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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 reveals strong financial performance with 28% revenue growth, but concerns arise from a lack of shareholder return plans and competitive pressures. The Q&A highlights some uncertainties in market penetration and diagnosis rates. The absence of a new partnership or significant guidance changes tempers the outlook, resulting in a neutral sentiment. The market cap is not specified, suggesting a cautious stance.
Combined Net Product Revenues $469 million, representing 28% growth year-over-year, driven primarily by a robust 45% year-over-year growth of the U.S. TTR franchise.
TTR Franchise Revenues $359 million, representing a 36% increase compared to Q1 2024, driven by strong performance in hereditary ATTR-PN and the new CM indication.
Rare Disease Franchise Revenues $109 million, representing 8% growth compared to Q1 2024, with GIVLAARI and OXLUMO showing patient growth of approximately 15% and 20% respectively.
Collaboration Revenue $99 million, a 16% decrease compared to Q1 2024, primarily due to a $65 million Roche milestone achieved in Q1 2024.
Royalty Revenue $26 million, representing a $16 million increase compared to last year, driven by increased sales of Novartis’ Leqvio.
Gross Margin on Product Sales 85%, consistent with Q1 2024, but expected to decrease for the balance of the year due to escalating AMVUTTRA royalty rates.
Non-GAAP R&D Expenses $241 million, in line with prior year, with increases in clinical trial expenses offset by reductions from the HELIOS-B Phase 3 study.
Non-GAAP SG&A Expenses Increased 12% compared to the same period last year, primarily driven by investments in support of AMVUTTRA for the cardiomyopathy launch.
Non-GAAP Operating Profit $75 million, representing a $73 million improvement compared to last year, driven by top line growth and moderate growth in operating expenses.
Cash, Cash Equivalents and Marketable Securities $2.6 billion, compared to $2.7 billion at the end of 2024.
AMVUTTRA: Expanded indication for ATTR cardiomyopathy with approvals in the U.S. and Brazil, and a positive CHMP opinion in the EU.
Qfitlia: Approval of the 6th Alnylam-discovered RNAi therapeutic for hemophilia A or B.
TTR Franchise Growth: U.S. TTR franchise delivered $469 million in combined net product revenues, representing 28% growth year-over-year, with a 45% increase in U.S. TTR sales.
International Market Growth: TTR franchise grew 24% compared to Q1 2024, driven by increased demand for AMVUTTRA.
Operational Efficiency: AMVUTTRA captured approximately 70% of new patient starts in the U.S. hATTR PN market.
Patient Access: AMVUTTRA included on formulary in over half of 170 health systems within four weeks of label expansion.
Strategic Focus: Reiterating guidance for sustainable non-GAAP profitability in 2025 and focusing on executing a strong launch in ATTR cardiomyopathy.
Pipeline Development: Plans to initiate TRITON-CM Phase 3 study of nucresiran in ATTR-CM in the first half of 2025.
Regulatory Issues: There is uncertainty related to potential evolutions in policies including tariffs, FDA personnel, reorganization, and other biotech industry initiatives. While Alnylam believes it is insulated from potential impacts, the evolving regulatory landscape poses a risk.
Supply Chain Challenges: The company’s commercial supply chain is global, with most products manufactured through third-party contract manufacturing organizations in the U.S. This positioning may limit exposure to potential future pharma tariffs, but the uncertainty surrounding these tariffs remains a challenge.
Competitive Pressures: Despite new competition entering the market at the end of 2023, Alnylam has maintained a strong market position with AMVUTTRA capturing approximately 70% of new patient starts. However, the presence of competitors in the market could impact future growth.
Economic Factors: The recent weakening of the U.S. dollar could have a positive impact on product sales, with an expected currency upside of approximately $50 million if current rates persist. However, fluctuations in currency rates can pose risks to financial guidance.
TTR Leadership: Alnylam aims to become the global leader in TTR, which is critical for sustainable growth and value creation.
Launch of AMVUTTRA in ATTR-CM: The launch of AMVUTTRA for ATTR cardiomyopathy is progressing well, with a focus on securing access and driving awareness.
Pipeline Advancements: Alnylam has several multibillion-dollar opportunities in its pipeline, including the launch of nucresiran.
Sustainable Profitability: The company aims to achieve sustainable non-GAAP profitability in 2025.
Alnylam P5x25 Goals: The company is working towards its Alnylam P5x25 goals to establish itself as a top-tier biotech company.
2025 Revenue Guidance: Alnylam is reiterating its guidance for 2025, projecting robust growth in TTR franchise revenues.
TTR Franchise Growth: The company expects a 36% year-over-year growth in TTR franchise revenues at the midpoint of guidance.
Rare Franchise Growth: Full year product sales growth for the rare franchise is expected to be approximately 15%.
Cash Position: Alnylam ended Q1 2025 with cash, cash equivalents, and marketable securities of $2.6 billion.
Upcoming Milestones: Key milestones include initiating the TRITON-CM Phase 3 study and additional approvals for AMVUTTRA in Japan and the EU.
Shareholder Return Plan: Alnylam Pharmaceuticals has not announced any share buyback program or dividend program during the Q1 2025 earnings call.
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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