1 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 September 30, 1998 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 September 30, 1998: 22,379,847 1 2 BARR LABORATORIES, INC. INDEX PAGE ----- ---- PART I. FINANCIAL INFORMATION Item 1. Financial Statements Consolidated Balance Sheets as of September 30, 1998 and June 30, 1998 3 Consolidated Statements of Earnings for the three months ended September 30, 1998 and 1997 4 Consolidated Statements of Cash Flows for the three months ended September 30, 1998 and 1997 5 Notes to Consolidated Financial Statements 6-8 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 9-11 PART II. OTHER INFORMATION Item 6. Exhibits and Reports on Form 8-K 12 SIGNATURES 12 2 3 BARR LABORATORIES, INC. CONSOLIDATED BALANCE SHEETS (THOUSANDS OF DOLLARS, EXCEPT SHARE AMOUNTS) (UNAUDITED) SEPTEMBER 30, JUNE 30, 1998 1998 --------- --------- ASSETS Current assets: Cash and cash equivalents $ 60,285 $ 72,956 Marketable securities 7,800 7,320 Accounts receivable, less allowances of $2,777 and $2,738, respectively 52,445 46,760 Supply agreement receivable 14,917 14,667 Inventories 92,987 74,377 Prepaid expenses 603 806 --------- --------- Total current assets 229,037 216,886 Property, plant and equipment, net 91,010 90,649 Other assets 5,032 3,316 --------- --------- Total assets $ 325,079 $ 310,851 ========= ========= LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable $ 105,549 $ 103,321 Accrued liabilities 8,490 9,460 Deferred income taxes 1,000 1,000 Current portion of long-term debt 1,967 4,467 Income taxes payable 7,837 3,357 --------- --------- Total current liabilities 124,843 121,605 Long-term debt 32,039 32,174 Other liabilities 165 162 Deferred income taxes 625 981 Commitments & Contingencies Shareholders' equity Common stock $.01 par value per share; authorized 100,000,000; issued 22,497,802 and 22,424,645, respectively 225 224 Additional paid-in capital 68,908 68,064 Retained earnings 99,800 88,596 Unrealized loss on investments (1,513) (942) --------- --------- 167,420 155,942 Treasury stock at cost: 117,955 shares (13) (13) --------- --------- Total shareholders' equity 167,407 155,929 --------- --------- Total liabilities and shareholders' equity $ 325,079 $ 310,851 ========= ========= SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS. 3 4 BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF EARNINGS (IN THOUSANDS, EXCEPT PER SHARE AMOUNTS) (UNAUDITED) THREE MONTHS ENDED SEPTEMBER 30, 1998 1997 -------- -------- Revenues: Product sales $ 89,149 $ 89,101 Proceeds from supply agreements 8,000 7,166 -------- -------- Total revenues 97,149 96,267 Costs and expenses: Cost of sales 63,908 65,226 Selling, general and administrative 9,943 9,133 Research and development 5,370 5,198 -------- -------- Earnings from operations 17,928 16,710 Interest income 972 376 Interest expense (659) (237) Other (expense) income (14) 17 -------- -------- Earnings before income taxes 18,227 16,866 Income tax expense 7,023 6,469 -------- -------- Net earnings $ 11,204 $ 10,397 ======== ======== Earnings per common share $ 0.50 $ 0.48 ======== ======== Earnings per common share - assuming dilution $ 0.48 $ 0.45 ======== ======== Weighted average shares 22,335 21,467 ======== ======== Weighted average shares - assuming dilution 23,458 23,054 ======== ======== SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS. 4 5 BARR LABORATORIES, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED SEPTEMBER 30, 1998 AND 1997 (THOUSANDS OF DOLLARS) (UNAUDITED) 1998 1997 -------- -------- CASH FLOWS FROM (USED IN) OPERATING ACTIVITIES: Net earnings $ 11,204 $ 10,397 Adjustments to reconcile net earnings to net cash from (used in) operating activities: Depreciation and amortization 2,062 1,291 Deferred income tax (benefit) expense (1) 2,601 Other, net 19 -- Changes in assets and liabilities: (Increase) decrease in: Accounts receivable and supply agreement receivable, net (5,935) (25,318) Inventories (18,610) 7,276 Prepaid expenses 203 (192) Other assets (478) (52) Increase (decrease) in: Accounts payable, accrued liabilities and other 1,261 186 Income taxes payable 4,480 2,509 -------- -------- Net cash (used in) operating activities (5,795) (1,302) -------- -------- CASH FLOWS FROM (USED IN) INVESTING ACTIVITIES: Purchases of property, plant and equipment (2,390) (5,876) Purchases of strategic investments (2,250) (4,069) Other, net (446) 65 -------- -------- Net cash (used in) investing activities (5,086) (9,880) -------- -------- CASH FLOWS FROM (USED IN) FINANCING ACTIVITIES: Principal payments on long-term debt (135) (136) Activity on revolving line of credit, net (2,500) -- Proceeds from exercise of stock options and employee stock purchases 845 1,827 -------- -------- Net cash (used in) from financing activities (1,790) 1,691 -------- -------- (Decrease) in cash and cash equivalents (12,671) (9,491) Cash and cash equivalents at beginning of period 72,956 31,923 -------- -------- Cash and cash equivalents at end of period $ 60,285 $ 22,432 ======== ======== SUPPLEMENTAL CASH FLOW DATA - CASH PAID DURING THE PERIOD Interest, net of portion capitalized $ 126 $ -- Income taxes $ 2,543 $ 1,500 SEE ACCOMPANYING NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS. 5 6 BARR LABORATORIES, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (IN THOUSANDS OF DOLLARS, EXCEPT PER SHARE AMOUNTS) (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, 1998. 