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Alnylam Pharmaceuticals(ALNY) - 2023 Q3 - Quarterly Report
2023-11-01 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 O ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q2 - Earnings Call Presentation
2023-08-03 17:41
Nathan (USA) Diagnosed with AHP Second Quarter 2023 Financial Results August 3, 2023 1 © 2023 Alnylam Pharmaceuticals, Inc. Agenda Welcome ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q2 - Earnings Call Transcript
2023-08-03 17:40
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Christine Lindenboom - Senior Vice President-Investor Relations and Corporate Communication Yvonne Greenstreet - Chief Executive Officer Tolga Tanguler - Chief Commercial Officer Pushkal Garg - Chief Medical Officer and EVP, Development & Medical Affairs Jeff Poulton - Chief Financial Officer Conference Call Participants Michael Ulz - Morgan Stanley David Lebowitz - Citi Paul Matteis - ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15( ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q1 - Earnings Call Transcript
2023-05-04 16:22
Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) Q1 2023 Earnings Conference Call May 4, 2023 8:30 AM ET Company Participants Christine Lindenboom – Senior Vice President-Investor Relations and Corporate Communication Yvonne Greenstreet – Chief Executive Officer Tolga Tanguler – Chief Commercial Officer Akshay Vaishnaw – President Jeff Poulton – Chief Financial Officer Pushkal Garg – Chief Medical Officer Conference Call Participants Ritu Baral – TD Cowen Tazeen Ahmad – BofA Paul Matteis – Stifel Gena Wang – Bar ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q1 - Earnings Call Presentation
2023-05-04 14:46
Nathan (USA) Diagnosed with AHP First Quarter 2023 Financial Results May 4, 2023 1© 2023 Alnylam Pharmaceuticals, Inc. Agenda Welcome • Christine Lindenboom Senior Vice President, Investor Relations & Corporate Communications Overview • Yvonne Greenstreet, MBChB, MBA Chief Executive Officer Commercial Highlights • Tolga Tanguler Chief Commercial Officer Alnylam Pipeline • Akshay Vaishnaw, M.D., Ph.D. President Financial Summary and Upcoming Milestones • Jeff Poulton Chief Financial Officer Q&A Session 2 Aln ...
Alnylam Pharmaceuticals(ALNY) - 2023 Q1 - Quarterly Report
2023-05-03 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Title of Each Class Trading Symbol(s) Name of Each Exchange on Which Registered Common Stock, $0.01 par value per share ALNY The Nasdaq Stock Market LLC Large accelerated filer x Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☐ ...
Alnylam Pharmaceuticals(ALNY) - 2022 Q4 - Earnings Call Transcript
2023-02-23 18:46
Financial Data and Key Metrics Changes - Alnylam achieved full year 2022 net product revenues of $894 million, representing year-over-year growth of 35% or 43% at constant exchange rates, with a 13% increase from Q3 to Q4 [7][34] - Total product revenues for 2022 were $894 million, reflecting a 35% increase compared to 2021, with growth contributions from all four commercial products [34] - Non-GAAP operating loss for 2022 was $554 million, approximately flat compared to 2021, with expectations to reduce this loss in 2023 [37][40] Business Line Data and Key Metrics Changes - The TTR franchise achieved $191 million in global net product revenues in Q4, a 12% increase from Q3 and a 38% increase from Q4 2021 [12][13] - GIVLAARI generated $47 million in global net product revenues in Q4, representing a 3% increase compared to Q3 and a 16% increase year-over-year [19] - OXLUMO achieved $24 million in global net product revenues in Q4, a 45% increase compared to Q3 [20] Market Data and Key Metrics Changes - In the U.S., combined sales of ONPATTRO and AMVUTTRA increased 12% versus Q3, driven by a 19% increase in demand growth [14][15] - The U.S. market for AMVUTTRA saw a 72% growth compared to Q4 2021, with over 2,975 patients on treatment worldwide by the end of 2022 [13][15] - International sales of ONPATTRO and AMVUTTRA also increased 12% versus Q3, primarily due to initial launches in Germany and Japan [14][18] Company Strategy and Development Direction - Alnylam aims to expand its ATTR franchise and become a global leader in delivering impactful medicines, while also addressing more common disease areas [10] - The company is focusing on sustainable innovation through new platform enhancements and finding new genetically validated targets [10] - Alnylam plans to advance TTRsc04, a new investigational RNAi therapeutic, which may offer a transformative profile with potential for annual dosing [30] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming FDA review and potential approval of patisiran for cardiomyopathy, with a PDUFA date set for October 8, 2023 [24][39] - The company anticipates combined net product revenues for 2023 to be between $1.2 billion and $1.285 billion, reflecting a growth range of 34% to 44% [39][40] - Management highlighted the strong initial commercial performance of AMVUTTRA and its potential to expand the market opportunity for the TTR franchise [21][22] Other Important Information - Alnylam ended 2022 with cash, cash equivalents, and marketable securities of $2.2 billion, down from $2.4 billion at the end of 2021 [38] - The company plans to submit an sNDA in Brazil for patisiran in early 2023, focusing efforts on regions with positive results from ongoing studies [25] Q&A Session Summary Question: Advisory committee meeting topics - Management indicated no specific areas to address for the advisory committee meeting, as no review issues have been identified [44][45] Question: Learnings from AMVUTTRA dosing - Management stated that the quarterly regimen of AMVUTTRA has been effective, and the decision not to pursue a six-month regimen was strategic [48][49] Question: Top line data from ALN-APP study - Management confirmed that the top line data will focus on safety, tolerability, and target engagement, with results expected in early 2023 [52][54] Question: HELIOS-B study design rationale - Management explained that the all-cause mortality endpoint maximizes event capture and provides a clinically meaningful effect [57][59] Question: Impact of J-Code on AMVUTTRA launch - Management noted that the J-Code received would not significantly change the trajectory of the launch, as access strategies were already in place [82][84]
Alnylam Pharmaceuticals(ALNY) - 2022 Q4 - Annual Report
2023-02-22 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________________________________________________________________________________ Form 10-K _____________________________________________________________________________________________ ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ...