1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 1997 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 NO. 0-15242 DURAMED PHARMACEUTICALS, INC. Incorporated Under the IRS Employer I.D. Laws of the State No. 11-2590026 of Delaware 7155 East Kemper Road Cincinnati, Ohio 45249 (513) 731-9900 Indicate by checkmark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding 12 months, and (2) has been subject to such filing requirements for the past 90 days. YES X NO --- --- Common Stock, $.01 par value per share: Shares Outstanding as of May 9, 1997 14,781,232 Page 1 of 18 pages 2 DURAMED PHARMACEUTICALS, INC. INDEX PART I. Financial Information Page ITEM 1. Financial Statements (Unaudited) Consolidated Balance Sheets. . . . . . . . . . . . . . . . . . . . 3-4 Consolidated Statements of Operations . . . . . . . . . . . . . . . 5 Consolidated Statements of Cash Flows . . . . . . . . . . . . . . . 6 Consolidated Statements of Stockholders' Equity. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7 Notes to Consolidated Financial Statements. . . . . . . . . . . . . . . . . . . . . . . . . . .8-10 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. . . . . . . 11-15 PART II. Other Information ITEM 2. Changes in Securities . . . . . . . . . . . . . . . . . . . . . . .16 ITEM 6. Exhibits and Reports on Form 8-K . . . . . . . . . . . . . . . . . .16 SIGNATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .17 - 2 - 3 DURAMED PHARMACEUTICALS, INC. Consolidated Balance Sheets Assets March 31, December 31, 1997 1996 ------------ ------------ Unaudited Current assets: Cash and cash equivalents $ 3,500 $ 1,811,182 Trade accounts receivable, less allowance of $1,382,000 and $1,339,000, respectively 7,312,812 7,460,452 Inventories 11,138,289 13,188,627 Prepaid expenses and other assets 2,226,673 1,455,251 ------------ ------------ Total current assets 20,681,274 23,915,512 Property, plant and equipment: Land 1,000,000 1,000,000 Buildings and improvements 18,212,730 18,211,740 Equipment, furniture and fixtures 23,644,403 23,589,782 ------------ ------------ 42,857,133 42,801,522 Less accumulated depreciation and amortization (13,950,811) (13,499,466) ------------ ------------ Property, plant and equipment - net 28,906,322 29,302,056 Deposits and other assets 501,235 416,288 ------------ ------------ Total assets $ 50,088,831 $ 53,633,856 ============ ============ See accompanying notes. - 3 - 4 DURAMED PHARMACEUTICALS, INC. Consolidated Balance Sheets Liabilities and Stockholders' Equity March 31, December 31, 1997 1996 ------------ -------------- Unaudited Current liabilities: Accounts payable $ 4,882,904 $ 4,461,434 Accrued liabilities 6,135,503 5,178,068 Current portion of long-term debt and other liabilities 2,633,217 3,363,798 Current portion of capital lease obligations 1,084,130 1,113,114 ------------ ------------ Total current liabilities 14,735,754 14,116,414 ------------ ------------ Long-term debt, less current portion 12,008,442 9,989,461 Long-term capital leases, less current portion 1,468,912 1,727,587 Other long-term liabilities -- 161,171 ------------ ------------ Total liabilities 28,213,108 25,994,633 ------------ ------------ Stockholders' equity: Convertible Preferred Stock Series B, par value $.001; outstanding shares in 1997 and 1996 6 6 Common stock - authorized 50,000,000 shares, par value $.01; 14,707,431 and 14,603,516 shares in 1997 and 1996 respectively 147,074 146,035 Additional paid-in capital 81,067,409 80,073,586 Accumulated deficit (59,338,766) (52,580,404) ------------ ------------ Total stockholders' equity 21,875,723 27,639,223 ------------ ------------ Total liabilities and stockholders' equity $ 50,088,831 $ 53,633,856 ============ ============ See accompanying notes. - 4 - 5 DURAMED PHARMACEUTICALS, INC. Consolidated Statement of Operations (Unaudited) Three Months Ended March 31, 1997 1996 ----------- ----------- Net sales $10,738,791 $10,700,198 Cost of goods sold 7,865,592 7,825,200 ----------- ----------- Gross profit 2,873,199 2,874,998 ----------- ----------- Operating expenses: Product development 6,372,220 1,099,316 Selling 978,714 1,011,004 General and administrative 1,998,215 2,374,541 ----------- ----------- 9,349,149 4,484,861 ----------- ----------- Operating loss (6,475,950) (1,609,863) Interest expense 282,412 551,232 ----------- ----------- Loss before preferred dividends (6,758,362) (2,161,095) Preferred dividends -- 274,918 ----------- ----------- Net loss to common shareholders $(6,758,362) $(2,436,013) ----------- ----------- Loss per share $ (.46) $ (.28) ----------- ----------- Weighted average number of shares outstanding 14,674,318 8,565,621 =========== =========== See accompanying notes. - 5 - 6 DURAMED PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Three months ended March 31, 1997 1996 ------------ ------------ Cash flows from operating activities: Net loss $(6,758,362) $(2,161,095) Adjustments to reconcile net loss to net cash (used in) operating activities: Depreciation and amortization 465,559 556,082 Recognition of deferred revenues -- (250,000) Provision for doubtful accounts 42,150 37,871 Common stock issued in connection with employee compensation plans 54,886 61,905 Changes in assets and liabilities: Trade accounts receivable 105,490 (439,405) Inventories 2,050,338 (3,877,352) Prepaid expenses and other assets (771,421) (396,737) Accounts payable 421,470 887,751 Accrued liabilities 1,214,637 (192,462) Other (77,042) (12,086) ----------- ----------- Net cash (used in) operating activities (3,252,295) (5,785,528) ----------- ----------- Investing activities: Capital expenditures (79,611) (400,063) Refunds (deposits) on capital equipment 1,880 (5,808) ----------- ----------- Net cash (used for) investing activities (77,731) (405,871) ----------- ----------- Cash flows from financing activities: Payments of long-term debt, including current maturities (712,426) (1,994,078) Net increase (decrease) in revolving credit facility 2,424,918 (4,510,332) Long-term borrowings 20,772 1,798,832 Issuance of preferred stock - net -- 10,857,367 Issuance of common stock 46,282 162,350 Dividends paid (257,202) (122,740) ----------- ----------- Net cash provided by financing activities 1,522,344 6,191,399 ----------- ----------- Net change in cash (1,807,682) -- Cash at beginning of period 1,811,182 2,600 ----------- ----------- Cash at end of period $ 3,500 $ 2,600 =========== =========== Supplemental cash flow disclosures: Interest paid $ 317,391 $ 562,154 See accompanying notes. 7 DURAMED PHARMACEUTICALS, INC. CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (UNAUDITED) Preferred Stock Common Stock Additional --------------- -------------------- Paid-In Accumulated Series B Shares Amount Capital Deficit Total --------------- -------------------- ----------- ------------ ------------ BALANCE - DECEMBER 31, 1996 $ 6 14,603,516 $146,035 $80,073,586 ($52,580,404) $27,639,223 Issuance of stock in connection with benefit plans 5,501 55 54,831 54,886 Issuance of stock in connection with stock options 9,045 90 46,192 46,282 Issuance of stock in settlement of certain liabilities 89,369 894 892,800 893,694 Net loss for 1997 (6,758,362) (6,758,362) --- ---------- -------- ----------- ------------ ----------- BALANCE - MARCH 31, 1997 $ 6 14,707,431 $147,074 $81,067,409 ($59,338,766) $21,875,723 === ========== ======== =========== ============ =========== See accompanying notes. - 7 - 8 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS Note 1: Interim Financial Data The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. Operating results for the three month period ended March 31, 1997 are not necessarily indicative of the results that may be expected for the year ended December 31, 1997. For further information, refer to the consolidated financial statements and notes thereto included in the Annual Report of Duramed Pharmaceuticals, Inc. (the "Company" or "Duramed") on Form 10-K for the year ended December 31, 1996, as amended (the "1996 10-K"). Note 2: Loss Per Share Loss per share is computed using the weighted average of common shares outstanding only. Recognition of outstanding options, warrants and convertible preferred stock in computing loss per share is not required as their effect would be antidilutive. Note 3: Inventories Inventories are stated at the lower of cost (first-in, first-out) or market. Components of inventories include: March 31, December 31, 1997 1996 --------- ------------ Raw materials $ 7,106,876 $ 6,767,105 Work-in-process 475,238 452,905 Finished goods 4,700,401 7,520,247 Reserves (1,144,226) (1,551,630) ------------ ------------ Net inventory $ 11,138,289 $ 13,188,627 ============ ============ The Company had manufactured a commercial launch quantity of its conjugated estrogens product which was developed in accordance with the Food and Drug Administration's (FDA) guidance established in 1991 and current official USP compositional standards. On May 5, 1997, the Company was notified by the FDA that at this time, it would not approve a generic conjugated estrogens product developed in accordance with the guidance established by the FDA in 1991 and current official USP compositional standards. The Company is evaluating various options with respect to its conjugated estrogens product and related inventory. In view of the - 8 - 9 FDA's decision, however, the Company has determined that it is prudent to write off the conjugated estrogens inventory; accordingly, a charge in the amount of $3,465,000 