UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For 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 number 1-9860 BARR LABORATORIES, INC. (Exact name of Registrant as specified in its charter) New York 22-1927534 (State or Other Jurisdiction of (I.R.S. - Employer Incorporation or Organization) Identification No.) Two Quaker Road, P. O. Box 2900, Pomona, New York 10970-0519 (Address of principal executive offices) 914-362-1100 (Registrant's telephone number) (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 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 Number of shares of Common Stock, Par Value $.01, outstanding as of March 31, 1997: 21,200,956. <PAGE 1> BARR LABORATORIES, INC. INDEX PAGE PART I. FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets as of March 31, 1997 and June 30, 1996 3 Consolidated Statements of Earnings for the three and nine-months ended March 31, 1997 and 1996 4 Consolidated Statements of Cash Flows for the nine-months ended March 31, 1997 and 1996 5 Notes to Consolidated Financial Statements 6-8 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 9-12 PART II. OTHER INFORMATION Item 1. Legal Proceedings 13 Item 6. Exhibits and Reports on Form 8-K 13 SIGNATURES 13 BARR LABORATORIES, INC. CONSOLIDATED BALANCE SHEETS (thousands of dollars, except per share amounts) (unaudited) March 31, June 30, 1997 1996 ASSETS Current assets: Cash and cash equivalents $ 54,650 $ 44,893 Accounts receivable, less allowances of $ 1,651 and $1,799 respectively 31,607 32,065 Inventories 49,270 42,396 Deferred income taxes 2,842 2,771 Prepaid expenses 834 648 Total current assets 139,203 122,773 Property, plant and equipment, net 60,723 45,739 Other assets 824 708 Total assets $ 200,750 $169,220 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 64,206 $ 58,537 Accrued liabilities 6,072 6,332 Current portion of long-term debt 4,117 3,815 Income tax payable 5,609 1,104 Total current liabilities 80,004 69,788 Long-term debt 18,675 17,709 Other liabilities 222 238 Deferred income taxes 1,306 1,324 Commitments & Contingencies Shareholders' Equity: Common Stock $.01 par value per share Authorized 30,000,000; issued 21,318,912 and 14,115,664, respectively 142 141 Common stock distributable 71 - Additional paid-in capital 44,987 43,526 Retained earnings 55,356 36,507 100,556 80,174 Treasury stock at cost; 117,955 and 78,637 shares in 1997 and 1996, respectively (13) (13) Total shareholders' equity 100,543 80,161 Total liabilities and shareholders' equity $ 200,750 $169,220 <FN> See accompanying notes to the consolidated financial statements. BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF EARNINGS (thousands of dollars, except per share amounts) (unaudited) Three Months Nine Months Ended Ended March 31, March 31, 1997 1996 1997 1996 Revenues: Net product sales $60,164 $60,088 $191,730 $171,729 Proceeds from supply agreement 24,550 - 24,550 - Total revenues 84,714 60,088 216,280 171,729 Costs and expenses: Cost of sales 50,959 49,405 162,120 139,405 Selling, general and administrative 6,520 5,714 15,119 16,207 Research and development 3,409 3,552 9,356 8,325 Earnings from operations 23,826 1,417 29,685 7,792 Interest income 641 1,003 1,805 2,288 Interest expense (203) (457) (842) (1,361) Other (expense) income, net 51 - 58 (12) Earnings before income taxes and extraordinary loss 24,315 1,963 30,706 8,707 Income tax expense 9,390 694 11,786 3,248 Earnings before extraordinary loss 14,925 1,269 18,920 5,459 Extraordinary loss on early extinguishment of debt, net of taxes - (125) - (125) Net earnings $14,925 $1,144 $18,920 $5,334 PER COMMON SHARE: Earnings before extraordinary loss $ 0.66 $ 0.06 $ 0.85 $ 1.00 Extraordinary loss on early extinguishment of debt, net of taxes - (0.01) - (0.01) Net earnings per common and common equivalent shares $ 0.66 $ 0.05 $ 0.85 $ 0.25 Net earnings per common share assuming full dilution $ 0.66 $ 0.05 $ 0.84 $ 0.24 Weighted average number of common shares 22,495 20,982 22,279 20,943 Weighted average number of shares assuming full dilution 22,609 22,056 22,572 22,017 <FN> See accompanying notes to the consolidated financial statements. BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS For the Nine Months Ended March 31, 1997 and 1996 (thousands of dollars; unaudited) 1997 1996 CASH FLOWS FROM (USED IN) OPERATING ACTIVITIES: Net earnings $ 18,920 $ 5,334 Adjustments to reconcile net earnings to net cash provided by (used in) operating activities: Depreciation and amortization 3,723 3,681 Deferred income tax benefit (89) (230) Write-off of deferred financing fees associated with early extinguishment of debt - 31 Loss (gain) on disposal of equipment (50) 19 Changes in assets and liabilities: (Increase) decrease in: Accounts receivable 458 (2,629) Inventories (6,874) (5,953) Prepaid expenses (186) (139) Other assets (210) (620) Increase (decrease) in: Accounts payable and accrued liabilities 5,393 2,165 Income taxes payable 4,505 991 Net cash provided by operating activities 25,590 2,650 CASH FLOWS FROM (USED IN) INVESTING ACTIVITIES: Purchases of property, plant and equipment (18,612) (9,843) Proceeds from sale of property, plant