the shares for one year from the date of purchase and in accordance with SFAS 115, "Accounting for Certain Investments in Debt and Equity Securities", they are considered restricted stock and therefore recorded at cost on the balance sheet in Investment in long-term securities at December 31, 1997. Beginning in the first quarter of 1998, this stock will be classified as available for sale and recorded at fair market value. ALZA and USB are parties to a marketing and distribution agreement for Ethyol-registered trademark-, which is described in Note 4. In early 1997, ALZA purchased 2.0 million common shares of Alkermes (9.7% of the outstanding common shares) at a price of $25.00 per share, for an aggregate investment of $50.0 million. This stock is not restricted and is therefore classified as available-for-sale. In 1997, ALZA entered into a clinical development and option agreement with Alkermes for Cereport- registered trademark-, which is described in Note 4. NOTE 3. PER SHARE INFORMATION In February 1997, the Financial Accounting Standards Board issued SFAS No. 128, "Earnings per Share" ("SFAS 128"), which was adopted for the year ended December 31, 1997, with restatement of all prior periods. Under SFAS 128, basic earnings (loss) per share is calculated by dividing net income (loss) by the weighted average common shares outstanding for the period. Diluted earnings (loss) per share is calculated by dividing net income (loss) by the weighted average common shares outstanding for the period plus the dilutive effect of stock options, warrants and convertible securities. The following table sets forth the computation of ALZA's basic and diluted earnings (loss) per share (in millions, except per share amounts): 1997 1996 1995 __________________________________________________________________ NUMERATOR: Basic Net income (loss) $(261.1) $ 92.4 $ 72.4 ================================================================= Diluted Net income (loss) $(261.1) $ 92.4 $ 72.4 Interest on 5 1/4% Debentures, net of tax - 12.2 - _________________________________________________________________ Adjusted net income (loss) $(261.1) $104.6 $ 72.4 ================================================================= DENOMINATOR: Basic Weighted average shares 85.1 84.2 82.3 ================================================================== Diluted Weighted average shares 85.1 84.2 82.3 Effect of dilutive securities: Employee stock options - 0.7 0.3 5 1/4% Debentures - 12.3 - __________________________________________________________________ Weighted average shares and assumed conversions 85.1 97.2 82.6 ================================================================== Basic earnings (loss) per share $ (3.07) $ 1.10 $ 0.88 ================================================================== Diluted earnings (loss) per share $ (3.07) $ 1.08 $ 0.88 ================================================================== The potentially dilutive effect of outstanding options to purchase 6.1 million shares of ALZA's common stock and the 5 1/4% Debentures would have been anti-dilutive in 1997 and were therefore excluded from the 1997 diluted calculation. The 5% Debentures were not included in the diluted earnings per share calculation for the periods presented as their inclusion would have been anti-dilutive. NOTE 4: ACQUISITIONS OF PRODUCT RIGHTS AND DEVELOPMENT AND OPTION AGREEMENTS Product Acquisitions In late 1995, ALZA entered into a marketing and distribution agreement with USB for Ethyol-registered trademark-. Under the terms of the agreement, ALZA has exclusive rights to market the product in the United States for five years after its launch in April 1996, and is responsible for sales and marketing; the USB sales force copromotes the product with ALZA. After the five-year period, which ALZA has an option to extend for one year, marketing rights to Ethyol-registered trademark- will revert to USB, and ALZA will receive payments from USB for ten years based on continued sales of the product. ALZA paid USB an upfront payment and initial distribution fees totaling $20.0 million in 1995 and 1996. Of this amount, approximately $13.3 million was attributed by ALZA to the initial FDA approved indication (ovarian cancer) and was capitalized. Approximately $6.7 million, which was attributed by ALZA to potential expanded product indications not yet approved by the FDA, was charged to selling, general and administrative expenses. ALZA paid $10.0 million in distribution fees in 1997 based on USB clinical activities relating to Ethyol-registered trademark-, and paid an additional $5.0 million in early 1998, both of which were capitalized. In July 1997, ALZA acquired exclusive rights to Mycelex- registered trademark- Troche in the United States from Bayer. Under the terms of the agreement with Bayer, ALZA made a $50.0 million upfront payment to Bayer, which was capitalized, and will make an additional payment if net sales of the product during a certain period are above a specified level. Bayer manufactures Mycelex-registered trademark- Troche for ALZA, and receives payments from ALZA based on sales of the product. In October 1997, ALZA acquired the exclusive