Alnylam Pharmaceuticals, Inc. (ALNY) Q4 2025 Earnings Call Transcript
Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
Overview
The earnings call highlights strong financial performance, increased revenue guidance, and robust product launches, particularly AMVUTTRA. Despite higher expenses, the operating income surge and cash reserves growth are positive indicators. The Q&A reveals confidence in future guidance and strategic market positioning. Although some management responses were vague, the overall sentiment is positive, with increased revenue expectations and strategic growth initiatives likely to boost stock performance.
Key Financial Performance
Net Product Revenues (2025) Nearly $3 billion, representing 81% growth compared to 2024. The growth was driven by the strong performance of the TTR franchise, particularly the launch of AMVUTTRA for ATTR cardiomyopathy.
Q4 Combined Net Product Revenues $995 million, representing 121% growth year-over-year and 17% growth versus the prior quarter. Growth was driven by the TTR franchise and rare disease business.
Rare Disease Portfolio (Q4) Generated $136 million in net revenue, up 26% year-over-year. Growth was driven by increased patient demand and favorable order timing in partner markets.
TTR Franchise (Q4) Global TTR net revenues reached $858 million, up 18% versus the prior quarter and 151% growth year-over-year. Growth was driven by increased U.S. patient demand and international market momentum.
Gross Margin on Product Sales (2025) 77%, a 4% decrease compared to 2024. The decrease was due to increased royalties on AMVUTTRA as higher revenues resulted in an increased average royalty rate payable to Sanofi.
Non-GAAP R&D Expenses (2025) Approximately $1.2 billion, a 17% increase compared to 2024. The increase was driven by costs associated with the initiation of 3 Phase III clinical studies.
Non-GAAP SG&A Expenses (2025) Approximately $1 billion, a 22% increase compared to 2024. The increase was driven by investments in support of the AMVUTTRA-ATTR-CM launch in the U.S.
Non-GAAP Operating Income (2025) $850 million, representing a $755 million increase compared to 2024. The increase was driven by strong top-line results.
Royalty Revenue (2025) $174 million, a 90% increase compared to 2024. The increase was driven by higher Leqvio sales from Novartis.
Cash, Cash Equivalents, and Marketable Securities (End of 2025) $2.9 billion, compared to $2.7 billion at the end of 2024. The increase was driven by improved operating performance and proceeds from stock option exercises.
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Operating Highlights
AMVUTTRA approval for ATTR cardiomyopathy: Achieved a landmark approval and generated nearly $3 billion in combined net product revenues, marking an 81% growth compared to 2024.
siRELIS manufacturing platform: Developed and launched a potential best-in-class enzymatic ligation-based RNAi manufacturing platform to expand capacity and reduce costs.
Global TTR leadership: Aspired to lead the market in revenue by 2030, with plans to launch nucresiran in 2028 for polyneuropathy and 2030 for cardiomyopathy.
ATTR-CM market expansion: AMVUTTRA rapidly gained traction in the U.S. and international markets, with significant growth in Japan and Germany.
Revenue growth: Delivered $995 million in Q4 net product revenues, representing 121% growth year-over-year.
Profitability: Achieved GAAP profitability for the full year 2025 and expect sustained profitability going forward.
Alnylam 2030 goals: Outlined three strategic pillars: achieving global TTR leadership, delivering transformative medicines, and scaling with discipline to drive sustained growth.
Pipeline expansion: Initiated 3 Phase III studies and expanded the clinical pipeline with 4 proprietary CTAs and 5 partner-led programs.
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Risk or Challenges
Regulatory and Pricing Challenges: The company faces challenges in aligning pricing for AMVUTTRA in international markets, such as Germany, where pricing adjustments have led to a modest near-term impact on total TTR revenue. Additionally, local pricing and reimbursement reviews in other international markets could delay launches.
Market Penetration and Competition: Despite strong early momentum for AMVUTTRA in the U.S., the ATTR-CM market remains underpenetrated, with the majority of patients untreated. There is also competition in the hereditary ATTR polyneuropathy legacy business, which could impact market share.
Economic and Operational Risks: The company anticipates a mid-single-digit net price decrease for AMVUTTRA in the U.S. in 2026, which could impact revenue growth. Additionally, annual insurance reauthorizations and fewer product shipping weeks in Q1 2026 are expected to result in lower quarter-on-quarter TTR revenue growth.
Pipeline and Clinical Development Risks: The company is heavily investing in clinical trials, including three Phase III studies, which carry inherent risks of failure or delays. The success of these trials is critical for future product launches and revenue growth.
Supply Chain and Manufacturing Challenges: The company has launched a new RNAi manufacturing platform, siRELIS, to expand capacity and reduce costs. However, scaling this platform effectively to meet global demand could pose operational challenges.
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Guidance & Outlook
Revenue Growth: The company anticipates combined net product sales for its four commercial products to be within a range of $4.9 billion to $5.3 billion in 2026, representing a 71% growth compared to 2025 at the midpoint of the guidance range.
TTR Franchise: The TTR franchise is expected to generate $4.4 billion to $4.7 billion in revenue in 2026, representing 83% growth compared to 2025 at the midpoint of the guidance range. The company expects U.S. TTR category growth to remain brisk and consistent with prior years, with a mid-single-digit net price decrease for AMVUTTRA in 2026.
Rare Disease Portfolio: The rare disease portfolio is expected to generate $500 million to $600 million in revenue in 2026, representing 10% growth compared to 2025 at the midpoint of the guidance range.
