WOODCLIFF LAKE, N.J., Aug. 8 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today reported net earnings of $45.3 million, or $0.41 per share, for the quarter ended June 30, 2007, compared to net earnings of $82.3 million, or $0.76 per share, for the same period last year. Revenues for the current quarter totaled $637 million, compared to $352 million for the same period last year. Adjusted earnings per share were $0.84 for the second quarter of 2007, compared to adjusted earnings per share of $0.93 in the prior year period. A reconciliation of GAAP-based earnings per share to adjusted earnings per share is presented in the table at the end of this press release.
For the six months ended June 30, 2007, net earnings were $56.9 million, or $0.52 per share, compared to $158.4 million, or $1.46 per share, in the prior year period. Revenues for the first six months of 2007 totaled $1.2 billion, compared to $679 million for the same period last year. Adjusted earnings per share were $1.62 for the six months ended June 30, 2007, compared to adjusted earnings per share of $1.77 in the prior year period.
“Our strong results for the quarter reflect sound contributions from both our generic and brand segments,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “In addition to strong generic oral contraceptive sales, we also experienced strong performance in the U.S. proprietary business from our Plan B(R) emergency contraceptive and ParaGard(R) IUD product. Royalties related to our Allegra(R) agreement with Teva boosted alliance and development revenue for the quarter as well. When we look across the global business, the integration of PLIVA continues to progress well, we continued to invest in our future through $65 million in product development expenditures during the second quarter, and we initiated our direct-to-consumer marketing campaign for the SEASONIQUE(R) extended-cycle oral contraceptive at the beginning of the third quarter. Overall, we are very pleased with the performance of the business during the first half of 2007.”
Revenues
Generic Product Sales
Sales of the Company’s generic products increased to $487 million for the second quarter of 2007, compared to $222 million in the prior year period. For the first six months of 2007, generic product sales increased to $961 million, compared to $423 million for the prior year period. A discussion of the Company’s generic product sales for the second quarter of 2007 compared to the prior year period is presented below.
U.S. Generic Sales Sales of U.S. generic products totaled $296 million for the second quarter of 2007, compared to $222 million in the prior year period. The increase in sales is primarily related to the inclusion of sales from PLIVA’s U.S. product line. These products are now being sold under the Barr label. The increase also reflects strong sales of Fentanyl Citrate, a generic version of ACTIQ(R) that we launched in late September 2006, and higher generic oral contraceptive sales. Sales of generic oral contraceptives, the Company’s largest single category of generic products, were $116 million for the second quarter of 2007, compared to $107 million in the prior year period. This growth is primarily related to sales of Balziva(TM) and Jolessa(TM), which the Company launched in October 2006 and September 2006, respectively, as well as to increased sales of Kariva(R). Europe and Rest of the World (“ROW”) Generic Sales Sales of generic products in Europe and the ROW through our PLIVA subsidiary were $191 million in the second quarter of 2007. Revenues were primarily driven by sales of PLIVA products in the key markets of Germany, Croatia, Poland and Russia. Prior to the Company’s acquisition of PLIVA in October 2006, Barr did not have any product sales in Europe or the ROW.
Proprietary Product Sales
The Company’s proprietary product sales were $102 million for the second quarter of 2007, compared to $97 million in the prior year period. For the first six months of 2007, proprietary product sales were $191 million, the same as in the prior year period. For the second quarter, the $5 million increase in proprietary sales was primarily attributable to higher sales of Plan B(R) Over-the-Counter/Rx and Adderall(R) IR, both of which were launched in the quarter ended December 31, 2006, and sales of SEASONIQUE(R) which was launched in August 2006. These increases more than offset lower sales of our SEASONALE(R) extended-cycle oral contraceptive, which faced generic competition in September 2006 following the expiration of three years of market exclusivity.
Alliance and Development Revenue
During the second quarter of 2007, the Company reported alliance and development revenue of $36 million, compared to $32 million in the prior year period. For the first six months of 2007, alliance and development revenue was $62 million, down from $65 million in the prior year period. The increase for the quarter ended June 30, 2007 reflects reimbursement under the Shire agreement that was entered into in August 2006 and higher reimbursement from the Adenovirus agreement with the U.S. Department of Defense.