rights in the United States and Canada to Elmiron-registered trademark- and three additional urology products, BiCitra-registered trademark-, PolyCitra-registered trademark- and Neutra-Phos-registered trademark-, from Baker Norton Pharmaceuticals, Inc. and its parent, IVAX. Under the terms of the agreement, ALZA paid a $75.0 million upfront fee to IVAX, which was capitalized, and will pay additional fees if specified Elmiron-registered trademark- sales levels are achieved during the next five years. IVAX manufactures the products for ALZA and receives payments from ALZA based on sales of the products. In October 1997, ALZA acquired the rights in the United States to the immediate-release Ditropan-registered trademark- product and trademark from HMRI. Under the terms of the agreement, ALZA made an upfront payment to HMRI, which was capitalized, and will make additional payments if specified sales levels of Ditropan-registered trademark- are achieved. HMRI manufactures the product for ALZA for a price based upon net sales. ALZA has the right to market other products in the United States under the Ditropan-registered trademark- trademark. HMRI will receive royalty payments from ALZA if the trademark is used by ALZA with other products. Development and Option Agreements In September 1997, ALZA entered into a clinical development and option agreement with Alkermes relating to Cereport-trademark- , a compound for facilitating chemotherapy drug delivery to the brain. Under the terms of the agreement, ALZA paid Alkermes $10.0 million, which was charged to acquisition of in-process research and development. Alkermes will conduct additional clinical activities related to Cereport-trademark-, and ALZA has the option to acquire exclusive worldwide commercialization rights to the product. ALZA entered into two agreements with Janssen, effective December 31, 1997, modifying the arrangements between the parties related to two E-TRANS-trademark- fentanyl products. Under a development and commercialization agreement, ALZA and Janssen modified the agreement pursuant to which they were jointly developing an E-TRANS-trademark- fentanyl product for the treatment of acute pain. In connection with this modified agreement, ALZA made a one-time payment of $21.5 million to Janssen, which was charged to acquisition of in-process research and development. ALZA will receive a share of the U.S. operating profits from the product and royalties from sales of the product outside the United States. The product is currently in Phase III clinical trials. Under the second agreement, ALZA will continue the development of an E-TRANS-trademark- fentanyl product for the treatment of chronic pain. Janssen will have an option, until a specified time, to take over funding of the continued development of the product and to commercialize the product worldwide. If Janssen exercises its option, ALZA will receive a share of the U.S. operating profits from the product and royalties from sales of the product outside the United States. If Janssen does not exercise its option, ALZA may continue the development of this product, which is currently under development with Crescendo. For the arrangements described above, the amounts paid by ALZA were charged to acquisition of in-process research and development because the products were under development and had not been approved by the FDA, and the products had no alternative future use. NOTE 5: DEBT OBLIGATIONS AND OTHER LONG-TERM LIABILITIES In 1996, ALZA issued $500 million of 5% convertible subordinated debentures due 2006 (the "5% Debentures"). Each 5% Debenture is convertible, at the option of the holder, into shares of ALZA common stock at an initial conversion price of $38.19 per share, subject to certain anti-dilution adjustments. Interest is payable semiannually. The 5% Debentures rank pari passu with ALZA's outstanding 5 1/4% Debentures discussed below. Unamortized costs related to the issuance of the 5% Debentures were $10.0 million at December 31, 1997 and were included in other assets. At December 31, 1997 and 1996, the fair value of the 5% Debentures was $526.9 million and $490.0 million, respectively. In 1994, ALZA issued 5 1/4% zero coupon convertible subordinated debentures due 2014 (the "5 1/4% Debentures"). The 5 1/4% Debentures were issued at a price of $354.71 per $1,000 principal amount at maturity. The 5 1/4% Debentures have a principal amount at maturity of $948.8 million, with a yield to maturity of 5 1/4% per annum, computed on a semiannual bond equivalent basis. There are no periodic interest payments. At the option of the holder, each 5 1/4% Debenture is convertible into 12.987 shares of common stock. At the option of the holder, the 5 1/4% Debentures will be purchased by ALZA on July 14, 1999, July 14, 2004 or July 14, 2009, at a purchase price equal to the issue price plus accreted original issue discount to such purchase date. ALZA, at its option, may elect to deliver either common stock or cash in the event of conversion or purchase of the 5 1/4% Debentures. ALZA, at its option, may redeem any or all of the 5 1/4% Debentures for cash after July 14, 1999 at a redemption price equal to