has been recorded and is reflected in product development expenses for the quarter ended March 31, 1997. The product currently meets the required stability criteria and will be retained until such time as it no longer passes those tests. In the event the Company is ultimately successful in obtaining approval for the product, some, or all of the inventory write-off may be recovered. Note 4: Debt and Other Long-Term Liabilities Debt March 31, December 31, 1997 1996 ------------ ------------ Revolving credit facility $ 2,424,918 $ -- Manufacturing facility expansion loan 5,362,500 5,500,000 Equipment liability 4,000,000 4,000,000 Equipment loan 1,920,140 2,118,979 Note payable to State of Ohio 832,329 877,342 Installment notes payable 101,772 124,415 ------------ ------------ 14,641,659 12,620,736 Less amount classified as current 2,633,217 2,631,275 ------------ ------------ $ 12,008,442 $ 9,989,461 ============ ============ During 1997, the Company funded its operations with net proceeds received previously from private placements of Convertible Preferred Stock and borrowings under its revolving credit facility. The amended terms of the revolving credit facility permit the Company to borrow up to $6.5 million based upon eligible collateral ($11.2 million as of May 9, 1997) and the Company's current financial condition and operating performance. Borrowings on the revolving credit facility bear interest at the rate of prime plus 1%, and are collateralized by substantially all assets of the Company including inventory, receivables and the manufacturing facility. As of May 9, 1997, the Company had $3,309,000 in borrowings outstanding under its revolving credit facility. The manufacturing facility expansion loan is a ten year $5.5 million facility which provided a portion of the financing for the expansion of the Company's manufacturing facility and is supported by a loan guaranty from Johnson & Johnson. Principal payments on this loan commenced on January 1, 1997. Interest is payable monthly based upon the prime rate. The equipment liability of $4.0 million at December 31, 1996 represents an obligation to Ortho-McNeil Pharmaceutical Corporation ("Ortho-McNeil") for equipment that was provided in connection with the Company's facility expansion that was completed in 1995. Since the Company did not receive regulatory approval to market its conjugated estrogens product, the Company will be required, at Ortho-McNeil's option, either to return the equipment or to purchase it at fair market value. The Company and Ortho-McNeil are currently in negotiations, which could revise the terms of the agreement and the repayment schedule for this equipment. However, based on the current agreement terms, if Ortho-McNeil requires Duramed to purchase - 9 - 10 the equipment, repayments would be established on the basis of equal quarterly payments over a three year period based upon the fair market value of the equipment at the time, and the obligation would be subject to interest at the prime rate in effect. The Company anticipates that the manufacturing facility expansion and related equipment will be utilized to commercialize products on file with the FDA (exclusive of the Company's conjugated estrogens product) as well as other products under development. Accordingly, the facility and its equipment are an integral part of the Company's business plan. The equipment loans represent financing by the Company's bank for equipment purchases, bear interest at the rate of prime plus 1%, and require monthly installments of principal and interest. One of the loans is payable over a three year term and requires a monthly principal payment of $42,355 plus interest through April 1, 1999; the other loan is payable over a five year term and requires a monthly principal payment of $23,925 plus interest through March 1, 2000. These loans are collateralized by the assets financed. The note payable to the State of Ohio is secured by the Company's manufacturing facility. The loan bears interest at 7.5%. In the third quarter of 1996, the State waived the balloon payment that was due on November 1, 1996 and revised the terms to require minimum monthly payments of $20,394 through November 1, 2000, and certain other payments as defined by the agreement. This debt is personally guaranteed by a former officer and by a director. Other long-term debt also includes facilities of varying amounts and terms which are generally collateralized by the assets financed. The Company's other long-term liabilities consist of the following: Other Long-Term Liabilities March 31, December 31, - --------------------------- 1997 1996 ---------------------------- Abandoned facility obligation - net $ -- $ 893,694 Less amount classified as current -- 