Apr 30, 2026
− Achieved First Quarter 2026 Global Net Product Revenues of
− Reiterates 2026 Financial Guidance, Including Combined Net Product Revenues of
− 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 –
“2026 is off to a strong start for
First Quarter 2026 and Recent Significant Business Highlights
Total TTR: AMVUTTRA® (vutrisiran) & ONPATTRO® (patisiran)
Total Rare: GIVLAARI® (givosiran) & OXLUMO® (lumasiran)
Other Highlights
Additional Business Updates
Key Upcoming Events
In the first half of 2026,
In the second half of 2026,
Financial Results for the Quarter Ended
|
|
Three Months Ended |
|
% Change |
||||
|
(In thousands, except per share amounts and percentages) |
|
2026 |
|
|
2025 |
|
|
|
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 |
|
% Change |
|
% Change
|
||||||
|
(In thousands, except percentages) |
|
2026 |
|
|
2025 |
|
|
||||
|
Net product revenues: |
|
|
|
|
|
|
|
||||
|
AMVUTTRA |
$ |
889,931 |
|
$ |
309,992 |
|
187 |
% |
|
183 |
% |
|
ONPATTRO |
|
20,481 |
|
|
49,489 |
|
(59 |
)% |
|
(61 |
)% |
|
Total TTR net product revenues |
|
910,412 |
|
|
359,481 |
|
153 |
% |
|
150 |
% |
|
GIVLAARI |
|
74,394 |
|
|
66,968 |
|
11 |
% |
|
7 |
% |
|
OXLUMO |
|
51,321 |
|
|
42,089 |
|
22 |
% |
|
13 |
% |
|
Total Rare net product revenues |
|
125,715 |
|
|
109,057 |
|
15 |
% |
|
10 |
% |
|
Total net product revenues |
|
1,036,127 |
|
|
468,538 |
|
121 |
% |
|
117 |
% |
|
Net revenues from collaborations: |
|
|
|
|
|
|
|
||||
|
Roche |
|
35,641 |
|
|
17,056 |
|
109 |
% |
|
109 |
% |
|
Regeneron Pharmaceuticals |
|
46,336 |
|
|
51,039 |
|
(9 |
)% |
|
(9 |
)% |
|
Other |
|
98 |
|
|
31,090 |
|
(100 |
)% |
|
(100 |
)% |
|
Total net revenues from collaborations |
|
82,075 |
|
|
99,185 |
|
(17 |
)% |
|
(17 |
)% |
|
Royalty revenue |
|
48,973 |
|
|
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 |
|||||||||||
Total Net Product Revenues
Net Revenues from Collaborations
Royalty Revenue
Operating Expense Summary
|
|
Three Months Ended
|
|
%
|
|||||||
|
(In thousands, except percentages) |
|
2026 |
|
|
|
2025 |
|
|
||
|
Cost of goods sold |
$ |
207,520 |
|
|
$ |
70,183 |
|
|
196 |
% |
|
% of net product revenues |
|
20.0 |
% |
|
|
15.0 |
% |
|
|
|
|
Cost of collaborations and royalties |
$ |
3,602 |
|
|
$ |
858 |
|
|
320 |
% |
|
|
$ |
364,866 |
|
|
$ |
265,122 |
|
|
38 |
% |
|
|
$ |
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
Research & Development (R&D) Expenses
Selling, General & Administrative (SG&A) Expenses
Other Financial Highlights
Interest expense
Provision for income taxes
Financial position
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 |
|
|
|
Total Rare net product revenues (GIVLAARI, OXLUMO)1 |
|
|
|
Total net product revenues1 |
|
|
|
Net product revenues growth vs. 2025 at currency exchange rates as of |
|
64% to 77% |
|
Net product revenues growth vs. 2025 at constant exchange rates2 |
|
64% to 77% |
|
Net revenues from collaborations and royalties |
|
|
|
Non-GAAP R&D and SG&A expenses3 |
|
|
|
|
|
|
|
1 Full-year 2026 guidance utilizing currency exchange rates as of |
||
|
2Representing growth calculated as if the exchange rates had remained unchanged from those used in 2025, which is a non-GAAP financial measure |
||
|
3Excludes |
||
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
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
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
About ONPATTRO® (patisiran)
ONPATTRO is an RNAi therapeutic that is approved in
About GIVLAARI® (givosiran)
GIVLAARI (givosiran) is an RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) approved in
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
About 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 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
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.