the issue price plus accreted original issue discount. Unamortized costs related to the issuance of the 5 1/4% Debentures were $7.5 million at December 31, 1997. At December 31, 1997 and 1996, the fair value of the 5 1/4% Debentures was $441.2 million and $397.3 million, respectively. Other Long-term Liabilities ALZA's other long-term liabilities are as follows(in millions): 1997 1996 _________________________________________________________________ Deferred compensation $ 35.8 $31.2 Deferred income taxes - 25.4 Long-term debt 25.0 10.9 _________________________________________________________________ Total other long-term liabilities $60.8 $67.5 ================================================================= ALZA has deferred compensation arrangements under which selected employees may defer a portion of their salaries. ALZA has purchased life insurance policies that it intends to use to partially finance amounts to be paid in the future to participants, based on their deferred salary amounts plus interest. The cash surrender value of these policies totaled $71.2 million and $58.4 million at December 31, 1997 and 1996, respectively, and is included in other assets. At December 31, 1997 and 1996, long-term debt consists of notes representing the required future payments under investments of $32.1 million and $11.9 million, respectively, in low income housing partnerships (included in other assets). The aggregate annual maturities of long-term debt at December 31, 1997 were $1.8 million in 1998, $5.6 million in 1999, $3.7 million in 2000, $3.6 million in 2001 and $3.4 million in 2002. NOTE 6: CAPITAL STOCK AND WARRANTS In January 1996, privately held warrants to purchase 1.0 million shares of ALZA common stock were exercised. Net proceeds to ALZA totaled $25.0 million. In connection with the formation of TDC, ALZA issued warrants to purchase approximately 1.0 million shares of common stock at an exercise price of $65 per share. The warrants, to the extent not exercised, will expire on December 31, 1999. ALZA is authorized to issue 100,000 shares of preferred stock, $.01 par value, none of which was outstanding at December 31, 1997 or 1996. The Board of Directors may determine the rights, preferences and privileges of any preferred stock issued in the future. NOTE 7: ARRANGEMENTS WITH THERAPEUTIC DISCOVERY CORPORATION AND CRESCENDO PHARMACEUTICALS CORPORATION Therapeutic Discovery Corporation On September 29, 1997, ALZA purchased all of the Class A Common Stock of TDC for $100.0 million in cash. This acquisition was recorded as a purchase and, accordingly, the purchase price was allocated to assets acquired based upon their fair market value on the acquisition date. The purchase resulted in a charge of $77.0 million to acquisitions of in-process research and development, and the remaining $23.0 million of the purchase price was allocated to a deferred tax asset arising from TDC's net operating loss carryforward and capitalized research and development. The amounts paid by ALZA were charged to acquisition of in-process research and development because the TDC products were under development and had not been approved by the FDA, and they had no alternative future use. ALZA and TDC had a development contract pursuant to which ALZA conducted research and development activities on behalf of TDC. Product development revenues from TDC during 1997, 1996 and 1995 under this development contract were $67.8 million, $100.7 million and $70.1 million, respectively. ALZA performed certain administrative services for TDC under an administrative services agreement for which ALZA was reimbursed its direct costs, plus certain overhead expenses. For the years ended 1997, 1996 and 1995, administrative service revenue under this agreement was $0.4 million, $0.2 million and $0.1 million, respectively, and is included in royalties, fees and other revenues. Crescendo Pharmaceuticals Corporation Crescendo was formed by ALZA for the purpose of selecting and developing human pharmaceutical products, and commercializing such products, most likely through licensing to ALZA. On September 29, 1997, ALZA contributed $300.0 million in cash to Crescendo. On September 30, 1997, all of the Crescendo Shares were distributed to the holders of ALZA common stock and ALZA's outstanding convertible subordinated debentures. ALZA recorded a charge of $247.0 million (including expenses of $4.0 million) and interest expense of $8.0 million related to the distribution to stockholders and debenture holders, respectively. ALZA also recorded a dividend of $49.1 million for the distribution of the Crescendo Shares to ALZA stockholders. The interest expense and dividend amount were determined according to the fair market value (based on NASDAQ trading prices immediately following the distribution) of the Crescendo shares distributed to debenture holders and stockholders, respectively. The excess of the amount contributed to Crescendo over the fair market value of the shares, along with transaction expenses, was recorded as an expense. In connection with the contribution to Crescendo and the distribution of the Crescendo Shares, ALZA and Crescendo entered into