Other Revenue
Other revenue primarily includes revenue from non-core operations acquired in connection with the PLIVA acquisition, including the diagnostic, disinfectants, dialysis and infusions business. Other revenue totaled $12 million for the second quarter of 2007 and $22 million for the first six months of 2007.
Margins
Generic: Margins in the generic segment for the second quarter of 2007 and the first six months of 2007 were 48% and 46%, respectively, down from 65% and 65%, respectively, in the prior year periods. Generic margins for the quarter ended June 30, 2007 were negatively impacted by amortization costs arising from the PLIVA acquisition.
Proprietary: Margins in the proprietary segment for the second quarter of 2007 and the first six months of 2007 were 79% and 73%, respectively, up from 69% and 70%, respectively, in the prior year periods. Proprietary margins for the quarter ended June 30, 2007 increased primarily due to the launch of SEASONIQUE and a stronger mix of higher margin product sales.
Update on R&D Activities
Research and development investment totaled $65 million for the second quarter of 2007, compared to $36 million in the prior year period. R&D for the first six months of 2007 totaled $127 million, compared to $74 million for the prior year period. The significant increases reflect greater investment in generic and bio-generic development activities, both in the U.S. and Europe, as well as in proprietary development activities in the United States.
Generic Products
At June 30, 2007, the Company had approximately 60 Abbreviated New Drug Applications, including tentatively approved applications, pending at the U.S. Food and Drug Administration (FDA) targeting branded pharmaceutical products with an estimated $30 billion in sales. The Company also had approximately 230 product registrations, representing 78 molecules, pending with regulatory bodies in Europe and in the ROW.
During the second quarter of 2007, the Company received seven generic product approvals in the U.S. from the FDA, including tentative approvals, and 25 approvals, representing 23 molecules, from regulatory bodies in Europe and in the ROW.
Proprietary Products
The Company currently has an extensive proprietary clinical development program that includes six products in Phase III studies and several New Drug Applications pending at the FDA. During the quarter, the Company received two FDA approvals related to its ENJUVIA(TM) (synthetic conjugated estrogens, B) product.
Selling, General and Administrative
The Company’s SG&A expenses totaled $189 million during the second quarter of 2007, compared to $104 million in the prior year period. SG&A for the first six months of 2007 totaled $370 million, compared to $182 million for the prior year period. The substantial increase in SG&A for the quarter and six months ended June 30, 2007 is primarily attributable to the addition of PLIVA’s sales and marketing activities, including, but not limited to, the costs associated with approximately 1,400 sales representatives that PLIVA utilizes to promote branded generic products to physicians and pharmacists in many countries, and other general and administrative expenses associated with our worldwide operations.
Interest Expense/Income and Other Income
During the second quarter of 2007, the Company recorded $42 million of interest expense, almost all of which is related to interest on the $2.6 billion of debt incurred in connection with the PLIVA acquisition and a one- time bank fee associated with a bridge loan related to the acquisition. The Company recorded $0.3 million of interest expense in the prior year period.
During the second quarter of 2007, interest income increased by $2 million over the prior year period. This increase was primarily related to higher available balances invested during the second quarter of 2007 as compared to the prior year period, in addition to rising interest rates.
Other income in the second quarter of 2007 totaled $3.7 million and included a gain of $3.5 million relating to the unwinding of a treasury lock on a ten-year U.S. Treasury security that was used to hedge forecast interest payments.
Stock-Based Compensation
During the second quarter of 2007, the Company recorded stock-based compensation expenses of $8.1 million, or $0.05 per share. For the first six months of 2007, the Company recorded stock-based compensation expenses of $15.4 million, or $0.10 per share. The impact for the quarter and the six months ended June 30, 2007 is allocated to cost of sales, SG&A and R&D, and is reflected in the accompanying selected adjusted financial data chart.
