-----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, Wr5xrAEctb6uV/bOp9DIYgUqMzEFVXLoZrgzK7moYdWUf5e3ViG1N5YtdMA2A33n RS1zE+8CTK1GkPwQLcqWvA== 0000927016-00-000854.txt : 20000314 0000927016-00-000854.hdr.sgml : 20000314 ACCESSION NUMBER: 0000927016-00-000854 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 19991231 FILED AS OF DATE: 20000313 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CREATIVE BIOMOLECULES INC CENTRAL INDEX KEY: 0000857121 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 942786743 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-K SEC ACT: SEC FILE NUMBER: 000-19910 FILM NUMBER: 568349 BUSINESS ADDRESS: STREET 1: 45 S STREET CITY: HOPKINTON STATE: MA ZIP: 01748 BUSINESS PHONE: 5087821100 MAIL ADDRESS: STREET 1: 45 SOUTH ST CITY: HOPKINTON STATE: MA ZIP: 01748 10-K 1 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ----------------------------- FORM 10-K [X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 1999 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____________ to ____________ Commission file number: 0-19910 ----------------------------- CREATIVE BIOMOLECULES, INC. (Exact name of registrant as specified in its charter) Delaware 94-2786743 (State or other jurisdiction (I.R.S. Employer of incorporation or organization) Identification No.) 45 South Street, Hopkinton, MA 01748 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (508) 782-1100 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, $.01 par value per share (Title of Class) ----------------------------- Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (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. [_] The aggregate market value of the registrant's voting stock held by non- affiliates of the registrant (without admitting that any person whose shares are not included in such calculation is an affiliate) on March 10, 2000, was approximately $621 million, based on the last sale price as reported on The Nasdaq Stock Market. As of March 10, 2000, the registrant had 38,231,502 shares of Common Stock outstanding. Documents incorporated by reference: None PART I Item 1. BUSINESS SUMMARY We are a biopharmaceutical company focused on the development of products for human tissue regeneration and repair. Our core technologies are based on understanding the role that morphogenic proteins play in human biology. These proteins are involved in the initiation and regulation of the cellular events responsible for the formation of human tissues and organs. Our goal is to apply certain aspects of genetic engineering and our understanding of cellular biology to the development and commercialization of morphogenic proteins and related compounds to treat a wide array of medical conditions. We have product candidates in development for several applications including orthopaedic and dental reconstruction, treatment of kidney disease, and treatment of stroke and other neurological disorders. Through our efforts to patent and license our technology, we have a strong intellectual property position covering morphogenic proteins as therapies. Our lead product candidate, the OP-1 bone graft device, is in the final stages of development and commercialization by Stryker Corporation. On February 15, 2000, we announced that we will merge with Ontogeny, Inc., and Reprogenesis, Inc., to form a public company named Curis, Inc. Under the terms of the merger, which is subject to stockholder approval, our stockholders will receive three Curis shares for every ten shares of our Common Stock. Following completion of the transaction, our stockholders will hold approximately 43%, Ontogeny's stockholders will hold approximately 38% and Reprogenesis' stockholders will hold approximately 19% of Curis. For accounting purposes, Curis, our successor, will record the merger as a purchase of Reprogenesis and Ontogeny. The merger is expected to close in June 2000. Orthopaedic Reconstruction and Dental Therapeutics. We have had a long-term collaboration with Stryker Corporation, a leading surgical and medical products company, to develop Osteogenic Protein-1, or OP-1, for use in the repair or replacement of bone and joint tissue, orthopaedic reconstruction, and dental therapeutics. Prior to November 1998, we were responsible for manufacturing OP- 1 products for Stryker and conducting research for Stryker in the orthopaedic reconstruction and dental fields. Stryker was responsible for clinical and regulatory development and sales and marketing of OP-1 products in these fields. We restructured our agreement with Stryker in November 1998 to provide Stryker with the exclusive rights to manufacture OP-1 products in these fields. At that time Stryker acquired our commercial manufacturing operations. As a result, Stryker has the exclusive right to develop, market, manufacture, and sell products based on OP-1 proteins for use in orthopaedic reconstruction and dental therapeutics. In return, we agreed with Stryker to increase the royalty rate under our agreement. Stryker has completed a pivotal study of an OP-1 bone graft device designed to induce new bone formation. This trial was conducted in 122 patients with non- union fractures of the tibia, the major bone of the lower leg. The objective of this trial was to demonstrate that treatment with the OP-1 device could repair non-union fractures of the tibia as well as treatment with the currently most widely used treatment, autograft. Autograft is a procedure which involves removal of bone from the hip and implanting that bone at the fracture site to induce healing. The results of the trial, as presented in March 1998, demonstrated that the group of patents treated with the OP-1 bone graft device had comparable clinical success to the autograft group without the need for a second invasive procedure to harvest autograft bone. In June 1999, Stryker announced that it had submitted a Pre-Market Approval application to the U.S. Food and Drug Administration and a Marketing Authorization Application in Europe to the European Medicines Evaluation Agency. The FDA accepted Stryker's application for filing in July 1999. In December 1999, Stryker also filed for regulatory approval in Australia. The applications are Stryker's formal requests to the various regulatory authorities for approval to market the OP-1 device. 1 In addition to the pivotal trial in non-union fractures, Stryker has reported initiating clinical studies in other bone graft indications. These studies include a 200 patient clinical trial in Canada to evaluate use of the OP-1 device to treat fresh fractures, a U.S. clinical trial to evaluate the use of the OP-1 device in spinal fusion, a study in Australia to treat patients with difficult to heal orthopaedic indications, and several pilot studies in Europe. Stryker is also developing an OP-1 device for the treatment of periodontal disease. Completed preclinical studies indicate that an OP-1 device may restore the periodontal tissues necessary to maintain tooth attachment when used in conjunction with standard surgical treatments of periodontal disease. Stryker is conducting a clinical trial in the United States to test an OP-1 device in the treatment of periodontal disease. Neurological Disorders. We are developing morphogenic protein therapies for neurological disorders, including stroke and Parkinson's disease. In-vitro studies have shown that OP-1 enhances the survival of neurons and may promote the establishment of new neuronal connections. In several preclinical studies, OP-1 improved the rate and extent of motor function recovery in animal models of stroke. Such positive results in preclinical studies of stroke have been observed even if treatment with OP-1 is initiated up to three days after the stroke. Additional preclinical studies are currently underway in preparation of a stroke therapy IND and to evaluate the effectiveness of our proprietary proteins in treating other neurological disorders, including traumatic brain injury, spinal cord injury and Parkinson's disease. Kidney Disorders. We are developing an OP-1 based therapy for chronic renal failure, a condition characterized by the slow progressive loss of kidney function ultimately resulting in the need for kidney transplantation or dialysis. Chronic renal failure represents a substantial unmet medical need. Preclinical studies indicate that OP-1 administration improves kidney function in animal models of both acute and chronic renal failure. Through December 1999, we had a development agreement with Biogen under which Biogen provided funding for and retained an option to OP-1 based therapies for chronic renal failure. As of December 31, 1999, Biogen did not exercise its option, and we have assumed all rights to OP-1 renal therapies. Other Programs. In addition to our work with OP-1, we are conducting research directed toward the development of new therapeutic applications for other related morphogenic proteins in our proprietary portfolio. We also have a program underway to develop and identify orally-active drug compounds that either promote morphogenic protein expression or mimic the biological activities of morphogenic proteins. Creative BioMolecules is a Delaware corporation with principal offices at 45 South Street, Hopkinton, Massachusetts, USA, 01748. Our telephone number is (508) 782-1100. RISK FACTORS Reliance on the closing of the announced merger between Creative BioMolecules, Inc., Ontogeny, Inc. and Reprogenesis, Inc. to form Curis, Inc. Our merger with Ontogeny and Reprogenesis to form Curis is subject to approval by our stockholders. If the merger is not completed as a result of the failure of our stockholders to approve the merger, we may be required to pay a termination fee of $1,500,000 to Reprogenesis. The market price of our common stock reflects a market assumption that the merger will be completed. If the merger is terminated and we seek another merger or business combination, we may not be able to find a partner willing to pay an equivalent or more attractive price than the price to be received by the stockholders in this merger. The number of shares of our common stock to be exchanged for the shares of common stock of Curis was determined by negotiations among us, Ontogeny and Reprogenesis may not be indicative of prices that will prevail in the trading market. We will face challenges in integrating with Ontogeny and Reprogenesis and, as a result, may not realize the expected benefits of the anticipated merger. Integrating the operations and personnel of all three companies will be a complex process, and we are uncertain that the integration will be completed rapidly or will achieve the anticipated benefits of the merger. The diversion of the attention of our management and any difficulties encountered in the process of combining the companies could cause the disruption of, or a loss of momentum in, the activities of our business. Further, the process of combining the 2 three companies could negatively affect employee morale and our ability to retain some of our key employees after the merger. If we do not successfully integrate with Ontogeny and Reprogenesis, or the merger's benefits do not meet the expectations of financial or industry analysts, the market price of our common stock may decline. Reliance on collaborative partners for funding and commercialization of our products. Our success is highly dependent on whether our collaborative partners are successful in meeting their obligations under our agreements with them. If any such collaborative partners are unsuccessful, the negative impact on us may be significant. For example, our partner, Stryker Corporation, through the efforts of their wholly-owned subsidiary, Stryker Biotech, is responsible for pursuing clinical trials, obtaining all regulatory and marketing approvals, manufacturing on a commercial scale and taking all steps necessary to market and sell OP-1 products for orthopaedic reconstruction and dental therapies. Stryker's failure to pursue clinical trials vigorously, obtain regulatory approvals, manufacture an adequate supply of material, or effectively market and sell OP-1 products could have a material adverse effect on our financial condition. We expect to pursue discussions with other potential collaborative partners for our other major programs, including neurological disorders, chronic kidney failure, and other applications of morphogenic and other proteins. If executed, we expect that these collaborations will also impose obligations on the collaborative partner to provide research and development funding, pursue clinical development and manufacturing, seek regulatory approval and pursue marketing and sales. Although we will seek to include legally enforceable diligence obligations and penalties in all collaborative agreements, we cannot assure you that we will be able to establish any collaborations or that any collaborations will be on terms acceptable to us. If our collaborators fail to meet their obligations under our agreements with them, our research programs could be delayed and our business would be adversely affected. We have not successfully commercialized any products to date, and if we do not successfully commercialize any products we will not be profitable. We have not yet successfully developed or received regulatory approval to market any products. The products that we are developing will require additional research and development, clinical trials and regulatory approval prior to any commercial sale. These products may not be effective in treating any of our targeted disorders or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may prevent or limit their commercial use. Moreover, there can be no assurance that government health administration authorities, private health care providers or other third party payors will accept our products, even if our products prove to be safe and effective and are approved for marketing by the FDA and other regulatory authorities. We currently have no products for sale by us or our collaborative partners and do not expect to have any products available for sale for at least one year. If we or our collaborative partners are not successful in developing and commercializing any products, we will never become profitable. Reliance on our lead product candidate, OP-1. Our lead product for orthopaedic reconstruction and dental therapy utilizes the OP-1 protein. In addition, our chronic renal failure program and our neurological program focusing on stroke recovery are based on various forms of the OP-1 protein. Although we are actively manufacturing preclinical quantities of other proprietary proteins in order to develop them for therapeutic uses, we are heavily dependent on our lead molecule. Because of this dependence, a failure in any one of these programs involving the OP-1 protein may have an adverse effect on the other programs. Reliance on preclinical programs. Our chronic renal failure program and neurological program are in various stages of preclinical development. We are conducting research, both independently and through our collaborators, focusing on the use of morphogenic proteins in other therapeutic applications as well as orally-active compounds that mimic or regulate morphogenic protein activity. Such research, however, is at an early stage. We believe that the scientific data in all of these programs are promising and warrants our continued investment and development. Other than the use of the OP-1 protein for orthopaedic reconstruction and dental therapeutics, we do not currently have any products that are or have been clinically tested in humans. It is possible that the preclinical efficacy demonstrated in the laboratory for these other applications will not be 3 repeated in humans. It is also possible that there may be a significant period of time during which we do not have a product in clinical stage development. If we fail to have our products progress to the clinical stage of development, our revenues and results of operations could be adversely affected. We have no sales and marketing experience or infrastructure. We have no sales, marketing and distribution experience or infrastructure. We plan to rely significantly on sales, marketing and distribution arrangements with third parties for the products that we are developing until we are able to develop internal sales, marketing and distribution capability. We may have limited or no control over the sales, marketing and distribution activities of our present or any future collaborative partners. Our future revenues will be materially dependent upon the success of the efforts of these third parties. If in the future we determine to perform sales, marketing and distribution functions ourselves, we would face a number of additional risks, including: . we may not be able to attract and build a significant marketing staff or sales force; . the cost of establishing a marketing staff or sales force may not be justifiable in light of any product revenues; and . our direct sales and marketing efforts may not be successful. Reliance on key management personnel. Our current senior management team is comprised of five officers, including Michael Tarnow, President and CEO, Charles Cohen, PhD, Chief Scientific Officer, Carl M. Cohen, PhD, Vice President, Research and Development, Cheryl Lawton, General Counsel and Vice President, Administration, and Steven Basta, Vice President, Finance and Business Development. All of these officers have employment contracts which renew annually unless notice is given to the contrary. The departure of one or more of these individuals may have a material adverse effect on our management and strategic direction. Competition relating to the research and development of morphogenic proteins and other therapies. There is intense competition among companies, individuals and academic and research institutions who are actively pursuing research in and the development of morphogenic proteins and other therapies currently under development by us. For example, we are aware that Genetics Institute, or GI, which was acquired by American Home Products Corporation in 1996, and GI's collaborative partners are pursuing the development of bone morphogenetic proteins and have initiated human clinical trials using a product similar to the OP-1 bone graft device being commercialized by Stryker. In addition, bone regeneration products based on non-protein technologies, such as autograft, allograft and electrical stimulation devices, could compete effectively with the OP-1 product. There are a number of biotechnology and pharmaceutical companies pursuing the development of recombinant protein based products, as well as traditional drug therapies for the treatment of renal and neurological disorders. Although we have broad patent protection and significant expertise and technical know-how in the field of morphogenic proteins, other entities and competitive products may materially affect the revenue we derive from the sale of our products as well as our fiscal condition. Year 2000: Information technology use. We did not experience any difficulties related to the Year 2000 problem on December 31, 1999 and we are not aware of any such difficulties since that date. Our operations have not, to date, been adversely affected by any difficulties experienced by any of our suppliers or customers in connection with the Year 2000 problem. Our Year 2000 Compliance Plan also addressed issues related to the date February 29, 2000 and management will continue to monitor our systems for potential difficulties through that date and the remainder of calendar year 2000. Conditions affecting the biotechnology industry. The continuation of several negative market conditions could continue to make it difficult for small biotechnology companies to obtain access to private and/or public funding. These negative market conditions include the recent highly publicized failure of several biotech products to show efficacy in human clinical testing and the lack of investor confidence in the overall performance of the biotech industry. Lack of significant analyst coverage for small cap companies in the biotechnology field may limit the general availability of third party information about small biotechnology companies like us. This could, in turn, limit the amount of funding available from investors. In addition, we do not yet know the extent to which government will regulate the biotechnology field. These general 4 economic and market conditions could materially affect our ability to fund our programs and expand our technology platform. Uncertainty as to whether we will be reimbursed for our products from government, private health insurers and other organizations. The availability of reimbursement by governmental and other third party payors affects the market for our pharmaceutical products. These third party payors continually attempt to contain or reduce the costs of healthcare. In the United States and in certain foreign jurisdictions there have been a number of legislative and regulatory proposals to change the healthcare system, and further proposals are likely. We could experience pricing pressure on our current and future products due to the trend toward managed health care, the increasing influence of health maintenance organizations, and additional legislative proposals. We may not be able to sell our products profitably if reimbursement is unavailable or limited in scope. In addition, we may not be able to market any products that we develop ourselves or in conjunction with a partner at acceptable prices or receive commercial acceptance in the markets that we expect to target. OUR TECHNOLOGY We have played a significant role in advancing the scientific understanding of the process of tissue repair and regeneration. We have established a technology platform based on the molecular and cellular events responsible for tissue and organ development. We were the first to identify and characterize certain morphogenic proteins that are key regulators of tissue and organ formation in humans. These morphogenic proteins, and our understanding of the biology related to the activity of these proteins, provide the basis for the development of our proprietary therapeutic products. The role of morphogenic proteins in the formation, maintenance and repair of many tissues has led us to believe that morphogenic proteins may provide therapies to treat several types of acute injury or chronic disease. Our research and that of our collaborators has indicated that morphogenic proteins are significant in the formation of many tissues including bone, cartilage, kidney, dental and brain tissues. OP-1, a morphogenic protein, has been developed in a formulation with a collagen matrix to induce bone formation. In human trials, this OP-1 and collagen device has demonstrated the ability to repair bone defects in several hard-to-heal orthopaedic indications. Additional clinical trials are currently underway to evaluate this device in other indications, including the treatment of periodontal disease, fresh fractures and spinal fusion. Together with our collaborators, we are exploring the role of several other morphogenic proteins in the development of tissues throughout the body. We have determined that several of these proteins are important in neurological development and appear to interact with neurons to promote certain biological functions of these neurons. These findings form the basis of the therapies we are developing for stroke and other neurological diseases. We have also determined that OP-1 is critical to the normal development of the kidney and plays an important role in kidney function. This knowledge may assist us in developing a chronic renal failure therapy based on OP-1. We are similarly exploring the role of several of the morphogenic proteins in tissues throughout the body to identify new product opportunities for therapies based on these proteins. In addition to identifying and characterizing several morphogenic proteins, including OP-1, we have identified with our collaborators the DNA sequences which regulate the expression of OP-1. We have also discovered the cellular receptors to which OP-1 and other morphogenic proteins bind and through which they act as well as the three-dimensional structure of OP-1. These discoveries have enabled us to initiate a small molecule program, the goal of which is to identify second generation, orally-active drug compounds that either promote morphogenic protein expression or mimic the biological activities of morphogenic proteins. BUSINESS STRATEGY Our objective is to be the leader in the discovery and development of therapeutics for tissue repair and regeneration based on the biology of morphogenic proteins. Key elements of our continuing business strategy include: 5 Receiving Royalties from the Sale of OP-1 Orthopaedic and Dental Products by Stryker. We have had a long-term research and development agreement with Stryker that we restructured in November 1998. Under our agreement with Stryker, we receive royalties on sales of Stryker's OP-1 products. Stryker is seeking approval from regulatory authorities to market and sell the OP-1 bone graft device in the United States and foreign markets. If approved, Stryker will be responsible for worldwide commercialization of the OP-1 bone graft device and we will receive royalties on such sales. We cannot assure you that Stryker can obtain such regulatory approvals or successfully commercialize its OP-1 products. If Stryker does not commercialize its OP-1 products, we may never receive significant royalties on its OP-1 products. Developing Morphogenic Protein Therapies for Stroke and Other Neurological Disorders. Preclinical studies have demonstrated that the administration of OP- 1 following stroke can improve the rate and extent of motor skills recovery. We are currently conducting additional preclinical studies which are intended to support the filing of an Investigational New Drug, or IND, application with the FDA in order to enable us to initiate clinical trials for a new stroke therapy. We are also evaluating morphogenic protein therapies designed to treat other neurological disorders. Developing OP-1 as a Therapy for Renal Disease. Preclinical results have demonstrated that OP-1 may be beneficial in protecting against kidney damage in acute conditions and in slowing kidney function decline in chronic disease. We are currently conducting additional preclinical studies which are intended to support the filing of an IND application with the FDA in order to enable us to initiate clinical trials for a therapy to treat chronic renal failure. Creating New Morphogenic Protein Therapies. We have proprietary rights covering several morphogenic proteins that may be involved in the formation and repair of several tissues and organs. We are investigating the role of these proteins in several new therapeutic indications. Developing Molecular Therapeutics Based on Morphogen Biology. We believe that certain small compounds may be able to stimulate important biological responses involved in the activity of morphogenic proteins. We further believe that since such small compounds are more likely to lead to orally available therapies, they could be attractive candidates for commercial development. We are developing biochemical and cell-based screens based on the biology of morphogenic proteins and have a collaboration with Neogenesis, Inc. to screen chemistry libraries and identify small molecule therapeutic candidates. Establishing Corporate Collaborations. We may elect to establish corporate collaborations to achieve several purposes. We hope that such collaborations would allow us to strengthen our financial resources, broaden our pipeline of programs, access complementary technologies, and gain development, manufacturing and commercialization expertise. Establishing Academic Collaborations. We utilize a large network of academic collaborators to extend our expertise and knowledge about tissue formation and morphogenic protein biology, to identify additional therapeutic uses for morphogenic proteins, and to conduct preclinical studies of our therapies. 6 PRODUCT DEVELOPMENT AND RESEARCH PROGRAMS We or our collaborators are developing several therapeutic products. The following table sets forth our product development programs:
Potential Application Commercial Rights Development Status(1) - --------------------- ----------------- --------------------- Orthopaedic Reconstruction and Dental Applications Non-Union Fractures, Tibia Stryker U.S. Pivotal Trial Completed Regulatory review underway in the United States, Europe and Australia Non-Union Fractures, All Long Bones Stryker U.S. Treatment Study Fresh Fractures Stryker Canadian Clinical Study Spinal Fusion Stryker U.S. Clinical Study Other Bone Graft Indications(2) Stryker International Clinical Studies Periodontal Disease Stryker U.S. Clinical Study Cartilage Regeneration Stryker Preclinical Kidney Disorders Acute Renal Failure Creative BioMolecules Preclinical Chronic Renal Failure Creative BioMolecules Preclinical Neurological Disorders Stroke Creative BioMolecules Preclinical Other Neurological Disorders Creative BioMolecules Preclinical
