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Alnylam Pharmaceuticals(ALNY) - 2025 Q3 - Earnings Call Presentation
2025-10-30 12:30
Financial Performance - Total net product revenues reached $851 million in Q3 2025, representing a 103% year-over-year growth compared to Q3 2024[17, 24] - Total TTR net revenues were $724 million in Q3 2025, a 135% increase year-over-year[17, 31] - U S total TTR net revenues amounted to $543 million in Q3 2025, demonstrating a 194% year-over-year growth[17] - The company increased its 2025 total net product revenue guidance to a range of $2950 million to $3050 million, a 10% increase at the midpoint[17] - Non-GAAP operating income was $476 million, resulting in a 38% non-GAAP operating margin[65] Product Performance - Rare disease franchise revenues totaled $127 million in Q3 2025, a 14% increase year-over-year[28] - OXLUMO sales grew by 31% year-over-year, driven by a 15% increase in global patients on therapy[29] - AMVUTTRA's ATTR-CM launch contributed significantly to growth, with estimated ATTR-CM revenue of approximately $300 million in Q3 2025 in the U S [33, 34] Pipeline and Clinical Development - Phase 3 trial initiated for nucresiran in ATTR-CM, with topline results expected in 2028 and targeting launch around 2030[17, 47] - Phase 3 cardiovascular outcomes trial (CVOT) initiated for zilebesiran in high cardiovascular risk patients with uncontrolled hypertension, randomizing approximately 11,000 patients[17, 56] - HELIOS-B data showed a 37% risk reduction in time-to-first ACM and CV events with long-term vutrisiran treatment[43]
Alnylam Pharmaceuticals(ALNY) - 2025 Q3 - Quarterly Report
2025-10-30 12:16
Financial Performance - The company has an accumulated deficit of $7.16 billion as of September 30, 2025, primarily due to research and development costs and general administrative expenses [156]. - Total revenues for Q3 2025 reached $1,249.0 million, a 149% increase from $500.9 million in Q3 2024 [186]. - Net product revenues increased by 103% to $851.1 million in Q3 2025, compared to $420.1 million in Q3 2024 [187]. - Collaboration revenues surged by 512% to $351.7 million in Q3 2025, driven by a $300.0 million milestone from Roche [190]. - Royalty revenue rose by 98% to $46.2 million in Q3 2025, up from $23.4 million in Q3 2024 [190]. - Net income for Q3 2025 was $251.1 million, a significant recovery from a loss of $111.6 million in Q3 2024 [186]. - The company reported global net product revenues of $685.3 million for AMVUTTRA and $39.1 million for ONPATTRO in Q3 2025 [168]. - Global net product revenues for GIVLAARI and OXLUMO in Q3 2025 were $73.9 million and $52.8 million, respectively [169]. Research and Development - The company launched the Alnylam P x25 strategy in early 2021, aiming to transition to a top-tier biotech company by the end of 2025, with a focus on delivering transformative medicines [142]. - As of September 30, 2025, the company has six marketed products and over 20 clinical programs, including several in late-stage development [142]. - The company is advancing mivelsiran for Alzheimer's disease, with a Phase 2 clinical trial expected to start in Q4 2025 [151]. - Nucresiran demonstrated mean reductions of serum TTR of greater than 90% from baseline in a Phase 1 clinical trial, with ongoing Phase 3 trials for ATTR amyloidosis [150]. - The company initiated the TRITON-PN Phase 3 trial of nucresiran and reported positive results from the Phase 3 NIMBLE trial of cemdisiran [175]. - The company expects research and development expenses to continue increasing in 2025 as it builds out its global commercial infrastructure and prepares for future product launches [202]. Financial Position and Cash Flow - The company issued $661.25 million in Convertible Senior Notes in September 2025, maturing in 2028, with specific conversion rights for holders [158]. - A $500.0 million revolving line of credit was established, with a $150.0 million letter of credit sublimit, allowing for incremental commitments [161]. - Net cash provided by operating activities increased to $360,525,000 for the nine months ended September 30, 2025, compared to $86,350,000 in 2024, driven by stronger cash receipts from increased product sales [209]. - Net cash provided by investing activities was $473,495,000 for the nine months ended September 30, 2025, compared to a cash outflow of $(63,930,000) in 2024, primarily due to the timing of marketable securities transactions [210]. - The company believes its cash, cash equivalents, marketable securities, and available borrowing capacity will satisfy near-term capital needs for at least the next 12 months [218]. Expenses and Costs - Total operating costs and expenses for Q3 2025 were $881.0 million, a 52% increase from $577.8 million in Q3 2024 [186]. - Cost of goods sold increased by 141% to $197,231,000 for the three months ended September 30, 2025, compared to $81,980,000 in 2024, and by 101% to $409,443,000 for the nine months ended September 30, 2025, compared to $203,864,000 in 2024 [192]. - Research and development expenses rose by 32% to $358,814,000 for the three months ended September 30, 2025, compared to $270,926,000 in 2024, and by 15% to $947,557,000 for the nine months ended September 30, 2025, compared to $826,063,000 in 2024 [198]. - Selling, general and administrative expenses increased by 46% to $322,076,000 for the three months ended September 30, 2025, compared to $220,993,000 in 2024, and by 30% to $885,339,000 for the nine months ended September 30, 2025, compared to $680,187,000 in 2024 [199]. Collaborations and Partnerships - Collaboration revenues from partnerships with Roche, Regeneron, and Novartis have been a significant source of income in recent years [157]. - Roche made an upfront payment of $310.0 million for the zilebesiran collaboration, with potential contingent payments of up to $2.15 billion based on milestones [174]. - The company recognized $300,000,000 in milestone revenue from collaboration with Roche in September 2025 related to the ZENITH Phase 3 clinical trial of zilebesiran [193]. - The company retains broad global rights to liver-directed clinical and preclinical pipeline programs not part of the Regeneron Collaboration [178]. - The company is eligible for tiered, low double-digit royalties based on net sales of zilebesiran outside the U.S. [176]. - Regeneron provided an upfront payment of $10.0 million under the Amended C5 License Agreement, with potential milestone payments of up to $325.0 million [181]. - Sanofi is eligible to receive tiered royalties up to 30% on global annual net sales of AMVUTTRA exceeding $1.5 billion [183]. Debt and Financing - The company paid $35.3 million for capped call transactions related to the issuance of the 2028 Notes, which are expected to reduce potential dilution upon conversion [159]. - The company repurchased approximately $637.8 million of its 1.00% Convertible Senior Notes due 2027 for a total cost of approximately $1,105.8 million [160]. - Net cash used in financing activities increased, with $1.10 billion paid for the repurchase of $637.8 million of 2027 Notes, offset by $646.4 million from the 2028 Notes offering [211]. - The total repurchase cost for the 2027 Notes was approximately $1.11 billion, with $397.2 million remaining outstanding as of September 30, 2025 [215]. - A $500.0 million Revolving Credit Agreement was established, maturing in September 2030, with no borrowings and $17.5 million of letters of credit outstanding as of September 30, 2025 [216]. - Interest on borrowings under the Revolving Credit Agreement ranges from 1.50% to 2.50% based on the Total Leverage Ratio, with a commitment fee of 0.20% to 0.35% on unused commitments [162]. Market Outlook - The company anticipates continued fluctuations in operating results and plans to target financial self-sustainability by the end of 2025 [156]. - The company expects an increase in cost of goods sold in 2025 due to anticipated higher sales of AMVUTTRA and associated royalties [195]. - Financial market risks related to interest rates remain unchanged since December 31, 2024, with no anticipated near-term changes [219].
