ALNYLAM PHARMACEUTICALS, INC. (ALNY): Results of Operations and Financial Condition
ALNYLAM PHARMACEUTICALS, INC. (ALNY) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Contacts: Alnylam Pharmaceuticals, Inc. Bo Piela (Media) 508-308-9783 Josh Brodsky (Investors) 617-551-8276 Alnylam Pharmaceuticals Reports Second Quarter 2026 Financial Results and Highlights Recent Period Progress − Achieved Second Quarter 2026 Global Net Product R
How this was made
The 30-second read
Why it matters
The most decision-relevant disclosure is the full-year 2026 TTR net product revenue guidance revision downward, explicitly attributed to learnings from the initial ATTR-CM launch phase and normalization in second-line volume. Additional clinical data (HELIOS-B subgroup and safety analyses) and commercial actions (China commercialization agreement, AI screening collaboration) provide offsetting positive catalysts but do not change the guidance reset already embedded in forecasts.
Market read
Traders can update valuation and positioning based on the explicit TTR guidance cut and weigh it against new ATTR-CM commercialization and pipeline/clinical readout momentum.
What to watch
The filing highlights DETECT-ATTR AI screening collaboration and additional AMVUTTRA launches/partnerships, which could accelerate diagnosis and future demand beyond what near-term guidance implies.
Alnylam Pharmaceuticals Reports Second Quarter 2026 Financial Results and Highlights Recent Period Progress
Second-quarter revenue, TTR revenue, operating income, net income and per-share results increased materially from the prior-year period, but the company reduced full-year 2026 TTR net product revenue guidance to reflect launch learnings and normalization of second-line volume growth after pent-up demand.
Key metrics
as reported| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenues (In thousands)GAAP | $ 1,290,948 | – | 67 % |
| Total net product revenues (In thousands)other | $ 1,172,109 | – | 74 % |
| GAAP Income (loss) from operations (In thousands)GAAP | $ 231,441 | – | Not meaningful |
| Non-GAAP Income from operations (In thousands)non-GAAP | $ 318,066 | – | 233 % |
| GAAP Net income (loss) (In thousands)GAAP | $ 164,494 | – | Not meaningful |
| Non-GAAP Net income (In thousands)non-GAAP | $ 251,801 | – | greater than 500% |
| GAAP Net income (loss) per common share — basicGAAP | $ 1.23 | – | Not meaningful |
| GAAP Net income (loss) per common share — dilutedGAAP | $ 1.21 | – | Not meaningful |
| Non-GAAP Net income per common share — basicnon-GAAP | $ 1.88 | – | greater than 500% |
| Non-GAAP Net income per common share — dilutednon-GAAP | $ 1.84 | – | greater than 500% |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| AMVUTTRAU.S. TTR net product revenues increased $106 million compared with Q1 2026, driven by a $129 million increase in demand, partially offset by approximately $20 million in inventory impact and a modest reduction in net price. | $ 1,011,762 (In thousands) | – | 106 % |
| ONPATTRONo product-specific driver reported. | $ 18,461 (In thousands) | – | (65) % |
| Total TTR net product revenuesInternational TTR net product revenues increased $14 million compared with Q1 2026, driven primarily by increased demand in both hATTR-PN and ATTR-CM across international markets. | $ 1,030,223 (In thousands) | – | 89 % |
| GIVLAARINo product-specific driver reported. | $ 89,764 (In thousands) | – | 11 % |
| OXLUMONo product-specific driver reported. | $ 52,122 (In thousands) | – | 11 % |
| Total Rare net product revenuesGrowth in GIVLAARI and OXLUMO global net product revenues. | $ 141,886 (In thousands) | – | 11 % |
Full-Year 2026 outlook
- RevenueTTR net product revenue guidance of $4,200 to $4,500 Million
- Note75% Growth Compared with 2025 at Revised Midpoint
- NoteRevised from $4,400 to $4,700 Million
What drove it
- Global net product revenues were $1,172 million, with total TTR net product revenues of $1,030 million.
- AMVUTTRA global net product revenues were $1,011,762 (In thousands), up 106 %.
- U.S. TTR growth reflected a $129 million increase in demand, partly offset by approximately $20 million in inventory impact and a modest reduction in net price.
- International TTR net product revenue growth was driven primarily by increased demand in hATTR-PN and ATTR-CM across international markets.
- The company initiated Phase 2 trials of ALN-6400 in von Willebrand disease and mivelsiran in Down syndrome-associated Alzheimer's disease.
- The company initiated a Phase 1 clinical trial of ALN-6222 in obesity.
Concerns
- Full-year 2026 TTR net product revenue guidance was revised to $4,200 to $4,500 Million from $4,400 to $4,700 Million.
- The company cited normalization of growth in second line volume after satisfying pent-up demand from patients waiting for a new therapy.
- ONPATTRO net product revenues were $ 18,461 (In thousands), with a year-over-year change of (65) %.
- U.S. TTR revenue growth was partially offset by approximately $20 million in inventory impact and a modest reduction in net price.
What to watch
- Initial Phase 1 results for ALN-HTT02 in Huntington's disease are scheduled for Friday, October 23, 2026.
- The Zilebesiran RNAi Roundtable is scheduled for Thursday, September 17, 10:30 am ET.
- The ALN-HTT02 RNAi Roundtable is scheduled for Monday, October 26, 10:00 am ET.
- The company expects results from Phase 1 and Phase 2 trials of ALN-6400 in healthy volunteers and patients with hereditary hemorrhagic telangiectasia, respectively, in the second half of 2026.
