Pharmaceutical News: Narrower Loss at BioMarin

UPDATE 1-Cephalon profit misses, company likes Teva deal

* Q1 adjusted EPS $1.98 vs Street view $2.04

* Revenue $745.1 million

* Says Teva offer provides maximum shareholder value

NEW YORK, May 3 (Reuters) – Cephalon Inc (CEPH.O), which this week agreed to be bought by Teva Pharmaceutical Industries Ltd (TEVA.TA) for $6.8 billion, reported lower-than-expected first-quarter earnings as costs jumped 37 percent and revenue fell short of Wall Street estimates.

Cephalon had resisted an unsolicited takeover bid by Canada-based Valeant Pharmaceuticals International (VRX.TO) when Israel-based Teva swooped in with its higher offer.

“After analyzing a full range of strategic options, our board concluded that the Teva offer provides the maximum shareholder value for Cephalon shareholders,” Chief Executive Kevin Buchi said in a statement.

The specialty pharmaceutical company reported a net profit of $211.1 million, or $2.64 per share, compared with a profit of $100.3 million, or $1.35 per share, a year ago.

Excluding items, Cephalon had adjusted earnings of $1.98 per share. Analysts on average expected $2.04 cents per share, according to Thomson Reuters I/B/E/S.

Revenue rose 25 percent to $745.1 million, but fell short of Wall Street estimates of $751 million.

Costs and expenses rose 37 percent to $569.3 million. (Reporting by Bill Berkrot. Editing by Robert MacMillan)

Jazz Pharmaceuticals Announces First Quarter 2011 Financial Results

Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the first quarter of 2011.

Total revenues for the quarter ended March 31, 2011 were $50.9 million, compared to $35.2 million for the first quarter of 2010. Total revenues included net product sales, royalties and contract revenues.

GAAP net income for the first quarter of 2011 was $21.8 million, or $0.48 per diluted share, compared to $1.5 million, or $0.04 per diluted share, for the first quarter of 2010. Adjusted net income for the first quarter of 2011 was $26.8 million, or $0.59 per diluted share, compared to $6.1 million, or $0.18 per diluted share, for the first quarter of 2010. A reconciliation of GAAP net income to adjusted net income and the related per diluted share amounts is included with this press release.

Net sales of Xyrem® (sodium oxybate) oral solution increased 49 percent to $42.8 million for the first quarter of 2011, compared to net sales of $28.7 million for the first quarter of 2010. Net sales of once-daily Luvox CR® (fluvoxamine maleate) were $7.1 million for the first quarter of 2011, compared to $5.5 million for the prior year period, an increase of 29 percent.

“Our first quarter results reflect strong sales momentum for Xyrem,” said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. “We are committed to helping patients suffering from narcolepsy.”

Selling, general and administrative expenses for the first quarter of 2011 were $19.9 million, compared to $16.8 million for the first quarter of 2010, primarily due to higher headcount related expenses, including stock based compensation, and legal and information technology expenses. Research and development expenses for the first quarter of 2011 were $3.7 million, compared to $6.2 million for the first quarter of 2010, reflecting lower product development spending.

Interest expense for the first quarter of 2011 was $0.8 million, compared to $5.8 million for the prior year period. As of March 31, 2011, cash and cash equivalents were $65.1 million, an increase of 45 percent from $44.8 million at December 31, 2010.

Pipeline Developments

Jazz Pharmaceuticals is also providing an update on its JZP-6 and JZP-8 development programs:

The company has decided that it will not proceed with the additional clinical studies to support the development of JZP-6 (sodium oxybate) in fibromyalgia requested by the Food and Drug Administration (FDA) in its October 2010 complete response letter. This decision follows an internal analysis of the cost, development time and likelihood of regulatory success associated with further clinical development.
Given the estimated costs, development timeline and competitive environment for JZP-8 (intranasal clonazepam), the company is reevaluating whether or how to proceed with additional development.

Narrower Loss at BioMarin

BioMarin Pharmaceutical Inc.’s (BMRN – Analyst Report) first quarter 2011 loss of $0.04 per share was narrower than the Zacks Consensus loss estimate of $0.10 per share. The narrower-than-expected loss was attributable to higher-than-expected revenues recorded by BioMarin in the first quarter of 2011. The company reported break-even earnings (on an adjusted basis) in the year-ago quarter.

Total revenues climbed approximately 28.9% to $109.5 million in the reported quarter. Revenues surpassed the Zacks Consensus Estimate of $104 million. Revenues were boosted by higher sales of the key products at BioMarin.

Net product revenues in the reported quarter climbed approximately 29.7% to $109.1 million. Naglazyme, approved for treating MPS-VI, a rare genetic enzyme deficiency disorder, contributed the bulk of the net product revenues recorded in the quarter. Revenues from the drug climbed 24.7% to $60.6 million. Naglazyme revenues were boosted by the receipt of an order from the Brazilian government in the quarter.

