- ------------------------------------------------------------------------------ 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 December 31, 1997 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 February 9, 1998 --------------------- ---------------- $.50 par value 122,149,289 MYLAN LABORATORIES INC. AND SUBSIDIARIES INDEX Page Number ----------- PART I. FINANCIAL INFORMATION ITEM 1: Financial Statements Consolidated Balance Sheets - December 31, 1997 and March 31, 1997 2A and 2B Consolidated Statements of Earnings - Three and Nine Months Ended December 31, 1997 and 1996 3 Consolidated Statements of Cash Flows - Nine Months Ended December 31, 1997 and 1996 4 Notes to Consolidated Financial Statements - Nine Months Ended December 31, 1997 5 through 7 ITEM 2: Management's Discussion and Analysis of Financial Condition and Results of Operations 8 and 9 PART II. OTHER INFORMATION 10 MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS ASSETS December 31, March 31, 1997 1997 Unaudited Audited Current Assets: Cash and cash equivalents $115,130,000 $126,156,000 Marketable securities 18,492,000 13,876,000 Accounts receivable - net 108,044,000 115,303,000 Inventories: Raw materials 67,783,000 51,796,000 Work in process 23,531,000 20,843,000 Finished goods 44,287,000 28,251,000 ------------ ------------ 135,601,000 100,890,000 Prepaid refundable income taxes 4,887,000 - Deferred income tax benefit 6,778,000 13,532,000 Other current assets 10,029,000 9,263,000 ------------ ------------ Total Current Assets 398,961,000 379,020,000 Property, Plant and Equipment - at cost 217,169,000 197,466,000 Less accumulated depreciation 71,329,000 61,637,000 ------------ ------------ 145,840,000 135,829,000 Deferred Income Tax Benefit 2,625,000 - Marketable Securities, non-current 21,907,000 23,668,000 Investment in and Advances to Somerset 28,178,000 25,113,000 Intangible Assets-net of accumulated amortization 131,267,000 137,062,000 Other Assets 86,205,000 76,888,000 ------------ ------------ Total Assets $814,983,000 $777,580,000 ============ ============ See Notes to Consolidated Financial Statements -2A- LIABILITIES AND SHAREH0LDERS' EQUITY December 31, March 31, 1997 1997 Unaudited Audited Current Liabilities: Trade accounts payable $ 14,996,000 $ 18,039,000 Current portion of long-term obligations 16,336,000 17,453,000 Income taxes payable 7,701,000 13,795,000 Other current liabilities 22,880,000 24,566,000 Cash dividend payable 4,896,000 4,893,000 ------------ ------------ Total Current Liabilities 66,809,000 78,746,000 Long-Term Obligations 31,996,000 32,593,000 Deferred Income Tax Liability - 6,501,000 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 123,022,547 shares at December 31, 1997 and 122,814,956 shares at March 31, 1997 61,511,000 61,407,000 Additional paid-in capital 92,093,000 89,262,000 Retained earnings 568,069,000 513,750,000 Net unrealized gain (loss) on investments 646,000 (947,000) ------------ 722,319,000 663,472,000 Less Treasury stock - at cost, 887,358 shares at December 31, 1997 and 752,950 shares at March 31, 1997 6,141,000 3,732,000 ------------ ------------ Net Worth 716,178,000 659,740,000 ------------ ------------ Total Liabilities and Shareholders' Equity $814,983,000 $777,580,000 ============ ============ See Notes to Consolidated Financial Statements -2B- MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF EARNINGS UNAUDITED Three Months Ended December 31, Nine Months Ended December 31, ------------------------------- ------------------------------ 1997 1996 1997 1996 ---- ---- ---- ---- REVENUES: Net Sales $129,517,000 $113,981,000 $365,838,000 $321,505,000 Other Revenues - - 26,822,000 - ------------ ------------ ------------ ------ Total Revenues 129,517,000 113,981,000 392,660,000 321,505,000 COST AND EXPENSES: Cost of Sales 75,077,000 66,729,000 207,657,000 186,344,000 Research and Development 7,891,000 10,775,000 31,707,000 31,561,000 Selling and Administrative 21,239,000 19,566,000 72,460,000 60,282,000 ------------ ------------ ------------ ------------ 104,207,000 97,070,000 311,824,000 278,187,000 EQUITY IN EARNINGS OF SOMERSET 1,839,000 4,462,000 8,431,000 14,507,000 OTHER INCOME 3,923,000 2,505,000 10,186,000 10,266,000 ------------ ------------ ------------ ------------ EARNINGS BEFORE INCOME TAXES 31,072,000 23,878,000 99,453,000 68,091,000 INCOME TAX RATE 29% 24% 31% 27% INCOME TAXES 9,089,000 5,797,000 30,482,000 18,651,000 ------------ ------------ ------------ ------------ NET EARNINGS $ 21,983,000 $ 18,081,000 $ 68,971,000 $ 49,440,000 ============ ============ ============ ============ EARNINGS PER SHARE-basic and diluted $ .18 $ .15 $ .57 $ .41 ============ ============ ============ ============ WEIGHTED AVERAGE COMMON SHARES-basic 122,127,000 121,916,000 122,074,000 121,892,000 ============ ============ ============ ============ The Company has paid regular quarterly cash dividends of $.04 per share since October 1995. See Notes to Consolidated Financial Statements -3- MYLAN LABORATORIES INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE NINE MONTHS ENDED DECEMBER 31, 1997 AND 1996 UNAUDITED 1997 1996 ---- ---- CASH FLOWS FROM OPERATING ACTIVITIES Net Earnings $ 68,971,000 $ 49,440,000 Adjustments to reconcile net earnings to net cash provided from operating activities: Depreciation and amortization 15,983,000 13,896,000 Deferred income tax benefit (2,243,000) (312,000) Equity in the earnings of Somerset (8,431,000) (14,507,000) Cash received from Somerset 5,366,000 15,546,000 Allowances on accounts receivable 2,967,000 (805,000) Other non-cash items (401,000) 949,000 Changes in operating assets and liabilities: Accounts receivable 4,042,000 (23,934,000) Inventories (34,567,000) 3,223,000 Trade accounts payable (3,043,000) (2,758,000) Income taxes payable (11,316,000) (1,767,000) Other operating assets and liabilities (2,450,000) 7,125,000 ----------- ----------- Net cash provided from operating activities 34,878,000 46,096,000 CASH FLOWS FROM INVESTING ACTIVITIES Additions to property, plant and equipment (19,703,000) (20,094,000) Increase in intangible and other assets (6,760,000) (29,257,000) Proceeds from investment securities 12,086,000 17,078,000 Purchase of investment securities (12,489,000) (20,952,000) ----------- ----------- Net cash used in investing activities (26,866,000) (53,225,000) CASH FLOWS FROM FINANCING ACTIVITIES Cash dividends paid (14,651,000) (14,617,000) Payments on long-term obligations (4,187,000) (1,423,000) Repurchase of Common Stock (2,459,000) - Proceeds from exercise of stock options 2,259,000 912,000 ----------- ----------- Net cash used in financing activities (19,038,000) (15,128,000) ----------- ----------- Net Decrease in Cash and Cash Equivalents (11,026,000) (22,257,000) Cash and Cash Equivalents - Beginning of Period 126,156,000 176,980,000 ----------- ----------- Cash and Cash Equivalents - End of Period $115,130,000 $154,723,000 ============ ============ CASH PAID DURING THE PERIOD FOR: Interest $ 1,187,000 $ 433,000 Income Taxes $ 44,015,000 $ 20,728,000 See Notes to Consolidated Financial Statements -4- MYLAN LABORATORIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NINE MONTH PERIOD ENDED DECEMBER 31, 1997 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 December 31, 1997 and March 31, 1997 together with the results of operations and cash flows for the interim periods ended December 31, 1997 and 1996. The consolidated results of operations for the three and nine months ended December 31, 1997 and 1996 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 1997 Annual Report and Report on Form 10-K and subsequent filings under the Securities Exchange Act of 1934. C. In June 1997, the Company's subsidiary Mylan Pharmaceuticals Inc. ("Mylan") entered into an exclusive supply and distribution agreement with Genpharm Inc. ("Genpharm"), a Canadian corporation, relating to the sale of ranitidine HCL tablets ("ranitidine") in the United States. Ranitidine is the generic version of Glaxo's Zantac(R). Under the terms of the agreement Mylan and Genpharm will share in the combined profits resulting from the sale, by Mylan, of ranitidine tablets manufactured by either Mylan or Genpharm. In addition, the agreement provides that Mylan shall be entitled to share in any benefit received by Genpharm as a result of Genpharm entering into any agreement with any third party, which would affect either the marketing of ranitidine or Genpharm's ability to supply product to Mylan. Due to unresolved legal matters with Glaxo, on July 31, 1997, Genpharm entered into an agreement with Novopharm Limited, a Canadian Corporation, and its United States subsidiary Granutec Inc. ("Novopharm"). Under the terms of the agreement between Genpharm and Novopharm, Genpharm is entitled to receive compensation from Novopharm predicated upon Novopharm's sales of the product through December 31, 1997 and a profit allocation factor which is significantly reduced after the exclusivity period. Under the terms of the agreement between Mylan and Genpharm, Mylan is entitled to share in the compensation received by Genpharm from