EXHIBIT 99.1
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| Media Contact |
| Jeff Richardson |
| 610-738-6126 |
| jcrichard@cephalon.com |
| |
| Investor Contact |
| Chip Merritt |
| 610-738-6376 |
| cmerritt@cephalon.com |
For Immediate Release
Cephalon Reports Outstanding Financial Results for 2004
Revenue Exceeds $1 Billion For the First Time;
Sales Increase 43 Percent;
Earnings Exceed Guidance By 7 Cents;
Cephalon Reiterates 2005 Guidance
West Chester, PA – February 15, 2005 – Cephalon, Inc. [Nasdaq: CEPH] today reported 2004 revenue of $1.0 billion, a 42 percent increase over 2003. Earlier in the year the company recorded charges related to the acquisition of CIMA LABS INC and the exchange or repurchase of Cephalon notes, among other items, that resulted in a diluted loss per share for 2004 of $1.31. Excluding these items and amortization expense, diluted adjusted earnings per share were $2.42, a 31 percent increase over the comparable figure of $1.85 recorded in 2003.
Sales totaled $980.4 million in 2004, compared with 2003 sales of $685.3 million, a 43 percent increase. All three lead products posted outstanding sales increases. In 2004, sales of PROVIGIL® (modafinil) Tablets [C-IV] increased 51 percent to $439.7 million; sales of ACTIQ® (oral transmucosal fentanyl citrate) [C-II] increased 45 percent to $345.0 million; and sales of GABITRIL® (tigabine hydrochloride) Tablets were $94.2 million, a 48 percent increase. Sales of other products totaled $101.5 million in 2004.
Prescribing activity continued its upward trend in 2004 for Cephalon’s flagship products. Total prescriptions for PROVIGIL, ACTIQ, and GABITRIL in the United States increased 37 percent over 2003 and exceeded 3.3 million prescriptions.
—more—
“We have quadrupled sales since 2001, and our accomplishments in 2004 have positioned Cephalon for significant growth ahead,” said Frank Baldino Jr., Ph.D., Chairman and CEO. “We expect to file four NDAs in 14 months. We believe that the success of these four products – ATTENACE®, NUVIGIL®, OraVescent Fentanyl, and GABITRIL® for generalized anxiety disorder – will deliver significant sales and earnings growth for the company in the years ahead.”
For the fourth quarter of 2004, the company reported total revenue of $299.0 million, a 42 percent increase from the fourth quarter of 2003 and sales of $281.4 million, up 39 percent from the same quarter last year. Diluted earnings per share for the fourth quarter of 2004 were $1.23. Excluding amortization expense, and a deferred tax gain resulting from adjustments to tax valuation allowances, diluted adjusted earnings per share were $0.82, which is a 37 percent increase over the comparable figure of $0.60 in the fourth quarter of 2003.
Cephalon is reiterating guidance for 2005 sales of between $1.20-$1.25 billion, which includes PROVIGIL sales of $550-$600 million, ACTIQ sales of $390-$420 million, GABITRIL sales of $110-$120 million, and other product sales of $110-$125 million. Cephalon’s 2005 guidance for diluted adjusted earnings per share is between $2.80 and $2.95. Our guidance does not include amortization expense or the expense related to employee stock option grants, which will be a required expense under GAAP in 2005.
The company is introducing first quarter 2005 sales guidance of $280 to $290 million and diluted adjusted earnings per share of $0.45 to $0.50.
Cephalon’s management will discuss the company’s full-year and fourth quarter 2004 performance in a conference call with investors beginning at 5 p.m. (EST) on Tuesday, February 15, 2005. To participate in the conference call, dial 913-981-5543 and refer to conference code number 492828. Investors can listen to the call live by logging on to the company’s website at www.cephalon.com and clicking on “Investor Relations,” then “Webcast.” The conference call will be archived and available to investors for one week after the call.
Cephalon, Inc.
