Alnylam Pharmaceuticals Flying High Despite Limited Near-Term Clinical Catalysts

 

The market has proved much more interested in Alynylam Pharmaceuticals (NASDAQ:ALNY) since my last update, with the shares up 45% and far head of the two major biotech indices, as the market has shrugged off some strong competitor data and looked past a period of relatively little thesis-changing clinical data.

While I’m bullish on the company’s pipeline, including vutrisiran for ATTR amyloidosis and zilebesiran for hypertension, I can’t argue that the shares are going underappreciated now. There are still potential incremental value-drivers (like cemdisiran) and early-stage programs well worth watching in areas like gout and NASH, but the current valuation seems to capture that pretty well.

 

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Alnylam Pharmaceuticals Flying High Despite Limited Near-Term Clinical Catalysts

Alnylam Pharmaceuticals Logs Another Clinical Win For Its Amyloidosis Program

Despite a few hiccups recently in partnered/out-licensed programs, Alnylam (ALNY) recently announced another clinical win for its ATTR amyloidosis program, and the company moves into 2021 with three approved products, a fourth soon to come, and a deep pipeline that the company discussed in more detail during a two-day R&D event back in December.

Alnylam had a respectable 2020 from a market performance standpoint, but couldn’t keep pace with the broader biotech sector. With 2021 looking a little light in terms of thesis-changing events, it could be a little harder to maintain the momentum, but I do believe the pipeline and commercial opportunities support a fair value in the mid-$160’s.

 

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Alnylam Pharmaceuticals Logs Another Clinical Win For Its Amyloidosis Program

Alnylam Seeing A Rebound In Onpattro And Encouraging Early-Stage Hypertension Data

Trading in Alnylam Pharmaceuticals (ALNY) shares has been choppy since my last update, and all year frankly, with a small decline in the share price since that last update in late September. Since then, the company has reported another good quarter of Onpattro sales, as the healthcare community learns more about how to work around the COVID-19 pandemic, as well as further positive data on multiple programs, including the early-stage ALN-AGT program in hypertension.

While a pause in a Phase III study of fitusiran (managed/controlled by partner Sanofi (SNY)) is a negative development, updates on Oxlumo and ALN-AGT have been more positive, leading to a small net improvement in my estimated fair value, taking the fair value to a little over $160. Two more Alnylam compounds should receive FDA approval before year-end, and 2021 is set to see multiple significant clinical developments, including the initiation of a study for a compound that works outside the liver. Given a high-quality pipeline, the potential to expand its technology into new treatment areas, and solid growth potential in its approved compounds, I continue to believe that Alnylam is a biotech stock worth owning at these levels.

 

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Alnylam Seeing A Rebound In Onpattro And Encouraging Early-Stage Hypertension Data

Alnylam Reports Another Positive Study Outcome, Securing More Of Its Future Revenue Growth

While the last couple of months have been a little quiet, Alnylam (ALNY) continues to make progress across its business. Positive topline results from the ILLUMINATE-B study not only should help solidify the revenue outlook for lumasiran, they also mark the first study of an RNA interference (or RNAi) therapy in a young pediatric population, with a clean safety profile possibly paving the way to future clinical opportunities. The company has also since secured some R&D financing for its vitusiran and ALN-AGT programs, and shown additional positive long-term data on Gilvaari.

Incremental as these updates may be, they’re positive additions to the story and certainly better than the alternative. I expect Alnylam to report improving trends for Onpattro in the third quarter as the situation starts to normalize after disruptions created by COVID-19, but more significant drivers like additional clinical data on ALN-AGT and the approval and launch of inclisiran are still a little further off. A lack of strong near-term drivers is a concern, but I believe Alnylam is undervalued below the $150’s and still worth buying/owning at these levels.

 

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Alnylam Reports Another Positive Study Outcome, Securing More Of Its Future Revenue Growth

Clinical Data Reaffirm That Lumasiran Will Almost Certainly Be Alnylam's Third Commercial Product

Alnylam (ALNY) is well on its way to having its third commercial product before the end of 2020. A prior release of positive top-line data from the company's pivotal ILLUMINATE-A study of lumasiran already indicated approvable efficacy, but the full data presented on Sunday June 7 added some valuable context to what should be a worthwhile commercial opportunity for the company.