Alnylam Pharmaceuticals(ALNY) - 2025 Q3 - Quarterly Results
2025-10-30 12:06
Financial Performance - Generated Q3 2025 total net product revenues of $851 million, representing a 103% growth compared to Q3 2024, driven primarily by total TTR revenues of $724 million, which grew by 135% year-over-year[1]. - Total revenues for Q3 2025 reached $1,249 million, a 149% increase from $501 million in Q3 2024[11]. - Alnylam reported net product revenues of $851,082 thousand for Q3 2025, a 102.5% increase from $420,146 thousand in Q3 2024[47]. - Total revenues for the nine months ended September 30, 2025, reached $2,616,904 thousand, up 58.2% from $1,655,077 thousand in the same period of 2024[47]. - The company achieved a net income of $251,084 thousand in Q3 2025, compared to a net loss of $111,570 thousand in Q3 2024[47]. - GAAP net income for Q3 2025 was $251 million, compared to a loss of $112 million in Q3 2024[11]. - The company reported a non-GAAP net income of $396,180 thousand for Q3 2025, compared to a non-GAAP net loss of $64,199 thousand in Q3 2024[48]. Revenue Guidance - Raised 2025 guidance for TTR franchise net revenues to between $2,475 million and $2,525 million, and total net product revenues to between $2,950 million and $3,050 million, indicating a $275 million or 10% increase at midpoint[1]. - Updated full-year 2025 total net product revenues guidance is $2,950 million - $3,050 million, an increase from the prior guidance of $2,650 million - $2,800 million[26]. - The company expects net product revenues growth of 79% to 85% compared to 2024 at currency exchange rates as of September 30, 2025, up from the previous estimate of 61% to 70%[26]. Product Performance - Achieved global net product revenues for GIVLAARI and OXLUMO of $74 million and $53 million, respectively, totaling $127 million in total Rare net product revenue, reflecting a 14% growth compared to Q3 2024[4]. - AMVUTTRA's patient demand approximately doubled in Q3 2025 compared to Q2 2025, with broad uptake and the majority of patients paying $0 in out-of-pocket costs[6]. - AMVUTTRA net product revenue growth reported at 165%, with a constant currency growth of 162%[50]. - ONPATTRO net product revenue growth reported at (22)%, with a constant currency growth of (25)%[50]. - Total TTR net product revenue growth reported at 135%, with a constant currency growth of 131%[50]. - GIVLAARI net product revenue growth reported at 4%, with a constant currency growth of 2%[50]. - OXLUMO net product revenue growth reported at 31%, with a constant currency growth of 27%[50]. - Total Rare net product revenue growth reported at 14%, with a constant currency growth of 11%[50]. - Total net product revenue growth reported at 103%, with a constant currency growth of 99%[50]. - Total revenue growth reported at 149%, with a constant currency growth of 147%[50]. Research and Development - Presented new data from the HELIOS-B Phase 3 study showing vutrisiran reduced the risk of all-cause mortality or first cardiovascular event by 37% in the overall population[6]. - Initiated the TRITON-PN Phase 3 trial of nucresiran in patients with hATTR-PN, with topline results expected in 2028[6]. - Research and development expenses for Q3 2025 were $358,814 thousand, up 32.3% from $270,926 thousand in Q3 2024[48]. - Non-GAAP R&D and SG&A expenses guidance for full-year 2025 is updated to $2,150 million - $2,200 million, compared to the prior guidance of $2,100 million - $2,200 million[26]. - The company has a deep pipeline of investigational medicines, including multiple product candidates in late-stage development[40]. Financial Position - Total cash, cash equivalents, and marketable securities decreased to $2.7 billion as of September 30, 2025, down from $2.9 billion as of June 30, 2025, primarily due to the partial repurchase of convertible senior notes[25]. - Alnylam's cash and cash equivalents increased to $1,490,249 thousand as of September 30, 2025, from $966,428 thousand at the end of 2024[45]. - Alnylam's total assets increased to $4,851,662 thousand as of September 30, 2025, compared to $4,239,983 thousand at the end of 2024[45]. - Alnylam's total liabilities increased to $4,617,768 thousand as of September 30, 2025, from $4,172,895 thousand at the end of 2024[45]. - Net cash used in financing activities for the three months ended September 30, 2025, included $1.1 billion paid to repurchase $638 million of convertible senior notes due 2027[25]. Tax and Other Financial Matters - The company recorded a benefit from income taxes of $12 million during the three months ended September 30, 2025, primarily due to a reduction in pre-tax loss in the U.S.[23]. - Total other expense, net for the three months ended September 30, 2025, was $129 million, which included a $65 million charge related to the change in fair value of the development derivative liability[22]. - The company maintains a full valuation allowance against net deferred tax assets in the U.S. and certain deferred tax assets in Switzerland[24]. Strategic Goals - The company expects to achieve sustainable profitability and aims to deliver transformational innovation to patients as part of its Alnylam P5x25 strategy[42]. - The company plans to continue advancing its pipeline of RNAi therapeutics and successfully launch its approved products globally[42].