Cephalon currently employs approximately 2,300 people in the United States and Europe. U.S. sites include the company’s headquarters in West Chester, Pennsylvania, and offices and manufacturing facilities in Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European offices are located in Guildford, England, Martinsried, Germany, and Maisons-Alfort, France.
The company currently markets three proprietary products in the United States: PROVIGIL, GABITRIL, and ACTIQ and more than 20 products internationally. Further information about Cephalon and 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, including our ability to launch four products in the 2006 timeframe, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, including our ability to deliver exceptional growth in the future, yearly and quarterly sales and earnings guidance for 2005, 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 Income (Loss) per Common Share, as adjusted,” “Diluted Income (Loss) Per Common Share, as adjusted,” and “Diluted Adjusted Earnings Per Share Guidance” 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.
Cephalon, Inc. and Subsidiaries
Consolidated Statement of Operations
(Amounts in Thousands, Except per Share)
(Unaudited)
| | Three Months Ended December 31, 2004 | | Three Months Ended December 31, 2003 | |
| | GAAP | | Adjustments | | “Adjusted” | | GAAP | | Adjustments | | “Adjusted” | |
Revenues: | | | | | | | | | | | | | |
Sales | | $ | 281,400 | | | | $ | 281,400 | | $ | 202,505 | | | | $ | 202,505 | |
Other revenues | | 17,599 | | | | 17,599 | | 8,735 | | | | 8,735 | |
| | 298,999 | | — | | 298,999 | | 211,240 | | — | | 211,240 | |
Costs and Expenses: | | | | | | | | | | | | | |
Cost of sales | | 30,374 | | | | 30,374 | | 27,092 | | | | 27,092 | |
Research and development | | 75,764 | | | | 75,764 | | 52,657 | | | | 52,657 | |
Selling, general and administrative | | 95,569 | | | | 95,569 | | 68,632 | | | | 68,632 | |
Depreciation and amortization | | 15,871 | | (11,297 | )(1) | 4,574 | | 11,515 | | (8,303 | )(1) | 3,212 | |
| | 217,578 | | (11,297 | ) | 206,281 | | 159,896 | | (8,303 | ) | 151,593 | |
| | | | | | | | | | | | | |
Income from operations | | 81,421 | | 11,297 | | 92,718 | | 51,344 | | 8,303 | | 59,647 | |
| | | | | | | | | | | | | |
Other Income and Expense: | | | | | | | | | | | | | |
Interest income | | 4,847 | | | | 4,847 | | 3,161 | | | | 3,161 | |
Interest expense | | (5,298 | ) | | | (5,298 | ) | (6,331 | ) | | | (6,331 | ) |
Other income (expense), net | | (2,931 | ) | | | (2,931 | ) | (101 | ) | | | (101 | ) |
| | (3,382 | ) | — | | (3,382 | ) | (3,271 | ) | — | | (3,271 | ) |
| | | | | | | | | | | | | |
Income before income taxes | | 78,039 | | 11,297 | | 89,336 | | 48,073 | | 8,303 | | 56,376 | |
| | | | | | | | | | | | | |
Income tax expense | | 66 | | (38,276 | )(2) | (38,210 | ) | (16,848 | ) | (2,964 | )(2) | (19,812 | ) |
| | | | | | | | | | | | | |
Net Income (loss) | | $ | 78,105 | | $ | (26,979 | ) | $ | 51,126 | | $ | 31,225 | | $ | 5,339 | | $ | 36,564 | |
| | | | | | | | | | | | | |
Basic income per common share * | | $ | 1.35 | | | | $ | 0.89 | | $ | 0.55 | | | | $ | 0.65 | |
| | | | | | | | | | | | | |
Diluted income per common share * | | $ | 1.23 | | | | $ | 0.82 | | $ | 0.51 | | | | $ | 0.60 | |
| | | | | | | | | | | | | |
Weighted average number of common shares outstanding | | 57,754 | | | | 57,754 | | 55,706 | | | | 55,706 | |
| | | | | | | | | | | | | |
Weighted average number of common shares outstanding-assuming dilution | | 64,889 | | | | 64,889 | | 64,162 | | | | 64,162 | |
| | | | | | | | | | | | | | | | | | | | | |
* Prior period EPS shown is restated for adoption of guidance from EITF 03-6 and EITF 04-8.