and equipment 50 179 Net cash used in investing activities (18,562) (9,664) CASH FLOWS FROM (USED IN) FINANCING ACTIVITIES: Principal payments on long-term debt (118) (2,032) Proceeds from borrowings 1,386 - Costs associated with stock split - (20) Proceeds from exercise of stock options and employee stock purchases 1,461 1,153 Net cash provided by (used in) financing activities 2,729 (899) Increase (decrease) in cash 9,757 (7,913) Cash and cash equivalents, beginning of period 44,893 52,987 Cash and cash equivalents, end of period $ 54,650 $ 45,074 Supplemental cash flow data-Cash paid during the period: Interest, net of portion capitalized $ 361 $ 906 Income taxes $ 7,370 $ 2,681 <FN> See accompanying notes to the consolidated financial statements. BARR LABORATORIES, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (unaudited) (in thousands, except share information) 1. Basis of Presentation The consolidated financial statements include the accounts of Barr Laboratories, Inc. and its wholly-owned subsidiaries (the "Company" or "Barr"). In the opinion of the Management of the Company, the interim consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the financial position, results of operations and cash flows for the interim periods. Interim results are not necessarily indicative of the results that may be expected for a full year. These financial statements should be read in conjunction with the Company's Annual Report on Form 10-K for the year ended June 30, 1996, and quarterly reports on Form 10-Q for the periods ended September 30, and December 31, 1996. 2. Proceeds from Supply Agreement In January 1997, Bayer AG and Bayer Corporation ("Bayer") and the Company reached an agreement to settle the then pending litigation regarding Bayer's patent protecting ciprofloxacin hydrochloride ("Settlement Agreement"). As a result, the U. S. Federal Court for the Southern District of New York entered a Consent Judgment ending the litigation. In connection with the Settlement Agreement, the Company acknowledged the validity and enforceability of Bayer's world- wide ciprofloxacin patent, received an initial cash payment of $24.6 million, and signed a contingent, non-exclusive Supply Agreement ("Supply Agreement") which becomes effective in January, 1998 and ends at patent expiry in December, 2003. During the term of the Supply Agreement, Bayer has the option of supplying Barr and an unrelated third party with ciprofloxacin hydrochloride to market and distribute pursuant to a license from Bayer or making quarterly cash payments to Barr beginning in March, 1998. 3. Inventories Inventories consisted of the following: March 31, June 30, 1997 1996 Raw materials and supplies $20,471 $19,648 Work-in-process 7,181 4,920 Finished goods 21,618 17,828 $49,270 $42,396 Tamoxifen Citrate, purchased as a finished product, accounted for approximately $16,085 and $12,590 of finished goods as of March 31, 1997 and June 30, 1996, respectively. 4. Earnings Per Common Share and Common Share Equivalents For the three and nine-month periods ended March 31, 1997, earnings per primary common and common equivalent shares was computed by dividing the earnings applicable to common stock by the weighted average number of common and dilutive common equivalent shares outstanding during the period. For the three and nine-month periods ended March 31, 1996, earnings per primary common and common equivalent shares was computed by dividing the earnings applicable to common stock by the weighted average number of common shares outstanding during the period. Fully diluted earnings per share was calculated including dilutive stock options. The shares and per share amounts reflected in the accompanying Consoldated Balance Sheet as of March 31, 1997 and Statements of Earnings are calculated after giving effect to the Company's 3-for-2 stock split effected in the form of a 50% stock dividend which was declared on April 11, 1997 and distributed on May 7,1997. 5. Cash and Cash Equivalents Cash equivalents consist of short-term, highly liquid investments (primarily market auction securities with interest rates that are re-set in intervals of 7 to 49 days) which are readily convertible into cash at par value (cost). As of March 31, 1997 and June 30, 1996 approximately $24,947 and $20,924, respectively, of the Company's cash was held in an escrow account. Such amounts represent the portion of the Company's payable balance to the Innovator of Tamoxifen, which the Company has decided to secure in connection with its cash management policy. The Company pays the Innovator monthly interest based on the average unsecured monthly Tamoxifen payable balance. 6. Other Included within selling, general and administrative expenses ("SG&A") for the three- and nine-months ended March 31, 1996 are certain non-recurring charges of approximately $700 in connection with a voluntary early retirement program and a legal settlement. SG&A expenses also include a credit of $700 in legal costs reimbursed by another company. See Management's Discussion and Analysis. Interest income for the three- and nine-months ended March 31, 1996 includes $485 of interest received in February 1996 in connection with an income tax refund from the Internal Revenue Service. 