CAMBRIDGE, Mass.--(BUSINESS WIRE)--Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced the launch of the Family Health History Road Trip, its program designed to encourage conversations between family members about their health history so they can discuss with their doctor to better understand their risk for developing an inherited disease like hereditary ATTR (hATTR) amyloidosis. Inspired by the traditional family road trip, the program follows genealogist a ...

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 ...

Core Insights - Alnylam Pharmaceuticals experienced a significant stock decline of 9.5% following the announcement of its Q4 and full-year 2023 results, with a peak drop of 12.6% earlier in the day [1] - The company reported Q4 total revenue of $439.7 million, reflecting a 31% year-over-year increase, but slightly below analysts' expectations of $442.9 million [1] - Alnylam posted a net loss of $137.9 million, or $1.10 per share, under GAAP, while the non-GAAP net loss was $96.6 million, or $0.77 per share, which was better than the consensus estimate of a $1.32 loss per share [1] Financial Performance - Q4 total revenue: $439.7 million, up 31% year-over-year [1] - Net loss in Q4: $137.9 million, or $1.10 per share (GAAP) [1] - Non-GAAP net loss: $96.6 million, or $0.77 per share [1] Investor Concerns - Investors were likely more troubled by the revised statistical analysis plan and timing for the Helios-B phase 3 study for vutrisiran, which included changes to outcome measures and secondary endpoints, extending the trial by up to three months [2] - Analyst Kostas Biliouris suggested that the changes might indicate a lack of management confidence in the Helios-B results [2] Market Outlook - Despite the small revenue miss, three of Alnylam's four approved products are showing strong sales growth, although Onpattro's sales are declining due to competition from Amvuttra [3] - Management's adjustments to the Helios-B study may reflect a cautious approach, but could also indicate a more confident outlook for the trial's success [3] - The stock is considered risky, with conservative investors advised to avoid it, while aggressive investors might see the current dip as a buying opportunity [3]

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 ...

Core Insights - Alnylam Pharmaceuticals reported strong financial performance in 2023, achieving $1.24 billion in global net product revenues and treating over 5,000 patients with its commercial medicines [2][10][12] - The company demonstrated leadership in RNAi therapeutics with significant clinical advancements, including the first gene silencing in the human brain [2][5] - Looking ahead, Alnylam anticipates important milestones in 2024, including results from key clinical studies and the initiation of several new studies [2][9] Financial Performance - For Q4 2023, Alnylam's total net product revenues reached $346.3 million, a 32% increase compared to Q4 2022, while full-year revenues were $1.24 billion, up 39% year-over-year [10][12] - The company reported a GAAP net loss of $137.9 million for Q4 2023, compared to a loss of $207.5 million in Q4 2022, and a full-year net loss of $440.2 million [10][40] - Cash, cash equivalents, and marketable securities increased to $2.44 billion as of December 31, 2023, primarily due to significant upfront payments from partnerships [17] Product Revenue Highlights - Alnylam's TTR therapies, ONPATTRO and AMVUTTRA, generated Q4 revenues of $79 million and $175 million, respectively, with annual growth of 40% compared to 2022 [3][11] - The Ultra-Rare disease therapies, GIVLAARI and OXLUMO, achieved Q4 revenues of $59 million and $33 million, respectively, reflecting a 35% annual growth [4][11] Research and Development Updates - Alnylam announced updates to the HELIOS-B Phase 3 study of vutrisiran, with topline results expected in late June or early July 2024 [5][9] - Positive initial results from the KARDIA-1 Phase 2 study of zilebesiran were presented, and the FDA has cleared the initiation of the multiple-dose part of the ALN-APP Phase 1 study [6][7] Future Guidance - For 2024, Alnylam projects combined net product revenues for its key therapies to be between $1.4 billion and $1.5 billion, representing a growth of 13% to 21% compared to 2023 [19][20] - The company expects net revenues from collaborations and royalties to range from $325 million to $425 million [19]