Cephalon, Inc. and Subsidiaries
Notes to Reconciliation of GAAP Net Income to “Adjusted” Net Income
Three Months Ended December 31, 2004 and December 31, 2003
(1) To exclude the ongoing amortization of acquired intangible assets including technology, trademark and marketing rights acquired from Group Lafon and CIMA LABS INC., Gabitril marketing rights, Actiq marketing rights, and product marketing rights acquired in conjunction with our Novartis collaboration.
(2) To reflect the tax effect of adjustments at the applicable tax rates. Fourth quarter adjustments include the impact of tax benefits due to the reassessment of the realizability of deferred tax assets and an adjustment for the recognition of a tax benefit on the write-off of our investment in MDS Proteomics, Inc.
Cephalon, Inc. and Subsidiaries
Consolidated Statement of Operations
(Amounts in Thousands, Except per Share)
(Unaudited)
| | Year Ended December 31, 2004 | | Year Ended December 31, 2003 | |
| | GAAP | | Adjustments | | “Adjusted” | | GAAP | | Adjustments | | “Adjusted” | |
Revenues: | | | | | | | | | | | | | |
Sales | | $ | 980,375 | | | | $ | 980,375 | | $ | 685,250 | | | | $ | 685,250 | |
Other revenues | | 35,050 | | | | 35,050 | | 29,557 | | | | 29,557 | |
| | 1,015,425 | | — | | 1,015,425 | | 714,807 | | — | | 714,807 | |
Costs and Expenses: | | | | | | | | | | | | | |
Cost of sales | | 119,973 | | | | 119,973 | | 92,375 | | | | 92,375 | |
Research and development | | 273,972 | | | | 273,972 | | 168,222 | | | | 168,222 | |
Selling, general and administrative | | 339,477 | | 4,214 | (3) | 343,691 | | 254,088 | | | | 254,088 | |
Depreciation and amortization | | 52,798 | | (37,753 | )(1) | 15,045 | | 44,073 | | (33,054 | )(1) | 11,019 | |
Impairment charge on investment in MDS Proteomics Inc. | | 30,071 | | (30,071 | )(4) | — | | — | | | | — | |
Acquired in-process research and development | | 185,700 | | (185,700 | )(5) | — | | — | | | | — | |
| | 1,001,991 | | (249,310 | ) | 752,681 | | 558,758 | | (33,054 | ) | 525,704 | |
| | | | | | | | | | | | | |
Income from operations | | 13,434 | | 249,310 | | 262,744 | | 156,049 | | 33,054 | | 189,103 | |
| | | | | | | | | | | | | |
Other Income and Expense: | | | | | | | | | | | | | |
Interest income | | 16,486 | | | | 16,486 | | 11,298 | | | | 11,298 | |
Interest expense | | (22,186 | ) | | | (22,186 | ) | (28,905 | ) | | | (28,905 | ) |
Debt exchange expense | | (28,230 | ) | 28,230 | (6) | — | | — | | | | — | |
Charge on early extinguishment of debt | | (2,313 | ) | 2,313 | (7) | — | | (9,816 | ) | 9,816 | (7) | — | |
Other income (expense), net | | (5,375 | ) | | | (5,375 | ) | 1,688 | | | | 1,688 | |
| | (41,618 | ) | 30,543 | | (11,075 | ) | (25,735 | ) | 9,816 | | (15,919 | ) |
| | | | | | | | | | | | | |
Income (loss) before income taxes | | (28,184 | ) | 279,853 | | 251,669 | | 130,314 | | 42,870 | | 173,184 | |
| | | | | | | | | | | | | |
Income tax expense | | (45,629 | ) | (56,737 | )(2) | (102,366 | ) | (46,456 | ) | (15,305 | )(2) | (61,761 | ) |
| | | | | | | | | | | | | |
Net Income (loss) | | $ | (73,813 | ) | $ | 223,116 | | $ | 149,303 | | $ | 83,858 | | $ | 27,565 | | $ | 111,423 | |