__________ (1) "Pivotal Clinical Trials" are investigations conducted under an Investigational Device Exemption, IDE, intended to be used as the primary supporting documentation for regulatory approval of a new medical device. "Treatment Study" denotes an open label study pursuant to a supplement to an IDE. "Clinical Studies" vary in scope from a Canadian Clinical Trial in 200 patients with fresh fractures to several physician sponsored feasibility investigations conducted among a small number of patients. "Preclinical" denotes the collection and analysis of data from multiple studies in animals relating to toxicity and/or efficacy in preparation for an Investigational New Drug, IND, or IDE application filing. See "-Regulatory Issues." In any case where more than one product formulation or composition may be developed, the status stated relates to the most advanced product in that field. (2) Stryker has announced that it has initiated clinical studies for several orthopaedic reconstruction applications of OP-1. Preliminary data has been reported from some of the ongoing studies. Orthopaedic Reconstruction and Dental Applications - Stryker Products in Development We have collaborated with Stryker, a leading specialty surgical and medical products company, to develop and commercialize orthopaedic reconstruction and dental therapy products. Under our collaboration agreement with Stryker, we granted Stryker exclusive rights to develop, manufacture and commercialize OP-1 products 7 in orthopaedic reconstruction and dental applications, for which we will receive royalties on commercial sales of OP-1 products in this field. See "- Collaborative and Licensing Agreements - Stryker Corporation." Orthopaedic Reconstruction. We believe there is a significant commercial opportunity for the use of OP-1 products to regenerate bone and cartilage tissue in orthopaedic reconstruction. We believe that in 1995 there were more than 1.6 million procedures in the United States that may have benefited from an OP-1 bone graft device, if it were available. These procedures included repair of non-healing fractures (170,000), open fracture reductions (440,000), spinal fusions (200,000), maxillofacial reconstructions (220,000), prosthetic fixations (540,000), and gap fillings (30,000). In addition, in 1995 there were 570,000 cartilage-related injuries in the United States. Through our collaboration with Stryker, we have generated substantial evidence that OP-1 is a potent stimulator of bone and cartilage formation. Numerous studies in six different animal species have demonstrated that OP-1 is capable of inducing bone regeneration at a wide array of sites within the body in which bone is normally present. Bone formed in response to OP-1 has been shown to be biochemically and biomechanically identical to normal bone. The most widely employed reconstruction procedure for the replacement of lost or damaged bone is bone grafting. Grafting involves surgical transplantation of bone or bone chips to the site of the defect to facilitate new bone formation. Autograft, the currently preferred grafting approach, involves two surgical steps: a first step to harvest the graft, and a second step to implant the graft at the site of the defect or injury. In addition to the pain and cost associated with this two-step procedure, many patients experience complications resulting from the graft harvesting step. A second approach involving allograft procedures utilizes bone grafts or demineralized bone taken from cadavers. We believe that the OP-1 bone graft device applied locally to the site of the defect could be used as an alternative to many bone graft procedures, and may provide reliable healing without the need for graft harvesting with its associated complications. Stryker has reported completing a pivotal clinical trial under an IDE to evaluate the use of an OP-1 bone graft device as a bone graft substitute. The randomized prospective study included 122 patients at 18 different centers throughout the United States. Patients included in the study had tibial non- union fractures for at least nine months following initial injury without demonstrating progress toward union for the previous three months. Such non- union fractures are often caused by high-energy trauma, do not usually heal well, and generally require repeated surgical interventions. The study was designed to evaluate whether treatment with the OP-1 bone graft device is equivalent to autograft, the current standard of treatment. The OP-1 bone graft device used in this study consisted of a paste-like formulation that was applied locally at the fracture site. The results of the trial, presented in March 1998 at the American Academy of Orthopaedic Surgeons, demonstrated that the OP-1 bone graft device had comparable clinical success to autograft without the need for a second invasive procedure to harvest autograft bone from the hip. The analysis of the data in this trial showed statistical equivalence between OP-1 and autograft with respect to the clinically important areas of weight-bearing and pain. In addition, the data confirmed that there were comparable rates of re-operation for the two groups of patients. Specifically, eleven of the 61 autograft patients and ten of the 61 OP-1 patients have required re-operation to date. Finally, the data showed a significant reduction in blood loss for the OP-1 patients as compared to the autograft patients and the elimination of certain other complications associated with the harvest of autograft. Radiographic evidence of healing did not meet the predicted target for either group and was approximately 10% higher for the autograft group during the long-term follow-up period. In October 1995, the FDA approved a supplemental treatment arm, or an Open-Label Trial, of the pivotal trial, allowing Stryker to expand the study to test the OP-1 bone graft device for the treatment of all long bone non-union fractures. Stryker has completed the selection of patients in this Open-Label Trial. Data presented at a scientific conference in November 1998 from an Australian clinical experience involving 80 patients indicated good clinical and radiological success with use of an OP-1 device to treat patients with 8 hard-to-heal orthopaedic indications. The presenting clinician reported that, 41 (93%) of the 44 patients who had completed five months of follow-up showed clinical or radiological improvement following OP-1 device treatment. Patients enrolled in this study had a variety of orthopaedic indications including non-union fractures, spinal fusions, revision arthroplasty, peri-prosthetic fractures, bone defects, and arthrodeses. Since the data were presented, Stryker has continued enrollment of additional patients in this study. Stryker has initiated a 200 patient clinical study in Canada to evaluate the use of the OP-1 bone graft device for the treatment of fresh fractures and a U.S. clinical study to evaluate the OP-1 device in spinal fusion. Stryker has also initiated clinical studies in several European countries. Stryker may initiate additional clinical trials to demonstrate the utility of OP-1 based products in additional orthopaedic indications. We and Stryker have also conducted preclinical studies indicating the potential utility of OP-1 in the treatment of cartilage defects. We believe that Stryker's goal is to market OP-1 products for a number of orthopaedic reconstruction indications in major markets around the world. Based on the results of the U.S. pivotal trial, other clinical and preclinical data, and our development of a commercial scale manufacturing process and facility, Stryker submitted a Pre-Market Approval application to the U.S. Food and Drug Administration and a Marketing Authorization Application in Europe to the European Medicines Evaluation Agency in June 1999. In December 1999, Stryker also filed for regulatory approval in Australia. The applications are pending. Periodontal Tissue Repair. Periodontal disease is a bacterially induced inflammatory disorder that results in the progressive destruction of the periodontal tissues that hold teeth in place. Reliable and effective restoration of periodontal tissue damaged or lost as a result of periodontal disease is not possible with current therapies. Based on data from the most recent American Dental Association Survey of Services Rendered, or ADA Survey, in 1995 approximately four million patients underwent periodontal surgery in the United States for severe periodontal disease. We believe that many of these procedures would have been candidates for treatment with an OP-1 periodontal product. Stryker is conducting a clinical trial in the United States to test an OP-1 device in the treatment of periodontal disease. This trial follows preclinical studies which demonstrated that an OP-1 device was capable of regenerating the normal tissue structures surrounding the tooth root. Kidney Disorders Kidney disorders, particularly various types of renal failure, are a large and growing health care problem. Billions of dollars are spent annually in the United States on the treatment of renal failure patients. Despite these expenditures, mortality rates remain high and quality of life low. Studies conducted by our scientists and academic collaborators have shown that OP-1 is a key morphogenic signal that initiates kidney formation at the earliest stages of kidney development. Chronic Renal Failure. Chronic renal failure is characterized by a gradual and progressive loss of kidney function. The most common conditions associated with onset of chronic renal failure are diabetes and high blood pressure. Chronic renal failure eventually results in end stage renal disease, a condition that requires dialysis or kidney transplantation. Aside from the substantial economic costs associated with dialysis, quality of life is significantly impacted, and the average life expectancy of patients on dialysis is substantially diminished. Based on reports from the United States Renal Data System and epidemiology studies, there were more than 360,000 patients suffered from end-stage renal disease in 1997. Seventy-nine thousand new patients with chronic renal failure begin dialysis therapy in the United States every year. We believe that there is a significant commercial opportunity for a therapy that could reduce, delay or prevent the need for dialysis or that could halt the progression of chronic renal failure. Under the terms of our partnership in renal therapy with Biogen, Inc., or Biogen, a leading protein therapeutics company, we received financial support from Biogen through 1999 to develop an OP-1-based therapy to 9 moderate or halt the progression of chronic renal failure. As of January 1, 2000, we have reacquired all rights to the renal therapy program. See "- Collaborative and Licensing Agreements - Biogen, Inc." We have initiated a series of studies to investigate the potential of OP-1 to moderate the progression of chronic renal failure. Results indicate that systemic administration of OP-1 can retard the progressive loss of kidney function in an animal model of chronic renal failure. Additional preclinical studies are currently underway. We hope to initiate human clinical investigation of an OP-1 product for the treatment of chronic renal failure once preclinical studies are completed. Acute Renal Failure. Acute renal failure is the rapid and sudden loss of the kidneys' ability to perform their essential functions and is often associated with multiple organ failure and a high mortality rate. The primary causes of acute renal failure are interruptions of blood flow (often as a result of certain surgical procedures or cardiac arrest), trauma and certain medications with toxic side effects to the kidneys. Based on data from the National Center for Health Statistics and other sources there were 250,000 diagnosed cases of acute renal failure in the United States in 1995. Currently, therapies that prevent, improve recovery or reduce the extent of kidney injury from acute renal failure are limited. Animal studies have been conducted by our scientists and collaborators to determine if acute renal failure can be treated with systemic administration of OP-1. Results of these studies indicate that an OP-1 product can reduce the extent of injury to the kidneys and promote more rapid recovery of kidney function in animal models of acute renal failure. Although clinical trials are difficult to design in this indication, we are currently exploring potential avenues for a therapy in acute renal failure. Neurological Disorders A number of neurological disorders, including stroke, Parkinson's disease, brain trauma, Alzheimer's Disease, and Amyotrophic Lateral Sclerosis (Lou Gehrig's Disease), are characterized by the acute or progressive death of neurons or the loss of neuronal function. We have completed a number of cell-based studies which indicate that OP-1 can promote neuron survival and can induce the formation or development of dendrites, the structures on neurons which pick up signals from other neurons. This dendrite formation effect of OP-1 may be an important factor in maintaining or recovering function following neurological injury or disease. Based on these findings, we have initiated a preclinical investigation to study the use of OP-1 as a treatment for certain neurological disorders. In addition to our research activities with OP-1, we are investigating the effect of other proprietary proteins in the treatment of disease and injury affecting the central nervous system. To complement our in- house proteins, we have licensed exclusive rights to GDF-1, a growth factor with potential in the treatment of a number of nervous system disorders. Stroke. Strokes occur when blood flow to the brain is interrupted by a clogged or burst artery. The interruption deprives the brain of oxygen and nutrients, and causes neurons to die. Stroke is the third leading cause of death in the United States and the number one cause of adult disability. The National Stroke Association has estimated that approximately 730,000 Americans suffer strokes every year and that four million Americans are permanently disabled because of stroke. Therapeutics currently available to aid the recovery from stroke are limited. We believe that there is a substantial commercial opportunity for a protein-based therapy that could promote enhanced recovery from stroke. Research by our academic collaborators has indicated that OP-1 can promote the development of dendrites on neurons and thereby enhance the ability of neurons to establish connections with adjacent neurons. This activity may enable the brain to form new neuronal connections and may aid recovery following stroke. In preclinical studies conducted by our collaborators at Massachusetts General Hospital, the OP-1 group showed a statistically significant improvement in the rate and extent of motor skills recovery compared to the control group with administration a full three days following the stroke. We are continuing these studies with the goal of initiating human clinical investigation of OP-1 as a treatment to enhance recovery from stroke. 10 We believe that OP-1 represents a potential significant advance in stroke therapy. Most therapies in development or on the market for stroke are designed to limit the damage caused to the brain tissue and must therefore be administered within hours of the stroke's onset. In contrast, OP-1 appears to enhance the body's natural regenerative processes to help the brain compensate for areas damaged by the stroke. The ability to administer this agent three days after a stroke may also provide a clinical advantage in design of trials and in the care of patients. All of the data generated in our stroke therapy research is derived from preclinical studies. The therapy has not yet been tested in human clinical trials. Research Programs New Applications of Morphogenic Proteins. The morphogenic proteins to which we have proprietary rights are involved in the development of several tissues and mediate the activity of many cell types. We are exploring the biology and activity of these proteins to identify new therapeutic applications of our proteins. Among these potential applications in early research are the treatment of inflammatory bowel disease, treatment of certain vision impairments and other new product opportunities. These programs are in an early stage of research and require significant development work to determine the therapeutic potential of such possible future products. Molecular Therapeutics. In addition to identifying and characterizing OP-1 and other morphogenic proteins, we have identified the DNA sequences which regulate the expression of OP-1, identified the cellular receptors to which morphogenic proteins bind and through which they act, and determined the three-dimensional structure of OP-1. We are currently seeking to use this knowledge to format assays for screening to identify orally-active drug compounds that either promote endogenous morphogenic protein expression or mimic morphogenic protein biological activities. In addition, the information that relates to the three- dimensional structure of OP-1 can be used to aid the rational design or modification of small molecule drug candidates. These assays and information have enabled us to develop a molecular therapeutics program that seeks to identify the next generation of drug development candidates based on morphogenic protein biology. COLLABORATIVE AND LICENSING AGREEMENTS Stryker Corporation. We have had a collaboration agreement with Stryker to identify and develop bone-inducing proteins and to develop dental therapeutics. OP-1 was first isolated and characterized by our scientists under this collaboration. Under such agreement, in exchange for research funding, future royalties and revenue from commercial manufacturing, we developed OP-1 as a therapy for orthopaedic reconstruction and cartilage regeneration, and supplied Stryker material for use in clinical trials. We devoted significant time and resources to developing and implementing the commercial scale process for manufacturing the OP-1 bone graft device. We restructured our agreement with Stryker in November 1998 to provide Stryker with the exclusive rights to manufacture OP-1 products in these fields. At that time Stryker acquired our commercial manufacturing operations. As a result, Stryker has the exclusive right to develop, market, manufacture, and sell products based on OP-1 proteins for use in orthopaedic reconstruction and dental therapies. In June 1999, Stryker announced that they had submitted a Pre-Market Approval application to the U.S. Food and Drug Administration and a Marketing Authorization Application in Europe to the European Medicines Evaluation Agency. The FDA accepted Stryker's application for filing in July 1999. In December 1999, Stryker also filed for regulatory approval in Australia. The applications are Stryker's formal requests to the various regulatory authorities for approval to market the product. Under our agreement with Stryker, as amended, Stryker has exclusive rights to develop, market and sell products incorporating bone and cartilage-inducing proteins developed under the research program, including OP-1, for use in the field of orthopaedic reconstruction and dental therapeutics. Subject to certain exceptions in connection with the acquisition or merger of our company, we have also agreed not to undertake any research, development or commercialization of any products in the fields of orthopaedic reconstruction and dental therapeutics, on our own behalf or for third parties, for the term of certain patents. We have the exclusive and irrevocable right to develop, market and sell products incorporating morphogenic proteins 11 developed under the research program, including OP-1, for all uses and applications other than orthopaedic and dental reconstruction such as renal failure, neurological diseases, osteoporosis, and others. Subject to certain exceptions in connection with the acquisition or merger of Stryker, Stryker has agreed not to undertake any research, development or commercialization of any products in our field, on their own behalf or for third parties, for the term of those patents. Each of our companies has the right to grant licenses to third parties in its respective field, and each is obligated to pay royalties to the other on its sales of such products and to share royalties received from licensees. We maintain an exclusive license in our field (applications other than orthopaedic reconstruction and dental therapies) under certain patents and claims that we assigned to Stryker in November 1998, as part of the sale of certain manufacturing rights and assets to Stryker. In addition, we granted Stryker an exclusive license under patents in our morphogen portfolio for use in the fields of orthopaedic reconstruction and dental therapeutics. Biogen, Inc. We are developing an OP-1 based therapy for chronic renal failure, a condition characterized by the slow progressive loss of kidney function ultimately resulting in the need for kidney transplantation or dialysis. Chronic renal failure represents a substantial unmet medical need. Preclinical studies indicate that OP-1 administration improves kidney function in animal models of both acute and chronic renal failure. Through December 1999, we had a development agreement with Biogen under which Biogen provided funding for and retained an option to OP-1 based therapies for chronic renal failure. Biogen did not exercise its option, and we have assumed all rights to OP-1 renal therapies. Genetics Institute. We have a cross-license agreement with Stryker and Genetics Institute, Inc., a wholly-owned subsidiary of American Home Products Corporation. Each party to the agreement has cross-licensed its worldwide patent rights to each of the other parties, royalty-free, in the bone morphogenetic/ osteogenic protein family. The agreement allows the companies to commercialize their respective lead compounds, which are now in clinical trials for bone repair and regeneration, free of the risk of patent litigation among the parties. Under the agreement, which covers both then issued patents and pending patent applications, we and Stryker have exclusive rights to OP-1, under both our own and Genetics Institute's patents. Genetics Institute and Yamanouchi Pharmaceutical Company, Ltd., its collaborative partner in the worldwide development of certain bone growth factors, have exclusive rights to BMP-2, their lead compound, under both their own and each of Creative BioMolecules' and Stryker's patents. In addition, the companies have granted each other royalty- free, non-exclusive cross-licenses to patents and patent applications covering certain other related morphogenic proteins. Academic Collaborations. We have relationships with a number of academic investigators who are focused on testing morphogenic proteins in tissue regeneration and restoration applications. In our collaborations, we seek to expand the scientific knowledge concerning tissue formation as well as the activities and characteristics of various proteins under development by our scientists. The academic collaborators are not our employees. Hence, we have limited control over their activities and limited amounts of their time are dedicated to our projects. From time to time, we have relationships with other commercial entities, some of which may be our competitors. Although the precise nature of each relationship varies, the collaborators and their primary affiliated institutions generally sign agreements that provide for confidentiality of our proprietary technology and results of studies. We seek to obtain exclusive rights to license developments that may result from these studies; however, we cannot assure you that we will obtain them. Enzon Cross-Licensing Agreement. We own a number of issued U.S. and foreign patents with broad claims on the composition of BABS(TM) (Biosynthetic Antibody Binding Sites) proteins and their interdomain linkers. BABS(TM) is a separate technology developed by us, and to which we have retained rights, but which is not currently being utilized in our morphogen development programs. Some of our BABS(TM) technology is also covered by patents held by Enzon Corporation, or Enzon. In December 1993, we signed cross-licensing and collaboration agreements with Enzon which consolidate the two companies' intellectual property rights and know-how covering BABS(TM) proteins. The parties have agreed to outlicense the combined technology to third parties on a non-exclusive basis in exchange for license, milestone and royalty payments. We believe that 12 consolidation of the companies' respective positions relating to BABS(TM) proteins has created a strong proprietary position in the use and manufacture of these novel proteins. MANUFACTURING We developed significant manufacturing experience in the scale-up and production of recombinant proteins, including OP-1. This manufacturing experience prepares us to move forward with our morphogenic proteins programs. We have produced a number of protein candidates by bacterial fermentation as well as by mammalian cell culture techniques in the laboratory, scaled-up both of these production processes, and produced clinical grade recombinant proteins. Our protein formulation and analytical science capabilities support the development and preparation of clinical grade-materials incorporating BMPs. In addition, we currently maintain inventories of GMP-grade OP-1 suitable for clinical evaluation and research-grade material of other BMPs for research and preclinical evaluation. In November 1998, as part of our agreement with Stryker, we sold our commercial manufacturing operations to Stryker. COMPETITION The therapeutic products that we are developing will compete with existing and new products being developed by others for treatment of the same indications. Competition in the development of human therapeutics is particularly intense and includes many large pharmaceutical and biopharmaceutical companies, specialized biotechnology firms, universities and other research institutions. Many of these companies have extensive financial, marketing and human resources which may result in significant competition. Others have extensive experience in undertaking clinical trials, in obtaining regulatory approval to market products and in manufacturing on a large scale which may enhance their competitive position. The technology underlying the development of human therapeutic products is expected to continue to undergo rapid and significant advancement and change. In the future, our technological and commercial success will be based on our ability to develop proprietary positions in key scientific areas and efficiently evaluate potential product opportunities. We are aware of a number of companies that are engaged in the research and development of morphogenic proteins for the repair of bone and cartilage. We are aware that Genetics Institute, acquired in 1996 by American Home Products Corporation, and its collaborative partners are pursuing the development of bone morphogenetic proteins and have initiated human clinical trials of a recombinant bone morphogenetic protein for the repair of orthopaedic and other skeletal defects. Genetics Institute has entered into relationships with Yamanouchi Pharmaceuticals Co., Ltd. and Medtronic Sofamor Danek, Inc. covering development and marketing of bone morphogenetic proteins. Other companies may attempt to develop products incorporating proteins purified from bone, which may include bone morphogenetic proteins, for orthopaedic applications. In addition, we believe that a number of biopharmaceutical companies are developing other recombinant human proteins, primarily growth factors, for use in the repair of bone and cartilage defects and in other indications. A number of other companies are pursuing traditional therapies, including autografts, allografts and electrical stimulation devices, as well as cell and gene therapies for the repair of bone and cartilage defects that may compete with our products. We believe that potential dental or periodontal products that Stryker may develop, will compete primarily with traditional therapies and therapies incorporating other morphogenic proteins or growth factors. Genetics Institute is also pursuing the development of bone morphogenetic proteins for the repair of dental and periodontal tissue. Several biotechnology and pharmaceutical companies are developing recombinant protein based products for the treatment of renal and neurological disorders. In the field of renal failure, companies are evaluating several 13 different products in human clinical studies for acute renal failure, some of which may also be under review preclinically for chronic renal failure. We are not aware of any companies developing morphogenic protein based products for either acute or chronic renal failure. In the field of neurological disorders, particularly in the area of stroke therapy, there are several companies engaged in preclinical and clinical studies with recombinant protein based and more traditional small molecule products. A number of biotechnology and pharmaceutical companies are pursuing the development of other recombinant growth factors and hormones for the treatment of osteoporosis. We believe that only a limited number of companies are seeking to develop morphogenic proteins for the treatment of osteoporosis. However, many major pharmaceutical companies are pursuing the development of traditional drug therapies for the treatment of osteoporosis. Certain therapies approved or in development for osteoporosis have demonstrated efficacy at slowing the loss of bone mineral density and improving clinical outcomes for patients. Such therapies provide alternatives to the treatment of osteoporosis that would compete with any osteoporosis products developed by us. In addition to competing with pharmaceutical and biotechnology companies, our products and technologies will also compete with those developed by academic institutions, government agencies and other public organizations conducting research. Any of these organizations may discover new therapies, seek patent protection or establish collaborative arrangements for product research which are competitive with our products and technologies. In addition to a product's patent position, efficacy and price, the timing of a product's introduction may be a major factor in determining eventual commercial success and profitability. Early entry may have important advantages in gaining product acceptance and market share. Accordingly, the relative speed with which we or our collaborative partners can complete preclinical and clinical testing, obtain regulatory approvals, and supply commercial quantities of the product is expected to have an important impact on our competitive position, both in the United States and abroad. Other companies may succeed in developing similar products that are introduced earlier, are more effective, or are produced and marketed more effectively. If any research and development by others renders any of our products obsolete or noncompetitive, then our potential for success and profitability may be limited. PATENTS AND PROPRIETARY RIGHTS We pursue a policy of obtaining broad patent protection for patentable subject matter relating to our proprietary technology platform in tissue repair and regeneration. As of March 2, 2000, we owned or had rights to 79 issued patents and 72 pending patent applications in the United States, and owned or had rights to 58 issued foreign patents and 164 foreign patent applications. These patents and patent applications cover compositions of matter, fields of uses, screening, and methods of production as well as patents relating to our morphogenic protein technology, BABS(TM), and interdomaine linker technology. Certain patents and patent applications relating to morphogenic proteins, including OP-1, are owned by Stryker and have been licensed exclusively to us for use in all indications other than orthopaedic reconstruction and dental therapeutics. See "- Collaborative and Licensing Agreements - Stryker Corporation." Certain other patents and patent applications are owned jointly with other collaborators. There can be no assurance, however, that any such patent applications will issue as patents, or that any patent now issued, or to be issued, will provide a preferred position with respect to the technology or products it covers. Within our patent estate covering morphogenic protein technology, we own or have rights to 52 issued and 69 pending applications in the United States, and 44 issued and 145 pending counterpart foreign applications, which contain claims to novel therapies and processes, as well as numerous tissue applications, including renal, neural, bone, liver, periodontal, dentin, gastrointestinal tract and immune cell-mediated tissue applications. 