- The company expects results from a Phase 1 trial of ALN-2232 in obesity and weight management in the second half of 2026.
- Regeneron indicated an FDA target action date in November 2026 for cemdisiran in generalized myasthenia gravis.
Analysis
Alnylam reported total revenues of $ 1,290,948 (In thousands), up 67 %, and total net product revenues of $ 1,172,109 (In thousands), up 74 %. The TTR franchise was the central contributor: total TTR net product revenues were $ 1,030,223 (In thousands), up 89 %, while AMVUTTRA generated $ 1,011,762 (In thousands), up 106 %. Total Rare net product revenues were $ 141,886 (In thousands), up 11 %.
The reported results show a significant improvement in profitability. GAAP income from operations was $ 231,441 (In thousands), compared with GAAP loss from operations of $ (16,199) in the prior-year period. GAAP net income was $ 164,494 (In thousands), compared with a GAAP net loss of $ (72,228), and non-GAAP income from operations increased 233 % to $ 318,066 (In thousands). GAAP diluted net income per common share was $ 1.21 and non-GAAP diluted net income per common share was $ 1.84.
TTR demand and mix warrant particular attention. U.S. TTR net product revenues increased $106 million compared with Q1 2026, with a $129 million increase in demand partly offset by approximately $20 million in inventory impact and a modest reduction in net price. International TTR net product revenues increased $14 million compared with Q1 2026, primarily from increased hATTR-PN and ATTR-CM demand. AMVUTTRA growth contrasted with ONPATTRO revenue of $ 18,461 (In thousands), down (65) % year over year.
The principal offset to the strong reported quarter is the lower full-year TTR revenue outlook. The company revised TTR net product revenue guidance from $4,400 to $4,700 Million to $4,200 to $4,500 Million, citing launch learnings in ATTR-CM and normalization of second-line volume growth after pent-up demand was satisfied. Management nevertheless stated it is continuing to invest robustly in the TTR franchise as ATTR-CM diagnosis and treatment grow.
Pipeline activity remained active, with Phase 2 initiation for ALN-6400 in von Willebrand disease and mivelsiran in Down syndrome-associated Alzheimer's disease, as well as a Phase 1 initiation for ALN-6222 in obesity. Near-term milestones include initial ALN-HTT02 Phase 1 results on Friday, October 23, 2026, plus expected second-half results for ALN-6400 and ALN-2232.
Management, verbatim
We have lowered our 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 from patients waiting for a new therapy.
Yvonne Greenstreet, M.D., Chief Executive Officer
Given the strong foundation we have established and continued growth in ATTR-CM diagnosis and treatment, we remain confident in the trajectory of our ongoing ATTR-CM launch and are continuing to invest robustly in this franchise, as we bring AMVUTTRA to more patients and establish it as a foundational therapy.
Yvonne Greenstreet, M.D., Chief Executive Officer
Not in the filing
stated, not guessed- Complete Revenue Summary table details after the filing text truncates at the Roche collaboration revenue line.
- Gross profit and gross margin.
- Operating expense line items and operating expense guidance.
- Cash, cash equivalents, marketable securities, debt and other balance-sheet balances.
- Operating cash flow and free cash flow.
- Share repurchases, dividends and other capital-return information.
- Prior-quarter figures for total revenues, profitability metrics, EPS and product revenues.
- Prior-year and year-over-year figures for collaboration revenues because the Revenue Summary table is truncated.
- Full-year 2026 guidance for gross margin, operating expenses and tax rate.
- Previous release outlook for formal actual-versus-prior-guidance comparison.
AlphaAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
This is an SEC 8-K (Item 2.02) with Alnylam’s Q2 2026 financial results and business highlights, including TTR franchise performance and pipeline progress.
Ticker impact
Alnylam reported Q2 2026 results and revised full-year 2026 TTR net product revenue guidance to $4,200 to $4,500 million.
Near-term downside bias versus prior guidance, with volatility around ATTR-CM launch read-through and upcoming clinical/pipeline catalysts.
The filing discloses a specific full-year guidance reduction for TTR revenues, a key driver of earnings expectations, while also adding new clinical and commercial initiatives that may mitigate but not negate the guidance reset.
Market effects
Reinforces that RNAi TTR franchise growth is sensitive to ATTR-CM market dynamics and launch normalization, which can affect sentiment across rare-disease commercial models.
China commercialization agreement (subject to authorization) may influence regional rare-disease competitive expectations.
ATTR-CM diagnosis and treatment expansion themes could affect global investor appetite for late-stage rare-disease franchises.
Counterpoint
The guidance cut may reflect temporary normalization after pent-up demand rather than structural demand weakness, so the market may over-discount the long-term ATTR-CM trajectory.
Key entities
- issuerAlnylam Pharmaceuticals, Inc.
Reported Q2 2026 financial results and revised full-year 2026 TTR net product revenue guidance; highlighted ATTR-CM launch learnings and pipeline progress.
- productAMVUTTRA (vutrisiran)
Reported as the primary driver of Q2 2026 TTR net product revenues and central to the ATTR-CM franchise guidance discussion.
- productONPATTRO (patisiran)
Reported Q2 2026 TTR net product revenues as a smaller contributor versus AMVUTTRA.
- partnerBeOne Medicines
Entered an exclusive agreement for commercialization of AMVUTTRA in China, subject to marketing authorization.
- collaborationInceptive and a large California health care system
Strategic collaborations to support earlier identification of ATTR-CM and DETECT-ATTR study using an AI-enabled screening approach.
