Alnylam Finds A New Partner For Its Next Phase

Alnylam (ALNY) was a very different company five years ago – Onpattro was in Phase II development, fitusiran was in Phase I, and there were still substantial doubts about the entire RNAi concept, as large pharma companies like Novartis (NVS) and Merck (MRK) were backpedaling out of the space. At that time, the deal Alnylam signed with Sanofi (SNY) was valuable not only from the perspective of the capital it brought into the business but also the perceived stability and support of a major pharmaceutical drug company. Now, five years later, Alnylam is in a very different place and it has different needs and expectations for its partnerships. Sanofi, too, has different needs and goals, and with that the two companies have elected to wind down their development partnership. At the same time, Alnylam has forged a new development partnership with Regeneron (REGN) that will help fund the company’s expansion into treatments beyond the liver.

I continue to believe that Alnylam is a high-risk undervalued opportunity, underpinned by a development pipeline that should see several FDA approvals and commercial ramps over the next few years, with multiple $1B+/yr revenue opportunities.

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Alnylam Finds A New Partner For Its Next Phase

Seeking Alpha: Sanofi's Trying To Go On Offense While Playing Defense

Drug companies face what I consider to be an under-appreciated dilemma when managing their portfolios - the tradeoffs between market size and competition. Sanofi (NYSE:SNY) has done quite well for itself for years by working within a small oligopoly in insulin and vaccines, but now there are concerns that biosimliars and novel compounds from Novo Nordisk (NYSE:NVO) and Lilly (NYSE:LLY) will threaten that business. What's more, while Sanofi does have good exposure to rare diseases through its Genzyme business and multiple potential blockbusters by virtue of its relationship with Regeneron (NASDAQ:REGN), it has what increasingly looks like a token presence in oncology - the must-have market in many investors' minds.

I can't say that I'm a big fan of Sanofi at today's price. I think the company has backed itself into a corner in diabetes where it will have to fight hard to push me-too and also-ran drugs and I expect ample competition in cholesterol and anti-inflammatory/autoimmune diseases. I think long-term revenue growth in the mid-single digits and FCF margins in the mid-20%'s are reasonable expectations for the company, but that's not enough to drive an attractive valuation.

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Sanofi's Trying To Go On Offense While Playing Defense

The Motley Fool: Can This Drive Growth for Amarin Corporation plc?

Small-cap biopharmaceutical Amarin (NASDAQ: AMRN  ) has made it clear that the company is not giving up on Vascepa without a fight, several of them actually. In addition to challenging the FDA's decisions to rescind a Special Protocol Assessment (SPA) on the company's ANCHOR study and to refuse NCE status for the key ingredient in Vascepa, the company is now trying to augment its sales effort. A co-promotion agreement with Kowa Pharmaceuticals America will most likely cap the company's gross margin for the foreseeable future, but it adds nearly twice as many reps as Amarin has pushing the drug.

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Can This Drive Growth for Amarin Corporation plc?

The Motley Fool: Can Regeneron Keep Churning Out Blockbusters?

Developing a great drug is hard enough, but developing an R&D platform that reliably churns out new high-quality experimental compounds is a rare feat in biotech. That Regeneron (NASDAQ: REGN  ) has managed to create one of the strongest platforms in antibodies is both a credit to its leadership and IP, as well as a strong generator of long-term value for shareholders. Regeneron's shares do not look particularly cheap today, but upside from products like Eylea and alirocumab and de-risking of the pipeline give shareholders some reason to stay engaged.

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Can Regeneron Keep Churning Out Blockbusters?

The Motley Fool: FDA Cholesterol Drug Concerns: What You Should Know

As Sanofi (NYSE: SNY  ) / Regeneron (NASDAQ: REGN  ) , Pfizer (NYSE: PFE  ) , and Amgen (NASDAQ: AMGN  ) prepare for the stretch run to getting their PCSK9 inhibitors, high-potential new treatments for cholesterol, approved by the FDA, a new potential complication has emerged. Sanofi and Regeneron revealed through SEC filings that the FDA is now taking a closer look at potential neurocognitive issues with the entire PCSK9 inhibitor class.

The odds still seem to favor the thesis that PCSK9 inhibitors are safe enough for FDA approval. That said, the role of cholesterol in neurocognitive process is significant, so it's not a ridiculous notion to investigate – particularly considering the possibility that many millions of people will be taking these drugs once they are approved and available.