|
|
|||||||
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
|
(In thousands, except per share amounts) |
|||||||
|
|
|
|
|
||||
|
ASSETS |
(Unaudited) |
|
|
||||
|
Current assets: |
|
|
|
||||
|
Cash and cash equivalents |
$ |
1,710,779 |
|
|
$ |
1,657,250 |
|
|
Marketable debt securities |
|
1,298,444 |
|
|
|
1,251,234 |
|
|
Accounts receivable, net |
|
883,957 |
|
|
|
777,567 |
|
|
Inventory |
|
84,025 |
|
|
|
82,719 |
|
|
Prepaid expenses and other current assets |
|
242,103 |
|
|
|
281,892 |
|
|
Total current assets |
|
4,219,308 |
|
|
|
4,050,662 |
|
|
Property, plant and equipment, net |
|
518,257 |
|
|
|
513,147 |
|
|
Operating lease right-of-use assets |
|
189,299 |
|
|
|
194,916 |
|
|
Deferred tax assets |
|
116,960 |
|
|
|
125,975 |
|
|
Restricted investments |
|
22,170 |
|
|
|
22,170 |
|
|
Other assets |
|
63,553 |
|
|
|
59,461 |
|
|
Total assets |
$ |
5,129,547 |
|
|
$ |
4,966,331 |
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
||||
|
Current liabilities: |
|
|
|
||||
|
Accounts payable |
$ |
126,628 |
|
|
$ |
115,721 |
|
|
Accrued expenses |
|
946,485 |
|
|
|
1,080,197 |
|
|
Operating lease liabilities |
|
45,661 |
|
|
|
45,518 |
|
|
Deferred revenue |
|
3,213 |
|
|
|
4,845 |
|
|
Liabilities related to the sale of future royalties and development funding |
|
227,488 |
|
|
|
220,068 |
|
|
Total current liabilities |
|
1,349,475 |
|
|
|
1,466,349 |
|
|
Operating lease liabilities, net of current portion |
|
218,025 |
|
|
|
225,087 |
|
|
Convertible debt |
|
1,009,372 |
|
|
|
1,007,784 |
|
|
Liabilities related to the sale of future royalties and development funding, net of current portion |
|
1,469,684 |
|
|
|
1,470,341 |
|
|
Other liabilities |
|
7,611 |
|
|
|
7,594 |
|
|
Total liabilities |
|
4,054,167 |
|
|
|
4,177,155 |
|
|
Stockholders' equity: |
|
|
|
||||
|
Preferred stock, |
|
— |
|
|
|
— |
|
|
Common stock, |
|
1,334 |
|
|
|
1,324 |
|
|
Additional paid-in capital |
|
7,595,473 |
|
|
|
7,510,473 |
|
|
Accumulated other comprehensive loss |
|
(24,894 |
) |
|
|
(20,097 |
) |
|
Accumulated deficit |
|
(6,496,533 |
) |
|
|
(6,702,524 |
) |
|
Total stockholders' equity |
|
1,075,380 |
|
|
|
789,176 |
|
|
Total liabilities and stockholders' equity |
$ |
5,129,547 |
|
|
$ |
4,966,331 |
|
|
|
|||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||
|
(In thousands, except per share amounts) |
|||||||
|
(Unaudited) |
|||||||
|
|
Three Months Ended |
||||||
|
|
|
|
|
||||
|
Statements of Operations |
|
|
|
||||
|
Revenues: |
|
|
|
||||
|
Net product revenues |
$ |
1,036,127 |
|
|
$ |
468,538 |
|
|
Net revenues from collaborations |
|
82,075 |
|
|
|
99,185 |
|
|
Royalty revenue |
|
48,973 |
|
|
|
26,466 |
|
|
Total revenues |
|
1,167,175 |
|
|
|
594,189 |
|
|
Operating costs and expenses: |
|
|
|
||||
|
Cost of goods sold |
|
207,520 |
|
|
|
70,183 |
|
|
Cost of collaborations and royalties |
|
3,602 |
|
|
|
858 |
|
|
Research and development |
|
364,866 |
|
|
|
265,122 |
|
|
Selling, general and administrative |
|
322,551 |
|
|
|
239,949 |
|
|
Total operating costs and expenses |
|
898,539 |
|
|
|
576,112 |
|
|
Income from operations |
|
268,636 |
|
|
|
18,077 |
|
|
Other (expense) income: |
|
|
|
||||
|
Interest expense |
|
(69,286 |
) |
|
|