| | | | | | | | | | | | | |
Basic income (loss) per common share * | | $ | (1.31 | ) | | | $ | 2.63 | | $ | 1.49 | | | | $ | 1.98 | |
| | | | | | | | | | | | | |
Diluted income (loss) per common share * | | $ | (1.31 | ) | | | $ | 2.42 | | $ | 1.42 | | | | $ | 1.85 | |
| | | | | | | | | | | | | |
Weighted average number of common shares outstanding | | 56,489 | | | | 56,489 | | 55,560 | | | | 55,560 | |
| | | | | | | | | | | | | |
Weighted average number of common shares outstanding-assuming dilution | | 56,489 | | | | 64,358 | | 64,076 | | | | 64,076 | |
| | | | | | | | | | | | | | | | | | | | | |
* Prior period EPS shown is restated for adoption of guidance from EITF 03-6 and EITF 04-8.
Cephalon, Inc. and Subsidiaries
Notes to Reconciliation of GAAP Net Income (Loss) to “Adjusted” Net Income
Years Ended December 31, 2004 and December 31, 2003
(1) To exclude the ongoing amortization of acquired intangible assets including technology, trademark and marketing rights acquired from Group Lafon and CIMA LABS INC., Gabitril marketing rights, Actiq marketing rights, and product marketing rights acquired in conjunction with our Novartis collaboration.
(2) To reflect the tax effect of adjustments at the applicable tax rates and the impact of tax benefits due to the reassessment of the realizability of deferred tax assets.
(3) To exclude the gain resulting from the cancellation of postretirement health care benefits for current employees at Cephalon France.
(4) To exclude the impairment charge for the write-off of our investment in MDS Proteomics, Inc.
(5) To exclude the write-off of in-process research and development associated with the acquisition of CIMA LABS INC.
(6) To exclude the expense associated with the exchange of $78.3 million of Cephalon’s 2.5% Convertible Subordinated Notes into common stock.
(7) To exclude the charge on early extinguishment of debt in 2004 related to the repurchase of $33 million and $10 million of our 3.875% Convertible Subordinated Notes in August and March 2004, respectively. To exclude the charge on early extinguishment of debt in 2003 related to the redemption of $174 million of our 5.25% Convertible Subordinated Notes and the repurchase of $12 million of our 3.875% Convertible Subordinated Notes in July 2003.
Cephalon, Inc. and Subsidiaries
Consolidated Sales Detail
(Amounts in Thousands)
(Unaudited)
| | Three Months Ended December 31, | | % Increase | |
| | 2004 | | 2003 | | (Decrease) | |
| | United States | | Europe | | Total | | United States | | Europe | | Total | | United States | | Europe | | Total | |
Sales: | | | | | | | | | | | | | | | | | | | |
Provigil | | $ | 130,167 | | $ | 10,208 | | $ | 140,375 | | $ | 78,038 | | $ | 7,370 | | $ | 85,408 | | 67 | % | 39 | % | 64 | % |
Actiq | | 83,942 | | 2,575 | | 86,517 | | 71,854 | | 1,297 | | 73,151 | | 17 | % | 99 | % | 18 | % |
Gabitril | | 19,976 | | 2,156 | | 22,132 | | 17,984 | | 1,242 | | 19,226 | | 11 | % | 74 | % | 15 | % |
Other | | 8,046 | | 24,330 | | 32,376 | | — | | 24,720 | | 24,720 | | — | | (2 | )% | 31 | % |
| | | | | | | | | | | | | | | | | | | |
| | $ | 242,131 | | $ | 39,269 | | $ | 281,400 | | $ | 167,876 | | $ | 34,629 | | $ | 202,505 | | 44 | % | 13 | % | 39 | % |
