On August 1, 2025 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the second quarter of 2025 (Press release, Moderna Therapeutics, AUG 1, 2025, https://feeds.issuerdirect.com/news-release.html?newsid=4672625806029436&symbol=MRNA [SID1234654692]).

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"In the last three months, we advanced our pipeline with positive Phase 3 flu vaccine efficacy data and expanded our commercial portfolio with three new U.S. FDA approvals to drive future sales growth," said Stéphane Bancel, Chief Executive Officer of Moderna. "Today, we are updating our 2025 financial framework, reducing the high end of this year’s expected revenue range by $300 million due to the timing of shipments. We continue to operate with financial discipline and are improving expected annual operating expenses in 2025 by approximately $400 million. Looking forward, we have important catalysts over the next six months across our infectious disease and oncology programs that will help us deliver on the promise of our mRNA platform for patients."

Recent progress includes:

Commercial Updates

COVID-19: The Company reported $114 million in Spikevax sales in the second quarter of 2025, which includes $88 million of U.S. sales and $26 million of international sales. Moderna recently announced U.S. Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) for Spikevax in children 6 months through 11 years of age who are at increased risk for COVID-19 disease. The Company’s COVID-19 vaccine (mRNA-1273) was previously available for pediatric populations under Emergency Use Authorization (EUA). Additionally, the Company announced it has received final approval from the European Medicines Agency for Spikevax targeting the LP.8.1 variant in individuals six months of age and older. Moderna also announced FDA approval for mNEXSPIKE (mRNA-1283), a next-generation vaccine against COVID-19, for use in all adults aged 65 and older, as well as individuals aged 12-64 years with at least one underlying risk factor.

RSV: The Company reported negligible mRESVIA sales in the second quarter of 2025. Moderna’s RSV vaccine for adults aged 60 years and older has been approved in approximately 40 countries. Additionally, Moderna recently announced that the FDA has approved mRESVIA (mRNA-1345), expanding the previous indication, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.

Second Quarter 2025 Financial Results

Revenue: Total revenue for the second quarter of 2025 was $142 million, a 41% decrease from $241 million in the same period in 2024. The decline was primarily driven by lower COVID vaccine sales, which totaled $114 million in the quarter. Demand is expected to be concentrated in the second half of the year, aligning with the fall and winter seasons as the vaccine continues to transition into a seasonal respiratory product.

Cost of Sales: Cost of sales for the second quarter of 2025 was $119 million, which included third-party royalties of $6 million, inventory write-downs of $38 million, and unutilized manufacturing capacity and wind-down costs of $52 million. Cost of sales was relatively flat compared to the same period in 2024. The increase in cost of sales as a percentage of net product sales, to 105% from 62% in the second quarter of 2024, was mainly driven by the impact of lower net product sales.

Research and Development Expenses: Research and development expenses for the second quarter of 2025 were $700 million, a 43% decrease compared to the same period in 2024. The reduction was primarily driven by lower clinical trial and manufacturing expenses, reflecting reduced production spending, program wind-downs, and the timing of trial activities across the Company’s respiratory vaccine portfolio.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of 2025 were $230 million, a 14% decrease compared to the same period in 2024. The decline was primarily driven by broad-based cost reductions across consulting and external services, personnel-related expenses, and commercial and marketing activities, reflecting the Company’s continued cost discipline and ongoing efforts to streamline operations.

Income Taxes: Income tax provisions for both periods were not material, as the Company continues to maintain a global valuation allowance against most of its deferred tax assets.

Net Loss: Net loss was $(0.8) billion for the second quarter of 2025, compared to $(1.3) billion for the second quarter of 2024.

Loss Per Share: Loss per share was $(2.13) for the second quarter of 2025, compared to $(3.33) for the second quarter of 2024.

Cash Position: Cash, cash equivalents and investments as of June 30, 2025, were $7.5 billion, compared to $8.4 billion as of March 31, 2025. The decrease during the quarter was primarily due to ongoing research and development expenses and other operating activities.

2025 Financial Framework

Revenue: The Company updated its 2025 projected revenue range to $1.5 to $2.2 billion, reflecting a $300 million reduction at the high end of the range. This is primarily driven by the timing shift of deliveries of contracted revenue for the U.K. into the first quarter of 2026. For the second half of the year, Moderna expects a revenue split of 40-50% in the third quarter with the balance in the fourth quarter of 2025.

