Alnylam Pharmaceuticals, Inc. (ALNY) SEC Filings & Earnings Calls

Guidance cut signals deceleration in ATTR-CM launch after initial pent-up demand

“lowered TTR product sales guidance for full-year 2026 to reflect learnings from the initial phase of our launch in the evolving ATTR-CM market, in particular the normalization of growth in second line volume after satisfying pent-up demand”

Competitive pressure from next-generation TTR silencers (nucresiran) could impact future market share

“nucresiran ... still expects to launch ... in ATTR-CM by 2030”

AMVUTTRA revenue concentration

“If we are unable to sustain and grow revenues from sales of AMVUTTRA, our business would be materially harmed, our future operating results would be adversely impacted, and the market price of our common stock would likely decline.” · word for word

Tariff and trade policy risk

“The administration has initiated or is considering imposing tariffs on certain foreign goods, and has announced plans to impose or increase tariffs of potentially 100% or more on pharmaceuticals, including pharmaceutical products and components manufactured outside of the U.S.” · word for word

BIOSECURE Act supply chain risk

“The BIOSECURE ACT has the potential to severely restrict our ability to purchase services or products from, or otherwise collaborate with, certain Chinese 'biotechnology companies of concern' without losing the ability to contract with, or otherwise receive funding from, the U.S. government.” · word for word

Competitive pressure from next-generation TTR silencers (nucresiran) could impact future market share

“nucresiran ... still expects to launch ... in ATTR-CM by 2030”

AMVUTTRA revenue concentration

“If we are unable to sustain and grow revenues from sales of AMVUTTRA, our business would be materially harmed, our future operating results would be adversely impacted, and the market price of our common stock would likely decline.” · word for word

Tariff and trade policy risk

“The administration has initiated or is considering imposing tariffs on certain foreign goods, and has announced plans to impose or increase tariffs of potentially 100% or more on pharmaceuticals, including pharmaceutical products and components manufactured outside of the U.S.” · word for word

BIOSECURE Act supply chain risk

“The BIOSECURE ACT has the potential to severely restrict our ability to purchase services or products from, or otherwise collaborate with, certain Chinese 'biotechnology companies of concern' without losing the ability to contract with, or otherwise receive funding from, the U.S. government.” · word for word

No material risk signals; compensation arrangement is standard retention tool.

No material risk signals; strong revenue growth and profitability achieved.

Convertible note debt burden

“As of December 31, 2025, we had $1.02 billion in total aggregate principal amount of Notes issued and outstanding.” · word for word

Stock price volatility

“Our stock price has been and may in the future be volatile.” · word for word

Concentrated ownership

“As of December 31, 2025, our seven largest stockholders beneficially owned in excess of 50% of our outstanding shares of common stock.” · word for word

Preliminary results subject to audit; clinical and regulatory risks for pipeline.

“Preliminary selected financial results are unaudited, subject to adjustment.” · word for word

Insufficient detail to assess impact.

“No details in excerpt.”

Board composition change may signal governance transition but no disagreement cited, low immediate risk.

“Resignations not due to disagreement; board size reduced from 11 to 10.”

Pipeline dependency; clinical trial risks for zilebesiran, nucresiran, and early-stage programs.

“Advanced multiple pipeline programs, including two new Phase 3 trials, ZENITH for Zilebesiran in Hypertension, and TRITON-PN for Nucresiran in hATTR-PN” · word for word

History of losses and accumulated deficit

“We have a history of losses and may not become and remain profitable. As of September 30, 2025, we had an accumulated deficit of $7.16 billion.” · word for word

Dependence on collaborators

“If any collaborator materially amends, terminates or fails to perform its obligations under agreements with us, the development and commercialization of certain of our product candidates could be delayed or terminated.” · word for word

Manufacturing reliance on third parties

“We rely, and expect to continue to rely, on third parties to manufacture our products and product candidates. The loss of these or future third-party suppliers, or their inability to provide us with sufficient supply, could harm our business.” · word for word