7. Extraordinary Item In the quarter ended March 31, 1996, the Company negotiated the prepayment of $2 million in principal of its $20 million 10.15% Senior Secured Notes. This prepayment allowed the Company to complete an equipment financing to support its ongoing expansion efforts under more favorable terms. The cash payment of $2,213 included a prepayment penalty of $169 and accrued interest through March 15, 1996 of $44. The Company successfully negotiated a lower prepayment penalty than the amount required by the Note Agreement. The prepayment penalty of $169 and the related write-off of approximately $31 in previously deferred financing costs resulted in an extraordinary loss for the three- and nine- months ended March 31, 1996. This extraordinary loss from early extinguishment of debt, net of taxes of $76, was $125 or $0.01 per share. 8. Commitments and Contingencies At March 31, 1997, the Company was involved in lawsuits normal and incidental to its business, including patent infringement actions. Management, based on the advice of legal counsel, believes that the ultimate disposition of these lawsuits will not have a significant adverse effect on the Company's consolidated financial statements. 9. Subsequent Events On April 11, 1997, the Company's Board of Directors declared a 3-for-2 stock split effected in the form of a 50% stock dividend. Approximately 7.1 million additional shares of common stock were distributed on May 7, 1997 to shareholders of record as of April 24, 1997. All current and prior year share and per share amounts have been adjusted for the stock split. In December 1995, the Company received a "30-day" letter from the IRS disallowing approximately $750 in research and development tax credits, originating from the fiscal years ended June 30, 1987 through June 30, 1992, on the grounds that research and development tax credits taken in developing generic drugs for approval under the ANDA procedure are excluded from the definition of the term "qualified research" by the duplication exclusion contained in section 41(d)(4)(C) of the IRS Code, and other grounds. On May 12, 1997 the Company settled the claim with the IRS, without agreeing that the Company's activities do not qualify for credit, for approximately $822 including interest. A provision for an estimate of the settlement amount had been previously included in the Company's 1996 consolidated financial statements, and therefore the payment will not have any signif- icant adverse effect on the Company's consolidated financial statements. BARR LABORATORIES, INC. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations: Comparison of the Quarter Ended March 31, 1997 to the Quarter Ended March 31, 1996 - (thousands of dollars) Total revenues increased to $84,714 from $60,088. This increase is primarily the result of $24,550 in proceeds from supply agreement (See Note 3 to consolidated financial statements). Net product sales increased to $60,164 from $60,088. The increase is attributable to slight increases in Tamoxifen Citrate ("Tamoxifen"), the breast cancer treatment distributed by the Company, offset by a slight decrease in Barr-manufactured products. Third quarter sales of Tamoxifen totaled $44,846 and were consistent with the prior year, the result of heavy buying by several customers during the end of the second quarter in anticipation of a price increase that did not occur at the beginning of the third quarter, even though the Company's market share continued to increase during the quarter. Tamoxifen represented approximately 75% of total net product sales in the current quarter compared to 74% in the prior year. Tamoxifen is a patent protected product manufactured for the Company by the Innovator, and is distributed by the Company under a non- exclusive license agreement with the Innovator. Currently Tamoxifen only competes against the Innovators products, which are sold under the brand name. Net sales of Barr-manufactured products remained consistent with prior years. Barr-manufactured net sales include revenues from five new products compared to two new products in the same period last year. Revenues from new products and volume increases on the Company's existing product line offset price declines and higher discounts on certain existing products. Revenues from new products represented approximately 13% of total Barr-manufactured sales for the quarter ended March 31, 1997. Cost of sales increased to $50,959 or 85% of net product sales from $49,405 or 82%. The increase in cost of sales as a percentage of net product sales is primarily the result of two factors. First, an increase in Tamoxifen's share of the total Company revenues and second, lower net product sales due to increases in sales discounts and allowances, the result of increased competition. The increase in Tamoxifen's portion of total revenues negatively impacts the cost of sales percentage because the cost of distributed products is generally greater than that of manufactured products. Increased sales discounts and allowances are offered by the Company to maintain