Today morning, Biogen Idec (BIIB) reported third quarter earnings per share of $1.12, beating the Zacks Consensus Estimate of $1.02. The company reported earnings of 98 cents in the year-ago period. Revenues increased 3% to $1.12 billion, with Tysabri being the primary growth driver. Tysabri sales came in at $207 million, up 21% from the prior period. The company estimates that as of the end of September 2009, about 46,200 patients were on commercial and clinical Tysabri therapy worldwide. This represents an increase from the 43,300 patients reported by the company in the second quarter of 2009. Tysabri is an important growth driver and we expect the product, which is partnered with Elan (ELN), to cross $1 billion in worldwide sales in 2009. Meanwhile, Biogen’s lead multiple sclerosis (MS) product Avonex posted sales of $580 million (up 1%) with U.S. sales growing 8% to ...

Biogen Beats Expectations Despite Tysabri PML Fears Yesterday, Biogen Idec (BIIB) reported financial results for the second quarter of 2009. Non-GAAP diluted earnings per share (EPS) came in at $0.75, beating the consensus estimate of $0.68. EPS declined on a y-o-y basis due to a $110 million charge (EPS impact of $0.32) taken by Biogen related to its recently signed deal with Acorda Therapeutics (ACOR). GAAP EPS, which includes stock-based compensation and amortization of intangibles, declined 30% to $0.49. Although EPS declined from the year-ago quarter, revenues jumped 10% to 1,093.3 million, slightly above ours and the Street’s estimate of $1.07 billion. Avonex and Tysabri were the primary growth drivers. Avonex sales increased 12% to $591.2 million (U.S. sales increased 20%; ex-U.S. sales increased 2%). New long-term efficacy data and increased promotional efforts should drive Avonex sales going forward. Meanwhile, we were encouraged ...

Sanofi-Aventis (SNY) posted EPS of e5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced significantly declining sales including Ambien, Tritace and Copaxone.For 2009 we expect revenue growth to return, as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 6% in 2009 and EPS of e5.93 ($4.10), up 11% from 2008. EPS should continue to benefit from strong contributions to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting. We also expect foreign exchange to benefit both revenue and EPS in 2009 as the U.S. dollar strengthens against the Euro.Generic competition will continue to be a concern, however. While we expect new product launches to make significant revenue contributions in the ...

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  

On 5/19/09, Biogen [BIIB: 50.69, +0.30 (+0.60%)] and Genentech (acquired by Roche) [RHHBY: 0.00, N/A (N/A)] announced that the companies submitted two supplemental Biologics License Applications (sBLAs) to the FDA for Rituxan (rituximab) plus standard chemotherapy for people with

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We highlight Sanofi-Aventis SA (SNY) and Biogen Idec Inc. (BIIB).Sanofi-Aventis SA (SNY) posted EPS of EUR5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced a significant decline in sales including: Ambien, Tritace and Copaxone.However, for 2009 we expect revenue growth to return as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 6% in 2009 and EPS of EUR5.89 ($3.90), up 10% from 2008.EPS should continue to benefit from strong contribution to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting. We also expect foreign exchange to benefit both revenue and EPS in 2009 as the U.S. dollar strengthens against the Euro.Generic competition will continue to be a ...

Highlights include Sanofi-Aventis SA (SNY) and Biogen Idec Inc. (BIIB).Sanofi-Aventis SA (SNY) posted EPS of EUR5.36 in 2008, an increase of just 2% from 2007. Revenue fell 1% in 2008 as a number of products experienced significantly declining sales including Ambien, Tritace and Copaxone.For 2009 we expect revenue growth to return as generic erosion is more than offset by strong growth of Taxotere, Lantus, Avapro and the vaccines business. We expect revenue growth of 4% in 2009 and EPS of EUR5.81 ($3.82), up 8% from 2008. EPS should continue to benefit from continued strong contribution to royalty income from U.S. Plavix sales and operating margin improvement as a result of cost-cutting.Generic competition will continue to be a concern, however. While we expect new product launches to make significant revenue contributions in the early part of the next decade, they will ...

