Alnylam shares hold steady as BMO maintains Outperform rating

On Thursday, BMO Capital maintained a positive outlook on Alnylam Pharmaceuticals (NASDAQ:ALNY) by reiterating an Outperform rating and a $300.00 price target. The firm's confidence is bolstered by management's presentation on Amvuttra, highlighting its unique position in the market based on recent HELIOS-B study data, insurance coverage details, and the drug's modality characteristics.

Management at Alnylam has expressed strong confidence in Amvuttra's market potential, especially in the treatment of ATTR-CM, a type of cardiac disease. Despite the competitive nature of the ATTR-CM market, the company's management has taken a conservative yet balanced approach, recognizing the significant efforts needed to maintain a competitive edge.

BMO Capital notes Alnylam's track record of successful execution and its established presence in the treatment of ATTR-PN, an inherited peripheral nerve disease, as indicators of a potentially successful launch for Amvuttra in the ATTR-CM segment. This optimism is further supported by the company's swift submission of a supplemental New Drug Application (sNDA) for Amvuttra, which set a record for the fastest readout-to-filing time among ATTR-CM treatments.

The anticipated acceptance of Amvuttra's sNDA by December 8, 2024, is seen as likely, with a low expectation for an Advisory Committee (AdCom) meeting. This is due to Amvuttra's achievement of all primary and secondary endpoints in its clinical trials, suggesting a smooth regulatory process ahead.

In other recent news, Alnylam Pharmaceuticals has been making significant strides, particularly with its Q2 earnings report exceeding expectations in both revenue and profit. This led to an updated 2024 revenue guidance of between $1.575 billion and $1.65 billion, attributable to the growth of its TTR franchise and a milestone payment from a licensing agreement with Regeneron (NASDAQ:REGN).

Alnylam also submitted a supplemental New Drug Application (sNDA) to the FDA for vutrisiran, a treatment for ATTR amyloidosis with cardiomyopathy (ATTR-CM), following positive results from the HELIOS-B Phase 3 study.

Analyst firms including Goldman Sachs, TD Cowen, BofA Securities, Piper Sandler, and Canaccord Genuity have maintained positive ratings on Alnylam, reflecting these recent developments. Alnylam's commercial strategy for the launch of Amvuttra in treating ATTR-CM received positive feedback from BofA Securities. The company plans to establish Amvuttra as the first-line treatment of choice for this condition, leveraging the encouraging HELIOS-B trial data and a more convenient dosing regimen.

In collaboration with BridgeBio Pharma (NASDAQ:BBIO), Alnylam presented a new post hoc analysis of recurrent all-cause mortality and cardiovascular-related hospitalization events. Alnylam also plans to expand its sales force to target an estimated 5,000 cardiologists currently prescribing Vyndamax.

InvestingPro Insights

Alnylam Pharmaceuticals' strong market position and potential for growth, as highlighted in BMO Capital's analysis, are reflected in several key metrics from InvestingPro. The company's impressive revenue growth of 89.46% over the last twelve months and a substantial 107% growth in the most recent quarter underscore its expanding market presence. This aligns well with the positive outlook on Amvuttra's potential in the ATTR-CM market.

InvestingPro Tips reveal that Alnylam boasts impressive gross profit margins, which stood at a robust 87% for the last twelve months. This financial strength supports the company's ability to invest in research and development, crucial for maintaining its competitive edge in the pharmaceutical industry.

Furthermore, the stock has shown a strong performance, with a 60.24% price return over the past year and is currently trading near its 52-week high. This market sentiment appears to reflect investor confidence in Alnylam's growth prospects, particularly with the anticipated Amvuttra launch.

It's worth noting that InvestingPro offers 13 additional tips for Alnylam Pharmaceuticals, providing investors with a comprehensive analysis of the company's financial health and market position.

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