14 We have entered into a cross-license agreement with Stryker and Genetics Institute in which the parties granted worldwide, royalty-free, cross licenses to each other in the bone morphogenetic/osteogenetic protein family. This agreement reduces the threat of potential litigation to our development programs and with Stryker's efforts to commercialize OP-1. We have also entered into a cross-license agreement with Stryker under which we assigned ownership of certain manufacturing and other patents and patent applications to Stryker relating primarily to the OP-1 bone regeneration and dental therapeutics products. We retained an irrevocable, exclusive license to these patents for all uses outside the fields of orthopaedic reconstruction and dental therapeutics. We also granted to Stryker a license to certain patents and patent applications in our morphogen portfolio for use exclusively in the fields of orthopaedic reconstruction and dental therapeutics. Our success will depend in part on our ability to obtain marketing exclusivity for our products for a period of time sufficient to establish a market position and achieve an adequate return on our investment in product development. We believe that protection of our products and technology under United States and international patent laws and other intellectual property laws is an important factor in securing such market exclusivity. U.S. patents issued from applications filed prior to June 8, 1995 have a term of the longer of 17 years from patent grant or 20 years from the earliest filing date. U.S. patents issued from applications filed on or after June 8, 1995, have a term of 20 years from the earliest filing date. Patents in most foreign countries have a term of 20 years from the date of the filing of the patent application. In the United States and certain foreign countries, the exclusivity period provided by patents covering pharmaceutical products may be extended by a portion of the time required to obtain regulatory approval for a product. Certain patents relating to OP-1 owned by Stryker and licensed to us will begin expiring in 2005. Although we pursue patent protection for our technology, significant legal issues remain as to the extent to which patent protection may be afforded in the field of biotechnology, in both the United States and foreign countries. Furthermore, the scope of protection has not yet been broadly tested. Therefore, we also rely upon trade secrets, know-how and continuing technological advancement to develop and maintain our competitive position. Disclosure of our know-how is generally protected under confidentiality agreements. We do not know, however, whether all our confidentiality agreements will be honored, that third parties will not develop equivalent technology independently, that disputes will not arise as to the ownership of technical information or that wrongful disclosure of our trade secrets will not occur. Certain products and processes important to us may be subject in the future to patent protection obtained by others. The field of biotechnology is developing rapidly. Because many patent applications have been filed in this field in recent years, we cannot predict the scope that courts will give to the claims of patents issued from such applications and the nature of these claims. Several patent applications based on work done years ago have been issued to others with broad claims directed to the use of basic recombinant DNA technology. We believe that it is premature to predict what general trend, if any, will emerge as to the breadth of allowed claims for biotechnology products and related uses. The allowance of broader claims may increase the incidence and cost of interference proceedings at the United States Patent and Trademark Office and the risk of infringement litigation. A policy of allowing narrower claims, conversely, could limit the value of our proprietary rights under our patents. It is possible that Patent and Trademark Office interference proceedings will occur with respect to a number of our patent applications or issued patents. It is also likely that subject matter patented by others will be required by us to research, develop, or commercialize at least some of our products. If we are unable to obtain licenses under any such patent rights of others on acceptable terms then we may have to limit or terminate the development of some or all of our products. REGULATORY ISSUES Regulation by governmental agencies in the United States and other countries is a significant factor in the clinical evaluation and licensing of our potential products as well as in the development and research of new 15 products. All of our products currently under development will require regulatory approval by the FDA under the Food, Drug, and Cosmetic Act, or FD&C Act, as a drug or device, or under the Public Health Service Act as a biological, to be marketed in the United States. Regardless of the classification assigned to our products, all human diagnostic and therapeutic products are subject to rigorous testing. Generally, considerable time and expense are required to clinically evaluate the safety and efficacy of a new product. Moreover, even after extensive preclinical testing, unanticipated side effects can arise during clinical trials that can halt or delay the regulatory process at any point. Seeking and obtaining regulatory approval for a new therapeutic or diagnostic product is likely to take several years and will require the expenditure of substantial resources. Products developed through genetic engineering, such as ours, are relatively new, and state and local regulation may increase as genetically engineered products become more common. The federal government oversees certain recombinant DNA research activity through the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules, or the NIH Guidelines. We believe that our activities comply with the NIH Guidelines, which prohibit or restrict certain recombinant experiments, set forth levels of biological and physical containment of recombinant DNA molecules to be met for various types of research, and require that institutional biosafety committees approve certain experiments before they are initiated. Compliance with the NIH Guidelines has not had, and we do not foresee that it will have, a material effect on our competitive position or cash flow. Discussions have been underway since 1996 between NIH and FDA regarding alternative models for regulation of recombinant DNA research and the products resulting from such research, and the appropriateness of any continued NIH role. It is not possible to predict the effect of such potential regulatory changes on us or our potential competitors. On November 21, 1997, the FDA Modernization Act of 1997, or FDAMA, was enacted into law. In addition to reauthorizing the collection of user fees for prescription drugs, FDAMA changed the FD&C Act in numerous ways. Because some provisions of FDAMA require the FDA to develop further regulations, or are unclear, it is not possible for us to predict the overall effect of FDAMA on us or our potential competitors. Pharmaceutical and Biological Products. We expect that certain of our potential products will be regulated by the FDA as pharmaceuticals or biologicals. The regulatory approval of pharmaceutical and biological products in the United States intended for therapeutic use in humans involves many steps. The initial phase of the FDA approval process involves preclinical testing to demonstrate that the product would not be an unreasonable hazard in clinical studies with human subjects. Preclinical tests must typically meet the FDA's good laboratory practices regulations if they are to be used for the purpose of an application to the agency. Upon completion of preclinical testing, an IND application must be filed with the FDA. The application must include the following distinct sets of information: 1) Information on the composition of the product including pharmacology and toxicology; 2) Chemistry, manufacturing, and control information; 3) Results of all the preclinical safety and efficacy investigations including in vivo and in vitro studies; 4) Information on any previous human experience with the product; 5) A clinical development plan and protocol; 6) Information on the investigators; 7) The necessary agreements among parties involved in the testing; and, 8) Approval of an Institutional Review Board at the center(s) conducting the study or studies. If the application has not been denied or if additional information has not been requested by the FDA within 30 days of filing, the applicant may then begin clinical studies. Clinical testing usually occurs in three phases to demonstrate safety and efficacy of the product. 1) Phase I clinical trials consist of testing for the safety and tolerance of the product with a small group of subjects and may also yield preliminary information about the efficacy and dosage levels of the product. 16 2) Phase II clinical trials involve testing for efficacy, determination of optimal dosage and identification of possible side effects in a larger patient group. 3) Phase III clinical trials consist of additional testing for efficacy and safety with an expanded patient group. Currently, FDA requires the filing of new information for each distinct clinical study. After product approval, FDA may request or require an additional phase (Phase IV) of clinical studies to provide additional information on safety and efficacy. Upon successful completion of Phase III testing, either a New Drug Application, or NDA or Biologics License Application, or BLA must be filed, depending upon whether the product is designated as a drug or a biological, respectively. The FDA generally requires at least two adequate and well-controlled clinical trials for product approval. All approvals require a detailed review of all data collected from clinical studies, the composition of the drug or biological, non- clinical pharmacology and toxicology data, environmental impact data, human pharmacokinetics and bioavailability data, patient information, certain case report data and forms, the labeling that will be used, information on chemistry, manufacturing, and controls, and samples of the product. After the FDA completes its review of the application, the product is typically reviewed by a panel of independent medical experts, and the applicant is required to answer questions on its safety and efficacy. The FDA considers the recommendation of the panel, and may at its own discretion approve an NDA or BLA. If so approved, the product may then be marketed. Devices. We expect that certain of our potential products will be regulated by the FDA as Class III devices. Preclinical evaluations of Class III devices are similar to those of pharmaceuticals and biologicals, with additional emphasis on implant persistence, implant sensitization, and carrier characterization and specifications. Upon completion of preclinical testing, an IDE application is filed with the Center for Devices and Radiological Health in the FDA. This application consists of the following distinct sets of information: 1) Identifying information on the sponsor; 2) Complete reports of prior investigations of the device; 3) Summary of the investigational plan (or the complete plan); 4) Description of the methods, facilities, and controls used for manufacturing, processing, packing, storage, and installation of the device; 5) Example investigator agreements; 6) List of investigators; 7) Certifications concerning investigators and Investigational Review Boards; 8) Copies of labeling; and, 9) Materials relating to environmental impact and informed consent. If the application has not been denied by the FDA within 30 days of filing, the applicant may then begin clinical studies. The FDA may notify the applicant of approval before the end of the 30 day period, in which case the applicant may begin clinical studies immediately. The clinical testing of a device may consist of a preliminary feasibility study leading to a much larger pivotal safety and effectiveness study, or it may consist of only one or more larger pivotal safety and effectiveness studies. Upon successful completion of the clinical testing and compilation of the data, a PMA application can be filed. This application consists of the following: 1) Indications for use; 2) Product description; 3) Discussion of alternatives to use of the device; 4) Marketing history (worldwide); 5) Review of clinical studies and results; 6) Methods, facilities and controls (as in an IDE); 7) Non-clinical data; 17 8) If only one clinical study is used, a justification of that approach; 9) Identification and bibliography of any information relevant to the safety and effectiveness of the device; 10) Product samples; 11) Product labeling; and, 12) Certain environmental information. The FDA is required to respond to the PMA submission within 180 days, although the FDA may not adhere to this schedule and further review may take additional time. After the FDA completes its review of the application, the product is typically reviewed by a panel of medical experts, and the applicant is required to answer questions on its safety and effectiveness. At the recommendation of the panel, a PMA may be granted, and the product may then be marketed. Treatment IND Status. Before the completion of clinical trials for a specific product, a company may file for Treatment IND status under provisions of the IND regulations. These regulations apply to products for patients with serious or life-threatening diseases and are intended to facilitate the availability of new products to desperately ill patients after clinical trials have shown convincing evidence of efficacy, but before general marketing approval has been granted by the FDA. Under these regulations, it may be possible for us to recover some of the costs of research, development and manufacture of qualified products before commercial marketing begins. We may seek Treatment IND status for qualified products, although the decision whether to grant such status lies with the FDA. FDAMA codifies many of the FDA's previous treatment IND regulations. In addition, it creates new authority for expanded access to investigational therapies for serious diseases, if the request is performed through a physician, the product shows sufficient evidence of safety and efficacy, and provision of the product would not interfere with ongoing clinical research. The FDA has also adopted regulations intending to accelerate the approval of therapeutic products for serious and life threatening diseases under certain circumstances. We may seek to utilize these regulations for qualified products. Approvals under these regulations may be conditioned on further studies, may include restrictions on marketing, may require prior submission of promotional materials, and may be subject to expedited withdrawal of approval. In addition to existing FDA regulations, FDAMA added new "fast track" authority allowing FDA to expedite the approval of drugs for serious or life-threatening conditions. Requirements for fast track drugs are similar to those for accelerated approval, including FDA authority to require post- approval clinical studies, presubmission of promotional materials, and enhanced NDA withdrawal authority. User Fees. FDAMA amended existing laws to continue FDA authorization to charge user fees for prescription drug products. The purpose of the user fee provisions of FDAMA is to reduce the time that FDA takes to act on completed applications. Under an informal letter arrangement, FDA has committed to act on priority applications within 6 months, regular applications within 12 months (reducing to 10 months over the next 5 years), manufacturing supplements within 6 months (reducing to 4 months over the next 5 years), and resubmissions with relatively minor new information within 6 months (reducing to 2 months over the next 5 years). The user fee provisions of FDAMA contemplate that the fees will be used to fund additional resources at FDA to enable it to meet these informal review deadlines. However, the law itself does not impose an affirmative obligation on FDA to meet these deadlines or any overall approval goals. Some companies may receive an exemption from user fees, either because they qualify as small businesses, because their products are used for rare diseases or conditions, or because they meet other technical exceptions contained in the law. FDAMA continues FDA authority to grant waivers to protect the public health, if fees would exceed costs, on equitable grounds, or for small businesses. Because FDAMA changed the existing waiver provisions of the previous user fee law, it is not clear whether existing FDA draft guidances on waiver criteria apply or will have to be redrafted. We may seek exceptions or waivers for our products as appropriate, although given the 18 current uncertainty of the law, we can not predict whether such exceptions or waivers will be granted. The user fee provisions of the FD&C Act, as modified by FDAMA, do not currently apply to medical devices. Facilities Inspection. In addition to product approval prior to marketing, we must also obtain FDA approval of the facility in which our products will be manufactured. In the case of a pharmaceutical, biological or a device, we must be in compliance with cGMP requirements. The FDA may inspect our facilities to determine such compliance as part of the overall NDA, BLA, or PMA approval. Since any NDA, BLA or PMA approved by the FDA is both site and process specific, any material change in our manufacturing process, equipment or location would necessitate additional FDA review and approval process. Recently, the FDA promulgated new regulations concerning cGMPs for medical devices. These new regulations include elements drawn from existing international standards and a new emphasis on design control of medical devices (in addition to the existing focus on manufacturing). Until these new regulations are better understood by industry, compliance with medical device cGMPs may prove more difficult than in the past, and may require the use of additional resources or even the redesign of some existing devices or facilities. Foreign Regulations. Regulations concerning the marketing of human therapeutic and diagnostic products are generally imposed by foreign governments and may have an impact on our anticipated operations. The requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement levels vary widely from country to country. We attempt to conduct our development activities in a manner that would also support regulatory filings in selected foreign countries. Other. Amendments to the federal laws have loosened export restrictions on therapeutic products, including amendments permitting the export of products not yet approved in the United States but approved in certain foreign countries. We may choose to conduct such exports of our products prior to obtaining FDA marketing approval in the United States. In addition, we are subject to regulation under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Research Conservation and Recovery Act, regulations administered by the Nuclear Regulatory Commission, national restrictions on technology transfer, import, export and customs regulations and certain other local, state or federal regulation. From time to time, other federal agencies and congressional committees have indicated an interest in implementing further regulation of biotechnology applications. We are not able to predict whether any such regulations will be adopted or whether, if adopted, such regulations will adversely affect our business. EMPLOYEES In October 1999, we refocused our operational and financial resources on the development of our morphogenic protein-based clinical candidates for the treatment of stroke and renal disease. This redirected effort resulted in a reduction of our employee headcount. Currently, we have approximately 40 full- time employees, 20 of whom hold Ph.D. degrees. We consider our relations with our employees to be good and, apart from the recent restructuring, have experienced a low rate of employee turnover. None of our employees are parties to a collective bargaining agreement. We have entered into confidentiality agreements with all of our employees. RECENT UPDATE On February 15, 2000, we announced that we will merge with Ontogeny, Inc., and Reprogenesis, Inc., to form a public company named Curis, Inc. Under the terms of the merger, which is subject to stockholder approval, our stockholders will receive three Curis shares for every ten shares of our Common Stock. Following completion of the transaction, our stockholders will hold approximately 43%, Ontogeny's stockholders will hold approximately 38% and Reprogenesis' stockholders will hold approximately 19% of Curis. For accounting purposes, Curis, our successor, will record the merger as a purchase of Reprogenesis and Ontogeny. The merger is expected to close in June 2000. 19 Item 2. DESCRIPTION OF PROPERTY We currently lease an aggregate of 35,400 square feet in two adjacent facilities in Hopkinton, Massachusetts. The location of the facilities is approximately 30 miles west of Cambridge and Boston and 20 miles east of Worcester, all of which are major research centers in health care and biotechnology in Massachusetts. Our Hopkinton facilities house research and development laboratories, small scale production suites, and corporate offices. Both leases expire in 2001. In addition, we currently lease 10,500 square feet of office space in Boston, Massachusetts for administrative offices. The office lease expires in 2002. We believe that our existing facilities are adequate for our near term needs. We expect that additional facilities may be required to meet future needs; however, we cannot assure you that we will be able to lease or acquire additional facilities. 20 Item 3. LEGAL PROCEEDINGS There are no material pending legal proceedings to which we are a party or of which any of our property is the subject. Item 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matters were submitted during the fourth quarter of the year ended December 31, 1999, to a vote of our security holders. 21 PART II Item 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS Market Information Our Common Stock is traded on The Nasdaq Stock Market under the symbol CBMI. The following table presents quarterly information on the price range of our Common Stock, indicating the high and low sale prices reported by The Nasdaq Stock Market. High Low ---- --- 1999 - ---- 4th Quarter .............................. $5.00 $2.19 3rd Quarter .............................. 6.38 3.13 2nd Quarter .............................. 4.44 2.13 1st Quarter .............................. 3.69 2.00 1998 - ---- 4th Quarter .............................. $3.81 $1.75 3rd Quarter .............................. 5.00 2.31 2nd Quarter .............................. 8.75 4.13 1st Quarter .............................. 11.00 7.63 Stockholders As of February 25, 2000 we had approximately 332 stockholders of record of our Common Stock. Dividends We have never paid any dividends on our Common Stock and we do not intend to pay any dividends on our Common Stock in the foreseeable future. We intend to retain earnings, if any, for the development of our business. Recent Sales of Unregistered Securities During 1999, we issued a total of 1,311,395 shares of Common Stock in connection with the conversion of 2,928 shares of Series 1998/A Preferred Stock by the holders of such stock at conversion prices ranging from $2.16 to $2.52 per share. The aggregate conversion price was $3,055,762. We issued the shares of Common Stock without registration under Section 4(2) of the Securities Act of 1933, as amended. We did not use any underwriters in the transaction. On May 7, 1999, the Company repurchased the remaining shares of Series 1998/A Preferred Stock. 22 Item 6. SELECTED CONSOLIDATED FINANCIAL DATA We derived the selected consolidated financial data set forth below with respect to the consolidated statements of operations for the years ended December 31, 1999, 1998 and 1997, and with respect to the consolidated balance sheets as of December 31, 1999 and 1998, from the consolidated financial statements that have been audited by Deloitte & Touche LLP, independent auditors. The consolidated financial statements are included elsewhere in this Form 10-K. We derived the consolidated statements of operations data for the year ended December 31, 1996, for the three months ended December 31, 1995 and the year ended September 30, 1995, and the consolidated balance sheet data as of December 31, 1997, 1996 and 1995 from audited consolidated financial statements not included in this Form 10-K. You should read the data set forth below in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations" and the Consolidated Financial Statements and related Notes included in this Form 10-K.
Three Years Ended Months Year December 31, Ended Ended --------------------------------------------- December September Consolidated Statement of Operations Data: 1999 1998 1997 1996 31, 1995(1) 31, 1995(1) (In thousands, except per share amounts) ---- ---- ---- ---- ----------- ----------- Revenues: Research and development contracts $ 3,160 $ 10,419 $ 12,693 $ 5 ,548 $ 971 $ 5,824 Manufacturing contracts - - 394 4,486 770 6,159 License fees and royalties 52 10 - 11,122 2 544 Interest 1,924 2,184 2,331 1,174 261 649 Other 2 12 15 22 - 53 --------- --------- -------- -------- --------- --------- Total revenues 5,138 12,625 15,433 22,352 2,004 13,229 --------- --------- -------- -------- --------- --------- Costs and expenses: Research and development 10,435 24,856 25,122 15,651 3,194 11,688 Cost of manufacturing contracts - - 274 3,823 715 5,330 General and administrative 6,396 7,475 6,473 4,901 1,254 3,604 1999 reorganization and 1998 sale of manufacturing operations 256 1,362 - - - - Interest 161 327 216 217 61 229 --------- --------- -------- -------- --------- --------- Total costs and expenses 17,248 34,020 32,085 24,592 5,224 20,851 --------- --------- -------- -------- --------- --------- Net loss (12,110) (21,395) (16,652) (2,240) (3,220) (7,622) Accretion and repurchase costs on Series 1998/A Preferred Stock (2,395) (987) - - - - --------- --------- -------- -------- --------- --------- Net loss applicable to common stockholders $ (14,505) $ (22,382) $(16,652) $ (2,240) $ (3,220) $ (7,622) ========= ========= ======== ======== ========= ========= Basic and diluted loss per common share(2) $(0.40) $(0.66) $(0.50) $(0.07) $(0.11) $(0.37) ========= ========= ======== ======== ========= ========= Common shares for basic and diluted loss computation(2) 36,665 33,672 33,078 30,062 28,120 20,431 ========= ========= ======== ======== ========= ========= December 31, --------------------------------------------------------- 1999 1998 1997 1996 1995 ---- ---- ---- ---- ---- Consolidated Balance Sheet Data: (In thousands) Cash, cash equivalents and marketable securities $ 21,371 $ 57,935 $ 30,598 $ 50,075 $ 20,002 Working capital 17,116 49,613 32,381 48,174 21,743 Total assets 28,892 66,164 59,038 73,819 41,341 Capital lease obligations, less current 1,009 713 2,005 1,651 1,711 portion Accumulated deficit (124,977) (110,472) (88,090) (71,438) (69,198) Total stockholder's equity 23,422 33,105 52,709 67,261 37,829