Tax Rate
The Company’s tax rate for second quarter of 2007 was 35.5%, compared to 34.6% for the prior year period. For the first six months of 2007, the tax rate was 37.1%, compared to 34.9% for the prior year period. The increase in the reported effective tax rate is primarily due to the impact of purchase accounting adjustments related to the PLIVA acquisition, losses incurred in certain legal entities without a tax benefit and additional U.S. taxes related to the PLIVA acquisition. The increase was somewhat offset by benefits realized related to the enactment of the research and development incentive in Croatia, retroactive to the beginning of the tax year, as well as the release of certain FIN 48 tax liabilities related to audit settlements in various tax jurisdictions.
Balance Sheet
The Company’s cash, cash equivalents and marketable securities totaled approximately $767.5 million and its debt totaled $2.5 billion at June 30, 2007.
EBITDA
Earnings before interest, taxes, depreciation and amortization, including amortization of inventory step-up charges (EBITDA), for the second quarter of 2007 totaled $175 million, compared to $130 million in the prior year period. For the first six months of 2007, EBITDA totaled $331 million, compared to $269 million for the prior year period. Please see the reconciliation table at the end of this press release for the calculation of EBITDA.
2007 Financial Outlook
The Company is reiterating that it expects adjusted earnings per fully diluted share for the year ending December 31, 2007 to be in the range of approximately $3.00 - $3.30. The adjustments are discussed in the paragraph immediately below. The Company expects total revenues for 2007 to be in the range of $2.4 - $2.5 billion, including total product sales in the range of $2.3 - $2.4 billion. On the expense side, the Company now expects slightly higher R&D investment of approximately $250 - $255 million, and continues to expect SG&A expenses to be approximately $740 - $760 million.
The Company’s adjusted guidance for 2007 excludes amortization costs associated with acquired products, charges related to the step-up of inventory acquired from PLIVA, contributions from operations that the Company anticipates divesting during 2007, incremental depreciation related to the step-up of PLIVA’s assets, the tax impact related to PLIVA’s U.S. net operating losses and stock-based compensation costs. The Company’s adjusted guidance for 2007 also excludes the impact of potential patent challenge outcomes, other business development activities, and potential refinancing activities that may be completed by December 31, 2007.
Conference Call/Webcast
The Company will host a Conference Call at 8:30 AM Eastern time on Wednesday, August 8th to discuss earnings results for the quarter and six- month period ended June 30, 2007. The number to call from within the United States is: (800) 230-1059 and (612) 234-9960 Internationally. A replay of the conference call will be available from 12 Noon Eastern time on August 8th through 11:59 PM Eastern time August 22nd, and can be accessed by dialing (800) 475-6701 in the United States or (320) 365-3844 Internationally and using the access code 879946.
The conference call will also be webcast live on the Internet. Investors and other interested parties may access the live webcast through the Investors section, under Calendar of Events, on Barr’s website at www.barrlabs.com. Log on at least 15 minutes before the call begins to register and download or install any necessary audio software.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. The Barr
group of companies markets more than 115 generic and 25 proprietary products in the U.S. and more than 1,200 products globally outside of the U.S.