a number of agreements. Crescendo and ALZA entered into a Development Agreement for the selection and development of human pharmaceutical products. Under the agreement, Crescendo funds the development of products recommended by ALZA for development and accepted by Crescendo. The development of certain specified products was funded by Crescendo beginning August 25, 1997, the date on which TDC ceased funding the development of such products. Under a Technology License Agreement between ALZA and Crescendo, ALZA has granted to Crescendo a worldwide license to use ALZA technology solely to select and develop Crescendo products, and to conduct related activities, and to commercialize such products. In exchange for the license to use existing ALZA technology relating to seven products initially under development by Crescendo and ALZA, Crescendo pays a technology fee to ALZA, payable monthly over a period of three years, in the amount of $1.0 million per month for the 12 months following the distribution of the Crescendo Shares, $667,000 per month for the following 12 months and $333,000 per month for the following 12 months. The technology fee will no longer be payable at such time as fewer than two of the seven initial products are being developed by Crescendo and/or have been licensed by ALZA pursuant to the option, granted to it by Crescendo, to license any or all Crescendo products. ALZA recorded technology fee revenue from Crescendo of $4.0 million for 1997. Five of the seven initial products were in development at January 31, 1998. ALZA recognizes the technology fee from Crescendo when earned. Since Crescendo owes the fee at the end of each month if, and only if, at least two of the "Initial Products" remain in development at the end of each month, the fee is not earned until the end of each month in which the test is satisfied. Development of any or all of the Initial Products could be terminated by Crescendo at any time, and four of these products are no longer in active development. The monthly technology fee payments are not guaranteed, and the conditions precedent to their payment have not been fulfilled and cannot be fulfilled before the end of each month. At the time ALZA accrues the Crescendo technology fee, ALZA has no future performance obligations to Crescendo in order to earn the fee that is being accrued. ALZA has an option to acquire an exclusive, royalty-bearing license to each product developed by Crescendo under the Development Agreement. The option is exercisable on a product-by- product, country-by-country, basis. Also, under Crescendo's Restated Certificate of Incorporation, ALZA has the right to purchase all (but not less than all) of the Crescendo Shares at a price based upon a pre-established formula. NOTE 8: EMPLOYEE COMPENSATION AND BENEFIT PROGRAMS Bonuses and Awards ALZA has a company-wide bonus program under which substantially all regular employees are eligible to receive a bonus. The annual bonus, if any, is determined by ALZA's Board of Directors, at its discretion, based on ALZA's performance during the year. Bonus and award expenses under this program for 1997, 1996 and 1995 were $7.9 million, $6.9 million and $5.3 million, respectively. Defined Contribution Plan ALZA has a company-funded, defined contribution retirement plan for its employees. This plan provides for an annual basic contribution and allows for additional discretionary contributions on a year-by-year basis. Such contributions are allocated to participants based on the participants' salaries and ages. For 1997, 1996 and 1995, the total expense for such contributions to this plan was $3.6 million, $2.9 million and $2.7 million, respectively. Employee Savings Plan ALZA has an employee savings plan which permits participants to make contributions by salary reductions pursuant to section 401(k) of the Internal Revenue Code. The Company matches contributions up to a specified amount per participant. In 1997 and 1996, ALZA's contributions to the plan were $1.1 million and $0.7 million. There were no matching contributions in 1995. Stock Plan ALZA has a stock plan whereby incentive stock options to purchase shares of ALZA common stock at not less than the fair market value of the stock at the date of the grant may be granted to employees; nonstatutory stock options to purchase shares of ALZA common stock at not less than 85% of the fair market value of the stock at the date of grant may be granted to employees, directors and consultants; and restricted stock may be issued. Options typically vest one to three years from date of grant and generally expire ten years after the date of grant. A total of 8.9 million shares of ALZA's common stock have been reserved for issuance under its stock plan. To date, all options granted have had exercise prices equal to the fair market value of common stock on the date of grant. In 1997, a total of 25,000 shares of restricted stock were issued to one employee at a price of $0.01 per share, the par value of the common stock. ALZA has the right to repurchase a declining portion of the shares, at par value, if the employee's employment with ALZA terminates within three years of the date