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Alnylam Pharmaceuticals(ALNY) - 2024 Q4 - Annual Report

Financial Performance - Total revenues for 2024 reached 2,248,243,anincreaseof232,248,243, an increase of 23% compared to 1,828,292 in 2023, and a significant increase of 76% from 1,037,418in2022[491].Netproductrevenuesincreasedto1,037,418 in 2022[491]. - Net product revenues increased to 1,646,228 in 2024, up 33% from 1,241,474in2023,drivenprimarilybysalesofAMVUTTRA[492].Thecompanyreportedanetlossof1,241,474 in 2023, driven primarily by sales of AMVUTTRA[492]. - The company reported a net loss of 278,157 for 2024, a decrease of 37% from a net loss of 440,242in2023[491].Totaloperatingcostsandexpensesfor2024were440,242 in 2023[491]. - Total operating costs and expenses for 2024 were 2,425,128, reflecting a 15% increase from 2,110,467in2023[491].Netrevenuesfromcollaborationsdecreasedto2,110,467 in 2023[491]. - Net revenues from collaborations decreased to 510,221 in 2024, down 7% from 546,185in2023,primarilyduetoreducedrevenuefromtheRochecollaboration[496].Royaltyrevenueincreasedsignificantlyto546,185 in 2023, primarily due to reduced revenue from the Roche collaboration[496]. - Royalty revenue increased significantly to 91,794 in 2024, a 126% increase from 40,633in2023,attributedtohigherroyaltiesfromLeqviosalesbyNovartis[496].TheaccumulateddeficitasofDecember31,2024,was40,633 in 2023, attributed to higher royalties from Leqvio sales by Novartis[496]. - The accumulated deficit as of December 31, 2024, was 7.29 billion, reflecting ongoing investments in research and development[488]. - The company anticipates achieving financial self-sustainability by the end of 2025, despite expected fluctuations in operating results[488]. Sales Performance - Sales of ONPATTRO decreased by 29% in 2024 compared to 2023, while AMVUTTRA sales surged by 74% during the same period[493]. - The company expects net revenues from collaborations to increase in 2025, driven by anticipated higher revenues under the Roche collaboration[498]. - AMVUTTRA sales in the United States surged to 630.6millionin2024,comparedto630.6 million in 2024, compared to 411.2 million in 2023, reflecting a 53.3% growth[627]. Cost and Expenses - Cost of goods sold increased to 306.5millionin2024,up14306.5 million in 2024, up 14% from 268.2 million in 2023, with a significant increase of 91% from 140.2millionin2022[500].Costofgoodssoldasapercentageofnetproductrevenuesdecreasedto18.6140.2 million in 2022[500]. - Cost of goods sold as a percentage of net product revenues decreased to 18.6% in 2024 from 21.6% in 2023, attributed to one-time charges in 2023 that did not recur[501]. - Research and development expenses rose to 1.1 billion in 2024, a 12% increase from 1.0billionin2023,anda141.0 billion in 2023, and a 14% increase from 883.0 million in 2022[505]. - Selling, general and administrative expenses increased to 975.5millionin2024,a23975.5 million in 2024, a 23% rise from 795.6 million in 2023, driven by marketing investments and higher employee compensation[507]. Cash Flow and Investments - Net cash used in operating activities was (8.3)millionin2024,adecreaseof(8.3) million in 2024, a decrease of 112.5 million compared to 104.2millionin2023,primarilyduetodecreasedcashreceivedfromcollaborators[512].Netcashusedininvestingactivitiesdecreasedto104.2 million in 2023, primarily due to decreased cash received from collaborators[512]. - Net cash used in investing activities decreased to (116.8) million in 2024 from (336.4)millionin2023,mainlyduetothetimingofinvestmentsinmarketabledebtsecurities[514].Netcashprovidedbyfinancingactivitiesincreasedto(336.4) million in 2023, mainly due to the timing of investments in marketable debt securities[514]. - Net cash provided by financing activities increased to 294.2 million in 2024, up 122.0millionfrom122.0 million from 172.1 million in 2023, primarily due to increased proceeds from stock options[515]. - Cash outflows for capital expenditures were 34.3millionin2024,comparedto34.3 million in 2024, compared to 62.2 million in 2023, with expectations for an increase in 2025 to support manufacturing and production capacity needs[517]. Liabilities and Future Obligations - The liability related to the sale of future royalties totals approximately 1.02billion,withnoprincipalpaymentsexpectedwithinthenext12months[517].PaymentstoBlackstoneassociatedwiththeliabilityrelatedtothesaleoffutureroyaltieswere1.02 billion, with no principal payments expected within the next 12 months[517]. - Payments to Blackstone associated with the liability related to the sale of future royalties were 57.0 million in 2024, with an estimated 131.8milliontobepaidwithinthenext12months[517].Thecompanyhasestablishedadevelopmentderivativeliabilityof131.8 million to be paid within the next 12 months[517]. - The company has established a development derivative liability of 486.9 million as of December 31, 2024[683]. Market Position and Strategy - The company aims to transition to a top-tier biotech company by the end of 2025 under its Alnylam P x25 strategy, focusing on sustainable innovation and exceptional financial performance[563]. - The company has five marketed products as of December 31, 2024, including one product commercialized by a collaborator[516]. - Alnylam has five marketed products as of December 31, 2024, generating worldwide product revenues primarily from ONPATTRO, AMVUTTRA, GIVLAARI, and OXLUMO[563]. Accounting and Revenue Recognition - The company recognizes revenue when control of promised goods or services is transferred to a customer, following a five-step model[8]. - Net product revenues are recognized net of variable consideration, with the expected value method used for estimating variable consideration related to product sales[11]. - The liability related to the sale of future royalties is accounted for as debt financing, with interest recognized using the effective interest rate method[14]. - The company does not capitalize any costs to obtain contracts as of December 31, 2024, and 2023[10]. Collaborations and Agreements - Roche made an upfront, non-refundable payment of 310.0millionaspartofthecollaborationagreementforthedevelopmentofzilebesiran[637].ThetotaltransactionpriceundertheRocheAgreementwasdeterminedtobe310.0 million as part of the collaboration agreement for the development of zilebesiran[637]. - The total transaction price under the Roche Agreement was determined to be 1.31 billion as of December 31, 2024, an increase of 457.5millionfromthepreviousyear[651].TheRocheAgreementincludesa457.5 million from the previous year[651]. - The Roche Agreement includes a 310.0 million upfront payment and 547.0millioninadditionalvariableconsiderationrelatedtodevelopmentandmanufacturingservices[647].Thecompanyhasearned547.0 million in additional variable consideration related to development and manufacturing services[647]. - The company has earned 180.0 million in milestones from the collaboration with Novartis AG and is entitled to royalties ranging from 10% to 20% based on annual worldwide net sales[680].