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Alnylam (NASDAQ: ALNY) posts Q1 2026 profit on 121% product revenue growth

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Alnylam Pharmaceuticals reported a very strong first quarter of 2026, driven by its transthyretin (TTR) franchise. Total revenues nearly doubled to $1.17 billion, with net product revenues of $1.04 billion, up 121% from the same quarter in 2025.

The company swung from a GAAP net loss of $18.3 million in Q1 2025 to GAAP net income of $206.0 million, and non‑GAAP net income rose to $273.0 million. AMVUTTRA generated $889.9 million in sales, and total TTR net product revenues reached $910.4 million, a 153% increase. Rare disease products GIVLAARI and OXLUMO added $125.7 million, up 15%.

Alnylam reiterated its full‑year 2026 guidance, including total net product revenues of $4.9–$5.3 billion and non‑GAAP R&D and SG&A expenses of $2.7–$2.8 billion, while highlighting broad pipeline progress and upcoming clinical readouts in the second half of 2026.

Positive

  • Revenue inflection and profitability: Total revenues rose 96% year over year to $1.17 billion, driven by 121% net product revenue growth, and Alnylam shifted from a GAAP net loss to $206 million of GAAP net income in Q1 2026.
  • Explosive TTR franchise growth: AMVUTTRA generated $889.9 million and total TTR net product revenues reached $910.4 million, representing 153% year‑over‑year growth and establishing a high‑revenue anchor for the portfolio.
  • Reaffirmed robust 2026 outlook: Management reiterated full‑year 2026 guidance, including $4.9–$5.3 billion in total net product revenues and $2.7–$2.8 billion in non‑GAAP R&D and SG&A expenses, supporting a sustained growth and investment trajectory.

Negative

  • None.

Insights

Q1 2026 shows transformational revenue growth and a clean move to profitability for Alnylam.

Alnylam delivered total revenues of $1.17 billion, up 96% year over year, with net product revenues of $1.04 billion growing 121%. The TTR franchise led performance: AMVUTTRA sales reached $889.9 million, driving total TTR net product revenues to $910.4 million, up 153%.

Profitability improved sharply. GAAP income from operations rose to $268.6 million from $18.1 million, and GAAP net income was $206.0 million versus a prior‑year loss. Non‑GAAP operating income more than quadrupled to $338.8 million, and diluted non‑GAAP EPS increased to $1.99. Cost of goods sold rose to 20% of product revenues, reflecting higher AMVUTTRA‑linked royalties, but was offset by strong volume growth.

Management reiterated full‑year 2026 guidance for total net product revenues of $4.9–$5.3 billion and non‑GAAP R&D and SG&A expenses of $2.7–$2.8 billion. Cash and marketable securities of about $3.0 billion at March 31 2026 support continued investment in multiple late‑stage programs, with several clinical readouts planned in the second half of 2026.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Total revenues $1,167,175 thousand Three months ended March 31, 2026; up 96% year over year
Total net product revenues $1,036,127 thousand Three months ended March 31, 2026; up 121% year over year
AMVUTTRA net product revenues $889,931 thousand Q1 2026; 187% growth versus Q1 2025
Total TTR net product revenues $910,412 thousand Q1 2026; 153% growth versus Q1 2025
GAAP net income $205,991 thousand Three months ended March 31, 2026; prior-year was a loss
Non-GAAP net income $273,038 thousand Three months ended March 31, 2026
2026 total net product revenue guidance $4,900–$5,300 million Full-year 2026 guidance reiterated
Cash, cash equivalents and marketable securities $3,009,223 thousand As of March 31, 2026
non-GAAP financial
"For an explanation of our use of non-GAAP financial measures, refer to the “Use of Non-GAAP Financial Measures” section"
Non-GAAP refers to financial measures that companies use to show their earnings or performance without including certain expenses or income that are often added back to give a different picture. It matters because it can make a company's results look better or more favorable, but it may also hide important costs, so investors need to look at both GAAP (official rules) and non-GAAP numbers to get a full understanding.
constant exchange rates financial
"Change at constant exchange rates, or CER, represents growth calculated as if exchange rates had remained unchanged"
A way companies report results that removes the effect of changing currency rates so financial figures from different periods are comparable. Like using the same ruler to measure two things, it shows how sales or profits moved because of the business itself rather than because currencies got stronger or weaker, helping investors judge true operational growth and trends without foreign exchange noise.
ATTR-CM medical
"Vutrisiran improved health-related quality-of-life in patients with ATTR-CM relative to placebo"
RNAi therapeutics medical
"Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company"
RNAi therapeutics are medicines that harness a natural cell process called RNA interference to silence specific genes by destroying or blocking the messenger RNA that carries instructions for making a protein—think of removing a recipe from a cookbook so the dish is no longer made. Investors care because this approach can create highly targeted treatments for diseases, offering potential for breakthrough drugs, faster development paths and distinct market or patent advantages, while carrying technical and regulatory risks.
Phase 3 clinical trial medical
"progressing three ongoing Phase 3 trials, and initiating a Phase 1 study"
A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.
stock-based compensation expenses financial
"The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures ... are stock-based compensation expenses"
Stock-based compensation expenses are the accounting cost a company records when it pays employees or contractors with company shares or options instead of cash. Like paying staff with pieces of ownership rather than dollars, this reduces reported profit and increases the number of shares outstanding, which can dilute existing shareholders. Investors watch it because it affects earnings, cash flow comparisons, and the value of each share over time.
Total revenues $1,167,175 thousand 96% year-over-year
Total net product revenues $1,036,127 thousand 121% year-over-year
Total TTR net product revenues $910,412 thousand 153% year-over-year
GAAP net income $205,991 thousand vs. $18,251 thousand loss prior year
Non-GAAP net income $273,038 thousand vs. $37,941 thousand prior year
Guidance