Novopharm. -5- MYLAN LABORATORIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NINE MONTH PERIOD ENDED DECEMBER 31, 1997 Unaudited C. (con't) During the quarter ended September 30, 1997, the Company recognized income of $26,822,000 related to the Genpharm Novopharm agreement. Such income was recorded under the caption "Other Revenue" and increased net earnings for the quarter ended September 30, 1997 by approximately $16,388,000 or $.13 per share. The Company collected the entire receivable recorded as of September 30, 1997 during the quarter ended December 31, 1997. As a result of a dispute between Genpharm and Novopharm relating to contract interpretation, the Company did not recognize any additional revenue during the quarter ended December 31, 1997. The amount of revenue to be recognized by the Company in the future will be determined by a final accounting of the net sales and expenses incurred by Novopharm during the contract period and resolution of the dispute between Genpharm and Novopharm. D. For the quarter ended December 31, 1997, the Company adopted the provisions of Statement of Accounting Standards No. 128, "Earnings per Share." The diluted per-share computations for the three and nine months ended December 31, 1997 and 1996, include 1,287,000 and 885,000, and 909,000 and 1,030,000, of potential shares of common stock from the exercise of stock options, respectively. E. 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. -6- MYLAN LABORATORIES INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS NINE MONTH PERIOD ENDED DECEMBER 31, 1997 Unaudited E. (con't) Condensed unaudited financial information of Somerset for the three and nine month periods ended December 31, 1997 and 1996 are as follows: (in thousands): Three Months Ended Nine Months Ended December 31, December 31, 1997 1996 1997 1996 ---- ---- ---- ---- Net Sales $12,301 $19,685 $44,684 $76,052 Costs and Expenses (6,865) (7,378) (20,119) (35,406) Income Taxes (1,910) (3,904) (8,550) (14,048) ------- ------- ------- ------- Net Earnings $ 3,526 $ 8,403 $16,015 $26,598 ======= ======= ======= ======= The above information represents 100% of Somerset's operations of which the Company has a 50% interest. Somerset's marketing exclusivity for Eldepryl(R) under the Orphan Drug Act expired on June 6, 1996, Somerset has experienced increased competition since August 1996, due to the approval of several generic tablet forms of Eldepryl(R) by the FDA. This has resulted in the decrease in sales and net earnings from 1996 to 1997. -7- PART 1 - FINANCIAL INFORMATION ITEM 2 - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Results of Operations Net earnings for the three months ended December 31, 1997 were $21,983,000 ($.18 per share)representing a 22% increase over the same quarter a year ago and for the nine months then ended were $68,971,000($.57 per share) representing a 40% increase over the same period a year ago. Net earnings for the nine month period ending December 31, 1997 includes approximately $.13 per share relating to revenue recognized by the Company as a result of the sale of generic ranitidine by an unrelated party during the period(see note C)and was reduced by approximately $.07 per share as a result of unusual promotional expense associated with the launch of new generic products by the Company, primarily the launch of generic ranitidine. In addition to the unusual items identified above, net earnings for both the three and nine month periods ended December 31, 1997 were favorably impacted by the addition of 14 products to the Company's generic product line since December 31, 1996 including 11 during the current fiscal year. The addition of the new generic products, continued volume increases throughout the generic product line and selective price increases have offset the price deterioration that exists in the generic industry. Generic volume of almost 2.0 billion tablets, capsules and patches for the quarter and 5.4 billion year to date, represents 15% growth over the same periods a year ago. As a result of the items identified in the previous paragraph, net sales for the three and nine month periods ended December 31, 1997 were a record high $129,517,000 and $365,838,000, respectively. This represents a 14% increase over the prior year comparable periods. Gross profit(net sales less cost of sales)as a percentage of net sales remained relatively unchanged from the prior year comparable periods. Due to the competitive nature of the generic pharmaceutical industry, the Company has long been subject to price deterioration