Forward-Looking Statements
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates” and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company’s business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment in the markets where we operate; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies (such as PLIVA d.d.) and products we acquire and implementing our new SAP enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; our expansion into international markets through our PLIVA acquisition, and the resulting currency, governmental, regulatory and other risks involved with international operations; our ability to service our significantly increased debt obligations as a result of the PLIVA acquisition; changes in generally accepted accounting principles; and other risks detailed in our SEC filings, including in our Transition Report on Form 10-K/T for the six months ended December 31, 2006.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Barr Pharmaceuticals, Inc. Selected Financial Data (in thousands, except per share amounts) Three Months Ended Six Months Ended June 30, June 30, 2007 2006 2007 2006 (unaudited) (unaudited) (unaudited) (unaudited) Revenues: Product sales $588,901 $319,619 $1,152,719 $613,140 Alliance and development revenue 36,423 32,049 61,544 65,369 Other revenue 11,626 - 22,065 - Total revenues 636,950 351,668 1,236,328 678,509 Costs and expenses: Cost of sales 277,613 107,328 580,148 205,835 Selling, general and administrative 189,364 104,303 370,229 182,460 Research and development 65,413 36,447 126,637 74,152 Write-off of acquired IPR&D 2,809 - 4,358 - Earnings from operations 101,751 103,590 154,956 216,062 Interest income 8,133 5,734 18,755 9,947 Interest expense 41,798 289 83,567 456 Other income (expense) 3,730 16,690 4,826 17,761 Earnings before income taxes and minority interest 71,816 125,725 94,970 243,314 Income tax expense 25,520 43,471 35,245 84,964 Minority interest (376) - (1,911) - Net earnings from continuing operations 45,920 82,254 57,814 158,350 Loss from discontinued operations, net of taxes (575) - (897) - Net earnings $45,345 $82,254 $56,917 $158,350 Earnings per common share - diluted: Earnings per common share - continuing operations $0.42 $0.76 $0.53 $1.46 Loss per common share - discontinued operations (0.01) - (0.01) - Net earnings per common share - diluted $0.41 $0.76 $0.52 $1.46 Weighted average shares - diluted 108,191 108,084 108,124 108,399 Stock-based compensation expense: Cost of sales $2,319 $1,745 $4,512 $3,757 Selling, general and administrative 4,409 3,230 8,223 6,728 Research and development 1,405 1,290 2,697 2,713 Total stock-based compensation expense $8,133 $6,265 $15,432 $13,198 As of As of Select Balance Sheet Data 6/30/07 12/31/06 Cash & cash equivalents $203,956 $231,975 Marketable securities - Current and long-term 563,565 682,692 Accounts receivable, net 477,080 515,303 Other receivables 68,099 76,491 Inventories, net 457,776 429,592 Accounts payable & accrued liabilities 380,504 425,443 Working capital 879,339 876,106 Total assets 4,808,752 4,961,862 Total debt 2,458,612 2,677,669 Shareholders’ equity 1,604,336 1,465,228
Reconciliation of Adjusted Earnings to GAAP Earnings; EBITDA
To supplement its consolidated financial statements presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), the Company is providing the supplemental financial information contained below to reflect (1) the adjusted earnings per share effect of certain unusual or infrequent charges or benefits that were taken or received in the three and six months ended June 30, 2007, and (2) the calculation of EBITDA for each period presented.
Adjusted earnings per share and EBITDA are non-GAAP financial measures. The Company is providing this information, however, because it believes that such information is useful to both management and investors in that it facilitates analysis by both management and investors in evaluating the Company’s performance and trends. The presentation of this additional information is not meant to be considered in isolation of, or as a substitute for, results prepared in accordance with GAAP.
