Alnylam Pharmaceuticals Inc.
07/30/2026 | Press release | Distributed by Public on 07/30/2026 06:11
Quarterly Report for Quarter Ending June 30, 2026 (Form 10-Q)
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion contains management's discussion and analysis of our financial condition and results of operations and should be read together with our unaudited condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a global commercial-stage biopharmaceutical company developing novel therapeutics based on ribonucleic acid interference, or RNAi. RNAi is a naturally occurring biological pathway within cells for sequence-specific silencing and regulation of gene expression. By harnessing the RNAi pathway, we have pioneered a new class of innovative medicines, known as RNAi therapeutics. RNAi therapeutics are comprised of small interfering RNA, or siRNA, that function upstream of conventional medicines by potently silencing messenger RNA, or mRNA, that encode for proteins implicated in the cause or pathway of disease, thus preventing them from being made. We believe this is a revolutionary approach with the potential to transform the care of patients across a broad range of disease areas and indications. To date, our efforts to advance this revolutionary approach have yielded the approval of six first-in-class RNAi-based medicines: AMVUTTRA® (vutrisiran), ONPATTRO® (patisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), Leqvio® (inclisiran) and Qfitlia® (fitusiran).
Our research and development strategy is to target genetically validated genes that have been implicated in the cause or pathway of human disease. We utilize an N-acetylgalactosamine (GalNAc) conjugate approach or lipid nanoparticle (LNP) to enable hepatic delivery of siRNAs. For delivery to the central nervous system, or CNS, and the eye (ocular delivery), we are utilizing an alternative conjugate approach based on a hexadecyl (C16) moiety as a lipophilic ligand. We are also advancing approaches for heart, skeletal muscle and adipose tissue delivery of siRNAs, and we are exploring peptide and antibody-based approaches for targeted siRNA delivery to new tissues. Our focus is on clinical indications where there is a high unmet need, a genetically validated target, early biomarkers for the assessment of clinical activity in Phase 1 clinical trials, and a definable path for drug development, regulatory approval, patient access and commercialization.
In early 2026, we launched our Alnylam 2030 strategy to drive our next era of growth and patient impact, and we currently have six marketed products, including two products that are commercialized by collaborators, and more than 25 clinical programs, including several in late-stage development.
AMVUTTRA is approved in the United States, or U.S., for the treatment of hereditary transthyretin-mediated amyloidosis, or hATTR amyloidosis, with polyneuropathy in adults, in the European Union, or EU, and the United Kingdom, or UK, for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, in Japan for the treatment of transthyretin, or TTR, type familial amyloidosis with polyneuropathy, and in multiple additional countries. In March 2025, the United States Food and Drug Administration, or the FDA, approved our supplemental New Drug Application, or sNDA, for AMVUTTRA for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality, cardiovascular hospitalizations and urgent heart failure visits. In June 2025, the European Commission, or EC, granted approval of AMVUTTRA for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy, following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency. AMVUTTRA has also been approved by the Brazilian Health Regulatory Agency, or ANVISA, the Japanese Health Authority, or PMDA, the UK's Medicines and Healthcare Products Regulatory Agency, or MHRA, and Health Canada for the treatment of ATTR amyloidosis with cardiomyopathy. Regulatory reviews continue in other territories.
ONPATTRO is approved in the U.S. for the treatment of the polyneuropathy of hATTR amyloidosis in adults and is also approved in the EU for the treatment of hATTR amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, in Japan for the treatment of TTR-type familial amyloidosis with polyneuropathy, and in multiple additional countries. In February 2025, ONPATTRO received regulatory approval from ANVISA in Brazil for the treatment of ATTR amyloidosis with cardiomyopathy.
GIVLAARI is approved in the U.S. for the treatment of adults with acute hepatic porphyria, or AHP, in the EU for the treatment of AHP in adults and adolescents aged 12 years and older, and in several other countries. Regulatory filings for givosiran (the generic name of GIVLAARI) in additional territories are pending or planned during 2026 and beyond.
OXLUMO is approved in the U.S. for the treatment of primary hyperoxaluria type 1, or PH1, to lower urinary and plasma oxalate levels in pediatric and adult patients, and in the EU and the UK for the treatment of PH1 in all age groups. OXLUMO has also been approved in several other countries and regulatory filings for lumasiran (the generic name of OXLUMO) in additional territories are pending or planned during 2026 and beyond.
Leqvio (inclisiran) is being developed and commercialized by our collaborator Novartis AG, or Novartis, and has received marketing authorization from the EC for the treatment of adults with hypercholesterolemia or mixed dyslipidemia and from the FDA as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol, or LDL-C, in adults with hypercholesterolemia, adults and pediatric patients aged 12 years and older with heterozygous familial hypercholesterolemia, or HeFH, and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia. Leqvio has also been
approved in China and Japan, and as of the end of June 2026, Leqvio is registered in 109 countries worldwide and is commercially available in 89 countries.
Qfitlia (fitusiran) is being commercialized by our collaborator, Genzyme Corporation, a Sanofi Company, or Sanofi, and was approved by the FDA in March 2025 for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B, with or without factor VIII or IX inhibitors (neutralizing antibodies), and by China's National Medical Products Administration in December 2025, for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in pediatric patients 12 years of age and older, and adults with severe hemophilia A with or without factor VIII inhibitors or severe hemophilia B with or without factor IX inhibitors. Qfitlia is the first and only therapeutic designed to lower antithrombin, a protein that inhibits blood clotting, with the goal of promoting thrombin generation to rebalance hemostasis and prevent bleeds.
In addition to our marketed products, we have multiple potential drivers of future growth, including additional transformative medicines currently in development for TTR and both other rare and prevalent diseases. We are advancing nucresiran, our next-generation investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. In November 2024, we announced positive results from the ongoing Phase 1 clinical trial of nucresiran in healthy volunteers. These results demonstrated that twice annual dosing of 300 mg of nucresiran resulted in mean reductions of serum TTR of greater than 90% from baseline at day 15 that were maintained over six months. In September 2025, we initiated the TRITON-PN Phase 3 clinical trial of nucresiran in patients with hATTR polyneuropathy, and in June 2025, we initiated the TRITON-CM Phase 3 clinical trial of nucresiran in patients with ATTR amyloidosis with cardiomyopathy. In April 2026, we announced that, due to enrollment in TRITON-CM proceeding faster than anticipated, we exercised a pre-specified protocol option to expand target enrollment by approximately 500 patients, or from 1,250 to approximately 1,750 patients in total. Given the current pace of enrollment and the anticipated accrual of endpoint events, we continue to expect to launch nucresiran in ATTR-CM by 2030, assuming positive data and regulatory approval.