| | | | | | | | | | | | | | | | | | | |
| | Year Ended December 31, | | % Increase | |
| | 2004 | | 2003 | | (Decrease) | |
| | United States | | Europe | | Total | | United States | | Europe | | Total | | United States | | Europe | | Total | |
Sales: | | | | | | | | | | | | | | | | | | | |
Provigil | | $ | 406,238 | | $ | 33,429 | | $ | 439,667 | | $ | 264,324 | | $ | 26,141 | | $ | 290,465 | | 54 | % | 28 | % | 51 | % |
Actiq | | 337,072 | | 7,925 | | 344,997 | | 234,111 | | 3,356 | | 237,467 | | 44 | % | 136 | % | 45 | % |
Gabitril | | 87,349 | | 6,815 | | 94,164 | | 57,774 | | 5,925 | | 63,699 | | 51 | % | 15 | % | 48 | % |
Other | | 13,270 | | 88,277 | | 101,547 | | — | | 93,619 | | 93,619 | | — | | (6 | )% | 8 | % |
| | | | | | | | | | | | | | | | | | | |
| | $ | 843,929 | | $ | 136,446 | | $ | 980,375 | | $ | 556,209 | | $ | 129,041 | | $ | 685,250 | | 52 | % | 6 | % | 43 | % |
Cephalon, Inc. and Subsidiaries
Consolidated Balance Sheets
(Amounts in Thousands)
(Unaudited)
| | December 31 2004, | | December 31, 2003 | |
CURRENT ASSETS: | | | | | |
Cash and cash equivalents | | $ | 574,244 | | $ | 1,115,699 | |
Investments | | 217,432 | | 39,464 | |
Receivables, net | | 203,594 | | 86,348 | |
Inventory, net | | 86,629 | | 61,249 | |
Deferred tax asset | | 65,302 | | 57,972 | |
Other current assets | | 32,819 | | 9,198 | |
Total current assets | | 1,180,020 | | 1,369,930 | |
| | | | | |
Property and equipment, net | | 244,834 | | 126,442 | |
Goodwill | | 372,534 | | 298,769 | |
Other intangible assets, net | | 449,402 | | 326,445 | |
Debt issuance costs, net | | 25,401 | | 35,250 | |
Deferred tax asset, net | | 145,436 | | 168,506 | |
Other assets | | 22,549 | | 56,314 | |
| | $ | 2,440,176 | | $ | 2,381,656 | |
| | | | | |
CURRENT LIABILITIES: | | | | | |
Current portion of long-term debt | | $ | 5,114 | | $ | 9,637 | |
Accounts payable | | 52,488 | | 28,591 | |
Accrued expenses | | 157,841 | | 99,038 | |
Current portion of deferred revenues | | 868 | | 422 | |
Total current liabilities | | 216,311 | | 137,688 | |
| | | | | |
Long-term debt | | 1,284,410 | | 1,409,417 | |
Deferred revenues | | 1,769 | | 1,736 | |
Deferred tax liabilities | | 94,100 | | 45,665 | |
Other liabilities | | 13,542 | | 16,780 | |
Total liabilities | | 1,610,132 | | 1,611,286 | |
| | | | | |
STOCKHOLDERS’ EQUITY: | | | | | |
Common stock, $0.01 par value | | 580 | | 558 | |
Additional paid-in capital | | 1,172,499 | | 1,052,059 | |
Treasury stock, at cost | | (14,860 | ) | (13,692 | ) |
Accumulated deficit | | (395,118 | ) | (321,305 | ) |
Accumulated other comprehensive income | | 66,943 | | 52,750 | |
Total stockholders’ equity | | 830,044 | | 770,370 | |
| | $ | 2,440,176 | | $ | 2,381,656 | |
Cephalon, Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(Amounts in Thousands)
(Unaudited)
| | Year Ended December 31, | |
| | 2004 | | 2003 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | | | | | |
Net (loss) income | | $ | (73,813 | ) | $ | 83,858 | |
Adjustments to reconcile net (loss) income to net cash provided by operating activities: | | | | | |