2. PROCEEDS FROM SUPPLY AGREEMENTS/SUPPLY AGREEMENT RECEIVABLE In accordance with the Ciprofloxacin Supply Agreement, the Company recognizes income and a related receivable on a monthly basis, as certain contingencies are met. Collection of certain of these receivables occurs quarterly. The Company has recognized revenue of $6,500 for the three months ended September 30, 1998. The Company received payment of $6,250 in September 1998 for amounts earned in the three-month period ended February 28, 1998. Also included in Proceeds from supply agreements is the final $1,500 earned under a separate contingent supply agreement related to the ciprofloxacin litigation. 3. CASH AND CASH EQUIVALENTS Cash equivalents consist of short-term, highly liquid investments (primarily market auction securities with interest rates that are re-set every 7 days) which are readily convertible into cash at par value (cost). As of September 30, 1998 and June 30, 1998, approximately $49,649 and $59,321, respectively, of the Company's cash was held in an interest bearing escrow account. Such amounts represent the portion of the Company's payable balance with the Innovator of Tamoxifen, which the Company has decided to secure in connection with its cash management policy. The Company pays the Innovator a monthly fee based on the average unsecured monthly Tamoxifen payable balance, as defined in the December 1995 Alternative Collateral Agreement. 4. OTHER ASSETS On September 23, 1998, the Company made a strategic investment in Gynetics, Inc. ("Gynetics") by acquiring 806,451 shares of Gynetics common stock through a private placement, for $2,250. The investment is carried at cost and is included in Other assets on the Consolidated Balance Sheets. 6 7 5. INVENTORIES Inventories consisted of the following: September 30, June 30, 1998 1998 ------- ------- Raw materials and supplies $15,359 $17,459 Work-in-process 6,528 4,132 Finished goods 71,100 52,786 ------- ------- $92,987 $74,377 ======= ======= Tamoxifen Citrate, purchased as a finished product, accounted for approximately $57,509 and $40,777 of finished goods as of September 30, 1998 and June 30, 1998, respectively. 6. EARNINGS PER SHARE In February 1997, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("SFAS") No. 128, "Earnings per Share". SFAS No. 128 specifies the computation, presentation and disclosure requirements for earnings per share ("EPS") and became effective for both interim and annual periods ending after December 15, 1997. All prior period EPS data have been restated to conform with the provisions of SFAS No. 128. The following is a reconciliation of the numerators and denominators used to calculate Earnings per common share in the Consolidated Statements of Earnings: Three Months Ended September 30, 1998 1997 ------- ------- EARNINGS PER COMMON SHARE: Net earnings (numerator) $11,204 $10,397 Weighted average shares (denominator) 22,335 21,467 Net earnings $ 0.50 $ 0.48 ======= ======= EARNINGS PER COMMON SHARE - ASSUMING DILUTION: Net earnings (numerator) $11,204 $10,397 Weighted average shares 22,335 21,467 Effect of dilutive options 1,123 1,587 ------- ------- Weighted averages shares - assuming dilution (denominator) 23,458 23,054 Net earnings $ 0.48 $ 0.45 ======= ======= (share amounts in thousands) 7 8 During the three months ended September 30, 1998, there were 518,250 outstanding options that were not included in the computation of diluted EPS, because the options' exercise prices were greater than the average market price of the common stock for the period. 7. COMMITMENTS AND CONTINGENCIES Invamed, Inc. Lawsuit On February 25, 1998, Invamed, Inc. ("Invamed") named the Company and several others as defendants in a lawsuit filed in the United States District Court for the Southern District of New York, charging that the Company unlawfully blocked access to the raw material source for Warfarin Sodium. The Company believes that the suit filed against it by Invamed is without merit and intends to defend its position vigorously. This action is currently in the discovery stage. It is anticipated that this matter will take several years to be resolved but an adverse judgement could have a material adverse impact on the Company's consolidated financial statements. Other Litigation The Company, at September 30, 1998, was involved in other lawsuits incidental to its business, including patent infringement actions. Management of the Company, based on the advice of legal counsel, believes that the ultimate disposition of such other lawsuits will not have any significant adverse effect on the Company's consolidated financial statements. 8. NEW ACCOUNTING PRONOUNCEMENTS In 1997, the FASB issued SFAS No. 130, "Reporting Comprehensive Income." Comprehensive income is defined as the total change in shareholders' equity during the period other than from transactions with shareholders. For the Company, comprehensive income is comprised of net income and the net changes in unrealized gains and losses on securities classified for SFAS No. 115 purposes as "available for sale." Total comprehensive income for the three months ended September 30, 1998 and 1997 was $10,633 and $10,623. In 1997, the FASB issued SFAS No. 131, "Disclosures about Segments of an Enterprise and Related Information." As required by the standard, the Company will begin reporting under SFAS No. 131 in its fiscal 1999 Annual Report. 