Barr Pharmaceuticals, Inc. Selected Adjusted Financial Data (in thousands, except per share amounts) Three Months Ended June 30, 2007 Adjusted GAAP Adjustments Earnings Revenues: Product sales $588,901 - $588,901 Alliance and development revenue 36,423 - 36,423 Other revenue 11,626 - 11,626 Total revenues 636,950 - 636,950 Costs and expenses: Cost of sales 277,613 (47,440) (b)(c)(d) 230,173 Selling, general and administrative 189,364 (6,553) (b)(c)(d)(f) 182,811 Research and development 65,413 (1,552) (b)(c)(d) 63,861 Write-off of acquired IPR&D 2,809 (2,809) (e) - Earnings from operations 101,751 58,354 160,105 Interest income 8,133 - 8,133 Interest expense 41,798 - 41,798 Other income, net 3,730 - 3,730 Earnings before income taxes and minority interest 71,816 58,354 741 130,911 Income tax expense 25,520 13,520 (j) 39,040 Minority interest 376 142 14 532 Net earnings from continuing operations 45,920 44,692 727 (a) 91,339 Loss from discontinued operations, net of taxes (575) 575 (k) - Net earnings $45,345 $45,267 $727 $91,339 Basic Earnings per common share - continuing operations $0.43 $0.85 Earnings per common share - discontinued operations $(0.01) $- Net earnings per common share - basic $0.42 $0.85 Weighted average shares - basic 106,909 106,909 Diluted Earnings per common share - continuing operations $0.42 $0.84 Earnings per common share - discontinued operations $(0.01) $- Net earnings per common share - diluted $0.41 $0.84 Weighted average shares - diluted 108,191 108,191 Three Months Ended June 30, 2006 Adjusted GAAP Adjustments Earnings Revenues: Product sales $319,619 $- $319,619 Alliance and development revenue 32,049 - 32,049 Other revenue - - - Total revenues 351,668 - 351,668 Costs and expenses: Cost of sales 107,328 (18,681) (b)(d) 88,647 Selling, general and administrative 104,303 (25,730) (d)(g) 78,573 Research and development 36,447 (1,290) (d) 35,157 Write-off of acquired IPR&D - - - Earnings from operations 103,590 45,701 149,291 Interest income 5,734 - 5,734 Interest expense 289 - 289 Other income, net 16,690 (17,000) (h)(i) (310) Earnings before income taxes and minority interest 125,725 28,701 154,426 Income tax expense 43,471 10,506 (j) 53,977 Minority interest - - - Net earnings from continuing operations 82,254 18,195 100,449 Loss from discontinued operations, net of taxes - - - Net earnings $82,254 $18,195 $100,449 Basic Earnings per common share - continuing operations $0.77 $0.95 Earnings per common share - discontinued operations $- $- Net earnings per common share - basic $0.77 $0.95 Weighted average shares - basic 106,185 106,185 Diluted Earnings per common share - continuing operations $0.76 $0.93 Earnings per common share - discontinued operations $- $- Net earnings per common share - diluted $0.76 $0.93 Weighted average shares - diluted 108,084 108,084 Summary Of Adjustment Items: Three Months Ended June 30, 2007 2006 (a) Net loss from operations expected to be divested, net of minority interest (727) - These businesses are expected to be divested by early 2008. The Company believes adjusting GAAP earnings for these losses will allow investors to better assess our ongoing activities. (b) Amortization and inventory step up adjustments: Cost of sales - Inventory step up - PLIVA (448) - Inventory step up - FEI (8,289) PLIVA-related product amortization (29,040) - Barr product amortization (11,114) (8,647) Subtotal Cost of sales (40,602) (16,936) PLIVA - Selling, general and administrative (281) PLIVA - Research and development (18) - Total (40,901) (16,936) (c) Incremental PLIVA depreciation due to purchase accounting write up of fixed assets: Cost of sales (4,519) - Selling, general and administrative (363) - Research and development (129) - Total (5,011) - (d) Stock option expense: Cost of sales (2,319) (1,745) Selling, general and administrative (4,409) (3,230) Research and development (1,405) (1,290) Total (8,133) (6,265) (e) Write off of acquired IPR&D associated with purchase of PLIVA equity (2,809) - (f) Litigation reserve (1,500) - (g) Litigation settlement - Invamed - (22,500) (h) Unrealized gain on venture fund - 6,700 (i) Foreign currency hedge appreciation - 10,300 (j) Adjustments to tax expense, including: Tax impact of adjustments (A) - (I) above. 16,145 10,506 Tax (benefit) from recognition of acquired NOL (2,625) - Total 13,520 10,506 (k) In order to provide investors and management a basis to evaluate the performance of the ongoing operations, adjusted earnings exclude the impact of discontinued operations Accounted for as discontinued operations 575 - EBITDA Calculation: Three Months Ended June 30, 2007 2006 Earnings from operations $101,751 $103,590 Depreciation 32,838 9,794 Amortization 40,453 8,647 Inventory step up 448 8,289 EBITDA $175,490 $130,320 Barr Pharmaceuticals, Inc. Selected Adjusted Financial Data (in thousands, except per share amounts) Six Months Ended June 30, 2007 Adjusted GAAP Adjustments Earnings Revenues: Product sales $1,15