Cost of Sales: Cost of sales for 2025 is expected to be approximately $1.2 billion.

Research and Development Expenses: Full-year 2025 research and development expenses are anticipated to be $3.6 to $3.8 billion, lowered from previous expectations of approximately $4.1 billion.

Selling, General and Administrative Expenses: Selling, general and administrative expenses for 2025 are projected to be approximately $1.1 billion.

Income Taxes: The Company continues to expect its full-year tax expense to be negligible.

Capital Expenditures: Capital expenditures for 2025 are expected to be approximately $0.3 billion, lowered from previous expectations of approximately $0.4 billion.

Cash and Investments: Year-end cash and investments for 2025 are projected to be approximately $6 billion.

Recent Progress and Upcoming Late-Stage Pipeline Milestones

Respiratory vaccines:

Seasonal flu vaccine: In June, Moderna announced positive Phase 3 efficacy results for its seasonal flu vaccine (mRNA-1010), which demonstrated superior relative vaccine efficacy that was 26.6% (95% CI; 16.7%, 35.4%) higher than a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. The Company is submitting mRNA-1010 data for publication, presenting data at medical conferences and preparing to file for FDA approval.

Seasonal flu + COVID vaccine: Moderna shared positive Phase 3 immunogenicity data for its flu/COVID combination vaccine (mRNA-1083) for adults aged 50 years and older at its 2024 R&D Day event. In May 2025, the Company announced that in consultation with the FDA, it had voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083 with the plan to resubmit after vaccine efficacy data from the Phase 3 trial of its investigational seasonal flu vaccine (mRNA-1010) are available. The Company is engaging with regulators on data requirements for resubmitting the BLA for mRNA-1083.

Latent and other vaccines:

Cytomegalovirus (CMV) vaccine: The Company shared 36-month durability data from a Phase 2 extension trial of its CMV vaccine candidate (mRNA-1647) at the ESCMID 2025 Global Congress. The pivotal Phase 3 study of mRNA-1647 is fully enrolled and has now accrued sufficient cases for evaluation of the primary endpoint of the study, evaluating its efficacy, safety and immunogenicity in the prevention of primary infection in women of childbearing age. Moderna is updating its analysis plan to incorporate additional secondary endpoints. The Company remains blinded and anticipates a Phase 3 final analysis in 2025.

Norovirus vaccine: The Phase 3 study evaluating the efficacy, safety and immunogenicity of Moderna’s trivalent vaccine against norovirus (mRNA-1403) is accruing cases. The timing of the Phase 3 readout will be dependent on case accruals.

Oncology therapeutics:

Intismeran autogene: Moderna continues to make progress on advancing mRNA-4157 in the clinic. In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma is fully enrolled. Two non-small cell lung cancer (NSCLC) Phase 3 studies for those with and without prior neoadjuvant treatment are enrolling. Separate randomized Phase 2 studies for high-risk muscle invasive and high-risk non-muscle invasive bladder cancer are also enrolling, and a randomized Phase 2 study for adjuvant renal cell carcinoma is fully enrolled. Further, Moderna and Merck have launched a new Phase 2 study of first-line treatment for patients with metastatic melanoma.

Checkpoint adaptive immune modulation therapy (AIM-T): The Phase 1/2 study of mRNA-4359 is ongoing and the Phase 2 study, which includes cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, is enrolling NSCLC patients.

The Company recently announced that three abstracts on its investigational mRNA therapeutics have been accepted for presentation at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

Rare disease therapeutics:

Propionic acidemia (PA) therapeutic: In an ongoing Phase 1/2 study designed to evaluate safety and pharmacology in trial participants with PA, Moderna’s investigational therapeutic (mRNA-3927) has been generally well-tolerated to date with no events meeting protocol-defined dose-limiting toxicity criteria. Early results suggest potential decreases in annualized metabolic decompensation event (MDE) frequency compared to pre-treatment, and the majority of patients have elected to continue on the open label extension study. The Company’s PA program is in a registrational study.

Methylmalonic acidemia (MMA) therapeutic: Moderna’s investigational therapeutic for MMA (mRNA-3705) has been selected by the FDA for the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program. The FDA and Moderna have agreed on the pivotal study design. The Company expects to start a registrational study in 2025.