For full-year 2026, Alnylam reiterated guidance for total net product revenues of $4,900–$5,300 million, TTR net product revenues of $4,400–$4,700 million, Rare net product revenues of $500–$600 million, net revenues from collaborations and royalties of $400–$500 million, and non-GAAP R&D and SG&A expenses of $2,700–$2,800 million.

false000117867000011786702026-04-302026-04-30

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________
FORM 8-K
___________________________________________

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 30, 2026
___________________________________________
Alnylam Pharmaceuticals, Inc.
___________________________________________
(Exact Name of Registrant as Specified in Charter)
Delaware
001-36407
77-0602661
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
675 West Kendall Street,
Henri A. Termeer Square
 Cambridge, Massachusetts
02142
(Address of Principal Executive Offices)(Zip Code)
Registrant’s telephone number, including area code: (617) 551-8200
Not applicable
(Former Name or Former Address, if Changed Since Last Report)
___________________________________________
    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
        Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)



        Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
        Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
        Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
 
Title of Each ClassTrading Symbol(s)Name of Each Exchange on Which Registered
Common Stock, $0.01 par value per shareALNYThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company    
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐






Item 2.02.     Results of Operations and Financial Condition
On April 30, 2026, Alnylam Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter ended March 31, 2026. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 2.02 of this Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01.     Financial Statements and Exhibits

(d) Exhibits

The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:

99.1    Press Release dated April 30, 2026.

104    Cover Page Interactive Data File (embedded within the Inline XBRL document).





SIGNATURE
          Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: April 30, 2026
ALNYLAM PHARMACEUTICALS, INC.
By: /s/ Jeffrey V. Poulton
Jeffrey V. Poulton
Executive Vice President, Chief Financial Officer



Exhibit 99.1
Contacts:
Alnylam Pharmaceuticals, Inc.
logoforera.jpg
Christine Akinc
(Investors and Media)
617-682-4340

Josh Brodsky
(Investors)
617-551-8276

Alnylam Pharmaceuticals Reports First Quarter 2026 Financial Results and Highlights Recent Period Progress

− Achieved First Quarter 2026 Global Net Product Revenues of $1,036 Million (121% Growth Compared with Q1 2025), Driven Primarily by Total TTR Revenues of $910 Million (153% Growth Compared with Q1 2025) –

− Reiterates 2026 Financial Guidance, Including Combined Net Product Revenues of $4,900 Million to $5,300 Million, and Total TTR Net Product Revenues of $4,400 to $4,700 Million –

− New Data Presented at ACC.26 Further Support Use of Vutrisiran as First-Line Treatment for ATTR-CM –

− Established Collaborations with Viz.ai and AHA Focused on Earlier Diagnosis, Coordinated Care and Long-Term Patient Impact in ATTR-CM –

− Deep Pipeline Progressing Toward Multiple Clinical Readouts During the Second Half of 2026 Expected to Support Long-Term Growth –

CAMBRIDGE, Mass., April 30, 2026 – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter ended March 31, 2026, and reviewed recent business highlights.

“2026 is off to a strong start for Alnylam with the end of the first quarter marking one year since the U.S. launch of AMVUTTRA for ATTR-CM, and also representing a significant financial milestone with the achievement of over $1 billion in quarterly product revenues for the first time in our history,” said Yvonne Greenstreet, M.D., Chief Executive Officer of Alnylam. “At the same time, we continued to advance our deep and high-value pipeline of RNAi therapeutics, progressing three ongoing Phase 3 trials, and initiating a Phase 1 study for our first adipose-targeted program for obesity and weight management. In addition, multiple programs across our pipeline are advancing toward key clinical readouts this year. Together, this represents important initial progress toward our Alnylam 2030 goals of achieving global TTR leadership, driving growth through innovation, and scaling with financial discipline as we work to deliver substantial patient impact and create long-term value.”

First Quarter 2026 and Recent Significant Business Highlights

Total TTR: AMVUTTRA® (vutrisiran) & ONPATTRO® (patisiran)

Achieved global net product revenues for AMVUTTRA and ONPATTRO for the first quarter of $890 million and $20 million, respectively, together representing $910 million in total TTR net product revenues and 153% total TTR growth compared to Q1 2025.

