|Biogen Earnings Beat Street As MS Drug Shines; Clazakizumab Promising Phase IIb Data to Be Presented|
|By Staff and Wire Reports|
|Monday, 28 October 2013 18:58|
Big-cap biotech Biogen Idec's (NASDAQ:BIIB) stock hit a new high Monday after it beat analysts' Q3 estimates and raised its guidance on the strength of its new multiple sclerosis drug. Still, a new note of uncertainty with the launch of its hemophilia drug kept analysts cautious.
Biogen said quarterly sales rose 32% over the year-earlier quarter to $1.83 billion, beating analysts' consensus by almost $40 million. Per-share profit minus one-time items jumped 44% to $2.35. The company said full-year revenue should rise 23% to 25%, with EPS of $8.65 to $8.85 vs. $6.53 last year. Both were on the high side of consensus.
The earnings beat came almost entirely on the strength of Tecfidera, the oral MS treatment that Biogen launched six months ago. Sales totaled $286 million in the quarter, some $80 million above the consensus number and also past the "whisper number," according to ISI Group analyst Mark Schoenebaum. "This is really, truly incredible," he wrote in an email to clients early Monday.
Those sales more than made up for a shortfall in Tysabri, Biogen's older MS blockbuster, whose $401 million in revenue was $29 million below consensus. This was not a surprise, however, as Elan (ELN) reported its royalty revenue from the product in its own Q3 report last week.
On a conference call with analysts to discuss results, Biogen Executive Vice President Tony Kingsley said Tysabri's growth in Europe is getting hit by competition from oral drugs — presumably meaning Novartis' (NVS) Gilenya and Sanofi's (SNY) Aubagio, since Tecfidera has not yet launched there. He also said that nearly half of the shortfall came from deferred revenue at Biogen's Italian affiliate. For the last two years, the company has been entangled in a dispute with Italian regulators over reimbursement for the drug.
"For Tysabri, we hope to record a revenue benefit of approximately $95 million by the end of the year related to the pending settlement with the Italian National Medicines Agency, but this may not happen," Biogen CFO Paul Clancy said on the call. Biogen CEO George Scangos updated two important regulatory matters. He said the company learned in discussions with the FDA last week that there might be a delay in the launch of Eloctate, the long-acting treatment for hemophilia A that had been on track to launch next year. He said the issue did not have to do with the safety or efficacy of the drug, but with the manufacturing process, and thus doesn't affect the odds of approval. Because the development is so new, he said he could not give further details.
Bristol-Myers Squibb Company (NYSE: BMY) and Alder Biopharmaceuticals today announced the presentation of efficacy and safety data from a Phase IIb dose-ranging study of subcutaneous (SC) clazakizumab in adults with moderate-to-severe rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). Clazakizumab is a humanized anti-IL-6 monoclonal antibody that is directed against the IL-6 cytokine rather than its receptor.
In the Phase IIb study clazakizumab doses ranging from 25-200 mg monotherapy and in combination with MTX were studied vs. MTX alone. Adalimumab in combination with MTX was included as an active reference arm. All clazakizumab treatment arms, alone or in combination with MTX, demonstrated efficacy in controlling the signs and symptoms of RA, and met the predefined primary endpoint of a higher ACR20 response rate vs. MTX alone after 12 weeks of treatment. All clazakizumab treatment groups were also associated with improved ACR 20/50/70 response rates and HAQ-DI scores vs. MTX at week 24. Rates of low disease activity and remission with clazakizumab plus MTX, as measured by DAS28 CRP, CDAI and SDAI criteria were numerically greater for clazakizumab at 12 and 24 weeks than the active comparator.
The adverse event (AE) rates were similar across all clazakizumab arms. The most frequent AE for clazakizumab was dose-related injection site reactions. The most frequent reason for discontinuation due to AE in clazakizumab treated patients was laboratory abnormality, predominantly transaminase elevations, more frequent in MTX-containing arms. The most frequent serious adverse events (SAEs) were serious infections. Rates of serious infections were generally comparable for clazakizumab and adalimumab combination arms and were numerically greater than MTX alone.
“There is a great need for additional disease-modifying therapies that can provide more patients with deep and sustainable remission, helping preserve function and limit further joint damage,” said Paul Emery, M.D., director of MSK Biomedical Unit at the Leeds Teaching Hospitals Trust in the United Kingdom. “Currently, less than 30% of RA patients experience sustained remission as defined by ACR criteria. Clazakizumab is an investigational therapy that neutralizes IL-6 signaling by blocking the IL-6 cytokine, and provides promising remission data that will need to be further investigated.”
