ALNYLAM PHARMACEUTICALS (ALNY) Company Report

Alnylam is on the cusp of delivering its P5x25 goals, which include achieving sustainable non-GAAP profitability, and plans to announce new objectives early next year.
The Amvuttra cardiomyopathy launch has had a "terrific start," with patient volume demand doubling in the last quarter and broad utilization across first-line and second-line patients. The company expects continued growth in the TTR market, where only 20% of an estimated 150,000 US patients are currently diagnosed.
Alnylam is advancing Nucresiran, its next-generation TTR program, with Phase 3 studies targeting market entry around 2028 for polyneuropathy and 2030 for cardiomyopathy, offering >95% TTR knockdown and a twice-a-year regimen.
The company has initiated a Phase 1 study for its Huntington's disease program, which aims to knock down the full-length Huntington protein and exon one fragment.

Nov 19, 2025, 11:30 AM

Transcript

Alnylam Discusses Strong Amvuttra Launch and Pipeline at Jefferies Conference

ALNY

Product Launch

Guidance Update

New Projects/Investments

Alnylam, a leading RNAi company, is on the cusp of achieving its P5x25 goals, which include sustainable non-GAAP profitability, and will announce new objectives early next year.
The launch of Amvuttra for cardiomyopathy has seen a "terrific start", with access to key healthcare systems achieved rapidly and patient volume demand doubling in the last quarter (Q3 2025), leading to increased guidance.
The company anticipates continued growth in the TTR cardiomyopathy market, where only 20% of an estimated 300,000 global patients are currently diagnosed, and is advancing Nucresiran, a next-generation TTR therapy, with potential launches in 2028 (polyneuropathy) and 2030 (cardiomyopathy).
Alnylam's clinical pipeline includes several potential blockbuster opportunities, such as zilebesiran for hypertension and a promising Phase 1 program for Huntington's disease, which is considered a key catalyst.

Nov 19, 2025, 11:30 AM

Transcript

Alnylam Reports Strong Amvuttra Launch and Pipeline Progress

ALNY

Product Launch

New Projects/Investments

Guidance Update

Alnylam reported a terrific start to the Amvuttra cardiomyopathy launch, with patient volume demand doubling in the last quarter (Q3 2025). Amvuttra is gaining traction as a first-line therapy and capturing a significant share of second-line opportunities.
The company is advancing Nucresiran, its next-generation TTR program, targeting over 95% TTR knockdown with a twice-a-year regimen. Phase III studies are underway, with potential market entry in 2028 for polyneuropathy and 2030 for cardiomyopathy.
Alnylam is focused on its broader clinical pipeline, including a Phase 1 study for Huntington's disease, which is considered a key program.
The market for TTR amyloidosis with cardiomyopathy is expected to grow for years, as only 20% of the estimated 150,000 U.S. patients are currently diagnosed.
Alnylam is on track to achieve its P5x25 goals, including sustainable non-GAAP profitability, and plans to announce new five-year objectives early next year.

Nov 19, 2025, 11:30 AM

Transcript

Alnylam Pharmaceuticals Reports Strong Q3 2025 CM Revenue and Achieves 2025 Goals

ALNY

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

Alnylam Pharmaceuticals reported $300 million in cardiomyopathy (CM) revenue for Q3 2025, doubling Q2 revenue, and upgraded full-year guidance for the TTR business by $275 million at the midpoint.
The company successfully achieved its "P to the fifth by 25" goals, including a 40% CAGR in top-line growth and reaching non-GAAP profitability.
New 2030 goals will be unveiled at JPMorgan, focusing on TTR leadership, pipeline progression beyond TTR, and the company's financial profile (top-line and margin).
The Amvuttra launch for CM is demonstrating strong momentum with rapid formulary access and effective payer policies enabling first-line access, anticipating a mid-single-digit year-over-year price decline for the TTR business in 2025, which is expected to be offset by significant volume growth.
Alnylam is advancing Zilebesiran, its next-generation product, which is expected to achieve 95% TTR reduction with twice-annual dosing, and has initiated outcome studies for ATTR cardiomyopathy and hereditary polyneuropathy.

Nov 10, 2025, 3:15 PM

Transcript

Alnylam Pharmaceuticals Reports Strong Q3 CM Revenue and Updates on 2025 Goals and Future Pipeline

ALNY

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

Alnylam Pharmaceuticals reported strong Q3 2025 cardiomyopathy (CM) revenue of $300 million and raised full-year guidance for the second time, increasing the midpoint by $275 million for the TTR business.
The company is on track to achieve its P5x25 goals by the end of 2025, including exceeding a 40% CAGR for top-line growth and reaching non-GAAP profitability. New 2030 goals focusing on TTR leadership, pipeline growth, and financial profile will be unveiled at JPMorgan.
For its TTR business, Alnylam anticipates a mid-single-digit year-over-year net price decline in 2025, with volume growth expected to offset this reduction, a trend projected to continue into 2026.
The next-generation product, Zilebesiran, is expected to launch for CM around 2030 (and hereditary PN a year or two earlier), offering an anticipated 95% TTR reduction with twice-annual dosing, and is expected to significantly expand gross margins due to no royalty burden.

