Core Insights - The fourth-quarter earnings season for the biotech sector is currently underway, with several major companies reporting results, including Bristol Myers, Regeneron, and Amgen, all of which showed varying degrees of performance and outlooks for 2025 [1] Biotech Sector Performance - As of February 5, 39.3% of companies in the Medical sector reported quarterly earnings, with 87.5% beating earnings expectations and 83.3% exceeding revenue forecasts. Year-over-year earnings increased by 20.1%, while revenues grew by 9% [3] - The overall expectation for the Medical sector's fourth-quarter earnings is an increase of 11.1% year over year, with revenues projected to grow by 9% [3] Company-Specific Insights Bristol Myers - Reported better-than-expected fourth-quarter results but provided a lackluster guidance for 2025 [1] Regeneron - Beat fourth-quarter earnings and sales expectations and initiated a quarterly dividend [1] Amgen - Delivered decent fourth-quarter results, beating both earnings and sales expectations, but faced investor disappointment due to a regulatory setback for its obesity drug [1] Vertex Pharmaceuticals - Vertex has beaten earnings estimates in three of the last four quarters, with an average surprise of 3.26%. The company is expected to report fourth-quarter earnings on February 10, with consensus estimates of $2.77 billion in sales and $3.99 per share in earnings [5][6][7] Gilead Sciences - Gilead has also beaten earnings expectations in three of the last four quarters, with an average surprise of 15.46%. The consensus estimates for fourth-quarter sales and earnings are $7.06 billion and $1.66 per share, respectively. The company is set to report results on February 11 [8][9][10] Biogen - Biogen has beaten expectations in three of the last four quarters, with an average surprise of 9.99%. The consensus estimates for fourth-quarter sales and earnings are $2.42 billion and $3.42 per share, respectively. Biogen will report results on February 12 [11][12] Alnylam Pharmaceuticals - Alnylam has beaten estimates in three of the last four quarters, with an average surprise of 65.67%. The consensus estimates for sales and earnings are $570.1 million and a loss of $0.21 per share, respectively. Alnylam is set to report results on February 13 [13][14] Moderna - Moderna has consistently beaten earnings estimates, with an average surprise of 72.65%. The consensus estimates for fourth-quarter sales and earnings are $956.11 million and a loss of $2.65 per share, respectively. The company is expected to report results on February 14 [15][16]

In its upcoming report, Alnylam Pharmaceuticals (ALNY) is predicted by Wall Street analysts to post quarterly loss of $0.21 per share, reflecting an increase of 80.9% compared to the same period last year. Revenues are forecasted to be $570.11 million, representing a year-over-year increase of 29.7%.The consensus EPS estimate for the quarter has undergone an upward revision of 0.3% in the past 30 days, bringing it to its present level. This represents how the covering analysts, as a whole, have reassessed t ...

Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:Alnylam Pharmaceuticals, Inc. (ALNY) : This biopharmaceutical company has seen the Zacks Consensus Estimate for its current year earnings increasing 15.2% over the last 60 days.HBT Financial, Inc. (HBT) : This bank holding company has seen the Zacks Consensus Estimate for its current year earnings increasing 8.8% over the last 60 days.Amphenol Corporation (APH) : This electrical and electronics manufacturing company has seen the Zacks C ...

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Here are three stocks with buy rank and strong momentum characteristics for investors to consider today, January 21st:CareDx, Inc (CDNA) : This diagnostic solutions company for transplant patients and caregivers has a Zacks Rank #1 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 7.5% over the last 60 days.CareDx’s shares gained 13.6% over the last six months compared with the S&P 500’s advance of 7.7%. The company possesses a Momentum Score  of A.Anavex Life Sciences Corp ...