As I indicated in my last article on Alnylam, I still regard this stock as a long-term holding in my portfolio, but I wasn't as excited about the near-term price performance potential in early May. With the shares down about 10% since then, the opportunity is more interesting now, though I have some modest "strategic" concerns that the strong rally in biotech relative to the S&P could leave the sector more vulnerable to near-term profit-taking as investors regain confidence in a stronger/quicker post-Covid-19 economic recovery.

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Clinical Data Reaffirm That Lumasiran Will Almost Certainly Be Alnylam's Third Commercial Product

Alnylam Pharmaceuticals Continues To Execute, Though Covid-19 Is A Near-Term Hurdle

Alnylam’s (ALNY) management simply continues to execute, logging another quarter of better than expected results and moving the pipeline forward. While Covid-19 is going to create some near-term challenges for the Onpattro franchise, it should be recoverable later in the year provided that a renewed surge in infections doesn’t prompt another round of shutdowns. On a more lingering note, though, Covid-19 is creating some trial delays that won’t be recovered, but these aren’t particularly material.

With the shares up roughly 30% from my last article a month ago, I can’t complain about the performance. I do still see some upside from here, and I personally consider this a long-term holding, but I can’t really recommend it as enthusiastically as before given the lower relative undervaluation. Given the historical volatility, though, I’d suggest keeping an eye on this for a “buy on a pullback” opportunity.

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Alnylam Pharmaceuticals Continues To Execute, Though Covid-19 Is A Near-Term Hurdle

Alnylam Out-Licenses A Less-Promising Program

Biotech has held up surprisingly well in this market downturn, more or less tracking the S&P, but Alnylam (ALNY) has managed to outperform on a relative basis – showing only a small year-to-date decline. I’d like to believe that’s a recognition of the company’s strong pipeline, as well as the fact that it really doesn’t need near-term financing, but there’s always guesswork in interpreting near-term moves like that.

I continue to believe that Alnylam shares are undervalued, and that management is running the company with a sound business plan. The latest example is the company’s decision to out-license ALN-AAT02 for alpha-1 antitrypsin deficiency; a move that cuts the company’s R&D spending needs for a less-promising program while still maintaining some upside based on the work done to date.

While 2020 isn’t the most catalyst-rich year for this company, Alnylam investors should nevertheless see FDA approvals for two more compounds (inclisiran, licensed to Novartis (NVS), and wholly-owned lumasiran), allowing the company to enter 2021 with four approved drugs and key data on the way from its TTR amyloidosis program.

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Alnylam Out-Licenses A Less-Promising Program

Alnylam Pharmaceuticals Beats Again, But The Bar Keeps Moving Higher

Closing the books on a very successful 2019, Alnylam (ALNY) didn’t offer all that much that was new at the JPMorgan Healthcare conference, and that more than anything may well explain why the stock didn’t perform particularly well after the company’s presentation. It looks to me as though a lot of stocks, particularly in biotech, were set up for a “buy into the conference, sell during the presentation” trade, as there hasn’t yet been much in the way of thesis-changing news (let alone the M&A activity some were hoping for) coming out of the meeting.

Turning back to Alnylam, though, there’s still a great deal to like about this biotech. Last year saw several successful trial read-outs, particularly the extensive trials done by The Medicines Co (now owned by Novartis (NVS)) for inclisian, largely de-risk the company’s platform, and other studies have validated the company’s new delivery chemistry – chemistry that should prove key in targeting diseases outside the liver. On top of all that, the company has a well-balanced pipeline with two drugs lined up for possible approval in 2020 and multiple compounds in Phase III and Phase II testing.

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Alnylam Pharmaceuticals Beats Again, But The Bar Keeps Moving Higher

With Positive Phase III Data From Lumasiran, Alnylam On Track For Another Approval

Some investors may well believe that Alnylam (ALNY) had already de-risked its lumasiran program for primary hyperoxaluria Type 1 (or PH1) with strong Phase II and open-label extension study data, but there is a reason that the FDA requires pivotal studies, and Alnylam came through with strong clinical results that will support a New Drug Application to the FDA early in 2020 and likely an approval before the end of the year.

With the positive lumasiran results, Alnylam is closing in on its third wholly-owned commercial product (joining Onpattro and Givlaari), and The Medicines Co. (MDCO) (which is being acquired by Novartis (NVS)) moving forward with inclisiran, Alnylam will likely be generating revenue from four drugs in 2020, with a fifth (Sanofi's (NASDAQ:SNY) fitusiran) not far behind in 2021.

