Alnylam flags potential 2027 Medicare reimbursement cuts, delays data

 

Alnylam flags potential 2027 Medicare reimbursement cuts, delays ALN-6400 and ALN-2232 data to February, postpones 2027 product revenue guidance until Q4 results

• Q3 2026 non-GAAP EPS was $16.26, up 784% YoY, on revenue of $1.5B, beating estimates.
• Q3 2026 global net product revenue was $1.292B, up 52% YoY, led by TTR franchise.
• TTR product revenue was $1.15B, up 59% YoY and 12% sequential, aided by inventory and pricing.
• Management now expects 2026 TTR revenue at low end of already-cut $4.2–4.5B guidance range.
• Company reiterated full-year 2026 financial guidance following release of its third-quarter 2026 results.
• Sales-force expansion increased physician engagement but has not yet accelerated Amvuttra demand growth.
• Amvuttra reached ~24% total TTR prescriptions and >30% new-to-brand share.
• Q4 outlook factors potential ordering volatility from pending 340B rule and UnitedHealth step therapy.
• TRITON CM Phase 3 nucresiran trial enrollment expanded during Q3 2026 to ~2,250 patients to offset lower event rates.
• Huntington's candidate brazosiran showed 60–64% cerebrospinal fluid mutant huntingtin reduction with clean safety.
• Gross margin fell to 72%, down 5 points YoY, driven by higher royalty costs.
• Company recognized $1.9B noncash tax benefit, releasing valuation allowance and boosting GAAP net income.
• Main concern is slower-than-expected Amvuttra demand conversion and potential disruption from 340B and payer policy changes.
• Mixed quarter, driven by robust TTR revenue growth but tempered by slower demand ramp and access uncertainty.

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