Net product revenues from Kuvan tablets, indicated for treating mild-to-moderate forms of phenylketonuria (PKU), grew 25.9% to $26.7 million. The increase was attributable to the higher demand for commercial tablets in the US. Revenues for BioMarin from another enzyme replacement therapy, Aldurazyme, increased 31.7% over the prior-year quarter to $18.7 million. BioMarin co-markets the drug with Sanofi-Aventis (SNY – Analyst Report).

In addition to the above-mentioned products, BioMarin possesses the rights to Firdapse through its acquisition of Huxley Pharmaceuticals in October 2009. Net revenues from Firdapse, currently marketed in Europe, were $3.1 million in the quarter. Firdapse was launched in April 2010, in the European Union, for treating patients suffering from Lambert Eaton Myasthenic Syndrome (LEMS) – a rare autoimmune disorder.

2011 Guidance

Apart from announcing financial results, BioMarin also provided guidance for 2011. The lower ends of the guidance range for total revenue and net product revenue have been raised. Total revenues are expected in the range of $422 million-$452 million (old guidance $417 million-$452 million). Net product revenues are expected in the range of $416 million- $446 million (old guidance $411 million-$446 million).

Revenue guidance for the marketed products at BioMarin is as follows: Naglazyme – $211 million-$225 million (old guidance $206-$225 million); Kuvan – $112-$120 million (unchanged); Aldurazyme – $79–$83 million (unchanged); and Firdapse – $14-$18 million (unchanged). The outlook for selling, general and administrative expenses and research & development expense remained unchanged at $164-$174 million and $195-$205 million respectively.

Perrigo Q3 Profit Rises; Lifts FY11 Earnings View – Update

Perrigo Co. (PRGO: News ), Monday reported an increase in profit for the third quarter, driven mainly by higher sales, reflecting the acquisitions of PBM Holdings and Orion Laboratories. The pharmaceutical and nutritional products maker also raised its full-year 2011 earnings guidance.

Perrigo’s net income for the quarter was $89.09 million or $0.95 per share, compared to $62.18 million or $0.67 per share last year.

Income from continuing operations for the quarter improved to $91.53 million or $0.98 per share from $61.54 million or $0.66 per share in the year-ago quarter. Excluding few one-time charges, adjusted income from continuing operations for the quarter rose to $100.21 million or $1.07 per share from $75.43 million or $0.81 per share in the prior year.

Analysts polled by Thomson Reuters expected the company to report earnings of $0.97 per share for the quarter. Analysts’ estimate typically excludes special items.

Net sales for the quarter grew 29 percent to $691.56 million from $537.63 million last year, mainly helped by the acquisitions of PBM Holdings and Orion Laboratories, as well as $44 million in new product sales.

Analysts expected the company to generate revenues of $687.93 million for the quarter.

Gross margin for the quarter improved to 34.3 percent from 33.3 percent last year.

Consumer Healthcare segment net sales for the quarter advanced 13 percent to $425 million from last year, reflecting nearly $36 million in additional existing product sales as well as $9 million from new product sales and $7 million of incremental sales from the acquisition of Orion.

Nutritionals segment net sales for the quarter more than doubled to $124 million from $59 million last year, mainly helped by additional sales of almost $81 million attributable to the acquisition of PBM Holdings.

The Rx Pharmaceuticals segment third-quarter net sales grew 66 percent to $84 million from last year, due primarily to new product sales of $23 million related to the authorized generic of Aldara and the generic version of Xyzal.

Looking forward, the company raised its fiscal year 2011 guidance for earnings from continuing operations to a range of $3.43 to $3.53 per share, from previous range of $3.28 to $3.43 per share.

Excluding one-time items, fiscal year 2011 earnings from continuing operations are now expected in the range of $3.90 – $4 per share, from the previous range of $3.75 to $3.90 per share.

Analysts currently expect earnings of $3.89 per share for the full year.

PRGO is currently trading on the Nasdaq at $87.48, down $2.50 or 2.78%, on a volume of 1.19 million shares.

Optimer Pharmaceuticals Expands Senior Management Team

Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the appointment of Nancy Ruiz, M.D., as Senior Vice President of Research and Development, Cynthia Schwalm as Senior Vice President of International and Kasia Petchel, M.D., as Senior Vice President of Pharmacovigilance. These newly created positions will strengthen the senior management team as the Company prepares for the potential launch of its lead product candidate, DIFICID™, while seeking to build its hospital specialty products capability and pipeline.

“With the recent FDA Advisory Committee’s unanimous vote in favor of market approval of DIFICID for the treatment of Clostridium difficile infection, we are taking additional steps to build a powerful team that will contribute to a successful product launch and long term company growth,” said Pedro Lichtinger, Optimer’s President and CEO. “These additions to our senior management team will support the safety and risk management of DIFICID, maximize our international business, and improve our capability to build our product pipeline.”