We are developing zilebesiran, an investigational, subcutaneously administered RNAi therapeutic targeting angiotensinogen, for the treatment of hypertension. In 2023, we entered into a Collaboration and License Agreement, or the Roche Collaboration and License Agreement, with F. Hoffmann-La Roche Ltd. and Genentech, Inc. or, collectively, Roche, pursuant to which we established a worldwide, strategic collaboration for the joint development and commercialization of zilebesiran. In August 2025, we reported that our KARDIA-3 Phase 2 clinical trial, which was designed to evaluate the efficacy and safety of zilebesiran as an add-on therapy in adult patients with high cardiovascular risk and uncontrolled hypertension despite treatment with two to four standard of care antihypertensive medications, met the objective of informing the design, patient population, and dose for a global Phase 3 cardiovascular outcomes trial. In September 2025, we initiated a Phase 3 cardiovascular outcomes clinical trial, ZENITH (ZilebEsiraN CardIovascular OuTcome Study in Hypertension), which is designed to evaluate the potential of zilebesiran to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension on two or more antihypertensives, one being a diuretic.
We are advancing mivelsiran (formerly ALN-APP), an investigational RNAi therapeutic targeting amyloid precursor protein in development for the treatment of cerebral amyloid angiopathy, or CAA, and Alzheimer's disease, or AD. In July 2025, we presented single- and multiple-dose data from the Phase 1 clinical trial of mivelsiran in patients with early-onset AD. These data demonstrated that single and multiple doses of mivelsiran were generally well tolerated and demonstrated robust, durable, dose-dependent reductions of soluble amyloid precursor protein beta, or sAPPβ, in cerebrospinal fluid. In July 2025, we presented an analysis of safety data from single and multiple doses of mivelsiran in the Phase 1 clinical trial showing no evidence of increased risk of amyloid-related imaging abnormality events. In July 2024, we initiated the cAPPricorn-1 Phase 2 clinical trial of mivelsiran in patients with CAA and in July 2026, we announced that we had completed enrollment in this trial. In July 2026, we announced the initiation of a Phase 2 clinical trial of mivelsiran in patients with Down syndrome-associated AD.
We are developing ALN-6400, a GalNAc-conjugated RNAi therapeutic that targets plasminogen, or PLG, for the treatment of a wide range of bleeding disorders. In preclinical studies, ALN-6400 demonstrated a greater than 90% reduction in circulating PLG in non-human primates with no evidence of increased risk of thrombosis. In early 2025, we shared data from the first cohort of participants in a Phase 1 clinical trial in healthy volunteers, demonstrating favorable impact on an ex-vivo hemostasis assay. In late 2025, we initiated a Phase 2 clinical trial of ALN-6400 in patients with Hereditary Hemorrhagic Telangiectasia, or HHT, and we plan to share additional data from the Phase 1 clinical trial as well as initial results in the Phase 2 clinical trial in HHT the second half of 2026. We also initiated a Phase 2 clinical trial of ALN-6400 in patients with von Willebrand Disease in the first half of 2026.
We are advancing ALN-HTT02, an investigational, intrathecally administered RNAi therapeutic targeting huntingtin, or HTT, that is in development in collaboration with Regeneron Pharmaceuticals, Inc., or Regeneron, for the treatment of Huntington's Disease, or HD. ALN-HTT02 is designed to target a conserved sequence in exon 1 of the HTT messenger RNA, thereby reducing the expression of all isoforms of HTT protein, including the shorter HTT1a isoform encoded by the first exon of the gene. In 2024 and 2025, we presented nonclinical data supporting the tolerability of deep and sustained HTT-lowering in wild-type nonhuman primates after single and repeated intrathecal administration of ALN-HTT02. In October 2025, we
initiated a Phase 1b clinical trial of ALN-HTT02 in adult patients with HD and expect to present initial data from this trial in the second half of 2026.
We have additional late-stage investigational programs advancing toward potential commercialization with collaborators, including cemdisiran for the treatment of complement-mediated diseases. Our collaborator, Regeneron, is advancing cemdisiran in combination with its anti-C5 monoclonal antibody, pozelimab, in a Phase 3 clinical trial in paroxysmal nocturnal hemoglobinuria, and as a monotherapy and in combination with pozelimab in Phase 3 clinical trials in myasthenia gravis and geographic atrophy. In August 2025, Regeneron announced that cemdisiran monotherapy met the primary and key secondary endpoints in the Phase 3 NIMBLE clinical trial in generalized myasthenia gravis and in April 2026, Regeneron filed a New Drug Application, or NDA, for cemdisiran monotherapy with the FDA, which was accepted for review in June 2026 with a target action date of November 2026, following use of a Priority Review Voucher. A corresponding application was also accepted for review by the European Medicines Agency, or EMA, with a decision from the EC anticipated in the second half of 2027.
We achieved profitability for the first time in 2025. Nevertheless, we have incurred significant losses since inception, and as of June 30, 2026, we had an accumulated deficit of $6.33 billion. Historically, we generated losses primarily from costs associated with research and development activities; acquiring, filing and protecting our intellectual property rights; and selling, general and administrative activities. With the achievement of profitability in 2025, going forward we expect to be able to fund our operations primarily from product revenues, which we expect will be supplemented by collaboration revenue and royalty revenue from products commercialized by our collaborators.
We expect to continue investing significantly in research and development to advance our RNAi platform and clinical pipeline. These planned expenditures include costs associated with our activities as we (i) progress our late-stage programs, including the Phase 3 TRITON-PN and TRITON-CM clinical trials of nucresiran (our next generation TTR silencer) in patients with hATTR-PN and ATTR-CM, respectively, and the Phase 3 ZENITH cardiovascular outcomes trial of zilebesiran in patients with uncontrolled hypertension, all three of which we initiated in 2025; (ii) progress our early stage clinical pipeline, including CNS and metabolic programs; (iii) continue our efforts to deliver RNAi therapeutics to additional tissues and to treat new disease areas; and (iv) selectively pursue complementary modalities through business development.
Through these investments, we plan to expand our efforts to discover, develop and commercialize the next wave of RNAi therapeutics and aim to achieve the goals associated with our Alnylam 2030 strategy. These goals include expanding to 10 tissue types and more than 40 clinical programs, delivering at least two new transformative medicines beyond TTR with blockbuster potential, investing approximately 30% of our revenues in non-GAAP R&D (including select external innovation), achieving 25%+ total revenue compound annual growth rate, and delivering approximately 30% non-GAAP operating margin through year-end 2030.