732,523 ---------- ------------ $ -- $ 161,171 ========== ============ The abandoned facility obligation represented the amounts due, net of sublease income, under terms of a lease which extended through September 30, 1998. Due to the Company's financial condition at the time, the Company was unable to meet its commitments under the lease and vacated the facility in 1991. During the first quarter of 1997, the Company settled the remaining obligation through the issuance of 89,369 shares of Duramed common stock. - 10 - 11 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS RESULTS OF OPERATIONS CONJUGATED ESTROGENS UPDATE The Company has had an application on file with the FDA for a generic conjugated estrogens product since September 1994. The product was developed based upon the bioequivalency guidance established by the FDA in 1991, which had been reaffirmed repeatedly over the past six years, and current official USP compositional standards. On May 5, 1997, the Company was notified by the FDA that at this time it would not approve a generic conjugated estrogens product based upon the guidance established by the FDA in 1991 and current official USP compositional standards. The Company's science, regulatory and legal team is reviewing the FDA's decision to determine the appropriate response and course of action with regards to its product. The Company believes it has various options with respect to its conjugated estrogens product including instituting certain studies encouraged by the FDA, seeking a new drug approval for the product and seeking approval for the product in markets outside the United States. In view of the FDA's decision, however, the Company has determined that it is prudent to write off the conjugated estrogens inventory, accordingly, a charge in the amount of $3,465,000 has been recorded and is reflected in product development expenses for the quarter. The product currently meets the required stability criteria and will be retained until such time as it no longer passes those tests. In the event the Company is ultimately successful in obtaining approval for the product, some, or all of the inventory write-off may be recovered. Additionally, the Company accrued approximately $300,000 in pre-marketing expenses for the quarter related to the terms of certain contractual commitments associated with its conjugated estrogens product. NET SALES Net sales for the three month period ended March 31, 1997 were comparable to the same period in 1996. The Company has agreements with several manufacturers including Ortho-McNeil, whereby the Company markets and distributes their generic prescription drug products. The terms of these agreements vary, but typically provide for a sharing of profits between the Company and the manufacturer. For the period ended March 31, 1997 and 1996, the percentage of the Company's sales comprised of products marketed for others were 34.3%. Recognition of deferred revenues from Ortho-McNeil contributed $250,000 to net sales in the first quarter of 1996. GROSS MARGIN The gross margin, and the corresponding percentage of net sales, was $2.9 million (26.8%) for the first quarter of 1997 compared to $2.9 million (26.9%) for the first quarter of 1996 resulting from - 11 - 12 a comparable sales mix. The gross margin in the first quarter of 1996 was favorably impacted by the recognition of $250,000 in deferred revenues, which were fully recognized in 1996. The gross profit generated by products distributed by the Company pursuant to agreements with manufacturers including Ortho-McNeil was approximately $559,000, and $652,000 for the period ended March 31, 1997 and 1996, respectively. There can be no assurance that, with the Company's current product line, the present gross margin levels can be maintained if the Company's products, particularly Methylprednisolone, should experience increased competition. OPERATING EXPENSES Product Development Excluding the $3,465,000 conjugated estrogens inventory charge, product development expenditures increased by $1,808,000 (164.5%) in the period ended March 31, 1997 compared to the comparable period in 1996. The increase was due to spending for bioequivalency studies, milestone payments to product development partners and the expansion of the Company's product development capabilities through the acquisition of Hallmark Pharmaceuticals, Inc. ("Hallmark"). The increase in product development expenditures reflects the Company's commitment to expanding its product line. The Company's product development program is broad-based with product development activities in Cincinnati, the Hallmark division in New Jersey, Kiel Labs in Georgia and Duramed Europe in Oxford, England. The product development emphasis is on products and therapeutic