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With Positive Phase III Data From Lumasiran, Alnylam On Track For Another Approval

Alnylam Pharmaceuticals Sheds Some Light On Its Expanding Early-Stage Opportunities

Although I hadn’t planned writing two articles on Alnylam Pharmaceuticals (ALNY) in close succession, the early approval of Givlaari and the subsequent R&D meeting both argued for a write-up, as both are significant to the long-term investment story.

Alnylam’s Nov 22 R&D Day was perhaps more evolutionary than revolutionary, but it confirmed what I believe are some key points to the story – management is attentive to the need to become a profitable enterprise, the company’s ongoing investments in basic chemistry continue to pay dividends, and the company has established a strong R&D platform that could produce multiple new drug candidates every year.

With expanded information on a handful of early-stage programs, I’ve raised my fair value estimate by a small amount, but the key drivers remain the commercial uptake of Onpattro, the success of trials that could enable Onpattro and vitusiran to compete in the larger AATR cardiomyopathy and mixed phenotype markets, the launch of Givlaari, and path to commercialization for lumasiran, inclisiran, and fitusiran.

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Alnylam Pharmaceuticals Sheds Some Light On Its Expanding Early-Stage Opportunities

Alnylam Pharmaceuticals Secures Its Second Approval, And The Pipeline Is Still Attractive

With Alnylam Pharmaceuticals (ALNY) shares up almost 30% since my last update on the company, I can’t complain that the Street is undervaluing this RNAi pioneer nearly as much as before. Still, the company continues to build a strong investment case with two approvals in hand, another possible in 2020, and an increasingly attractive pipeline with expanding delivery options and potential therapeutic targets.

More than 55% of my fair value estimate for Alnylam is still tied to its ATTR amyloidosis portfolio, but compounds like Givlaari, inclisiran, fitusiran, and lumasiran are not just “also-rans”, and Alnylam management may well use its upcoming R&D day to further illuminate its clinical development priorities for the next few years. At this point, I believe Alnylam shares should trade closer to $130.

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Alnylam Pharmaceuticals Secures Its Second Approval, And The Pipeline Is Still Attractive

Alnylam Executing, But Concerns About Safety And Competition Linger

In terms of controlling what they can control, I believe Alnylam Pharmaceuticals (ALNY) management is doing a good job. While there has certainly been criticism of the high cash burn and the large sums that the company spends on R&D, I believe funding a robust Phase III development program is a sound strategy to build the business. In the meantime, though, the shares seemed to be dogged not only about concerns about the ongoing cash burn, but also concerns about competition and platform safety. My position remains that Alnylam is in a stronger position than the share price reflects.
 Competition is always going to be a threat (any indication worth targeting will attract competition), but I believe the safety questions are closer to resolution. With another approval likely in early 2020 and a robust late-stage platform, I still believe these shares should trade closer to $130.

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Alnylam Executing, But Concerns About Safety And Competition Linger

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.

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Alnylam Posts Another Encouraging Quarter Early In Onpattro's Launch

Data On Givosiran And Lumasiran Should Help The Alnylam Story

Even as Alnylam (ALNY) works toward its second commercial drug filing, questions remain about the safety and efficacy of givosiran, not to mention the platform as a whole. But with good full Phase III data on givosiran and encouraging open-label extension data on lumasiran over the last few days, the story has gotten a little better in my view. These shares still remain undervalued, but there remain numerous risks including FDA approval, the efficacy and safety of the lead pipeline candidates, competition, and challenges related to commercialization, including identifying patients and securing reimbursement.

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Data On Givosiran And Lumasiran Should Help The Alnylam Story

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

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

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

Alnylam Pharmaceuticals Could Use Some Straightforward Good News

Alynlam Pharmaceuticals (ALNY) could really use some straightforward, clean, good news right now, as several of the company’s recent positive events have been “yes … but” situations. Today’s update on givosiran in acute hepatic porphyria is a case in a point. While the drug seems to be effective (as expected), with a highly statistically-significant reduction in ALA (a biomarker), the safety of the drug is likely to be a talking point until, and perhaps after, the full Phase III data package is available. On the back of some concerns about the cardiac safety profile of Onpattro (and implications for the important ALN-TTRsc02 (“sc02”) program), it’s not exactly the news investors really want to hear.

I continue to believe that Alnylam is undervalued, and that it’s pipeline of drugs for rare diseases, led by recently-approved Onpattro, will generate substantial revenue in the coming years. I’ve tweaked some of modeling assumptions, but I continue to believe that the shares should trade over $140, though there are above-average risks.

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Alnylam Pharmaceuticals Could Use Some Straightforward Good News