As of June 30, 2026, we generate worldwide product revenues from our four commercialized products, AMVUTTRA, ONPATTRO, GIVLAARI and OXLUMO, primarily in the U.S. and Europe. Collaboration and royalty revenues, in particular from our collaborations with Roche, Regeneron and Novartis, have also represented a meaningful portion of our total revenues in recent years. We expect our sources of potential funding for the next several years to be derived primarily from sales of our commercialized products, with contributions from our existing collaborations, including royalties on sales of Leqvio by Novartis and on sales of Qfitlia by Sanofi, and any new strategic collaborations that we may enter in the future. However, we and our collaborators may not be able to successfully market and sell our existing commercialized products or any approved products in the future. Moreover, our ongoing development and regulatory efforts may not be successful, and we and our collaborators may not be able to commence sales of any other products in the future. We anticipate that our operating results will continue to fluctuate for the foreseeable future, and therefore, period-to-period comparisons should not be relied upon as predictive of the results in future periods.
Given the significant and growing contribution of AMVUTTRA to our total product revenues following regulatory approvals of AMVUTTRA for the treatment of ATTR-CM, our cost of goods sold, operating income and operating margin have been significantly impacted by the royalties we pay to Sanofi on global sales of AMVUTTRA, and we expect this will continue in future years. Under our license agreement with Sanofi, Sanofi is eligible to receive tiered royalties on global annual net sales of AMVUTTRA across all indications in the following tiers: 15% of global annual net sales of $0 to $150.0 million; 17.5% of global annual net sales greater than $150.0 million to $300.0 million; 20% of global annual net sales greater than $300.0 million to $500.0 million; 25% of global annual net sales greater than $500.0 million to $1.50 billion; and 30% of global annual net sales in excess of $1.50 billion. There are no royalties owed on nucresiran, our next-generation investigational RNAi therapeutic, which is currently in development for the treatment of ATTR amyloidosis. Assuming successful development and regulatory approval, we believe that with its anticipated product profile, nucresiran has the potential to become a leading therapy for ATTR amyloidosis and to significantly improve our gross margins on product sales and operating income margin.
Convertible Senior Notes and Repurchases
In September 2025, we issued $661.3 million aggregate principal amount of 0.00% Convertible Senior Notes due 2028, or the 2028 Notes. The 2028 Notes will mature on September 15, 2028, unless earlier converted, redeemed or repurchased. The 2028 Notes will not bear regular interest. Before June 15, 2028, holders of 2028 Notes will have the right to convert their 2028
Notes in certain circumstances and during specified periods. From and after June 15, 2028, the 2028 Notes will be convertible at the option of the holders of 2028 Notes at any time prior to the close of business on the second scheduled trading day immediately preceding the maturity date. We will settle any conversions of 2028 Notes by paying or delivering, as applicable, cash or shares of our common stock, par value $0.01 per share, or Common Stock, or a combination of cash and shares of Common Stock, at our election.
In connection with the issuance of the 2028 Notes, we paid $35.3 million, including expenses to enter into privately negotiated capped call transactions with certain initial purchasers of the 2028 Notes or their respective affiliates and certain other financial institutions, or capped call transactions. The capped call transactions are expected generally to reduce the potential dilution upon conversion of the 2028 Notes in the event that the market price per share of our Common Stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the 2028 Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the 2028 Notes. The initial cap price of the capped call transaction is approximately $837.61 per share, and is subject to certain adjustments under the terms of the capped call transactions.
Concurrently with the pricing of the 2028 Notes, we entered into privately negotiated transactions, or the September 2025 note repurchase transactions, with certain holders of our 1.00% Convertible Senior Notes due 2027, or the 2027 Notes, to repurchase for cash approximately $637.8 million aggregate principal amount of the 2027 Notes for a total repurchase cost (including accrued and unpaid interest) of approximately $1.11 billion. In addition, in December 2025, we entered into additional privately negotiated transactions, or the December 2025 note repurchase transactions, with certain holders of our 2027 Notes to repurchase for cash approximately $34.4 million aggregate principal amount of the 2027 Notes for a total repurchase cost (including accrued and unpaid interest) of approximately $52.3 million. Following the closing of the December 2025 note repurchase transactions, or, together with the September 2025 note repurchase transactions, the note repurchase transactions, approximately $362.8 million aggregate principal amount of the 2027 Notes remain outstanding. We had previously entered into capped call transactions with certain financial institutions in connection with the issuance of the 2027 Notes, which transactions remain in place following the note repurchase transactions.
Revolving Credit Facility
In September 2025, we entered into a revolving credit agreement, or the Revolving Credit Agreement, among the lenders party thereto, Bank of America, N.A., as Administrative Agent, or the Agent, and the other parties named therein. The Revolving Credit Agreement provides for a $500.0 million revolving line of credit, or the Revolving Credit Facility, including a $150.0 million letter of credit sublimit. The Revolving Credit Agreement provides that we have the right at any time and from time to time to incur one or more incremental revolving commitments and/or incremental term loans, subject to certain customary conditions and other requirements.
At our option, and subject to certain conditions, borrowings bear interest at a base rate, a term Secured Overnight Financing Rate, or SOFR, rate or an alternative currency term rate, plus, in each case, an applicable margin based upon our Total Leverage Ratio (as defined in the Revolving Credit Agreement). For borrowings that bear interest at a term SOFR rate, the applicable margin is a per annum amount equal to an amount between 1.50% and 2.50% (depending on our Total Leverage Ratio). Interest is payable quarterly in arrears with respect to borrowings bearing interest at the alternate base rate or on the last day of an interest period, but at least every three months, with respect to borrowings bearing interest at a term SOFR rate or an alternative currency term rate. We are also required to pay on a quarterly basis a commitment fee in a per annum amount equal to an amount between 0.20% to 0.35% (depending on our Total Leverage Ratio) of unused available commitments under the Revolving Credit Facility. We are also obligated to pay the Agent fees customary for revolving credit facilities of this size and type.
The obligations under the Revolving Credit Agreement are required to be guaranteed by certain of our material domestic subsidiaries and are secured by substantially all of our assets and the assets of such subsidiary guarantors, subject to customary exceptions. The Revolving Credit Agreement contains customary affirmative and negative covenants and conditions to borrowing, as well as customary events of default.