categories such as hormones, oncology, cardiovascular and pain. These products are being developed through sophisticated technology including patented control release delivery systems and biotechnology. In addition to nine product applications awaiting approval at the FDA, the Company has approximately 35 active product development projects which should result in filed applications by the end of 1998. The Company received approval of its Prochlorperazine product which is the generic equivalent of Compazine(R) on May 2, 1997. The Company filed the application for this product on July 28, 1996 and expects to begin shipments in the third quarter of 1997, following completion of process validation. Product development expenditures in the 1996 period are net of reimbursements received from Schein Pharmaceutical, Inc. ("Schein") pursuant to the terms of a contractual agreement in connection with the development of the conjugated estrogens product. Selling The Company's sales and marketing expenses in the first quarter of 1997 decreased by $332,000 (32.8%) over the same period in 1996 excluding a charge of $300,000 in connection with certain contractual commitments associated with its conjugated estrogens product. The reduction in selling expenses is a reflection of the Company's steps taken during 1996 to reduce operating expenses. - 12 - 13 General and Administrative The decrease in general and administrative expenses in the first quarter of 1997 compared to the same period in 1996 was due primarily to a reduction of staff positions and attendant costs. The expense levels in both the first quarter of 1996 and 1997 reflect comparable levels of legal and consulting costs associated with responding to various issues in connection with its Abbreviated New Drug Application ("ANDA") for conjugated estrogens. Net Interest Expense Interest expense decreased in the first quarter of 1997 compared to the same period in 1996, due primarily to a reduction in borrowings under the Company's revolving credit facility. Income Taxes Due to the reported net loss in the first quarters of 1996 and 1997, no provision for income tax was recorded. Preferred Dividends Preferred dividends in the first quarter of 1996 were $274,918, which represented the dividend provision associated with outstanding Convertible Preferred Stock. All issued Convertible Preferred Stock converted into common stock during 1996, accordingly; there is no continuing dividend requirement. Other Matters Under the terms of agreements with Ortho-McNeil, Duramed has non-exclusive distribution rights to the Ortho-McNeil products Acetaminophen with Codeine, Tolmetin Sodium, Tolmetin Sodium DS, Oxycodone with Acetaminophen and Estropipate. The distribution agreement for each of these products specifies a term of ten years subject to reduction to three years (if not extended) from the date of first sale if Duramed's conjugated estrogens product is not approved. Duramed commenced marketing Estropipate during the fourth quarter of 1993 and the other Ortho-McNeil products during the fourth quarter of 1994. The Company is continuing to distribute the products and is discussing an extension of these rights with Ortho-McNeil. Loss of these distribution rights would likely have a material adverse effect upon the Company's financial position and results of operations. - 13 - 14 Management believes that it is in the best interest of the Company and its shareholders to continue its product development program and accordingly plans to continue its spending on its product development program which will likely result in operating losses in the range of $3.0 to $5.0 million per quarter until the Company receives approval on pending product applications and commences marketing the products. The Company expects to begin to generate a profit from operations during the second half of 1998. LIQUIDITY AND CAPITAL RESOURCES The Company has funded its operations by raising capital through the issuance of Convertible Preferred Stock, all of which has converted into common stock as of December 31, 1996; and through borrowings under its revolving credit facility. The amended terms of the Company's revolving credit facility permits the Company to borrow up to $6.5 million, based upon eligible collateral ($11.2 million as of May 9, 1997) unless the Company's operating results substantially improve or the Company obtains additional sources of financing. As of May 9, 1997 the Company had $3,309,000 in borrowings under the revolving credit facility. In connection with various agreements related to the Company's conjugated estrogens product along with the distribution rights for certain products, Ortho-McNeil provided $2 million in cash and the use of $4 million in equipment for