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FDA Cholesterol Drug Concerns: What You Should Know

Seeking Alpha: After The Twists And Turns, Sanofi Still A Value

It's been an interesting few days for Sanofi (SNY) and its shareholders. While the shares were thumped last week on what was seen as disappointing guidance, Monday saw a rebound on news of regulatory troubles at rival Novo Nordisk (NVO). Through it all, Sanofi still looks like a relative value and may in fact be one of the best bargains in the Big Pharma space.

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After The Twists And Turns, Sanofi Still A Value

Seeking Alpha: AstraZeneca Suspends The Buyback: Let The M&A Speculation Commence

With new CEO Pascal Soriot just getting comfy in the CEO chair at AstraZeneca (AZN), he lost little time in making a mark on the company. On Monday, the large (but struggling) but British drug company announced that it would suspend its buyback pending a "review of the company's strategy". While it certainly makes sense that the new CEO may just as soon keep $2 billion on hand (the company has completed $2.3 billion of an approved $4.5 billion buyback) for the time being, there are widespread assumptions that this is prelude to a larger deal.

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AstraZeneca Suspends The Buyback: Let The M&A Speculation Commence

Seeking Alpha: Is Biotech Getting Too Frothy? Investor Sentiment Suggests Irrational Exuberance

Investors with many years of experience in biotech know there's something to the idea that the best time to prepare for war is during peace (and vice versa). With the biotech sector heading for its second straight year of strong returns, it's worth asking whether investors are getting a little too cavalier about risk and whether investors in the sector are getting set up for a sizable correction.

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Is Biotech Getting Too Frothy? Investor Sentiment Suggests Irrational Exuberance

Investopedia: The Week Ahead In Healthcare

Earnings season is now winding down and very little has changed in the healthcare sector. Hospitals in the U.S. are still being cautious with their capital spending, while European health systems are pushing back hard on prices for both devices and drugs. Companies with differentiated products are doing well (Abbott Labs' (NYSE:ABT) Humira, Edwards Lifesciences' (NYSE:EW) transcatheter heart valve), Intuitive Surgical's (Nasdaq:ISRG) DaVinci surgical robot and tools), but general trends seem more like "muddle through" right now.

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Seeking Alpha: Sanofi Still Surprising And Surpassing

It typically takes a while for the Street to really buy into a better-than-expected story, and it looks like catch-up is still the name of the game around French drug giant Sanofi (SNY). While growth is not great in absolute terms, there's more value here than many analysts seem able to see. Investors can take advantage of a company that should offer above-average growth and yield over the next three to five years.

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Sanofi Still Surprising And Surpassing

Seeking Alpha: Will Alnylam Raise Money Soon?

There's an old adage in biotech that says you raise money when you can, regardless of whether you really need it at the moment. With very strong early-stage data in hand on lead compound ALN-TTR02, Alnylam Pharmaceuticals (ALNY) may well be considering whether it is time to raise money again.

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Will Alnylam Raise Money Soon?

Seeking Alpha: Alnylam Far From Primetime, But Still An Intriguing Prospect

Here at the midpoint, 2012 is looking like a strong year for biotech and some risky names have done quite well. Although not coming close to the gains seen in Arena Pharmaceuticals (ARNA), Amylin Pharmaceuticals (AMLN), or Lexicon Pharmaceuticals (LXRX), RNA interference specialist Alnylam Pharmaceuticals (ALNY) has come on strong with encouraging early-stage data and a greater risk tolerance on the part of investors.

All of the standard warnings apply to Alnylam, as the company is indeed many years from potential product approvals and none of the company's programs are in advanced trials. Upping the risk even more is the fact that RNA interference is still an unproven approach and many Big Pharma companies appear to have backed away from the technology. All that said, this company has a broad clinical program, numerous high-value targets, deep IP, and a healthy balance sheet.

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Alnylam Far From Primetime, But Still An Intriguing Prospect

Seeking Alpha: Sanofi May Just Have It All

Although I don't own it, I'm wondering if Sanofi (SNY) may just be the model of what a Big Pharma ought to look like. The company is exceptionally well-balanced geographically (with roughly 30% exposure to the U.S., EU, and emerging markets) and has a complimentary array of businesses that includes generics, vaccines, OTC, and branded drugs. Sanofi also strikes a solid balance between drug types (biologics, etc.) and pipeline risk/reward.

While Sanofi still has some patent expirations to digest, this company actually has one of the better growth profiles in the space right now. It also happens to look meaningfully undervalued.

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Sanofi May Just Have It All

Seeking Alpha: Is AEterna Zentaris Really Worth All This Fuss?