These Are The 5 Best Stocks To Buy Now Or Watch
Investors· 2025-10-28 20:21
Core Insights - The article discusses the current stock market performance and highlights five stocks as prime candidates for investment: Nvidia, Tesla, Broadcom, Quanta Services, and Alnylam Pharmaceuticals [1][18]. Market Overview - The stock market has performed well in 2023 and 2024, recovering from initial pressures due to Donald Trump's tariff agenda and benefiting from recent tariff easements [2]. - The S&P 500 and Nasdaq composite have surpassed their 50-day and 200-day moving averages, indicating a bullish trend [8]. Investment Strategy - The IBD Methodology suggests investing in stocks with quarterly and annual earnings growth of at least 25%, focusing on companies with innovative products and strong institutional support [4][5]. - Investors should monitor market trends and sell stocks that decline by 7% to 8% from their purchase price [9]. Stock Analysis Nvidia (NVDA) - Nvidia stock is currently above an ideal entry point of 184.48 and has shown strong performance with a 41% increase in 2025 [12][13]. - The stock has an IBD Composite Rating of 99, with earnings growth averaging 53% over the past three quarters [14]. - Analysts have a consensus strong buy rating with a price target of 211.26, citing Nvidia's leading position in AI technology [15][16]. Tesla (TSLA) - Tesla stock is forming a cup-with-handle base with an early buy point of 451.68 [20]. - The stock has an IBD Composite Rating of 77, with a 7% increase in 2025 and a significant rise from its April lows [21]. - Institutional ownership is at 34%, with notable funds holding shares [23]. Broadcom (AVGO) - Broadcom is forming a cup-with-handle base with an ideal entry point of 363.24 and has an IBD Composite Rating of 99 [25][27]. - Earnings are expected to grow by 39% this year, with a 53% increase in 2025 [28]. - The company has secured a deal to supply AI processors for OpenAI, enhancing its market position [30][31]. Quanta Services (PWR) - Quanta Services has rallied back into the buy zone above a cup base entry of 424.94, with an IBD Composite Rating of 96 [33][34]. - Earnings are projected to rise by 18% in 2025, with institutional ownership at 59% [35][36]. - The company has been expanding through acquisitions and is well-positioned in the energy infrastructure market [37]. Alnylam Pharmaceuticals (ALNY) - Alnylam is near a flat base ideal entry point of 484.21, with an IBD Composite Rating of 83 [38][39]. - The company is expected to swing from a loss to an EPS of $1.44 this year, with significant institutional backing at 74% [40][41]. - Alnylam has received FDA approval for its drug Amvuttra, expanding its market potential [42][43].
