TREANDA and AMRIX Lead Sales Growth of 19 Percent over First Quarter 2008
Oncology Sales Climb 179 Percent to Reach 15 Percent of Total Sales
Success in Business Development and Research & Development Bolster Pipeline
NUVIGIL OSA Comorbid Major Depressive Disorder Study is Positive
FRAZER, Pa., May 5 /PRNewswire-FirstCall/ -- Cephalon, Inc. today reported first quarter 2009 sales of $514.4 million, compared to sales of $433.9 million for the first quarter 2008 and the company’s sales guidance of $510 - $530 million. Basic income per common share for the quarter was $0.85. Excluding amortization expense and certain other items, basic adjusted income per common share for the quarter was $1.47, an increase of 31 percent over the comparable figure of $1.12 for the same period in 2008. This exceeded the company’s earnings guidance range of $1.30 to $1.40.
Central nervous system (CNS) franchise sales were $269.6 million during the quarter, a 19 percent increase compared to the same period last year. Pain franchise reported sales of $122.2 million, a 3 percent decrease versus first quarter 2008, with growing sales of AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules) largely offsetting the continued generic erosion of the company’s fentanyl-based products. Oncology franchise sales were $76.6 million, a 179 percent increase over the same period last year due to the strong launch of TREANDA(R) (bendamustine hydrochloride) that began in April 2008.
During the quarter the company announced three transactions. The first was an option agreement to acquire Ception Therapeutics and its lead product candidate reslizumab for the treatment of pediatric eosinophilic esophagitis and eosinophilic asthma in adults. The second was the exercise of an option to license worldwide rights to ImmuPharma’s product, Lupuzor(TM), for the treatment of Systemic Lupus Erythematosus. The third was the launch of a takeover offer for Australian biotechnology company Arana Therapeutics, and its pipeline of biologic compounds for inflammatory diseases and cancer.
The company also recently obtained statistically significant results from three clinical trials studying NUVIGIL(R) (armodafinil) Tablets [C-IV]. The Phase 4 study of NUVIGIL in obstructive sleep apnea (OSA) patients with comorbid depression was positive. In addition the company previously announced positive results from a Phase 2 clinical trial of NUVIGIL as adjunctive therapy for treating major depressive disorder in adults with bipolar I disorder and its plan to advance to Phase 3 clinical trials for this indication. The company also announced positive results from a Phase 3 clinical trial of NUVIGIL as a treatment of excessive sleepiness associated with jet lag disorder and its plan to file a supplemental new drug application with the FDA during the third quarter of 2009 for this indication.
“While the economy and various healthcare reform proposals create uncertainty for investors, we are taking steps to continue to build a world class biopharmaceutical company,” said Frank Baldino, Jr., Ph.D., Chairman and CEO. “In the short run, AMRIX and TREANDA will supply growth. Longer term, we expect that our recent business development transactions will enable us to create a new franchise in inflammatory diseases and our clinical development work with NUVIGIL will allow it to reach new markets.”
The company is updating its guidance for 2009. Total sales guidance remains $2.175-$2.225 billion. This includes CNS franchise sales of $1.16-$1.19 billion, pain franchise sales which were decreased to $530-$555 million, oncology franchise sales which were increased to $300-$320 million, and other product sales which were decreased to $150-$175 million. Full year R&D and SG&A guidance remains at $440-$460 million and $840-$860 million, respectively. Adjusted net income guidance remains at $452-$459 million and basic adjusted income per common share guidance remains at $6.50-$6.60.
For the second quarter 2009, Cephalon is introducing sales guidance of $515-$535 million, adjusted net income guidance of $96.6-$103.5 million and basic adjusted income per common share guidance of $1.40-$1.50.
Basic adjusted income per common share guidance for both the second quarter 2009 and full-year 2009 is reconciled below and is subject to the assumptions set forth therein.
Cephalon’s management will discuss the company’s first quarter 2009 performance in a conference call with investors beginning at 5:00 p.m. U.S. EDT today. To participate in the conference call, dial +1-913-312-1232 and refer to conference code number 9819274. 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 commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 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 has a growing presence in Europe, the Middle East and Africa. The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris. Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries. Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.
The company’s proprietary products in the United States include: AMRIX(R), TREANDA(R) for Injection, FENTORA(R) (fentanyl buccal tablet) [C-II], PROVIGIL(R) (modafinil) Tablets [C-IV], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), NUVIGIL(R) and ACTIQ(R) (oral transmucosal fentanyl citrate) [C-II]. 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; creation of a new therapeutic focus on inflammatory diseases; interpretation of clinical results, including recent results of NUVIGIL clinical studies; prospects for regulatory approval; manufacturing development and capabilities; market prospects for its products, including the growth and acceptance of Amrix and Treanda in the market; sales, adjusted net income and basic adjusted income per common share guidance for the second quarter and full-year 2009 and SG&A and R&D guidance for the full-year 2009; 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.
CONTACT: Media: Sheryl Williams, +1-610-738-6493, swilliam@cephalon.com,
Investors: Robert (Chip) Merritt, +1-610-738-6376, cmerritt@cephalon.com
Web site: http://www.cephalon.com/
