February 12, 1998
REPLIGEN CORP (RGEN) Quarterly Report (SEC form 10-Q)
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Cautionary Statement Regarding Forward-Looking Statements Statements in this Quarterly Report on Form 10-Q under this caption, "Management's Discussion and Analysis of Financial Condition and Results of Operations," as well as oral statements that may be made by the Company or by officers, directors or employees of the Company acting on the Company's behalf, that are not historical facts constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1996. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to be materially different from the historical results or from any results expressed or implied by such forward-looking statements. Certain Factors That May Affect Future Results The Company's future operating results are subject to risks and uncertainties and are dependent upon many factors, including, without limitation, the Company's ability to (i) meet its working capital and future liquidity needs, (ii) successfully implement its restructuring and strategic growth strategies, (iii) understand, anticipate and respond to rapidly changing technologies and market trends, (iv) develop, manufacture and deliver high quality, technologically advanced products on a timely basis to withstand competition from competitors which may have greater financial, information gathering and marketing resources than the Company, (v) obtain and protect licensing and intellectual property rights necessary for the Company's technology and product development on terms favorable to the Company, (vi) recruit and retain highly talented professionals in a competitive job market. Each of these factors, and others, are discussed from time to time in the filings made by the Company with the Securities and Exchange Commission. The Company Repligen Corporation is developing a new class of synthetic drugs designed to block important protein-carbohydrate and protein-protein interactions. Although clinical experience with complex natural products and monoclonal antibodies has shown that many of these interactions are important in disease, it has not been possible to identify easily synthesized organic compounds for these types of targets. Repligen is developing technologies to discover drugs which can block protein-macromolecule interactions including methods for the rapid synthesis of chemical compound libraries with "natural product-like" complexity and high throughput screening assays based on specific biological targets. In a proprietary program these technologies are being applied to the discovery of small molecule inhibitors for several growth factors responsible for angiogenesis or new blood vessel growth. Compounds which inhibit angiogenic growth factors may have application in certain ocular diseases (including diabetic retinopathy or macular degeneration) and oncology. The Company's high throughput screening assays can identify inhibitors of the interaction of these growth factors with cell surface carbohydrates by screening customized combinatorial chemical libraries. The Company also has ongoing collaborations with Pfizer Inc., Glaxo Wellcome and Cambridge NeuroScience based on its drug discovery technologies. 9 Repligen also manufactures and markets a line of products for the production of monoclonal antibodies intended for human clinical use. These products are based on recombinant Protein A for which Repligen holds patents in the United States and major foreign markets. In addition, the Company has out-licensed certain intellectual property pertaining to its former programs on biological products. Results of Operations Revenues Total revenues for the three month periods ended December 31, 1997 and 1996 were $753,000 and $1,067,000, respectively, a decrease of approximately 29%. Year to date total revenues decreased approximately 33% to $1,932,000 at December 31, 1997 from $2,888,000 at December 31, 1996. This decrease is largely attributable to the one-time sales of securities and equipment for approximately $505,000 reported as "Other Income" in the nine month period ended December 31, 1996. Research and development revenues for the three month period ended December 31, 1997 were $378,000 compared to $440,000 in the comparable fiscal 1997 period. In the first nine months of fiscal 1998, the Company recorded research and development revenues totaling $802,000 consisting primarily of approximately $620,000 from contracted research and development programs and $182,000 from licensing revenues. In the first nine months of fiscal 1997, the Company recorded research and development revenues totaling $891,000 consisting primarily of $662,000 from contracted research and development programs and $229,000 from licensing revenues. Product revenues for the three months ended December 31, 1997 and 1996 were $316,000 and $503,000, respectively, and were $856,000 and $1,124,000 for the nine months ended December 31, 1997 and 1996, respectively. This decrease is