Wolfe Research has maintained its Peerperform rating for Alnylam Pharmaceuticals (NASDAQ: ALNY), with expectations set for the stock's performance to stabilize until potential regulatory approval of its drug acoramidis, which may occur in November 2024.
The firm anticipates discussions to intensify in the first quarter of 2025 regarding the market adoption of acoramidis.
Alnylam's stock experienced a decline of 8% following news from the European Society of Cardiology on August 30, contrasting with mixed reactions seen in the sector, as Ionis Pharmaceuticals (NASDAQ: NASDAQ:IONS) fell by 4%, while BridgeBio Pharma (NASDAQ:BBIO) (not covered by Wolfe Research) saw a 13% increase.
The analyst pointed out that Alnylam's market activity is likely to remain subdued until the company's drug acoramidis, aimed at treating ATTR-CM, a heart condition, receives approval.
The analyst's long-term view on Alnylam includes the impacts of the Inflation Reduction Act's changes to Medicare Part D, which are expected to reduce out-of-pocket costs for competing drugs like Vyndaqel and acoramidis by 88% by January 2025.
Despite Alnylam's statement that over 70% of patients have zero out-of-pocket expenses, the analyst suggests this could potentially be a disadvantage for the uptake of Alnylam's recently approved drug, Amvuttra.
Looking ahead, Alnylam could see a resurgence in activity as a launch stock with the anticipated approval of Amvuttra for ATTR-CM, possibly in the second quarter of 2025 if a priority review voucher is used.
In other recent news, Alnylam Pharmaceuticals has been the focus of several analyst firms following the release of data from the HELIOS-B study.
TD Cowen and H.C. Wainwright maintained their Buy ratings on Alnylam, with price targets of $282 and $400 respectively, highlighting the potential of the company's vutrisiran as a first-line treatment.
Similarly, BMO Capital and Barclays reiterated their positive outlooks on Alnylam, emphasizing the potential of the company's Amvuttra treatment.
The HELIOS-B study data, which supports the use of vutrisiran, showed a significant mortality benefit and the ability to measure biomarker response. Regulatory progress is expected, with filings for a US supplemental New Drug Application (sNDA) planned for the second half of 2024, and filings in the European Union and Japan by the end of 2024.
Alnylam's second-quarter earnings report exceeded expectations in revenue and profit, primarily due to the growth of its TTR franchise and a milestone payment from a licensing agreement with Regeneron (NASDAQ:REGN). The company updated its 2024 revenue guidance, now expecting product revenues to reach between $1.575 billion and $1.65 billion.
Citi maintained a Neutral rating on Alnylam, focusing on the upcoming events for the company, including the sharing of additional data at the Heart Failure Society of America meeting and the company's TTR investor day. Alnylam is preparing for potential regulatory approval, with plans to submit a supplemental New Drug Application by the end of 2024.
InvestingPro Insights
As Alnylam Pharmaceuticals (NASDAQ:ALNY) navigates through the anticipation of regulatory approval for acoramidis, real-time data and insights from InvestingPro reveal a nuanced picture of the company's financial health and stock performance. According to the latest InvestingPro data, Alnylam boasts a robust gross profit margin of 87.0% for the last twelve months as of Q2 2024, underscoring the company's impressive ability to manage its cost of goods sold and maintain profitability at the gross level. Additionally, the company's revenue has experienced a significant growth of 89.46% during the same period, reflecting a strong potential for scaling operations and increasing market share.
InvestingPro Tips highlight that 10 analysts have revised their earnings upwards for the upcoming period, indicating a positive sentiment among experts regarding Alnylam's financial prospects. However, it's important to note that analysts do not anticipate the company will be profitable this year, which aligns with the P/E ratio of -447.12, suggesting that investors are valuing the company based on expectations of future earnings rather than current profitability. The company's liquid assets exceed short-term obligations, providing financial stability and flexibility to navigate upcoming challenges. For investors seeking more insights, there are additional tips available on InvestingPro, which can be found at the dedicated Alnylam page on the InvestingPro website.
With the Wolfe Research's outlook and the InvestingPro data combined, stakeholders can gain a more comprehensive understanding of Alnylam's financial landscape and the potential trajectory of its stock as it approaches key milestones in its drug approval process.
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