As a general rule, if you want to get the hate mail rolling in, write about a controversial biotech stock. And since I'm feeling a decided lack of people questioning my intelligence, ethics, and consanguinity of my parents, I thought I would wade into the maelstrom that is AEterna Zentaris (AEZS).

A New Contender For A Sizable Market
Treatment-resistant cancers are a popular target for biotechs and pharmaceuticals these days, as the thresholds of approvable efficacy tend to be more reasonable and the lack of alternatives usually supports very profitable pricing. One of the larger markets within this group is resistant colorectal cancer; although colorectal cancer is generally very treatable if caught early, not all patients are so lucky and the sheer frequency of the cancer makes the treatment-resistant population sizable.

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Is AEterna Zentaris Really Worth All This Fuss?

Investopedia: Sanofi's Investment Prospects

Although Sanofi (NYSE:SNY) has not always gotten the attention that other major pharmas have drawn for their respective restructuring efforts, Sanofi has changed in some meaningful respects over the past few years. The company could still handle some of its internal operations a bit better, and there are definitely still some challenges to its revenue base, but investors would do well to consider one of the largest pharmaceutical companies in the world for their portfolios.

The Good  
Sanofi certainly has the scale that it takes to compete in the modern global pharmaceuticals market, as this is not only the fifth-largest drug company, but also one that is well-balanced between markets in the United States and non-U.S. markets. Moreover, the company has a sizable vaccines franchise and has been reinvesting capital in ancillary divisions like consumer health and animal care. (For related reading, see A Primer On The Biotech Sector.)

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Investopedia: XOMA Rearranges The Deck Chairs One More Time

XOMA (Nasdaq:XOMA) really is a remarkable story in many ways. Few companies have survived so long, and raised capital so many times, and done so little with it. While the company has actually approached $100 million in reported sales, and not many biotechs do even that much, the company has never had any real success in the clinic and has basically strung along successive generations of investors on hype and hope. Now that the company is changing up management yet again, investors should be asking themselves if there is really a good reason to stick by a company that has floundered around for more than 20 years to no real purpose.


A Change at the Top
XOMA announced Wednesday that it's CEO Steve Engle was bailing on the company. Engle said, "I am looking forward to applying my expertise building life science companies in the future."

Hmmm, expertise? Engle became XOMA's CEO in August of 2007. In the those four years, XOMA has gone from a market cap north of $350 million to a current market cap of just under $64 million, and the company really is not a great deal closer to having a winning product in its portfolio.


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http://stocks.investopedia.com/stock-analysis/2011/XOMA-Rearranges-The-Deck-Chairs-One-More-Time-XOMA-REGN-PFE-ABT-ISIS-VICL-CELG0901.aspx

Seeking Alpha: Do Dendreon's Problems Matter To Your Biotech Portfolio?

There was no shortage of skeptics about the true market potential of Dendreon's (DNDN) Provenge cancer vaccine, but there were few credible prognosticators who predicted the magnitude of the disappointment in Provenge sales. What has been most interesting about the reaction to this shortfall, though, is how it blitzed the entire biotech sector. While the data gets sketchier the further back one goes, the post-Dendreon reaction Thursday (a bad day for the market overall), may have resulted in the worst single day in the history of the sector.

The question for investors, though, is whether or not the problems at Dendreon really have anything to do with their particular holdings. Though many investors may have sold their biotech stocks after the Dendreon news thinking that it's just too hard to figure out the eventual winners and losers (after all, FDA approval is supposed to the key to the vault), the reality is that nothing at all has really changed for the large majority of companies developing new drugs for diseases like hepatitis C, diabetes, or cancer.

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Do Dendreon's Problems Matter to Your Biotech Portfolio?

Can Savient Soar On One Specialty Drug?

Getting Food and Drug Administration approval for a new drug is usually a slam-dunk piece of good news for a company. For Savient Pharmaceuticals (Nasdaq:SVNT), though, it is only part of the story. While approval of the company's new gout treatment is absolutely a major positive development for shareholders, the ultimate fate of the company is still up in the air.  (Learn about some of the most profitable drugs of all time in Stocks On Drugs: What It Takes To Get High.)  


A Specialty Drug for a Rare Indication
Although gout is thought of as a disease from yesteryear, it still occurs in the Western world. For whatever reason, there is a modest percentage of gout patients who do not respond to current therapies, and Savient's drug (Krystexxa) could be a new option for them.

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http://stocks.investopedia.com/stock-analysis/2010/Can-Savient-Soar-On-One-Specialty-Drug-SVNT-NVS-REGN-RDEA-AMGN-RHHBY-BMY0916.aspx