attributed to the timing of large production scale orders of Protein A. Investment income decreased in fiscal 1998 over the comparable three and nine month periods in fiscal 1997 primarily due to lower average funds available for investment. Other revenues for the three and nine month periods ended December 31, 1997 decreased from the comparable fiscal 1997 periods primarily due to the Company's one-time sales of equipment and furnishings of approximately $205,000 and non-investment securities of approximately $300,000 during fiscal 1997. Expenses Total expenses for the three month periods ended December 31, 1997 and 1996 decreased 28% to $848,000 from $1,171,000. This decrease is largely attributable to the $365,000 charge for purchased research and development that occurred in the quarter ended December 31,1997 relating to the acquisition of Proscure, Inc. For the nine months ended December 31, 1997 and 1996, expenses were $2,412,000 and $3,203,000, respectively. Research and development expenses for the three months ended December 31, 1997 and 1996 were $349,000 and $240,000, respectively, an increase of 45%. For the nine months ended 10 December 31, 1997 and 1996, research and development expenses were $1,063,000 and $935,000, respectively, an increase of 14%. This increase is largely attributable to increased investment in the Company's proprietary product development during fiscal 1998. Selling, general and administrative expenses for the three month and nine month periods ended December 31, 1997 were $301,000 and $923,000, respectively, which reflects a decrease of $53,000 and $617,000, respectively, from the comparable 1997 periods. These decreases resulted from the reduction of administrative personnel and related expenses as part of the Company's cost reduction efforts in April through June of 1996. Cost of goods sold for the three month and nine month periods ended December 31, 1997 were $199,000 and $426,000, respectively, as compared to $212,000 and $363,000 for the three and nine months ended December 31, 1996. Cost of goods sold in the three month periods ended December 31, 1997 and 1996 were 63% and 42% of product revenues, respectively. In the nine month periods ended December 31, 1997 and 1996, cost of goods sold was 50% and 32% of product sales, respectively. The increase in cost of sales as a percentage of revenue is primarily a result of the realization of inventory that had been previously reserved for in the three and nine month periods ended December 31, 1996. Liquidity and Capital Resources The Company's total cash, cash equivalents and marketable securities increased to $4,919,000 at December 31, 1997 from $3,538,000 at March 31, 1997, an increase of $1,381,000 or 39%. The increase reflects $2,000,000 of proceeds (before expenses) resulting from the sale of Common Stock and Warrants through a private placement that took place during the three months ended December 31, 1997 offset by the net losses during the nine month period ended December 31, 1997 of approximately $480,000, an increase in inventory of $76,000, the reduction of accounts payable and accrued expenses of $260,000, offset in part by the reduction in accounts receivables and prepaid expenses of $203,000. Working capital increased to $5,635,000 at December 31, 1997 from $3,990,000 at March 31, 1997. During the nine months ended December 31, 1997, the Company entered into a $450,000 note receivable with a licensee for past due licensing fees. As the Company has historically recorded licensing fees under this agreement on a cash basis, the Company has not recorded this note receivable as an asset. The note requires full payment of principal and interest in August 1998. The Company will continue to record this license fee on a cash basis. The Company has funded operations primarily with cash derived from the sales of its equity securities, revenue derived from research and development contracts, product sales and investment income. The Company believes it has sufficient cash equivalents and marketable securities to satisfy its working capital and capital expenditure requirements for the next twenty-four months. Should the Company need to secure additional financing to meet its future liquidity requirements, there can be no assurances that the Company will be able to secure such financing, or that such financing, if available, will be on terms favorable to the Company. On February 23, 1998, Nasdaq will initiate new requirements for listing on the Nasdaq National Market. Currently, the Company believes it is in compliance with all of the new requirements. There can be no assurance, however, that the Company will be able to continue to satisfy all the requirements issued by Nasdaq or that the Company's Common Stock will continue 11 to be listed on the Nasdaq National Market. Should it occur, the delisting of the Company's Common Stock from the Nasdaq National Market could have a material adverse effect on the Company's business, results of operations and financial condition. |