Highlights include Biogen Idec, Inc. (BIIB), AstraZeneca plc (AZN), Bristol-Myers Squibb, Inc. (BMY) and Sanofi-Aventis SA (SNY).R&D Day Highlights the Best Pipeline In Biotech

Last week, Biogen Idec (BIIB) held an R&D Day, highlighting the broad depth of the company's pipeline. In total, Biogen Idec boasts 7 programs in phase III registration programs and 20 other programs in phase II "proof-of-concept" programs. Biogen's development programs span oncology, neurology and cardiovascular disease, and include both small molecules and biologics. In our opinion, it's the best pipeline in biotech.

Phase III / Registration programs include:   

BG-12: An anti-inflammatory second generation oral fumaric acid molecule that offers a more convenient and potentially neuroprotective treatment option for multiple sclerosis. BG-12 is currently in 2 phase III trials, DEFINE and CONFIRM, with data expected in 2010 and 2011.     ...

Highlighted stocks include Sanofi-Aventis (SNY) and Biogen-Idec (BIIB).On February 11, 2009, Sanofi-Aventis (SNY) announced financial results for the 4th quarter 2008. Revenue of EUR7,456 million increased by 3% from the 4th quarter of 2007, and was ahead of our estimate of EUR7,101 million. Revenue benefitted from strong sales of Lantus, Lovenox, Plavix and Ambien CR.Revenue was also positively impacted by foreign exchange translation. EPS, adjusted for non-recurring charges, was EUR1.25 in the 4th quarter, compared to our estimate of EUR1.24. Relative to our expectations, EPS was negatively impacted by higher R&D and SG&A spend and a slightly tighter-than-expected gross margin, partially offset by a lower tax rate.For the full-year 2008, revenue of EUR28.8 billion was down 1% from 2007, while EPS increased by 2% to EUR5.36. Foreign exchange negatively impacted sales and EPS by 5% and 8%, respectively, for the ...

Highlighted companies include Biogen Idec (BIIB), Genentech (DNA), Merck (MRK) and Sanofi-Aventis (SNY).At 13x our 2009 EPS of $4.05 per share, we believe that Biogen Idec's (BIIB) stock is too attractive to ignore. Valuation is below the biotech peer-group average, where several names are trading at a significant premium.The company should post non-GAAP EPS up roughly 11% in 2009, even with all the Tysabri PML issues. However, valuation alone is not enough of a reason to buy the stock. We are comfortable with owning the name here based on two other reasons.Firstly, Biogen has a significant late-stage pipeline. There are 22 programs in phase II or beyond. Six of these products are in phase III registration programs right now: lumiliximab for chronic lymphocytic leukemia (CLL), galiximab for non-Hodgkin's lymphoma (NHL), BG-12 for relapsing / remitting multiple sclerosis (RR-MS), ...

div style="text-align: justify;"Goldman Sachs is upgrading span style="font-weight: bold;"Biogen-Idec (NASDAQ:BIIB)/span to Buy from Neutral and adding the stock to their Conviction Buy list with a $61 tgt (up from $57).br /br /According to the firm this is based on potential upside revision to earnings and attractive valuation. They believe the threat of generics and competition should be manageable, leading to their 2009/2010 EPS (incl. ESO) of $4.14 amp; $4.55 vs. consensus of $3.97 and $4.23, resp. BIIB’s pipeline is underestimated and should gain visibility in 2009/2010. The product profile and manufacturing capacity might be attractive for potential pharma acquirers. The intrinsic value of $46 implies a pipeline value of $3 which the firm views as attractive.br /br /span style="font-weight: bold;"Catalyst/spanbr /span style="font-weight: bold;"/spanbr /1) Safety data from over 10,000 patients on Tysabri therapy by yearend.br /br /2) In 2009, MLCO expects Phase 3 data on Rituxan in lupus nephritis (1Q, ...