Top Analyst Upgrades-Downgrades in BioHealth Sector (BMRN, CBST, CYTK, ELN, PPDI, RGEN)
This morning we have seen an unusual number of analyst upgrades and downgrades in the drug and biotech space that comprises BioHealth. These are the top analyst upgrades, downgrades, and initiations in the BioHealth sector this Thursday morning:
- BioMarin (NASDAQ: BMRN) Raised to Outperform at Credit Suisse.
- Cubist Pharmaceuticals (NASDAQ: CBST) Raised to Perform at Oppenheimer.
- Cytokinetics (NASDAQ: CYTK) Cut to Hold at Needham.
- Elan Corp. plc (NYSE: ELN) Cut to Neutral at UBS.
- Pharmaceutical Product Development (NASDAQ: PPDI) Cut to Market Perform at Wells Fargo.
- Repligen (NASDAQ: RGEN) Cut to Sector Perform at RBC Capital.
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JON C. OGG
More TYSABRI MS Woes, Sort Of (BIIB, ELN, ACOR)
Biogen Idec Inc. (NASDAQ: BIIB) is feeling the pain of regulatory review this morning. And Elan Corp. plc (NYSE: ELN) is feeling it even worse. The reason these are under pressure this Friday is because a European panel has begun a review of Biogen’s controversial yet effect multiple sclerosis drug TYSABRI. The review is over higher rates of PML brain infections (progressive multifocal leukoencephalopathy) than had been disclosed.
The European Medicines Agency’s Committee for Medicinal Products for Human Use showed some 23 PML cases since the launch of TYSABRI. Previous data showed that there were 13 cases since TYSABRI came back on the market in 2006 after the company voluntarily removed it to study the PML data. The European panel will discuss additional measures, if needed, to ensure a safe use of the drug and how to measure risks.
Biogen Idec is already in U.S. talks with the FDA over the TYSABRI label. Most recent data showed more than 46,000 people were taking TYSABRI, and over 13,000 patients had been taking TYSABRI for more than two years and were classified under long-term use.
It is impossible to pre-judge this situation, but personal discussions have given a personal belief here that the reason people keep taking TYSABRI is because many think it is the best MS drug on the market. As far as a 1 in a thousand risk, that is a very low incident ratio compared to other drugs that treat other diseases and many are willing to take that risk.
Biogen Idec is down 5.7% at $44.50 and Elan is down almost 17% at $5.35. Acorda Therapeutics, Inc. (NASDAQ: ACOR) has been noted this week as having an MS drug candidate pending under priority review date and that has been extended out to January 2010 by the FDA.
JON C. OGG
OCTOBER 23, 2009
BioHealth Earnings Floodgates Opening (BSX, BIIB, GILD, ISRG, PFE, DGX, SYK, AMGN, ELN, LLY, GENZ, STJ, BMY, MRK, SGP, ZMH)
Next week is going to be the mother of all earnings reports for the BioHealth community. We have included the key device companies as well in this calendar with the routine top drug and biotech companies. As a reminder, these estimates may change between now and when some of the players report earnings. In the screens for earnings we have the estimates included listed as the Thomson Reuters consensus figures.