of issuance. Financial Accounting Standards Board SFAS No. 123, "Accounting for Stock-Based Compensation" ("SFAS 123"), effective beginning in 1996, prescribes a fair value method of accounting for employee stock options. SFAS 123 gives companies a choice of recognizing related compensation expense by adopting the new fair value method or continuing to measure compensation under Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees" ("APB 25"). The Company has elected to continue to follow APB 25 in accounting for its employee stock options and employee stock purchase plan. Had compensation expense for stock options and shares issued under the stock purchase plan been determined using the fair value method in accordance with SFAS 123, ALZA's pro forma net income (loss) and earnings (loss) per share would have been as follows: (in millions, except per share amounts) 1997 1996 1995 _________________________________________________________________ Net income (loss) As reported $(261.1) $92.4 $72.4 Pro forma (270.4) 85.8 70.0 Earnings (loss) per share (basic) As reported $(3.07) $1.10 $0.88 Pro forma (3.18) 1.02 0.85 Earnings (loss) per share (diluted) As reported $(3.07) $1.08 $0.88 Pro forma (3.18) 1.01 0.85 The fair value for these options was estimated at the date of grant using the Black-Scholes option pricing model with the following weighted average assumptions: 1997 1996 1995 _________________________________________________________________ Risk-free interest rate 6.4% 6.0% 6.1% Expected dividend yield 0 0 0 Expected volatility 30% 30% 30% Expected life (in years) 4.0 3.6 3.9 Changes in the assumptions can materially affect the fair value estimate and therefore the existing models do not necessarily provide a reliable single measure of the fair value of ALZA's employee stock options or shares issued under the employee stock purchase plan. A summary of ALZA's stock option activity, and related information for 1997, 1996 and 1995 follows: 1997 1996 1995 _________________________________________________________________ Weighted Weighted Weighted Average Average Average Options Exercise Options Exercise Options Exercise (in millions) Price (in millions) Price (in millions) Price _________________________________________________________________ Outstanding- beginning of year 5.5 $24 5.7 $ 23 4.4 $ 21 Granted 1.6 29 0.9 27 1.8 23 Exercised (0.6) 21 (0.9) 20 (0.3) 14 Forfeited (0.4) 26 (0.2) 25 (0.2) 21 _________________________________________________________________ Outstanding-end of year 6.1 25 5.5 24 5.7 23 Exercisable-end of year 2.7 24 2.2 23 1.8 23 Weighted-average fair value of options granted $9.93 $8.13 $7.75 At December 31, 1997 and 1996, shares available for grant under the stock plan were 2.7 million and 4.0 million, respectively. OPTIONS OUTSTANDING _________________________________________________________________ Number Weighted-Average Range of Outstanding Remaining Weighted-Average Exercise at 12/31/97 Contractual life Exercise Prices (in millions) (in years) Price _________________________________________________________________ $12.00-21.75 1.7 5.79 $19.94 22.00-24.75 1.5 7.39 24.11 24.88-29.06 2.4 8.60 27.51 29.63-49.25 0.5 6.16 34.37 _________________________________________________________________ 6.1 OPTIONS EXERCISABLE _________________________________________________________________ Number Range of Exercisable Weighted-Average Exercise at 12/31/97 Exercise Prices (in millions) Price _________________________________________________________________ $12.00-21.75 1.4 $19.83 22.00-24.75 0.5 24.33 24.88-29.06 0.5 25.75 29.63-49.25 0.3 36.55 _________________________________________________________________ 2.7 Employee Stock Purchase Plan ALZA has an employee stock purchase plan in which essentially all ALZA employees may participate and purchase stock at 85% of its fair market value at certain specified dates. Employee contributions are limited to 15% of compensation. In 1997, 1996 and 1995 total shares of ALZA common stock purchased by the participants under the terms of this plan were 260,130, 237,950 and 165,314, respectively. Since adoption of this plan in 1984, 1,665,528 shares have been issued under this plan and 384,472 shares are available for issuance. The fair value of the employees' purchase rights was estimated using the Black-Scholes option pricing model with the following weighted average assumptions for 1997, 1996 and 1995: risk free interest rates of 5.4%, 5.3% and 4.8%, respectively; dividend yields of zero; an expected volatility factor of the market price of ALZA's common stock of 30%; and an expected life of six months. The weighted- average fair value for shares issued under the employee stock purchase plan for 1997, 1996 and 1995 was $6.52, $6.00 and $5.62, respectively. NOTE 9: INCOME TAXES The provision for income taxes is as follows (in millions): 1997 1996 1995 _________________________________________________________________ Federal Current $ 46.9 $47.9 $30.1 Deferred (12.9) (2.4) 5.6 _________________________________________________________________ 34.0 45.5 35.7 State Current 16.5 11.2 6.4 Deferred (0.8) - 2.3 _________________________________________________________________ 