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]

·2 Alnylam Third Quarter 2024 Financial Results October 31, 2024 1© 2024 Alnylam Pharmaceuticals, Inc. Agenda Welcome • Christine Lindenboom Chief Corporate Communications Officer Overview • Yvonne Greenstreet, MBChB, MBA Chief Executive Officer Commercial Highlights • Tolga Tanguler Chief Commercial Officer Alnylam Pipeline • Pushkal Garg, M.D. Chief Medical Officer Financial Summary and Upcoming Milestones • Jeff Poulton Chief Financial Officer Q&A Session 2 Alnylam Forward Looking Statements This present ...

Financial Data and Key Metrics Changes - In Q3 2024, Alnylam Pharmaceuticals achieved a 34% year-over-year growth in global net product revenue, generating $420 million across its four marketed products [6][38] - Net revenue from collaborations decreased by $370 million compared to the previous year, primarily due to the recognition of a $310 million upfront payment from Roche in Q3 2023 [39] - Royalty revenue for the quarter was $23 million, more than double the amount recognized in Q3 2023, driven by higher sales of Leqvio [40] - Gross margin on product sales improved to 80% from 75% in Q3 2023, attributed to lower costs associated with canceled manufacturing commitments in 2023 [41] Business Line Data and Key Metrics Changes - The TTR franchise generated $309 million in global net product revenues, reflecting a 34% increase year-over-year [11] - The rare franchise, including GIVLAARI and OXLUMO, delivered $111 million in combined net product sales, representing an 8% increase compared to Q2 2024 and 34% growth compared to Q3 2023 [18] Market Data and Key Metrics Changes - In the U.S., combined sales of ONPATTRO and AMVUTTRA increased by 37% year-over-year, driven by a 31% increase in demand for AMVUTTRA [13] - Internationally, the TTR franchise grew by 31% year-over-year, despite a 9% quarter-on-quarter decrease due to gross to net adjustments [14] Company Strategy and Development Direction - Alnylam aims to establish its TTR portfolio as a flagship franchise, similar to EYLEA for Regeneron, to drive long-term growth and investment in R&D [7] - The company is focused on advancing its pipeline, with plans to file proprietary INDs for 9 programs by the end of 2025, targeting various disease areas [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the Alnylam P5x25 goals by year-end 2025, emphasizing a strong pipeline of first and/or best-in-class product candidates [9] - The management highlighted the significant unmet need in ATTR cardiomyopathy and the potential for vutrisiran to address this market upon regulatory approval [15][16] Other Important Information - Alnylam announced the decision to stop clinical development of ALN-KHK, focusing resources on more promising programs [35] - The company ended Q3 2024 with cash, cash equivalents, and marketable securities of $2.8 billion, an increase from $2.4 billion at the end of 2023 [45] Q&A Session Summary Question: Can you elaborate on the work done to improve RNAi delivery to adipose tissue and muscle? - Management highlighted the well-tolerated nature of RNAi therapeutics and the sustained knockdown of disease-causing proteins, guided by human genetics for disease validation [49][50] Question: Regarding ALN-HTT02, what are the expectations for Phase 1 data? - Management expressed excitement about the Huntington's program, emphasizing the potential for sustained knockdown and unique efficacy due to targeting the exon 1 fragment of the gene [54][56] Question: How has the second silencer impacted the market for polyneuropathy? - Management noted a 37% year-over-year growth in the U.S. for polyneuropathy treatments, indicating strong demand despite new competition [60][61] Question: What are the payer discussions regarding potential label expansion? - Management discussed the importance of clinical outcomes in payer discussions and the company's patient access philosophy, which aims to minimize co-pay burdens for patients [71][73] Question: How does the company view the potential for a bolus of patients seeking new treatments? - Management indicated that the fast progression of ATTR cardiomyopathy will lead to early diagnosis and treatment, positioning AMVUTTRA as a first-line therapy [82][84] Question: What are the expectations for the acoramidis label and its relevance to Alnylam's launch? - Management expressed confidence in their data from HELIOS-B and indicated that they are closely monitoring the acoramidis label [87][88] Question: How should spending levels in SG&A be viewed relative to the upcoming launches? - Management indicated an expectation of double-digit growth in SG&A as they prepare for the launches in both the U.S. and Europe [93] Question: What are the company's thoughts on potential business development activities? - Management emphasized the focus on internal pipeline growth while remaining open to opportunities that enhance their platform [102]