UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 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 December 31, 1996 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) 914-353-8403 (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 December 31, 1996: 14,053,673. 1 OF 12 BARR LABORATORIES, INC. INDEX PAGE PART I. FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets as of December 31, 1996 and June 30, 1996 3 Consolidated Statements of Earnings for the three and six-months ended December 31, 1996 and 1995 4 Consolidated Statements of Cash Flows for the six-months ended December 31, 1996 and 1995 5 Notes to Consolidated Financial Statements 6-8 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 8-11 PART II. OTHER INFORMATION Item 1. Legal Proceedings 11 Item 4. Submission of Matters to a Vote of Security Holders 12 Item 6. Exhibits and Reports on Form 8-K 12 SIGNATURES 12 2 OF 12 BARR LABORATORIES, INC. CONSOLIDATED BALANCE SHEETS (thousands of dollars, except share amounts) (unaudited) December June 30, 31, 1996 1996 ASSETS Current assets: Cash and cash equivalents $ 45,636 $ 44,893 Accounts receivable, less allowances of $2,021 and $1,799, respectively 33,936 32,065 Inventories 39,344 42,396 Deferred income taxes 2,842 2,771 Prepaid expenses 899 648 Total current assets 122,657 122,773 Property, plant and equipment, net 54,389 45,739 Other assets 797 708 Total assets $ 177,843 $ 169,220 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 59,765 $ 58,537 Accrued liabilities 6,826 6,332 Current installments of Long Term Debt 4,079 3,815 Income taxes payable 2,368 1,104 Total current liabilities 73,038 69,788 Long-term debt 18,810 17,709 Other liabilities 244 238 Deferred income taxes 1,306 1,324 Commitments & Contingencies Shareholders' Equity: Common Stock $.01 par value per share Authorized 30,000,000; issued 14,132,310 and 14,115,664, respectively 141 141 Additional paid-in capital 43,815 43,526 Retained earnings 40,502 36,507 84,458 80,174 Treasury stock at cost: 78,637 shares (13) (13) Total shareholders' equity 84,445 80,161 Total liabilities and shareholders'equity $ 177,843 $ 169,220 <FN> See accompanying notes to the consolidated financial statements. 3 OF 12 BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF EARNINGS (thousands of dollars, except per share amounts) (unaudited) Three Months Six Months Ended Ended December 31, December 31, 1996 1995 1996 1995 Net sales $ 67,335 $ 57,465 $ 131,566 $ 111,641 Cost of sales 57,685 46,541 111,161 90,000 Gross Profit 9,650 10,924 20,405 21,641 Costs and expenses: Selling, general and administrative 3,386 5,433 8,599 10,493 Research and development 3,106 2,529 5,947 4,773 Earnings from operations 3,158 2,962 5,859 6,375 Interest income 685 601 1,164 1,285 Interest expense (291) (432) (639) (904) Other (expense) income, net 2 5 7 (12) Earnings before income taxes 3,554 3,136 6,391 6,744 Income tax expense 1,326 1,147 2,396 2,554 Net earnings $ 2,228 $ 1,989 $ 3,995 $ 4,190 PER COMMON SHARE: Earnings per common and common equivalent share $ 0.15 $ 0.14 $ 0.27 $ 0.30 Earnings per common share assuming full dilution $ 0.15 $ 0.14 $ 0.27 $ 0.29 Weighted average number of common and common equivalent shares 14,803 13,958 14,782 13,949 Weighted average number of shares assuming full dilution 14,803 14,515 14,814 14,506 <FN> See accompanying notes to the consolidated financial statements. 4 OF 12 BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS For the Six Months Ended December 31, 1996 and 1995 (thousands of dollars; unaudited) 1996 1995 CASH FLOWS FROM (USED IN) OPERATING ACTIVITIES: Net earnings $ 3,995 $ 4,190 Adjustments to reconcile net earnings to net cash provided by (used in) operating activities: Depreciation and amortization 2,443 2,470 Deferred income tax benefit (89) (298) Loss on disposal of equipment - 19 Changes in assets and liabilities: (Increase) decrease in: Accounts receivable (1,871) (4,940) Inventories 3,052 (3,425) Prepaid expenses (251) (290) Other assets (150) (471) Increase (decrease) in: Accounts payable and accrued liabilities 1,728 4,517 Income taxes payable 1,264 532 Net cash provided by operating activities 10,121 2,304 CASH FLOWS FROM (USED IN) INVESTING ACTIVITIES: Purchases of property, plant and equipment (11,032) (4,867) Proceeds from sale of property, plant and equipment - 179 Net cash used in investing activities (11,032) (4,688) CASH FLOWS FROM (USED IN) FINANCING ACTIVITIES: Principal payments on long-term debt (22) (21) Proceeds from loans 1,387 - Proceeds from exercise of stock options and employee stock purchases 289 564 Net cash provided by financing activities 1,654 543 Increase (decrease) in cash 743 (1,841) Cash and cash equivalents at beginning of 44,893 52,987 period Cash and cash equivalents at end of period $ 45,636 $ 51,146 Supplemental cash flow data-Cash paid during the period: Interest, net of amount capitalized $ 507 $ 903 Income taxes $ 1,221 $ 2,320 <FN> See accompanying notes to the consolidated financial statements. 5 OF 12 BARR LABORATORIES, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (thousands of dollars; unaudited) 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 report on Form 10-Q for the period ended September 30, 1996. Certain amounts in prior years' financial statements have been reclassified to conform with the current year presentation. 2. Inventories Inventories consisted of the following: December June 30, 31, 1996 1996 Raw materials and supplies $19,016 $19,648 Work-in-process 5,790 4,920 Finished goods 14,538 17,828 ------- ------- $39,344 $42,396 ======= ======= Tamoxifen Citrate, purchased as a finished product, accounted for approximately $9,009 and $12,590 of finished goods as of December 31, 1996 and June 30, 1996, respectively. 