Revolving loans under the Revolving Credit Agreement may be borrowed, repaid and reborrowed, without premium or penalty (subject to customary breakage costs), until their maturity date under the Revolving Credit Agreement, or the Maturity Date, at which time all amounts borrowed must be repaid. The Maturity Date is currently September 30, 2030, but may be adjusted to an earlier date upon the occurrence of certain events in accordance with the terms of the Revolving Credit Agreement.
Research and Development
Since our inception, we have focused primarily on drug discovery and development programs. Research and development expenses represent a substantial percentage of our total operating expenses, as reflected by our broad pipeline of clinical development programs, which includes multiple programs in late-stage development.
Our Product Pipeline
Our broad pipeline includes six approved products and multiple late and early-stage investigational RNAi therapeutics across a broad range of disease areas and indications. We describe our commercial and clinical-stage pipeline in more detail below. The clinical-stage therapeutics described below are in various stages of clinical development and the scientific information included about these therapeutics is preliminary and investigative. These clinical-stage therapeutics have not been approved by the FDA, EMA, or any other health authority and no conclusions can or should be drawn regarding the safety or efficacy of these investigational therapeutics.
The table below represents our commercial products and late- and early-stage development programs as of July 30, 2026.
During the second quarter of 2026 and recent period, we reported the following updates from our commercially approved products and our late-stage clinical programs:
Commercial
Total TTR: AMVUTTRA & ONPATTRO
•We achieved global net product revenues for AMVUTTRA and ONPATTRO for the second quarter of 2026 of $1.01 billion and $18.5 million, respectively.
Total Rare: GIVLAARI & OXLUMO
•We achieved global net product revenues for GIVLAARI and OXLUMO for the second quarter of 2026 of $89.8 million and $52.1 million, respectively.
Late-Stage Clinical Development
•Our partner, Regeneron, announced that the FDA and the EMA have accepted regulatory applications for cemdisiran to treat adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. Regeneron indicated that the FDA will review the NDA under Priority Review with a target action date in November 2026, following use of a Priority Review Voucher, and that a decision from the EC is anticipated in the second half of 2027.
There is a risk that any drug discovery or development program may not produce revenue for a variety of reasons, including the possibility that we will not be able to adequately demonstrate the safety and effectiveness of the product candidate or obtain approval or the desired labeling for the product candidate from regulatory authorities. The success of AMVUTTRA, ONPATTRO, GIVLAARI, OXLUMO or any other product candidate we develop is highly uncertain. Due to the numerous risks associated with developing drugs, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts necessary to complete the development of any potential product candidate or indication, or the period, if any, in which material net cash inflows will commence from any approved product or indication. Any failure to complete any stage of the development of any potential products in a timely manner or successfully launch, market and sell any of our commercially approved products, could have a material adverse effect on our operations, financial position and liquidity. A discussion of some of the risks and uncertainties associated with completing our research and development programs within the planned timeline, or at all, and the potential consequences of failing to do so, are set forth in Part II, Item 1A below under the heading "Risk Factors."
Strategic Collaborations
Our business strategy is to develop and commercialize a broad pipeline of RNAi therapeutic products directed across a broad range of disease areas and indications. As part of this strategy, we have entered into, and expect to enter into additional, collaboration and licensing agreements as a means of accessing resources and capabilities to advance our investigational RNAi therapeutic programs. Our collaboration strategy is to form collaborations that create significant value for ourselves and our collaborators in the advancement of RNAi therapeutics. We expect these collaborations to provide us with research and development support, sales and marketing support and/or financial support.
Below is a brief description of our key collaborations.
Roche. In July 2023, we entered into the Roche Collaboration and License Agreement, pursuant to which we and Roche established a worldwide, strategic collaboration for the joint development of pharmaceutical products containing zilebesiran, which we refer to as the Roche Collaboration. Under the Roche Collaboration and License Agreement, we granted to Roche (i) co-exclusive rights to develop zilebesiran worldwide and commercialize zilebesiran in the U.S., (ii) exclusive rights to commercialize zilebesiran outside of the U.S., and (iii) non-exclusive rights to manufacture zilebesiran for the development and commercialization of zilebesiran outside of the U.S. Roche made an upfront payment of $310.0 million and in April 2024 we achieved the development milestone associated with the dosing of the first patient in the KARDIA-3 Phase 2 clinical trial and received a $65.0 million development milestone payment from Roche. In September 2025, we achieved the development milestone associated with dosing the first patient in the ZENITH Phase 3 clinical trial and received a $300.0 million development milestone payment from Roche. In addition, we are eligible to receive up to an additional $2.15 billion in contingent payments based on the achievement of specified development, regulatory and sales-based milestones. We are responsible for forty percent (40%), and Roche is responsible for sixty percent (60%), of development costs incurred in the conduct of development activities that support regulatory approval of zilebesiran globally. We and Roche share equally (50/50) all costs incurred in connection with development activities that are conducted primarily to support regulatory approval of zilebesiran in the U.S. if incremental development activities are needed. Roche will be solely responsible for costs incurred in connection with commercialization of zilebesiran outside of the U.S. and will pay us tiered, low double digit royalties based on net sales of zilebesiran on a country-by-country basis outside of the U.S. during the royalty term. We and Roche will share equally (50/50) profits and losses (including commercialization costs) of zilebesiran in the U.S.
Regeneron. In April 2019, we entered into a global, strategic collaboration with Regeneron to discover, develop and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic targets expressed in the eye and CNS, in addition to a select number of targets expressed in the liver, which we refer to as the Regeneron Collaboration. The Regeneron Collaboration is governed by a Master Agreement, referred to as the Regeneron Master Agreement, which became effective in May 2019.
Under the terms of the Regeneron Collaboration, we worked exclusively with Regeneron to discover RNAi therapeutics for eye and CNS diseases and a select number of target genes expressed in the liver for an initial research period, or the Initial Research Term. The Initial Research Term expired in May 2026. As a result of such expiration, we will no longer work exclusively with Regeneron to discover RNAi therapeutics for eye and CNS diseases. We will, however, continue to collaborate exclusively with Regeneron on the programs targeting gene targets that were nominated during the Initial Research Term, provided that lead candidates for such targets are designated within two years of the expiration of the Initial Research Term.
Regeneron leads development and commercialization for all programs targeting eye diseases (subject to limited exceptions), entitling us to certain potential milestone and royalty payments pursuant to the terms of a license agreement, the form of which has been agreed upon by the parties. We and Regeneron are alternating leadership on CNS and liver programs, with the lead party retaining global development and commercial responsibility.