- ---------- (1) In January 1996, we changed our fiscal year end from September 30 to December 31, effective with the three month period ended December 31, 1995. (2) See Note 1 of Notes to Consolidated Financial Statements for an explanation of the computation of basic and diluted loss per common share. 23 Item 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS General To date, we have derived most of our revenues from research and development payments and license fees under agreements with collaborative partners. We anticipate that over the next several years we will derive most of our revenues from agreements with collaborative partners, including possible royalty revenues from Stryker. We have never been profitable and expect to incur additional operating losses in 2000. Results beyond 2000 will depend largely on the timing and magnitude of royalty payments from Stryker if the OP-1 Device, currently under regulatory review with the Food and Drug Administration, or FDA, is approved for commercial sale and is sold. There can be no assurance we will receive substantial royalties from Stryker or, if we do, when those royalties will be received. We may incur continued losses in future years. Our research agreements with collaborative partners have typically obligated such collaborative partners to provide for the partial or complete funding of research and development for specified projects and pay royalties to us in exchange for licenses to market the resulting products. We have been a party to research collaborations with Stryker to develop products for orthopaedic reconstruction and dental therapeutics and with Biogen to develop products for the treatment of renal disorders. Each of these research collaborations was restructured in 1998. Under the research portion of our collaboration with Stryker, prior to its restructuring in November 1998, we supplied OP-1 products to Stryker for clinical trials and other uses, provided manufacturing regulatory support and performed research work pursuant to work plans we both established periodically. In November 1998, we sold certain of our OP-1 manufacturing rights and facilities to Stryker. In fiscal 1999, we have focused internal research efforts on developing new tissue regeneration therapies in non-bone applications and do not anticipate significant revenue from Stryker in 2000. We are developing an OP-1 based therapy for chronic renal failure, a condition characterized by the slow progressive loss of kidney function ultimately resulting in the need for kidney transplantation or dialysis. Chronic renal failure represents a substantial unmet medical need. Preclinical studies indicate that OP-1 administration improves kidney function in animal models of both acute and chronic renal failure. In 1998, we modified our partnership in renal therapy with Biogen, Inc., or Biogen, a leading protein therapeutics company. Biogen provided research funding to us through December 1999 pursuant to an option to resume responsibility for development of OP-1 as a therapy for chronic renal failure. As of December 31, 1999, Biogen did not exercise its option, and we have assumed all rights to OP-1 renal therapies. In October 1999, we reorganized and the Board approved a plan to focus our operations and financial resources on the development of morphogenic protein- based clinical candidates for the treatment of stroke and renal disease. In connection with this reorganization, we reduced our headcount from 70 to 43 employees. We recorded approximately $511,000 in operating expenses for salary termination costs. Although we are seeking and in the future may seek to enter into collaborative arrangements with respect to certain other projects, there can be no assurance that we will be able to obtain such agreements on acceptable terms or that the costs required to complete the projects will not exceed the funding available for such projects from the collaborative partners. We earn and recognize revenue based upon work performed, upon the sale or licensing of product rights, upon shipment of product for use in preclinical and clinical testing or upon attainment of benchmarks specified in collaborative agreements. Our results of operations vary significantly from year to year and quarter to quarter and depend on, among other factors, the timing of payments made by collaborative partners and the timing of contract manufacturing activities. The timing of our contract revenues may not match the timing of our associated product development expenses. As a result, research and development expenses may exceed contract revenues in any particular period. Furthermore, aggregate research and development contract revenues for any product may not offset all of our development expenses for such product. Results of Operations 24 Years Ended December 31, 1999 and 1998 Our total revenues in the year ended December 31, 1999 were $5,138,000. Our total revenues in the year ended December 31, 1998 were $12,625,000. Research and development contract revenues decreased 70% to $3,160,000 in 1999 from $10,419,000 in 1998. The decrease in research and development contract revenues from 1998 to 1999 was primarily the result of a decrease in our research and development contract revenues from Stryker because we are no longer providing research services or supplying OP-1 to Stryker. We anticipate that research and development contract revenues in the year ended December 31, 2000 will be substantially less than the comparable period in 1999. License fees and royalties revenues increased by $42,000 to $52,000 in 1999 from $10,000 in 1998. The increase in license fees and royalties revenue is partially due to royalties from Stryker and partially due to an increase in revenue from licensing patent rights and know-how associated with certain protein technology which is not central to our business. We expect that royalty revenues in the year ended December 31, 2000 will depend largely on the timing and magnitude of royalty payments from Stryker if the OP-1 Device, currently under regulatory review with the FDA, is approved for commercial sale. Interest revenues decreased 12% to $1,924,000 in 1999 from $2,184,000 in 1998 in part because we had lower average balances of cash and marketable securities and in part because of lower interest rates in 1999, as compared to 1998. In May 1998, we sold 25,000 shares of Series 1998/A Preferred Stock. Net proceeds to us, after deducting fees and other expenses of the offering, were approximately $23,618,000. In addition, we received approximately $19,530,000 in the fourth quarter of 1998 from the sale of our OP-1 manufacturing-related assets to Stryker. As discussed further below, in May 1999 we repurchased all of the outstanding Series 1998/A Preferred Stock for approximately $22,470,000 in cash. Our total costs and expenses decreased 49% to $17,248,000 in 1999 from $34,020,000 in 1998. Research and development expenses decreased 58% to $10,435,000 in 1999 from approximately $24,856,000 in 1998. The decrease in research and development expenses was primarily due to the sale of certain of our OP-1 manufacturing rights and facilities to Stryker in November 1998 and the elimination of manufacturing and facility-related expenses with respect thereto. We had previously reported the costs associated with such production of OP-1 as research and development expenses. During 1999, our research and development expenses included research relating to the following: (i) a renal disease therapy as part of the Biogen collaboration, (ii) neurological disease therapies and (iii) other indications proprietary to us. Stryker initiated a modular PMA filing for the bone graft substitute product in 1998. In June 1999, Stryker stated that it had completed submission of the modular PMA to the FDA, and in July 1999 stated that the FDA had accepted the PMA for filing. Stryker has also submitted for European and Australian regulatory review the OP-1 bone graft substitute product. General and administrative expenses decreased 14% to $6,396,000 in 1999 from $7,474,000 in 1998. The decrease was primarily due to a reduction in external legal and other consulting costs and a reduction in personnel-related costs. In October 1999, we reorganized and the Board approved a plan to focus our operations and financial resources on the development of morphogenic protein- based clinical candidates for the treatment of stroke and renal disease. In connection with this reorganization, we reduced our headcount from 70 to 43 employees. We recorded approximately $511,000 in operating expenses for salary termination costs. In addition, related to the 1998 sale of manufacturing operations, in the fourth quarter of 1999, we determined that health insurance claims were less than originally estimated. This resulted in a reduction in the loss on sale of manufacturing operations of approximately $255,000 in 1999. 25 The following table summarizes the effect to the income statement of the 1999 reorganization charges and 1998 sale of manufacturing operations during 1999: 1999 salaries and termination benefits $511,000 1998 salaries and termination benefits settled for amounts less than anticipated (255,000) -------- Total Net $256,000 ======== Interest expense decreased approximately 51% to $161,000 in 1999 from $327,000 in 1998. The decrease in interest expense was due to a decrease in our obligations under capital leases. As part of the sale to Stryker of certain of our manufacturing-related assets in November 1998, Stryker assumed $710,000 of our obligations under equipment lease agreements and $1,727,000 of our obligations under a facility capital lease. As a result of the foregoing, we incurred a net loss of $12,110,000 in 1999 compared to a net loss of $21,395,000 in 1998. Accretion and repurchase costs on Series 1998/A Preferred Stock was $2,395,000 for the year ended December 31, 1999, and included the following: $385,000 calculated at the rate of 5% per annum of the stated value of the outstanding Series 1998/A Preferred Stock; $144,000 of accretion of issuance costs related to the sale of Series 1998/A Preferred Stock; and as a result of the repurchase of the Series 1998/A Preferred Stock on May 7, 1999 (see discussion in "Liquidity and Capital Resources" below), a one-time charge of approximately $1,867,000 recorded in the second quarter of 1999 which represents accretion of the Series 1998/A Preferred Stock up to its repurchase amount and accretion of all remaining issuance costs. Accretion on Series 1998/A Preferred Stock for the year ended December 31, 1998 was $987,000 and includes $733,000, calculated at the rate of 5% per annum of the stated value of the outstanding Series 1998/A Preferred Stock from May 27, 1998 and $254,000 of accretion of issuance costs related to the sale of Series 1998/A Preferred Stock. As a result of the repurchase of the Series 1998/A Preferred Stock, there will be no further charges relating to the Series 1998/A Preferred Stock. In computing the net loss applicable to common stockholders for the years ended December 31, 1999 and 1998, the above mentioned accretion and repurchase costs of the Series 1998/A Preferred Stock is included. Years Ended December 31, 1998 and 1997 Our revenues in the year ended December 31, 1998 were $12,625,000. Our revenues in the year ended December 31, 1997 were $15,433,000. Research and development contract revenues decreased 18% from $12,693,000 in 1997 to $10,419,000 in 1998. The decrease in research and development contract revenues from 1997 to 1998 primarily is a result of a decrease in our research activity under the research collaboration with Biogen, partially offset by an increase in research and development contract revenues from the supply of OP-1 to Stryker. License fees and royalties revenues in the year ended December 31, 1998 included $10,000 in revenue from licensing patent rights and know-how associated with certain protein technology which is not central to our business. Interest revenues decreased 6% from $2,331,000 in 1997 to $2,184,000 in 1998 because we had higher average balances in cash and marketable securities in 1997 than we had in 1998. In December 1996, under the Biogen Research Agreement and a Restricted Stock Purchase Agreement, Biogen paid to us a $10,000,000 license fee and made an $18,000,000 equity investment in our Common Stock. In May 1998, we sold 25,000 shares of Series 1998/A Preferred Stock. Net proceeds to us, after deducting fees and other expenses of the offering, were approximately $23,618,000. In addition, we received approximately $20,000,000 in the fourth quarter of 1998 from the sale of our OP-1 manufacturing related assets to Stryker. Our total costs and expenses, consisting primarily of research and development expenses, increased approximately 6% from $32,085,000 in the year ended December 31, 1997, to $34,020,000 in the year ended December 31,1998. Research and development expenses decreased 1% from $25,122,000 in 1997 to $24,856,000 in 1998. Our research and development expenses for 1998 were slightly less than 1997 due to the sale of our OP-1 manufacturing rights and facilities to Stryker in November 1998 and the elimination of manufacturing and facility-related expenses. 26 General and administrative expenses increased 15% from $6,473,000 in 1997 to $7,475,000 in 1998. The increase primarily is due to approximately $600,000 in increased costs associated with additions to our legal and administrative staff and from increases in external legal and other consulting costs and from costs associated with our administrative office. In November 1998, we sold certain of our OP-1 manufacturing rights and facilities to Stryker. We expect that the sale will provide us with increased royalties on Stryker products, if approved for commercial sale, in lieu of the manufacturing revenue anticipated under the prior agreement. Proceeds and expenses associated with this transaction included the following: Total proceeds $19,530,000 Less: Net book value of manufacturing related assets 18,929,000 Employee termination costs 1,438,000 Legal, accounting and consulting costs 525,000 -------------- Loss on sale of manufacturing operations $(1,362,000) ============== We recorded a charge of $1,362,000 in the quarter ended December 31, 1998, in connection with this transaction. Interest expense increased 51% from $216,000 in 1997 to $327,000 in 1998. The increase in interest expense is due to an increase in our obligations under an equipment lease agreement. As part of the sale to Stryker of the manufacturing related assets, Stryker assumed $710,000 of our obligations under equipment lease agreements and $1,727,000 of our obligations under a facility capital lease. As a result of the foregoing, we incurred a net loss of $21,395,000 in the year ended December 31, 1998, compared to a net loss of $16,652,000 in the year ended December 31, 1997. Accretion on Series 1998/A Preferred Stock for the year ended December 31, 1998, includes $733,000, calculated at the rate of 5% per annum of the stated value of the outstanding Series 1998/A Preferred Stock from May 27, 1998 and $254,000 of accretion of issuance costs related to the sale of Series 1998/A Preferred Stock. We are accreting the Series 1998/A Preferred Stock up to its conversion value. In computing the net loss applicable to common stockholders for the year ended December 31, 1998, accretion of the Series 1998/A Preferred Stock mentioned above is included. Liquidity and Capital Resources At December 31, 1999, our principal sources of liquidity consisted of cash, cash equivalents and marketable securities of $21,371,000. We have financed our operations primarily through placements of equity securities, revenues received under agreements with collaborative partners, manufacturing contracts and the sale of certain of our OP-1 manufacturing rights and facilities to Stryker. We increased our investment in property, plant and equipment to $8,625,000 at December 31, 1999 from $7,702,000 at December 31, 1998. We currently plan to spend approximately $260,000 in the year ending December 31, 2000 in leasehold improvements and equipment purchases to upgrade our research and development capabilities. In May 1999, we extended a master lease agreement, which was originally entered into in October 1997, that provides for the sale and leaseback or lease of up to $750,000 of laboratory and office equipment. This lease commitment expired on December 31, 1999. On May 27, 1998, we completed a private placement with three institutional investors for the sale of 25,000 shares of Series 1998/A Preferred Stock, with a stated value of $1,000 per share resulting in net proceeds of approximately $23,618,000 after expenses. Since issuance of the Series 1998/A Preferred Stock, the holders converted a total of 4,514 shares of Series 1998/A Preferred Stock into 2,043,765 shares of Common Stock through May 7, 1999. On May 7, 1999, we repurchased 20,486 shares which represented all of the outstanding Series 1998/A Preferred Stock following final conversions, for approximately $22,470,000 in 27 cash. As a result of this transaction, the Series 1998/A Preferred Stock has been retired and there will be no subsequent conversions into Common Stock. In November 1998, we sold certain of our OP-1 manufacturing rights and facilities to Stryker for total proceeds of approximately $19,530,000. In addition, we expect that the sale will provide us with increased royalties on Stryker products, if approved for commercial sale, in lieu of the manufacturing revenues anticipated under the prior agreement. We paid approximately $647,000 of accrued costs related to the sale of the manufacturing operation, principally for employee termination costs, in the year ended December 31, 1999. In prior years, we received significant revenue from Stryker for research support and the supply of OP-1. As a result of the sale of these OP-1 manufacturing rights and facilities to Stryker, we received significantly reduced research funding in the year ended December 31, 1999 and anticipate the same in the year ending December 31, 2000. In December 1998, we signed the Biogen Amendment Agreement. Under the Biogen Amendment, Biogen paid $3,000,000 to fund our research in 1999 for development of OP-1 as a therapy for chronic renal failure. Biogen retained an option through December 1999 to resume responsibility for development of OP-1 as a therapy for chronic renal failure. Biogen did not exercise its option by December 31, 1999 and has no further obligation to provide funds to us. We have assumed all rights and responsibilities, independent of Biogen, for the development of renal failure therapies. We anticipate that our existing capital resources should enable us to maintain our current and planned operations through approximately March 31, 2001. We expect to incur substantial additional research and development and other costs, including costs related to preclinical studies and clinical trials. Our ability to continue funding planned operations is dependent upon our ability to generate sufficient cash flow from royalties on Stryker products, if approved for commercial sale, from collaborative arrangements and from additional funds through equity or debt financings, or from other sources of financing, as may be required. We are seeking additional collaborative arrangements and also expect to raise funds through one or more financing transactions, if conditions permit. Over the longer term, because of our significant long-term capital requirements, we intend to raise funds when conditions are favorable, even if we do not have an immediate need for additional capital at such time. If Stryker products are not approved for commercial sale, or are approved but do not result in our receiving significant royalty payments from Stryker, and substantial additional funding is not available, our business will be materially and adversely affected. New Accounting Standards In June 1998, the Financial Accounting Standards Board, or FASB, released Statement of Financial Accounting Standards, or SFAS, No. 133, "Accounting for Derivative Instruments and Hedging Activities," or SFAS No. 133, which we will be required to adopt effective January 1, 2001. SFAS No. 133 establishes standards for reporting and accounting for derivative instruments, and conforms the requirements for treatment of hedging activities across the different types of exposures hedged. We have not yet completed our evaluation of SFAS No. 133, and are therefore unable to disclose the impact adoption will have on our consolidated financial position or results of operations. Year 2000 Compliance We did not experience any difficulties related to the Year 2000 problem on December 31, 1999 and are not aware of any such difficulties since that date. Our operations have not, to date, been adversely affected by any difficulties experienced by any of our suppliers or customers in connection with the Year 2000 problem. The Company's Year 2000 Compliance Plan also addressed issues related to the date February 29, 2000 and management will continue to monitor our systems for potential difficulties for the remainder of calendar year 2000. 28 Cautionary Factors with Respect to Forward-Looking Statements This Form 10-K contains forward-looking statements which are based on management's current expectations and which involve risks and uncertainties. Our actual results may differ significantly from the results discussed in the forward-looking statements. We caution investors that there is no guarantee that the actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to the following: . Our reliance on current and prospective collaborative partners to supply funds for research and development and to commercialize our products; . Uncertainty as to timing of and our ability to commercialize our products; . Our reliance on our lead product candidate; . Our lack of control over the clinical progress of several applications for our products, which are controlled by our collaborative partners; . Our reliance on programs in various stages of preclinical development and early stage research; . Our reliance on key management personnel; . Intense competition related to the research and development of morphogenic and other proteins for various applications and therapies and the possibility that others may discover or develop, and we may not be able to gain rights with respect to, the technology necessary to commercialize our products; . Our lack of development, commercial manufacturing, marketing and sales experience and the risk that any products that we develop may not be able to be marketed at acceptable prices or receive commercial acceptance in the markets that we expect to target; . Uncertainty related to market conditions affecting the biotechnology industry; . Uncertainty as to the extent of future government regulation of our business; . Our lack of control over governmental approvals on our lead product; . Uncertainty as to whether there will exist adequate reimbursement for our products from government, private health insurers and other organizations; and . Uncertainty as to whether the merger will be approved by our shareholders and regulatory authorities, and if approved, whether the benefits of integration will be achieved. As a result, our future development and commercialization efforts involve a high degree of risk. For further information, refer to the more specific risks and uncertainties described in "Risk Factors" and throughout this annual report on Form 10-K. 29 ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK We invest cash balances in excess of operating requirements in short-term marketable securities, generally corporate bonds and notes with minimum rating of A and United States Government and agency instruments. The maturities of these instruments range from one to twenty-nine months, with a weighted average maturity of less than one year. All marketable securities are considered available for sale. At December 31, 1999, the fair market value of these securities amounted to $18,620,000, with unrealized losses of $30,800 included as a component of stockholders' equity. If interest rates were to increase rapidly by 5%, an event we consider unlikely, the carrying value of the securities portfolio could decline by approximately $465,000. However, because of the quality of the investment portfolio and the short term nature of the marketable securities, we do not believe that the principal amount of the securities would be impaired and, therefore, no loss would be ultimately recognized in the statement of operations. 30 Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA Page Index to Consolidated Financial Statements Number - ------------------------------------------ ------ Creative BioMolecules, Inc. and Subsidiary: Financial Statements: Independent Auditors' Report....................................... 32 Consolidated Balance Sheets........................................ 33 Consolidated Statements of Operations.............................. 34 Consolidated Statements of Comprehensive Loss...................... 34 Consolidated Statements of Stockholders' Equity.................... 35 Consolidated Statements of Cash Flows.............................. 36 Notes to Consolidated Financial Statements......................... 37 31 INDEPENDENT AUDITORS' REPORT To the Board of Directors and Stockholders of Creative BioMolecules, Inc. We have audited the accompanying consolidated balance sheets of Creative BioMolecules, Inc. and its subsidiary as of December 31, 1999 and 1998, and the related consolidated statements of operations, comprehensive loss, stockholders' equity, and cash flows for each of the three years in the period ended December 31, 1999. 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, such consolidated financial statements present fairly, in all material respects, the financial position of the Company and its subsidiary at December 31, 1999 and 1998, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 1999, in conformity with generally accepted accounting principles. As discussed in Note 13 to the Consolidated Financial Statements, on February 15, 2000, the Company entered into a merger agreement with Ontogeny, Inc. and Reprogenesis, Inc. to form Curis, Inc. /s/ Deloitte & Touche LLP - ------------------------- Deloitte & Touche LLP Boston, Massachusetts February 15, 2000 32 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- CONSOLIDATED BALANCE SHEETS - --------------------------- December 31, -------------------------------- 1999 1998 ---- ---- ASSETS - ------ CURRENT ASSETS: Cash and cash equivalents $ 2,751,069 $ 17,738,044 Marketable securities 18,619,516 40,197,407 Accounts receivable 60,296 669,232 Inventory - 28,733 Prepaid expenses and other 146,764 272,168 -------------- -------------- Total current assets 21,577,645 58,905,584 -------------- -------------- PLANT AND EQUIPMENT - net 2,130,158 1,925,602 -------------- -------------- OTHER ASSETS: Notes receivable - officers - 116,668 Patents and licensed technology - net 951,198 375,000 Deferred patent application costs - net 4,124,716 4,732,629 Deposits and other 108,574 108,574 -------------- -------------- Total other assets 5,184,488 5,332,871 -------------- -------------- TOTAL $ 28,892,291 $ 66,164,057 ============== ============== LIABILITIES AND STOCKHOLDERS' EQUITY - ------------------------------------ CURRENT LIABILITIES: Lease obligations - current portion $ 347,323 $ 165,934 Accounts payable 612,811 1,621,417 Accrued liabilities 1,895,634 2,508,161 Accrued compensation 944,270 1,335,692 Deferred revenue 661,279 3,661,279 -------------- -------------- Total current liabilities 4,461,317 9,292,483 -------------- -------------- LEASE OBLIGATIONS 1,009,388 713,459 -------------- -------------- COMMITMENTS SERIES 1998/A PREFERRED STOCK, $.01 par value 23,414 shares issued and outstanding at December 31, 1998, liquidation preference of $24,113,598 at December 31, 1998 - 23,052,787 -------------- -------------- STOCKHOLDERS' EQUITY: Preferred stock, $.01 par value, 10,000,000 shares authorized, 23,414 issued and outstanding at December 31, 1998 Common Stock, $.01 par value, 50,000,000 shares authorized, 36,665,115 shares and 34,457,469 shares issued and outstanding at December 31, 1999 and 1998, respectively 366,651 344,575 Additional paid-in capital 148,062,906 143,127,113 Accumulated other comprehensive income (30,801) 105,461 Accumulated deficit (124,977,170) (110,471,821) -------------- -------------- Total stockholders' equity 23,421,586 33,105,328 -------------- -------------- TOTAL $ 28,892,291 $ 66,164,057 ============== ============== See notes to consolidated financial statements 33 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- CONSOLIDATED STATEMENTS OF OPERATIONS - -------------------------------------
Years Ended December 31, ------------------------------------------------ 1999 1998 1997 ---- ---- ---- REVENUES: Research and development contracts $ 3,159,460 $ 10,419,071 $ 12,692,475 Manufacturing contracts - - 393,926 License fees and royalties 52,400 10,000 - Interest 1,924,313 2,183,472 2,330,743 Other 1,777 12,391 15,615 --------------- --------------- --------------- Total revenues 5,137,950 12,624,934 15,432,759 --------------- --------------- --------------- COSTS AND EXPENSES: Research and development 10,434,560 24,856,147 25,122,039 Cost of manufacturing contracts - - 273,757 General and administrative 6,396,094 7,474,372 6,472,821 1999 reorganization and 1998 sale of manufacturing operations 255,701 1,362,249 - Interest 161,385 327,304 215,815 --------------- --------------- --------------- Total costs and expenses 17,247,740 34,020,072 32,084,432 --------------- --------------- --------------- NET LOSS (12,109,790) (21,395,138) (16,651,673) --------------- --------------- --------------- ACCRETION AND REPURCHASE COSTS ON SERIES 1998/A PREFERRED STOCK (2,395,559) (986,587) - --------------- --------------- --------------- NET LOSS APPLICABLE TO COMMON STOCKHOLDERS $(14,505,349) $(22,381,725) $(16,651,673) =============== =============== =============== BASIC AND DILUTED LOSS PER COMMON SHARE $(0.40) $(0.66) $(0.50) =============== =============== =============== COMMON SHARES FOR BASIC AND DILUTED LOSS COMPUTATION 36,665,115 33,672,105 33,078,120 =============== =============== =============== CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - --------------------------------------------- NET LOSS $(12,109,790) $(21,395,138) $(16,651,673) UNREALIZED GAIN/(LOSS) ON MARKETABLE SECURITIES (136,262) 105,461 - --------------- --------------- --------------- COMPREHENSIVE LOSS $(12,246,052) $(21,289,677) $(16,651,673) =============== =============== ===============
See notes to consolidated financial statements 34 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - -----------------------------------------------
