Alnylam Pharmaceuticals(ALNY) - 2023 Q1 - Quarterly Report

Product Development and Market Performance - The company has five marketed RNAi therapeutics and over ten clinical programs, with four products in the Genetic Medicines strategic area: ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO[98] - Leqvio, the company's fifth product, has received marketing authorization in over 75 countries, including the U.S. and EU, for treating hypercholesterolemia and mixed dyslipidemia[100] - The company is advancing multiple late-stage investigational programs, including patisiran and vutrisiran for ATTR amyloidosis with cardiomyopathy, and fitusiran for hemophilia[99] - The company reported positive interim data from the Phase 1 study of zilebesiran, an investigational RNAi therapeutic for hypertension, with Phase 2 studies expected to yield results in mid-2023 and at year-end 2023[99] - Alnylam continues to advance patisiran for ATTR amyloidosis, submitting 18-month data from the APOLLO-B Phase 3 study to the U.S. FDA[109] - The U.S. launch of AMVUTTRA contributed significantly to revenue growth, with total revenues from AMVUTTRA reaching $101,768,000, as it was launched in Q3 2022[119] - The company plans to continue advancing its product candidates into later-stage development and expand its global commercial infrastructure[132] Financial Performance - As of March 31, 2023, the company reported an accumulated deficit of $6.74 billion, primarily due to research and development costs and general administrative expenses[100] - Total revenues for Q1 2023 reached $319.3 million, a 50% increase from $213.3 million in Q1 2022[115] - Net product revenues for Q1 2023 were $276.3 million, up 48% from $186.9 million in Q1 2022[117] - Global net product revenues for ONPATTRO and AMVUTTRA in Q1 2023 were $102.5 million and $101.8 million, respectively[109] - Global net product revenues for GIVLAARI and OXLUMO in Q1 2023 were $47.9 million and $24.2 million, respectively[109] - Net revenues from collaborations in Q1 2023 were $36.5 million, a 41% increase from $25.9 million in Q1 2022[117] - Royalty revenue in Q1 2023 surged to $6.5 million, a 1,371% increase from $442,000 in Q1 2022[117] - The net loss for Q1 2023 was $174.1 million, a decrease of 28% from a net loss of $240.3 million in Q1 2022[115] Research and Development Expenses - The company anticipates continued operating losses as it invests in research and development, clinical trials, and commercialization efforts, although it expects 2019 to be the peak operating loss year[100] - Research and development expenses rose by 36% to $230,569,000, primarily due to increased clinical research and headcount to support the R&D pipeline[129] - Selling, general and administrative expenses increased by 19% to $183,659,000, attributed to higher compensation and strategic investments for the global launch of AMVUTTRA[132] Cash Flow and Financing - The company issued $1.04 billion in Convertible Senior Notes in September 2022, with proceeds used to repay borrowings and for general corporate purposes[103] - Interest expense decreased by 32% to $28,955,000 compared to $42,362,000 in the same period last year[135] - Interest income increased by 1,743% to $18,655,000 from $1,012,000 year-over-year[135] - Net cash used in operating activities decreased to $(166,475,000) from $(171,193,000) year-over-year[136] - Net cash used in investing activities decreased to $(76,217,000) from $(147,419,000) year-over-year[138] - Net cash provided by financing activities increased to $46,371,000 from $34,956,000 year-over-year[139] - The company expects its cash and marketable securities will be sufficient for at least the next 12 months[142] Strategic Alliances and Compliance - The company has formed alliances with leading pharmaceutical companies, including Regeneron and Novartis, to support development and commercialization efforts[100] - The company maintains a focus on enhancing its global compliance program to align with its strategic objectives and mitigate risks[99] Market Trends and Expectations - The company expects net product revenues to continue increasing in 2023 as new patients are added to commercial products and products are launched in additional markets[119] - The company anticipates variability in net revenues from collaborations and royalties in 2023 due to timing and achievement of milestones[123] - Total net product revenues decreased by 25% in the U.S. for ONPATTRO, reflecting a shift in patient demand to AMVUTTRA[119] - There have been no significant changes to financial market risks related to interest rates since December 31, 2022[143]