and increase market share in light of increased competition. New products such as Megestrol Acetate and Danazol, which were introduced in November 1995 and August 1996, respectively, as well as Medroxyprogesterone and Meperidine which were introduced in the quarter ended December 31, 1996, are currently subject to less competition and therefore, generate margins which help offset the declining margins on the Company's more established products. The Company continues to experience competition on sales of its other products, and it is impossible to predict whether further price erosion will occur. If further price erosion were to occur, this could have a material adverse effect on the Company's gross margins and gross profits. Selling, general and administrative expenses increased from $5,714 to $6,520 and increased as a percentage of net product sales from 10% to 11%. The majority of the increase in both dollars and percentage is attributable to costs associated with the Company's pre-launch activities for Warfarin Sodium and increased legal expenses. The prior year quarter also included approximately $700 in non-recurring charges in connection with a voluntary early retirement program and a legal settlement. These non-recurring charges were offset by a reduction in legal fees of approximately $700. During the quarter ended March 31, 1996, Barr entered into an agreement with another company to share in the development and litigation costs associated with one of its patent challenges. This agreement resulted in the above mentioned reduction of $700 in legal fees which were reimbursed by the other company. Research and development expenses decreased from $3,552 to $3,409. This decrease is primarily the result of lower outside testing, due to the cyclical nature of the research and development program, partially offset by increases in salaries and related costs associated with the addition of scientists and higher outside consulting costs necessary to support the number of products in development. Interest income decreased by $362 in comparison to the prior year. The decrease is primarily the result of $485 in interest income included in the prior year amounts in connection with interest earned on an income tax refund from the Internal Revenue Service. This was offset by a 27% increase in the average cash and cash equivalent balance in comparison to the same period in the prior year. Interest expense decreased $254 primarily due to an increase in capitalized interest associated with an increase in capital improvements as compared to the prior year. The increase in capitalized interest was partially offset by interest on the Company's equipment financing agreement entered in April 1996 and interest on the unsecured Tamoxifen balance. In the quarter ended March 31, 1996, the Company incurred an extraordinary loss on the early extinguishment of debt. In March 1996, the Company negotiated the prepayment of $2 million in principal of its $20 million 10.15% Senior Secured Notes. The Company recorded an extraordinary loss for the related prepayment penalty and write-off of deferred financing costs. Results of Operations: Comparison of the Nine Months Ended March 31, 1997 to the Nine Months Ended March 31, 1996 (thousands of dollars) Total revenues increased to $216,280 from $171,729. This increase is attributable to $24,550 in proceeds from supply agreement (see Note 3 to consolidated financial statements); a continued increase in demand for Tamoxifen Citrate ("Tamoxifen"), the breast cancer treatment distributed by the Company; as well as increased sales for the balance of the Company's product lines. Tamoxifen sales increased 15% to $144,531 or 75% of net product sales from $126,038 or 73% of net product sales in the prior year. The growth primarily resulted from increases in the Company's market share. Net sales of Barr-manufactured products increased approximately 3%. Barr-manufactured products included revenues from five new products in fiscal 1997 compared to two new products in fiscal 1996. These products represent approximately 11% and 2% of total Barr-manufactured sales in 1997 and 1996, respectively. Revenues from these products and volume increases on the Company's existing product line more than offset price declines on certain existing products. Cost of sales increased to $162,120 or 85% of net product sales from $139,405 or 81%. The increase is primarily attributable to higher product costs associated with an increase in Tamoxifen's share of total Company revenues and an increase in sales discounts and allowances due to increased competition. The resulting lower margins were partially offset by higher margins earned on new products which are currently subject to less competition. Research and development expenses increased 12% to $9,356. The increase is primarily the result of increases in salaries and related costs associated with the addition of scientists and higher outside consulting costs necessary to support the number of products in development. Selling, general and administrative expenses decreased to $15,119 from $16,207 primarily as a result of approximately $3,400 of reimbursed