3. Earnings Per Common Share and Common Share Equivalents For the three and six-month periods ended December 31, 1996, earnings per common share 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 six-month periods ended December 31, 1995, 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. 6 OF 12 4. 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 cost. As of December 31, 1996 and June 30, 1996, approximately $14,153 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. 5. Accounts Receivable In August 1996, one of the Company's largest wholesale customers filed for bankruptcy. Subsequent to the filing, the Company entered into negotiations with a third party to sell its outstanding receivable balance at a discount. In December 1996, the Company finalized this arrangement and received cash for the discounted receivable. 6. Other As indicated in Part II, Item 1. Legal Proceedings, in December, 1996, Bayer AG and Bayer Corporation ("Bayer") and the Company entered into an agreement to extend the date for filing of certain pre-trial documents from December 20, 1996 to January 13, 1997. In consideration of this extension and the additional legal expenses incurred by Barr, the Company earned approximately $1.5 million from Bayer and an additional $0.8 million from its Ciprofloxacin Partner. These items have been included in the Consolidated Statements of Earnings as a reduction of selling, general and administrative expenses. 7. Commitments and Contingencies At December 31, 1996, 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 any significant adverse effect on the Company's consolidated financial statements. 8. Subsequent Event 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 approximately $25 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 7 OF 12 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 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Comparison of the Quarter Ended December 31, 1996 to the Quarter Ended December 31, 1995 - (thousands of dollars) Net sales increased 17% to $67,335 from $57,465. The increase is attributable to 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 23% to $50,785 or 75% of net sales compared to $41,433 or 72% of net sales in the prior year. The growth primarily resulted from increases in the Company's market share. Tamoxifen is a patented 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 Innovator's products, which are sold under a brand name. Prior to December 1995, the Company competed against the Innovator's 10 mg dosage strength only. In January 1996, the Innovator introduced a 20 mg strength of this product and as permitted under the terms of its existing agreement with the Innovator, the Company began distributing the 20 mg strength in December 1996. Neither the Innovator's nor the Company's introduction of the 20 mg strength has had a significant impact on the Company's net sales. Net sales of Barr-manufactured products increased by approximately 3% primarily as a result of additional volume. Barr-manufactured net sales include revenues from four 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 more than offset price declines and higher discounts on certain existing products. Revenues from new products represented 12% of total Barr-manufactured sales for the quarter ended December 31, 1996. Gross profit decreased to $9,650 from $10,924 and the gross margin decreased as a percentage of sales to 14% from 19%. The decrease in margins is generally attributable to two factors. First, an increase in Tamoxifen's share of total Company revenues and second, an increase in sales discounts and allowances due to increased competition. The increase in Tamoxifen's portion of total revenues negatively impacts margins because the profit margin the Company earns as a distributor is generally below the margin it earns as a manufacturer. Increased sales discounts and allowances reduce the Company's net selling price and margins, but 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 to offset the declining margins on the Company's more 8 OF 12 established products. The Company continues to experience competition on sales of its other products, and it is impossible to predict whether future price erosion will occur. If further price erosion were to occur, this could have an adverse effect on the Company's gross margins and gross profits. Selling, general and administrative expenses decreased from $5,433 to $3,386, primarily as a result of approximately $3,000 in reimbursement of legal fees. The reduction in legal fees was partially offset by increased personnel and advertising costs. Total research and development expenses increased approximately $577 or 23% over the prior year. Contributing factors include increases in salaries and related costs associated with the addition of scientists; increases in amounts paid to outside laboratories to conduct biostudies; and higher outside consulting costs necessary to support the number of products in development. Interest income remained relatively constant in comparison to the prior year. For the quarter ended December 31, 1996, interest income included interest earned in connection with the reimbursement of legal fees. This offset lower earnings associated with a 15% decline in the average cash and cash equivalent balance in comparison to the same period in the prior year. Interest expense declined by $141 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 unsecured Tamoxifen balance (see Note 4) and interest on its equipment financing agreement entered in April 1996. Results of Operations: Comparison of the Six Months Ended December 31, 1996 to the Six Months Ended December 31, 1995 (thousands of dollars) Net sales increased 18% to $131,566 from $111,641. The increase is attributable to 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 23% to $99,673 or 76% of net sales