Dr. Ruiz joins Optimer with more than 20 years of Phase 1 through Phase 4 clinical research experience in infectious diseases and immunology, which includes more than 15 years in the pharmaceutical industry. She joins Optimer from Merck Research Laboratories (formerly Schering-Plough Research Institute) where she served as Vice President, Project and Pipeline Management for Infectious Diseases. During that tenure she fulfilled several leadership and strategic roles, including Senior Project Leader of early and late development teams responsible for the C. difficile monoclonal antibody program, as well as the antifungal, antibacterial, vaccines, HIV and hepatitis C teams (including the development and recent filing of boceprevir). Previously, Dr. Ruiz held several leadership roles at Bristol-Myers Squibb, where she gained global early and late clinical development and medical affairs experience in infectious diseases (HIV- Sustiva®, Reyataz®; hepatitis B-Baraclude®) and immunology (rheumatoid arthritis- Orencia® and transplant- belatacept). Prior to initiating her career as a clinician and clinical investigator, Dr. Ruiz received her B.A. at Temple University in Philadelphia and her M.D. at the Ponce School of Medicine in Puerto Rico. She is a Diplomat of the American Board of Internal Medicine and the American Board of Infectious Diseases and a Fellow of the American College of Physicians and Fellow of the Infectious Diseases Society of America.

Ms. Schwalm brings a strong track record of growth and development in hospital and specialty markets during her 30 years of experience in the fields of pharmaceuticals, biotechnology, medical devices and health care delivery. She joins Optimer from Eisai Pharmaceuticals, Inc., the U.S. commercial arm of Tokyo-based Eisai Co., LTD, where she served as President. Ms. Schwalm had full operating responsibilities for Eisai Pharmaceuticals where she led commercial, medical and manufacturing functions. Her team built independent commercial capabilities for Eisai and drove double digit top line and bottom line P&L growth during her tenure. She came to Eisai in 2008 from Amgen Inc. where, over the course of her five-year tenure, she rose to Vice President and General Manager of the U.S. oncology business. Under her leadership, the unit’s annual revenues tripled to over $5 billion, as she directed approximately 500 people in all areas of oncology strategy and commercialization. Prior to Amgen, she spent 18 years at Johnson & Johnson holding positions of increasing responsibility, culminating in her appointment as the managing director of Ortho-Biotech UK & Ireland. At Johnson & Johnson Ms. Schwalm also led worldwide franchise development for two franchises in the pharmaceuticals division. Ms. Schwalm is a member of Harvard JFK School of Public Policy Women’s Leadership Board and the International Women’s Forum, a merit-based organization of the highest ranking women in business. In April 2009, she was recognized as one of New Jersey’s Top 50 Women in Business by NJ Biz. Ms. Schwalm also serves on the boards of the Sarah Cannon Research Institute, The Children’s Aid and Family Services Organization of Bergen County, NJ and Beth Abrahams Family Services, NYC. She holds a B.S. degree in nursing from the University of Delaware and an M.B.A. from the Wharton School of Business.

Dr. Petchel joins Optimer with more than 20 years of pharmaceutical industry experience in safety science, pharmacovigilance and risk management. Prior to joining Optimer, Dr. Petchel was the Vice President, Global Head Drug Safety Risk Management at Roche. There she led the company’s Global Safety organization and initiated significant changes to advance into proactive benefit risk management. During this time, Dr. Petchel also chaired Roche’s Drug Safety Committee (DSC), the highest corporate body for all assessments of product safety. Prior to that, she served as an executive at Pfizer, Inc. from 1996 to 2006, most recently as the Vice President and Global Head Safety Surveillance Reporting, where she oversaw more than 500 staff in four global locations, focusing on long-term strategic planning for safety. Prior to her career at Pfizer, she worked at various positions in the pharmaceutical industry including late Phase 3 development activities, global medical affairs and drug safety, spanning companies such as Ciba-Geigy, Sanofi and Zeneca, with assignment locations in North America, Switzerland, Singapore and South East Asia. Dr. Petchel is a board-certified physician epidemiologist and received her M.D. at the University of Zagreb, Croatia and her postgraduate training at Harvard University. Dr. Petchel is also a founding board member and a past Vice President and President of the American Academy of Pharmaceutical Physicians.

About Optimer Pharmaceuticals

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICID™ (fidaxomicin) and Pruvel™ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company’s request for six-month Priority Review of Optimer’s NDA for DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea.

Forward Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation all statements related to the potential approval and commercial launch of DIFICID, Optimer’s establishment of a commercial organization, the potential growth of Optimer’s product pipeline and the future roles and contributions of Dr. Petchel, Ms. Schwalm, and Dr. Ruiz at Optimer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intend,” “will,” “goal” and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer’s business including, without limitation, risks relating to: the timing, progress and likelihood of success of its product development efforts, the receipt of regulatory approvals, Optimer’s ability to recruit and retain a commercial sales force, Optimer’s ability to identify and develop additional product candidates and other risks detailed in Optimer’s filings with the Securities and Exchange Commission.

This entry was posted in News. Bookmark the permalink.

Comments are closed.