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ALNY Q3 Earnings and Revenues Top Estimates on Higher Amvuttra Sales
ZACKS· 2025-10-31 16:20
Core Insights - Alnylam Pharmaceuticals reported Q3 2025 earnings of $2.90 per share, exceeding the Zacks Consensus Estimate of $1.67, primarily due to increased revenues from Amvuttra sales [1][11] - Total revenues reached $1.25 billion, surpassing the Zacks Consensus Estimate of $1.02 billion, marking a 149% year-over-year increase [2][11] - Despite strong earnings and revenue growth, ALNY shares fell by 6.7% due to investor concerns over an external inquiry into commercial practices [3] Revenue Breakdown - Net product revenues were $851.1 million, a 103% increase year over year, driven by demand for Amvuttra, Givlaari, and Oxlumo [3][9] - Collaboration revenues totaled $351.7 million, boosted by a $300 million milestone payment from Roche related to the ZENITH phase III clinical study [4][11] - Royalty revenues increased by 98% year over year to $46.2 million [5] Product Performance - Amvuttra sales reached $685.3 million, a 165% increase, driven by demand from patients with ATTR amyloidosis and cardiomyopathy [8][11] - Onpattro sales were $39.1 million, down 22% year over year, missing estimates [6] - Givlaari recorded sales of $73.9 million, a 4% increase, but also missed estimates [9] Financial Guidance - Alnylam raised its 2025 net product revenue guidance to $2.95-$3.05 billion from $2.65-$2.80 billion [16] - Collaboration and royalty revenue guidance remains at $650-$750 million, while adjusted R&D and SG&A expenses are now expected to be $2.15-$2.20 billion [17] Research and Development - Adjusted R&D expenses rose 23% year over year to $310.1 million, driven by costs associated with the ZENITH study and other clinical trials [13] - Adjusted SG&A expenses increased 35% year over year to $262.6 million, primarily due to higher employee compensation and marketing investments for Amvuttra [14]
Can Alnylam's Broader Portfolio Ease Its Dependence on Amvuttra?
ZACKS· 2025-10-01 16:05
Core Insights - Alnylam Pharmaceuticals' primary revenue driver is its newest drug, Amvuttra, approved for treating hATTR amyloidosis and ATTR-CM, with strong uptake from new patients and switches from Onpattro [1][10] Product Portfolio - Alnylam markets several products in rare disease and cardiovascular markets, contributing incremental revenues to the top line [2] - Givlaari is approved for acute hepatic porphyria in adults and adolescents, with strong uptake and plans for regulatory submissions in additional regions through 2025 [3] - Oxlumo is approved for primary hyperoxaluria type 1, with an expanded label for lowering urinary and plasma oxalate levels, enhancing its growth potential [4] - Leqvio, in collaboration with Novartis, treats hypercholesterolemia and has an expanded label for high-risk cardiovascular patients, generating royalties for Alnylam [5] Financial Performance - In the first half of 2025, Alnylam generated $236.8 million in net product revenues from its rare disease portfolio, reflecting a 16% year-over-year increase, with expectations for sustained growth and diversified revenue streams [6][10] Competitive Landscape - Amvuttra faces increasing competition in the ATTR-CM market from therapies like Pfizer's Vyndaqel/Vyndamax and BridgeBio's Attruby, which are already approved and competing for market share [7] - Pfizer's Vyndaqel family generated $3.1 billion in revenues in the first half of 2025, a 27% increase year-over-year, driven by rising diagnosis and treatment rates [8] - BridgeBio's Attruby, approved in late 2024, generated $108.2 million in sales in the first half of 2025, with significant uptake reported [9]
Intellia Highlights Clinical Improvements With One-Time Dose Of Experimental Drug
Benzinga· 2025-09-25 17:57
Core Insights - Intellia Therapeutics Inc. has released long-term follow-up data from its Phase 1 study of nexiguran ziclumeran (nex-z) for treating hereditary ATTR amyloidosis with polyneuropathy, showcasing significant TTR reductions and clinical improvements [1][2][6] Data Summary - A one-time dose of 0.3 mg/kg or higher resulted in a mean serum TTR reduction of 92% at 24 months, with an absolute serum TTR level of 17.3 g/mL [2] - Among 12 patients with 36 months of follow-up, the mean serum TTR reduction was 90%, corresponding to a serum TTR level of 20 g/mL [2] - Favorable trends indicating stability or improvement were observed in most patients after a single dose of nex-z [3] Clinical Measures - Stability or improvement was assessed using various clinical and biomarker measures, including NIS, mNIS+7, mBMI, QoL-DN questionnaire, NfL, and PND score [4] - Of the 18 patients assessed at 24 months, 72% showed clinically meaningful improvements of ≥4 points in mNIS+7, including those who had previously progressed on Alnylam's Onpattro [5] Secondary Endpoints - Mean values for secondary endpoints mBMI, QoL-DN, and NfL trended towards disease improvement, with 89% of patients showing improvement or stability in PND scores through 24 months [6] - Nex-z was generally well tolerated, with mild to moderate infusion-related reactions being the most common treatment-related adverse events [6][7] Future Outlook - Patient screening for the Phase 3 MAGNITUDE-2 trial is progressing rapidly, with enrollment expected to complete in the first half of 2026 [8] - Intellia plans to submit a biologics license application (BLA) for ATTRv-PN by 2028 [8]