Today announced an update to the TRITON-CM Phase 3 study of nucresiran, an investigational next-generation TTR silencer, in patients with ATTR-CM.



Enrollment in the study is proceeding faster than anticipated. Consequently, the Company has decided to utilize a pre-specified protocol option to expand target enrollment from 1,250 to approximately 1,750 patients. While Alnylam is increasing the number of patients who will be enrolled in the trial, given the rapid pace of enrollment, the Company still expects to launch nucresiran, assuming positive data and regulatory approval, in ATTR-CM by 2030.

Presented new analyses from the HELIOS-B Phase 3 clinical trial of vutrisiran in patients with ATTR-CM at the American College of Cardiology's Annual Scientific Session and Expo.
Vutrisiran improved health-related quality-of-life in patients with ATTR-CM relative to placebo, with the treatment effect corresponding to the difference observed in ATTR-CM patients more than 10 years apart in age.
Consistent treatment effects of vutrisiran were observed across the ATTR-CM disease spectrum, including patients with the most advanced disease and diastolic dysfunction.
Real-world data demonstrated high adherence to and persistence of quarterly HCP-administered dosing with vutrisiran.

Announced new strategic efforts aimed at facilitating earlier diagnosis, coordinated care, and long-term patient impact in ATTR-CM.
Alnylam is partnering with Viz.ai to develop an AI-enabled ATTR-CM care pathway designed to assist in the identification of patients earlier in the course of disease and guide appropriate diagnostic evaluation and referral.
Alnylam is also supporting a national effort led by the American Heart Association which consists of a three-year initiative that will convene a 10-site cohort of multidisciplinary health systems in a national learning collaborative designed to identify gaps in care, share best practices, and scale effective models for diagnosing and managing ATTR-CM.

Hosted a TTR Investor Webinar highlighting Alnylam's progress delivering for patients with ATTR-CM as well as the long-term growth and durability of the Company's flagship TTR franchise. A replay is available here.

Total Rare: GIVLAARI® (givosiran) & OXLUMO® (lumasiran)

Achieved global net product revenues for GIVLAARI and OXLUMO for the first quarter of $74 million and $51 million, respectively, together representing $126 million in total Rare net product revenues and 15% total Rare growth compared to Q1 2025.

Other Highlights

Presented additional Phase 2 results for zilebesiran, in development for cardiovascular risk reduction in hypertension patients, including assessing the ability to provide continuous control of blood pressure, at the American College of Cardiology's Annual Scientific Session and Expo.
A comprehensive analysis of safety across the Phase 2 KARDIA program demonstrated an acceptable safety profile for zilebesiran, both as a monotherapy and in combination with standard-of-care antihypertensives, across patients with mild-to-moderate hypertension, those at high CV risk, or with lower eGFR at baseline.

Initiated a Phase 1 clinical trial of ALN-2232, Alnylam's first adipose-targeted RNAi therapeutic, targeting ACVR1C for obesity and weight management.

Alnylam's collaboration partner, Regeneron Pharmaceuticals, Inc., announced the submission of a New Drug Application (NDA) to the FDA for cemdisiran, an investigational RNAi therapeutic for adults with generalized myasthenia gravis. Additional global filings are planned for 2026.




Additional Business Updates

Entered into a research collaboration with Tenaya Therapeutics to discover novel human genetic targets for the potential development of disease-modifying treatments for cardiovascular diseases.

Announced a new multi-year agreement with Helix to drive precision medicine development, in which Alnylam will gain access to Helix's deeply phenotyped GenoSphereTM cohorts consisting of comprehensive genomic and longitudinal clinical data, and medical and pharmacy claims that cover a wide range of disease areas.

Key Upcoming Events

Alnylam will host its 10th RNAi Roundtable series later this year, at which Alnylam scientists and program leaders, as well as medical thought leaders, will discuss the progress and opportunity across key pipeline programs. A detailed schedule and registration information will be announced separately.

In the first half of 2026, Alnylam expects to:
Complete enrollment in the cAPPricorn-1 Phase 2 clinical trial of mivelsiran in patients with cerebral amyloid angiopathy.
Initiate a Phase 2 trial of mivelsiran in patients with Alzheimer’s disease.
Initiate a Phase 2 clinical trial of ALN-6400 in a second bleeding disorder.

In the second half of 2026, Alnylam expects to announce clinical data from several pipeline programs, including:
Results from Phase 1 and Phase 2 clinical trials of ALN-6400 in healthy volunteers and patients with hereditary hemorrhagic telangiectasia (HHT), respectively.
Results from a Phase 1 clinical trial of ALN-HTT02 in patients with Huntington's disease.
Results from a Phase 1 clinical trial of ALN-2232 in obesity and weight management.