Accumulated Common Stock Additional Other -------------------- Paid-In Accumulated Comprehensive Shares Amount Capital Deficit Income/(Loss) Total ---------- -------- ------------ -------------- ------------- ------------ BALANCE, JANUARY 1, 1997 32,769,553 $327,696 $138,371,802 $ (71,438,423) $ - $ 67,261,075 Stock based compensation 254,350 254,350 Other issuances of Common Stock 623,029 6,230 1,839,360 1,845,590 Net loss (16,651,673) (16,651,673) ---------- -------- ------------ -------------- ------------- ------------ BALANCE, DECEMBER 31, 1997 33,392,582 333,926 140,465,512 (88,090,096) - 52,709,342 Conversions of Series 1998/A Preferred Stock into Common Stock 732,370 7,324 1,544,842 1,552,166 Stock based compensation 48,000 480 321,520 322,000 Other issuances of Common Stock 284,517 2,845 795,239 798,084 Unrealized gain on marketable securities 105,461 105,461 Accretion on Series 1998/A Preferred Stock (986,587) (986,587) Net loss (21,395,138) (21,395,138) ---------- -------- ------------ -------------- ------------- ------------ BALANCE, DECEMBER 31, 1998 34,457,469 344,575 143,127,113 (110,471,821) 105,461 33,105,328 Conversions of Series 1998/A Preferred Stock into Common Stock 1,311,395 13,114 2,964,885 2,977,999 Warrant exercises into Common Stock 397,326 3,973 943,649 947,622 Other issuances of Common Stock 498,925 4,989 963,259 968,248 Stock based compensation 64,000 64,000 Unrealized loss on marketable securities (136,262) (136,262) Accretion and repurchase costs on Series 1998/A Preferred Stock (2,395,559) (2,395,559) Net loss (12,109,790) (12,109,790) ---------- -------- ------------ -------------- ------------- ------------ BALANCE, DECEMBER 31, 1999 36,665,115 $366,651 $148,062,906 $(124,977,170) $ (30,801) $ 23,421,586 ========== ======== ============ ============== ============= ============
See notes to consolidated financial statements 35 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- CONSOLIDATED STATEMENTS OF CASH FLOWS - -------------------------------------
Years Ended December 31, --------------------------------------------------- 1999 1998 1997 ---- ---- ---- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $(12,109,790) $(21,395,138) $(16,651,673) ---------------- ---------------- ---------------- Adjustments to reconcile net loss to net cash used: Gain on disposal of manufacturing related assets - (600,839) - Depreciation and amortization 989,490 2,485,753 2,103,906 Compensation expense 64,000 371,999 254,350 Deferred patent and application costs 537,781 - 188,055 Increase (decrease) in cash from: Accounts receivable 608,936 3,903,286 (3,117,822) Inventory and prepaid expenses 154,137 (104,428) 16,821 Accounts payable and accrued liabilities (2,012,555) 1,266,115 (653,619) Deferred contract revenue (3,000,000) 3,661,279 - ---------------- ---------------- ---------------- Total adjustments (2,658,211) 10,983,165 (1,208,309) ---------------- ---------------- ---------------- Net cash provided by (used for) operating activities (14,768,001) (10,411,973) (17,859,982) ---------------- ---------------- ---------------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of marketable securities (9,359,549) (30,021,298) (28,254,756) Sale of marketable securities 30,903,094 18,368,193 11,642,181 Expenditures for plant and equipment (610,013) (2,849,288) (2,810,611) Expenditures for patents (776,586) (1,120,609) (1,131,303) Note receivable from officer - (10,000) (40,000) Repayment of note receivable from officer 116,668 116,667 116,666 Decrease in deposits and other - 12,549 113,020 Proceeds from sale of manufacturing related assets - 17,092,322 - ---------------- ---------------- ---------------- Net cash provided by (used for) for investing activities 20,273,614 1,588,536 (20,364,803) ---------------- ---------------- ---------------- CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from sale of equity: Series 1998/A Preferred Stock - 25,000,000 - Warrant exercises 947,622 - - Common Stock - other 968,248 798,084 1,880,590 Costs of raising equity - (1,381,634) (35,000) Repurchase of Series 1998/A Preferred Stock (22,470,347) - - Increase in obligations under capital leases 311,031 193,524 346,766 Repayments of obligations under capital leases (249,142) (207,402) (57,650) ---------------- ---------------- ---------------- Net cash provided by (used for) financing activities (20,492,588) 24,402,572 2,134,706 ---------------- ---------------- ---------------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (14,986,975) 15,579,135 (36,090,079) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 17,738,044 2,158,909 38,248,988 ---------------- ---------------- ---------------- CASH AND CASH EQUIVALENTS, END OF YEAR $ 2,751,069 $ 17,738,044 $ 2,158,909 ================ ================ ================ SUPPLEMENTAL DISCLOSURE OF NON CASH INVESTING AND FINANCING ACTIVITIES: Property and equipment purchased under capital lease obligations $ 313,512 $ 1,089,164 $ 135,361 ================ ================ ================ Capital leases assumed by buyer in connection with sale of manufacturing operations $ - $ 2,437,802 $ - ================ ================ ================ Conversion of Series 1998/A Preferred Stock $ 2,978,000 $ 1,552,166 $ - ================ ================ ================
See notes to consolidated financial statements 36 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Nature of Business - Creative BioMolecules, Inc. ("the Company") is a ------------------ discovery and development company focused on proprietary protein-based therapeutics for human tissue regeneration and restoration. The Company's therapeutics are based on proteins that act as signals in initiating and regulating the cellular events involved in tissue regeneration and organ formation. The Company operates in one segment. Use of Estimates - The preparation of the Company's consolidated financial ---------------- statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the collectability of receivables, the carrying value of property and equipment and intangible assets and the value of certain liabilities. Actual results may differ from such estimates. Reclassifications - Certain amounts in prior years have been reclassified ----------------- to conform to the current year presentation. Consolidation - The accompanying consolidated financial statements include ------------- the Company and its wholly owned subsidiary, California Medicinal Chemistry Corporation (the "Subsidiary"). Intercompany balances are eliminated in consolidation. The Subsidiary has been inactive since 1985. Revenue Recognition - The Company's research agreements with collaborative ------------------- partners have typically provided for the partial or complete funding of research and development for specified projects and royalties payable to the Company in exchange for licenses to market resulting products or sales of products. Revenue is earned and recognized based upon work performed, upon the sale or licensing of product rights, upon shipment of product for use in preclinical and clinical testing or upon attainment of benchmarks specified in the related agreements. The Company's manufacturing contracts provided for technical collaboration and manufacturing for third parties. Revenue was earned and recognized based upon work performed. The Company sold its manufacturing facilities to Stryker Corporation in November 1998 (Note 2). During the years ended December 31, 1999, 1998 and 1997, total revenues from major customers as a percent of total revenues of the Company were as follows: Years Ended December 31, ---------------------------- Customer 1999 1998 1997 -------- ---- ---- ---- Biogen, Inc. 95% 28% 50% Stryker Corporation 3% 55% 34% Research and Development - Research and development costs are charged to ------------------------ operations as incurred. Certain research and development projects are partially funded by research and development contracts, and the expenses related to these activities are included in research and development costs. 37 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) Cash Equivalents and Marketable Securities - Cash equivalents consist of ------------------------------------------ short-term, highly liquid investments purchased with remaining maturities of three months or less. All other liquid investments are classified as marketable securities. Marketable securities have been designated as "available for sale" and are stated at market value with any unrealized holding gains or losses included as a component of stockholders' equity. The Company's marketable securities portfolio included approximately $18,620,000 and $40,197,000 in corporate bonds and notes as of December 31, 1999 and 1998, respectively, all with maturities ranging from one to fifty- eight months. For the years ended December 31, 1999, 1998 and 1997, gross realized gains and losses were not material. In computing gross realized gains and losses, the Company computes the cost of its investments on a specific identification basis. Such cost includes the direct cost to acquire the securities, adjusted for the amortization of premiums or accretion of discounts. At December 31, 1999, gross unrealized losses were $30,801. At December 31, 1998, gross unrealized gains and losses were $126,000 and $21,000, respectively. At December 31, 1997, gross unrealized gains and losses were not material. Fair Value of Financial Instruments - The estimated fair value of financial ----------------------------------- instruments has been determined by the Company using available market information and appropriate valuation methodologies. However, considerable judgment is required in interpreting data to develop the estimates of fair value. The estimated fair value of cash, accounts and notes receivable and accounts payable approximates fair value due to the short-term nature of these instruments. The fair value of marketable securities is based on current market values. The carrying amounts of the Company's lease obligations also approximate fair value (Note 7). Inventory - Inventory consists principally of raw materials and laboratory --------- supplies. Inventories are stated at the lower of cost (first-in, first- out) or market. Equipment - Purchased equipment is recorded at cost. Leased equipment is --------- recorded at the lesser of cost or the present value of the minimum lease payments. Depreciation and amortization are provided on the straight-line method over the estimated useful lives of the related assets (three to twenty-five years) or the remaining terms of the leases. Patents and Licensed Technology - The Company has filed applications for ------------------------------- United States and foreign patents covering aspects of its technology. Costs related to pending patent applications have been deferred. Costs related to successful patent applications and costs related to pending applications from which the Company is currently deriving economic benefit, are amortized over the estimated useful life of the patent, generally 16 to 20 years, using the straight-line method. Costs related to licensed technology also have been deferred and are amortized over the estimated useful life of the underlying technology, generally 10 to 17 years, using the straight-line method. Accumulated amortization was approximately $912,000 and $669,000 at December 31, 1999 and 1998, respectively. 38 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 1. NATURE OF BUSINESS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED) Long-lived Assets - The Company evaluates its long-lived assets for ----------------- impairment whenever events or changes in circumstances indicate that carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds the fair value of the asset. Assets to be disposed of are reported at the lower of the carrying amount of fair value, less cost to sell. Basic and Diluted Loss Per Common Share - Basic loss per common share is --------------------------------------- computed after giving effect to accretion and repurchase costs on Series 1998/A Preferred Stock using the weighted average number of common shares outstanding during each year. Diluted loss per common share reflects the effect of the Company's outstanding options and warrants, except where such items would be anti-dilutive. In 1999, 1998 and 1997, the effect of stock options and warrants was anti-dilutive and, therefore, not included in the computation of diluted loss per share. SFAS No. 128, "Earnings Per Share," provides that if there is a loss from continuing operations, a company should not include potential common shares in the denominator of a dilutive per share computation, even if including those potential common shares in other dilutive per share computations may be dilutive to their comparable basic per share amounts. Therefore, earnings per share excludes the dilutive effect of options, warrants and preferred stock of 4,426,000, 8,404,000 and 2,525,000 for the years ended December 31, 1999, 1998 and 1997, respectively. Stock-Based Compensation - The Company's stock options and purchase plans ------------------------ are accounted for under APB No. 25 ("APB 25"), "Accounting for Stock Issued to Employees" (Note 9). New Accounting Standards - In June 1998, the Financial Accounting Standards ------------------------ Board ("FASB") released Statement of Financial Accounting Standards No. 133, "Accounting for Derivative Instruments and Hedging Activities," which the Company will be required to adopt effective January 1, 2001. SFAS No. 133 establishes standards for reporting and accounting for derivative instruments, and conforms the requirements for treatment of hedging activities across the different types of exposures hedged. The Company has not yet completed its evaluation of SFAS No. 133, and is, therefore unable to disclose the impact adoption will have on its consolidated financial position or results of operations. 2. SALE OF MANUFACTURING OPERATIONS AND REORGANIZATION CHARGES In November 1998, the Company sold certain of its OP-1 manufacturing rights and facilities to Stryker. In addition to cash consideration in exchange for the manufacturing facility, the transaction is expected to provide the Company with increased royalties on Stryker products, if approved for commercial sale, in lieu of the manufacturing revenue anticipated under the prior agreement. Proceeds and expenses associated with this transaction include the following: 39 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 2. SALE OF MANUFACTURING OPERATIONS AND REORGANIZATION CHARGES (CONTINUED) Total proceeds $19,530,000 Less: Net book value of manufacturing related assets 18,929,000 Employee termination costs 1,438,000 Legal, accounting and consulting costs 525,000 -------------- Loss on sale of manufacturing operations $(1,362,000) ============== As a result of this transaction, the Company recorded a charge of $1,362,000 in the quarter ended December 31, 1998. The charge included $885,000 related primarily to employee termination benefits and $548,000 related to estimated health insurance claims on the terminated employees, which $903,000 remained to be paid as of December 31, 1998. During the quarter ended December 31, 1999, the Company determined that health insurance claims were less than originally estimated. This resulted in a reduction in the loss on sale of manufacturing operations and the related accrual of approximately $255,000. In addition, the Company recorded a charge of $64,000 and $205,000 related to a change in the exercise terms of stock option agreements in connection with the sale of manufacturing operations for the years ended December 31, 1999 and 1998, respectively. Effective October 19, 1999, the Company was reorganized and the Board approved a plan to focus our operations and financial resources on the development of morphogenic protein-based clinical candidates for the treatment of stroke and renal disease. The reorganization charge included $511,000 related primarily to termination benefits in the reduction of employees from 70 to 43. Salaries and termination benefits, either in the form of one-time or periodic payments, were made when the employee ceased employment. These employees were in management, research and development and administrative support. As of December 31, 1999, there was approximately $95,503 of accrued costs, principally representing future cash outlays for employee termination costs. The Company expects to pay these accrued costs by June 2000. 1999 1998 Sale of Reorganization Charges Manufacturing Operations ---------------------- ------------------------ Expensed $1,362,000 Paid (459,000) Reversed - ------------------------ Accrued at December 31, 1998 $ 903,000 ------------------------ Expensed $ 511,000 - Paid (415,000) (648,000) Reversed - (255,000) ---------------------- ------------------------ Accrued at December 31, 1999 $ 96,000 $ - ====================== ======================== 40 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 2. SALE OF MANUFACTURING OPERATIONS AND REORGANIZATION CHARGES (CONTINUED) The following table summarizes the effect to the income statement for Reorganization Charges and Sale of Manufacturing Operations for the year ended December 31, 1999: Salaries and termination benefits $ 511,000 Salaries and termination benefits settled for amounts less than anticipated (255,000) ----------- Total $ 256,000 =========== 3. COLLABORATIVE RESEARCH AND DEVELOPMENT AGREEMENT In December 1996, the Company entered into a Research Collaboration and License Agreement with Biogen to collaborate on the development of novel therapeutics based on OP-1 for the treatment of renal disorders. The initial focus of the collaboration was on advancing the development of the Company's morphogenic protein, OP-1, for the treatment of acute and chronic renal failure. Under the agreement, the Company granted to Biogen exclusive worldwide rights to manufacture, market and sell OP-1 and OP-1 products developed through the collaboration for the treatment of renal disease. The agreement provided for $10,500,000 in research funding over a three-year period ending December 31, 1999, of which $7,500,000 had been recognized through December 31, 1998. In December 1998, Biogen and the Company signed an Amendment Agreement and Biogen paid $3,000,000 in research support for the year ending December 31, 1999. The $3,000,000 has been recognized through December 31, 1999. Under the Biogen Amendment, the Company has assumed primary responsibility for the development of the Company's morphogenic protein, OP-1, for the treatment of renal disorders and Biogen retained an option through 1999 to resume responsibility for development of OP-1 as a therapy for chronic renal failure.. As of December 31, 1999, Biogen did not exercise its option, and the Company has assumed all rights to OP-1 renal therapies. 4. NOTES RECEIVABLE - OFFICERS In July 1997, the Company loaned $40,000 to an officer of the Company. The loan was evidenced by a fully secured promissory note bearing interest at the annual rate of 6.65%. Twenty-five percent of the principal and accrued interest was forgiven on February 7, 1998 and then an equal portion of the principal sum and accrued interest was to have been forgiven monthly over the remaining term of thirty-six months, provided the officer was employed by the Company. In July 1998, the Company loaned an additional $10,000 to the officer. In December 1998, as part of a severance agreement, the Company agreed to forgive the remaining principal of $31,700 plus accrued interest. Accordingly, there was a charge of approximately $39,000 in the 1998 statement of operations. In September 1996, the Company loaned $350,000 to an officer of the Company. The loan was evidenced by a fully secured promissory note bearing interest at the annual rate of 6.02% and payable in three equal annual installments, plus accrued interest. As of December 31, 1999, the loan has been paid in full. On February 8, 2000, the Company loaned to two executive officers an aggregate of $1,131,380, which was equal to the aggregate exercise price of incentive stock options exercised by them on the same date. The officers immediately used these funds to pay the Company the exercise price of such incentive stock options. These full recourse loans each bear interest at an annual rate of 7% and the principal is due and payable on the earlier of May 8, 2002 or 30 days following the sale of the stock purchased with these funds. 41 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 5. PLANT AND EQUIPMENT
Plant and equipment consisted of the following: December 31, ----------------------------------- 1999 1998 ---- ---- Laboratory equipment and furniture $ 5,564,575 $ 4,954,427 Leasehold improvements 764,021 572,319 Office furniture and equipment 2,296,666 2,174,991 ---------------- --------------- 8,625,262 7,701,737 Less accumulated depreciation and amortization (6,495,104) (5,776,135) ---------------- --------------- Total $ 2,130,158 $ 1,925,602 ================ ===============
Amounts included in plant and equipment applicable to capital leases were as follows:
December 31, ---------------------------------- 1999 1998 ---- ---- Laboratory equipment and furniture $ 1,471,454 $ 913,176 Office furniture and equipment 374,683 312,024 ---------------- --------------- 1,846,137 1,225,200 Less accumulated amortization (519,766) (201,094) ---------------- --------------- Total $ 1,326,371 $ 1,024,106 ================ ===============
6. ACCRUED LIABILITIES Accrued liabilities consisted of the following:
December 31, ----------------------------------- 1999 1998 ---------------- --------------- Research collaboration costs $ 1,469,473 $ 1,332,291 Severance and related costs 95,503 903,330 Other 330,658 272,540 ---------------- --------------- Total $ 1,895,634 $ 2,508,161 ================ ===============
42 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 7. LEASE OBLIGATIONS In October 1997, the Company entered into a master lease agreement to provide for the lease financing for up to $2,000,000 of laboratory and office equipment. In May 1999, the Company extended the master lease agreement, that provides for the sale and leaseback or lease of up to $750,000 of laboratory and office equipment. The lease agreements expire in 2002 and in 2003. The lease commitment expired on December 31, 1999. The Company has noncancelable operating lease agreements for office and laboratory space and certain office and laboratory equipment. Rent expense for all operating leases was approximately $841,000, $1,037,000 and $775,000 for the years ended December 31, 1999, 1998 and 1997, respectively. Future minimum lease obligations at December 31, 1999, were as follows: Year Ending December 31, Capital Operating ------------------------------------------- ----------- ----------- 2000 $ 503,395 $ 735,642 2001 503,395 558,489 2002 460,110 274,558 2003 224,867 8,483 Thereafter - - ----------- ----------- Total minimum lease payments 1,691,767 $1,577,172 Less amount representing interest 335,056 =========== ----------- Present value of net minimum lease payments 1,356,711 Less current portion 347,323 ----------- Long-term obligations under capital leases $1,009,388 =========== 8. SERIES 1998/A PREFERRED STOCK AND WARRANTS On May 27, 1998 (the "Issue Date"), the Company completed a private placement with three institutional investors (the "Investors") for the sale of 25,000 shares of Series 1998/A Preferred Stock, $.01 par value per share (the "Series 1998/A Preferred Stock"), with a stated value of $1,000 per share resulting in gross proceeds of $25,000,000. Issuance costs totaled approximately $1,382,000 (offset against the Series 1998/A Preferred Stock proceeds in the accompanying balance sheet at December 31, 1998), resulting in net proceeds of approximately $23,618,000. Accretion on Series 1998/A Preferred Stock for the year ended December 31, 1998 was $987,000 and includes $733,000, calculated at the rate of 5% per annum of the stated value of the outstanding Series 1998/A Preferred Stock from May 27, 1998 and $254,000 of accretion of issuance costs related to the sale of Series 1998/A Preferred Stock. Through May 7, 1999 the holders converted a total of 4,514 shares of Series 1998/A Preferred Stock into 2,043,765 shares of Common Stock. On May 7, 1999, we repurchased 20,486 shares, which represented all of the then outstanding Series 1998/A Preferred Stock following final conversions, for approximately $22,470,000 in cash. Accretion and Repurchase Costs on Series 1998/A Preferred Stock was $21,396,000 for the year ended December 31, 1999, and included the following: $385,000 calculated at the rate of 5% per annum of the stated value of the outstanding Series 1998/A Preferred Stock; $144,000 of accretion of issuance costs related to the sales of Series 1998/A Preferred Stock; and as a result of the repurchase of the Series 1998/A Preferred Stock on May 7, 1999, a one-time 43 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 8. SERIES 1998/A PREFERRED STOCK AND WARRANTS (CONTINUED) charge of approximately $1,867,000 recorded in the second quarter of 1999 which represents accretion of the Series 1998/A Preferred Stock up to its repurchase amount and accretion of all remaining issuance costs. As a result of this transaction, the Series 1998/A Preferred Stock has been retired and there will be no subsequent conversions into Common Stock. Warrants - In connection with a private placement offering in 1994 and 1995, the Company sold 1,130,000 warrants, each to purchase one share of Common Stock. Each warrant is exercisable for a period of five years from the date of issuance at an exercise price of $2.385. During the year ended December 31, 1999, 397,326 warrants were exercised. Proceeds to the Company were approximately $948,000. At December 31, 1999, warrants to purchase 414,270 shares of Common Stock are outstanding, while 30,000 warrants expired unexercised in 1999. 9. STOCK PLANS Stock Option Plans - In May 1987, the Company established the 1987 Stock Plan ("1987 Plan") and terminated the 1983 Incentive Stock Option Plan ("1983 Plan") such that no further grants of options could be made thereunder. The 1987 Plan was subsequently amended to increase the number of shares of Common Stock authorized for issuance thereunder. A total of 6,800,000 shares of Common Stock had been reserved for issuance under the 1987 Plan upon the exercise of options or in connection with awards or direct purchases of stock. On June 30, 1999, the 1987 Plan expired. At December 31, 1999, there were no shares available for grant under the 1987 Plan. In April 1998, the Board of Directors adopted and in June 1998, the stockholders of the Company approved the 1998 Stock Plan ("1998 Plan") which permits the granting of incentive and non-qualified stock options. The number of shares of Common Stock subject to issuance under the 1998 Plan is 3,000,000. At December 31, 1999, 1,651,300 shares were available for grant under the 1998 Plan. Both the 1987 Plan and the 1998 Plan permit the granting of incentive and nonqualified stock options to consultants, employees or officers of the Company and its subsidiaries at prices determined by the Board of Directors. Awards of stock may be made to consultants, employees or officers of the Company and its subsidiaries, and direct purchases of stock may be made by such individuals also at prices determined by the Board of Directors. Options become exercisable as determined by the Board of Directors and expire up to ten years from the date of grant. Director Plan - The 1992 Non-Employee Director Non-Qualified Stock Option Plan ("Director Plan") provides for the granting of options to non-employee directors. The Director Plan was amended and approved by the stockholders of the Company in June 1999 increasing the number of shares of Common Stock authorized for issuance under the Plan from 300,000 to 500,000 shares. At December 31, 1999, 260,000 shares were available for grant under the Director Plan. On February 8, 2000, the Board of Directors approved the immediate acceleration of vesting of certain unvested stock options held by the Company's executive officers and outside directors and the extension of the exercise period for one year. 44 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 9. STOCK PLANS (CONTINUED) Activity under the stock option and director plans is summarized as follows:
Weighted Average Number Exercise Price of Shares Per Share ------------- -------------- Outstanding, January 1, 1997 4,490,407 $4.29 Granted 964,500 8.72 Exercised (301,176) 3.42 Canceled (137,384) 6.61 ------------- Outstanding, December 31, 1997 5,016,347 5.13 (2,593,897 exercisable at a weighted average price of $4.04 per share) Granted 1,391,675 4.70 Exercised (211,923) 2.04 Canceled (431,294) 7.78 ------------- Outstanding, December 31, 1998 5,764,420 4.94 (3,505,894 exercisable at a weighted average price of $4.53 per share) ============= Granted 1,161,450 3.07 Exercised (433,804) 1.80 Canceled (791,294) 6.78 ------------- Outstanding, December 31, 1999 5,700,772 4.54 (3,535,297 exercisable at a weighted average price of $4.64 per share) =============
The table below summarizes options outstanding and exercisable at December 31, 1999:
Options Outstanding Options Exercisable ----------------------------------------- --------------------------- Weighted Average Weighted Exercisable Weighted Remaining Average As of Average Range of Number of Contractual Exercise December 31, Exercise Exercise Price Options Life Price 1999 Price ------------------ ------------- ------------- ----------- -------------- ----------- $0.35 - $2.25 1,185,489 4.8 $2.01 872,739 $1.94 $2.26 - $4.50 2,502,400 7.1 2.96 1,348,740 2.86 $4.51 - $6.75 452,000 6.6 5.50 263,650 5.54 $6.76 - $9.00 698,818 6.3 7.74 367,218 7.83 Over $9.00 862,025 5.2 9.55 682,950 9.54 ------------- ------------- ----------- -------------- ----------- Total 5,700,772 6.2 $4.54 3,535,297 $4.64 ============= ============= =========== ============== ===========