legal fees related to the ciprofloxacin patent challenge. The reduction in legal fees was partially offset by increased personnel and marketing costs. Interest income decreased $483 to $1,805. The decrease is primarily the result of $485 in interest income included in the prior year's amount in connection with interest earned on an income tax refund from the Internal Revenue Service. Interest expense decreased $519 due to an increase in capitalized interest associated with an increase in capital improvements as compared to the prior year. The increase in capitalized interest was partially offset by interest on the Company's equipment financing agreement entered in April 1996 and interest on the unsecured Tamoxifen balance. Liquidity and Capital Resources The Company's cash and cash equivalents increased to $54,650 at March 31, 1997 from $44,893 at June 30, 1996. The Company's unrestricted portion of this balance increased from $20,924 at June 30, 1996 to $24,947 at March 31, 1997. Cash provided from operating activities was $25,590 for the nine months ended March 31, 1997, which included net earnings of $18,920. The increase in inventory is offset by increases in accounts payable and income taxes payable. The inventory increase is primarily the result of an increase in Tamoxifen and other new product inventory. Accounts payable increased primarily as a result of increased purchases of Tamoxifen and income taxes payable increased due to increased earnings. The Company invested $18,612 in capital assets during the nine months ended March 31, 1997 primarily in connection with the Company's expansion of its manufacturing capacity in its Virginia and New York facilities. During the remainder of fiscal 1997, the Company estimates that it will invest an additional $10 million in construction and new equipment for these facilities. During the nine months ended March 31, 1997 the company utilized $1,386 under its $18,750 equipment financing agreement with BankAmerica Leasing and Capital Group. As of March 31, 1997, $14,210 of this facility remains available for use through October, 1997. The Company has not drawn upon its 3-year $10 million revolving credit facility with Bank of America Illinois. Management believes that existing capital resources will be adequate to meet its needs for the foreseeable future. As indicated in Part II, Item 1. Legal Proceedings, in January 1997, Bayer and the Company reached an agreement to settle the then pending litigation regarding Bayer's patent protecting ciprofloxacin hydrochloride ("Settlement Agreement"). In connection with the Settlement Agreement, the Company acknowledged the validity and enforceability of Bayer's world- wide ciprofloxacin patent, received an initial cash payment of $24.6 million, and signed a contingent, non-exclusive Supply Agreement ("Supply Agreement") which becomes effective in January, 1998 and ends at patent expiry in December, 2003. During the term of the Supply Agreement, Bayer has the option of supplying Barr and an unrelated third party with ciprofloxacin hydrochloride to market and distribute pursuant to a license from Bayer or making quarterly cash payments to Barr beginning in March, 1998. If Bayer elects to continue making cash payments, the annual value to Barr would be approximately $25 million. If Bayer provides Barr with product, the amount Barr could earn would be dependent on market conditions. PART II. OTHER INFORMATION Item 1. Legal Proceedings As previously disclosed in the Company's annual report on Form 10- K for the year ended June 30, 1996, the Company is involved in certain legal proceedings. The following summarizes significant developments in previously reported matters. Ciprofloxacin Patent Challenge In January 1997, Bayer and the Company reached an agreement to settle the then pending litigation regarding Bayer's patent protecting ciprofloxacin hydrochloride ("Settlement Agreement"). As a result, the U.S. Federal Court for the Southern District of New York entered a Consent Judgment ending the litigation. In connection with the Settlement Agreement, the Company acknowledged the validity and enforceability of Bayer's world- wide ciprofloxacin patent, received an initial cash payment of $24.6 million, and signed a contingent non-exclusive Supply Agreement ("Supply Agreement") which becomes effective in January, 1998 and ends at patent expiry in December, 2003. During the term of the Supply Agreement, Bayer has the option of supplying Barr and an unrelated third party with ciprofloxacin hydrochloride to market and distribute pursuant to a license from Bayer or making quarterly cash payments to Barr beginning in March, 1998. Item 6. Exhibits (a) Exhibit Number Exhibit 11 Computation of per share earnings 27 Financial data schedule 10.14 Supply Agreement for ciprofloxacin hydrochloride dated January, 1997 (portions of this exhibit have been omitted pursuant to a request for confidential treatment.) (b) There were no reports filed on Form 8-K in the quarter ended March 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. BARR LABORATORIES, INC. Dated: May 14, 1997 /s/ William T. McKee Chief Financial Officer and Treasurer