the Company's hormone replacement therapy ("HRT") facility expansion and Ortho-McNeil's parent, Johnson & Johnson, guaranteed a $5.5 million construction loan for the HRT facility expansion. Under the terms of the agreement, if FDA approval of the conjugated estrogens product is not obtained, the Company may be required, at Ortho-McNeil's option, either to return the equipment or to purchase it at its fair market value at that time. Under the existing agreement, if the Company is required to purchase the equipment, the purchase price plus interest at the current prime rate will be payable on a quarterly basis over three years. In the fourth quarter of 1996, the Company recorded a $4.0 million liability for the equipment provided by Ortho-McNeil. In view of the FDA's decision the Company is discussing all aspects of its current contractual arrangements with Ortho-McNeil. At this time, the Company cannot predict the outcome of these discussions. The Company anticipates that the HRT manufacturing facility expansion and related equipment will be utilized to commercialize products on file with the FDA (exclusive of the Company's conjugated estrogens product) as well as a number of other products under development. Accordingly, the facility and its equipment are an integral part of the Company's business plan. - 14 - 15 Management is encouraged by the results to date from the Company's product development program and has concluded that it is in the best interests of the Company and its stockholders for the Company to continue substantial spending for research and development and for hiring incremental personnel and procuring necessary equipment to prepare for the production and launch of certain products on file. Management recognizes that such actions will result in continued reported losses for the Company until the Company begins to receive anticipated revenues from products now on file, or to be filed, with the FDA. The Company does not anticipate substantial revenues from such products before late 1997 and, accordingly, does not anticipate a return to profitable operations until the second half of 1998. In the meantime, the Company's product development program will not be supported from the Company's operations and therefore will require additional capital which may result in substantial dilution to current shareholders. The Company is in the final phase of accessing the financial resources to continue the execution of the Company's business plan. If necessary capital is not available, implementation of the Company's plans will be restricted or delayed with a negative effect upon the Company's prospects. Certain statements in this Form 10-Q constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including those concerning management's expectations with respect to future financial performance and future events, particularly relating to sales of current products as well as the introduction of new manufactured and distributed products. Such statements involve known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Factors that might affect such forward-looking statements set forth in this Form 10-Q include, among others, (i) increased competition from new and existing competitors and pricing practices from such competitors, (ii) the amount of funds continuing to be available for internal research and development and for research and development joint ventures, (iii) research and development project failures or delays, or delays in or the lack of obtaining regulatory approvals and (iv) the ability of the Company to retain and attract personnel in key operational areas. - 15 - 16 PART II - OTHER INFORMATION Item 2. Changes in Securities On February 27, 1997, the Company issued 89,369 shares of common stock to Charles J. Kubicki in exchange for the release from the abandoned facility obligation (see Note 4. Debt and Other Long-Term Liabilities). The issuance was exempt pursuant to Section 4 (2) of the Securities Act of 1933. Item 6. Exhibit and Reports on Form 8-K (a) Exhibit: (11) Statement re: Computation of Earnings Per Share (27) Financial Data Schedule* (b) Reports on Form 8-K for the quarter ended March 31, 1997: None - ------------------ *Contained only in electronic filing with Securities and Exchange Commission. - 16 - 17 SIGNATURES Pursuant to the requirements 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. DURAMED PHARMACEUTICALS, INC. Dated: May 15, 1997 by: /s/ E. THOMAS ARINGTON ------------ --------------------------------- E. Thomas Arington President, Chairman of the Board Chief Executive Officer Dated: May 15, 1997 by: /s/ TIMOTHY J. HOLT ------------ ----------------------------------- Timothy J. Holt Senior Vice President - Finance, Treasurer, Chief Financial Officer