15.7 11.2 8.7 _________________________________________________________________ Provision for income taxes $ 49.7 $56.7 $44.4 ================================================================= Tax benefits associated with employee stock option transactions reduced accrued income taxes by $2.3 million, $3.3 million and $1.0 million for 1997, 1996 and 1995, respectively. The provision for income taxes differs from the amount computed by applying the statutory federal income tax rate to income before income taxes. The sources and tax effects of the differences are as follows (in millions): 1997 1996 1995 _________________________________________________________________ Expected federal tax at 35% $ (73.0) $52.2 $40.9 State income taxes, net of federal benefit 10.2 7.3 5.7 Investment and research tax credits (5.2) (2.3) (1.3) Purchased in-process research and development 113.4 - - Other 4.3 (0.5) (0.9) _________________________________________________________________ Provision for income taxes $ 49.7 $ 56.7 $44.4 ================================================================= Temporary differences which give rise to a significant portion of deferred tax assets and liabilities at December 31, 1997 and 1996 are as follows (in millions): 1997 1996 _________________________________________________________________ Deferred tax assets: Capitalized intangibles $ 35.9 $ 6.1 Compensation 16.1 14.5 State income taxes 7.4 4.8 Investments 5.7 1.0 Inventories 5.6 5.7 Bad debt 3.0 2.3 Deferred revenue 0.1 0.1 Other 1.6 - _________________________________________________________________ Total deferred tax assets 75.4 34.5 _________________________________________________________________ Deferred tax liabilities: Property, plant and equipment 43.1 39.8 Unrealized losses on available-for-sale securities (3.4) (0.1) Other 3.9 2.5 _________________________________________________________________ Total deferred tax liabilities 43.6 42.2 _________________________________________________________________ Net deferred tax assets (liabilities) $ 31.8 $(7.7) ================================================================= NOTE 10: COMMITMENTS AND CONTINGENCIES Commitments ALZA leases certain buildings and equipment under operating leases, the terms of which range from one to 33 years. Rent expense under these leases for 1997, 1996 and 1995 was $4.0 million, $3.7 million and $1.7 million, respectively. In late 1997, ALZA acquired a 50% interest in a real estate joint venture for the development of a 13-acre parcel of land in Mountain View, California. ALZA invested $36.2 million in the joint venture, which will be applied to the construction of buildings on the parcel. ALZA is also obligated to make improvements to the buildings, the total cost of which is estimated to be between $60.0 million and $100.0 million. The joint venture will lease the buildings to ALZA upon completion of construction, currently scheduled for 1999. The leases provide for an initial term of 15 years with scheduled annual rent increases, followed by two 10-year extension periods with rent increases based upon the Consumer Price Index. ALZA will receive 50% of the joint venture's income. ALZA has also entered into a ground lease agreement for an adjacent seven-acre parcel of land on which it plans to construct a pilot plant, laboratories and other technical facilities. The term of the ground lease is approximately 33 years and includes options for ALZA to purchase, or to be required to purchase, the property. Aggregate minimum lease commitments under all non-cancelable operating lease arrangements as of December 31, 1997 were (in millions): 1998 $3.9 1999 9.2 2000 10.4 2001 10.2 2002 10.4 Later years 162.1 _________________________________________________________________ Total $206.2 In January 1998, ALZA purchased a building in Mountain View, California, which it had leased since 1992. The total purchase price was approximately $19.0 million, the majority of which was offset by the repayment of an outstanding note receivable from the seller. The note receivable was included in other assets at December 31, 1997. Contingencies Pharmaceutical companies are subject to product liability claims. Product liability suits have been filed against Janssen and ALZA from time to time relating to the Duragesic-registered trademark- product. Janssen is managing the defense of these suits in consultation with ALZA under an agreement between the parties. Historically, the cost of resolution of ALZA's liability (including product liability) claims has not been significant, and ALZA is not aware of any asserted or unasserted claims pending against it, including the suits mentioned above, the resolution of which would have a material adverse impact on ALZA's results of operations or financial position. NOTE 11: QUARTERLY FINANCIAL DATA (UNAUDITED) (In millions, except per share amounts) 1997 _________________________________________________________________ First Second Third(1) Fourth(2) _________________________________________________________________ Total revenues $ 105.5 $ 118.2 $ 114.5 $ 126.2 Gross margin 7.8 13.3 14.5 17.7 Operating income (loss) 39.2 42.9 (305.9) 