UNITED STATES 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 September 30, 1995 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OR THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_____to______ Commission file number 1-9114 MYLAN LABORATORIES INC. (Exact Name of registrant as specified in its charter) Pennsylvania 25-1211621 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 130 Seventh Street 1030 Century Building Pittsburgh, Pennsylvania 15222 (Address of principal executive offices) (Zip Code) 412-232-0100 (Registrant's telephone number, including area code) Not Applicable (Former name, former address and former fiscal year, if changed since last report) 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 twelve 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 the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date Outstanding at Class of Common Stock November 3, 1995 --------------------- ----------------- $.50 par value 120,063,314 ------------------------------------------------------------------ MYLAN LABORATORIES INC. AND SUBSIDIARIES ---------------------------------------- INDEX ----- Page Number ---------- PART I. FINANCIAL INFORMATION ITEM 1: Financial Statements Consolidated Balance Sheets - September 30, 1995 and March 31, 1995 2A and 2B Consolidated Statements of Earnings - Three and Six Months Ended September 30, 1995 and 1994 3 Consolidated Statements of Cash Flows - Six Months Ended September 30, 1995 and 1994 4 Notes to Consolidated Financial Statements - Six Months Ended September 30, 1995 5 and 6 ITEM 2: Management's Discussion and Analysis of Financial Condition and Results of Operations 7 and 8 PART II. OTHER INFORMATION 9 MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS ASSETS September 30, March 31 1995 1995 Unaudited Audited ------------- ----------- Current Assets Cash and cash equivalents $151,823,000 $127,280,000 Marketable securities 28,263,000 52,575,000 Accounts receivable 69,064,000 58,343,000 Inventories: Raw materials 29,132,000 29,795,000 Work in process 16,281,000 17,539,000 Finished goods 29,764,000 30,871,000 ----------- ----------- 75,177,000 78,205,000 Deferred income tax benefit 7,733,000 10,545,000 Other current assets 6,376,000 4,435,000 ----------- ----------- Total Current Assets 338,436,000 331,383,000 Property, Plant and Equipment - at cost Less accumulated depreciation 149,616,000 132,599,000 43,703,000 40,300,000 ----------- ----------- 105,913,000 92,299,000 Deferred Income Tax Benefit, non-current 1,032,000 1,043,000 Marketable Securities, non-current 22,253,000 21,958,000 Investment in and Advances to Somerset 23,557,000 22,055,000 Intangible Assets net of accumulated amortization 26,238,000 28,518,000 Other Assets 68,988,000 48,945,000 ------------ ------------ Total Assets $586,417,000 $546,201,000 ============ ============ See Notes to Consolidated Financial Statements -2A- LIABILITIES AND SHAREH0LDERS' EQUITY ------------------------------------ September 30, March 31, 1995 1995 Unaudited Audited --------- ------- Current Liabilities Trade accounts payable $ 11,093,000 $ 10,466,000 Income taxes payable 6,315,000 24,019,000 Other current liabilities 17,498,000 17,890,000 Cash dividend payable 4,776,000 3,976,000 ----------- ------------ Total Current Liabilities 39,682,000 56,351,000 Long-Term Obligations 8,581,000 7,122,000 Shareholders' Equity: Preferred stock, par value $.50 per share, authorized 5,000,000 shares, issued and outstanding - none - - Common stock, par value $.50 per share, authorized 300,000,000 shares, issued 119,360,123 shares at September 30, 1995 and 79,972,248 shares at March 31, 1995 60,027,000 39,986,000 Additional paid in capital 38,231,000 57,577,000 Retained earnings 440,105,000 386,212,000 Unrealized gain on investment 2,145,000 1,374,000 ----------- ----------- 540,508,000 485,149,000 Less Treasury stock - at cost, 694,784 shares at September 30, 1995 and 476,523 shares at March 31, 1995 2,354,000 2,421,000 ----------- ----------- Net Worth 538,154,000 482,728,000 ----------- ----------- Total Liabilities and Shareholders' Equity $586,417,000 $546,201,000 ============ ============ See Notes to Consolidated Financial Statements -2B- MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EARNINGS UNAUDITED --------- Three Months Ended September 30, Six Months Ended September 30, -------------------------------- ----------------------------- 1995 1994 1995 1994 ---- ---- ---- ---- NET SALES $ 97,715,000 $ 96,013,000 $ 206,907,000 $ 181,159,000 COST AND EXPENSES: Cost of Sales 44,859,000 40,222,000 95,487,000 73,218,000 Research and Development 9,438,000 6,863,000 17,612,000 13,207,000 Selling and Administrative 13,660,000 14,929,000 27,663,000 29,341,000 ----------- ----------- ----------- ------------ 67,957,000 62,014,000 140,762,000 115,766,000 EQUITY IN EARNINGS OF SOMERSET 6,138,000 6,141,000 11,709,000 11,489,000 OTHER INCOME 4,760,000 1,580,000 8,723,000 2,519,000 ----------- ----------- ----------- ----------- EARNINGS BEFORE INCOME TAXES 40,656,000 41,720,000 86,577,000 79,401,000 INCOME TAX RATE 28% 31% 28% 30% INCOME TAXES 11,180,000 13,062,000 23,934,000 23,613,000 NET EARNINGS $ 29,476,000 $ 28,658,000 $ 62,643,000 $ 55,788,000 ============ ============ ============= ============= EARNINGS PER SHARE $ .25 $ .24 $ .53 $ .47 ============ ============ ============= ============= WEIGHTED AVERAGE COMMON SHARES 119,319,000 118,908,000 119,294,000 118,867,000 ============ ============ ============= ============= The above Financial