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

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.

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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.

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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.

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Alnylam About A Week Away From Its First Approval

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

Astellas Changing Its Approach, But Investors Are Skeptical

Astellas (OTCPK:ALPMY) still has quite a bit of work to do. While Astellas is still among the largest of the Japanese drug companies (behind Takeda (OTCPK:TKPYY)) and one of the most profitable (in terms of CROCI), the company has a well-earned reputation for a weak internal R&D effort and a heavy reliance upon partnerships and M&A to drive its pipelines. Making matters worse, the company has had a number of setbacks, including stopping the development of Xtandi in breast cancer and halting its once-promising EGFR inhibitor for lung cancer.

Even with that sour backdrop, Astellas shares could be worth a look. There are credible reasons to believe that Xtandi sales growth could re-accelerate and late-stage pipeline assets like roxadustat, gilteritinib, and claudiximab should help offset the loss of patent coverage for Vesicare (a major sales contributor). Moreover, Astellas seems to have accepted that its internal R&D efforts are not up to snuff, and instead of throwing good money after bad, has chosen to refocus around partnering and external development. It's a risky move, but it arguably does play to Astellas's relative strength as a marketing operation (versus an R&D innovator). With the shares potentially undervalued by more than 10%, Astellas is worth consideration from investors looking to add some OUS pharmaceutical exposure.

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Astellas Changing Its Approach, But Investors Are Skeptical

The Motley Fool: Can Roche Find Rare Success In Alzheimer's?

Tomorrow will be an interesting day for Roche (NASDAQOTH: RHHBY  ) , its shareholders, and those interested in the treatment of Alzheimer's disease (or AD). Roche is scheduled to report phase 2 data on its antibody therapy crenezumab in patients with mild and moderate Alzheimer's. It is wise to expect little from any experimental AD, as this disease has frustrated almost every company that has attempted to develop a therapy, but the potential of a successful drug is so high that any credible attempt is at least worth watching.

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Can Roche Find Rare Success In Alzheimer's?

The Motley Fool: AbbVie and Shire Close, but Not There Yet

Patience and persistence on the part of AbbVie (NYSE: ABBV  ) may be close to paying off in its pursuit of Shire plc (NASDAQ: SHPG  ) . Shire's management has indicated that it can recommend AbbVie's latest offer, and it is an offer that still leaves some upside for AbbVie and its shareholders. It's definitely not a done deal though – not only might the two companies come to an impasse over "other items" still to be resolved, but now that the price is more or less set other bidders may jump into the fray.

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AbbVie and Shire Close, but Not There Yet

The Motley Fool: Is Pfizer Putting the Car-T Before the Horse?

Immuno-onocology is grabbing a large share of the headlines in oncology drug development these days and generating significant buzz for Big Pharma companies including Merck and Bristol-Myers Squibb (NYSE: BMY  ) . While Pfizer (NYSE: PFE  ) has not been seen as a leader in IO drug development, the company does have antibodies in development targeting IO targets like 4-1BB, OX-40, and PD-1. Now the company has added more shots on goal to its IO platform, striking a collaboration agreement with French biotech Cellectis to develop chimeric antigen receptor T-cell therapies, an unproven but high-potential emerging therapeutic class.

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Is Pfizer Putting the Car-T Before the Horse?

The Motley Fool: 3 Undervalued Amgen Growth Opportunities to Watch

Amgen (NASDAQ: AMGN  ) hasn't put as many eggs into the megablockbuster basket as Merck or Bristol-Myers Squibb, nor has it sought to utterly dominate a therapeutic area the way Biogen Idec may dominate MS. What Amgen does offer, though, is a deep pipeline that goes well beyond the much-discussed PCSK9 cholesterol market. Biosimilar risk is a real threat to the current marketed portfolio, and Amgen does not have much to offer within the hot immuno-oncology sector. Less-appreciated opportunities in psoriasis and migraine could offer upside as analysts start working those into their models, though.

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3 Undervalued Amgen Growth Opportunities to Watch

The Motley Fool: 4th Time Not (Yet) the Charm for Pfizer

Pfizer (NYSE: PFE  ) is certainly not letting AstraZeneca (NYSE: AZN  ) slip away without a good fight. While Pfizer has been on a charm offense on both sides of the ocean trying to convince politicians that the deal is a legitimate business combination and not a cost-cutting tax dodge, the company has also stepped up its financial consideration to AstraZeneca shareholders. With AstraZeneca's board rejecting the latest and according to Pfizer the "final" offer, it remains to be seen if the international charm offensive can win over enough AstraZeneca shareholders to lead them to put pressure on their board to come to the negotiating table.

