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ALNYLAM PHARMACEUTICALS, INC. 8-K Report, Financial Results (Jul 30, 2026)

Reports
Earnings & Results·Exhibits & Filings
Filing Date
Filed July 30, 2026
Period End
July 30, 2026
Security
ALNY
In the record · 2016–202610-K1110-Q328-K121

ALNY filed 11 annual reports (10-K), 32 quarterly reports (10-Q) and 121 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · May ’17May ’17
  2. Leadership change8-K · Jul ’19Jul ’19
  3. Leadership change8-K · Dec ’21Dec ’21
  4. Material agreement8-K · Oct ’25Oct ’25

01—Abstract

Summary

Summary of the 8-K filed July 30, 2026. Cited figures are marked; the original filing is the authoritative source.

Alnylam reported Q2 2026 total revenues of $1,290.9 milliona, up 67% year over year, with total net product revenues of $1,172.1 million (up 74%).

Growth was driven primarily by TTR franchise sales: AMVUTTRA net product revenue reached $1,011.8 millionb (up 106%), and total TTR net product revenues were $1,030.2 million (up 89%), with the U.S. ATTR-CM launch the main contributor. GAAP income from operations was $231.4 million versus a loss of $16.2 million a year earlier, and GAAP net income was $164.5 million, or $1.21 per diluted share. Cash, cash equivalents and marketable securities rose to $3.3 billion from $2.9 billion at year-end 2025.

The most important investor item is a cut to full-year 2026 guidance. Total TTR net product revenue guidance was lowered to $4.2c–4.5 billion from $4.4–4.7 billion, and total net product revenue guidance was lowered to $4.7–5.1 billion from $4.9–5.3 billion. Management attributed the change to normalization of second-line U.S. AMVUTTRA demand after a pent-up demand benefit in the early launch period.

Collaboration and royalty revenue guidance was raised to $575d–625 million from $400–500 million, and non-GAAP R&D and SG&A guidance was reiterated. Pipeline and business development activity continued, including Phase 2 starts for ALN-6400 (von Willebrand disease) and mivelsiran (Down syndrome-associated Alzheimer's disease), a China commercialization agreement for AMVUTTRA with BeOne Medicines, and an AI collaboration with Inceptive.

Regeneron's cemdisiran NDA for generalized myasthenia gravis has a target FDA action date in November 2026. The filing does not disclose a cause for the guidance cut beyond management's commentary, and the rising interest expense and royalty-financing liabilities warrant continued monitoring.

02—Key points

Key Highlights

  1. Q2 2026 total revenues of $1,290.9M, up 67% YoY; total net product revenues of $1,172.1M, up 74%.
  2. AMVUTTRA net product revenues of $1,011.8M (up 106%); total TTR net product revenues of $1,030.2M (up 89%), now exceeding $1B in a quarter.
  3. Full-year 2026 total TTR net product revenue guidance lowered to $4.2–4.5B from $4.4–4.7B, citing normalized second-line U.S. ATTR-CM demand after pent-up demand in early launch.
  4. Full-year 2026 total net product revenue guidance lowered to $4.7–5.1B from $4.9–5.3B; net revenues from collaborations and royalties raised to $575–625M from $400–500M.
  5. GAAP operating income of $231.4M vs. a $16.2M loss a year ago; GAAP diluted EPS of $1.21 vs. $(0.55); non-GAAP diluted EPS of $1.84 vs. $0.28.
  6. Cash, cash equivalents and marketable securities of $3.3B at June 30, 2026, up from $2.9B at December 31, 2025, driven by operating cash inflows.
  7. Pipeline progress: Phase 2 starts for ALN-6400 and mivelsiran; China AMVUTTRA partnership with BeOne Medicines; Regeneron cemdisiran FDA action date targeted for November 2026.

03—Questions

Frequently Asked Questions

  1. Why did Alnylam lower its 2026 TTR revenue guidance?

    Management said growth in second-line U.S. AMVUTTRA demand moderated in early 2026 to what it now considers a normalized level. The early ATTR-CM launch had benefited from pent-up demand among patients on stabilizers who were waiting for a new treatment, and the company says it now sees that effect as temporary.

  2. How did Q2 2026 results compare with Q2 2025?

    Total revenues rose 67% to $1,290.9M. Total net product revenues rose 74% to $1,172.1M, led by AMVUTTRA at $1,011.8M (up 106%). GAAP operating income was $231.4M, compared with a $16.2M loss in Q2 2025, and GAAP net income was $164.5M, compared with a $72.2M loss.

  3. Did Alnylam change its profitability or expense outlook?

    Non-GAAP R&D and SG&A expense guidance of $2.7–2.8B was reiterated. Guidance for net revenues from collaborations and royalties was raised to $575–625M from $400–500M, reflecting the strong royalty revenue and collaboration activity in the quarter. Q2 interest expense was $82M, including financing-related charges on the Leqvio royalty sale and development funding liabilities.

  4. What are the key upcoming catalysts mentioned in the filing?

    Regeneron's cemdisiran NDA for generalized myasthenia gravis has a targeted FDA action date in November 2026 under Priority Review. Alnylam expects Phase 1 and Phase 2 data for ALN-6400 in the second half of 2026, as well as Phase 1 data for ALN-2232 in obesity. Initial ALN-HTT02 Phase 1 results in Huntington's disease are scheduled for presentation at EHDN on October 23, 2026.

04—Continue

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