Alnylam Pharmaceuticals(US:ALNY)2025-05-01 12:15Part I. Financial Information Financial Statements (Unaudited) For the first quarter of 2025, Alnylam reported a 20% year-over-year increase in total revenues to $594.2 million, driven by strong product sales, while recording a net loss of $57.5 million, an improvement from the $65.9 million loss in the same period last year, with total assets at $4.21 billion and sufficient capital to fund operations for at least the next 12 months Condensed Consolidated Balance Sheets Balance Sheet Summary (as of March 31, 2025) | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Total Current Assets | $3,268,258 | $3,295,285 | | Total Assets | $4,213,811 | $4,239,983 | | Total Current Liabilities | $1,075,623 | $1,186,272 | | Total Liabilities | $4,098,376 | $4,172,895 | | Total Stockholders' Equity | $115,435 | $67,088 | Condensed Consolidated Statements of Operations Statement of Operations Summary (Three Months Ended March 31) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change | | :--- | :--- | :--- | :--- | | Total Revenues | $594,189 | $494,333 | +20.2% | | Net Product Revenues | $468,538 | $365,163 | +28.3% | | Net Revenues from Collaborations | $99,185 | $118,548 | -16.3% | | Income (Loss) from Operations | $18,077 | $(43,435) | N/A | | Net Loss | $(57,479) | $(65,935) | +12.8% | | Net Loss per Share | $(0.44) | $(0.52) | +15.4% | Condensed Consolidated Statements of Cash Flows Cash Flow Summary (Three Months Ended March 31) | Activity | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(118,314) | $(81,515) | | Net cash provided by (used in) investing activities | $113,769 | $(67,620) | | Net cash provided by financing activities | $44,084 | $28,911 | Notes to Condensed Consolidated Financial Statements - The company has six marketed products and generates revenue from four: AMVUTTRA, ONPATTRO, GIVLAARI, and OXLUMO24 - Based on the current operating plan, the company believes its cash, cash equivalents, and marketable securities as of March 31, 2025, are sufficient to fund operations for at least the next 12 months29 Net Product Revenues by Product (Three Months Ended March 31) | Product | 2025 (in thousands) | 2024 (in thousands) | Change | | :--- | :--- | :--- | :--- | | AMVUTTRA | $309,992 | $195,241 | +59% | | ONPATTRO | $49,489 | $69,217 | -29% | | GIVLAARI | $66,968 | $58,056 | +15% | | OXLUMO | $42,089 | $42,649 | -1% | | Total | $468,538 | $365,163 | +28% | - Net revenues from collaborations decreased to $99.2 million in Q1 2025 from $118.5 million in Q1 2024, primarily because the 2024 period included a $65.0 million milestone payment from Roche, partially offset by a $30.0 million payment from Vir Biotechnology in Q1 2025395371 - The company is involved in patent infringement lawsuits against Pfizer/BioNTech and Moderna concerning their mRNA COVID-19 vaccines, and is also being sued by the University of Texas over its ONPATTRO product96106108 Management's Discussion and Analysis (MD&A) Management discusses the company's performance, highlighting a 28% increase in net product revenues, driven by AMVUTTRA's 59% growth, while advancing its late-stage pipeline and executing its Alnylam P⁵x25 strategy to achieve sustainable operating profitability by the end of 2025, despite a 7% rise in operating expenses and a 14% increase in SG&A due to marketing investments, maintaining a strong liquidity position with $2.63 billion in cash and marketable securities Overview and Pipeline - The company is executing its "Alnylam P⁵x25" strategy, aiming to become a top-tier biotech company by the end of 2025 with sustainable innovation and strong financial performance118 - AMVUTTRA received FDA approval in March 2025 for the treatment of the cardiomyopathy of ATTR amyloidosis, a significant label expansion119 - Key late-stage pipeline programs include zilebesiran (hypertension), nucresiran (ATTR amyloidosis), and mivelsiran (Alzheimer's disease and CAA)126127 Results of Operations Revenue Breakdown (Three Months Ended March 31) | Revenue Type | 2025 (in thousands) | 2024 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Net product revenues | $468,538 | $365,163 | +28% | | Net revenues from collaborations | $99,185 | $118,548 | -16% | | Royalty revenue | $26,466 | $10,622 | +149% | | Total Revenues | $594,189 | $494,333 | +20% | - The 28% increase in net product revenues was primarily driven by increased patient demand for AMVUTTRA, partially offset by a decrease in ONPATTRO sales due to patient switches to AMVUTTRA158 - Collaboration revenue decreased mainly due to the recognition of a $65.0 million milestone from Roche in Q1 2024, partially offset by a $30.0 million payment from Vir and increased revenue from the Regeneron collaboration in Q1 2025160164 - Royalty revenue increased 149% due to higher global net sales of Leqvio by collaborator Novartis160 - Selling, general and administrative (SG&A) expenses increased 14% to $239.9 million, primarily due to increased marketing investment for TTR therapies and higher employee compensation168 Liquidity and Capital Resources - Net cash used in operating activities was $118.3 million for the quarter, an increase from $81.5 million in the prior year period, mainly due to higher bonus payouts and interest payments174175 - The company believes its cash, cash equivalents, and marketable securities as of March 31, 2025, are sufficient to meet its capital and operating needs for at least the next 12 months180 Quantitative and Qualitative Disclosures About Market Risk The company reports no significant changes in its financial market risk exposures, primarily related to interest rates, since December 31, 2024 - There have been no significant changes to the financial market risks described as of December 31, 2024181 Controls and Procedures Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls over financial reporting during the quarter - The CEO and CFO concluded that disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2025182 - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls183 Part II. Other Information Legal Proceedings This section refers to Note 12 of the financial statements, which details the company's material pending legal proceedings, including patent infringement lawsuits filed by Alnylam against Pfizer and Moderna, and a lawsuit filed against Alnylam by the University of Texas - For a discussion of material pending legal proceedings, the report refers to Note 12, Commitments and Contingencies, in the financial statements184 Risk Factors The company outlines significant risks to its business, including a history of $7.35 billion in accumulated losses and the need for substantial funding, heavy dependence on third parties for collaborations and manufacturing, prominent industry risks such as potential clinical trial failures, regulatory hurdles, intense competition for products like AMVUTTRA, pricing pressures from regulations like the Inflation Reduction Act, and significant legal risks from ongoing patent litigation with Pfizer, Moderna, and the University of Texas - The company has a history of significant operating losses, with an accumulated deficit of $7.35 billion as of March 31, 2025196 - The company relies on third parties for manufacturing and collaborations, and failure by collaborators like Roche, Novartis, or Sanofi to perform could delay or terminate product development and commercialization189216221 - AMVUTTRA faces competition from Pfizer's VYNDAQEL/VYNDAMAX and BridgeBio's ATTRUBY for ATTR-CM, both of which are oral medications with lower list prices366 - The Inflation Reduction Act (IRA) could negatively impact business, for example by requiring rebates if drug prices increase faster than inflation or by subjecting products to Medicare price negotiation301 - The company is engaged in significant patent litigation, including lawsuits against Pfizer and Moderna for infringement related to their mRNA COVID-19 vaccines, and is being sued by the University of Texas over its ONPATTRO product351354 - The company has $1.04 billion in convertible notes outstanding and may not have sufficient cash flow to service this indebtedness or repurchase the notes if required384