MONDAY OCTOBER 19
- Boston Scientific Corporation (NYSE: BSX) $0.14 EPS on $2.04 billion in revenues
TUESDAY OCTOBER 20
- Biogen Idec Inc. (NASDAQ: BIIB) $1.04 EPS on $1.11 billion in revenues
- Gilead Sciences Inc. (NASDAQ: GILD) $0.67 EPS on $1.76 billion in revenues
- Intuitive Surgical, Inc. (NASDAQ: ISRG) $1.46 EPS and $256.44 million in revenues
- Pfizer Inc. (NYSE: PFE) $0.48 EPS and $11.4 billion in revenues
- Quest Diagnostics Inc. (NYSE: DGX) $0.96 EPS and $1.89 billion in revenues
- Stryker Corp. (NYSE: SYK) $0.69 EPS and $$1.62 billion in revenues
WEDNESDAY, OCTOBER 21
- Amgen Inc. (NASDAQ: AMGN) $1.27 EPS and $3.79 billion in revenues
- Elan Corporation, plc (NYSE: ELN) -$0.13 EPS on $285.18 million in revenues
- Eli Lilly & Co. (NYSE: LLY) $1.01 EPS and $5.4 billion in revenues
- Genzyme Corporation (NASDAQ: GENZ) $0.44 EPS and $1.11 billion in revenues
- St. Jude Medical, Inc. (NYSE: STJ) $0.58 EPS and $1.16 billion in revenues
THURSDAY, OCTOBER 22
- Bristol-Myers Squibb (NYSE: BMY) $0.51 EPS and $5.5 billion in revenues
- Merck & Co., Inc. (NYSE: MRK) $0.83 EPS and $6 billion in revenues
- Schering-Plough Corporation (NYSE: SGP) $0.39 EPS and $4.45 billion in revenues
- Zimmer Holdings Inc. (NYSE: ZMH) $0.86 EPS and $953.6 million in revenues
JON C. OGG
OCTOBER 16, 2009
Is Biogen Idec's Fast Track Status on MS Candidate a Game Changer? (BIIB, ELN)
Biogen Idec (NASDAQ: BIIB) has been having issues with its MS franchise TYSABRI for what is becoming a multi-year event. It already has a blockbuster with its AVONEX for RMS. But the stock is enjoying a second day of gains today after its “other” Multiple Sclerosis treatment has received an FDA Fast Track Designation. The announcement was made on Wednesday that its PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis (RMS) received the designation.
Our take has long been that TYSABRI has been given a bit of a bad wrap because of the PML cases. It isn’t that this is not an issue. Having spoken with multiple TYSABRI users and family members of theirs over the years, it is our opinion that most users feel that TYSABRI is worth the risk as the PML cases are so isolated. But it would be foolish to not acknowledge that this has significantly lowered the number of TYSABRI ‘clients.’
After looking through the data, it seems that there is a chance that this PEGylated interferon beta-1a (BIIB017) for relapsing multiple sclerosis could end up being a significant game changer for the company. With a risk, of course. Elan Corp. plc (NYSE: ELN) is the TYSABRI partner, and while recent developments may help Elan it has spent its time in and out of being considered a “troubled stock” for longer than memory would serve.
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BioHealth Pre-Market Analyst Calls
Today we are seeing pretty thin coverage from analysts regarding biotech, drug, and healthcare stocks. These are the few we are seeing with over 90 minutes to to go before the market opens:
- Elan (ELN) Raised to Equal-weight at Lehman.
- Health Net (HNT) Cut to Hold at Citigroup.
- Novartis (NVS) Cut to Neutral at JPMorgan.
Jon C. Ogg
August 6, 2008
Wyeth & Elan: More Questions in Alzheimer's Study Results (WYE, ELN)
Today was the long awaited Alzheimer’s drug data presented from Elan Corporation, plc (NYSE: ELN) and Wyeth (NYSE: WYE). The companies presented detailed results from their 18-month Phase II study of bapineuzumab in patients with mild to moderate Alzheimer’s disease.
The study was on 234 randomized with findings reported on 229 patients, and efficacy was measured from a baseline of 78 weeks. The data looked very positive on the surface with safety and efficacy results supporting the design of an ongoing global Phase III program.
Some data is mixed and shares were hit as a result. It showed statistically significant and clinically meaningful effects were observed in multiple endpoints in ApoE4 non-carriers. The company also noted that pre-specified efficacy analysis did not reach significance in the total population.
Favorable directional changes were seen in some endpoints in ApoE4 carriers, warranting further study. The post-hoc anlysis showed statistically significant and clinically meaningful benefits in important subgroups.
You can read about the full results here. There were measurements of less or slower brain shrinkage combined with better memory test results observed in the study, and if our data is correct that would be superior to any existing treatments and is probably above other study reports to date.
The problem is the pre-specified efficacy analysis as well as a few deaths in the trial (which were noted as “unbelieved to be from the drug” despite no deaths in teh placebo group.
This data was shown at the Alzheimer’s Association’s International Conference on Alzheimer’s Disease 2008 in Chicago, Illinois.
Shares are getting slapped down in after-hours. Wyeth stock is down 8.5% at $41.25 and Elan stock is down 15% at $28.49 in after-hours trading. Both stocks had been higher initially ahead of the data. This looks more and more like mixed data, and unfortunately it looks like Alzheimer’s patients have a long way to go before even any meaningful help will arrive.
Jon C. Ogg
July 29, 2008 (5:45 PM EST)
