Alnylam Is A Step Closer To Its Second Approved Drug

The last twelve months haven’t been particularly good in terms of market performance for Alnylam Pharmaceuticals (ALNY), and that hasn’t really changed much over the last three months either, as the shares continue to lag biotech indices. With top-line Phase III givosiran data looking good on efficacy but leaving some questions as to safety, the ENVISION study hasn’t been much of a catalyst and that may be the case for a little while longer. I do believe these shares remain undervalued, though, and offer some attractive long-term upside.

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Alnylam Is A Step Closer To Its Second Approved Drug

Alnylam Reports Improved Onpattro Sales Going Into A Busy Year

Alnylam's (ALNY) shareholders have been holding on in the hope of some good news and the company finally provided some with the start of J.P. Morgan’s annual healthcare conference. A stronger quarterly result for the company’s lone commercialized drug (Onpattro) should restore some confidence in this program while management continues to stay very busy on the clinical front.

I continue to believe that Alnylam is undervalued, but the reality is that biotech is not in favor and this company still has a lot to prove. Over half of the value I estimate for the company is tied to clinical programs that have yet to produce pivotal data, and the long-term sales execution on Onpattro is not guaranteed. Likewise, Alnylam is targeting multiple diseases that are challenging not only from a biological perspective, but from a commercial one as all (finding patients, getting them on therapy, etc.). Though I continue to expect meaningful long-term gains from Alnylam, this is by no means a name suited for nervous investors.

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Alnylam Reports Improved Onpattro Sales Going Into A Busy Year

Alnylam Pharmaceuticals Tries To Rally The Troops With A Blizzard Of New R&D Candidates

There are two criticisms you’ll never read about Alnylam (ALNY) – that management is insufficiently promotional of the company, and that it doesn’t have enough pipeline candidates/ideas. Always a company with many irons in the fire, Alnylam hosted an R&D day Thursday that was a little like drinking from a fire hose in terms of the sheer number of early-stage projects and potential clinical compounds.

In terms of valuation-driving news, though, there wasn’t too much to come out of this event. I am not generally fond of assigning values to compounds before Ph I results are in hand, and I tend to think that assigning values for “platforms” or pre-clinical pipelines is most often used as a way to goose price targets beyond what the actual pipeline would otherwise support. Be that all as it may, I continue to believe that Alnylam shares are meaningfully undervalued, but the company really needs to issue a positive update on Onpattro sales in January to drive better sentiment for the shares.

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Alnylam Pharmaceuticals Tries To Rally The Troops With A Blizzard Of New R&D Candidates

2018 Brings New Challenges And Opportunities For Alnylam Pharmaceuticals

By any reasonable set of standards, 2017 was a successful year for Alnylam (ALNY), as this biotech reported excellent data from the pivotal study of its lead drug patisiran and advanced other compounds further into development as well. This year will bring a new set of challenges, including the commercialization of patisiran and its transition to a product revenue-generating biotech company. Although I believe patisiran's strong data will lead to it claiming the lion's share of its market, commercialization offers a different set of challenges. What's more, while Alnylam should be looking at multiple commercializations in the next few years, recharging the pipeline may start to become a bigger talking point later this year.

I continue to believe that Alnylam is risky but attractively-priced. Patisiran makes up over 60% of my fair value estimate on the shares, but there are opportunities for additional clinical data on/from givosiran and lumasiran to add more value over the next 12 months.

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2018 Brings New Challenges And Opportunities For Alnylam Pharmaceuticals

Seeking Alpha: Alnylam Pharmaceuticals Continues To Post Encouraging Results

Having written about Alnylam Pharmaceuticals (NASDAQ:ALNY) in early November, I thought I'd be done with covering the stock for a few months. Alnylam likes to make its analysts and shareholders work, though, and the updates from the company since then do merit further discussion.

Fortunately for shareholders, the updates are universally positive. Revusiran appears to be safe and while efficacy remains unknown, the company has launched the Phase III ENDEAVOUR study. Alnylam has also reported encouraging early-stage data on its ALN-AT3 hemophilia treatment, started a Phase I/II study for ALN-CC5, and has seen partner The Medicines Company (NASDAQ:MDCO) start clinical studies of ALN-PCSsc. Last and not least, the company has shifted its strategic and research priorities a bit, with three large areas of focus.

Much as I don't like the well-trod path on the sell-side of "the stock has reached my price target, so I'll raise my target", the changes in just the last month do prompt me to bump my fair value estimate higher.

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Alnylam Pharmaceuticals Continues To Post Encouraging Results

Seeking Alpha: Alnylam Pharmaceuticals Staying Ridiculously Busy

Investors who prefer biotechs with potential platform technologies that can support multiple drug candidates can still find a lot to like in Alnylam Pharmaceuticals (NASDAQ:ALNY). With the shares up about 60% over the past year, a $6.6 billion-plus market cap, and multiple analysts following the stock, this is no longer an under-the-radar play on RNA interference, but the company's preclinical research efforts continue to produce interesting new candidates while those already in the clinic are showing meaningful potential.

For a company with one late-stage program, it may seem hard to argue that Alnylam shares are seriously undervalued today. At the same time, I would note that trial read-outs later this year and in 2015 could add significant value as investors revise their projected odds of approval and revenue expectations. I continue to hold these shares myself and I certainly think they make sense in a portfolio for investors who are comfortable with the risks that attend biotech stocks.

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Alnylam Pharmaceuticals Staying Ridiculously Busy