In August 2019, in connection with the Regeneron Master Agreement, we and Regeneron entered into (i) a co-co collaboration agreement covering the development of cemdisiran, our C5 siRNA, as a monotherapy for C5 complement-mediated diseases, or the C5 Co-Co Collaboration Agreement, and (ii) a license agreement to evaluate anti-C5 antibody-siRNA combinations for C5 complement-mediated diseases including evaluating the combination of Regeneron's pozelimab and cemdisiran, or the C5 License Agreement.
In June 2024, we entered into an amended and restated C5 License Agreement, or the Amended C5 License Agreement, which terminated the C5 Co-Co Collaboration Agreement and granted Regeneron a worldwide license to cemdisiran as a monotherapy in addition to the license to cemdisiran in combination with anti-C5 antibodies. Through the Amended C5 License Agreement, Regeneron is now solely responsible for development, manufacturing, and commercialization of cemdisiran as a monotherapy and in combination with anti-C5 antibodies. Regeneron provided us with an upfront payment of $10.0 million and we will receive certain milestone payments upon receipt of regulatory approval for cemdisiran as a monotherapy, and tiered, double-digit royalties on net sales. The Amended C5 License Agreement did not change our rights to receive low double-digit royalties and commercial milestones of up to $325.0 million on any potential product sales if cemdisiran is used as part of a combination product.
In May 2024, Regeneron notified us of its decision to opt-out of the further co-development of mivelsiran, an investigational RNAi therapeutic in development for the treatment of hereditary CAA and Alzheimer's Disease under our co-co collaboration agreement with respect to mivelsiran. As a result of Regeneron's opt-out, we now have full global development and commercialization rights to mivelsiran in all indications, and we are responsible for all development and commercialization costs of mivelsiran other than Regeneron's share of the then-current Phase 1 budget. Regeneron will no longer share potential future profits from sales of mivelsiran with us, although we remain subject to certain financial obligations to Regeneron under the mivelsiran co-co collaboration agreement. We continue to advance multiple other programs with Regeneron.
Sanofi. We formed a broad strategic alliance with Sanofi in 2014. In January 2018, we and Sanofi amended our 2014 collaboration and entered into the Exclusive License Agreement, referred to as the Exclusive TTR License, under which we were granted exclusive rights to pursue the further global development and commercialization of TTR products, including ONPATTRO, AMVUTTRA and certain back-up products, and the ALN-AT3 Global License Terms, referred to as the AT3 License Terms, under which Sanofi has the exclusive right to pursue the further global development and commercialization of Qfitlia and certain back-up products. Under the Exclusive TTR License, Sanofi is eligible to receive (i) royalties up to 25% increasing over time, based on annual net sales of ONPATTRO in territories excluding the U.S., Canada and Western Europe, provided royalties on annual net sales of ONPATTRO in Japan were set at 25% beginning at the effective date of the Exclusive TTR License and (ii) tiered royalties on global annual net sales of AMVUTTRA across all indications in the following tiers: 15% of global annual net sales of $0 to $150.0 million; 17.5% of global annual net sales greater than $150.0 million to $300.0 million; 20% of global annual net sales greater than $300.0 million to $500.0 million; 25% of global annual net sales greater than $500.0 million to $1.50 billion; and 30% of global annual net sales in excess of $1.50 billion. In April 2019, we and Sanofi amended and restated the AT3 License Terms to modify certain of the business terms. The material collaboration terms for Qfitlia were unchanged. Under the amended and restated AT3 License Terms, we are eligible to receive tiered royalties on global annual net sales of Qfitlia by Sanofi, its affiliates and its sublicensees. The royalty tiers and amounts that we are eligible to receive on global annual net sales of Qfitlia are the same as the royalty tiers and amounts that we owe to Sanofi on global annual net sales of AMVUTTRA.
Novartis. In February 2013, we entered into an exclusive, worldwide license with MDCO (acquired by Novartis AG in January 2020) pursuant to which MDCO was granted the right to develop, manufacture and commercialize RNAi therapeutics targeting proprotein convertase subtilisin/kexin type 9 for the treatment of hypercholesterolemia and other human diseases, including Leqvio.
Inceptive Nucleics. In June 2026, we entered into a collaboration agreement with Inceptive, which is designed to accelerate the discovery of prospective novel RNAi therapeutics by integrating Inceptive's generative AI models with our pipeline. We also entered into a stock purchase agreement with Inceptive pursuant to which we purchased shares of Inceptive's preferred stock for a total purchase price of $15.0 million.
Critical Accounting Policies and Estimates
Our critical accounting policies are described in the "Management's Discussion and Analysis of Financial Condition and Results of Operations" section of our Annual Report on Form 10-K for the year ended December 31, 2025, which we filed with the SEC on February 12, 2026. There have been no significant changes to our critical accounting policies since the beginning of this fiscal year.
