01—Abstract
Summary
Summary of the 8-K filed January 13, 2025. Cited figures are marked; the original filing is the authoritative source.
Alnylam Pharmaceuticals (ALNY) furnished a Form 8-K on January 12, 2025 (Item 2.02, Exhibit 99.1) announcing preliminary unaudited fourth quarter and full year 2024 global net product revenues.
Full year 2024 net product revenues for ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO were approximately $1,646 milliona, up 33% year over year and at the high end of the company's revised guidance range. Fourth quarter net product revenues were approximately $451 million. Growth was led by the Total TTR franchise (ONPATTRO and AMVUTTRA), which rose 34% for the year to about $1,223 million, while the Total Rare franchise (GIVLAARI and OXLUMO) grew 29% to about $423 million.
The more consequential disclosure is forward-looking guidance. Alnylam guided 2025 combined net product revenues of $2,050 million to $2,250 millionb, implying roughly 31% growth at the midpoint, and expects to reach non-GAAP operating income profitability in 2025. The TTR guidance of $1,600 million to $1,725 million depends heavily on the expected U.S. launch of AMVUTTRA for ATTR-CM, with the PDUFA target action date of March 23, 2025.
Investors should note that the guidance explicitly assumes FDA approval by that date, so a delay or refusal would materially affect the outlook. Collaboration and royalty revenue and operating expense guidance were deferred to the fourth quarter and full year 2024 earnings release. The release also laid out 2025 pipeline milestones, including a Phase 3 start for nucresiran, KARDIA-3 Phase 2 results for zilebesiran, interim Phase 1 data and a Phase 2 start for mivelsiran, and a Phase 2 start for ALN-6400.
Partner-led catalysts include Sanofi's fitusiran PDUFA date of March 28, 2025. All financial figures are preliminary, unaudited and subject to adjustment ahead of the February 2025 full results. The information is furnished under Item 2.02 and is not deemed filed for Exchange Act liability purposes.
02—Key points
Key Highlights
- FY2024 preliminary net product revenues of approximately $1,646 million, up 33% year over year and at the high end of revised guidance
- Q4 2024 preliminary net product revenues of approximately $451 million (ONPATTRO $56M, AMVUTTRA $287M, GIVLAARI $65M, OXLUMO $44M)
- Total TTR franchise FY2024 revenue grew 34% to about $1,223 million; Total Rare franchise grew 29% to about $423 million
- 2025 combined net product revenue guidance of $2,050M to $2,250M, about 31% growth at the midpoint
- 2025 TTR guidance of $1,600M to $1,725M (36% midpoint growth) hinges on FDA approval of AMVUTTRA for ATTR-CM by the March 23, 2025 PDUFA date
- Company expects to achieve non-GAAP operating income profitability in 2025 if revenue guidance is met
- Key 2025 catalysts include the ATTR-CM PDUFA date, zilebesiran KARDIA-3 Phase 2 results, nucresiran Phase 3 initiation, and Sanofi's fitusiran PDUFA date of March 28, 2025
03—Questions
Frequently Asked Questions
How much revenue did Alnylam generate in 2024 and how did it compare to prior guidance?
Preliminary, unaudited full year 2024 global net product revenues were approximately $1,646 million across ONPATTRO, AMVUTTRA, GIVLAARI and OXLUMO, a 33% increase over 2023. The company said this was at the high end of its revised guidance range.
What is the 2025 revenue outlook?
Alnylam guided combined 2025 net product revenues of $2,050 million to $2,250 million. This implies about 31% growth at the midpoint. The TTR franchise is guided to $1,600 million to $1,725 million and the Rare franchise to $450 million to $525 million.
What is the key risk to the 2025 guidance?
The TTR guidance assumes FDA approval of AMVUTTRA for ATTR amyloidosis with cardiomyopathy by the March 23, 2025 PDUFA target action date. Vutrisiran has not yet been approved for this indication, so a delay or rejection would pressure the guidance. Other risks in the filing include reimbursement, pipeline results, and dependence on partners such as Roche, Novartis, Sanofi, Regeneron and Vir.
When does Alnylam expect to reach non-GAAP profitability?
The company anticipates delivering non-GAAP operating income profitability in 2025, contingent on meeting its net product revenue guidance. Non-GAAP operating income excludes stock-based compensation expense. Specific operating expense and collaboration revenue guidance was deferred to the Q4 and full year 2024 earnings release in February 2025.
Are these 2024 figures final?
No. The figures are preliminary, unaudited, subject to adjustment, and provided as an approximation ahead of the company's complete financial results expected in February 2025. Investors should await the full-year earnings release and the audited 10-K for final numbers.
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