Financial Results for the Quarter Ended March 31, 2026
Three Months Ended March 31,
% Change
(In thousands, except per share amounts and percentages)
20262025
Total revenues$1,167,175 $594,189 96 %
GAAP Income from operations$268,636 $18,077 *
Non-GAAP Income from operations$338,790 $74,789 353 %
GAAP Net income (loss)$205,991 $(18,251)**
Non-GAAP Net income$273,038 $37,941 *
GAAP Net income (loss) per common share — basic$1.55 $(0.14)**
GAAP Net income (loss) per common share — diluted$1.51 $(0.14)**
Non-GAAP Net income per common share — basic$2.05 $0.29 *
Non-GAAP Net income per common share — diluted$1.99 $0.29 *
* Indicates the percentage change period over period is greater than 500%
** Not meaningful
For an explanation of our use of non-GAAP financial measures, refer to the “Use of Non-GAAP Financial Measures” section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measure, see the tables at the end of this press release.



Revenue Summary
Three Months Ended March 31,
% Change
% Change at CER*
(In thousands, except percentages)
20262025
Net product revenues:
AMVUTTRA$889,931 $309,992 187 %183 %
ONPATTRO20,481 49,489 (59)%(61)%
Total TTR net product revenues910,412 359,481 153 %150 %
GIVLAARI74,394 66,968 11 %%
OXLUMO51,321 42,089 22 %13 %
Total Rare net product revenues125,715 109,057 15 %10 %
Total net product revenues1,036,127 468,538 121 %117 %
Net revenues from collaborations:
Roche35,641 17,056 109 %109 %
Regeneron Pharmaceuticals46,336 51,039 (9)%(9)%
Other98 31,090 (100)%(100)%
Total net revenues from collaborations82,075 99,185 (17)%(17)%
Royalty revenue48,973 26,466 85 %85 %
Total revenues$1,167,175 $594,189 96 %93 %
* Change at constant exchange rates, or CER, represents growth calculated as if exchange rates had remained unchanged from those used during the three months ended March 31, 2025. CER is a non-GAAP financial measure.
Total Net Product Revenues
Total net product revenues increased 121% and 117% at actual currency and CER, respectively, during the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to growth from AMVUTTRA revenues driven by increased patient demand, mainly in patients with ATTR-CM in the U.S., which was partially offset by a decreased number of patients on ONPATTRO, and due to growth from an increased number of patients on GIVLAARI and OXLUMO.
Net Revenues from Collaborations
Net revenues from collaborations decreased during the three months ended March 31, 2026, as compared to the same period in 2025, primarily driven by recognition of a $30 million payment in connection with the amendment to our agreement with Vir Biotechnology, Inc. in March 2025.
Royalty Revenue
Royalty revenue increased during the three months ended March 31, 2026, as compared to the same period in 2025, due to increased volume and rate of royalties earned from global net sales of Leqvio by Novartis.
Operating Expense Summary
Three Months Ended March 31,
% Change
(In thousands, except percentages)
20262025
Cost of goods sold$207,520 $70,183 196 %
% of net product revenues20.0 %15.0 %
Cost of collaborations and royalties$3,602 $858 320 %
GAAP Research and development expenses$364,866 $265,122 38 %
Non-GAAP Research and development expenses$334,754 $241,324 39 %
GAAP Selling, general and administrative expenses$322,551 $239,949 34 %
Non-GAAP Selling, general and administrative expenses$282,509 $207,035 36 %



Cost of Goods Sold
Cost of goods sold as a percentage of net product revenues increased to 20% during the three months ended March 31, 2026, as compared to the same period in 2025, primarily as a result of increased sales of AMVUTTRA and an associated increase in the blended royalty rate payable on net sales of AMVUTTRA.
Research & Development (R&D) Expenses
GAAP and non-GAAP R&D expenses for the three months ended March 31, 2026 increased as compared to the same period in 2025, primarily due to increased clinical trial expenses for the ZENITH Phase 3 clinical trial of zilebesiran, the TRITON-CM Phase 3 clinical trial of nucresiran in patients with ATTR-CM and the TRITON-PN Phase 3 clinical trial of nucresiran in patients with hATTR-PN.
Selling, General & Administrative (SG&A) Expenses
GAAP and non-GAAP SG&A expenses for the three months ended March 31, 2026 increased as compared to the same period in 2025, primarily due to higher employee compensation costs and increased marketing investment associated with the ongoing global commercial launch of AMVUTTRA in ATTR-CM.
Other Financial Highlights
Interest expense
Interest expense for the three months ended March 31, 2026 of $69 million included interest of $40 million attributed to the liability related to the sale of future Leqvio royalties and $26 million attributed to the liabilities related to the vutrisiran and zilebesiran development funding.
Provision for income taxes
During the three months ended March 31, 2026, we recorded a provision for income taxes of $16 million primarily related to U.S. state income taxes, utilization of Switzerland net deferred tax assets, as well as taxable income from jurisdictions in which we are subject to tax. We will utilize deferred tax assets in Switzerland to offset current cash tax liabilities and will continue to maintain a full valuation allowance against our net deferred tax assets in the U.S. and certain deferred tax assets in Switzerland.
Financial position
Cash, cash equivalents and marketable securities were $3.0 billion as of March 31, 2026, as compared to $2.9 billion as of December 31, 2025, with the increase primarily driven by net cash inflows from operating activities.
Net cash provided by operating activities for the three months ended March 31, 2026 included $30 million of payments associated with the liability related to the sale of future Leqvio royalties recorded to interest expense, as well as $32 million of payments associated with the liabilities related to vutrisiran and zilebesiran development funding recorded to interest expense.
A reconciliation of our GAAP to non-GAAP financial results is included in the tables at the end of this press release.




