Full Year 2025 Preliminary* Net Product Revenues of $2,987 Million (81% Growth vs. 2024), Driven Primarily by Preliminary* Total TTR Revenues of $2,487 Million (103% Growth vs. 2024)

Alnylam Pharmaceuticals, Inc. the leading RNAi therapeutics company, announced its new five-year strategy, “Alnylam 2030,” focused on scaling the Company’s operations through achieving leadership in ATTR amyloidosis, driving long-term growth through sustainable innovation, and delivering exceptional financial results with discipline and agility. Alnylam also reported preliminary* fourth quarter and full year 2025 global net product revenues for AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO.

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New Five-Year Strategy: Alnylam 2030

Alnylam 2030 continues the Company’s 15-year heritage of establishing and delivering on ambitious five-year goals, the most recent of which was Alnylam P5x25. Over that time period, Alnylam has either met or exceeded all of its prior five-year goals.

Alnylam 2030 is focused on continuing to successfully scale the Company’s operations. Specifically, the Company intends to achieve the following by the end of 2030:

  • Achieve Global TTR Leadership: Build a Durable TTR Franchise
    • Lead TTR market in revenue by 2030 and cumulatively across five-year period
    • Launch best-in-class, next-gen silencer, nucresiran, in polyneuropathy by 2028 and cardiomyopathy by 2030
  • Grow Through Sustainable Innovation: Deliver Therapies that Prevent, Halt, or Reverse Disease
    • Deliver 2+ new transformative medicines beyond TTR with blockbuster potential
    • Expand to 10 tissue types and >40 clinical programs
    • Invest ~30% of revenues in non-GAAP R&D, including select external innovation
  • Scale with Discipline & Agility: Drive Sustained, Profitable Growth
    • Achieve 25%+ total revenue CAGR through year-end 2030
    • Deliver ~30% non-GAAP operating margin

“The past five years have been transformational, as we delivered on our ambitious goals to expand the reach of our commercial product portfolio, grow our pipeline of transformative RNAi therapeutics, and achieve strong financial results leading to sustainable profitability,” said Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam. “The success we have delivered with the early launch momentum of AMVUTTRA in ATTR-CM has laid the foundation for our first flagship commercial franchise. Our focus for the next five-year period is clear: continue to establish durable leadership in TTR; harness topline growth to invest in a high-yielding pipeline with blockbuster opportunities; and continue to operate with financial discipline and agility to enable the Company to scale efficiently. As the pioneer in RNAi therapeutics that has delivered six approved products, Alnylam 2030 provides the strategic direction to catalyze our growth during the next stage of our evolution.”

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Preliminary Fourth Quarter and Full Year 2025 Commercial and Financial Performance

Total TTR: AMVUTTRA (vutrisiran) & ONPATTRO (patisiran)

  • Preliminary* global net product revenues for AMVUTTRA and ONPATTRO for the fourth quarter were approximately $827 million and $32 million, respectively, together representing 151% total TTR growth compared to Q4 2024, and for the full year 2025 were approximately $2,314 million and $173 million, respectively, together representing 103% total TTR growth compared to full year 2024.

Total Rare: GIVLAARI (givosiran) & OXLUMO (lumasiran)

  • Preliminary* global net product revenues for GIVLAARI and OXLUMO for the fourth quarter were approximately $87 million and $50 million, respectively, together representing 26% total Rare growth compared to Q4 2024, and for the full year 2025 were approximately $308 million and $191 million, respectively, together representing 18% total Rare growth compared to full year 2024.

2026 Combined Net Product Revenue Guidance

Alnylam announced today full year 2026 combined net product revenue guidance for AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO of $4,900 million to $5,300 million, representing 71% growth compared to 2025* at the mid-point of the guidance range. On a franchise level, the guidance is as follows:

  • Total TTR (AMVUTTRA & ONPATTRO): $4,400 million to $4,700 million, representing 83% growth compared to 2025 at the mid-point of the guidance range.
  • Total Rare (GIVLAARI & OXLUMO): $500 million to $600 million, representing 10% growth compared to 2025* at the mid-point of the guidance range.

The Company plans to provide additional guidance for collaboration and royalty revenue and operating expenses when fourth quarter and full year 2025 earnings are released.

2026 Pipeline Goals

Nucresiran – an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. Alnylam expects to:

  • Advance the TRITON-CM Phase 3 trial in ATTR-CM and the TRITON-PN Phase 3 trial in hATTR-PN.

Zilebesiran – an investigational RNAi therapeutic in development for the treatment of hypertension, in collaboration with Roche. Alnylam expects to:

  • Advance the ZENITH Phase 3 cardiovascular outcomes trial.

Mivelsiran – an investigational RNAi therapeutic in development for the treatment of cerebral amyloid angiopathy (CAA) and Alzheimer’s disease. Alnylam expects to:

  • Complete enrollment of the cAPPricorn-1 Phase 2 trial in cerebral amyloid angiopathy in H1.
  • Initiate a Phase 2 trial in Alzheimer’s disease in H1.

ALN-6400 – an investigational RNAi therapeutic in development for the treatment of bleeding disorders. Alnylam expects to:

  • Report Phase 1 data in healthy volunteers in H2.
  • Report clinical proof of concept in hereditary hemorrhagic telangiectasia in H2.
  • Initiate a Phase 2 trial in a second bleeding disorder in H1.

ALN-4324 – an investigational RNAi therapeutic in development for the treatment of type 2 diabetes mellitus. Alnylam expects to:

  • Initiate a Phase 2 trial in H1.

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Source- businesswire