“Bristol-Myers Squibb has a long-standing commitment to immunoscience research and the development of innovative medicines for patients living with chronic immune-mediated diseases, such as RA,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “Despite the recent advances in the treatment of RA, more efficacious therapies are needed. The results of this study support the potential for clazakizumab to fulfill the need for new medicines that can help patients with RA achieve disease control and remission.”
Bristol-Myers Squibb has exclusive worldwide rights to develop and commercialize clazakizumab for all indications outside of cancer under a collaboration agreement with its discoverer, Alder Biopharmaceuticals.
“We are excited about the Phase IIb data and its confirmation of the earlier promise seen in Phase IIa,” added Randall Schatzman, PhD, president and CEO of Alder Biopharmaceuticals. “We look forward to the clinical advancement of clazakizumab and the potential it has to bring a new treatment to patients suffering with RA.”
In a separate pre-clinical study of in-vitro assays, also being presented at the ACR annual meeting, clazakizumab was shown to bind to the IL-6 cytokine with high affinity and block various IL-6-induced functions more potently than tocilizumab, an RA treatment currently on the market that targets the IL-6 pathway.
Array BioPharma Inc. (Nasdaq: ARRY) will report financial results for the first quarter of fiscal 2014 and hold a conference call to discuss those results on Thursday, October 31, 2013. Ron Squarer, Chief Executive Officer and Michael Carruthers, Chief Financial Officer will lead the call.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today released, from the Annual American Academy of Pediatrics National Conference (Booth #515), pediatric mental health data from its national cohort of pediatricians spanning from 2009 to 2013. Full results of the pediatric mental health study can be found here: http://www.athenahealth.com/blog/.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today expressed strong support for the ongoing commitment by the Department of Veterans Affairs to telehealth, as represented by the VA's recently released 2014-2020 Draft Strategic Plan.
Cancer Genetics, Inc. (Nasdaq:CGIX), a diagnostics company focused on developing genomic-based, oncology tests and services, today announced the closing of its previously announced public offering of 3,286,700 shares of its common stock (including 428,700 shares that were offered and sold by Cancer Genetics pursuant to the exercise in full of the underwriters' over-allotment option) at a price to the public of $14.00 per share.
Quantros, the leading provider of cloud-based services for quality, safety, and clinical business intelligence solutions across the continuum of care, and athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced a first-of-its-kind arrangement between a Patient Safety Organization (PSO) and a health IT supplier, in which thousands of clinical providers and provider organizations across the U.S. will gain free access to a safe, privileged environment in which they can easily submit patient safety concerns and findings as well as share best practices to enhance safety and improve care.
Boston Scientific Corporation (NYSE: BSX) will highlight the strength of its advanced portfolio and plans for delivering additional meaningful innovation to clinicians and patients through a robust schedule of sponsored research presentations at the 25th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation, October 27 – November 2 in San Francisco.
Baxano Surgical, Inc. (Nasdaq:BAXS) announced today that it plans to release third quarter 2013 financial and operating results after market close on Wednesday, November 6, 2013. Ken Reali, President and Chief Executive Officer and Tim Shannon, Interim Chief Financial Officer, will host a conference call starting at 4:30 pm ET on the same day.
Caliber Imaging & Diagnostics (OTCQB:LCDX) formerly Lucid, Inc., plans to raise capital through a general solicitation with H.C. Wainwright & Co., LLC acting as placement agent.
China Biologic Products, Inc. (NASDAQ: CBPO), a leading fully integrated plasma-based biopharmaceutical company in China, today announced that the Company plans to release third quarter 2013 financial results on Tuesday, November 5, 2013 after the market closes.
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company specializing in DNA-based testing services for developmental disorders and cancer diagnostics, today reported summary selected preliminary unaudited third quarter financial results.
Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, will be hosting a meeting for securities analyst attending the Transcatheter Cardiovascular Therapeutics Annual Scientific Symposium.
Gentium S.p.A. (Nasdaq:GENT) announced today that it will report its financial results for the third quarter 2013 on Thursday, October 31, 2013 and will hold a conference call and live webcast at 7:00 a.m. ET / 12:00 p.m. CET.