Exploring Analyst Estimates for Alnylam (ALNY) Q3 Earnings, Beyond Revenue and EPS
ZACKS· 2025-10-28 14:16
Core Insights - Alnylam Pharmaceuticals (ALNY) is expected to report quarterly earnings of $1.67 per share, reflecting a year-over-year increase of 434% [1] - Anticipated revenues are projected to reach $1.02 billion, marking a 104% increase compared to the same quarter last year [1] Earnings Projections - The consensus EPS estimate has been revised upward by 43.6% over the past 30 days, indicating a collective reassessment by analysts [2] - Changes in earnings projections are crucial for predicting investor reactions, with empirical studies showing a strong correlation between earnings estimate trends and short-term stock price movements [3] Revenue Estimates - Analysts estimate 'Revenues- Product revenues, net' at $779.02 million, representing an 85.4% year-over-year change [5] - 'Revenues- Royalty revenue' is projected at $45.94 million, indicating a 96.5% increase from the prior-year quarter [5] Product Revenue Forecasts - 'Net Product Revenue- Givlaari' is expected to be $79.33 million, reflecting an 11.7% increase year-over-year [6] - 'Revenues- Net revenues from research collaborators' are forecasted to reach $177.25 million, showing a significant change of 208.9% from the previous year [6] - 'Net Product Revenue- Oxlumo' is projected at $50.27 million, indicating a 25% increase from the prior-year quarter [6] Additional Product Revenue Insights - 'Net Product Revenue- Onpattro' is expected to decline to $46.56 million, a decrease of 7.4% from the prior-year quarter [7] - 'Net Product Revenue- Amvuttra' is forecasted to reach $602.44 million, suggesting a 133% year-over-year increase [7] - 'Net revenues from research collaborators- Regeneron Pharmaceuticals' are estimated at $17.50 million, indicating a significant decline of 53.9% [7] - 'Net revenues from research collaborators- Roche' are projected at $156.00 million, reflecting an impressive increase of 857.7% year-over-year [8] Stock Performance - Over the past month, Alnylam shares have returned +7%, outperforming the Zacks S&P 500 composite's +3.6% change [8] - Currently, ALNY holds a Zacks Rank 3 (Hold), suggesting its performance may align with the overall market in the near future [8]
Why Alnylam (ALNY) Might be Well Poised for a Surge
ZACKS· 2025-10-20 17:21
Core Insights - Alnylam Pharmaceuticals is experiencing solid improvement in earnings estimates, which may lead to continued stock price momentum [1][2] - Analysts are optimistic about the earnings prospects of Alnylam, driving higher estimates that correlate with stock price movements [2][3] Earnings Estimates - Current-quarter earnings estimate is $1.65 per share, reflecting a year-over-year increase of +430.0% [6] - The Zacks Consensus Estimate for the current quarter has risen by 20.29% over the last 30 days, with two estimates increasing and one decreasing [6] - For the full year, the earnings estimate is $3.81 per share, indicating a significant change of +19,150.0% from the previous year [7] - The consensus estimate for the current year has increased by 8.52% due to two upward revisions and no negative revisions [8] Zacks Rank - Alnylam currently holds a Zacks Rank 2 (Buy), indicating promising estimate revisions and potential for outperformance [9] - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have historically outperformed the S&P 500 [9] Stock Performance - Alnylam's stock has increased by 6.2% over the past four weeks due to strong estimate revisions [10] - There may still be further upside potential in the stock, suggesting it could be a good addition to investment portfolios [10]
Alnylam price target raised to $535 from $459 at Truist
Yahoo Finance· 2025-10-18 13:05
Core Viewpoint - Truist has raised the price target for Alnylam Pharmaceuticals (ALNY) to $535 from $459 while maintaining a Buy rating ahead of the company's Q3 results [1] Group 1: Sales Estimates - The Q3 sales estimate for Amvuttra has been increased to $690 million [1] - The upward revision in forward estimates reflects strong early adoption and more rapid adoption as a first-line agent than previously expected [1] Group 2: Market Insights - Feedback from prescribers indicates that extracardiac manifestations of ATTR-CM are more widespread than previously appreciated [1]
