• Total Product Revenues: $469 million, representing 28% growth year over year.
• TTR Franchise Revenue: $359 million, a 36% increase compared to Q1 2024.
• US TTR Franchise Growth: 45% year-over-year increase.
• Rare Disease Franchise Revenue: $109 million, 8% growth compared to Q1 2024.
• Gross Margin on Product Sales: 85% for the quarter.
• Non-GAAP Operating Profit: $75 million, a $73 million improvement from the previous year.
• Cash, Cash Equivalents, and Marketable Securities: $2.6 billion at the end of the quarter.
• Collaboration Revenue: $99 million, a 16% decrease from Q1 2024.
• Royalty Revenue: $26 million, a $16 million increase from the previous year.
• Non-GAAP R&D Expenses: $241 million, consistent with the prior year.
• Non-GAAP SG&A Expenses: Increased by 12% compared to Q1 2024.

• Warning! GuruFocus has detected 6 Warning Signs with BIIB.

Release Date: May 01, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) reported a 28% year-over-year growth in combined net product revenues, reaching $469 million.
• The US TTR franchise experienced a robust 45% year-over-year growth, driven by continued uptake in the hereditary polyneuropathy population.
• AMVUTTRA received expanded indication approvals for ATTR cardiomyopathy in the US and Brazil, with a positive CHMP opinion in the EU.
• The company reiterated its guidance for the year, expressing confidence in achieving sustainable non-GAAP profitability in 2025.
• Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) launched its 6th RNAi therapeutic, Qfitlia, for hemophilia A or B, in collaboration with Sanofi.

Negative Points

• Collaboration revenue decreased by 16% compared to the first quarter of last year, primarily due to a significant milestone achieved in the previous year.
• Gross margin on product sales is expected to decrease for the remainder of the year due to escalating AMVUTTRA royalty rates.
• Non-GAAP SG&A expenses increased by 12% in the first quarter compared to the same period last year, driven by investments in support of AMVUTTRA's cardiomyopathy launch.
• There is uncertainty related to potential evolution in policies, including tariffs and FDA personnel reorganization, which could impact the biotech industry.
• The company faces competition in the market, with new entrants potentially affecting its market share and growth trajectory.

Q & A Highlights

Q: Can you provide additional color on the initial patients starting treatments with AMVUTTRA? Are the prescribers familiar with the drug, or are there new doctors involved? A: We are seeing a broad uptake among cardiologists, including those familiar with AMVUTTRA and those new to it. The encouraging part is the rapid inclusion of AMVUTTRA in formularies, which opens up significant opportunities for us. (Tolga Tanguler, Chief Commercial Officer)

Q: Regarding the ATTR franchise's quarter-over-quarter growth, was there any revenue contribution from ATTR cardiomyopathy? A: The growth was entirely from TTR polyneuropathy, highlighting the strong profile of AMVUTTRA in this area and the quality of our commercial execution. (Yvonne Greenstreet, CEO)

Q: How are you leveraging your commercial expertise to be competitive in capturing the market? A: We offer a new mechanism of action that sets us apart from stabilizers. Physicians are interested in treating the disease early with the best options, and AMVUTTRA provides a clear first-line option. We are also seeing patients switch from stabilizers to AMVUTTRA. (Tolga Tanguler, Chief Commercial Officer)

Q: What are you seeing in terms of formulary access and pricing for AMVUTTRA between polyneuropathy and cardiomyopathy? A: We have a single price for both indications, and we are seeing limited use of our Quick Start Program. Most patients are getting on therapy with zero co-pay, similar to polyneuropathy. (Tolga Tanguler, Chief Commercial Officer)

Q: With the launch of AMVUTTRA, are you seeing any headwinds from new competition in the market? A: We are in a category growth story, with a large and growing market. Our data is complete and consistent, and we are seeing strong uptake across all payer mixes without any significant headwinds. (Tolga Tanguler, Chief Commercial Officer)

Q: Can you provide more details on the type of patients making up the first-line use of AMVUTTRA? A: Physicians are treating both new and progressing patients with AMVUTTRA. The decision is based on the compelling data set we present, rather than the type of patient. (Tolga Tanguler, Chief Commercial Officer)

Q: Are you seeing any standardized guidelines for identifying stabilizer progressors among healthcare providers? A: Doctors are well-trained to evaluate heart failure patients and recognize those not doing well on stabilizers. Our data shows AMVUTTRA favorably impacts disease progression, supporting its use in these patients. (Pushkal Garg, Chief Medical Officer)

Q: How are you addressing potential step edits for AMVUTTRA in commercial and Medicare Advantage patients? A: We have seen broad uptake across all payer mixes without significant restrictions. Our value-based agreements and the product's clinical value support access, and we have tools to address any step edits if they arise. (Tolga Tanguler, Chief Commercial Officer)

For the complete transcript of the earnings call, please refer to the full earnings call transcript.