45 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 9. STOCK PLANS (CONTINUED) Employee Stock Purchase Plan - The Employee Stock Purchase Plan permits eligible employees to purchase Common Stock of the Company up to an aggregate of 750,000 shares. During the year ended December 31, 1999, 65,121 shares were issued under this plan at the fair market value prices of $2.84 and $2.95 per share; during the year ended December 31, 1998, 105,815 shares were issued under this plan at prices of $3.90 and $2.90 per share and during the year ended December 31, 1997, 62,950 shares were issued under this plan at prices of $6.08 and $5.84 per share. In June 1998, the stockholders of the Company voted to amend the Employee Stock Purchase Plan to increase by 250,000 from 500,000 to 750,000 the aggregate number of shares of Common Stock which may be purchased by eligible employees. Stock-Based Compensation - As discussed in Note 1, the Company continues to account for its stock-based awards using the intrinsic value method in accordance with APB 25 and its related interpretations. Accordingly, no compensation expense has been recognized in the consolidated financial statements at the date of grant for employee stock option arrangements. The Company recorded a charge of $64,000 and $205,000 related to a change in the exercise terms of stock option agreements in connection with the sale of manufacturing operations for the years ended December 31, 1999 and 1998, respectively. Under SFAS 123, "Accounting for Stock-Based Compensation," the fair value of stock-based awards to employees is calculated through the use of option pricing models, even though such models were developed to estimate the fair value of freely tradable, fully transferable options without vesting restrictions, which significantly differ from the Company's stock option awards. These models also require subjective assumptions, including future stock price volatility and expected time to exercise, which greatly affect the calculated values. The Company's calculations were made using the Black-Scholes option pricing model with the following assumptions: expected life, six months following total vesting; stock volatility, 94% in 1999 and 1998, and 71% in 1997; risk free interest rates, 6.4% in 1999, 4.7% in 1998 and 5.4% in 1997; and no dividends during the expected term. The Company's calculations are based on a multiple option valuation approach and forfeitures for broad-based grants are estimated at 2% per year and adjusted to actual as they occur. Forfeitures for grants to executives are recognized as they occur. The weighted average fair value of options granted was $2.26, $3.49 and $5.11 in 1999, 1998 and 1997 respectively. If the computed fair values of the 1999, 1998 and 1997 awards had been amortized to expense over the vesting period of the awards, pro forma net loss would have been $14,804,644 or a net loss of $0.40 per share (basic and diluted) for the year ended December 31, 1999, $25,466,000 or a net loss of $0.79 per share (basic and diluted) for the year ended December 31, 1998 and $19,892,000 or a net loss of $0.60 per share (basic and diluted) for the year ended December 31, 1997. The Company also granted stock options to non-employee consultants in 1997. These options were valued based on the fair value of the options granted. Total compensation expense recognized related to these options was $254,000 in 1997. The Company did not grant stock options to non-employee consultants in 1998 and in 1999. 46 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 10. INCOME TAXES No income tax provision or benefit has been provided for federal income tax purposes as the Company has incurred losses since inception. As of December 31, 1999, the Company had available federal and state net operating loss carryforwards of approximately $81,700,000 for income tax purposes. In addition, the Company had approximately $1,837,000 of unused investment and research and development tax credits. These net operating loss and tax credit carryforwards will expire at various dates between 2000 and 2020. The components of deferred income taxes at December 31, 1999 and 1998 consisted primarily of the following: 1999 1998 -------------- -------------- Deferred Tax Assets: Net operating loss carryforwards $ 32,916,000 $ 30,600,000 Investment credit and research and 1,600,000 Development tax credit carryforwards 1,837,000 Research and development expenditures 11,929,000 9,800,000 Other 124,000 -------------- -------------- Total $ 46,806,000 $ 42,000,000 Valuation allowance (46,806,000) (42,000,000) -------------- -------------- Net deferred tax assets $ - $ - ============== ============== The Company has not yet achieved profitable operations. In addition, the future availability of the Company's tax benefits may be significantly limited under Section 382 of the Internal Revenue Code. Section 382 limits the use of net operating loss carryforwards, credit carryforwards and certain other tax attributes as a result of changes in a company's ownership. Accordingly, management believes that the tax benefits as of December 31, 1999 and 1998 do not satisfy the realization criteria set forth in SFAS No. 109 and has recorded a valuation allowance for the entire net asset. 11. ROYALTY AGREEMENTS The Company has entered into various license agreements which require the Company to pay royalties based upon a set percentage of certain product sales and license fee revenue subject, in some cases, to certain minimum amounts. Total royalty expense approximated $23,000 for the years ended December 31, 1999 and 1998 and $37,000 for the year ended December 31, 1997. 12. RETIREMENT SAVINGS PLAN The Company has a 401(k) retirement savings plan covering substantially all of the Company's employees. Matching Company contributions are at the discretion of the Board of Directors. The Board of Directors authorized matching contributions up to 3% of participants' salaries amounting to approximately $160,000, $286,000 and $250,000 for the years ended December 31, 1999, 1998 and 1997, respectively. 47 CREATIVE BIOMOLECULES, INC. AND ITS SUBSIDIARY - ---------------------------------------------- NOTES TO CONSOLIDATED FINANCIAL STATEMENTS - -------------------------------------------------------------------------------- 13. SUBSEQUENT EVENT On February 15, 2000, the Company announced that it will merge with Ontogeny, Inc., and Reprogenesis, Inc., to form a public company named Curis, Inc. Under the terms of the merger, which is subject to stockholder approval, Creative's stockholders will receive three Curis shares for every ten shares of Creative Common Stock. Following completion of the transaction, Creative's stockholders will hold approximately 43%, Ontogeny's stockholders will hold approximately 38% and Reprogenesis' stockholders will hold approximately 19% of Curis. Curis, the successor to Creative, will record the merger as a purchase of Reprogenesis and Ontogeny. The merger is expected to close in June 2000. 48 Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE Not applicable. 49 PART III Item 10. DIRECTORS AND OFFICERS OF THE REGISTRANT Information Concerning Current Directors, Nominees and Executive Officers Information regarding our executive officers and directors on February 25, 2000, is set forth below as of that date:
Name Age Position - ---- --- -------- Michael M. Tarnow.............. 55 Chief Executive Officer, President and Director Brian H. Dovey................. 58 Chairman of the Board and Director Charles Cohen, Ph.D............ 49 Chief Scientific Officer and Director Steven L. Basta................ 34 Vice President, Finance and Business Development Carl M. Cohen, Ph.D............ 54 Vice President, Research and Development Cheryl K. Lawton............... 39 General Counsel and Vice President, Jeremy L. Curnock Cook......... 50 Administration Martyn D. Greenacre............ 58 Director Suzanne Denbo Jaffe............ 56 Director Michael Rosenblatt, M.D........ 52 Director James R. Tobin ................ 55 Director
- ------------- Michael M. Tarnow joined us as President, Chief Executive Officer and Director in July 1995. Prior to joining us, Mr. Tarnow was a career pharmaceutical executive at Merck & Co., Inc., beginning in 1973. From 1988 to 1990, Mr. Tarnow headed Merck's worldwide business development activities as Executive Director of Corporate Development. In 1990, he was appointed President and CEO of Merck Frosst Canada, Merck's Canadian subsidiary. In 1994, Mr. Tarnow returned to the United States as Executive Vice President of Medco Containment Services and Merck Managed Care, where he was responsible for initiating managed care programs in several international markets. Mr. Tarnow received his J.D. from the University of Illinois and bachelor's degree from Wayne State University. He also serves as a director of Novopharm Biotech, Inc., NeuroVir, Inc. and Xenon Bioresearch, Inc. Brian H. Dovey has served as Chairman of the Board since January 1995 and as a member of our Board of Directors since September 1992. Since 1988 Mr. Dovey has been General Partner of Domain Associates, a venture capital firm, affiliates of which are stockholders of the Company. From 1983 to 1988, Mr. Dovey was employed at Rorer Group Inc., now Rhone-Poulenc Rorer Inc., where he held various management positions, most recently as President. He also serves as a director of Connetics Corporation, Geron Corporation, NABI, Inc., Trimeris, Inc. and Vivus, Inc. Charles Cohen, Ph.D., one of the founders, has served as Chief Scientific Officer since June 1990 and as a member of our Board of Directors since April 1982. Dr. Cohen previously served as Chief Executive Officer from January 1985 to December 1991 and from November 1993 to July 1995, President from January 1985 to December 1991 and from January to July of 1995, Chairman of the Board from June 1990 to January 1995 and Vice President and Scientific Director from April 1982 to January 1985. Prior to co-founding us, he was Manager of Biochemical Development for Waters Associates, a manufacturer of chromatography and filtration equipment, then a subsidiary of Millipore Corporation. He also serves as a director of Exelixis Pharmaceuticals, Inc. and Xenon Bioresearch, Inc. Dr. Cohen received his Ph.D. in Basic Medical Science from New York University School of Medicine. Dr. Cohen served as a Research Fellow in the University of Virginia's Department of Biophysics and Biochemistry. Steven L. Basta has served as Vice President, Finance and Business Development, and as our Chief Financial Officer, since January 1999. Mr. Basta previously served as Vice President, Corporate Development and Investor Relations from February 1997 to January 1999. Prior to joining us, he was associated with Jundt 50 Associates, an investment management firm, from July 1996 to December 1996. From September 1990 to June 1996, Mr. Basta held several positions with The Immune Response Corporation including Executive Director of Product Development from 1994 to 1996, Program Director for an HIV research joint venture from 1992 to 1993, and Director of Investor Relations and Market Development from 1991 to 1992. From 1988 to 1990, he served as an Associate with Dillon, Read & Co, Inc. He received an M.B.A. from the Kellogg Graduate School of Management of Northwestern University. Carl M. Cohen, Ph.D. has served as Vice President, Research and Development since January 1999. Dr. Cohen previously served as Vice President, Research from November 1997 to January 1999. Prior to joining us, he has served as Acting Chairman, Department of Biomedical Research since 1996, Chief, Division of Cellular and Molecular Biology, Department of Biomedical Research from 1979 to 1997 and Associate Chairman, Department of Biomedical Research since 1983 at St. Elizabeth's Medical Center of Boston. In addition, he has served as a Professor, Department of Medicine and Department of Anatomy and Cellular Biology since 1991 at Tufts University School of Medicine. Dr. Cohen received his Ph.D. in Biophysics Research from Harvard University. Cheryl K. Lawton has served as Vice President and General Counsel since January 1997 and General Counsel and Vice President, Administration since January 1999. Prior to joining us, she served as Vice President beginning in January 1996, General Counsel beginning in April 1995 and Associate General Counsel from May 1994 to April 1995 at MediSense, Inc., an international medical device manufacturing company. From November 1989 to April 1994 she held various legal positions and last served as Assistant General Counsel at Damon Corporation, a clinical laboratory service provider. Ms. Lawton received her J.D. from Suffolk University School of Law. Jeremy L. Curnock Cook has been a member of our Board of Directors since January 1995. He is currently a director of Rothschild Asset Management Limited which acts as a manager to International Biotechnology Trust, of which he is also a Director. In 1975 Mr. Curnock Cook founded and became Managing Director of The International Biochemical Group Ltd., a company engaged in applied biotechnology, which was subsequently acquired by Royal Dutch/Shell Group of Companies in 1985. He also serves as a director of Cell Therapeutics, Ribozyme Pharmaceuticals, Inc., Angiotech Pharmaceuticals, Inc. and Targeted Genetics Corp. Martyn D. Greenacre has been a member of our Board of Directors since June 1993. He is currently Chief Executive Officer and President of Delsys Pharmaceutical Corporation. From 1993 to 1996, Mr. Greenacre was President and Chief Executive Officer of Zynaxis, Inc., a biopharmaceutical company. Prior to Zynaxis, from 1973 through 1992, he was with SmithKline Beecham where he held several senior management positions, most recently as chairman of European operations. He also serves as a director of Delsys Pharmaceutical Corp. and GENSET, S.A. Suzanne Denbo Jaffe has been a member of our Board of Directors since January 1997. She currently serves as President of S.D.J. Associates, Inc. From 1994 to 1999, Ms Jaffe was Managing Director of Hamilton & Co., an investment management consulting firm. From 1985 to 1993 Ms. Jaffe was a Managing Director of Angelo, Gordon & Co., L.P., a money management firm. From 1983 to 1985 she was Deputy Comptroller of New York State. She served under President Reagan on the Board of Trustees of the Social Security and Medicare Trust Funds and also was a member of the ERISA Advisory Council of the Department of Labor. She is currently a director of Axel Johnson, Inc. and Research Corporation. Michael Rosenblatt, M.D. has been a member of our Board of Directors since June 1993. From 1992-1998, Dr. Rosenblatt served as the Robert H. Ebert Professor of Molecular Medicine at the Harvard Medical School and the director of the Harvard-MIT Division of Health Sciences and Technology. He has served since 1992, and currently serves as Chief of the Division of Bone and Mineral Metabolism at Beth Israel Deaconess Medical Center. Since 1993, he has also been a faculty member in the department of Biological Chemistry and Molecular Pharmacology, Division of Medical Sciences at Harvard University. From 1996- 1999, he was the executive director of the Carl J. Shapiro Institute for Education and Research at Harvard Medical School and Beth Israel Deaconess Medical Center. Since 1996, he has been Harvard faculty dean for academic programs at the Beth Israel Deaconess Medical Center. He is now the President (interim) of Beth Israel Deaconess 51 Medical Center and the George R. Minot Professor of Medicine at Harvard Medical School. Prior to 1992, Dr. Rosenblatt was the Senior Vice President for Research at Merck Research Laboratories, a pharmaceutical company. He also serves as a director of ArQule, Inc. James R. Tobin has been a member of our Board of Directors since January 1995. He is currently Chief Executive Officer and President of Boston Scientific Corporation. He served as President and Chief Executive Officer from February 1997 to December 1998 and President and Chief Operating Officer of Biogen from February 1994 to February 1997. Prior to joining Biogen, Mr. Tobin was with Baxter International Inc., a health care products company, where he served as President and Chief Operating Officer from 1992 to 1994 as Executive Vice President from 1988 to 1992 and in various management positions prior to 1988. He also serves as a director of Pathogenesis Corporation, Boston Scientific Corporation and PE Corporation. Officers are elected and serve at the discretion of the Board of Directors. There are no family relationships among any of the directors and executive officers of the Company. SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE Compliance with Section 16(a) of the Securities Exchange Act of 1934, requires our directors and officers, and persons who own more than ten percent of our Common Stock, to file with the Securities and Exchange Commission initial reports of beneficial ownership and reports of changes in beneficial ownership of our Common Stock. Officers, directors and greater than ten-percent beneficial owners are required by SEC regulation to furnish us with copies of all Section 16(a) forms they file. To our knowledge, based solely on our review of the copies of such reports furnished to us and written representations that no other reports were required, during the fiscal year ended December 31, 1999, all Section 16(a) filing requirements applicable to our officers, directors and greater than ten-percent beneficial owners were complied with. ITEM 11. EXECUTIVE COMPENSATION Compensation of Directors and Executive Officers Director Compensation Standard Arrangements. For their services to us, our non-employee directors of the Company receive cash payments in the amount of an annual retainer of $10,000 and $1,000 for each Board meeting attended in person. Non-employee directors who are members of a committee of the Board receive $1,000 for each committee meeting attended on a day other than a day on which a Board meeting is held. There are no cash payments for participation in Board or committee meetings held by telephone conference call. Directors who are employed by us do not receive compensation for attendance at Board or committee meetings. Directors are reimbursed for any expenses incurred attendant to Board membership. Pursuant to our 1992 Non-Employee Director Non-Qualified Stock Option Plan, or the Director Plan, provides that each non-employee director will be granted an option to purchase 20,000 shares of Common Stock upon election to the Board of Directors. In addition, the Director Plan provides the grant of an annual option to purchase 5,000 shares of Common Stock to each non-employee member of the Board serving as of the Annual Meeting. All of the options under the Director Plan are granted at the fair market value of the Common Stock on the date the option is granted. All of the options granted under the Director Plan vest at the rate of 25% on each of the first four anniversaries after the date of grant. 52 Item 11. EXECUTIVE COMPENSATION (CONTINUED) Executive Compensation Compensation which was earned for services in all capacities for the years ended December 31, 1999, 1998 and 1997 and which we paid to or accrued for the Chief Executive Officer during 1999 and each of our four other most highly compensated executive officers for service rendered during such periods, is set forth in the following table.
Summary Compensation Table Long-Term Annual Compensation Compensation Awards ----------------------------------------- ------------------------ Restricted Securities Other Annual Stock Underlying All Other Salary Bonus Compensation Awards Options Compensation Name and Principal Position Year ($)(1) ($) ($)(2) ($)(3) (#)(4) ($) - ------------------------------ ---- -------- -------- ------------ ----------- --------- ------------ Michael M. Tarnow(5) 1999 $352,917 $200,000 - - 200,000 $5,000 (6) President and 1998 330,000 176,625 - 24,375 81,000 4,750 (6) Chief Executive Officer 1997 315,000 133,000 75,500 (5) - - 4,500 (6) Charles Cohen, Ph.D. 1999 293,333 175,000 - - 150,000 5,000 (6) Chief Scientific Officer 1998 275,000 140,375 - 14,625 67,000 4,500 (6) 1997 262,500 102,000 - - - 4,500 (6) Carl M. Cohen, Ph.D.(7) 1999 200,000 30,000 - - 75,000 5,000 (6) Vice President, Research 1998 176,000 24,000 - - 75,000 - and Development 1997 29,333 10,000 - - 100,000 - Cheryl K. Lawton 1999 178,083 30,000 - - 75,000 5,000 (6) General Counsel and Vice 1998 157,000 56,875 - 14,625 125,000 3,494 (6) President, Administration 1997 145,481 30,000 - - 70,000 - Steven L. Basta 1999 157,583 30,000 - - 75,000 5,000 (6) Vice President, Finance and 1998 131,000 37,500 - - 125,000 25,950 (8) Business Development 1997 108,414 17,000 - - 50,000 42,760 (8)
_____ (1) The amounts shown include the individual's before-tax contributions to our 401(k) retirement plan. (2) Unless included in the table, non-cash benefits were less than the lesser of 10% of each such person's respective cash compensation or $50,000. (3) Represents issue of 10,000 shares of Common Stock to Mr. Tarnow and 6,000 shares of Common Stock each to Dr. Charles Cohen and Ms. Cheryl Lawton. (4) Options to purchase the number of shares shown were granted pursuant to our 1987 Stock Plan and 1998 Stock Plan. (5) Mr. Tarnow joined us in July 1995. The amounts reported as Other Annual Compensation in fiscal 1997 consist of reimbursed relocation and related expenses, including reimbursement of related income taxes. (6) Consists of matching 401(k) contributions. (7) Dr. Carl Cohen joined us in November 1997. (8) Mr. Basta joined us in February 1997. The amounts reported as Other Annual Compensation in fiscal 1997 and 1998 consist of reimbursed relocation expenses. 53 Option Grants The following table shows, as to each person named, the options to purchase Common Stock granted by us under the 1987 Stock Plan and 1998 Stock Plan in fiscal year 1999. Option Grants in Last Fiscal Year
Potential Realizable Value at Assumed Annual Rates of Stock Price Appreciation Individual Grants for Option Term (2) --------------------------------------------------------- ---------------------------------- % of Total Number of Options Securities Granted to Underlying Employees Exercise Options in Fiscal Price Expiration Name Granted (#) Year ($/Share) Date 0% ($) 5% ($) 10% ($) - ---- ----------- ---- --------- ---------- ------ ------ ------- Michael M. Tarnow 200,000 (1)(3) 17.2% $3.00 2/12/2009 $ - $377,337 $956,245 Charles Cohen, Ph.D. 150,000 (1)(3) 12.9% 3.00 2/12/2009 - 283,033 717,184 Carl M. Cohen, Ph.D. 75,000 (1)(3) 6.5% 3.06 11/09/2009 3,563 150,252 375,303 Cheryl K. Lawton 75,000 (1)(3) 6.5% 3.06 11/09/2009 3,563 150,252 375,303 Steven L. Basta 75,000 (1)(3) 6.5% 3.06 11/09/2009 3,563 150,252 375,303
- ---------- (1) These options are stock options granted under our 1998 Stock Plan at fair market value. Mr. Tarnow's and Dr. Charles Cohen's options become exercisable as to 25% on February 12, 2000 and thereafter vest in equal annual portions through February 12, 2003. Ms. Lawton's and Mr. Basta's and Dr. Carl Cohen's options become exercisable as to 25% on November 9, 2000 and thereafter vest in equal annual portions through November 9, 2003. These options were amended as described in note (3) below. (2) Amounts represent hypothetical gains that could be achieved for the respective options if exercised at the end of the option term. These gains are based on assumed rates of stock price appreciation of 0%, 5% and 10% compounded annually from the date the respective options were granted. (3) On February 8, 2000, the Board of Directors approved amendments to certain stock option agreements of each of Mr. Tarnow, Dr. Charles Cohen, Dr. Carl Cohen, Ms. Lawton, and Mr. Basta. The amendments provided for the immediate acceleration of all their unvested stock options and to provide that upon such person's termination of employment in connection with the proposed merger into Curis, all vested stock options will remain exerciseable for up to one year following the date of such termination. As of February 8, 2000: . Mr. Tarnow held options to purchase 1,473,747 shares of Common Stock after giving effect to his exercise of options to purchase 180,243 shares on that date; . Dr. Charles Cohen held options to purchase 1,051,555 shares of Common Stock after giving effect to his exercise of options to purchase 285,445 shares on that date; . Dr. Carl Cohen held options to purchase 250,000 shares of Common Stock; . Ms. Lawton held options to purchase 270,000 shares of Common Stock; and . Mr. Basta held options to purchase 250,000 shares of Common Stock. 54 Aggregated Option Exercises and Fiscal Year End Option Values The following table shows, as to each person named, the aggregated stock options exercised under our stock option plans in fiscal year 1999 and year-end values. Aggregated Option Exercises in Last Fiscal Year and Fiscal Year-End Option Values
Number of Shares Securities Underlying Value of Unexercised Acquired Unexercised Options In-the-Money Options on Value at Fiscal Year-End (#) at Fiscal Year-End ($)(2) Exercise Realized -------------------------- -------------------------- Name (#) ($)(1) Exercisable Unexercisable Exercisable Unexercisable - ---- -------- -------- ----------- ------------- ----------- ------------- Michael M. Tarnow - - 1,113,240 340,750 $1,775,707 $340,000 Charles Cohen, Ph.D. 41,667 79,167 856,750 280,250 1,271,145 255,000 Carl M. Cohen, Ph.D. - - 68,750 181,250 47,063 264,000 Cheryl K. Lawton - - 66,250 203,750 47,063 264,000 Steven L. Basta - - 56,250 193,750 47,063 264,000
(1) Based upon the closing price of our Common Stock on various dates of exercise as reported by The Wall Street Journal. The options each had an exercise price equal to the fair market value of our Common Stock on the date the options were granted. The value realized upon exercise of the options resulted directly from appreciation in our stock price during the optionee's tenure with us. (2) Based upon the $4.9375 closing price of our Common Stock on December 31, 1999, as reported by The Wall Street Journal. The options each had an exercise price equal to the fair market value of our Common Stock on the dates the options were granted. The valuation of the unexercised in-the- money options results directly from appreciation in our stock price during the optionee's tenure with us. Employment Agreements We have entered into an employment agreement with Michael M. Tarnow pursuant to which Mr. Tarnow has agreed to serve as our President and Chief Executive Officer at a current annual base salary of $355,000 (subject to increase), plus an annual performance bonus at the discretion of the Board of Directors of up to 60% of his annual salary. Our agreement with Mr. Tarnow was for an initial two- year term ending on July 16, 1997 and thereafter for successive one year periods, unless terminated by either party by prior written notice of at least 90 days. Notwithstanding the foregoing, the employment agreement may be terminated for cause. In the event that we terminate Mr. Tarnow's employment other than for cause or Mr. Tarnow is constructively terminated by having his authority and role materially reduced or by no longer serving as our President and Chief Executive Officer or as a Director, we have agreed to pay his salary for a period of twelve months after the date of termination and have agreed to pay a pro rata portion of his annual bonus through the date of his termination. Pursuant to this agreement, Mr. Tarnow was granted options to purchase 1,000,000 shares of our Common Stock. The options became exercisable as to 20% immediately and thereafter vest in equal annual portions through July 16, 1999. We have entered into an employment agreement with Dr. Charles Cohen pursuant to which we retained Dr. Cohen's services at a current annual salary of $295,000 (subject to increase) and a target annual bonus of 60% of his annual salary based on performance. Our original agreement with Dr. Cohen was for an initial term ending on December 31, 1993 and thereafter continues for additional periods of one year, unless at anytime 55 during the term such agreement is terminated by either party by written notice of not less than 90 days. Notwithstanding the foregoing, the employment agreement may be terminated for cause. In the event we terminate Dr. Cohen's employment other than for cause, or Dr. Cohen terminates his employment as a result of breach by us or in certain other limited circumstances constituting a constructive termination, the Company has agreed to pay his salary at the annual rate in effect on the date of termination for twelve months after the date of termination or, if sooner, the date of his employment by a third party. We have entered into an employment agreement with Dr. Carl Cohen, which agreement provides for a current annual salary of $212,000 (subject to increase), plus a bonus to be determined annually based upon mutually agreed objectives. Pursuant to this agreement, Dr. Cohen was granted stock options to purchase 100,000 shares of Common Stock vesting annually over four years. We have entered into an employment agreement with Cheryl K. Lawton, which agreement provides for a current annual salary of $191,000 (subject to increase), plus a bonus to be determined annually based upon mutually agreed objectives. Pursuant to this agreement, Ms. Lawton was granted stock options to purchase 70,000 shares of Common Stock vesting annually over four years. We have entered into an employment agreement with Steven L. Basta, which agreement provides for a current annual salary of $170,000 (subject to increase), plus a bonus to be determined annually based upon mutually agreed objectives. Pursuant to this agreement, Mr. Basta was granted stock options to purchase 50,000 shares of Common Stock vesting annually over four years. On February 8, 2000, the Board of Directors approved amendments to certain stock option agreements of our directors and executive officers to provide for the immediate acceleration of all their unvested stock options and to provide that upon such person's termination of employment or removal from the board of directors, as applicable, in connection with the merger into Curis, all vested stock options will remain exerciseable for up to one year following the date of such termination or removal, as applicable. Compensation Committee Interlocks and Insider Participation The members of the Compensation Committee are Mr. Tobin, Mr. Dovey and Dr. Rosenblatt. None of our executive officers is a member of the Compensation Committee. There are no interlocks between the members of the Compensation Committee and our executive officers. 56 Item 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT Security Ownership of Certain Beneficial Owners and Management The following table sets forth certain information regarding beneficial ownership of our Common Stock as of March 10, 2000, by (i) each stockholder known by us to be the beneficial owner of more than 5% of the outstanding shares of Common Stock, (ii) each of our directors, (iii) each of our executive officers named in the Summary Compensation Table herein, and (iv) all directors and current executive officers as a group. Except as otherwise indicated, we believe that the beneficial owners of the Common Stock listed below, based on information furnished by such owners, have sole investment and voting power with respect to such shares.
