Alnylam Posts Another Encouraging Quarter Early In Onpattro's Launch

As difficult as it is to get a drug from the lab to the market, that's only part of the formula for success for biotechs - successful commercialization is every bit as important, and commercialization can have its own frustrating bumps along the road. While I see nothing wrong with the launch trajectory of Alnylam's (ALNY) Onpattro, it would seem that investors were spooked by quarter-to-quarter lumpiness in some of the launch metrics.

I continue to believe Alnylam is an appealing albeit high-risk investment opportunity. Onpattro is off to a good start, and the company should see a series of needle-moving regulatory approvals and commercial launches over the next few years, with more than a couple drugs holding $1 billion-plus revenue potential.

Follow this link to the rest of the article:
Alnylam Posts Another Encouraging Quarter Early In Onpattro's Launch

A Sluggish Start With Onpattro Is Not What Alnylam Shareholders Needed

There’s not much any company can do about a bad tape, but Alnylam (ALNY) has seen sentiment sour pretty sharply since late 2017 despite the approval and launch of its first drug Onpattro. Between worries about greater competition (moreso from Pfizer (PFE) than Ionis (IONS)/Akcea (AKCA)), competition in other disease indications, longer clinical timelines, overall drug pricing, and so on, Alnylam added one more worry to the mix with a disappointing initial quarterly launch number for Onpattro.

While it’s true that a single quarter doesn’t tell you much of anything about a drug’s future, it’s still not the beginning that investors wanted for a highly-valued biotech that made the choice to take on more commercial responsibility ostensibly to maximize the value of its pipeline. I’m still a believer in Alnylam, but the Onpattro launch could well be less like Ionis/Biogen’s (BIIB) Spinraza, Alexion’s (ALXN) Strensiq, or Vertex’s (VRTX) Kalydeco than investors had hoped, and further disappointment is just not what the stock needs right now.

Continue here:
A Sluggish Start With Onpattro Is Not What Alnylam Shareholders Needed

Approval, Labeling, Pricing, And Competitor Data All Give Alnylam Pharmaceuticals A Wild Ride

It’s been an interesting period of time to be an Alnylam (ALNY) shareholder, as the company got its first FDA approval (Onpattro), but with a narrower label than hoped and a somewhat confusing price structure. On top of that, a key potential competitor that wasn’t even seen as much of a player just a year ago has come out with data that, while strong, doesn’t exactly lock the door on Alnylam.

I’m finding that relatively conservative expectations have helped me out with Alnylam; the company’s announced net pricing was 1.5% lower than my estimate, and I never had modeled any revenue for Onpattro from more cardiomyopathy-oriented hATTR patients. While data from Pfizer’s (PFE) tafamidis does set a high bar for Alnylam’s ALN-TTRsc02 (or “sc02”), here too I haven’t been expecting Alnylam to run away with the market. All told, I’m still feeling relatively comfortable continuing to own these shares and with a $150 fair value estimate.

Follow this link for the full article:
Approval, Labeling, Pricing, And Competitor Data All Give Alnylam Pharmaceuticals A Wild Ride

Alnylam About A Week Away From Its First Approval

With an FDA PDUFA date about one week away for its lead drug patisiran (which Alnylam (ALNY) will market as “Onpattro”), the value in the company’s second quarter earnings report was mostly in regard to its pipeline updates. Alynylam has ample cash to continue moving its deep clinical pipeline toward commercialization, and Alnylam could well be looking at meaningful new drug approvals in 2018 (patisiran), 2019 (givosiran), 2020 (lumasiran, fitusiran, and inclisiran), and 2021 (ALN-TTRsc02), with total peak-revenue potential in the multiple billions of dollars.

Alnylam shares have been weak of late, and there is some modest risk going into the PDUFA date – less so in terms of whether the drug will be approved, but rather what the label will look like. There will also be a more detailed presentation of data from Pfizer’s (PFE) tafamadis later this month, a drug that has more recently re-emerged as a potential competitive threat. All told, though, I believe Alynylam shares remain substantially undervalued today.

Continue here:
Alnylam About A Week Away From Its First Approval

Despite Recurrent Market Jitters, Alnylam Is Closing In On Multiple Drug Approvals

Holding shares in Alnylam Pharmaceuticals (ALNY) isn’t for the weak-hearted, as seen recently in reaction to a competitor’s unexpectedly strong clinical data. While Alnylam has long been volatile, and remains risky given the nature of the diseases it targets and its reliance on biomarker data, it is also close to its first drug approval and what may well prove to be a multiyear run of drug approvals that will quickly make the company a player in rare diseases.

Click here to continue:
Despite Recurrent Market Jitters, Alnylam Is Closing In On Multiple Drug Approvals