Alnylam Pharmaceuticals (ALNY) and partner Roche (RHHBY) announced positive results from the phase II KARDIA-2 study evaluating their investigational RNAi therapeutic zilebesiran in adults with hypertension (or high blood pressure).The KARDIA-2 study enrolled 672 adults with mild-to-moderate hypertension who were randomized to receive either a 600-mg dose of zilebesiran or placebo on top of one of three approved hypertension medications, namely olmesartan, amlodipine or indapamide.Study participants who rec ...

As former leader of Pfizer's infant nutrition and consumer healthcare businesses, Schulman brings extensive experience in the space, in addition to serving on the boards of several biotech and pharmaceutical companies; This marks ByHeart's first non-executive Board chair appointment In addition to Schulman, ByHeart appoints Niall Mullane, PhD, as Chief Quality Officer to join the experienced executive team; Mullane brings 15 years of quality and food safety experience in the infant nutrition category NEW YO ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the KARDIA-2 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, met the primary endpoint showing that zilebesiran resulted in clinically and statistically significant additive, placebo-adjusted reductions in 24-hour mean systolic blood pressure (SBP) at Mont ...

Alnylam Pharmaceuticals (ALNY) reported a loss of $1.10 per share in the fourth quarter of 2023, narrower than the Zacks Consensus Estimate of a loss of $1.20. The company had incurred a loss of $1.68 per share in the year-ago quarter.The fourth-quarter loss included stock-based compensation expenses, unrealized gain on equity securities and loss on extinguishment of debt. Excluding these items, the adjusted loss was 77 cents per share, narrower than the adjusted loss of $1.39 reported in the year-ago quart ...

Fourth Quarter and Full Year 2023 Financial Results February 15, 2024 1 © 2024 Alnylam Pharmaceuticals, Inc. Agenda Welcome • Christine Lindenboom ...

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q4 2023 Earnings Conference Call February 15, 2024 8:30 AM ET Company Participants Christine Lindenboom - Senior Vice President, Investor Relations and Corporate Communications Yvonne Greenstreet - Chief Executive Officer Tolga Tanguler - Chief Commercial Officer Pushkal Garg - Chief Medical Officer Jeff Poulton - Chief Financial Officer Akshay Vaishnaw - Chief Innovation Officer Conference Call Participants Ritu Baral - TD Paul Matteis - Stifel Ellie Merle - UBS ...

Shares of Alnylam Pharmaceuticals (ALNY -10.09%) were sinking 9.5% lower as of 11:27 a.m. ET on Thursday after falling as much as 12.6% earlier in the day. The sell-off came after the drugmaker announced its fourth-quarter and full-year 2023 results.Alnylam reported Q4 total revenue of $439.7 million, up 31% year over year. This result came in a little below the average analysts' estimate of $442.9 million.The company posted a net loss in Q4 of $137.9 million, or $1.10 per share, based on generally accepted ...

For the quarter ended December 2023, Alnylam Pharmaceuticals (ALNY) reported revenue of $439.72 million, up 31.2% over the same period last year. EPS came in at -$1.10, compared to -$1.68 in the year-ago quarter.The reported revenue represents a surprise of -1.31% over the Zacks Consensus Estimate of $445.57 million. With the consensus EPS estimate being -$1.20, the EPS surprise was +8.33%.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compar ...

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the fourth quarter and full year ended December 31, 2023 and reviewed recent business highlights. “2023 was a year of strong execution at Alnylam. We delivered robust product revenue growth across our four wholly-owned commercial medicines, with $1.24 billion in global net product revenues, and achieved over 5,000 patients now being ...

Financial Performance - Total revenues for the year ended December 31, 2023, were $1,828,292, a 76% increase from $1,037,418 in 2022[221]. - Net product revenues increased to $1,241,474 in 2023, up 39% from $894,329 in 2022, primarily due to the launch of AMVUTTRA[225]. - Net revenues from collaborations surged to $546,185 in 2023, a 305% increase from $134,912 in 2022, driven by revenue from Roche and Novartis[226]. - The net loss for 2023 was $440,242, a 61% reduction compared to a net loss of $1,131,156 in 2022[221]. - Total revenues for the year 2023 reached $1.83 billion, a 76.2% increase from $1.04 billion in 2022[270]. - The company recorded a net loss of $440.2 million for 2023, compared to a net loss of $1.13 billion in 2022, indicating a 61.0% improvement[270]. Operating Costs and Expenses - Operating costs and expenses rose to $2,110,467 in 2023, reflecting a 16% increase from $1,822,490 in 2022[221]. - Research and development expenses increased to $1.0 billion in 2023, a 14% increase from $883.0 million in 2022, driven by higher headcount and clinical trial costs[229][233]. - Selling, general and administrative expenses rose to $795.6 million in 2023, a 3% increase from $770.7 million in 2022, attributed to investments supporting strategic growth[236]. - Total operating costs and expenses increased by 16% in 2023, reaching $2.1 billion compared to $1.8 billion in 2022[229]. Cash Flow and Liquidity - Net cash provided by operating activities for the year ended December 31, 2023, was $104.2 million, a significant increase from a cash used of $(541.3) million in 2022, primarily due to a $310.0 million up-front payment from Roche and a $100.0 million payment from Regeneron[241]. - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities totaling $2.44 billion, up from $2.19 billion in 2022[245]. - Cash and cash equivalents decreased to $812.7 million in 2023 from $866.4 million in 2022, a decline of 6.2%[265]. - The total cash, cash equivalents, and restricted cash shown in the consolidated statements of cash flows was $814,884 as of December 31, 2023, down from $868,556 in 2022, a decrease of about 6.2%[367]. Revenue Sources - ONPATTRO's total net revenues decreased by 36% to $354,546 in 2023, compared to $557,608 in 2022, due to patient switches to AMVUTTRA[225]. - AMVUTTRA generated total net revenues of $557,838 in 2023, marking a significant increase of 495% from $93,795 in 2022[225]. - Royalty revenue increased to $40,633 in 2023, a 397% rise from $8,177 in 2022[226]. - GIVLAARI's total net revenues increased to $219.3 million in 2023 from $173.1 million in 2022, reflecting a growth of approximately 26.7%[319]. - OXLUMO's total net revenues rose to $109.8 million in 2023, compared to $69.8 million in 2022, marking a growth of about 57.3%[319]. Collaborations and Agreements - Revenue from collaborations recognized an additional $30.0 million in 2023 compared to 2022, primarily from commercialization and regulatory milestones achieved under the Novartis Collaboration Agreement[227]. - Roche made an upfront, nonrefundable payment of $310 million as part of a collaboration agreement for the development of zilebesiran, with potential contingent payments of up to $1.24 billion based on milestones[329]. - Regeneron Pharmaceuticals made an upfront payment of $400.0 million as part of the collaboration agreement[336]. - The company will lead the global clinical development for zilebesiran, sharing development costs with Roche at a ratio of 40% to 60%[329]. Assets and Liabilities - The company had an accumulated deficit of $7.01 billion as of December 31, 2023[218]. - Total assets increased to $3.83 billion in 2023, compared to $3.55 billion in 2022, marking a 7.9% growth[265]. - Total liabilities rose to $4.05 billion in 2023, up from $3.70 billion in 2022, reflecting a 9.5% increase[266]. - The liability related to the sale of future royalties was recorded at $1.38 billion as of December 31, 2023, with an interest expense of $106.6 million recognized for the year[261]. Stock and Compensation - The company reported stock-based compensation expense of $221,680 thousand for 2023, slightly down from $230,649 thousand in 2022[277]. - The total stock-based compensation expense for research and development in 2023 was $97,273 thousand, compared to $92,161 thousand in 2022[378]. - As of December 31, 2023, there were 1,025 thousand time-based restricted stock units outstanding, with a weighted-average fair value of $185.24 per share[385]. Future Outlook - The company aims to achieve financial self-sustainability by the end of 2025 while continuing to incur operating losses[218]. - The company anticipates a decrease in net revenues from collaborations in 2024, primarily due to reduced revenues from the Roche Collaboration and License Agreement[227]. - The company expects research and development and selling, general and administrative expenses to increase in 2024 as it advances its product candidates and expands its global commercial infrastructure[236]. Legal and Regulatory Matters - The company has ongoing patent infringement lawsuits against Pfizer and Moderna related to its biodegradable cationic lipids used in mRNA COVID-19 vaccines[410].