9. OTHER During the quarter ended June 30, 1998, the Company recorded a $1.2 million restructuring charge. Approximately half of this charge related to the write-off of equipment and leasehold improvements in connection with the closing of a leased New Jersey packaging facility, for which operations have been relocated to other company facilities. The remainder related to severance related expenses for certain operations employees, primarily those affiliated with the closed facility. As of September 30, 1998, the fourth quarter restructuring plan has been completed. 8 9 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Results of Operations: Comparison of the Quarter Ended September 30, 1998 to the Quarter Ended September 30, 1997 - (thousands of dollars) Three Months Ended September 30, 1998 1997 Change ---- ---- ------ Revenues: Product sales: Distributed $57,247 $60,444 $(3,197) Manufactured 31,902 28,657 3,245 ------- ------- ------- Total product sales 89,149 89,101 48 Proceeds from supply agreements 8,000 7,166 834 ------- ------- ------- Total revenues $97,149 $96,267 $ 882 Total revenues were consistent with the prior year with slight increases in Product sales and Proceeds from supply agreements. The increase in Product sales was attributable to an increase in sales of manufactured products offset by a decrease in distributed product sales. Distributed product sales declined 5% as sales of Minocycline, which the Company began distributing in October 1997, partially offset lower sales of Tamoxifen. The decrease in sales of Tamoxifen was the result of accelerated buying by customers during the first three quarters of fiscal 1998, which was attributable, in part, to customers anticipating a price increase for Barr's Tamoxifen, which occurred on April 1, 1998. 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 Innovator's product, which is sold under the brand name. Sales of manufactured products increased 11% primarily attributable to sales from eight products launched in the most recent four quarters including Naltrexone, Estradiol, Estropipate and Triamterene. The prior year quarter included sales from the July 1997 launch of Warfarin Sodium that included significant launch quantities purchased by major wholesalers and chain drug stores. The current quarter Warfarin Sodium sales were slightly higher than those of the previous year's quarter reflecting the increased demand experienced in the preceding twelve months. Revenue from products launched in the most recent four quarters more than offset lower sales on products being phased out of the Company's product line and price declines and higher discounts on certain existing products. As the Company anticipated, a second generic version of Warfarin Sodium was launched in October 1998. Based on the current Warfarin Sodium market, the Company believes that the second generic launch will not have a material adverse effect on the Company's future consolidated financial statements and that Warfarin Sodium will continue to be an important contributor to revenues and profits. 9 10 Proceeds from supply agreements increased 12% primarily from the final $1,500 proceeds earned under a separate contingent supply agreement related to the ciprofloxacin litigation (See Note 2 to the Consolidated Financial Statements). Cost of sales decreased from $65,226 or 73% of product sales to $63,908 or 72% of product sales. The decrease in both dollars and percent of product sales is the result of a more favorable mix within manufactured products, a better mix of manufactured products to distributed products, and higher margins on distributed products. This improved mix within manufactured products and between manufactured products and distributed products was the result of sales of products launched in the previous twelve months which generally have higher margins than certain existing products and distributed products. The increase in distributed product margins was due to the April 1998 price increase on Tamoxifen by the Innovator. Margins on Tamoxifen are expected to return to historical levels as the Company has depleted its lower-cost inventory. Selling, general and administrative expenses increased to $9,943 from $9,133. The largest component of the dollar increase related to legal expenses. The increased legal fees resulted from the Company's federal anti-trust suit against DuPont Pharmaceutical Company, the Company's upcoming Prozac(R) trial, as well as development of additional patent challenges. Total research and development expenses in the quarter increased 3% to $5,370. The increase is primarily the result of increased personnel costs to support the number of products in development and higher raw material costs offset by lower bio-study costs. The prior year amount included $645 for the acquisition of six Abbreviated New Drug Applications and related technologies to expand the Company's line of female healthcare products. Interest income increased by $596 primarily due to an increase in the average cash and cash equivalents balance as well as a slight increase in the market rates of the Company's short-term investments. Interest expense increased $422 due to