Exhibit 99.1
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| | News |
| | |
| Contacts: |
| Media: |
| Sheryl Williams |
| 610.738.6493 |
| swilliam@cephalon.com |
| |
| Investors: |
| Robert (Chip) Merritt |
| 610.738.6376 |
| cmerritt@cephalon.com |
Cephalon Reports Strong First Quarter Earnings
AMRIX Growing Rapidly
TREANDA Successfully Launched in April
Frazer, Pa. – May 1, 2008 – Cephalon, Inc. (Nasdaq: CEPH) today reported first quarter 2008 sales of $433.9 million, compared to sales of $423.9 million for the first quarter 2007 and the company’s sales guidance of $435 - $445 million. Basic income per common share for the quarter was $0.57. Excluding amortization expense and certain other items, basic adjusted income per common share for the quarter was $1.12, compared to $1.45 for the same period in 2007 and the company’s earnings guidance range of $1.00 to $1.10.
Central nervous system (CNS) franchise sales were $226.7 million during the quarter, a 4 percent increase compared to the same period last year. Pain franchise reported strong sales of $125.7 million, a decrease of only 4 percent versus 2007, with sales of AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) and FENTORA® (fentanyl buccal tablet) [C-II] largely offsetting the continued generic erosion of ACTIQ® (oral transmucosal fentanyl citrate) [C-II]. Oncology franchise sales were $27.5 million and do not include sales of TREANDA® (bendamustine hydrochloride), which was launched in April.
“We are receiving overwhelmingly positive feedback from the TREANDA launch,” said Frank Baldino, Jr., Ph.D., Chairman and CEO. “In addition, prescriptions for AMRIX doubled compared to last quarter as acceptance of this product in the market continues to grow. These two products will continue to drive Cephalon sales growth.”
SOURCE: Cephalon, Inc. · 41 Moores Road · Frazer, PA 19355 · (610) 344-0200 · Fax (610) 344-0065
The company is updating its guidance for 2008. Total sales guidance is $1.83-$1.88 billion. This includes CNS franchise sales of $975-$1,000 million, pain franchise sales of $500-$525 million, oncology franchise sales of $125-$150 million, and other product sales of $200-$225 million. Full year SG&A and R&D guidance is $740-$760 million and $340-$360 million, respectively. Adjusted net income guidance is $346-$353 million and basic adjusted income per common share guidance is $5.10-$5.20.
For the second quarter of 2008, Cephalon is introducing sales guidance of $455-$465 million, adjusted net income guidance of $74.6-$81.4 million and basic adjusted income per common share guidance of $1.10-$1.20.
Basic adjusted income per common share guidance for both the second quarter 2008 and full-year 2008 is reconciled below and is subject to the assumptions set forth therein.
Cephalon’s management will discuss the company’s second quarter 2008 performance in a conference call with investors beginning at 5:00 p.m. U.S. EDT today. To participate in the conference call, dial +1-913-981-5581 and refer to conference code number 7561641. Investors can listen to the call live by logging on to the company’s website at www.cephalon.com and clicking on “Investor Information,” then “Webcast.” The conference call will be archived and available to investors for one week after the call.
About Cephalon, Inc.
Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. A member of the Fortune 1000, Cephalon currently employs close to 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France.
The company’s proprietary products in the United States include: PROVIGIL® (modafinil) Tablets [C-IV], FENTORA, TRISENOX® (arsenic trioxide), AMRIX, TREANDA, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), and ACTIQ. The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Cephalon’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs; development of potential pharmaceutical products; interpretation of clinical results; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products, including the growth and acceptance of Amrix in the market and the relative success of the
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recent launch of Treanda; sales, adjusted net income and basic adjusted income per common share guidance for the second quarter and full-year 2008 and SG&A and R&D guidance for the full-year 2008; and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law. The Private Securities Litigation Reform Act of 1995 permits this discussion.
This press release and/or the financial results attached to this press release include “Adjusted Net Income,” “Basic Adjusted Income per Common Share,” “Adjusted Net Income Guidance,” “Basic Adjusted Income per Common Share Guidance,” and “Diluted Adjusted Income Per Common Share,” amounts that are considered “non-GAAP financial measures” under SEC rules. As required, we have provided reconciliations of these measures. Additional required information is located in the Form 8-K furnished to the SEC in connection with this press release.