Are You Looking for a Top Momentum Pick? Why Alnylam Pharmaceuticals (ALNY) is a Great Choice
ZACKS· 2025-10-15 17:01
Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Alnylam Pharmaceuticals (ALNY) - Alnylam Pharmaceuticals currently holds a Momentum Style Score of A, indicating strong momentum characteristics [2] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook based on historical performance metrics [3] Performance Metrics - Over the past week, ALNY shares increased by 0.9%, while the Zacks Medical - Biomedical and Genetics industry declined by 0.34% [5] - In the last quarter, ALNY shares rose by 44.29%, and over the past year, they gained 63.33%, significantly outperforming the S&P 500, which increased by 6.33% and 14.66% respectively [6] - The average 20-day trading volume for ALNY is 1,102,099 shares, indicating a bullish trend when combined with rising stock prices [7] Earnings Outlook - In the past two months, three earnings estimates for ALNY have been revised upwards, while none have been lowered, raising the consensus estimate from $3.35 to $3.98 [9] - For the next fiscal year, two estimates have increased, while one has decreased, reflecting a generally positive earnings outlook [9] Conclusion - Given the strong performance metrics and positive earnings outlook, ALNY is positioned as a promising investment opportunity with a Momentum Score of A [11]
Is the Options Market Predicting a Spike in Alnylam Pharmaceuticals Stock?
ZACKS· 2025-10-15 15:21
Core Insights - Investors in Alnylam Pharmaceuticals, Inc. (ALNY) should monitor stock movements due to significant implied volatility in the options market, particularly the Dec 19, 2025 $140.00 Put option [1] Company Overview - Alnylam Pharmaceuticals holds a Zacks Rank 2 (Buy) in the Medical - Biomedical and Genetics industry, which is in the top 36% of the Zacks Industry Rank [3] - Over the last 60 days, three analysts have raised their earnings estimates for the current quarter, increasing the Zacks Consensus Estimate from earnings of $1.14 per share to $1.71 [3] Market Sentiment - The high implied volatility suggests that options traders anticipate a significant price movement for Alnylam Pharmaceuticals shares, potentially indicating an upcoming event that could lead to a major rally or sell-off [2][3] - Options traders often seek high implied volatility options to sell premium, aiming to benefit from the decay of options value if the underlying stock does not move as much as expected [4]
Is Alnylam Pharmaceuticals (ALNY) Outperforming Other Medical Stocks This Year?
ZACKS· 2025-10-14 14:41
Company Overview - Alnylam Pharmaceuticals (ALNY) is a notable stock within the Medical sector, which consists of 956 individual stocks and ranks 6 in the Zacks Sector Rank [2] - The company is part of the Medical - Biomedical and Genetics industry, which includes 470 companies and currently ranks 94 in the Zacks Industry Rank [6] Performance Metrics - Alnylam Pharmaceuticals has achieved a year-to-date return of approximately 97.6%, significantly outperforming the average return of -0.1% for Medical companies [4] - The Zacks Consensus Estimate for ALNY's full-year earnings has increased by 189.3% over the past three months, indicating improved analyst sentiment and a stronger earnings outlook [4] Comparative Analysis - Another outperforming stock in the Medical sector is ALX Oncology Holdings Inc. (ALXO), which has returned 10.8% year-to-date and has a consensus EPS estimate increase of 5.1% over the past three months [5] - Stocks in the Medical - Biomedical and Genetics industry have averaged a gain of 7.7% this year, highlighting that Alnylam Pharmaceuticals is performing better than its industry peers [6] Future Outlook - Investors interested in Medical stocks should monitor Alnylam Pharmaceuticals and ALX Oncology Holdings Inc. for potential continued strong performance [7]