Statements give retroactive effect to the three-for-two stock split effective August 15, 1995 (See Note C). The Company paid regular quarterly cash dividends of $.027 per share from October 1993 to July 1994 and $.033 per share from October 1994 to July 1995. On October 13, 1995, the Company paid a regular quarterly cash dividend of $.04 per share. In addition, the Company paid a special one-time dividend of $.067 per share on January 13, 1995. See Notes to Consolidated Financial Statements -3- MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED SEPTEMBER 30, 1995 AND 1994 UNAUDITED 1995 1994 ---- ---- CASH FLOWS FROM OPERATING ACTIVITIES Net Earnings $ 62,643,000 $ 55,788,000 Adjustments to reconcile net earnings to net cash provided from operating activities: Depreciation and amortization 5,727,000 6,002,000 Deferred income taxes 2,494,000 608,000 Equity in the earnings of Somerset (11,709,000) (11,489,000) Cash received from Somerset 10,207,000 10,221,000 Other non-cash items (3,511,000) 14,117,000 Changes in operating assets and liabilities: Accounts receivable (6,523,000) (12,002,000) Inventories 3,155,000 (13,885,000) Trade accounts payable 627,000 4,255,000 Income taxes (17,704,000) 10,171,000 Other operating assets and liabilities (2,333,000) 6,866,000 ------------ ------------ Net cash provided from operating activities 43,073,000 70,652,000 CASH FLOWS FROM INVESTING ACTIVITIES Additions to property, plant and equipment (17,017,000) (7,765,000) Increase in intangible and other assets (19,360,000 (9,245,000) Proceeds from investment securities 35,848,000 12,953,000 Purchase of investment securities (10,731,000) (7,935,000) ------------ ------------ Net cash used in investing activities (11,260,000) (11,992,000) CASH FLOWS FROM FINANCING ACTIVITIES Cash dividend paid (7,950,000) (6,339,000) Payments on long-term obligations (15,000) (16,000) Proceeds from exercise of stock options 695,000 709,000 ----------- ----------- Net cash used in financing activities (7,270,000) (5,646,000) ----------- ----------- Net Increase in Cash and Cash Equivalents 24,543,000 53,014,000 Cash and Cash Equivalents - Beginning of Period 127,280,000 75,526,000 ------------ ------------ Cash and Cash Equivalents - End of Period $151,823,000 $128,540,000 ============ ============ CASH PAID DURING THE PERIOD FOR: Interest $ 12,000 $ 13,000 Income Taxes $ 39,226,000 $ 12,835,000 See Notes to Consolidated Financial Statements -4- MYLAN LABORATORIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS SIX MONTH PERIOD ENDED SEPTEMBER 30, 1995 Unaudited --------- A. In the opinion of management, the accompanying unaudited financial statements contain all adjustments (consisting of only normal recurring accruals) necessary to present fairly the financial position of the Company as of September 30, 1995 and March 31, 1995 together with the results of operations and cash flows for the interim periods ended September 30, 1995 and 1994. The consolidated results of operations for the three and six months ended September 30, 1995 and 1994 are not necessarily indicative of the results to be expected for the full year. Certain prior year amounts have been reclassified to conform to the current year presentation. B. These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto in the Company's 1995 Annual Report and Report on Form 10-K. C. On June 28, 1995 the Company announced a three-for-two stock split of the Company's common stock effective August 15, 1995 for shareholders of record at the close of business on July 31, 1995. The par value of the new shares issued totaled $20,004,000 and has been transferred from additional paid in capital to the common stock account. The weighted average shares outstanding and the earnings and dividends per share reflected in these financial statements give effect to the stock split. D. On September 29, 1995 the Company entered into a settlement agreement with Hoechst Marion Roussel Inc. (HMR) (formerly known as Marion Merrell Dow Inc.) and Tanabe Seiyaku Co. LTD (Tanabe) as discussed in Item 3 of the Report on Form 10-K for the year ended March 31, 1995. The agreement releases all parties from any further actions and suits as it relates to the manufacture of diltiazem. In consideration for such settlement HMR and Tanabe agreed to reimburse all of Mylan's defense costs incurred to date. The amount payable to Mylan is recorded as Other Income in the current quarter. E. On September 12, 1995 the Company enhanced its strategic alliance with VivoRx, Inc. (VivoRx), a California biotechnology company. VivoRx has developed a diabetes control technology, which is in FDA Phase I/II clinical trials. The Company has been funding VivoRx's research for encapsulated pancreatic islet cell transplants based on the attainment of milestones contained in equity and licensing agreements. The licensing agreement grants the Company exclusive rights to market and sell this product in North America. Following significant product development accomplishments, the Company expanded its commitment by investing $15,000,000 in convertible preferred stock of VivoRx. The Company's investment is recorded at cost in Other Assets. -5- MYLAN LABORATORIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS SIX MONTH PERIOD ENDED SEPTEMBER 30, 1995 Unaudited --------- F. On October 11, 1995 the Company entered into a definitive agreement to acquire UDL Laboratories, Inc. (UDL). UDL is the premier supplier of unit dose generic pharmaceuticals to the institutional and long term care markets. UDL