Moderna Corporate Updates

Moderna announced an organizational restructuring that will reduce its global workforce by approximately 10%. The Company anticipates a total headcount of under 5,000 by year-end.

Company Accolades

Moderna was named to the Boston Business Journal’s annual list of the Most Charitable Companies in Massachusetts (third consecutive year)

Moderna was recognized as a top-scoring company on Disability:IN’s Disability Equality Index and a Best Place to Work for Disability Inclusion (fourth consecutive year)

Key 2025 Investor and Analyst Event Dates

Analyst Day: November 20

Investor Call and Webcast Information

Moderna will host a live conference call and webcast at 8:00 a.m. ET on August 1, 2025. To access the live conference call via telephone, please register at the link below. Once registered, dial-in numbers and a unique pin number will be provided. A live webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website.

Telephone: View Source

Webcast: View Source

The archived webcast will be available on Moderna’s website approximately two hours after the conference call and will be available for one year following the call.

On August 1, 2025 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer and autoimmune disease, reported that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma (LBCL) (Press release, Allogene, AUG 1, 2025, View Source [SID1234654703]). This lymphodepletion regimen selection was made in conjunction with the ALPHA3 Data and Safety Monitoring Board (DSMB) and Steering Committee and following consultation with the U.S. Food and Drug Administration (FDA).

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The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. This decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. The event occurred on Day 54 post-infusion from hepatic failure, believed to have resulted from disseminated adenovirus infection in the setting of immune suppression. This event was deemed unrelated to cema-cel. Severe viral infections have been rare across Allogene’s clinical trials. However, when present, they have been attributed to immunosuppression due in part to ALLO-647. There have been no cases of adenoviral infection or hepatic failure in any participant treated with FC lymphodepletion across Allogene’s trials.

"The loss of a patient is always deeply saddening, and we extend our heartfelt condolences to the patient’s family," said David Chang, M.D., Ph.D., President, Chief Executive Officer, and Co-Founder of Allogene. "This event, which prompted an early review of the trial data, compelled us to make a decisive choice – one that may ultimately help bring this potentially life-saving therapy to patients more quickly. The ability to administer cema-cel following standard FC lymphodepletion in an outpatient setting will simplify study treatment and has the potential to accelerate trial enrollment and streamline regulatory review, ultimately transforming care for patients."

The adoption of standard FC in the ALPHA3 trial marks a key shift in Allogene’s clinical strategy. As a result, no trials open to enrollment or pipeline programs include ALLO-647. Instead, the Company is advancing its next-generation AlloCAR T product candidates using the proprietary Dagger Platform Technology, which is designed to minimize or potentially eliminate the need for standard lymphodepletion. This approach is showcased in the ALLO-316 TRAVERSE trial for advanced renal cell carcinoma and the ALLO-329 RESOLUTION trial for autoimmune diseases, both of which leverage the Dagger Technology to reduce reliance on traditional lymphodepletion strategies.

The amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same. The next milestone will be the futility analysis comparing MRD conversion and is expected to occur 1H 2026. To date, over 50 clinical sites are activated across the United States and Canada, including community cancer centers and major academic institutions.

Conference Call and Webcast Details
Allogene will host a live conference call and webcast today at 8:00 a.m. PT / 11:00 a.m. ET to discuss this recent update. If you would like the option to ask a question on the conference call, please use this link to register. Upon registering for the conference call, you will receive a personal PIN to access the call, which will identify you as the participant and allow you the option to ask a question. The listen-only webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

About Cemacabtagene Ansegedleucel (cema-cel)
Cemacabtagene ansegedleucel, or cema-cel, is a next generation anti-CD19 AlloCAR T investigational product for the treatment of large B cell lymphoma (LBCL). The ALPHA3 pivotal Phase 2 trial in first line (1L) consolidation for the treatment of LBCL launched in June 2024. Allogene has oncology rights to cema-cel in the US, EU and UK with options for rights in China and Japan.