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CEPHALON, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
(Unaudited)
| | Three Months Ended | |
| | March 31, | |
| | 2008 | | 2007 | |
REVENUES: | | | | | |
Sales | | $ | 433,897 | | $ | 423,879 | |
Other revenues | | 9,322 | | 13,155 | |
| | 443,219 | | 437,034 | |
COSTS AND EXPENSES: | | | | | |
Cost of sales | | 89,916 | | 86,546 | |
Research and development | | 81,435 | | 83,958 | |
Selling, general and administrative | | 198,984 | | 152,454 | |
Restructuring charges | | 3,911 | | — | |
Acquired in-process research and development | | 10,000 | | — | |
| | 384,246 | | 322,958 | |
| | | | | |
INCOME FROM OPERATIONS | | 58,973 | | 114,076 | |
| | | | | |
OTHER INCOME (EXPENSE): | | | | | |
Interest income | | 6,601 | | 6,576 | |
Interest expense | | (8,994 | ) | (4,595 | ) |
Other income, net | | 5,315 | | 2,756 | |
| | 2,922 | | 4,737 | |
| | | | | |
INCOME BEFORE INCOME TAXES | | 61,895 | | 118,813 | |
| | | | | |
INCOME TAX EXPENSE | | 23,044 | | 43,628 | |
| | | | | |
NET INCOME | | $ | 38,851 | | $ | 75,185 | |
| | | | | |
BASIC INCOME PER COMMON SHARE | | $ | 0.57 | | $ | 1.14 | |
| | | | | |
DILUTED INCOME PER COMMON SHARE | | $ | 0.52 | | $ | 0.99 | |
| | | | | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | | 67,665 | | 65,806 | |
| | | | | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION | | 74,286 | | 75,835 | |
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CEPHALON, INC. AND SUBSIDIARIES
Reconciliation of GAAP Net Income to Adjusted Net Income
(Unaudited)
| | Three Months Ended | |
| | March 31, | |
| | 2008 | | 2007 | |
| | | | | |
GAAP NET INCOME | | $ | 38,851 | | $ | 75,185 | |
| | | | | |
Cost of sales adjustments | | 27,888 | (1) | 20,965 | (1) |
Research and development adjustments | | 7,754 | (2) | 10,000 | (2) |
Selling, general and administrative adjustments | | 2,955 | (3) | — | |
In-process research and development adjustments | | 10,000 | (4) | — | |
Restructuring adjustments | | 3,911 | (5) | — | |
Interest expense adjustment | | 3,750 | (6) | — | |
Income tax adjustment | | (19,515 | )(7) | (10,982 | )(7) |
| | 36,743 | | 19,983 | |
| | | | | |
ADJUSTED NET INCOME | | $ | 75,594 | | $ | 95,168 | |
| | | | | |
BASIC ADJUSTED INCOME PER COMMON SHARE | | $ | 1.12 | | $ | 1.45 | |
| | | | | |
DILUTED ADJUSTED INCOME PER COMMON SHARE | | $ | 1.02 | | $ | 1.25 | |
| | | | | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | | 67,665 | | 65,806 | |
| | | | | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING-ASSUMING DILUTION | | 74,286 | | 75,835 | |
Notes to Reconciliation of GAAP Net Income to Adjusted Net Income
(1) | | To exclude the on-going amortization of acquired intangible assets ($26.2M in 2008; $21.0M in 2007) and accelerated depreciation related to restructuring ($1.7M in 2008). |
| | |
(2) | | To exclude charges related to payment for research and development collaboration, as well as other charges ($1.8M) related to severance in 2008. |
| | |
(3) | | To exclude charges related to employee severance costs. |
| | |
(4) | | To exclude charges related to the acquisition of the licensed technology in the oncology field. |
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(5) | | To exclude costs related to CIMA restructuring. |
| | |
(6) | | To exclude an estimate of accrued interest related to the agreement in principle reached with U.S. Attorney's Office in Philadelphia. |
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(7) | | To reflect the tax effect of pre-tax adjustments at the applicable tax rates and certain other tax adjustments primarily related to changes in valuation allowances and other changes in tax assets and liabilities. |
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CEPHALON, INC. AND SUBSIDIARIES