2026 Financial Guidance
Full-year 2026 financial guidance is reiterated and consists of the following:
Total TTR net product revenues (AMVUTTRA, ONPATTRO)1
$4,400 million - $4,700 million
Total Rare net product revenues (GIVLAARI, OXLUMO)1
$500 million - $600 million
Total net product revenues1
$4,900 million - $5,300 million
Net product revenues growth vs. 2025 at currency exchange rates as of December 31, 20252
64% to 77%
Net product revenues growth vs. 2025 at constant exchange rates2
64% to 77%
Net revenues from collaborations and royalties
$400 million - $500 million
Non-GAAP R&D and SG&A expenses3
$2,700 million - $2,800 million
1 Full-year 2026 guidance utilizing currency exchange rates as of December 31, 2025: 1 EUR = 1.17 USD and 1 USD = 157 JPY
2Representing growth calculated as if the exchange rates had remained unchanged from those used in 2025, which is a non-GAAP financial measure
3Excludes $300 million - $400 million of stock-based compensation expense from estimated GAAP R&D and SG&A expenses

Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses and non-recurring gains or losses outside the ordinary course of the Company’s business. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.
The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in this press release are stock-based compensation expenses, and realized and unrealized gains or losses on marketable equity securities. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards. The Company has excluded the impact of the realized and unrealized gains or losses on marketable equity securities because the Company does not believe these adjustments accurately reflect the performance of the Company’s ongoing operations for the period in which such gains or losses are reported, as their sole purpose is to adjust amounts on the balance sheet.
Percentage changes in revenue growth at CER are presented excluding the impact of changes in foreign currency exchange rates for investors to understand the underlying business performance. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.
The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between GAAP and non-GAAP measures is provided later in this press release.

Conference Call Information
Management will provide an update on the Company and discuss first quarter 2026 results as well as expectations for the future via conference call on Thursday, April 30, 2026, at 8:30 am ET. A live audio webcast of the call will be available on the Investors section of the Company’s website at www.alnylam.com/events. An archived webcast will be available on the Alnylam website approximately two hours after the event.

About AMVUTTRA® (vutrisiran)



AMVUTTRA® (vutrisiran) is a transthyretin (TTR) silencer that delivers rapid knockdown of TTR at the source to address the underlying cause of transthyretin amyloidosis (ATTR). In a clinical study, AMVUTTRA rapidly knocked down TTR in as early as six weeks and decreased TTR levels by 87% with two and a half years of treatment. It is approved as a treatment for the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults and for the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults in various countries, globally. Administered quarterly via subcutaneous injection, AMVUTTRA is the first and only silencer approved for the treatment of ATTR-CM and hATTR-PN. For more information about AMVUTTRA, including the full U.S. Prescribing Information, visit AMVUTTRA.com.

About ONPATTRO® (patisiran)
ONPATTRO is an RNAi therapeutic that is approved in the United States and Canada for the treatment of adults with hATTR amyloidosis with polyneuropathy. ONPATTRO is also approved in the European Union, Switzerland and Brazil for the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2 polyneuropathy, and in Japan for the treatment of hATTR amyloidosis with polyneuropathy. ONPATTRO is an intravenously administered RNAi therapeutic targeting transthyretin (TTR). It is designed to target and silence TTR messenger RNA, thereby reducing the production of TTR protein before it is made. Reducing the pathogenic protein leads to a reduction in amyloid deposits in tissues. For more information about ONPATTRO, including full Prescribing Information, visit ONPATTRO.com.

About GIVLAARI® (givosiran)
GIVLAARI (givosiran) is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in the United States and Brazil for the treatment of adults with acute hepatic porphyria (AHP). GIVLAARI is also approved in the European Union for the treatment of AHP in adults and adolescents aged 12 years and older. In the pivotal trial, GIVLAARI was shown to significantly reduce the rate of porphyria attacks that required hospitalizations, urgent healthcare visits or intravenous hemin administration at home compared to placebo. GIVLAARI is Alnylam’s first commercially available therapeutic based on its Enhanced Stabilization Chemistry ESC-GalNAc conjugate technology to increase potency and durability. GIVLAARI is administered via subcutaneous injection once monthly at a dose based on actual body weight and should be administered by a healthcare professional. GIVLAARI works by specifically reducing elevated levels of ALAS1 messenger RNA (mRNA), leading to reduction of toxins associated with attacks and other disease manifestations of AHP. For more information about GIVLAARI, including the full U.S. Prescribing Information, visit GIVLAARI.com.