Pipeline Expansion: The company plans to deliver 3 to 4 new INDs and expand delivery into new tissues in 2026. It also expects to share Phase I and II results from the ALN-6400 program and Phase I data on Huntington's and ACVR1C programs in the second half of the year.
Clinical Trials: The company aims to complete enrollment in the cAPPricorn 1 Phase II trial of mivelsiran in patients with CAA and initiate three Phase II trials in 2026. These include trials for ALN-4324 in type 2 diabetes, mivelsiran in Alzheimer's disease, and ALN-6400 in a second bleeding disorder.
Operating Margin: The company aims to achieve a non-GAAP operating margin of approximately 30% across the period through 2030, with potential to increase to mid-40s post-2030 if nucresiran demonstrates a best-in-class profile.
Long-Term Revenue Growth: The company aspires to achieve over 25% revenue CAGR through the end of 2030.
Product Launches: The company plans to launch nucresiran in 2028 for polyneuropathy and in 2030 for cardiomyopathy, with expectations of swift patient uptake and significant revenue contribution.
Innovation Goals: The company aims to deliver 2 or more transformative medicines beyond TTR with blockbuster potential and achieve delivery of RNAi to 10 tissue types by 2030.
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Shareholder Return Plan
The selected topic was not discussed during the call.
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Key Q&A
Q:What are the trends in new patient additions and the mix of first-line for vutrisiran versus tafamidis switches in 2026?
A:The company is pleased with the AMVUTTRA launch, seeing strong fundamentals driving growth. Improved first-line access, strengthening physician and patient preference, and continued category growth are contributing to confidence in 2026 guidance.
Q:What is the confidence in the TTR franchise guidance for the year, considering script choppiness and pricing dynamics?
A:The company feels well-positioned with most patients having first-line access and minimal out-of-pocket costs. Net price declined mid-single digits in 2025, and 2026 guidance assumes a similar decline. Pricing dynamics are integrated into the outlook.
Q:Have there been any seasonality effects in the fourth quarter, and could this be a tailwind for the first quarter of 2026?
A:While there is some seasonality in Q1, the company focuses on long-term category growth, which has been robust and sustained at about 40% over the past several years. Seasonality is not impacting the underlying momentum.
Q:What is the gross-to-net pattern expected over 2026, and how are competitive dynamics factored into this?
A:The mid-single-digit net price decrease in 2026 is expected to be gradual over the year. Competitive dynamics for 2027 are too early to predict, but the company feels well-positioned to manage growth and preserve category value.
Q:What is the strategy for external innovation and partnerships?
A:The company is focused on its internal pipeline but is open to select external innovation that complements its portfolio. High scientific and financial standards are applied to assess opportunities.
Q:What is the expected impact of nucresiran on operating margins post-2030?
A:Nucresiran is expected to have a best-in-class profile, leading to swift patient uptake and significant positive impact on margins post-2030. Margins are projected to reach mid-40s by 2030.
Q:What is the approach for the Huntington's program and the decision to start a Phase III trial?
A:The focus is on achieving convincing evidence of Huntington's protein knockdown and safety. Initial data will be shared later this year, and the company aims to accelerate the program responsibly based on unmet need.
Q:Why is the ACVR1C asset prioritized in the obesity pipeline, and what is the target product profile?
A:ACVR1C is prioritized due to its potency and potential to address unmet needs in weight loss and A1c reduction without muscle loss. The company aims to target unique patient segments and combinations for better outcomes.
Q:What are the trends in cardiomyopathy market share, particularly in the frontline setting?
A:The company has made meaningful progress in new-to-brand dynamics, approaching near parity with tafamidis. Continuous progress in first-line access and category growth supports confidence in 2026 guidance.
Q:What is the company's view on competitive silencer data and its potential impact on AMVUTTRA?
A:The company expects the competitive study to be positive but believes its broad label, strong clinical data, and convenient dosing position it well. Additional entrants may expand the category and benefit patients.
Q:What is the access situation for AMVUTTRA in community centers?
A:The company has broad and balanced access, with 90% of patients having injection sites within 10 miles of their residences. Alternative site of care agreements have been established to ensure accessibility.
Q:Review of Unclear Management Responses
A:Management avoided providing specific guidance for 2027 pricing dynamics, stating it was too early to predict. They also used vague language when discussing the potential impact of competitive silencer data on AMVUTTRA, emphasizing broad labels and category growth without detailed analysis.
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Earnings Word Cloud
The most frequently occurring keywords in this quarter's earning call
AMVUTTRA ATTR
Alzheimer disease
CM launch
CM market
Germany AMVUTTRA
II trial
III outcome
III study
Phase II
Phase III
Pushkal
RNAi
TRITON
TTR product
approach potential
approval ATTR
customer demand
development milestone
diagnosis
driver
future
goal Alnylam
ligation
manufacturing platform
medicine
metabolic
mivelsiran
outcome trial
partner
patient world
pillar
post
price
pricing
program Phase
program clinic
siRELIS
specialty
strength ATTR
success
trial zilebesiran
type
ALNY Transcript
Alnylam Pharmaceuticals, Inc. (ALNY) Q4 2025 Earnings Call Transcript
Positive2-12
The earnings call highlights strong financial performance, increased revenue guidance, and robust product launches, particularly AMVUTTRA. Despite higher expenses, the operating income surge and cash reserves growth are positive indicators. The Q&A reveals confidence in future guidance and strategic market positioning. Although some management responses were vague, the overall sentiment is positive, with increased revenue expectations and strategic growth initiatives likely to boost stock performance.
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Frequently Asked Questions
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