has its corporate headquarters in Rockford, Illinois and maintains manufacturing, research and development and distribution facilities in Rockford, Illinois as well as Largo, Florida. The transaction, which is expected to be completed by early 1996, will be accounted for under the purchase method of accounting. Payment of approximately $47,500,000 will be made through the issuance of newly registered common stock of the Company. G. Equity in Earnings of Somerset includes the Company's 50% portion of the net earnings of Somerset Pharmaceuticals Inc. (Somerset), certain management fees and amortization of intangible assets resulting from the acquisition of Somerset. Such intangible assets are being amortized over a 15 year period using the straight line method. Condensed unaudited financial information of Somerset for the three and six month periods ended September 30, 1995 and 1994 are as follows: (in thousands) Three Months Ended Six Months Ended September 30, September 30, 1995 1994 1995 1994 ---- ---- ---- ---- Net Sales $27,181 $31,474 $50,178 $56,495 Costs and Expense (11,300) (15,897) (20,153) (28,137) Income Taxes (5,191) (4,864) (9,628) (8,556) Net Earnings $10,690 $10,713 $20,297 $19,802 The above information represents 100% of Somerset's operations of which the Company has a 50% interest. Under the Orphan Drug Act, Somerset has exclusivity relating to marketing the chemical compound Eldepryl for use as a treatment for late stage Parkinson's disease through June of 1996. -6- PART 1 - FINANCIAL INFORMATION ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS ------------------------------------------------ Results of Operations - --------------------- Net sales for the three and six months ended September 30, 1995 were $97,715,000 and $206,907,000 representing increases over the prior year comparable periods of 2% and 14% respectively. Volume increases in all areas of the Company's business along with the addition of acebutolol to the generic product line continue to offset the normal pricing pressures on generic products introduced during fiscal 1995. Gross margin as a percent of net sales decreased from 58% and 60% for the three and six months ended September 30, 1994 to 54% for the three and six months ended September 30, 1995. The higher rates for the prior periods was due to the launch of three significant products, cimetidine, glipizide and flurbiprofen. Due to the competitive nature of the generic pharmaceutical industry the sales and gross margin recognized for the three and six months ended September 30, 1995 are not necessarily indicative of the results to be expected in future quarters. Research and development expenditures for the three and six month periods ended September 30, 1995 increased 38% to $9,438,000 and 33% to $17,612,000 over the prior year comparable periods. These increases are indicative of the Company's commitment to product development throughout the Company. Selling and administrative expenses were 14% and 13% of net sales for the three and six months ended September 30, 1995 as compared to 16% for the three and six months ended September 30, 1994. Equity in earnings of Somerset continues to provide a solid return for the Company. Somerset's contribution to net earnings per share for the three and six month periods was $.05 and $.09 in both 1995 and 1994. -7- Liquidity and Capital Resources and Financial Condition ------------------------------------------------------- Working capital increased from $275,032,000 at March 31, 1995 to $298,754,000 at September 30, 1995 as a result of continued strong operations. The ratio of current assets to current liabilities was 8.5 to 1 at September 30, 1995 and 5.9 to 1 at March 31, 1995. Net cash provided from operating activities was $43,073,000 for the six months ended September 30, 1995 compared to $70,652,000 for the same period last year. The change is primarily related to the timing of income tax payments. The Company paid $39,226,000 for income taxes in the six months ended September 30, 1995 compared to $12,835,000 for the same period a year ago. Additions to property, plant and equipment amounted to $17,017,000 for the six months ended September 30, 1995. Capital expenditures are principally related to the replacement of older properties with more updated equipment and facility expansion including ongoing construction of a 150,000 square foot research facility in Morgantown, West Virginia. Additionally the Company has acquired land adjacent to its existing manufacturing facility in Morgantown with the intent of expanding that facility to meet the continued increase in demand for the Company's product. The increase in intangible and other assets is due principally to the investment in VivoRx as described in Note E to the financial statements. -8- PART II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K (a) Exhibit 27 required by Item 601(c) of Regulation S-X filed herewith. (b) Reports on Form 8-K - On September 22, 1995 the Company filed a report on Form 8-K dated September 12, 1995 covering Item 5 thereof regarding the announcement of a strategic alliance with VivoRx, Inc. 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. Mylan Laboratories Inc. (Registrant) DATE 11/14/95 /s/ Milan Puskar ------------------- --------------------------------------- Milan Puskar Chairman of the Board, Chief Executive Officer and President DATE 11/14/95 /s/ Frank A DeGeorge -------------------- ------------------------------------- Frank A. DeGeorge Director of Corporate Finance -9-