About OXLUMO® (lumasiran)
OXLUMO (lumasiran) is an RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1). HAO1 encodes glycolate oxidase (GO). Thus, by silencing HAO1 and depleting the GO enzyme, OXLUMO inhibits production of oxalate – the metabolite that directly contributes to the pathophysiology of PH1. OXLUMO utilizes Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology, which enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. OXLUMO has received regulatory approvals from the U.S. Food and Drug Administration (FDA) for the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary and plasma oxalate levels in pediatric and adult patients and from the European Medicines Agency (EMA) for the treatment of PH1 in all age groups. In the pivotal ILLUMINATE-A trial, OXLUMO was shown to significantly reduce levels of urinary oxalate relative to placebo, with the majority of patients reaching normal or near-normal levels. In the ILLUMINATE-B pediatric Phase 3 trial, OXLUMO demonstrated an efficacy and safety profile consistent to that observed in ILLUMINATE-A. In the ILLUMINATE-C trial, OXLUMO resulted in substantial reductions in plasma oxalate in patients with advanced PH1. Across all three studies, injection site reactions (ISRs) were the most common drug-related adverse reaction. OXLUMO is administered via subcutaneous injection once monthly for three months, then once quarterly beginning one month after the last loading dose at a dose based on actual body weight. For patients who weigh less than 10 kg, ongoing dosing remains monthly. OXLUMO should be administered by a healthcare professional. For more information about OXLUMO, including the full U.S. Prescribing Information, visit OXLUMO.com.

About LNP Technology
Alnylam has licenses to Arbutus Biopharma lipid nanoparticle (LNP) intellectual property for use in RNAi therapeutic products using LNP technology.




About RNAi
RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a new class of medicines known as RNAi therapeutics is now a reality. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing or disease pathway proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

About Alnylam Pharmaceuticals
Alnylam (Nasdaq: ALNY) is a leading global biopharmaceutical company and the pioneer of the RNA interference (RNAi) revolution. The Company is focused on developing transformative therapies with the potential to prevent, halt, or reverse disease. For more than two decades, Alnylam has advanced the Nobel-prize-winning science of RNAi, delivering critical breakthroughs and six approved medicines. Alnylam has medicines available in more than 70 countries and a rapidly expanding and robust pipeline, in addition to consistently being recognized as an exceptional workplace and socially responsible organization. The Company is executing on its Alnylam 2030 strategy to accelerate innovation and scale impact to transform human health. For more information, please visit www.alnylam.com or follow Alnylam on X, LinkedIn, Facebook, Instagram, or YouTube.

Alnylam Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than historical statements of fact regarding Alnylam’s expectations, beliefs, goals, plans or prospects including, without limitation, statements regarding the potential long-term growth and durability of Alnylam’s TTR franchise; the potential for AMVUTTRA to be used as a first-line treatment for ATTR-CM; Alnylam’s ability to achieve the goals in its Alnylam 2030 strategy, including to achieve global TTR leadership, drive growth through innovation, and scale with financial discipline; the number of patients who will be enrolled in the TRITON-CM clinical trial; the timing of completion and the potential success of the TRITON-CM trial; the potential for Alnylam to launch nucresiran in ATTR-CM by 2030; the timing of the initiation, completion of enrollment in, or announcement of results from, any of Alnylam’s clinical trials; the potential for programs in Alnylam’s pipeline to achieve clinical de-risking events during 2026 or at any other time; the potential for any of Alnylam’s collaborations to achieve the goals for which they were established; and Alnylam’s projected commercial and financial performance, including the expected range for 2026 of TTR net product revenues, Rare net product revenues, total net product revenues, net revenues from collaborations and royalties, and non-GAAP R&D and SG&A expenses, should be considered forward-looking statements. Actual results and future plans may differ materially from those indicated by these forward-looking statements as a result of various important risks, uncertainties and other factors, including, without limitation, risks and uncertainties relating to: Alnylam’s ability to successfully execute on its “Alnylam 2030” strategy; Alnylam’s ability to successfully launch, market and sell Alnylam’s approved products globally, including AMVUTTRA; Alnylam’s ability to discover and develop novel drug candidates and delivery approaches and successfully demonstrate the efficacy and safety of its product candidates; the pre-clinical and clinical results for Alnylam’s product candidates; actions or advice of regulatory agencies and Alnylam’s ability to obtain and maintain regulatory approval for its product candidates, as well as favorable pricing and reimbursement; delays, interruptions or failures in the manufacture and supply of Alnylam’s marketed products or its product candidates; obtaining, maintaining and protecting intellectual property; Alnylam’s ability to manage its growth and operating expenses through disciplined investment in operations; Alnylam’s ability to maintain strategic business collaborations; Alnylam’s dependence on third parties for the development and commercialization of certain products, including Roche, Novartis, Sanofi, and Regeneron; the outcome of litigation and government investigations; the risk of future litigation and government investigations; and unexpected expenditures; as well as those risks and uncertainties more fully discussed in the “Risk Factors” filed with Alnylam’s 2025 Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), as may be updated from time to time in Alnylam’s subsequent Quarterly Reports on Form 10-



Q, and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation, except to the extent required by law, to update any forward-looking statements.