Why Alnylam Pharmaceuticals (ALNY) is a Top Momentum Stock for the Long-Term
ZACKS· 2025-09-24 14:51
Core Insights - Zacks Premium provides various tools for investors to enhance their stock market strategies and confidence [1] - The Zacks Style Scores are designed to complement the Zacks Rank, helping investors identify stocks likely to outperform the market in the short term [2] Zacks Style Scores Overview - Stocks are rated from A to F based on value, growth, and momentum characteristics, with A being the highest score [3] - The Style Scores are categorized into four types: Value Score, Growth Score, Momentum Score, and VGM Score [3][4][5][6] Value Score - Focuses on identifying undervalued stocks using financial ratios such as P/E, PEG, and Price/Sales [3] Growth Score - Concentrates on a company's financial health and future growth potential, analyzing projected and historical earnings, sales, and cash flow [4] Momentum Score - Targets stocks with upward or downward price trends, utilizing recent price changes and earnings estimate revisions to identify buying opportunities [5] VGM Score - Combines Value, Growth, and Momentum Scores to provide a comprehensive assessment of stocks, aiding in the selection of the most attractive investment opportunities [6] Zacks Rank Integration - The Zacks Rank uses earnings estimate revisions to identify stocks with the highest potential returns, with 1 (Strong Buy) stocks historically achieving an average annual return of +23.64% since 1988 [7][8] - Investors are encouraged to focus on stocks with a Zacks Rank of 1 or 2 and Style Scores of A or B for optimal investment success [9] Company Spotlight: Alnylam Pharmaceuticals - Alnylam Pharmaceuticals is a biopharmaceutical company specializing in RNA interference therapeutics, with a pipeline targeting genetic, cardio-metabolic, and hepatic infectious diseases [11] - The company has received multiple FDA approvals for its products, including Onpattro, Givlaari, Oxlumo, and Amvuttra, addressing various medical conditions [11] - Currently, Alnylam has a Zacks Rank of 3 (Hold) and a VGM Score of B, with a strong Momentum Style Score of A, indicating potential for upward movement [12][13]
Alnylam Q1 Earnings Beat Estimates, Product Revenues Rise Y/Y
ZACKS· 2025-05-02 15:55
Core Viewpoint - Alnylam Pharmaceuticals reported better-than-expected financial results for Q1 2025, with adjusted losses narrower than estimates and significant revenue growth driven by strong product sales, particularly for Amvuttra [1][2][16]. Financial Performance - The company reported total revenues of $594.2 million, exceeding the Zacks Consensus Estimate of $588.2 million, and reflecting a 20% year-over-year increase [2]. - Net product revenues reached $468.5 million, up 28% year-over-year, primarily due to increased demand for Amvuttra, Givlaari, and Oxlumo [2][6]. - Net revenues from collaborators were $99.2 million, down 16% from the previous year, largely due to a prior milestone payment from Roche [3]. Product Sales - Amvuttra generated sales of $310 million, a 59% increase year-over-year, and surpassed estimates [6]. - Givlaari recorded sales of $67 million, a 15% increase year-over-year, but slightly missed estimates [7]. - Oxlumo's sales were $42.1 million, remaining flat year-over-year and missing estimates [7]. Expenses and Cash Position - Adjusted R&D expenses were approximately $241.3 million, remaining stable year-over-year [10]. - Adjusted SG&A expenses increased by 12% to $207 million, driven by marketing efforts for Amvuttra [11]. - Cash, cash equivalents, and marketable securities totaled $2.63 billion as of March 31, 2025, down from $2.69 billion at the end of 2024 [11]. Guidance and Collaborations - The company reiterated its 2025 financial guidance, expecting net product revenues between $2.05 billion and $2.25 billion, and collaboration revenues between $650 million and $750 million [12]. - Alnylam is advancing several collaborations, including with Regeneron and Roche, which are expected to enhance its product pipeline and revenue streams [13][14][17]. Market Performance - Year-to-date, Alnylam's stock has gained 8.4%, outperforming the industry, which has seen a decline of 1.8% [8].