(58,309 |
) |
|
Interest income |
|
26,598 |
|
|
|
28,673 |
|
|
Other (expense) income, net |
|
(4,295 |
) |
|
|
9,191 |
|
|
Total other expense, net |
|
(46,983 |
) |
|
|
(20,445 |
) |
|
Income (loss) before income taxes |
|
221,653 |
|
|
|
(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 — basic |
|
132,893 |
|
|
|
129,676 |
|
|
Weighted-average common shares — diluted |
|
138,226 |
|
|
|
129,676 |
|
|
|
|||||||
|
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES |
|||||||
|
(In thousands, except per share amounts) |
|||||||
|
(Unaudited) |
|||||||
|
|
Three Months Ended |
||||||
|
|
|
|
|
||||
|
Reconciliation of GAAP to |
|||||||
|
|
$ |
364,866 |
|
|
$ |
265,122 |
|
|
Less: Stock-based compensation expenses |
|
(30,112 |
) |
|
|
(23,798 |
) |
|
|
$ |
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 expenses |
|
70,154 |
|
|
|
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 expenses |
|
70,154 |
|
|
|
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 expenses |
|
0.53 |
|
|
|
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 expenses |
|
0.51 |
|
|
|
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 |
|||||||
Please note that the figures presented above may not sum exactly due to rounding
|
|
||
|
RECONCILIATION OF GAAP TO NON-GAAP |
||
|
PRODUCT REVENUE GROWTH AT CONSTANT CURRENCY |
||
|
(Unaudited) |
||
|
|
|
|
|
|
Three Months Ended |
|
|
AMVUTTRA net product revenue growth, as reported |
187 |
% |
|
Add: Impact of foreign currency translation |
(4 |
) |
|
AMVUTTRA net product revenue growth at constant currency |
183 |
% |
|
|
|
|
|
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 reported |
153 |
% |
|
Add: Impact of foreign currency translation |
(3 |
) |
|
Total TTR net product revenue growth at constant currency |
150 |
% |
|
|
|
|
|
GIVLAARI net product revenue growth, as reported |
11 |
% |
|
Add: Impact of foreign currency translation |
(4 |
) |
|
GIVLAARI net product revenue growth at constant currency |
7 |
% |
|
|
|
|
|
OXLUMO net product revenue growth, as reported |
22 |
% |
|
Add: Impact of foreign currency translation |
(9 |
) |
|
OXLUMO net product revenue growth at constant currency |
13 |
% |
|
|
|
|
|
Total Rare net product revenue growth, as reported |
15 |
% |
|
Add: Impact of foreign currency translation |
(5 |
) |
|
Total Rare net product revenue growth at constant currency |
10 |
% |
|
|
|
|
|
Total net product revenue growth, as reported |
121 |
% |
|
Add: Impact of foreign currency translation |
(4 |
) |
|
Total net product revenue growth at constant currency |
117 |
% |
|
|
|
|
|
Total revenue growth, as reported |
96 |
% |
|
Add: Impact of foreign currency translation |
(3 |
) |
|
Total revenue growth at constant currency |
93 |
% |
View source version on businesswire.com: https://www.businesswire.com/news/home/20260430283413/en/
(Investors and Media)
617-682-4340
(Investors)
617-551-8276
Source:
For Media Inquiries, please contact:
Christine Akinc
Chief Corporate Communications Officer media@alnylam.com 617-682-4340
For Investor Inquiries, please contact:
Josh Brodsky
VP, Investor Relations & Corporate Communications investors@alnylam.com 617-551-8276
Essential assets and documents related to Alnylam