Results of Operations
The following data summarizes the results of our operations:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Total revenues | $ | 1,290,948 | $ | 773,689 | $ | 517,259 | 67 | % | $ | 2,458,123 | $ | 1,367,878 | $ | 1,090,245 | 80 | % | |||||||||||||||||||||||||||||||
|
Total operating costs and expenses
|
$ | 1,059,507 | $ | 789,888 | $ | 269,619 | 34 | % | $ | 1,958,046 | $ | 1,366,000 | $ | 592,046 | 43 | % | |||||||||||||||||||||||||||||||
| Income (loss) from operations | $ | 231,441 | $ | (16,199) | $ | 247,640 | ** | $ | 500,077 | $ | 1,878 | $ | 498,199 | * | |||||||||||||||||||||||||||||||||
| Total other expense, net | $ | (53,635) | $ | (25,110) | $ | (28,525) | 114 | % | $ | (100,618) | $ | (45,555) | $ | (55,063) | 121 | % | |||||||||||||||||||||||||||||||
| Provision for income taxes | $ | (13,312) | $ | (30,919) | $ | 17,607 | (57) | % | $ | (28,974) | $ | (46,802) | $ | 17,828 | (38) | % | |||||||||||||||||||||||||||||||
| Net income (loss) | $ | 164,494 | $ | (72,228) | $ | 236,722 | ** | $ | 370,485 | $ | (90,479) | $ | 460,964 | ** | |||||||||||||||||||||||||||||||||
| * Indicates the percentage change period over period is greater than 500% | |||||||||||||||||||||||||||||||||||||||||||||||
|
** Not meaningful
|
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Discussion of Results of Operations
Revenues
Total revenues consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Net product revenues | $ | 1,172,109 | $ | 672,212 | $ | 499,897 | 74 | % | $ | 2,208,236 | $ | 1,140,750 | $ | 1,067,486 | 94 | % | |||||||||||||||||||||||||||||||
|
Net revenues from collaborations
|
47,165 | 61,496 | (14,331) | (23) | % | 129,240 | 160,681 | (31,441) | (20) | % | |||||||||||||||||||||||||||||||||||||
| Royalty revenue | 71,674 | 39,981 | 31,693 | 79 | % | 120,647 | 66,447 | 54,200 | 82 | % | |||||||||||||||||||||||||||||||||||||
|
Total revenues
|
$ | 1,290,948 | $ | 773,689 | $ | 517,259 | 67 | % | $ | 2,458,123 | $ | 1,367,878 | $ | 1,090,245 | 80 | % | |||||||||||||||||||||||||||||||
Net Product Revenues
Net product revenues, classified based on the geographic region in which the product is sold and by franchise ("TTR," which includes AMVUTTRA and ONPATTRO, and "Rare," which includes GIVLAARI and OXLUMO), consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| AMVUTTRA | |||||||||||||||||||||||||||||||||||||||||||||||
| United States | $ | 809,079 | $ | 361,346 | $ | 447,733 | 124 | % | $ | 1,511,633 | $ | 559,310 | $ | 952,323 | 170 | % | |||||||||||||||||||||||||||||||
| Europe | 119,010 | 92,868 | 26,142 | 28 | % | 232,323 | 172,956 | 59,367 | 34 | % | |||||||||||||||||||||||||||||||||||||
| Rest of World | 83,673 | 37,739 | 45,934 | 122 | % | 157,737 | 69,679 | 88,058 | 126 | % | |||||||||||||||||||||||||||||||||||||
| Total | 1,011,762 | 491,953 | 519,809 | 106 | % | 1,901,693 | 801,945 | 1,099,748 | 137 | % | |||||||||||||||||||||||||||||||||||||
| ONPATTRO | |||||||||||||||||||||||||||||||||||||||||||||||
| United States | 9,863 | 22,053 | (12,190) | (55) | % | 20,029 | 37,625 | (17,596) | (47) | % | |||||||||||||||||||||||||||||||||||||
| Europe | 5,508 | 21,246 | (15,738) | (74) | % | 13,073 | 47,787 | (34,714) | (73) | % | |||||||||||||||||||||||||||||||||||||
| Rest of World | 3,090 | 9,239 | (6,149) | (67) | % | 5,840 | 16,615 | (10,775) | (65) | % | |||||||||||||||||||||||||||||||||||||
| Total | 18,461 | 52,538 | (34,077) | (65) | % | 38,942 | 102,027 | (63,085) | (62) | % | |||||||||||||||||||||||||||||||||||||
|
Total TTR
|
1,030,223 | 544,491 | 485,732 | 89 | % | 1,940,635 | 903,972 | 1,036,663 | 115 | % | |||||||||||||||||||||||||||||||||||||
| GIVLAARI | |||||||||||||||||||||||||||||||||||||||||||||||
| United States | 58,000 | 55,151 | 2,849 | 5 | % | 107,091 | 98,945 | 8,146 | 8 | % | |||||||||||||||||||||||||||||||||||||
| Europe | 24,323 | 20,966 | 3,357 | 16 | % | 44,613 | 39,510 | 5,103 | 13 | % | |||||||||||||||||||||||||||||||||||||
| Rest of World | 7,441 | 4,732 | 2,709 | 57 | % | 12,454 | 9,362 | 3,092 | 33 | % | |||||||||||||||||||||||||||||||||||||
| Total | 89,764 | 80,849 | 8,915 | 11 | % | 164,158 | 147,817 | 16,341 | 11 | % | |||||||||||||||||||||||||||||||||||||
| OXLUMO | |||||||||||||||||||||||||||||||||||||||||||||||
| United States | 18,545 | 16,019 | 2,526 | 16 | % | 35,510 | 30,128 | 5,382 | 18 | % | |||||||||||||||||||||||||||||||||||||
| Europe | 22,678 | 21,929 | 749 | 3 | % | 47,068 | 42,913 | 4,155 | 10 | % | |||||||||||||||||||||||||||||||||||||
| Rest of World | 10,899 | 8,924 | 1,975 | 22 | % | 20,865 | 15,920 | 4,945 | 31 | % | |||||||||||||||||||||||||||||||||||||
| Total | 52,122 | 46,872 | 5,250 | 11 | % | 103,443 | 88,961 | 14,482 | 16 | % | |||||||||||||||||||||||||||||||||||||
|
Total Rare
|
141,886 | 127,721 | 14,165 | 11 | % | 267,601 | 236,778 | 30,823 | 13 | % | |||||||||||||||||||||||||||||||||||||
| Total net product revenues | $ | 1,172,109 | $ | 672,212 | $ | 499,897 | 74 | % | $ | 2,208,236 | $ | 1,140,750 | $ | 1,067,486 | 94 | % | |||||||||||||||||||||||||||||||
Net product revenues increased during the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to growth from AMVUTTRA revenues driven by increased patient demand, mainly in patients with ATTR-CM in the U.S., and growth from an increased number of patients on GIVLAARI and OXLUMO, which was partially offset by a decreased number of patients on ONPATTRO.
Net Revenues from Collaborations and Royalty Revenue
Net revenues from collaborations and royalty revenue consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
|
Roche
|
$ | 41,888 | $ | 18,267 | $ | 23,621 | 129 | % | $ | 77,529 | $ | 35,323 | $ | 42,206 | 119 | % | |||||||||||||||||||||||||||||||
| Regeneron Pharmaceuticals | 5,020 | 32,542 | (27,522) | (85) | % | 51,356 | 83,581 | (32,225) | (39) | % | |||||||||||||||||||||||||||||||||||||
| Other | 257 | 10,687 | (10,430) | (98) | % | 355 | 41,777 | (41,422) | (99) | % | |||||||||||||||||||||||||||||||||||||
|
Total net revenues from collaborations
|
$ | 47,165 | $ | 61,496 | $ | (14,331) | (23) | % | $ | 129,240 | $ | 160,681 | $ | (31,441) | (20) | % | |||||||||||||||||||||||||||||||
|
Royalty revenue
|
$ | 71,674 | $ | 39,981 | $ | 31,693 | 79 | % | $ | 120,647 | $ | 66,447 | $ | 54,200 | 82 | % | |||||||||||||||||||||||||||||||
Net revenues from collaborations decreased during the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to lower revenue recognized under the Regeneron Collaboration. The decrease was driven by the completion of certain collaboration activities in 2025, the wind down of the Initial Research Term under the terms of the Regeneron Collaboration, and the impact of revised cost estimates related to those activities in the three months ended June 30, 2026. The decrease in net revenues from collaborations during the six months ended June 30, 2026 was also driven by the recognition of a $30.0 million payment in connection with the amendment to our agreement with Vir Biotechnology, Inc. in March 2025. These decreases were partially offset by increased revenue under the Roche Collaboration due to higher reimbursable development activities related to the ZENITH Phase 3 clinical trial of zilebesiran, as well as increased milestone and reimbursement activity under the Regeneron license agreements.