Deferred income tax expense | | 37,598 | | 32,437 | |
Tax benefit from exercise of stock options | | 9,205 | | 944 | |
Debt exchange expense | | 28,230 | | — | |
Tax effect on debt exchange | | (11,288 | ) | — | |
Depreciation and amortization | | 59,016 | | 45,135 | |
Amortization of debt issuance costs | | 8,275 | | 7,602 | |
Stock-based compensation expense | | 5,372 | | 2,224 | |
Non-cash charge on early extinguishment of debt | | 2,313 | | 3,615 | |
Pension curtailment | | (4,214 | ) | — | |
Loss on disposals of property and equipment | | 1,423 | | — | |
Impairment charge | | 30,071 | | — | |
Acquired in-process research and development | | 185,700 | | — | |
Increase (decrease) in cash due to changes in assets and liabilities, net of effect from acquisition: | | | | | |
Receivables | | (103,672 | ) | 4,691 | |
Inventory | | (16,699 | ) | (1,691 | ) |
Other assets | | (20,318 | ) | 7,741 | |
Accounts payable, accrued expenses and deferred revenues | | 47,550 | | 17,477 | |
Other liabilities | | 1,788 | | (3,792 | ) |
| | | | | |
Net cash provided by operating activities | | 186,537 | | 200,241 | |
| | | | | |
CASH FLOWS FROM INVESTING ACTIVITIES: | | | | | |
Purchases of property and equipment | | (50,244 | ) | (40,453 | ) |
Investments in non-marketable securities | | — | | (32,975 | ) |
Acquisition of CIMA, net of cash acquired | | (482,521 | ) | | |
Acquisition of intangible assets | | (53,704 | ) | — | |
Sales and (purchases) of investments, net | | (106,678 | ) | 55,836 | |
| | | | | |
Net cash used for investing activities | | (693,147 | ) | (17,592 | ) |
| | | | | |
CASH FLOWS FROM FINANCING ACTIVITIES: | | | | | |
Proceeds from exercises of common stock options | | 12,051 | | 4,528 | |
Acquisition of treasury stock | | (1,168 | ) | (1,703 | ) |
Principal payments on and retirements of long-term debt | | (51,905 | ) | (211,714 | ) |
Net proceeds from issuance of convertible subordinated notes | | — | | 727,085 | |
Proceeds from sale of warrants | | — | | 178,315 | |
Purchase of Convertible Hedge | | — | | (258,584 | ) |
| | | | | |
Net cash provided by (used for) financing activities | | (41,022 | ) | 437,927 | |
| | | | | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | | 6,177 | | 9,026 | |
| | | | | |
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | (541,455 | ) | 629,602 | |
| | | | | |
CASH AND CASH EQUIVALENTS, BEGINNING OF YEAR | | 1,115,699 | | 486,097 | |
| | | | | |
CASH AND CASH EQUIVALENTS, END OF YEAR | | $ | 574,244 | | $ | 1,115,699 | |
Cephalon, Inc. and Subsidiaries
Reconciliation of Projected GAAP Diluted Earnings per Share to Diluted Adjusted Earnings Per Share Guidance
(Unaudited)
| | Three Months Ended March 31, 2005 | | Twelve Months Ended December 31, 2005 | |
Projected GAAP diluted earnings per share | | $0.32 - $0.37 | | $2.29 - $2.44 | |
| | | | | |
Amortization of current intangibles | | $ | 0.20 | | $ | 0.81 | |
Tax benefit on adjustments | | $ | (0.07 | ) | $ | (0.30 | ) |
| | | | | |
Diluted adjusted earnings per share guidance | | $0.45 - $0.50 | | $2.80 - $2.95 | |
Note: Guidance does not include the effect of SFAS 123R, “Share-Based Payments”, which becomes effective July 1, 2005.