Number Percent of Shares of Class Beneficially Beneficially Name and Address of Beneficial Owner** Owned(1) Owned(1) - -------------------------------------- ------------ ------------ Entities associated with Apax Partners(2)................................... 3,423,022 9.0% 15 Portland Place London, United Kingdom Biotechnology Investments Limited(3)........................................ 2,266,122 5.9 St. Julian's Court St. Peter's Port Guernsey, Channel Islands Michael M. Tarnow(4)........................................................ 1,690,990 4.3 Steven L. Basta(5).......................................................... 264,449 * Carl M. Cohen, Ph.D.(11).................................................... 250,000 * Charles Cohen, Ph.D.(6)..................................................... 1,644,830 4.2 Jeremy L. Curnock Cook(7)................................................... 50,000 * 5 Arrows House St. Swithin's Lane London, United Kingdom Brian H. Dovey(8)........................................................... 1,375,861 3.6 One Palmer Square Princeton, NJ 08542 Martyn D. Greenacre(11)..................................................... 50,000 * Suzanne Denbo Jaffe(11)..................................................... 50,000 * Cheryl K. Lawton(9)......................................................... 278,692 * Michael Rosenblatt, M.D.(11)................................................ 60,000 * James R. Tobin(10).......................................................... 50,000 All directors and current executive officers as a group (11 Persons) (11)... 5,764,822 13.8
- ------------- * Less than 1% ** Addresses are given for beneficial owners of more than 5% of the outstanding Common Stock only. 57 (1) Applicable percentage of ownership is based on 38,231,502 shares of Common Stock outstanding as of March 10, 2000, together with applicable options or warrants for such stockholder. Beneficial ownership is determined in accordance with the rules of the Securities and Exchange Commission and generally includes voting or investment power with respect to securities. Shares of Common Stock subject to options or warrants which are currently exercisable or convertible or which will become exercisable or convertible within sixty (60) days after March 10, 2000, are deemed outstanding for computing the beneficial ownership of the person holding such option or warrant but are not outstanding for computing the beneficial ownership of any other person. Except as indicated by footnote, and subject to community property laws where applicable, the persons named in the table above have sole voting and investment power with respect to all shares of Common Stock shown as beneficially owned by them. (2) Includes 258,661 shares held by Banque Wormser Freres, Custodian for Apax CR IIA; 102,791 shares held by Banque Wormser Freres, Custodian for Apax CR IIC; 597,566 shares of Common Stock held by Coutts & Co (Jersey) Limited, Custodian for Apax Ventures II, Ltd.; 1,353,365 shares held by Apax Funds Nominees Ltd. "A" Account, Custodian for Apax Ventures III Trust and Apax Funds Nominees Ltd. "A" Account, Custodian for Apax Ventures III International Partners, L.P.; 1,037,583 shares held by Apax Funds Nominees Ltd. "B" Account, Custodian for Apax Ventures IV Trust and Apax Funds Nominees Ltd. "B" Account, Custodian for Apax Ventures IV International Partners, L.P., and 73,056 shares held by MMG Conseil (collectively "Entities associated with Apax Partners"). Ronald Cohen is a director of Apax Partners & Co. Ventures Ltd., and he may be deemed to be the beneficial owner of 3,126,284 shares of Common Stock (after giving effect to the exercise of warrants). The address for Banque Wormser Freres, Custodian for Apax CR IIA, Apax CR IIC and MMG Conseil, is No. 45 Avenue Kleber, Paris, 75116 France; the address for Coutts & Co (Jersey) Limited, Custodian for Apax Ventures II, Ltd., is 23/25 Broad Street, St. Helier, Jersey, Channel Islands, and the address for Apax Funds Nominees Ltd. "A" Account, Custodian for Apax Ventures III Trust and Apax Ventures III International Partners, L.P., and for Apax Funds Nominees Ltd. "B" Account, Custodian for Apax Ventures IV Trust and Apax Ventures IV International Partners, L.P., is 62 Green Street, London, United Kingdom. The address for Mr. Cohen and Apax Partners & Co. Ventures Ltd. is 15 Portland Place, London, United Kingdom. The information in the chart and in this footnote, other than the percentage of class beneficially owned, is based solely on information provided by counsel for the entities and persons listed in this footnote under a Stockholders' Agreement dated February 18, 2000. (3) Includes 2,266,122 shares of Common Stock beneficially owned by Biotechnology Investments Limited ("BIL"). Rothschild Asset Management Limited, a company with which Jeremy Curnock Cook is affiliated, and BIL have agreed to terminate Rothschild's financial advisory relationship with BIL in connection with BIL's reorganization. (4) Includes 217,243 shares of Common Stock, of which 10,000 shares are restricted, and 1,473,747 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. (5) Includes 14,449 shares of Common Stock and 250,000 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. (6) Includes 531,275 shares of Common Stock owned directly by Dr. Cohen, 50,000 shares of Common Stock owned by Dr. Cohen's wife, 12,000 shares of Common Stock owned by Dr. Cohen's children, and 1,051,555 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. (7) Includes 50,000 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. Does not include 2,266,122 shares of Common Stock beneficially owned by BIL due to the termination of the advisory relationship between BIL and Rothschild Asset Management 58 Limited in connection with the reorganization of BIL. Mr. Curnock Cook is also a shareholder, but is not an officer or director, of BIL. Rothschild Asset Management (C.I.) Limited is a wholly-owned subsidiary of Rothschild Asset Management Limited. Mr. Curnock Cook disclaims beneficial ownership of the shares owned by BIL. See Note 3. (8) Includes 1,188 shares of Common Stock owned directly by Mr. Dovey, 70,000 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter and 1,304,673 shares of Common Stock held by Entities associated with Domain Associates, L.L.C. Mr. Dovey is a Managing Member of Domain Associates, L.L.C. and a General Partner of the general partner of the Entities associated with Domain Associates, L.L.C. and may be deemed to be the beneficial owner of shares owned by the Entities associated with Domain Associates, L.L.C. Does not include 2,266,122 shares of Common Stock beneficially owned by BIL. Domain Associates is the U.S. venture capital advisor to BIL. Domain Associates has neither voting nor investment power over the shares owned by BIL and Mr. Dovey disclaims beneficial ownership of the shares owned by BIL. See Note 3. (9) Includes 8,692 shares of Common Stock and 270,000 shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. (10) Includes shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. Does not include shares owned by Biogen, Inc. Mr. Tobin was a Director, President and Chief Executive Officer of Biogen until December 1998. Mr. Tobin disclaims beneficial ownership of the shares owned by Biogen. (11) Includes shares of Common Stock subject to options exercisable on March 10, 2000 or within 60 days thereafter. Item 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS Certain Transactions In November 1998, we sold to Stryker Corporation, certain manufacturing rights and assigned certain obligations relating to the use and manufacture of OP-1 for orthopaedic and dental reconstruction. As part of that transaction, Stryker assumed all of our rights and obligations relating to the manufacturing contract with Biogen, executed in 1994 and extended through December 1999, to produce in our manufacturing facility in West Lebanon, New Hampshire several of Biogen's protein-based therapeutic candidates for use in Biogen's clinical trials. James R. Tobin, one of our directors since January 1995, was President and Chief Executive Officer of Biogen until December 1998. In December 1994 and January 1995, we, as part of a private placement, issued warrants exercisable for a period of five years from the date of issuance at an exercise price of $2.385 per share. The investors who held warrants included, among others, certain beneficial owners of more than 5% of the Common Stock. During the year ended December 31, 1999, the Entities associated with APAX Partners and Biotechnology Investments Limited exercised 372,326 and 100,584 warrants, respectively, at $2.385 per share. At December 31, 1999, warrants to purchase 414,270 shares of Common Stock were outstanding; none of which were held by investors who own more than 5% of the Common Stock. In September 1996, we loaned $350,000 to Michael M. Tarnow, President and Chief Executive Officer of the Company. The loan was evidenced by a fully secured promissory note bearing interest at the annual rate of 6.02% and payable in three equal annual installments, plus accrued interest. As of December 31, 1999, the loan has been paid in full. In December 1996, we entered into a Research Collaboration and License Agreement with Biogen to collaborate on the development of novel therapeutics based on OP- 1 for the treatment of renal disorders. The initial focus of the collaboration was on advancing the development of our morphogenic protein, OP-1, for the treatment of acute and chronic renal failure. Under the agreement, we granted to Biogen exclusive worldwide 59 rights to manufacture, market and sell OP-1 and OP-1 products developed through the collaboration for the treatment of renal disease. Biogen paid us a $10,000,000 license fee in 1996 and made an $18,000,000 equity investment which were recorded in the quarter ended December 31, 1996. In addition, the agreement provided for $10,500,000 in research funding over a three year period ending December 31, 1999, of which $7,500,000 was recognized through December 31, 1998. In December 1998, we and Biogen revised the terms of the Agreement. We assumed primary responsibility for the development of OP-1 for the treatment of renal disorders. Biogen provided $3,000,000 in research support during 1999 and retained an option through 1999 to resume development of OP-1 as a therapy for chronic renal failure. As of December 31, 1999, Biogen did not exercise its option, and we assumed all rights to OP-1 based renal therapies. On February 8, 2000 we loaned an aggregate amount of $1,131,380 to Michael Tarnow and Charles Cohen, Ph.D., both executive officers of the Company. The loan was used by these individuals to exercise incentive stock options on the same date. The amount of the loan was equal to the aggregate exercise price of the incentive stock options acquired by them on that day. These full recourse loans each bear interest at an annual rate of 7% and the principal is due and payable on the earlier of May 8, 2002 or 30 days following the sale of the stock purchased with these funds. As of March 10, 2000, the holders of approximately four million shares of outstanding or issuable Common Stock, or the Registrable Securities, are entitled to certain rights to register such shares under the Securities Act for sale to the public. The holders of Registrable Securities include, among others, Entities associated with Apax Partners, BIL, Entities associated with Domain Associates, and Biogen. Under the terms of the Second Amended and Restated Registration Rights Agreement dated as of January 31, 1992, as amended, in the event we propose at any time to register any of our securities under the Securities Act for sale for our own account, such holder shall be entitled to include shares of Common Stock in such registration. Such holders have the additional right to require us, on not more than three occasions, whether or not we propose to register any of our Common Stock for sale, to register all or part of their shares for sale to the public under the Securities Act, subject to certain conditions and limitations. In addition, holders of Registrable Securities may require the Company to register all or part of their shares on Form S-3 (or a successor short form of registration) if we then qualify for use of such form, subject to certain conditions and limitations. We have had equity transactions with BIL, Entities associated with Apax Partners, Dr. Hale individually, Entities associated with Domain Associates and Biogen, as described above. Mr. Curnock Cook, one of our directors, is a director of Rothschild Asset Management Limited, which was an advisor to BIL and to Rothschild Asset Management (C.I.) Limited, which was the manager of BIL. Mr. Dovey, one of our directors, is a General Partner of Domain Associates and a General Partner of the general partner of the Entities associated with Domain Associates. Mr. Tobin, one of our directors, was President and Chief Executive Officer of Biogen until December 1998. 60 PART IV Item 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K Item 14 (a) The following documents are filed as part of this Annual Report on Form 10-K. 14(a)(1) Financial Statements -------------------- See "Index to Consolidated Financial Statements" at Item 8 in this Annual Report on Form 10-K. 14(a)(2) Financial Statement Schedules and Other Financial Statements ------------------------------------------------------------ Financial statement schedules have not been included because they are not applicable or the information is included in the financial statements or notes thereto. 14(a)(3) Exhibits - See 14 (c) below. -------- Item 14(b) Reports on Form 8-K -------------------- No reports on Form 8-K were filed during the three month period ended December 31, 1999. Item 14 (c) Exhibits -------- The following is a list of exhibits filed as part of this Annual Report on Form 10-K: 3.1 Restated Certificate of Incorporation, as amended, of the Registrant. (Filed as Exhibit 3.1 to Registrant's Annual Report on Form 10-K for the period ended September 30, 1995 (File No. 0- 19910), and incorporated herein by reference.) 3.2 Restated By-Laws of the Registrant. (Filed as Exhibit 3.4 to Form S-1 Registration Statement (Registration No. 33-46200), or amendments thereto, and incorporated herein by reference.) 3.3 Certificate of Designations of the Series 1998/A Preferred Stock. (Filed as Exhibit 3.3 to Registrant's Report on Form 8-K for the May 27, 1998 Event (File No. 0-19910), and incorporated herein by reference.) 4.1 Article FOURTH of the Restated Certificate of Incorporation of the Registrant, as amended (see Exhibit 3.1). 10.1 Second Amended and Restated Registration Rights Agreement, dated as of January 31, 1992. (Filed as Exhibit 10.4 to Form S-1 Registration Statement (Registration No. 33-46200), or amendments thereto, and incorporated herein by reference.) 10.2 Amendment No. 1 to Second Amended and Restated Registration Rights Agreement, dated as of December 23, 1994, by and between the Registrant and certain of its Stockholders, and Instruments of Adherence to the Second Amended and Restated Registration Rights Agreement. (Filed as Exhibit 10.51 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1994 (File No. 0-19910), and incorporated herein by reference.) 61 10.3 Amendment No. 2 to Second Amended and Restated Registration Rights Agreement, dated as of May 24, 1996, by and between the Registrant and certain of its Stockholders. (Filed as Exhibit 10.1 to Form S-3 Registration Statement (Registration No. 333- 5477), and incorporated herein by reference.) 10.4 Amendment No. 3 to Second Amended and Restated Registration Rights Agreement, dated as of December 9, 1996, by and between the Registrant and certain of its Stockholders. (Filed as Exhibit 10.4 to Registrant's Annual Report on Form 10-K for the period ended December 31, 1996 (File No. 0-19910), and incorporated herein by reference.) #10.5 Master Restructuring Agreement, dated as of October 15, 1998, between the Registrant and Stryker Corporation. (Filed as Exhibit 10.10 to the Registrant's Annual Report on Form 10-K for the period ended December 31, 1998 (File No. 0-19910) and incorporated herein by reference.) #10.6 Asset Purchase Agreement, dated as of October 15, 1998, between the Registrant and Stryker Corporation. (Filed as Exhibit 10.11 to the Registrant's Annual Report on Form 10-K for the period ended December 31, 1998 (File No. 0-19910), and incorporated herein by reference.) #10.7 Creative Irrevocable License Agreement dated November 20, 1998 between the Registrant and Stryker Corporation. #10.8 Stryker Irrevocable License Agreement dated November 20, 1998 between the Registrant and Stryker Corporation. #10.9 Assignment from Creative to Stryker dated November 20, 1998. 10.10 Common Stock Purchase Warrant, dated June 1, 1987, issued by the Registrant to Phoenix Leasing Incorporated. (Filed as Exhibit 10.24 to Form S-1 Registration Statement (Registration No. 33-42159), or amendments thereto, and incorporated herein by reference.) 10.11 Real Estate Standard Form Industrial Lease, dated as of October 24, 1988, as amended September 17, 1991, by and between WRC Properties, Inc. and the Registrant. (Filed as Exhibit 10.26 to Form S-1 Registration Statement (Registration No. 33-42159), or amendments thereto, and incorporated herein by reference.) 10.12 Second Amendment, dated January 28, 1994, to Standard Form Industrial Lease dated October 24, 1988, as amended September 17, 1991, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.15 to Registrant's Annual Report on Form 10- K for the period ended September 30, 1994 (File No. 0-19910), and incorporated herein by reference.) 10.13 Third Amendment, dated September 20, 1994, to Standard Form Industrial Lease dated October 24, 1988, as amended September 17, 1991 and January 28, 1994, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.16 to Registrant's Annual Report on Form 10-K for the period ended September 30, 1994 (File No. 0-19910), and incorporated herein by reference.) 10.14 Fourth Amendment, dated April 10, 1997, to Standard Form Industrial Lease dated October 24, 1988, as amended September 17, 1991, January 28, 1994 and September 20, 1994, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.53 to Registrant's Quarterly Report on Form 10-Q for the period ended June 30, 1997 (File No. 0-19910), and incorporated herein by reference.) 62 10.15 Standard Form Industrial Lease, dated February 25, 1992, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.52 to Form S-1 Registration Statement (Registration No. 33-46200), or amendments thereto, and incorporated herein by reference.) 10.16 Partial Lease Termination Agreement and Amendment to Lease, dated February 28, 1999, between Creative and W9/TIB Real Estate Limited Partnership (as successor in interest to WRC Properties, Inc.) 10.17 First Amendment, dated February 28, 1994, to Standard Form Industrial Lease dated February 25, 1992 by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.32 to Registrant's Annual Report on Form 10-K for the period ended September 30, 1995 (File No. 0-19910), and incorporated herein by reference.) 10.18 Second Amendment, dated September 20, 1994, to Standard Form Industrial Lease dated February 25, 1992, as amended February 28, 1994, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.33 to Registrant's Annual Report on Form 10- K for the period ended September 30, 1995 (File No. 0-19910), and incorporated herein by reference.) 10.19 Third Amendment, dated April 10, 1997, to Standard Form Industrial Lease dated February 25, 1992, as amended February 28, 1994 and September 20, 1994, by and between the Registrant and WRC Properties, Inc. (Filed as Exhibit 10.54 to Registrant's Quarterly Report on Form 10-Q for the period ended June 30, 1997 (File No. 0-19910), and incorporated herein by reference.) #10.20 CBM Cross-License Agreement, dated as of November 26, 1993, between Enzon, Inc. and the Registrant. (Filed as Exhibit 10.42 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1993 (File No. 0-19910), and incorporated herein by reference.) #10.21 Enzon Cross-License Agreement, dated as of November 26, 1993, between Enzon, Inc. and the Registrant. (Filed as Exhibit 10.43 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1993 (File No. 0-19910), and incorporated herein by reference.) 10.22 Exclusive Marketing Agreement, dated as of November 26, 1993, between Enzon, Inc. and the Registrant. (Filed as Exhibit 10.44 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1993 (Filed No. 0-19910), and incorporated herein by reference.) 10.23 Form of Preferred Stock and Warrant Purchase Agreement, with Exhibits thereto, signed by the Registrant and the persons listed on the Schedule attached at the end of the Form of Preferred Stock and Warrant Purchase Agreement. (Filed as Exhibit 10.52 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1994 (File No. 0-19910), and incorporated herein by reference.) 10.24 Form of Warrant issued by the Registrant to the persons listed on the Schedule attached at the end of the Form of Warrant on various dates between December 23, 1994 and January 25, 1995. (Filed as Exhibit 10.53 to Registrant's Quarterly Report on Form 10-Q for the period ended December 31, 1994 (File No. 0-19910), and incorporated herein by reference.) 63 #10.25 Cross-License Agreement, dated as of July 15, 1996, between the Registrant, Genetics Institute, Inc. and Stryker Corporation. (Filed as Exhibit 10.1 to the Quarterly Report on Form 10-Q for the period ended September 30, 1996 of Genetics Institute, Inc. (File No. 0-14587), filed with the Securities and Exchange Commission on November 6, 1996 and incorporated herein by reference.) #10.26 Research Collaboration and License Agreement, dated December 9, 1996, between the Registrant and Biogen, Inc. (Filed as Exhibit 10.37 to Registrant's Annual Report on Form 10-K for the period ended December 31, 1996 (File No. 0-19910), and incorporated herein by reference.) 10.27 Amendment Agreement, dated December 30, 1998, by and between the Registrant and Biogen, Inc. (Filed as Exhibit 10.38 to the Registrant's Report on Form 10-K for the period ended December 31, 1998 (File No. 0-19910), and incorporated herein by reference.) 10.28 Restricted Stock Purchase Agreement, dated December 9, 1996, between the Registrant and Biogen, Inc. (Filed as Exhibit 10.38 to Registrant's Annual Report on Form 10-K for the period ended December 31, 1996 (File No. 0-19910), and incorporated herein by reference.) 10.29 Lease, dated June 16, 1997, by and between the Registrant and The Prudential Insurance Company of America. (Filed as Exhibit 10.55 to Registrant's Quarterly Report on Form 10-Q for the period ended June 30, 1997 (File No. 0-19910), and incorporated herein by reference.) 10.30 First Amendment, dated August 10, 1998, to Lease dated April 10, 1997, between the Registrant and The Prudential Insurance Company of America. (Filed as Exhibit 10.56 to Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1998 (File No. 0-19910), and incorporated herein by reference.) 10.31 Master Lease Agreement, dated October 6, 1997, by and between the Registrant and FINOVA Technology Finance, Inc. (Filed as Exhibit 10.38 to Registrant's Annual Report on Form 10-K for the period ended December 31, 1997 (File No. 0-19910), and incorporated herein by reference). 10.32 Form of Subscription Agreement dated May 29, 1998. (Filed as Exhibit 10.54 to Registrant's Report on Form 8-K for the May 27, 1998 Event (File No. 0-19910), and incorporated herein by reference.) *10.33 1983 Incentive Stock Option Plan, amended as of September 11, 1984. (Filed as Exhibit 10.34 to Form S-1 Registration Statement (Registration No. 33-42159), or amendments thereto, and incorporated herein by reference.) *10.34 1987 Stock Plan, as amended on May 20, 1997. (Filed as Exhibit 10.52 to Registrant's Quarterly Report on Form 10-Q for the period ended June 30, 1997 (File No. 0-19910), and incorporated herein by reference.) 64 *10.35 Employee Stock Purchase Plan, as amended on April 16, 1998. (Filed as Exhibit 10.41 to Registrant's Quarterly Report on Form 10-Q for the period ended June 30, 1998 (File No. 0- 19910), and incorporated herein by reference.) *10.36 1992 Non-Employee Director Non-Qualified Stock Option Plan, as amended on March 20, 1996. (Filed as Exhibit 10.25 to Registrant's Quarterly Report on Form 10-Q for the period ended March 31, 1996 (File No. 0-19910), and incorporated herein by reference.) 10.37 1998 Stock Plan. (Filed as Exhibit to Registrant's Preliminary Proxy Statement for 1998 Annual Meeting of Stockholders (File No. 0-19910), and incorporated herein by reference.) *10.38 Form of Employment Agreement with confidentiality provisions. (Filed as Exhibit 10.31 to Form S-1 Registration Statement (Registration No. 33-42159), or amendments thereto, and incorporated herein by reference.) *10.39 Employment Agreement, dated as of January 2, 1992, between Charles Cohen, Ph.D. and the Registrant. (Filed as Exhibit 10.47 to Form S-1 Registration Statement (Registration No. 33- 46200), or amendments thereto, and incorporated herein by reference.) *10.40 Employment Agreement, dated February 25, 1992, between Wayne E. Mayhew III and the Registrant. (Filed as Exhibit 10.51 to Form S-1 Registration Statement (Registration No. 33-46200), or amendments thereto, and incorporated herein by reference.) *10.41 Employment Agreement, dated July 17, 1995, between Michael M. Tarnow and the Registrant. (Filed as Exhibit 99.1 to Registrant's Report on Form 8-K for the August 31, 1995 Event (File No. 0-19910), and incorporated herein by reference.) *10.42 Employment Agreement, dated May 21, 1996, between Thomas J. Facklam, Ph.D. and the Registrant. (Filed as Exhibit 99.2 to Registrant's Report on Form 8-K for the June 3, 1996 Event (File No. 0-19910), and incorporated herein by reference.) *10.43 $350,000 Promissory Note, dated September 6, 1996, from Michael Tarnow to the Registrant. (Filed as Exhibit 10.56 to Registrant's Quarterly Report on Form 10-Q for the period ended September 30, 1997 (File No. 0-19910), and incorporated herein by reference.) *10.44 Employment Agreement, dated January 13, 1997, between Cheryl K. Lawton and the Registrant. (Filed as Exhibit 10.50 to Registrant's Quarterly Report on Form 10-Q for the period ended March 31, 1997 (File No. 0-19910), and incorporated herein by reference.) *10.45 Employment Agreement, dated February 18, 1997, between Steven L. Basta and the Registrant. (Filed as Exhibit 10.51 to Registrant's Quarterly Report on Form 10-Q for the period ended March 31, 1997 (File No. 0-19910), and incorporated herein by reference.) *10.46 Employment Agreement, dated September 17, 1997, between Carl M. Cohen, Ph.D., and the Registrant. (Filed as Exhibit 10.53 to Registrant's Annual Report on Form 10-K for the period ended December 31, 1997 (File No. 0-19910), and incorporated herein by reference.) 65 21 Subsidiaries of the Registrant. (Filed as Exhibit 22 to Form S-1 Registration Statement (Registration No. 33-42159), or amendments thereto, and incorporated herein by reference.) 23.1 Independent Auditors' Consent. 27 Financial Data Schedule. The Registrant will supply the Commission, upon request, with copies of all exhibits and schedules to exhibits listed above, as to which such exhibits and schedules have not been included herein. * Management contract or compensatory plan or arrangement required to be filed as an exhibit to this Form 10-K. # Documents with certain confidential information deleted. 66 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, in Hopkinton, Massachusetts, on March 13, 2000. CREATIVE BIOMOLECULES, INC. By: /s/ Steven L. Basta ---------------------------------------------------- Steven L. Basta Vice President, Finance and Business Development Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons in the capacities indicated below on date indicated. Signature Capacity Date - --------- -------- ---- /s/ Brian H. Dovey Chairman of the Board and Director March 13, 2000 - ---------------------------- Brian H. Dovey /s/ Michael M. Tarnow President and Chief Executive March 13, 2000 - ---------------------------- Officer Michael M. Tarnow and Director (principal executive officer) /s/ Charles Cohen, Ph.D. Chief Scientific Officer and March 13, 2000 - ---------------------------- Director Charles Cohen, Ph.D. /s/ Steven L. Basta Vice President, Finance and March 13, 2000 - ---------------------------- Business Development Steven L. Basta Treasurer (principal financial officer) /s/ Susan M. Letterie Director of Accounting (principal March 13, 2000 - ---------------------------- accounting officer) Susan M. Letterie Director March 13, 2000 - ---------------------------- Jeremy L. Curnock Cook /s/ Martyn D. Greenacre Director March 13, 2000 - ---------------------------- Martyn D. Greenacre /s/ Suzanne D. Jaffe Director March 13, 2000 - ---------------------------- Suzanne D. Jaffe /s/ Michael Rosenblatt, M.D. Director March 13, 2000 - ---------------------------- Michael Rosenblatt, M.D. /s/ James R. Tobin Director March 13, 2000 - ---------------------------- James R. Tobin 67