Royalty revenue increased during the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to increased volume and rate of royalties earned from global net sales of Leqvio by Novartis.
Net revenues from collaborations in any period is dependent on a variety of factors, including the level of work reimbursed by collaborators and achievement of milestones under our collaboration agreements. We expect royalty revenue will increase during 2026, as compared to 2025, primarily as a result of increased sales of Leqvio.
Operating Costs and Expenses
Operating costs and expenses consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Cost of goods sold | $ | 298,261 | $ | 142,029 | $ | 156,232 | 110 | % | $ | 505,781 | $ | 212,212 | $ | 293,569 | 138 | % | |||||||||||||||||||||||||||||||
| Cost of goods sold as a percentage of net product revenues | 25.4 | % | 21.1 | % | 22.9 | % | 18.6 | % | |||||||||||||||||||||||||||||||||||||||
| Cost of collaborations and royalties | 190 | 924 | (734) | (79) | % | 3,792 | 1,782 | 2,010 | 113 | % | |||||||||||||||||||||||||||||||||||||
| Research and development | 413,134 | 323,621 | 89,513 | 28 | % | 778,000 | 588,743 | 189,257 | 32 | % | |||||||||||||||||||||||||||||||||||||
|
Selling, general and administrative
|
347,922 | 323,314 | 24,608 | 8 | % | 670,473 | 563,263 | 107,210 | 19 | % | |||||||||||||||||||||||||||||||||||||
| Total | $ | 1,059,507 | $ | 789,888 | $ | 269,619 | 34 | % | $ | 1,958,046 | $ | 1,366,000 | $ | 592,046 | 43 | % | |||||||||||||||||||||||||||||||
Cost of Goods Sold
Cost of goods sold as a percentage of net product revenues increased to 25.4% and 22.9% during the three and six months ended June 30, 2026, respectively, as compared to 21.1% and 18.6% during the same periods 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.
We expect our cost of goods sold, including cost of goods sold as a percentage of net product revenues, will increase during 2026, as compared to 2025, primarily as a result of an expected increase in sales of AMVUTTRA and an associated increase in the blended royalty rate payable on net sales of AMVUTTRA.
Cost of Collaborations and Royalties
Cost of collaborations and royalties increased during the six months ended June 30, 2026, as compared to the same period in 2025, primarily due to the timing of demand for GalNAc material supplied to our collaborators in support of certain product manufacturing. Cost of collaborations and royalties was not significant during the three months ended June 30, 2026 and 2025.
We do not expect the cost of collaborations and royalties to be significant in 2026, primarily as a result of our collaborators having transitioned to producing GalNAc material independently.
Research and Development
Research and development expenses consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Clinical research and outside services | $ | 244,226 | $ | 140,692 | $ | 103,534 | 74 | % | $ | 443,483 | $ | 268,035 | $ | 175,448 | 65 | % | |||||||||||||||||||||||||||||||
| Compensation and related | 89,496 | 93,898 | (4,402) | (5) | % | 183,682 | 169,287 | 14,395 | 9 | % | |||||||||||||||||||||||||||||||||||||
|
Occupancy and all other costs(1)
|
43,518 | 39,479 | 4,039 | 10 | % | 84,829 | 78,071 | 6,758 | 9 | % | |||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 35,894 | 49,552 | (13,658) | (28) | % | 66,006 | 73,350 | (7,344) | (10) | % | |||||||||||||||||||||||||||||||||||||
|
Total research and development
|
$ | 413,134 | $ | 323,621 | $ | 89,513 | 28 | % | $ | 778,000 | $ | 588,743 | $ | 189,257 | 32 | % | |||||||||||||||||||||||||||||||
(1) Occupancy and all other costs includes facilities, information technology, depreciation and certain departmental expenses.
Research and development expenses for the three and six months ended June 30, 2026 increased as compared to the same periods 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.
These increases were partially offset by:
•decreased expenses within other clinical programs, in particular for the KARDIA-1, KARDIA-2 and KARDIA-3 Phase 2 clinical trials of zilebesiran due to the wind-down of clinical activities; and
•decreased stock-based compensation expense.
Additionally, research and development expenses for the six months ended June 30, 2026 increased as compared to the same period in 2025 due to increased employee compensation and related expenses.
Selling, General and Administrative
Selling, general and administrative expenses consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Compensation and related | $ | 115,888 | $ | 129,105 | $ | (13,217) | (10) | % | $ | 238,923 | $ | 227,628 | $ | 11,295 | 5 | % | |||||||||||||||||||||||||||||||
| Consulting and professional services | 120,721 | 82,637 | 38,084 | 46 | % | 225,898 | 147,324 | 78,574 | 53 | % | |||||||||||||||||||||||||||||||||||||
|
Occupancy and all other costs(1)
|
60,582 | 49,444 | 11,138 | 23 | % | 114,879 | 93,269 | 21,610 | 23 | % | |||||||||||||||||||||||||||||||||||||
| Stock-based compensation | 50,731 | 62,128 | (11,397) | (18) | % | 90,773 | 95,042 | (4,269) | (4) | % | |||||||||||||||||||||||||||||||||||||
|
Total selling, general and administrative
|
$ | 347,922 | $ | 323,314 | $ | 24,608 | 8 | % | $ | 670,473 | $ | 563,263 | $ | 107,210 | 19 | % | |||||||||||||||||||||||||||||||
(1) Occupancy and all other costs includes facilities, information technology, depreciation and certain departmental expenses.
