|
RxNews Recap for Friday 11-20-09
Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has set a new action date under the Prescription Drug User Fee Act for the review of the New Drug Application (NDA) for Exalgo™ (hydromorphone HCl extended-release) Tablets (CII), (Exalgo) of February 22, 2010.Antigenics Inc. (NASDAQ: AGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has formally adopted a negative opinion on the marketing authorization application (MAA) for Oncophage (vitespen) as a treatment in earlier-stage, localized renal cell carcinoma (kidney cancer).Inovio Biomedical Corporation (NYSE Amex:INO), a leader in DNA vaccine design, development and delivery, announced today that a combination of its synthetic consensus H1N1, H2N2, H3N2, and H5N1 influenza vaccine candidates achieved protective antibody responses against several different influenza sub-types and strains in ferrets.Genta Incorporated (OTCBB: GETA.OB) announced preliminary results that show a high objective response rate in a pilot study of patients with advanced melanoma that incorporates the Company’s lead oncology product, Genasense® (oblimersen sodium) Injection, administered for the first time as a 1-hour high-dose intravenous (IV) infusion.POZEN Inc. (NASDAQ: POZN) announced today the start of enrollment for the phase 3 studies for PA32540. PA32540 is a fixed-dose combination of 325 mg of enteric coated aspirin and 40 mg of immediate release omeprazole, under investigation for use in the secondary prevention of heart attacks and strokes in patients at risk for associated gastric ulcers.Novavax, Inc. (Nasdaq: NVAX) today announced that it has priced an underwritten public offering of 6,800,000 shares of its common stock at a price to the public of $3.30 per share.GLG Life Tech Corporation (TSX:GLG)(NASDA:GLGL), the vertically integrated leader in the agricultural and industrial development of high quality stevia extracts, announced today that it has commenced trading on the NASDAQ Global Market under the symbol "GLGL".PharMerica Corporation (NYSE: PMC), a national provider of institutional pharmacy and hospital pharmacy management services, announced that it has appointed Geoffrey G. Meyers to the Company’s Board of Directors.Cyberonics, Inc. (Nasdaq: CYBX) today announced that Dan Moore, President and Chief Executive Officer, and Greg Browne, Chief Financial Officer, will present at the 21st Annual Piper Jaffray Health Care Conference in New York on Wednesday, December 2, 2009 at 12:00 PM EST.Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for ABILIFY® (aripiprazole) for the treatment of irritability associated with autistic disorder in pediatric patients ages 6 to 17 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.Lannett Company, Inc. (NYSE AMEX: LCI) today announced that its Board of Directors has approved a reauthorization of the stock repurchase program. Under the program the company is authorized to repurchase up to $5 million of Lannett’s outstanding common stock from time to time in open market and privately negotiated transactions.Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that it will webcast its presentations at the Piper Jaffray 21st Annual Health Care Conference on Wednesday, December 2, 2009 at 2:00 p.m. EST and at the 2009 Deutsche Bank Biotech Boston Confab on Tuesday, December 15, 2009 at 9:00 a.m. EST.OPTIMIZERx Corporation (OTCBB:OPRX) has engaged Beringea LLC, an investment banking and private equity firm, to assist in financial planning and strategic positioning for the company's continued growth.Dendreon Corporation (Nasdaq: DNDN) today announced that the U.S. Food and Drug Administration (FDA) provided written acknowledgement that the Company's amended Biologics License Application (BLA) for PROVENGE® (sipuleucel-T) is a complete response.Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today announced that data from a preclinical study on its selective androgen receptor modulator (SARM) LGD-4033 was featured in a poster presentation at the 62nd Annual Meeting of the Gerontology Society of America in Atlanta. LGD-4033 exhibited desirable in vivo efficacy on skeletal muscle and bone measurements in animal models of male hypogonadism and postmenopausal osteoporosis.BD (Becton, Dickinson and Company) (NYSE:BDX) today announced the completion of its acquisition of HandyLab, Inc., an Ann Arbor, Michigan-based company that develops and manufactures molecular diagnostic assays and automation platforms.Soligenix, Inc. (OTC Bulletin Board: SNGX), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines.
-
BioMedReports.Com Sy...
|
|
|
Cyberonics Beats, Raises Outlook – Analyst Blog
Cyberonics, Inc. ( CYBX) reported second quarter fiscal 2010 earnings per share of 32 cents, beating the Zacks Consensus Estimate of 20 cents and the year-ago earnings of 14 cents.
Sales
Net sales in the reported quarter increased 13.0% year over year to $40.7 million. Of this, net product sales in the domestic market increased 15.1% year over year to $33.5 million. Growth was due to higher average selling prices (ASPs) and sales volume. ASPs and sales volume increased 10.0% and 5.1% year over year, respectively.
International sales increased 4.3% year over year to $6.8 million. Growth can be attributed to higher sales volume made through distributors, which was partly offset by lower ASPs. Licensing revenues constituted the remaining $0.4 million.
Margins
Gross margin increased 180 basis points (bps) year over year to 87.4%. Growth can be primarily attributed to higher sales volume, greater manufacturing efficiencies and higher ASPs due to a favorable product-mix.
Selling, general and administrative (SG&A) expenses as a percentage of sales declined 730 bps year over year to 52.5%. Research and development (R&D) expenses as a percentage of sales declined 70 bps year over year to 12.6%.
As a percentage of sales, higher gross margin coupled with lower SG&A and R&D expenses resulted in an increase in operating margin by 980 bps year over year to 22.3%.
Balance Sheet & Cash Flow
Cyberonics ended the reported quarter with cash and cash equivalents of $60.5 million, a decline of roughly 9% in the first six months of the fiscal year. Cash flow from operations was $12.9 million for the quarter.
Recent events
Cyberonics repurchased $7.5 million of outstanding convertible debt for a total of $6.7 million and recorded a net gain of roughly $0.7 million in the second quarter of fiscal 2010. Convertible debt outstanding was $39.2 million at the end of the second quarter.
Of this, the company repurchased an additional $8.3 million of outstanding convertible debt after the completion of the second quarter for a total of $7.6 million and will likely report a net gain of approximately $0.5 million in the next quarter.
Cyberonics reported a non-cash tax benefit of $40.5 million in the reported quarter due to reversal of its tax-valuation allowance related to net operating losses.
Outlook
Cyberonics raised its sales and operating income outlook for full fiscal 2010. For the year, it expects net sales in the range of $159 million to $162 million, compared to the prior guidance of $157 million to $161 million. Operating income is expected between $28 million and $30 million, versus the previous outlook of $24 million to $27 million.
Cyberonics reaffirmed its long-term goal of maintaining annual unit growth of 10% to 20% in the epilepsy business and achieving an operating margin of 25% by fiscal 2011.
Cyberonics is a neuromodulation company that develops and markets the VNS Therapy System for the treatment of refractory epilepsy and treatment-resistant depression. The VNS Therapy improves the patient’s quality of life by minimizing seizure reduction Read the full analyst report on "CYBX"Zacks Investment Research
-
Stock Market News & ...
|