a decrease in capitalized interest over the corresponding quarter of the prior fiscal year. The amount of interest capitalized declined due to the reduction in capital spending on the Virginia facility, which was substantially complete by the spring of 1998. Liquidity and Capital Resources The Company's cash and cash equivalents decreased from $72,956 at June 30, 1998 to $60,285 at September 30, 1998. During the three months ended September 30, 1998, the Company decreased the cash held in its interest bearing escrow account from $59,321 at June 30, 1998 to $49,649. Cash used in operating activities totaled $5,795 for the three months ended September 30, 1998 as working capital increases more than offset quarterly income. The working capital increase was led by increases in inventory and accounts receivable which were partially offset by increases in accounts payable. Accounts receivable increased due to a slight increase in collection times. The increase in inventory is primarily a result of the Company's increased investment in Tamoxifen inventory in anticipation of the U.S. Food and Drug Administration's ("FDA") approval of Tamoxifen for the reduction in the incidence of breast cancer in women at high risk for developing the disease. The FDA approval for that indication occurred in October 1998. During the first three months of fiscal 1999, the Company invested approximately $2 million in capital expenditures primarily on construction and new equipment for its facilities. This decline from the prior year was anticipated and was related to the reduction in capital spending on the Virginia facility, 10 11 which was substantially complete by the spring of 1998. The Company expects to invest an additional $11 million in capital assets in fiscal 1999. In September 1998, Barr made a strategic investment of $2,250 in Gynetics, Inc. (See Note 4 to the Consolidated Financial Statements). The Company continues to evaluate other growth opportunities including additional strategic investments, acquisitions and joint ventures, which could require significant capital resources. The Company believes that its current cash balances, cash flows from operations and existing borrowing capacity under its Revolving Credit Facility will be adequate to meet its needs and to take advantage of strategic opportunities as they occur. To the extent that additional capital resources are required, such capital may be raised by additional bank borrowings, equity offerings or other means. Other Matters Market Risk Disclosure As discussed in the 1998 Annual Report on Form 10-K, the Company's exposure to market risk from changes in interest rates, in general, is not material. Year 2000 As disclosed in the 1998 Annual Report on Form 10-K, during 1998, the Company established a project team to assess the impact of the Year 2000 issue on the Company's operations. The project team continues to verify that third parties, with which it has a material relationship, are in compliance or expect to be in compliance prior to January 1, 2000. In addition, the project team continues to review its information technology ("IT") and non-IT systems for compliance and will make modifications to these systems as necessary. To date the Company has spent less than $100 in remediation efforts and believes that the cost to gain company-wide compliance will not be material. To date the Company has not completed a formal contingency plan for non-compliance, but continues to develop such plans based on the information obtained from the third parties with which it has a material relationship and the on-going evaluation of its IT and non-IT systems. The foregoing discussion regarding the Year 2000 project's timing, effectiveness, implementation, and cost, contains forward-looking statements, which are based on management's best estimates, derived utilizing numerous assumptions of future events including the continued availability of certain resources, third party modification plans and other factors. However, there can be no guarantee that these estimates will be achieved, and actual results could differ materially from those contemplated estimates. Specific factors that might cause such material differences include, but are not limited to, the availability and cost of personnel trained in this area, the ability to locate and correct all relevant computer codes and similar uncertainties and remediation success of the Company's customers and suppliers. Forward Looking Statements Except for the historical information contained herein, this Form 10-Q contains forward looking statements that involve a number of risks and uncertainties including the timing and outcome of legal proceedings, impact of competition, fluctuations in operating results, capital spending, the impact of Year 2000 issues on the business and other risks detailed from time-to-time in the Company's filings with the Securities and Exchange Commission. 11 12 BARR LABORATORIES, INC. PART II. OTHER INFORMATION ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibit Number Exhibit -------------- ------- 27.1 Financial data schedule (b) There were no reports filed on Form 8-K in the quarter ended September 30, 1998. 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: November 11, 1998 /s/ William T. McKee -------------------- William T. McKee Chief Financial Officer 12