Selling, general and administrative expenses for the three and six months ended June 30, 2026 increased as compared to the same periods in 2025, primarily due to the following:
•increased marketing investment associated with the ongoing global commercial launch of AMVUTTRA in ATTR-CM; and
•increased occupancy and all other costs, primarily related to scaling our IT systems and infrastructure to support long-term growth.
These increases were partially offset by decreased stock-based compensation expense.
We expect that research and development expenses combined with selling, general and administrative expenses will increase during 2026 as compared to 2025, as we continue to launch our current commercial products into new markets, prepare
for future commercial product launches, including the continued global commercial launch of AMVUTTRA for the treatment of ATTR-CM, advance our product candidates, including collaborated programs, into later-stage development, advance and develop our platform and preclinical pipeline, and prepare regulatory submissions. However, we expect that certain expenses will be variable depending on the timing of manufacturing batches, clinical trial enrollment and results, regulatory review of our product candidates and programs, and stock-based compensation expenses based on our determination regarding the probability of vesting or assessed level of achievement for performance-based awards.
Other (Expense) Income
Other (expense) income consisted of the following:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Interest expense | $ | (82,051) | $ | (61,456) | $ | (20,595) | 34 | % | $ | (151,337) | $ | (119,765) | $ | (31,572) | 26 | % | |||||||||||||||||||||||||||||||
| Interest income | 28,143 | 27,486 | 657 | 2 | % | 54,741 | 56,159 | (1,418) | (3) | % | |||||||||||||||||||||||||||||||||||||
| Other income (expense), net | 273 | 8,860 | (8,587) | (97) | % | (4,022) | 18,051 | (22,073) | (122) | % | |||||||||||||||||||||||||||||||||||||
|
Total other expense, net
|
$ | (53,635) | $ | (25,110) | $ | (28,525) | 114 | % | $ | (100,618) | $ | (45,555) | $ | (55,063) | 121 | % | |||||||||||||||||||||||||||||||
Total other expense, net increased during the three and six months ended June 30, 2026, as compared to the same periods in 2025, primarily due to increased interest expense associated with the liabilities related to the sale of future royalties and development funding, as well as decreased net realized and unrealized foreign currency transaction gains.
Provision for Income Taxes
Provision for income taxes was as follows:
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2026 | 2025 | $ Change | % Change | 2026 | 2025 | $ Change | % Change | |||||||||||||||||||||||||||||||||||||||
| Provision for income taxes | $ | (13,312) | $ | (30,919) | $ | 17,607 | (57) | % | $ | (28,974) | $ | (46,802) | $ | 17,828 | (38) | % | |||||||||||||||||||||||||||||||
The provision for income taxes for the three and six months ended June 30, 2026 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. For the three and six months ended June 30, 2026, we maintained a full valuation allowance against our net deferred tax assets in the U.S. Based on our recent financial performance and our future projections, we could record a reversal of all or a portion of the U.S. valuation allowance in the second half of 2026. However, any such change is subject to actual performance and other considerations that may present positive or negative evidence at the time of the assessment.
Liquidity and Capital Resources
The following table summarizes our cash flow activities:
| Six Months Ended June 30, | |||||||||||
| (In thousands) | 2026 | 2025 | |||||||||
| Net cash provided by (used in): | |||||||||||
| Operating activities | $ | 397,228 | $ | 9,495 | |||||||
| Investing activities | $ | (388,999) | $ | (27,612) | |||||||
| Financing activities | $ | 51,951 | $ | 123,762 | |||||||
Operating activities
Net cash provided by operating activities increased during the six months ended June 30, 2026, compared to the same period in 2025, primarily due to stronger cash receipts from increased product sales, partially offset by increased employee compensation.
Investing activities
Net cash used in investing activities increased during the six months ended June 30, 2026, compared to the same period in 2025, primarily due to the timing of sales, maturities, and purchases of our marketable securities, as well as increased purchases of property, plant and equipment.
Financing activities
Net cash provided by financing activities decreased during the six months ended June 30, 2026, compared to the same period in 2025, primarily due to lower net proceeds from the issuance of common stock in connection with stock option exercises, partially offset by proceeds from liabilities related to the sale of future royalties and development funding.
Additional Capital Requirements
We currently have programs focused in many therapeutic areas and, as of June 30, 2026, have six marketed products, including two products commercialized by collaborators. However, our ongoing development efforts may not be successful and we may not be able to commence sales of any other products in the future. In addition, we may incur additional operating losses as a result of planned expenditures for research and development activities relating to our research platform, our drug development programs, including clinical trial and manufacturing costs, the continued build-out of late-stage clinical, manufacturing, commercial and compliance capabilities, including global operations, continued management and growth of our intellectual property, including our patent portfolio, collaborations and general corporate activities.
In September 2025, we entered into the Revolving Credit Agreement, which provides for a $500.0 million revolving line of credit, including a $150.0 million sublimit for issuance of letters of credit. The Revolving Credit Agreement matures in September 2030, subject to earlier springing maturity under certain circumstances. The Revolving Credit Agreement contains customary affirmative and negative covenants and conditions to borrowing, as well as customary events of default. In addition, the Revolving Credit Agreement contains financial covenants that require us to maintain a total leverage ratio less than or equal to 3.75:1.00 and an interest coverage ratio greater than or equal to 3.00:1.00, each tested at the end of each fiscal quarter. As of June 30, 2026, we had no borrowings and $17.5 million of letters of credit outstanding under the Revolving Credit Agreement. Please refer to Note 8, Convertible Debt and Other Financing, in the "Notes to Condensed Consolidated Financial Statements" in this Quarterly Report on Form 10-Q for further information.
Our expected working and other capital requirements are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 in "Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." As of June 30, 2026, other than the changes disclosed in the "Notes to Condensed Consolidated Financial Statements" and "Liquidity and Capital Resources" section in this Quarterly Report on Form 10-Q, there have been no other material changes to our expected working and other capital requirements as described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.
Based on our current operating plan, we believe that our cash, cash equivalents, marketable securities, as well as the revenue we expect to generate from product sales and under our existing collaborations, including royalties on sales of Leqvio and Qfitlia, and available borrowing capacity under the Revolving Credit Agreement as of June 30, 2026, will be sufficient to satisfy our near-term capital and operating needs for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. However, due to numerous factors described in more detail under the caption Part II, Item 1A, "Risk Factors" of this Quarterly Report on Form 10-Q, we may require significant additional funds earlier than we currently expect in order to continue to commercialize our approved products, and to develop, conduct clinical trials for, manufacture and, if approved, commercialize additional product candidates.
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