This release discusses investigational RNAi therapeutics and uses of previously approved RNAi therapeutics in development and is not intended to convey conclusions about efficacy or safety as to those investigational therapeutics or uses. There is no guarantee that any investigational therapeutics or expanded uses of commercial products will successfully complete clinical development or gain health authority approval.


ALNYLAM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
March 31, 2026December 31, 2025
ASSETS(Unaudited)
Current assets:
Cash and cash equivalents$1,710,779 $1,657,250 
Marketable debt securities1,298,444 1,251,234 
Accounts receivable, net883,957 777,567 
Inventory84,025 82,719 
Prepaid expenses and other current assets242,103 281,892 
Total current assets4,219,308 4,050,662 
Property, plant and equipment, net518,257 513,147 
Operating lease right-of-use assets189,299 194,916 
Deferred tax assets116,960 125,975 
Restricted investments22,170 22,170 
Other assets63,553 59,461 
Total assets$5,129,547 $4,966,331 
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable$126,628 $115,721 
Accrued expenses946,485 1,080,197 
Operating lease liabilities45,661 45,518 
Deferred revenue3,213 4,845 
Liabilities related to the sale of future royalties and development funding227,488 220,068 
Total current liabilities1,349,475 1,466,349 
Operating lease liabilities, net of current portion218,025 225,087 
Convertible debt1,009,372 1,007,784 
Liabilities related to the sale of future royalties and development funding, net of current portion1,469,684 1,470,341 
Other liabilities7,611 7,594 
Total liabilities4,054,167 4,177,155 
Stockholders' equity:
Preferred stock, $0.01 par value per share, 5,000 shares authorized and no shares issued and outstanding as of March 31, 2026 and December 31, 2025
— — 
Common stock, $0.01 par value per share, 250,000 shares authorized; 133,444 shares issued and outstanding as of March 31, 2026; 132,376 shares issued and outstanding as of December 31, 2025
1,334 1,324 
Additional paid-in capital7,595,473 7,510,473 
Accumulated other comprehensive loss(24,894)(20,097)
Accumulated deficit(6,496,533)(6,702,524)
Total stockholders' equity1,075,380 789,176 
Total liabilities and stockholders' equity$5,129,547 $4,966,331 



ALNYLAM PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)

Three Months Ended
March 31,
2026
March 31,
2025
Statements of Operations
Revenues:
Net product revenues$1,036,127 $468,538 
Net revenues from collaborations82,075 99,185 
Royalty revenue48,973 26,466 
Total revenues1,167,175 594,189 
Operating costs and expenses:
Cost of goods sold207,520 70,183 
Cost of collaborations and royalties3,602 858 
Research and development364,866 265,122 
Selling, general and administrative322,551 239,949 
Total operating costs and expenses898,539 576,112 
Income from operations268,636 18,077 
Other (expense) income:
Interest expense(69,286)(58,309)
Interest income26,598 28,673 
Other (expense) income, net(4,295)9,191 
Total other expense, net(46,983)(20,445)
Income (loss) before income taxes221,653 (2,368)
Provision for income taxes(15,662)(15,883)
Net income (loss)$205,991 $(18,251)
Net income (loss) per common share — basic$1.55 $(0.14)
Net income (loss) per common share — diluted$1.51 $(0.14)
Weighted-average common shares — basic132,893 129,676 
Weighted-average common shares — diluted138,226 129,676 



ALNYLAM PHARMACEUTICALS, INC.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES
(In thousands, except per share amounts)
(Unaudited)

