• Combined Net Product Revenue: $1.646 billion for 2024, representing 33% growth compared to 2023.
• TTR Franchise Revenue: $343 million in Q4 2024, a 35% increase compared to Q4 2023.
• Full Year TTR Revenue: $705 million in the US, a 39% increase compared to 2023.
• Rare Franchise Revenue: $108 million in Q4 2024, an 18% increase compared to Q4 2023.
• Gross Margin on Product Sales: 81% for the full year 2024, a 3% increase compared to 2023.
• Non-GAAP Operating Income: $95 million for the full year 2024.
• Cash, Cash Equivalents, and Marketable Securities: $2.7 billion at the end of 2024.
• 2025 Revenue Guidance: $2.05 billion to $2.25 billion in combined net product sales.
• 2025 TTR Revenue Guidance: $1.6 billion to $1.725 billion, assuming approval and launch of AMVUTTRA for ATTR cardiomyopathy.
• 2025 Rare Revenue Guidance: $450 million to $525 million.
• 2025 Collaboration and Royalty Revenue Guidance: $650 million to $750 million.
• 2025 Non-GAAP R&D and SG&A Expenses: $2.1 billion to $2.2 billion.

• Warning! GuruFocus has detected 3 Warning Sign with ALNY.

Release Date: February 13, 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 strong financial performance with combined net product revenues of over $1.6 billion, achieving a 33% growth compared to 2023.
• The company achieved a significant milestone with $95 million in non-GAAP operating income for the full year, marking its first year of profitability.
• The HELIOS-B Phase III study yielded highly positive results, leading to the submission of global regulatory filings for vutrisiran in ATTR cardiomyopathy.
• Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) has a robust pipeline with numerous multibillion-dollar opportunities, including the advancement of Nucresiran, which received orphan drug designation for ATTR amyloidosis.
• The company maintained its award-winning culture, which has been a critical enabler of its success, and is poised for sustainable growth and value creation in 2025 and beyond.

Negative Points

• The launch of AMVUTTRA for ATTR cardiomyopathy is expected to face delays in formulary uptake, with meaningful demand anticipated only in the second half of 2025.
• Gross margin on product sales is expected to decrease in 2025 due to the increased royalty burden on AMVUTTRA sales.
• The company faces competition in the market, particularly in the polyneuropathy segment, which could impact its market share and growth.
• There is uncertainty regarding payer policies and the establishment of value-based agreements for the expanded label of AMVUTTRA in cardiomyopathy.
• Alnylam Pharmaceuticals Inc (NASDAQ:ALNY) anticipates increased R&D and SG&A expenses in 2025, driven by clinical investments and the launch of AMVUTTRA, which could impact profitability.

Q & A Highlights

Q: How long will it take to establish payer policies after the approval of AMVUTTRA, and how might this impact the launch trajectory? A: Yvonne Greenstreet, CEO, mentioned that they are in a strong position due to their existing TTR franchise. Tolga Tanguler, Chief Commercial Officer, added that the formulary uptake is expected to be a second-half story, with meaningful uptake anticipated in the latter part of the year.

Q: What are your thoughts on premium pricing for AMVUTTRA compared to other silencing therapies, and how might this affect commercial insured patients? A: Tolga Tanguler stated that they are encouraged by payer engagements and the value AMVUTTRA brings. They expect uptake to be consistent with past experiences in the polyneuropathy market, with a focus on maintaining growth.

Q: Can you share the key factors impacting pricing adjustments for AMVUTTRA and the percentage of current sites with coding in place for its use? A: Yvonne Greenstreet emphasized the importance of considering product value and patient access when determining pricing. Tolga Tanguler noted that they already have a J code for AMVUTTRA, ensuring smooth coverage and access.

Q: What is the progress on label discussions for AMVUTTRA, and will it include unique wording related to quality of life and functional capacity? A: Pushkal Garg, Chief Medical Officer, expressed enthusiasm about the FDA review process and expects the label to reflect the study's demonstrated benefits, including mortality and hospitalization reductions, as well as quality of life improvements.

Q: How do you expect payer dynamics to evolve with the introduction of AMVUTTRA in the cardiomyopathy market? A: Tolga Tanguler explained that they anticipate similar dynamics to those seen in the polyneuropathy market, with favorable patient affordability and smooth access due to existing payer relationships and value-based agreements.

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