19.8 Net income (loss) 26.3 26.4 (326.5) 12.7 Earnings (loss) per share Basic $0.31 $0.31 $(3.83) $0.15 Diluted 0.30 0.30 (3.83) 0.15 1996 _________________________________________________________________ First Second Third Fourth _________________________________________________________________ Total revenues $88.5 $117.9 $98.4 $108.3 Gross margin 4.7 4.0 8.0 6.6 Operating income (loss) 31.0 38.1 33.7 36.4 Net income (loss) 20.4 23.2 23.1 25.7 Earnings (loss) per share Basic $ 0.24 $ 0.27 $ 0.27 $ 0.30 Diluted 0.24 0.27 0.27 0.30 (1)In the third quarter of 1997, ALZA recorded charges totaling $353.5 million, or $4.14 per share, diluted. These charges included a $247.0 million charge and $8.0 million of interest expense related to the distribution of Crescendo Shares, $87.0 million for acquired in-process research and development and an asset write-down of $11.5 million. (2)In the fourth quarter of 1997, ALZA recorded charges of $21.5 million for acquired in-process research and development and $1.8 million in costs related to a workforce reduction. Net of income taxes, these charges totaled $15.2 million, or $0.17 per share, diluted. REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS THE BOARD OF DIRECTORS AND STOCKHOLDERS ALZA CORPORATION We have audited the accompanying consolidated balance sheet of ALZA Corporation as of December 31, 1997 and 1996, and the related consolidated statements of operations, stockholders' equity and cash flows for each of the three years in the period ended December 31, 1997. 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 in accordance with generally accepted auditing standards. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of ALZA Corporation at December 31, 1997 and 1996, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 1997, in conformity with generally accepted accounting principles. Ernst & Young LLP Palo Alto, California February 13, 1998 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 ALZA incorporates by reference the information concerning its directors set forth under the heading "Election of Directors" on pages 1 to 4 in ALZA's definitive Proxy Statement dated March 27, 1998, for its Annual Meeting of Stockholders to be held on May 7, 1998 (the "Proxy Statement") and the information under the heading "Section 16(a) Beneficial Ownership Reporting Compliance" at page 7 in the Proxy Statement. Information concerning ALZA's executive officers appears at the end of Part I of this report on pages 28 to 30. Item 11. EXECUTIVE COMPENSATION ALZA incorporates by reference the information ("Summary Compensation Table", "1997 Option Grants", "1997 Aggregated Option Exercises and Fiscal Year-End Option Values" and "Certain Executive Agreements") set forth under the heading "Executive Compensation" on pages 5 to 7 in the Proxy Statement. Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT ALZA incorporates by reference the information set forth under the heading "Beneficial Stock Ownership" on page 13 in the Proxy Statement. Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS ALZA incorporates by reference the information set forth under the heading "Certain Transactions" on page 14 in the Proxy Statement. PART IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K (a) Documents filed as part of this Annual Report on Form 10-K: 1. Consolidated Financial Statements: Incorporated by reference to the Annual Report (see accompanying Index to Consolidated Financial Statements). 2. Consolidated Financial Statement Schedule: (see accompanying Index to Consolidated Financial Statement Schedule). 3. Exhibits: 3.1 Restated Certificate of Incorporation of ALZA Corporation filed with the Delaware Secretary of State on February 14, 1994(1) 3.2 Composite Bylaws of ALZA Corporation as restated on February 10, 1994 and amended on August 11, 1994, February 16, 1995, February 15, 1996, August 13, 1996 and February 10, 1998. 4.1 Indenture dated July 7, 1994 between ALZA Corporation and the Chase Manhattan Bank, N.A. as Trustee, relating to ALZA's 5 1/4% Liquid Yield Option-trademark- Notes(2) 4.2 Specimen of LYONs-trademark- Certificate (included in Exhibit 4.1) 4.3 Form of Warrant Agreement between ALZA Corporation and the Chase Manhattan Bank (with attached Warrant Certificate)(3) 4.4 Indenture dated April 23, 1996 between ALZA Corporation and the Chase Manhattan Bank, N.A., as Trustee, relating to ALZA's 5% Convertible Subordinated Debentures(4) 4.5 Specimen of 5% Convertible Subordinated Debenture (included in Exhibit 4.4) 10.1Technology License Agreement between ALZA Corporation and Crescendo Pharmaceuticals Corporation(5) See footnotes on page 34. 