Nov 10, 2025, 3:15 PM

Transcript

Alnylam Pharmaceuticals Reports Strong Q3 CM Revenue and Outlines Future Goals

ALNY

Guidance Update

Revenue Acceleration/Inflection

New Projects/Investments

Alnylam Pharmaceuticals reported $300 million in cardiomyopathy (CM) revenue for Q3 2025, doubling its Q2 revenue, and upgraded its full-year guidance for the TTR business a second time.
The company has achieved its "P5 by 25" five-year goals, including exceeding a 40% CAGR for top-line growth and reaching non-GAAP profitability.
Alnylam plans to announce new 2030 goals at JPMorgan, which will likely focus on TTR leadership, pipeline progression beyond TTR, and the company's evolving financial profile, including top-line expectations and margin profile.
The successful launch of the cardiomyopathy indication was driven by faster-than-anticipated access and first-line positioning for Amvuttra, with a projected mid-single-digit year-over-year price decline for the TTR business in 2025 expected to be offset by significant volume growth.
The next-generation product, Zilebesiran, is anticipated to launch in CM around 2030 with better efficacy and twice-annual dosing, offering potential for significant margin expansion due to no royalty burden.

Nov 10, 2025, 3:15 PM

Transcript

Alnylam Reports Strong Q3 2025 Results and Raises Full-Year Guidance

ALNY

Earnings

Guidance Update

Revenue Acceleration/Inflection

Alnylam reported Q3 2025 revenue of $1.249 billion and net income of $251.1 million, marking a swing to profitability and an adjusted EPS of $2.90, significantly beating the Zacks consensus of $1.67.
The quarter's performance was primarily driven by Amvuttra sales, which generated approximately $685 million, with ATTR-CM revenues from Amvuttra about doubling from Q2.
Management raised its 2025 revenue guidance to about $3.05 billion, citing robust Amvuttra launch momentum.
Despite the positive results and increased guidance, shares fell approximately 7% after the release, following a roughly 105% year-to-date gain.

Oct 30, 2025, 7:40 PM

CNBC

Alnylam Reports Strong Q3 2025 Results and Raises Full-Year Guidance

ALNY

Earnings

Guidance Update

Product Launch

Alnylam Pharmaceuticals reported Q3 2025 total net product revenues of $851 million, marking a 103% year-over-year growth. This was driven by TTR franchise revenues of $724 million, up 135% year-over-year, with U.S. TTR revenues reaching $543 million, a 194% year-over-year increase.
The company increased its total net product revenue guidance for 2025 from a range of $2.65 billion-$2.8 billion to a revised range of $2.95 billion-$3.05 billion, representing a $275 million or 10% increase at the midpoint.
The AMVUTTRA® ATTR cardiomyopathy launch continued its strong momentum, with patient demand roughly doubling quarter-over-quarter in Q3 2025. Health System Setup for AMVUTTRA® is now complete, and payer coverage remains broad.
Alnylam advanced its pipeline with the initiation of the ZENITH phase III cardiovascular outcomes trial for zilebesiran and the upcoming initiation of the TRITON-PN study for nucresiran in hATTR-PN.

Oct 30, 2025, 12:30 PM

Transcript

Alnylam Pharmaceuticals Reports Strong Q3 2025 Results and Raises Full-Year Guidance

ALNY

Earnings

Guidance Update

Product Launch

Alnylam Pharmaceuticals reported Q3 2025 total net product revenues of $851 million, a 103% year-over-year growth, primarily fueled by the AMVUTTRA ATTR CM launch in the U.S., which saw its revenue approximately double from Q2 to $300 million.
The company raised its full-year 2025 net product revenue guidance to $2.95 billion to $3.05 billion, an increase of 10% at the midpoint from prior guidance, and also increased its total TTR guidance.
Alnylam advanced its pipeline with the initiation of the ZENITH Phase 3 trial for zilebesiran in hypertension, a Phase 1 trial for ALN-5288 in Alzheimer's disease, and the ALN-6400 program moving into a Phase 2 trial for hereditary hemorrhagic telangiectasia.
Non-GAAP operating income for Q3 2025 was $476 million, a $507 million increase year-over-year, with $2.7 billion in cash, cash equivalents, and marketable securities at quarter-end.

Oct 30, 2025, 12:30 PM

Transcript

Alnylam Pharmaceuticals Announces Strong Q3 2025 Results and Upgraded Full-Year Guidance

ALNY

Earnings

Guidance Update

Product Launch

Alnylam Pharmaceuticals reported Q3 2025 total net product revenues of $851 million, marking 103% year-over-year growth, with the TTR franchise contributing $724 million (135% year-over-year growth) primarily due to the AMVUTTRA ATTR CM launch in the U.S..
The company increased its full-year 2025 total net product revenue guidance from a range of $2.65 billion to $2.8 billion to a revised range of $2.95 billion to $3.05 billion, and raised its total TTR guidance to $2.475 billion to $2.525 billion.
The U.S. AMVUTTRA ATTR CM launch demonstrated strong momentum, with patient demand roughly doubling compared to Q2, and the U.S. TTR franchise delivered $543 million in net product revenues.
Non-GAAP operating income for Q3 2025 was $476 million, a $507 million increase year-over-year, and the company maintained $2.7 billion in cash, cash equivalents, and marketable securities.
Key pipeline advancements include the initiation of the ZENITH Phase 3 cardiovascular outcomes trial for zilebesiran and the TRITON PN study for ALN-APP, along with ALN-6400 advancing into a Phase 2 trial for hereditary hemorrhagic telangiectasia.

Oct 30, 2025, 12:30 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for ALNYLAM PHARMACEUTICALS.

Q3 2025

Oct 30, 2025

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Q2 2025

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Q1 2025

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