CONSOLIDATED SALES DETAIL
(In thousands)
(Unaudited)
| | Three Months Ended | | % | |
| | March 31, | | Increase | |
| | 2008 | | 2007 | | (Decrease) | |
| | United States | | Europe | | Total | | United States | | Europe | | Total | | United States | | Europe | | Total | |
Sales: | | | | | | | | | | | | | | | | | | | |
PROVIGIL | | $ | 198,469 | | $ | 14,766 | | $ | 213,235 | | $ | 188,727 | | $ | 12,562 | | $ | 201,289 | | 5 | % | 18 | % | 6 | % |
GABITRIL | | 11,131 | | 2,293 | | 13,424 | | 13,884 | | 2,336 | | 16,220 | | (20 | )% | (2 | )% | (17 | )% |
CNS | | 209,600 | | 17,059 | | 226,659 | | 202,611 | | 14,898 | | 217,509 | | 3 | % | 15 | % | 4 | % |
| | | | | | | | | | | | | | | | | | | |
ACTIQ | | 37,517 | | 12,203 | | 49,720 | | 57,157 | | 8,571 | | 65,728 | | (34 | )% | 42 | % | (24 | )% |
Generic OTFC | | 27,318 | | — | | 27,318 | | 34,020 | | — | | 34,020 | | (20 | )% | 0 | % | (20 | )% |
FENTORA | | 38,933 | | — | | 38,933 | | 31,690 | | — | | 31,690 | | 23 | % | 0 | % | 23 | % |
AMRIX | | 9,768 | | — | | 9,768 | | — | | — | | — | | 100 | % | 0 | % | 100 | % |
Pain | | 113,536 | | 12,203 | | 125,739 | | 122,867 | | 8,571 | | 131,438 | | (8 | )% | 42 | % | (4 | )% |
| | | | | | | | | | | | | | | | | | | |
Oncology | | 5,188 | | 22,270 | | 27,458 | | 3,991 | | 19,290 | | 23,281 | | 30 | % | 15 | % | 18 | % |
| | | | | | | | | | | | | | | | | | | |
Other | | 13,527 | | 40,514 | | 54,041 | | 13,181 | | 38,470 | | 51,651 | | 3 | % | 5 | % | 5 | % |
| | | | | | | | | | | | | | | | | | | |
| | $ | 341,851 | | $ | 92,046 | | $ | 433,897 | | $ | 342,650 | | $ | 81,229 | | $ | 423,879 | | (0 | )% | 13 | % | 2 | % |
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CEPHALON, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except share data)
(Unaudited)
| | March 31, | | December 31, | |
| | 2008 | | 2007 | |
CURRENT ASSETS: | | | | | |
Cash and cash equivalents | | $ | 855,846 | | $ | 818,669 | |
Investments | | — | | 7,596 | |
Receivables, net | | 295,035 | | 276,776 | |
Inventory, net | | 117,726 | | 99,098 | |
Deferred tax assets, net | | 150,456 | | 176,619 | |
Other current assets | | 41,828 | | 43,267 | |
Total current assets | | 1,460,891 | | 1,422,025 | |
| | | | | |
PROPERTY AND EQUIPMENT, net | | 509,933 | | 500,396 | |
GOODWILL | | 486,865 | | 476,515 | |
INTANGIBLE ASSETS, net | | 822,342 | | 817,828 | |
DEFERRED TAX ASSETS, net | | 172,162 | | 141,752 | |
OTHER ASSETS | | 155,227 | | 147,753 | |
| | $ | 3,607,420 | | $ | 3,506,269 | |
| | | | | |
CURRENT LIABILITIES: | | | | | |
Current portion of long-term debt | | $ | 1,037,163 | | $ | 1,237,169 | |
Accounts payable | | 94,547 | | 91,437 | |
Accrued expenses | | 665,746 | | 677,184 | |
Total current liabilities | | 1,797,456 | | 2,005,790 | |
| | | | | |
LONG-TERM DEBT | | 203,317 | | 3,788 | |
DEFERRED TAX LIABILITIES, net | | 75,860 | | 56,540 | |
OTHER LIABILITIES | | 143,020 | | 138,084 | |
Total liabilities | | 2,219,653 | | 2,204,202 | |
| | | | | |
STOCKHOLDERS’ EQUITY: | | | | | |
Common stock, $0.01 par value | | 701 | | 700 | |
Additional paid-in capital | | 1,951,294 | | 1,934,965 | |
Treasury stock, at cost | | (158,197 | ) | (158,173 | ) |
Accumulated deficit | | (585,277 | ) | (624,128 | ) |
Accumulated other comprehensive income | | 179,246 | | 148,703 | |
Total stockholders’ equity | | 1,387,767 | | 1,302,067 | |
| | $ | 3,607,420 | | $ | 3,506,269 | |
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CEPHALON, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
| | Three Months Ended | |
| | March 31, | |
| | 2008 | | 2007 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | | | | | |
Net income | | $ | 38,851 | | $ | 75,185 | |
Adjustments to reconcile net income to net cash provided by operating activities: | | | | | |
Deferred income tax expense | | 6,141 | | 11,629 | |