Financial Performance - Preliminary net product revenues for Givlaari and Oxlumo were $65 million and $44 million, respectively, for Q4 2024 [1] - Full-year 2024 preliminary net product revenues for Givlaari and Oxlumo were $256 million and $167 million, respectively [1] - Preliminary net product revenues for Onpattro and Amvuttra were $56 million and $287 million, respectively, for Q4 2024 [13] - Full-year 2024 preliminary net product revenues for Onpattro and Amvuttra were $253 million and $970 million, respectively [13] - Combined net product revenues for Onpattro, Amvuttra, Givlaari, and Oxlumo are expected to be $2.05-$2.25 billion in 2025, implying 31% growth at the mid-point [11] - Total Onpattro and Amvuttra net product revenues are expected to be $1.60-$1.72 billion in 2025, reflecting 36% growth at the mid-point [11] - Total Givlaari and Oxlumo net product revenues are expected to be $450-$525 million in 2025, indicating 15% growth at the mid-point [12] Pipeline and Product Updates - FDA accepted Alnylam's sNDA for Amvuttra label expansion to treat ATTR amyloidosis with cardiomyopathy, with a decision expected on March 23, 2025 [2] - If approved, Amvuttra will be the first therapeutic in the US to treat both polyneuropathy and cardiomyopathy manifestations of ATTR amyloidosis [3] - Interim data from part B of the phase I study on mivelsiran for Alzheimer's disease is expected in H2 2025 [4] - Phase II study on mivelsiran for Alzheimer's disease is expected to initiate in H2 2025 [4] - Data from the phase II KARDIA-3 study on zilebesiran for hypertension is expected in H2 2025 [6] - Phase III cardiovascular outcomes study on zilebesiran is planned to initiate in H2 2025 [6] Market and Industry Trends - Amvuttra, Givlaari, and Oxlumo have seen strong patient demand, while Onpattro sales are declining due to patient switching to Amvuttra [10] - Alnylam's shares have rallied 23.1% in the past year, against the industry's decline of 16% [10] Collaborations and Rights - Alnylam regained full global development and commercialization rights to mivelsiran after Regeneron opted out of further co-development [5] - Regeneron will be eligible to receive low double-digit royalties on mivelsiran sales if approved [5] - Alnylam is collaborating with Roche on the development of zilebesiran [6]

Company Highlights - Alnylam Pharmaceuticals had an active 2024, with a significant highlight being the positive results from the Phase III HELIOS-B study of Amvuttra (vutrisiran) in ATTR amyloidosis with cardiomyopathy (ATTR-CM) [1] Clinical Trial Results - The Phase III HELIOS-B study of Amvuttra (vutrisiran) showed very positive results in treating ATTR-CM, a key development for the company [1] Future Prospects - The potential impact of the HELIOS-B study results on the company's future remains to be seen, but it represents a significant milestone in its clinical pipeline [1]

Core Viewpoint - Alnylam Pharmaceuticals (ALNY) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system emphasizes the importance of changing earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - An increase in earnings estimates typically leads to higher fair value calculations by institutional investors, resulting in buying or selling actions that affect stock prices [4]. Recent Performance and Projections - Alnylam is projected to earn -$0.39 per share for the fiscal year ending December 2024, reflecting an 88.9% year-over-year change [8]. - Over the past three months, the Zacks Consensus Estimate for Alnylam has increased by 19.3%, indicating a positive trend in earnings outlook [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - Alnylam's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10][11].

Alnylam Pharmaceuticals (ALNY) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking the label expansion of Amvuttra (vutrisiran) for review to treat ATTR amyloidosis with cardiomyopathy (ATTR-CM). Amvuttra, an RNAi therapeutic, is ALNY’s lead drug, which is currently approved in the United States for treating adult patients with polyneuropathy of transthyretin-mediated (hATTR) amyloidosis. It is also marketed in the EU for treating hATTR amyloidosis in adult patients with ...

Core Viewpoint - Alnylam Pharmaceuticals reported a significant decline in total revenues and adjusted loss per share for Q3 2024, primarily due to reduced collaboration revenues, despite strong growth in net product revenues driven by new drug demand. Financial Performance - Adjusted loss of 50 cents per share, matching Zacks Consensus Estimate, compared to earnings of $1.74 per share in the same quarter last year [1] - Total revenues of $500.9 million, missing the Zacks Consensus Estimate of $529 million, and down 33% year over year from $750.5 million [2] - Net product revenues increased to $420.1 million, up 34% year over year, driven by strong demand for Amvuttra, Givlaari, and Oxlumo [3] Collaboration and Royalties - Net revenues from collaborators fell to $57.4 million, down 87% from the previous year due to reduced revenues from collaborations with Roche and Regeneron [3] - Royalty revenues increased to $23.4 million, up from $9.9 million in the year-ago quarter, driven by higher sales of Leqvio by Novartis [7] Product Performance - Amvuttra generated sales of $258.6 million, up 74% year over year, exceeding estimates [9] - Givlaari sales reached $71 million, reflecting a 31% increase year over year, also surpassing estimates [10] - Oxlumo recorded revenues of $40.2 million, a 40% increase year over year, but missed estimates [10] - Onpattro sales were $50.3 million, down 38% year over year, missing estimates [8] Expenses and Cash Position - Adjusted R&D expenses rose 12% year over year to $251.1 million, while SG&A expenses increased 19% to $195 million [11] - Cash, cash equivalents, and marketable securities amounted to $2.78 billion as of September 30, 2024, up from $2.62 billion as of June 30, 2024 [12] Guidance and Pipeline Updates - The company expects combined net product revenues for 2024 to be between $1.575 billion and $1.650 billion, with collaboration and royalty revenues anticipated in the range of $575 million to $650 million [13] - Regulatory applications for Amvuttra's label expansion to treat ATTR amyloidosis with cardiomyopathy have been submitted in the U.S. and EU [14]