Hansen Medical, Inc. (NASDAQ: HNSN), a global leader in intravascular robotics, today announced that Dr. Barry Katzen, founder and Medical Director of Baptist Cardiac & Vascular Institute (Baptist Hospital of Miami), is scheduled to utilize the Magellan™ Robotic System in a live endovascular aneurysm repair (EVAR) case at the Transcatheter Cardiovascular Therapeutics (TCT) conference in the Main Arena II at the Moscone Center in San Francisco, California on Wednesday, October 30th at 2:30 PM ET.
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, has hired Yong Sun, a veteran global marketing and sales leader in the life sciences and medical device industries, as Harvard Bioscience's Vice President Strategic Marketing and Business Development, a newly created position, effective October 28.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal™.
Integra LifeSciences Holdings Corporation (Nasdaq:IART) today reported its financial results for the third quarter ending September 30, 2013. Total revenues for the third quarter were $213.2 million, reflecting an increase of $3.2 million over the third quarter of 2012.
LED Medical Diagnostics Inc. (TSX VENTURE:LMD) (OTCQX:LEDIF) (FRANKFURT:LME) announced today that it has received final approval of the TSX Venture Exchange to its previously announced and completed non-brokered private placement of 15,000,000 units at an issue price of CDN$0.35 per unit for gross proceeds of $5.25 million.
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of clinical systems and innovations that seek to transform healthcare, today announced that Sinai Health System, a Chicago-based non-profit health system comprised of seven member organizations, has selected Merge for its vendor-neutral archive (VNA), image sharing and picture archiving communication systems (PACS), as well as its cardiology information management and hemodynamics solution.
MiMedx Group, Inc. (NASDAQ: MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that the Company concluded a productive meeting with the Food and Drug Administration ("FDA") earlier today, October 28, 2013.
MRI Interventions, Inc. (OTCQB:MRIC) today announced that outcomes data from the use of its ClearPoint® Neuro Intervention System in "asleep" deep brain stimulation (DBS) surgery were presented during the 2013 Annual Meeting of the Congress of Neurological Surgeons (CNS) in San Francisco.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that validation data for the Myriad myPlan Lung Cancer test showed that it significantly predicted patients' risk of death from early-stage lung adenocarcinoma within five years of being diagnosed.
Portage Biotech Inc. (OTCBB: PTGEF) is pleased to announce that effective October 28, 2013, the common shares of Portage will be listed for trading in US currency on the Canadian National Stock Exchange (the "CNSX", www.cnsx.ca) under the symbol "PBT.U".
Press Ventures Inc. (OTCQB: PVEN) and its wholly-owned Polish subsidiary Biosafety Systems, Inc. Sp z o.o. ("BSI"), are pleased to announce that it has completed the merchant account administration process with PayPal.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of a broad range of diseases, today announced that it will host its Research and Development Day on Monday, November 4, 2013 from 9:00 a.m – 12:00 p.m. ET at the New York Palace Hotel in New York, NY.
ScripsAmerica, Inc. (OTCBB:SCRC) announced today that the Company's due diligence team will travel to China in November to begin formal RapiMed® distribution negotiations in preparation for a product launch into the Chinese OTC market, valued at over $32 billion.
SmallCapVoice.com, Inc. (SCV) announced today that a new audio interview with BioElectronics Corporation (OTC Pink:BIEL), the maker of advanced consumer pain management medical devices, is now available.
Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the initiation of a Phase I/II investigator-sponsored trial of vosaroxin, the company's lead product candidate, in adult patients with previously treated intermediate-2 or high-risk myelodysplastic syndrome (MDS).
Transcat, Inc. (Nasdaq:TRNS), a leading provider of accredited calibration, repair, inspection and compliance services and distributor of professional grade handheld test, measurement and control instrumentation, today reported financial results for its fiscal 2014 second quarter ended September 28, 2013.
TG Therapeutics, Inc. (Nasdaq:TGTX), reports that in view of the unusual market activity in the Company's stock price, NASDAQ MarketWatch has contacted the company in accordance with its usual practice.
Vision-Sciences, Inc. (Nasdaq:VSCI), a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced that the Company will release its financial results for the second quarter of fiscal 2014, ended September 30, 2013, after the market closes on Monday, November 11, 2013.
ZELTIQ Aesthetics, Inc. (Nasdaq:ZLTQ), a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced that D. Keith Grossman has joined its Board of Directors.