particularly on new products. Historically the Company has offset price deterioration by increasing volume and introducing new generic products. Recently, branded pharmaceutical companies have significantly increased legal procedures aimed at delaying the introduction of generic versions of their compounds. While the vast majority of these legal challenges prove to be without merit they have caused the Company to incur additional research and development costs and significant legal costs. More importantly they have delayed the introduction of several products. As a direct result of the increased cost involved in bringing new products to market, the Company has selectively increased prices on certain of its generic products. Mylan had to choose between discontinuing some money-losing items or increasing prices. We have chosen to increase prices and continue providing low-cost, effective, quality generic alternatives. -8- Research and development expenditures for the three and nine month periods ended December 31, 1997 were $7,891,000 and $31,707,000 compared to $10,775,000 and $31,561,000 for the three and nine month periods ended December 31, 1996. The decrease in the three months ended December 31, 1997 was primarily attributable to the Company's funding to VivoRx Inc. being substantially reduced due to various federal grants obtained by VivoRx Inc. relating to its diabetes research. The Company expects research and development expenses to return to levels experienced in prior quarters. Selling and administrative expenses were $21,239,000 and $72,460,000 for the three and nine month periods ended December 31, 1997 compared to $19,566,000 and $60,282,000 for the three and nine month periods ended December 31, 1996. Approximately 60% of the increase for the three month period and 86% of the increase for the nine month period relate to promotional expenses for customers associated with the launch of new generic products including ranitidine. Somerset's contribution to the Company's earnings per share was $.01 and $.06 for the three and nine month periods ended December 31, 1997 compared to $.03 and $.11 for the three and nine month periods ended December 31, 1996. Generic competition continues to adversely affect Somerset's contribution to the Company's net earnings per share. For the three month period ended December 31, 1997 the increase in the effective tax rate over the same period a year ago is primarily attributable to the increase in domestic earnings versus Puerto Rico earnings. In addition, the effective tax rate for the nine month period ended December 31, 1997 was further impacted by the Other Revenue recognized during the period which is subjected to the full Federal and State tax rates. Liquidity, Capital Resources and Financial Condition Working capital increased from $300,274,000 at March 31, 1997 to $332,152,000 at December 31, 1997. The ratio of current assets to current liabilities improved from 4.8 to 1 at March 31, 1997 and 6.0 to 1 at December 31, 1997. Net cash provided from operating activities was $34,878,000 for the nine months ended December 31, 1997 compared to $46,096,000 for the same period last year. Significant changes in balance sheet accounts between March 31, 1997 and December 31, 1997 relate principally to the settlement of the Internal Revenue Service audit and increased inventory levels attributable to continued higher demand for the Company's products. These timing items, partially offset by the increase in earnings, are primarily responsible for the change in cash flows from operating activities between the current period and the same period a year ago. Additions to property, plant and equipment amounted to $19,703,000 for the nine months ended December 31, 1997. Capital expenditures are principally related to the completion of a new distribution facility in Greensboro, North Carolina and expansion of the manufacturing facility in Morgantown, West Virginia. The acquisition of Maxzide(R) in the prior period is primarily responsible for the decrease in cash used in investing activities. -9- 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 - There were no reports on Form 8-K filed during the three months ended December 31, 1997. 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 2/13/98 /s/ Milan Puskar ------------------------ --------------------------------- Milan Puskar Chairman of the Board, Chief Executive Officer and President DATE 2/13/98 /s/ Milan Puskar ------------------------ -------------------------- Donald C. Schilling Vice President of Finance -10-