Shortfall tax benefits from stock-based compensation | | — | | (83 | ) |
Depreciation and amortization | | 41,577 | | 30,592 | |
Amortization of debt issuance costs | | 60 | | 60 | |
Stock-based compensation expense | | 10,950 | | 11,699 | |
Loss on disposals of property and equipment | | 252 | | — | |
Changes in operating assets and liabilities: | | | | | |
Receivables | | (11,126 | ) | (36,850 | ) |
Inventory | | (9,567 | ) | (14,585 | ) |
Other assets | | (7,961 | ) | (12,523 | ) |
Accounts payable, accrued expenses and deferred revenues | | (18,572 | ) | (9,160 | ) |
Other liabilities | | 13,639 | | 2,584 | |
Net cash provided by operating activities | | 64,244 | | 58,548 | |
| | | | | |
CASH FLOWS FROM INVESTING ACTIVITIES: | | | | | |
Purchases of property and equipment | | (18,295 | ) | (21,384 | ) |
Acquisition of intangible assets | | (25,046 | ) | — | |
Sales and maturities of available-for-sale investments | | 7,596 | | 18,023 | |
Purchases of available-for-sale investments | | — | | (4,786 | ) |
Net cash used for investing activities | | (35,745 | ) | (8,147 | ) |
| | | | | |
CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | |
Proceeds from exercises of common stock options | | 5,277 | | 17,479 | |
Windfall tax benefits from stock-based compensation | | 234 | | 1,431 | |
Acquisition of treasury stock | | (24 | ) | (128 | ) |
Payments on and retirements of long-term debt | | (1,029 | ) | (953 | ) |
Net cash provided by financing activities | | 4,458 | | 17,829 | |
| | | | | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | | 4,220 | | 2,688 | |
| | | | | |
NET INCREASE IN CASH AND CASH EQUIVALENTS | | 37,177 | | 70,918 | |
| | | | | |
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | | 818,669 | | 496,512 | |
| | | | | |
CASH AND CASH EQUIVALENTS, END OF PERIOD | | $ | 855,846 | | $ | 567,430 | |
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CEPHALON, INC. AND SUBSIDIARIES
Reconciliation of Projected GAAP Basic Income per Common Share
to Basic Adjusted Income Per Common Share Guidance
(Unaudited)
| | Three Months Ended | | Twelve Months Ended | |
| | June 30, 2008 | | December 31, 2008 | |
| | | | | | | | | | | | | |
Projected GAAP basic income per common share | | $ | 0.81 | | — | | $ | 0.91 | | $ | 3.75 | | — | | $ | 3.85 | |
| | | | | | | | | | | | | |
Amortization of current intangibles | | $ | 0.40 | | — | | $ | 0.40 | | $ | 1.58 | | — | | $ | 1.58 | |
Accelerated depreciation adjustment | | $ | 0.03 | | — | | $ | 0.03 | | $ | 0.10 | | — | | $ | 0.10 | |
Research and development adjustments | | $ | — | | — | | $ | — | | $ | 0.11 | | — | | $ | 0.11 | |
Selling, general and administrative adjustments | | $ | — | | — | | $ | — | | $ | 0.04 | | — | | $ | 0.04 | |
In-process research and development adjustment | | $ | — | | — | | $ | — | | $ | 0.15 | | — | | $ | 0.15 | |
Restructuring adjustments | | $ | 0.02 | | — | | $ | 0.02 | | $ | 0.10 | | — | | $ | 0.10 | |
Interest expense adjustment | | $ | — | | — | | $ | — | | $ | 0.06 | | — | | $ | 0.06 | |
| | | | | | | | | | | | | |
Tax effect of pre-tax adjustments at the applicable tax rates | | $ | (0.16 | ) | — | | $ | (0.16 | ) | $ | (0.79 | ) | — | | $ | (0.79 | ) |
| | | | | | | | | | | | | |
Basic adjusted income per common share guidance | | $ | 1.10 | | — | | $ | 1.20 | | $ | 5.10 | | — | | $ | 5.20 | |
The company’s guidance is being issued based on certain assumptions including:
· Entrance into the market of an additional generic version of ACTIQ in the second half of 2008;
· Adjusted effective tax rate of approximately 36 to 37 percent; and
· Weighted average number of common shares outstanding of 67.8 million shares for the three months ended June 30, 2008 and for the twelve months ended December 31, 2008, respectively.
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