EX-10.7 2 CREATIVE IRREVOCABLE LICENSE AGREEMENT EXHIBIT 10.7 CREATIVE IRREVOCABLE LICENSE AGREEMENT This Agreement, dated November 20, 1998 by and between Creative BioMolecules, Inc., a Delaware corporation with its principal office at 35 South Street, Hopkinton, Massachusetts 01748 ("CBM") and Stryker Corporation, a Michigan corporation with its corporate office at 2725 Fairfield Road, P.O. Box 4085, Kalamazoo, Michigan 49003-4085 ("Stryker"). WHEREAS, the patents and patent applications listed on Schedule 1 attached hereto have been assigned to Stryker by CBM; and WHEREAS, it is the intention of Stryker, by this Irrevocable License Agreement, to grant to CBM an exclusive license under the Assigned Patent Rights, subject, however, to the exclusive rights of Stryker in the Stryker Field (as such terms are defined herein); NOW, THEREFORE, in consideration of the foregoing, and of the assignment of the Assigned Patent Rights by CBM to Stryker, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, hereby agree as follows: 1. Definitions. As used herein, the following words shall have the ----------- following meanings: a. "Assigned Patent Rights" shall mean (i) the patents and patent applications listed on Schedule 1 attached hereto, (ii) any patent applications and patents deemed to be Assigned Patents pursuant to Section 4.2 of the Master Agreement, and (iii) all worldwide counterparts and registrations, continuations, divisions, reissues, extensions or supplementary protection certificates, continuations-in-part or additions (but only to the extent such continuations-in-part or additions claim inventions disclosed as required by 35 U.S.C. (S)112 (CIPs) or the applicable laws (additions) in the parent application therefor listed in Schedule 1) with respect thereto, and all patents issuing therefrom. b. "Biological Materials" shall mean any biological materials, assays, substances or reagents, including without limitation transformed or transfected cells (including any cell expressing an OP Product or any analog, mutation or heterodimer thereof), cell lines, DNA sequences, vectors, host cells, proteins, antibodies and any fragments or subcellular components thereof. c. "Bone Diseases" shall mean Osteoporosis, Osteomalacia and Paget's Disease. d. "OP" shall mean proteins (or the active sites thereof) or polypeptides or combinations of proteins and polypeptides which produce an osteogenic effect. e. "OP Products" shall mean OP and polyclonal or monoclonal antibodies of OP and specific inhibitors or inhibitory activities of the osteogenic effect of OP, which inhibitors or inhibitory activities are found and identified as such in the course of the Research Project (as defined in the Second Amended and Restated Research, Development and Supply Agreement, dated May 17, 1991, between CBM and Stryker, as amended). f. "OP Devices" shall mean the combination of OP Products with suitably biocompatible and biodegradable carriers. g. "Bone Disease Field" shall mean the prevention or treatment of the Bone Diseases other than (i) by the local application of OP Products and OP Devices in an insoluble formulation directly on bone or joint tissue for local, as opposed to general or systemic, effect and (ii) the treatment of fractures regardless of whether they result from a Bone Disease. h. "Stryker Manufacturing Know-How" means all inventions, know-how, Biological Materials, designs, trade secrets, copyrights, processes, formulas, techniques, discoveries, ideas and the like that, as of the Closing Date (as defined in the Master Agreement), are owned by Stryker or as to which Stryker has acquired rights which are 2 licensable hereunder, that are necessary or useful in the manufacture of OP Products or OP Devices. i. "Stryker Field" shall mean the field of (i) treatment, repair or replacement of bone and joint tissue, including, without limitation, meniscus and articular cartilage and ligaments and tendons, but excluding the Bone Disease Field, and (ii) treatment, repair or replacement of the tooth, dentin, alveolar bone, cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw) and/or periodontal ligament, but excluding the treatment of Oral Ulcerations (as defined below) or any other disease or disorder of the tissues of the mouth not involving the tooth, dentin, bone (including alveolar bone), cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), ligament (including the periodontal ligament), tendon and/or cartilage. As used herein, "Oral Ulcerations" means the formation of lesions on the surface of skin lining the oral cavity caused by loss of tissue but does not include Periodontal Disease (as defined below) or any other disease or disorder involving the tooth, dentin, bone (including alveolar bone), cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), ligament (including the periodontal ligament), tendon and/or cartilage. As used herein, "Periodontal Disease" means degeneration of the apparatus holding the tooth to the jaw involving damage to any or all of the gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), alveolar bone, cementum, enamel and periodontal ligament. j. "Creative Field" means all uses and applications other than the Stryker Field. The Creative Field includes, without limitation, the Bone Disease Field. 3 k. "Master Agreement" means the Master Restructuring Agreement dated October 15, 1998 between Stryker and CBM. 2. Grant of Exclusive License. Stryker hereby grants to CBM an irrevocable, -------------------------- exclusive, worldwide license, with the unrestricted right to grant sublicenses, to all of the Assigned Patent Rights for all uses and applications of all inventions claimed therein, except for the manufacture, use, importation and sale of OP Products and OP Devices for use in the Stryker Field, which grant shall be exclusive even as to Stryker, with respect to the Creative Field, it being understood that Stryker retains the exclusive right to manufacture, use, import and sell OP Products and OP Devices for use in the Stryker Field. Such license shall not be terminable by Stryker or any successor, assign or any party claiming through Stryker under any circumstances or for any reason (including, without limitation, any breach or default under any other agreement between Stryker and CBM). 3. Grant of Non-Exclusive License. Stryker hereby grants to CBM an ------------------------------ irrevocable, non-exclusive, worldwide license, with the unrestricted right to grant sublicenses under all Stryker Manufacturing Know-How solely for use (a) in the manufacture of OP, OP Products or products or devices formulated with OP for use in the Creative Field, and (b) in the manufacture of proteins or polypeptides (or combinations of proteins or polypeptides) other than OP. 4. Retained Rights. Notwithstanding Section 2, Stryker hereby retains for --------------- itself the right to use OP Products and OP Devices as research and development tools for the development of other products and devices for use in the Stryker Field. Nothing in the license granted to Creative hereunder shall preclude Stryker from engaging in the development, production and sale of products and devices in the Stryker Field. 5. Recording of License. Stryker shall record this license in the United -------------------- States Patent and Trademark Office and such other foreign patent offices as CBM shall determine to be appropriate. 4 6. Miscellaneous. ------------- a. This Agreement may only be amended by a written instrument signed by both parties, which makes specific reference to this Agreement. b. CBM may assign this Agreement without the consent of Stryker. This Agreement shall be binding upon and shall inure to the benefit of CBM and Stryker and their respective successors and assigns. c. This Agreement is governed by the laws of the State of Delaware. d. This Agreement shall supersede the Irrevocable License Agreement dated May 17, 1991 between Stryker and CBM. IN WITNESS WHEREOF, the parties have executed this Agreement under seal as of the date first above written. CREATIVE BIOMOLECULES, INC. STRYKER CORPORATION By: /s/ Michael M. Tarnow By: /s/ REK ---------------------------- --------------------------- Title: President and CEO Title: Assistant Secretary ------------------------ ------------------------- 5 EX-10.8 3 STRYKER IRREVOCABLE LICENSE AGREEMENT EXHIBIT 10.8 STRYKER IRREVOCABLE LICENSE AGREEMENT This Agreement, dated November 20, 1998 by and between Creative BioMolecules, Inc., a Delaware corporation with its principal office at 35 South Street, Hopkinton, Massachusetts 01748 ("CBM") and Stryker Corporation, a Michigan corporation with its corporate office at 2725 Fairfield Road, P.O. Box 4085, Kalamazoo, Michigan 49003-4085 ("Stryker"). WHEREAS, the patents and patent applications listed on Schedule 1 attached hereto are owned by CBM; and WHEREAS, it is the intention of CBM, by this Irrevocable License Agreement, to grant to Stryker an exclusive license under the Patent Rights Licensed to Stryker in the Stryker Field (as such terms are defined herein); NOW, THEREFORE, in consideration of the foregoing and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties, intending to be legally bound, hereby agree as follows: 1. Definitions. As used herein, the following words shall have the ----------- following meanings: a. "Patent Rights Licensed to Stryker" shall mean (i) the patents and applications listed on Schedule 1 attached hereto, (ii) any patent applications and patents deemed to be Patent Rights Licensed to Stryker pursuant to Section 4.6 of the Master Agreement, and (iii) all worldwide counterparts and registrations, continuations, divisions, reissues, extensions or supplementary protection certificates, continuations-in-part or additions (but only to the extent such continuations-in-part or additions claim inventions disclosed as required by 35 U.S.C. (S)112 (CIPs) or the applicable laws (additions) in the parent application therefor listed in Schedule 1) with respect thereto, and all patents issuing therefrom. b. "Biological Materials" shall mean any biological materials, assays, substances or reagents, including without limitation transformed or transfected cells (including any cell expressing an OP Product or an analog, mutation or heterodimer thereof conceived, made, developed or reduced to practice as part of the Research Project (as defined in the Master Agreement)), cell lines, DNA sequences, vectors, host cells, proteins, antibodies and any fragments or subcellular components thereof. c. "Bone Diseases" shall mean Osteoporosis, Osteomalacia and Paget's Disease. d. "OP" shall mean proteins (or the active sites thereof) or polypeptides or combinations of proteins and polypeptides which produce an osteogenic effect. e. "OP Products" shall mean OP and polyclonal or monoclonal antibodies of OP and specific inhibitors or inhibitory activities of the osteogenic effect of OP, which inhibitors or inhibitory activities are found and identified as such in the course of the Research Project (as defined in the Second Amended and Restated Research, Development and Supply Agreement, dated May 17, 1991, between CBM and Stryker, as amended). f. "OP Devices" shall mean the combination of OP Products with suitably biocompatible and biodegradable carriers. g. "Bone Disease Field" shall mean the prevention or treatment of the Bone Diseases other than (i) by the local application of OP Products and OP Devices in an insoluble formulation directly on bone or joint tissue for local, as opposed to general or systemic, effect and (ii) the treatment of fractures regardless of whether they result from a Bone Disease. h. "Creative Manufacturing Know-How" means all inventions, know-how, Biological Materials (including, without limitation, any cell line expressing an analog of OP-1 conceived, made, developed or reduced to practice as part of the Current Scope(s) 2 of Work conducted pursuant to Section 4.2 of the Master Agreement), designs, trade secrets, copyrights, processes, formulas, techniques, discoveries, ideas and the like that, as of the Closing Date (as defined in the Master Agreement), are owned by CBM or as to which CBM has acquired rights which are licensable hereunder, that are necessary or useful in the manufacture OP Products or OP Devices. i. "Stryker Field" shall mean the field of (i) treatment, repair or replacement of bone and joint tissue, including, without limitation, meniscus and articular cartilage and ligaments and tendons, but excluding the Bone Disease Field, and (ii) treatment, repair or replacement of the tooth, dentin, alveolar bone, cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw) and/or periodontal ligament, but excluding the treatment of Oral Ulcerations (as defined below) or any other disease or disorder of the tissues of the mouth not involving the tooth, dentin, bone (including alveolar bone), cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), ligament (including the periodontal ligament), tendon and/or cartilage. As used herein, "Oral Ulcerations" means the formation of lesions on the surface of skin lining the oral cavity caused by loss of tissue but does not include Periodontal Disease (as defined below) or any other disease or disorder involving the tooth, dentin, bone (including alveolar bone), cementum, enamel, gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), ligament (including the periodontal ligament), tendon and/or cartilage. As used herein, "Periodontal Disease" means degeneration of the apparatus holding the tooth to the jaw involving damage to any or all of the gingiva (to the extent, but only to the extent, the gingiva functions as part of the apparatus holding the tooth to the jaw), alveolar bone, cementum, enamel and periodontal ligament. 3 j. "Master Agreement" means the Master Restructuring Agreement dated October 15, 1998 between Stryker and CBM. 2. Grant of Exclusive License. CBM hereby grants to Stryker an irrevocable, -------------------------- exclusive, worldwide license, with the unrestricted right to grant sublicenses, to all of the Patent Rights Licensed to Stryker solely for the manufacture, use, importation and sale of OP Products and OP Devices in the Stryker Field, which grant shall be exclusive, even as to CBM, with respect to the Stryker Field, it being understood that CBM retains the exclusive right to manufacture, use, import and sell OP Products and OP Devices for use in all fields other than the Stryker Field. Such license shall not be terminable by CBM or any successor, assign or any party claiming through CBM under any circumstances or for any reason (including, without limitation, any breach or default under any other agreement between Stryker and CBM). 3. Grant of Non-Exclusive License. CBM hereby grants to Stryker an ------------------------------ irrevocable, non-exclusive, worldwide license, with the unrestricted right to grant sublicenses under all Creative Manufacturing Know-How, solely for use (a) in the manufacture of OP Products and OP Devices for use in the Stryker Field, (b) in the manufacture of OP Products and OP Devices for Creative and (c) in the manufacture of proteins or polypeptides (or combinations of proteins or polypeptides) other than OP. 4. Retained Rights. Notwithstanding Section 2, CBM hereby retains for --------------- itself the right to use OP Products and OP Devices as research and development tools for the development of other products and devices for use in the Creative Field. Nothing in the license granted to Stryker hereunder shall preclude CBM from engaging in the development, production and sale of products and devices in the Creative Field. 5. Recording of License. CBM shall record this license in the United -------------------- States Patent and Trademark Office and such other foreign patent offices as Stryker shall determine to be appropriate. 4 6. Miscellaneous. ------------- a. This Agreement may only be amended by a written instrument signed by both parties, which makes specific reference to this Agreement. b. Stryker may assign this Agreement without the consent of CBM. This Agreement shall be binding upon and shall inure to the benefit of CBM and Stryker and their respective successors and assigns. c. This Agreement is governed by the laws of the State of Delaware. IN WITNESS WHEREOF, the parties have executed this Agreement under seal as of the date first above written. CREATIVE BIOMOLECULES, INC. STRYKER CORPORATION By: /s/ Michael Tarnow By: /s/ John S. Brown ---------------------------- ------------------------------ Title: President and CEO Title: Chairman, President and CEO ------------------------- --------------------------- 5 EX-10.9 4 ASSIGNMENT EXHIBIT 10.9 ASSIGNMENT ---------- Creative BioMolecules, Inc., a Delaware corporation, having a place of business at 35 South Street, Hopkinton, MA, in consideration of One Dollar and other valuable consideration paid to it by Stryker Corporation, a Michigan corporation, having a principal place of business at 2725 Fairfield Road, Kalamazoo, MI, the receipt of which is hereby acknowledged, does hereby sell, assign and transfer unto said Stryker Corporation, its successors and assigns, its entire right, title and interest for the United States of America and all foreign countries, including all rights of priority under the International Convention for the Protection of Industrial Property, in the inventions and improvements disclosed in the U.S., foreign, and PCT applications listed in Schedule A attached hereto, and in all Letters Patent of the United States and all foreign countries which have been or shall be granted on said inventions, or any parts thereof, or on said applications, or any divisions, continuations, reissues, extensions or other applications based in whole or in part thereon. And CBM agrees, for itself and its successors and assigns, with said Stryker Corporation and its successors and assigns, but at its or their expense and charges, hereafter to execute all applications, amended specifications, deeds or other instruments, and to do all acts necessary or proper to secure the grant of Letters Patent in the United States and in all other countries to said Stryker Corporation, with specifications and claims in such form as shall be approved by the counsel of said Stryker Corporation and to vest and confirm in said Stryker Corporation, its successors and assigns, the legal title to all such patents and to otherwise give full effect to and perfect the rights of said Stryker Corporation under this Assignment. And it does hereby authorize and request competent authorities to issue such Letters Patent as shall be granted upon said applications to said Stryker Corporation, its successors and assigns. WITNESS its hand and seal this 20th day of November, 1998. Creative BioMolecules, Inc. By: /s/ Michael M. Tarnow ---------------------------- Michael M. Tarnow President State of Massachusetts County of Suffolk Then personally appeared the above-named Michael M. Tarnow, to me known and known to me to be the person who executed the foregoing instrument, and acknowledged it to be his free act and deed, before me, this 19th day of November, 1998. /s/ Gabrielle A. Brousseau -------------------------------- Notary Public My Commission Expires: 6/23/2000 EX-10.16 5 PARTIAL LEASE TERMINATION AGREEMENT Exhibit 10.16 PARTIAL LEASE TERMINATION AGREEMENT AND AMENDMENT TO LEASE This Partial Lease Termination Agreement and Amendment to Lease (this "Agreement") is hereby entered into as of the 28th day of February, 1999 (the "Early Termination Date") by and between W9/TIB REAL ESTATE LIMITED PARTNERSHIP, a Delaware limited partnership having an address c/o Archon Group, L.P., 1275 K Street, N.W., Suite 900, Washington, D.C. 20005 ("Landlord"), and CREATIVE BIOMOLECULES, INC., a Delaware corporation having an address at 35 South Street, Hopkinton, Massachusetts 01748 ("Tenant"). WHEREAS, WRC Properties, Inc. (the "Original Landlord"), as lessor, and Tenant, as lessee, entered into that certain Standard Form Industrial Lease dated October 24, 1988 (the "Original Lease"), by which the Original Landlord leased to Tenant a portion of the building (the "Building") located at and numbered 35 South Street, Hopkinton, Massachusetts 01748 consisting of approximately 33,098 square feet of floor area on the first floor of the Building (the "Original Premises"), as more particularly described in Article 1 of and Exhibit A attached to the Original Lease. WHEREAS, the Original Landlord and Tenant entered into that certain Lease Amendment dated September 17, 1991 (the "First Amendment"), by which the Original Landlord and Tenant agreed, among other things, to extend the term of the Original Lease so as to expire on August 31, 1994 and by which the Original Landlord agreed to lease to Tenant and Tenant agreed to lease from the Original Landlord an additional 5,970 square feet of floor area on the first floor of the Building (the "First Amendment Premises"). WHEREAS, the Original Landlord and Tenant entered into that certain Second Amendment dated January 28, 1994 (the "Second Amendment"), by which the Original Landlord and Tenant agreed, among other things, to extend the term of the Original Lease as amended by the First Amendment so as to expire on June 30, 1995 and by which the Original Landlord agreed to lease to Tenant and Tenant agreed to lease from the Original Landlord an additional 15,135 square feet of floor area on the first floor of the Building (the "Second Amendment Premises"). WHEREAS, the Original Landlord and Tenant entered into that certain Third Amendment dated September 20, 1994 (the "Third Amendment"), by which the Original Landlord and Tenant agreed, among other things, to extend the term of the Original Lease as amended by the First Amendment and the Second Amendment so as to expire on June 30, 1998. WHEREAS, the Original Landlord and Tenant entered into that certain Fourth Amendment dated April 10, 1994 (the "Fourth Amendment"), by which the Original Landlord and Tenant agreed, among other things, to extend the term of the Original Lease as amended by the First Amendment, the Second Amendment and the Third Amendment so as to expire on June 30, 2001. WHEREAS, the Original Premises, the First Amendment Premises and the Second Amendment Premises are herein referred to collectively as the "Premises". WHEREAS, the Premises consists of approximately 54,203 rentable square feet of floor area. WHEREAS, the Original Lease, as amended by the First Amendment, the Second Amendment, the Third Amendment and the Fourth Amendment, is hereinafter referred to as the "Lease". WHEREAS, the current term of the Lease expires on June 30, 2001. WHEREAS, Landlord has succeeded to the interest of the Original Landlord as owner of the Building and the land upon which it is located and as lessor under the Lease. WHEREAS, Landlord and Tenant have agreed to early termination of the Lease with respect to a portion of the Premises consisting of approximately 33,000 rentable square feet of floor area on the first floor of the Building as shown on Exhibit A attached hereto and incorporated herein by this reference (the "Terminated Premises") and have agreed to otherwise amend the Lease pursuant to the terms and provisions of this Agreement. WHEREAS, simultaneously with the execution and delivery of this Agreement, Landlord, as lessor, and Stryker Corporation, a Michigan corporation ("Stryker"), as lessee, have entered into that certain lease (the "Stryker Lease") dated as of the date hereof, by which Landlord has leased to Stryker the Terminated Premises. NOW, THEREFORE, in consideration of the premises and the mutual agreements contained herein and in the lease, Landlord and Tenant hereby agree as follows: 1. Notwithstanding anything in the Lease to the contrary, the term of the Lease with respect to the Terminated Premises only shall expire on the Early Termination Date, subject, however, to Tenant's obligation pursuant to the terms and provisions of the Lease to pay base rent, Lessee's Pro Rata Share of real estate taxes, Lessee's Pro Rata Share of operating expenses and Lessee's Pro Rata Share of insurance expenses, each with respect to the Terminated Premises for the period on and prior to the Early Termination Date, which obligation shall survive the expiration of the term of the lease with respect to the Terminated Premises. Therefore, commencing with the first day following the Early Termination Date through the expiration or earlier termination of the term of the Lease, the premises leased by Tenant under the lease as modified by this Agreement shall be a portion of the first floor of the Building consisting of approximately 21,203 rentable square feet of floor area as shown on Exhibit B attached hereto and incorporated herein by this reference (the "Retained Premises"). 2. On or prior to the Early Termination Date, Tenant shall deliver to Landlord the Terminated Premises and surrender the same in their "as is" condition as of the date hereof except with all of Tenant's equipment, trade fixtures and other personal property removed therefrom. -2- 3. Effective as of the first day after the Early Termination Date through the end of the term of the Lease, the base rent shall be $127,218.00 per year, payable in equal monthly installments of $10,601.50 (prorated for the month in which the Early Termination Date occurs if the Early Termination Date is not the first day of such month). 4. Effective as of the first day after the Early Termination Date through the end of the term of the Lease, "Lessee's Pro Rata Share" (as defined in Article I and Article XX of the Lease) shall be changed from "78.65%" to "30.73%". 5. Effective from and after the first day following the Early Termination Date, any references in the Lease to the Terminated Premises shall be deleted in their entirety such that (i) except with respect to such obligations which are attributable to periods on or prior to the Early Termination Date, Landlord shall have no further obligations to Tenant with respect to the Terminated Premises after the Early Termination Date, and (ii) except as otherwise expressly provided in paragraph 1 of this Agreement and except with respect to such obligations which are attributable to periods on or prior to the Early Termination Date, Tenant shall have no further obligations to Landlord with respect to the Terminated Premises after the Early Termination Date. 6. Paragraph 3 of the Fourth Amendment is hereby deleted in its entirety. Landlord and Tenant acknowledge and agree that, notwithstanding anything in the Lease to the contrary, Tenant shall have no right to extend the term of the Lease beyond June 30, 2001. 7. Paragraph 4 of the Fourth Amendment is hereby deleted in its entirety. Landlord and Tenant acknowledge and agree that, notwithstanding anything in the Lease to the contrary, Tenant shall have no rights to expand its leased premises and no rights of first offer or first refusal with respect to other space in the Building. 8. Pursuant to Article XXI of the Lease, Tenant has deposited with Landlord a security deposit in the amount $18,479.72 (the "Security Deposit"). Within thirty (30) days after the Early Termination Date, Landlord shall return to Tenant a portion of the Security Deposit in the amount of $11,250.87, such that, on and after the return of such amount of $11,250.87, the amount of the Security Deposit being held by Landlord will be $7,228.85. 9. Pursuant to Article XVIII of the Lease, any notice from Tenant to Landlord required or permitted under the Lease or this Agreement shall be addressed to Landlord as follows: "W9/TIB Real Estate Limited Partnership c/o Archon Group, L.P. K Street, N.S., Suite 900 Washington, D.C. 20005" 10. Pursuant to Article XVIII of the Lease, any notice from Landlord to Tenant required or permitted under the Lease or this Agreement shall be addressed to Tenant as follows: -3- "Creative Biomolecules, Inc. 101 Huntington Avenue Boston, Massachusetts 02199 Attention: Cheryl K. Lawton, Esquire" 11. Notwithstanding anything in the Lease or this Agreement to the contrary, Tenant shall have (i) the right to sublease and/or permit occupancy of all or any part of the Retained Premises to Stryker or any Affiliate of Stryker at any time and from time to time for such periods as Tenant may deem appropriate and/or (ii) the right to permit Stryker or any Affiliate of Stryker to access such areas within the Retained Premises as Tenant may deem appropriate. The foregoing rights of Tenant shall only be effective during such times as Stryker or any Affiliate of Stryker is occupying all or any material portion (i.e., ten percent (10%) or more) of the Terminated Premises pursuant to ---- the Stryker Lease. As used herein, the phrase "any Affiliate of Stryker" shall mean any entity which, directly or indirectly, controls, is controlled by or is under common control with Stryker. 12. Notwithstanding anything in the Lease or this Agreement to the contrary, Tenant agrees that (i) there shall not be more than 79 Occupants (as defined in Article XXV of the Lease) of the Retained Premises at any time and (ii) discharges from the Retained Premises into the sewer system (as defined in Article XXV of the Lease) shall not exceed 1,182 gallons per day. 13. Submission of the Agreement for examination or signature by Tenant does not constitute a binding agreement, and this Agreement shall not be effective unless and until execution and delivery thereof by both Landlord and Tenant. 14. In all other respects, Landlord and Tenant hereby reaffirm all of the covenants, agreements, terms, conditions and other provisions of the Lease except as modified hereby, and the Lease is hereby incorporated in full herein by this reference. The terms and provisions of this Agreement shall be effective as of the date first above written, except may otherwise be expressly provided herein. -4- IN WITNESS WHEREOF, Landlord and Tenant have executed this Partial Lease Termination Agreement and Amendment to Lease as a sealed instrument as of the date first above written. LANDLORD: W9/TIB REAL ESTATE LIMITED PARTNERSHIP By: W9/TIB GEN-PAR INC., its General Partner By: /s/ Stephen M. Abelman ------------------------------- Name: Stephen M. Abelman ----------------------------- Title: Assistant Vice President ---------------------------- TENANT: CREATIVE BIOMOLECULES, INC. By: /s/ Cheryl K. Lawton ------------------------------- Name: Cheryl K. Lawton ----------------------------- Title: General Counsel and Vice President Administration ---------------------------- -5- EXHIBIT A --------- PLAN SHOWING THE TERMINATED PREMISES ------------------------------------ [Floor plan graphic appears here] -6- EXHIBIT B PLAN SHOWING THE RETAINED PREMISES ---------------------------------- [Floor plan graphic shown here] -7- EX-23.1 6 INDEPENDENT AUDITORS' CONSENT Exhibit 23.1 INDEPENDENT AUDITORS' CONSENT We consent to the incorporation by reference in Registration Statement Nos. 33- 68084, 33-83276, 33-91150 and 333-58219 on Form S-3 and Registration Statement Nos. 33-56706, 33-61884, 33-80945, 333-36171, 333-36175, 333-69463, 333-84511 and 333-84507 on Form S-8 of Creative BioMolecules, Inc. report dated February 15, 2000 (which expresses an unqualified opinion and includes an emphasis of a matter in a paragraph relating to the potential merger described in Note 13), appearing in the Annual Report on Form 10-K of Creative BioMolecules, Inc. for the year ended December 31, 1999. /s/ Deloitte & Touche LLP - ------------------------- Deloitte & Touche LLP Boston, Massachusetts March 6, 2000 EX-27 7 FINANCIAL DATA SCHEDULE
5 12-MOS 12-MOS DEC-31-1999 DEC-31-1998 JAN-01-1999 JAN-01-1998 DEC-31-1999 DEC-31-1998 2,751,069 17,738,044 18,619,516 40,197,407 60,296 669,232 0 0 0 28,733 21,577,645 58,905,584 2,130,158 1,925,602 0 0 28,892,291 66,164,057 4,461,317 9,292,483 0 0 0 23,052,787 0 0 366,651 344,575 23,054,935 32,760,753 28,892,291 66,164,057 0 0 5,137,950 12,624,934 0 0 17,247,740 34,020,072 0 0 0 0 161,385 327,304 0 0 0 0 0 0 0 0 0 0 0 0 (14,505,349) (22,381,725) (0.40) (0.66) (0.40) (0.66)
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