10.2 Development Agreement between ALZA Corporation and Crescendo Pharmaceuticals Corporation(5) 10.3 License Option Agreement between ALZA Corporation and Crescendo Pharmaceuticals Corporation(5) 10.4 Restated Certificate of Incorporation of Crescendo Pharmaceuticals Corporation(5) 10.5 Amended and Restated Executive Deferral Plan II * 10.6 Executive Deferral Plan II for Chief Executive Officer(6)* 10.7 Executive Deferral Plan Amendments(7)* 10.8 Amendment Number 2 to Executive Deferral Plans II(8)* 10.9 ALZA Corporation Amended and Restated Stock Plan(9)* 10.10 Form of Executive Agreement between ALZA Corporation and Certain Executive Officers(10)* 10.11 Lease Agreement between ALZA and P/A Charleston Road LLC for Building One of Charleston Road Development Project (a substantially identical lease is in effect for each of two other office buildings) 10.12 Construction Agreement between ALZA and P/A Charleston Road LLC relating to three office building lease agreements 10.13 Ground Lease between ALZA and the Peery and Arrillaga Trusts relating to a seven- acre parcel in Mountain View 21 Subsidiaries (11) 23 Consent of Ernst & Young LLP, Independent Auditors (b) No reports on Form 8-K were filed during the quarter ended December 31, 1997. ______________________________________________________________ (1) Incorporated by reference to ALZA's Form 10-K Annual Report for the year ended December 31, 1993. (2) Incorporated by reference to ALZA's Form 10-Q Quarterly Report for the quarter ended June 30, 1994. (3) Incorporated by reference to ALZA's Form 8-A Registration Statement (Commission File No. 0-11234) dated March 31, 1993, as amended. (4) Incorporated by reference to ALZA's Form S-3 Registration Statement (Commission File No. 333-2343) dated April 8, 1996, as amended. (5) Incorporated by reference to ALZA's Form 10-Q Quarterly Report for the quarter ended September 30, 1997. (6) Incorporated by reference to ALZA's Form 10-Q Quarterly Report for the quarter ended September 30, 1993. (7) Incorporated by reference to ALZA's Form 10-K Annual Report for the year ended December 31, 1992. (8) Incorporated by reference to ALZA's Form 10-K Annual Report for the year ended December 31, 1994. (9) Incorporated by reference to ALZA's Form 10-Q Quarterly Report for the quarter ended June 30, 1995. (10) Incorporated by reference to ALZA's Form 10-K Annual Report for the year ended December 31, 1995. *A management contract or compensatory plan or arrangement required to be filed as an Exhibit pursuant to Item 14(c) of Form 10-K. ALZA CORPORATION INDEX TO CONSOLIDATED FINANCIAL STATEMENTS, REPORT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS AND CONSOLIDATED FINANCIAL STATEMENT SCHEDULE (Item 14(a)) Page Number Reference Form 10-K/A Consolidated statement of operations for the years ended December 31, 1997, 1996, 1995 56 Consolidated balance sheet at December 31, 1997 and 1996 57 Consolidated statement of stockholders' equity for the years ended December 31, 1997, 1996 and 1995 59 Consolidated statement of cash flows for the years ended December 31, 1997, 1996 and 1995 60 Notes to consolidated financial statements 62-72 Report of Ernst & Young LLP, Independent Auditors 83 The following consolidated financial statement schedule of ALZA Corporation is included: II - Consolidated valuation and qualifying accounts 84 All other schedules have been omitted because the required information is not present or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated financial statements, including the notes thereto. SCHEDULE II ALZA CORPORATION CONSOLIDATED VALUATION AND QUALIFYING ACCOUNTS Years Ended December 31, 1997, 1996 and 1995 Balance at Additions Deductions Beginning Charged to and Balance at of Year Income write-offs End of Year (In millions) Allowance for doubtful receivables: 1997 $ 0.6 $ 0.2 $ - $ 0.8 1996 $ 0.2 $ 0.4 $ - $ 0.6 1995 $ 0.3 $ - $ (0.1) $ 0.2 SIGNATURES Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. ALZA CORPORATION By: __________________________ Dr. Ernest Mario Chief Executive Officer Date: February 11, 1999 Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. _____________________________ ____________________________ Dr. Ernest Mario Dean O. Morton Chairman of the Board of Director Directors, Director and Chief Date: February 11, 1999 Executive Officer Date: February 11, 1999 _____________________________ ____________________________ Dr. William R. Brody Denise M. O'Leary Director Director Date: February 11, 1999 Date: February 11, 1999 _____________________________ ____________________________ William G. Davis Isaac Stein Director Director Date: February 11, 1999 Date: February 11, 1999 _____________________________ ____________________________ Dr. Robert J. Glaser Julian N. Stern Director Director Date: February 11, 1999 Date: February 11, 1999 ____________________________ Bruce C. Cozadd Senior Vice President, Chief Financial Officer and Principal Accounting Officer Date: February 11, 1999 EXHIBIT INDEX Exhibit 23 Consent of Ernst & Young LLP, Independent Auditors EX-23 2 CONSENT OF AUDITORS Exhibit 23 CONSENT OF ERNST & YOUNG LLP, INDEPENDENT AUDITORS We consent to the incorporation by reference in the Registration Statements (Forms S-3 No. 33-53671 and No. 333-02765 and Forms S-8 No. 2-92629, No. 2-97422, No. 33-21810, No. 33-36141, No. 33-49824, No. 33-51890, No. 333-21877 and No. 333-70799) and in the related Prospectuses, of our report dated February 13, 1998 with respect to the consolidated financial statements and schedule of ALZA Corporation for the year ended December 31, 1997 included herein. Ernst & Young LLP Palo Alto, California February 11, 1999 -----END PRIVACY-ENHANCED MESSAGE-----