Alnylam Will Skip 2027 Guidance At JPMorgan, Waiting On A Medicare 340B Rule

The drugmaker will give 2027 product revenue guidance in mid-February, after a pending 340B rule and a UnitedHealth policy change.

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Alnylam Will Skip 2027 Guidance At JPMorgan, Waiting On A Medicare 340B Rule

Alnylam Pharmaceuticals, which develops RNA interference medicines, will not give 2027 product revenue guidance at the JPMorgan conference this year, CFO Jeff Poulton said on the company's third-quarter earnings call Thursday. A pending federal rule on 340B drug-discount reimbursement leaves too little time to see how hospitals react, he said, so the outlook will come in mid-February with fourth-quarter and full-year results.

Why January is too early

Poulton said the company expects the final 340B rule in the coming weeks, effective January 1. That would leave only a short window before JPMorgan to watch how health systems behave under the new framework.

Alnylam will still give preliminary fourth-quarter and full-year 2026 revenue at JPMorgan in January, as it normally does. Waiting until February, Poulton said, lets the company fold in a better read on ordering patterns and where patients get treated.

Chief Commercialization Officer Tolga Tanguler said that if the rule is finalized as proposed, it would substantially cut Medicare reimbursement for Part B medicines bought through the 340B program, and the company expects hospital groups to mount legal challenges.

A low-end year for TTR sales

The company reiterated its 2026 guidance but now expects transthyretin (TTR) product sales at the low end of the $4.2 billion to $4.5 billion range. Poulton cited a prudent view of fourth-quarter hospital ordering while customers await the rule. He also cited a more restrictive first-line Amvutra policy in UnitedHealth's Medicare Advantage business, in effect since October 1.

The company also assumes no material 2026 revenue from its expanded sales force, whose added physician engagement has not yet become faster demand growth. CEO Yvonne Greenstreet said the company does not expect growth to accelerate in the fourth quarter.

Third-quarter product revenue rose 52% from a year earlier to about $1.3 billion, with TTR revenue of $1.15 billion. Poulton said an inventory benefit and a one-time gross-to-net adjustment helped reported results, and that both will weigh on fourth-quarter growth.

Price could move either way

Asked by Stifel and BMO Capital Markets analysts about the effect, Poulton said it is hard to predict. If hospitals stay in the 340B channel, net price falls, because Alnylam would give a discount below the current statutory rate. If they shift to list-price purchasing or move patients to other care sites, net price rises. Volume effects are unknown, he said.

An RBC Capital Markets analyst asked whether the target of 25%-plus total revenue growth through 2030 is now optimistic. Greenstreet did not answer yes or no. She pointed to market growth and share, projecting about 75,000 treated U.S. ATTR cardiomyopathy patients by 2030 and a goal of a third of category prescriptions, versus 24% now.

Poulton said the company will gather experience with the 340B rule in January before giving more detail on its February call.

Sources

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