Alnylam Pharmaceuticals(ALNY) - 2023 Q4 - Annual Report

Financial Performance - Total revenues for the year ended December 31, 2023, were $1,828,292, a 76$1,037,418 in 2022[221]. - Net product revenues increased to $1,241,474 in 2023, up 39$894,329 in 2022, primarily due to the launch of AMVUTTRA[225]. - Net revenues from collaborations surged to $546,185 in 2023, a 305$134,912 in 2022, driven by revenue from Roche and Novartis[226]. - The net loss for 2023 was $440,242, a 61$1,131,156 in 2022[221]. - Total revenues for the year 2023 reached $1.83 billion, a 76.2$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$1,822,490 in 2022[221]. - Research and development expenses increased to $1.0 billion in 2023, a 14$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$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$93,795 in 2022[225]. - Royalty revenue increased to $40,633 in 2023, a 397$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$4.05 billion in 2023, up from $3.70 billion in 2022, reflecting a 9.5$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].