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]

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].

Cavan Images One niche area of biotech that I've followed closely over the past several years has been the treatment and pipeline for transthyretin amyloidosis (ATTR). ATTR is a rare genetic disease where a mutation in the TTR gene causes the liver to produce a misfolded protein called transthyretin, which can build up in the body resulting in polyneuropathy and cardiomyopathy. This progressive disease is often diagnosed later in life only after patients start to experience a high disease burden, which incl ...

Company Overview - Alnylam Pharmaceuticals is a leading company in RNA interference (RNAi) therapeutics, aiming to transform the lives of patients with rare and prevalent diseases through innovative medicines [5][6] - The company has developed several commercial RNAi therapeutic products, including ONPATTRO® (patisiran), AMVUTTRA® (vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and Leqvio® (inclisiran) [5] - Alnylam is executing its "Alnylam P5x25" strategy to deliver transformative medicines while maintaining exceptional financial performance, establishing a strong position in the biotech industry [6] Leadership Recognition - Yvonne Greenstreet, CEO of Alnylam, has been named the 2024 Woman of the Year by the Healthcare Businesswomen's Association (HBA) for her extraordinary contributions to healthcare and women's advancement in the workplace [1][2] - Under Yvonne's leadership, Alnylam has been recognized as a socially responsible company and an exceptional workplace, earning accolades such as being listed among Fortune's Best Workplaces for Women and the Bloomberg Gender Equality Index [2][3] Leadership Background - Yvonne Greenstreet has over three decades of experience in the biopharmaceutical industry, having held significant positions at Pfizer and GlaxoSmithKline prior to joining Alnylam [3][4] - She has a medical degree from The University of Leeds and an MBA from INSEAD Business School, showcasing her strong educational background [4]

Alnylam Pharmaceuticals (ALNY) reported preliminary full-year 2023 net product revenues of $1.24 billion, representing 39% growth at a constant exchange rate. The Zacks Consensus Estimate for the same is pegged at $1.83 billion.The company’s net product revenues comprise sales of its four marketed products, such as Onpattro, Amvuttra, Givlaari and Oxlumo.In 2023, preliminary global net product revenues for Onpattro and Amvuttra were approximately $355 million and $558 million, respectively, representing a 4 ...