compared to $81,323 or 73% of net 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 5%. Barr manufactured net sales include revenues from four new products in fiscal 1997 compared to two new products in fiscal 1996. These products represented 10% and 1% of total Barr manufactured sales in 1997 and 1996, respectively. Revenues from these new products and volume increases on the Company's existing product line more than offset price declines on certain existing products. Gross profit declined to $20,405 from $21,641 and gross margin decreased as a percentage of sales to 16% from 19%. The decline in gross margin is primarily attributed to lower gross margins associated with an increase in Tamoxifen's share of total Company revenues and an increase in sales discounts and allowances due to increased competition. These lower margins were partially offset by margins earned on new products in the period which are currently subject to less competition. 9 OF 12 Selling, general and administrative expenses decreased from $10,493 to $8,599 primarily as a result of approximately $3,400 in reimbursement of legal fees. The reduction in legal fees was partially offset by increased personnel costs and advertising costs. Total research and development expenses increased 25% over the prior year, consistent with the Company's objective of researching and developing new products for manufacture and distribution. Interest income declined by $121 primarily due to a 15% decline in the average cash and cash equivalent balance in comparison to the same period in the prior year, as well as a shift in the investment mix. This decline was partially offset by approximately $200 in interest income earned in connection with the reimbursement of legal fees. Interest expense declined by $265 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 unsecured Tamoxifen balance (see Note 4) and interest on its equipment financing agreement entered in April 1996. Liquidity and Capital Resources The Company's cash and cash equivalents increased to $45,636 at December 31, 1996, from $44,893 at June 30, 1996. The Company's unrestricted portion of this balance also increased as the escrow account declined from $20,924 at June 30, 1996 to $14,153 at December 31, 1996 (see Note 4). Cash provided from operating activities was $10,121 for the six months ended December 31, 1996, which included net earnings of $3,995. Accounts receivable increased primarily as a result of higher sales volume and payables increased primarily due to Tamoxifen purchases. Lower Tamoxifen levels contributed to the decline in inventories. The Company purchased $11,032 in capital assets during the six months ended December 31, 1996 primarily in connection with the Company's investment in additional manufacturing capacity in its Virginia and New York facilities. During the remainder of fiscal 1997, the Company estimates that it will invest an additional $16 million in construction and new equipment for these facilities. During the six months ended December 31, 1996, the Company utilized $1,387 under its $18,750 equipment financing agreement with BankAmerica Leasing and Capital Group. As of December 31, 1996, $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 approximately $25 million, and signed a contingent, non-exclusive Supply Agreement ("Supply Agreement") which becomes effective in 10 OF 12 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 March 1996, the Company and an unrelated third party ("Ciprofloxacin Partner") entered into several agreements related to ciprofloxacin hydrochloride ("ciprofloxacin") including an agreement to share litigation costs associated with the patent litigation. In return, the third party is entitled to share in any settlements or in the proceeds from Barr's sale of the ciprofloxacin product. In December 1996, Bayer AG and Bayer Corporation ("Bayer") and the Company entered into an agreement to extend the date for filing of certain pre-trial documents from December 20, 1996 to January 13, 1997. In consideration of this extension and the additional legal expenses incurred by Barr, the Company earned approximately $1.5 million from Bayer and an additional $0.8 million from its Ciprofloxacin Partner. 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 approximately $25 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. 11 OF 12 Item 4. Submission of Matters to a Vote of Security Holders The Annual Meeting of Shareholders of Barr Laboratories, Inc. was held on December 4, 1996, at the Woodcliff Lake Hilton, Woodcliff Lake, New Jersey. Of the 14,053,673 shares entitled to vote, 13,564,175 shares were represented at the meeting by proxy or present in person. The meeting was held for the following purposes: 1. To elect a Board of Directors. All eight nominees were elected based on the following votes cast: For Shares Robert J. Bolger 13,406,110 Edwin A. Cohen 13,403,318 Bruce L. Downey 13,404,618 Michael F. Florence 13,403,968 Wilson L. Harrell 13,404,018 Jacob M. Kay 13,404,868 Bernard C. Sherman 13,404,068 George P. Stephan 13,404,068 2. To consider approval of an amendment to the Company's 1993 Stock Incentive Plan. The number of votes cast for, against and abstained were 10,158,563, 2,171,634, and 28,740 respectively. 3. To consider approval of an amendment to the Company's 1993 Stock Option Plan for Non-Employee Directors. The number of votes cast for, against and abstained were 12,079,506, 332,110, and 30,842 respectively. Item 6. Exhibits and Reports on Form 8-K a) Exhibit Number Exhibit 11 Computation of per share earnings 27 Financial data schedule (b) There were no reports filed on Form 8-K in the quarter ended December 31, 1996. 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: February 5, 1997 /s/ William T. McKee William T. McKee Chief Financial Officer 12 OF 12