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01/11 03:24
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call summary and Q&A indicate strong financial performance and optimistic guidance, particularly with increased revenue guidance and global expansion. The management's confidence in product launches and pipeline development, alongside positive reception from payers and no significant barriers, suggest a positive outlook. Although some uncertainties exist, such as CMS reimbursement changes, the overall sentiment remains positive with growth prospects in multiple areas.
TTR franchise revenues $724 million, 135% year-over-year growth. Growth largely attributable to the AMVUTTRA CM launch in the U.S., achieving total TTR revenues of $543 million, representing 194% year-over-year growth. The broader balance uptake in the second full quarter of launch drove an approximate doubling of TTR cardiomyopathy revenue compared to the prior quarter.
Total net product revenues $851 million, up 103% year-over-year. Growth driven by strong performance of the TTR franchise and the AMVUTTRA ATTR-CM launch.
Rare disease portfolio sales $127 million, up 14% versus Q3 2024. Growth driven largely by ongoing patient demand.
Collaboration revenue $352 million, representing a $294 million increase compared with last year. Increase primarily due to revenue recognized under collaboration and license agreement with Roche, including $300 million of milestone revenue.
Royalty revenue $46 million, doubling compared with last year. Growth driven by higher LEQVIO sales as Novartis continues to grow the product globally.
Gross margin on product sales 77% for the quarter, compared with 80% in Q3 2024. Decrease driven by increased royalties on AMVUTTRA as higher revenues resulted in an increase in the royalty rate.
Non-GAAP R&D expenses $310 million, increased 23% compared to last year. Increase driven by costs associated with the initiation of multiple Phase III clinical studies.
Non-GAAP SG&A expenses $263 million, increased 35% compared to last year. Increase driven by increased headcount and investments in support of the AMVUTTRA ATTR cardiomyopathy launch in the U.S.
Non-GAAP operating income $476 million, representing a $507 million increase compared with last year. Growth driven by strong top line results in product sales and revenue from collaborations.
Cash, cash equivalents, and marketable securities $2.7 billion, similar to the end of 2024. Cash impacted by refinancing activities, including issuance of new convertible notes and repurchase of convertible senior notes.
AMVUTTRA cardiomyopathy launch: Delivered strong quarterly performance with TTR franchise revenues of $724 million, a 135% year-over-year growth. U.S. TTR revenues reached $543 million, a 194% year-over-year growth.
Pipeline advancements: Initiated ZENITH Phase III cardiovascular outcomes trial for zilebesiran in hypertension and TRITON-PN study for nucresiran in hATTR-PN. Progress in bleeding and neurologic disorders.
Rare disease portfolio: Achieved $127 million in sales, up 14% year-over-year, driven by ongoing patient demand.
U.S. market growth: U.S. TTR franchise grew 42% quarter-over-quarter and 194% year-over-year, driven by AMVUTTRA ATTR-CM label expansion.
International market expansion: Revenues grew 13% quarter-over-quarter and 46% year-over-year. Early progress in Japan and Germany for AMVUTTRA ATTR-CM launch.
Financial performance: Achieved $851 million in total net product revenues, up 103% year-over-year. Increased 2025 revenue guidance to $2.95 billion-$3.05 billion.
Operational efficiency: Completed health system setup for AMVUTTRA in the U.S., ensuring 90% of patients can access treatment within 10 miles.
Strategic focus on TTR leadership: Dedicated to establishing long-term leadership in TTR with strong U.S. and international growth.
Innovation-driven growth: Focused on multibillion-dollar opportunities within the pipeline, including RNAi therapeutics and new indications.
Market Conditions: The company faces potential challenges in international markets, such as Germany, where final reimbursement decisions are still pending, which could delay the broader adoption of AMVUTTRA.
Regulatory Hurdles: The international AMVUTTRA ATTR-CM launches are contingent on the completion of local pricing and reimbursement reviews, which could delay market entry in key regions.
Competitive Pressures: The rare disease portfolio faces new competition, which could impact the growth trajectory of the hATTR polyneuropathy legacy business.
Economic Uncertainties: The company’s gross margin on product sales is expected to decrease due to increased royalties on AMVUTTRA, which could impact profitability.
Strategic Execution Risks: The company is heavily reliant on the success of AMVUTTRA and its TTR franchise for growth, which poses a risk if market adoption or competitive dynamics shift unfavorably.
Revenue Guidance: Alnylam has increased its total net product revenue guidance for 2025 from the range of $2.65 billion to $2.8 billion to a revised range of $2.95 billion to $3.05 billion, representing a $275 million or 10% increase at the midpoint. This reflects confidence in the AMVUTTRA ATTR-CM launch and other commercial products.
TTR Franchise Revenue: The guidance for the TTR franchise has been increased from $2.175 billion to $2.275 billion to a revised range of $2.475 billion to $2.525 billion, representing a 12% increase at the midpoint.
Ex-U.S. Launches: International AMVUTTRA ATTR-CM launches are anticipated across 2026, following the completion of local pricing and reimbursement reviews, which will extend global reach and contribute to launch momentum.
Pipeline Developments: The ZENITH Phase III cardiovascular outcomes trial of zilebesiran in hypertension has been initiated, with a potential launch around 2030. The TRITON-PN study of nucresiran in hATTR-PN will be initiated shortly, with top-line results expected in 2028. A Phase II trial of ALN-6400 in hereditary hemorrhagic telangiectasia (HHT) is underway, and a Phase I trial of ALN-5288 for Alzheimer's disease has been initiated.
AMVUTTRA ATTR-CM U.S. Launch: The U.S. launch of AMVUTTRA ATTR-CM continues to show strong momentum, with patient demand doubling quarter-over-quarter. The health system setup is complete, and payer coverage is broad, with nearly all patients having access to AMVUTTRA as a first-line treatment option.
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The earnings call summary and Q&A indicate strong financial performance and optimistic guidance, particularly with increased revenue guidance and global expansion. The management's confidence in product launches and pipeline development, alongside positive reception from payers and no significant barriers, suggest a positive outlook. Although some uncertainties exist, such as CMS reimbursement changes, the overall sentiment remains positive with growth prospects in multiple areas.
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