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4th Time Not (Yet) the Charm for Pfizer

The Motley Fool: Healthcare Buyout Mania: Now What?

It feels like there's nothing to talk about in the pharmaceutical space these days other than the latest M&A bid. Just in the last day and a half, investors have seen news on five completed or proposed transactions. And I doubt the deal-making is done.

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Healthcare Buyout Mania: Now What?

The Motley Fool: After Missing Earnings, Is Pfizer a Good Value?

When Pfizer (NYSE: PFE  ) last reported earnings I was pretty ambivalent about the stock, and since that late January piece the shares have lagged both the broader market and pharma industry peers like Merck, Lilly, and Novartis. It's not as though the company has been sitting still either, what with positive clinical updates on its Prevnar vaccine and palbociclib oncology drug. Dwarfing all of that is the potential megadeal for British pharma company AstraZeneca (NYSE: AZN  ) . Pfizer needs to guard against overpaying in this potential deal, but these shares are getting closer to an interesting entry point for long-term investors.

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After Missing Earnings, Is Pfizer a Good Value?

The Motley Fool: Pfizer, Inc. Rebuffed: Is AstraZeneca plc Worth Another Try?

Big-time pharma mergers have had a mixed track record, with large combinations often leading to significant cost reductions (and firings) in sales and administration but at the cost of large disruptions to R&D. Pfizer (NYSE: PFE  ) is apparently not afraid to give it another try, as word came out over the Easter holiday that the company has approached AstraZeneca (NYSE: AZN  ) with a $100 billion-plus bid to acquire this once-struggling pharma giant.

Time will tell if Pfizer can coax AstraZeneca to the negotiating table and seal a deal, but such a combination may not be as big of a risk for Pfizer as it may immediately seem.

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Pfizer, Inc. Rebuffed: Is AstraZeneca plc Worth Another Try?

Seeking Alpha: A Sharp Pullback In Celldex Could Be A Window Of Opportunity

To buy when others seemingly can't sell fast enough takes a lot of guts (and other less family-friendly attributes), but it can be one of the best ways to exploit Wall Street shortsightedness. Small-cap oncology immunotherapy biotech Celldex (CLDX) has gotten swept up in this biotech bubble-popping, even though the data from the company has generally been positive and supportive of the idea that this company has some promising high-potential drugs.

On a risk-adjusted basis, I calculate a fair value of $29 per share for Celldex, suggesting significant upside from today's level. Readers have to consider two key risks here. First, there is the ever-present biotech risk that Celldex's drugs will fail in advanced clinical studies and never make it to market. Second, there is a growing risk that investors are cycling out of biotech and may no longer be willing to use the same long-term revenue multiples and discount rates. A true rout in the biotech space could take these shares down another 50% without any bad news from the company, but investors who can stomach that risk as the price of admission to a potential winner should look further into this story.

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A Sharp Pullback In Celldex Could Be A Window Of Opportunity

The Motley Fool: Pfizer Inc's Palbociclib Delivers the Goods

Pfizer (NYSE: PFE  ) could use another blockbuster right now, and data presented from the phase 2 PALOMA-1 study for its CDK 4/6 inhibitor palbociclib over the weekend suggests it likely has one. The only major issue now could be the Street's already aggressive expectations, particularly as they pertain to Pfizer filing for approval on the basis of phase 2 data and getting to the market ahead of Lilly (NYSE: LLY  ) and Novartis (NYSE: NVS  ) . 

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Pfizer Inc's Palbociclib Delivers the Goods

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: Will Pfizer Inc's Vaccine Strategy Pay Off?

Pfizer (NYSE: PFE  ) recently lost a battle to preserve its patent coverage on Celebrex, but it's not all bad news for this pharmaceutical giant. The company's Prevnar-13 pneumococcal vaccine is shaping up as a stronger-than-expected product, with comprehensive outcomes data potentially supporting much broader recommendations for use and a larger addressable market. Better still, it's not just Prevnar that could drive higher vaccine sales for Pfizer in the coming years.

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Will Pfizer Inc's Vaccine Strategy Pay Off?

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