Three Months Ended
March 31,
2026
March 31,
2025
Reconciliation of GAAP to Non-GAAP Research and development expenses:
GAAP Research and development expenses$364,866 $265,122 
Less: Stock-based compensation expenses(30,112)(23,798)
Non-GAAP Research and development expenses$334,754 $241,324 
Reconciliation of GAAP to Non-GAAP Selling, general and administrative expenses:
GAAP Selling, general and administrative expenses$322,551 $239,949 
Less: Stock-based compensation expenses(40,042)(32,914)
Non-GAAP Selling, general and administrative expenses$282,509 $207,035 
Reconciliation of GAAP to Non-GAAP Income (loss) from operations:
GAAP Income from operations$268,636 $18,077 
Add: Stock-based compensation expenses70,154 56,712 
Non-GAAP Operating income$338,790 $74,789 
Reconciliation of GAAP to Non-GAAP Net income (loss):
GAAP Net income (loss)$205,991 $(18,251)
Add: Stock-based compensation expenses70,154 56,712 
Add: Realized and unrealized loss on marketable equity securities— 956 
Less: Income tax effect of GAAP to non-GAAP reconciling items(3,107)(1,476)
Non-GAAP Net income$273,038 $37,941 
Reconciliation of GAAP to Non-GAAP Net income (loss) per common share - basic:
GAAP Net income (loss) per common share — basic
$1.55 $(0.14)
Add: Stock-based compensation expenses0.53 0.44 
Add: Realized and unrealized loss on marketable equity securities— 0.01 
Less: Income tax effect of GAAP to non-GAAP reconciling items(0.02)(0.01)
Non-GAAP Net income per common share — basic
$2.05 $0.29 
Reconciliation of GAAP to Non-GAAP Net income (loss) per common share - diluted:
GAAP Net income (loss) per common share - diluted
$1.51 $(0.14)
Add: Stock-based compensation expenses0.51 0.43 
Add: Realized and unrealized loss on marketable equity securities— 0.01 
Less: Income tax effect of GAAP to non-GAAP reconciling items(0.02)(0.01)
Non-GAAP Net income per common share - diluted*
$1.99 $0.29 
*Non-GAAP Net income per common share - diluted is calculated by dividing the non-GAAP net income by the weighted-average number of common shares and dilutive potential common share equivalents outstanding during the period. The dilutive weighted-average common shares outstanding for the three months ended March 31, 2026 and 2025 would be 138,226 and 132,726 thousand shares, respectively.
Please note that the figures presented above may not sum exactly due to rounding


ALNYLAM PHARMACEUTICALS, INC.
RECONCILIATION OF GAAP TO NON-GAAP
PRODUCT REVENUE GROWTH AT CONSTANT CURRENCY
(Unaudited)
March 31, 2026
Three Months Ended
AMVUTTRA net product revenue growth, as reported187 %
Add: Impact of foreign currency translation(4)
AMVUTTRA net product revenue growth at constant currency183 %
ONPATTRO net product revenue growth, as reported(59)%
Add: Impact of foreign currency translation(2)
ONPATTRO net product revenue growth at constant currency(61)%
Total TTR net product revenue growth, as reported153 %
Add: Impact of foreign currency translation(3)
Total TTR net product revenue growth at constant currency150 %
GIVLAARI net product revenue growth, as reported11 %
Add: Impact of foreign currency translation(4)
GIVLAARI net product revenue growth at constant currency%
OXLUMO net product revenue growth, as reported22 %
Add: Impact of foreign currency translation(9)
OXLUMO net product revenue growth at constant currency13 %
Total Rare net product revenue growth, as reported15 %
Add: Impact of foreign currency translation(5)
Total Rare net product revenue growth at constant currency10 %
Total net product revenue growth, as reported121 %
Add: Impact of foreign currency translation(4)
Total net product revenue growth at constant currency117 %
Total revenue growth, as reported96 %
Add: Impact of foreign currency translation(3)
Total revenue growth at constant currency93 %

FAQ

How did Alnylam (ALNY) perform financially in the first quarter of 2026?

Alnylam delivered a strong Q1 2026, with total revenues of $1.17 billion, up 96% year over year. Net product revenues reached $1.04 billion, and the company generated $206 million in GAAP net income after a loss in the prior‑year quarter.

What drove Alnylam’s (ALNY) revenue growth in Q1 2026?

Growth was led by the TTR franchise, especially AMVUTTRA, which produced $889.9 million in sales. Total TTR net product revenues reached $910.4 million, a 153% increase, while GIVLAARI and OXLUMO added $125.7 million, up 15% from Q1 2025.

Did Alnylam (ALNY) achieve profitability in the first quarter of 2026?

Yes. Alnylam reported GAAP net income of $206.0 million in Q1 2026, compared with a GAAP net loss of $18.3 million a year earlier. Non‑GAAP net income was $273.0 million, reflecting higher product revenues and improved operating leverage.

What 2026 financial guidance did Alnylam (ALNY) reiterate?

Alnylam reiterated full‑year 2026 guidance for total net product revenues of $4.9–$5.3 billion. It also guided to TTR net product revenues of $4.4–$4.7 billion, Rare net product revenues of $500–$600 million, and non‑GAAP R&D and SG&A expenses of $2.7–$2.8 billion.

How fast are AMVUTTRA and Alnylam’s TTR revenues growing?

AMVUTTRA net product revenues reached $889.9 million in Q1 2026, up 187% year over year. Total TTR net product revenues, including AMVUTTRA and ONPATTRO, were $910.4 million, representing 153% growth compared with the first quarter of 2025.

What is Alnylam’s (ALNY) cash position after Q1 2026?

Alnylam ended March 31, 2026 with $3.0 billion in cash, cash equivalents and marketable securities. This compares with $2.9 billion at December 31, 2025, with the increase primarily driven by net cash inflows from operating activities during the quarter.

Filing Exhibits & Attachments

4 documents