About the ALPHA3 Trial
Over 60,000 patients are expected to be treated for LBCL annually in the US, the EU and the UK. While first line (1L) R-CHOP or other chemoimmunotherapy is effective for most patients, approximately 30% who initially respond will relapse and require subsequent treatment. The current standard of care after 1L treatment has been simply to "watch and wait" to see if the disease relapses. The pivotal Phase 2 ALPHA3 study takes advantage of cema-cel as a one-time, "off-the-shelf" treatment that can be administered immediately upon discovery of MRD following six cycles of R-CHOP or other chemoimmunotherapy, positioning it to become the standard "7th cycle" of frontline treatment available to all eligible patients with MRD.

On August 1, 2025 I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, reported the pricing of an underwritten offering in the United States of 33,333,334 American Depositary Shares (ADSs) representing 76,666,668 ordinary shares at an offering price of $1.95 per ADS, for total gross proceeds of approximately $65 million (Press release, I-Mab Biopharma, AUG 1, 2025, View Source [SID1234654726]). All of the ADSs to be sold in the offering will be offered by I-Mab. The offering is expected to close on August 5, 2025, subject to customary closing conditions.

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The offering included participation from new and existing investors including Everest Medicines, Janus Henderson Investors, Adage Capital Partners LP and Exome Asset Management.

Leerink Partners is acting as the lead bookrunning manager. BTIG is acting as a bookrunning manager. Lucid Capital Markets is acting as lead manager.

The Company intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, to fund ongoing clinical development of its pipeline product candidates, including a randomized Phase 2 trial of givastomig, a bispecific Claudin 18.2 x 4-1BB antibody, intended to have sufficient power and size to generate clinically meaningful progression-free survival (PFS) data by end of 2027, and for working capital and other general corporate purposes.

The ADSs are being offered pursuant to an effective F-3 shelf registration statement that was previously filed with the Securities and Exchange Commission (the SEC). A prospectus supplement will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. The offering will be made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, for free from Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, Massachusetts 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 1, 2025 Kazia Therapeutics Limited (NASDAQ: KZIA), an oncology-focused drug development company, reported that it has entered into a securities purchase agreement with certain established institutional investors for a private placement of equity securities (PIPE) (Press release, Kazia Therapeutics, AUG 1, 2025, View Source [SID1234654704]). Pursuant to the securities purchase agreement, the Company agreed to offer and sell to an aggregate of approximately $2.0 million of ordinary shares and prefunded warrants. The securities being sold in the PIPE are priced at a 5% premium to the closing price of Kazia’s ADSs on July 31, 2025. The PIPE is structured as a straightforward equity investment with no common warrant coverage. The transaction is expected to close on Monday, August 4, 2025, subject to customary closing conditions.

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The Company estimates that the net proceeds to the Company from the PIPE will be approximately $2 million, after deducting estimated offering expenses. The Company intends to use the net proceeds from this offering to support the continued clinical development of its lead programs, including paxalisib, a brain-penetrant dual PI3K/mTOR inhibitor currently in clinical trials for both brain cancer and advanced breast cancer, and EVT801, a selective VEGFR3 inhibitor, and for general corporate purposes.

"This transaction provides Kazia with additional capital to advance our clinical-stage assets through key near-term catalysts most notably additional data from our ongoing advanced breast cancer trial," said Dr. John Friend, CEO of Kazia Therapeutics. "We are grateful for the continued support of our investors and look forward to delivering updates on upcoming milestones."

The securities sold in this PIPE are being made in a transaction not involving a public offering and have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws, and may not be offered or sold in the United States absent an effective registration statement or an applicable exemption from registration requirements. Pursuant to the securities purchase agreement, the Company has agreed to file a shelf registration statement with the U.S. Securities and Exchange Commission (SEC) within 60 days of the closing to register the resale of ADSs representing the ordinary shares and those underlying the pre-funded warrants.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Any offering of the securities described above under the resale registration statement will only be by means of a prospectus.

On August 1, 2025 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported financial results for the second quarter of 2025 and provided a business update (Press release, Regeneron, AUG 1, 2025, View Source [SID1234654705]).

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"Regeneron had a strong quarter, marked by significant growth in U.S. sales of EYLEA HD and global sales of Dupixent and Libtayo along with multiple regulatory approvals," said Leonard S. Schleifer, M.D., Ph.D., Board co-Chair, President and Chief Executive Officer of Regeneron. "We have made significant progress in our oncology portfolio, including FDA approval for Lynozyfic for relapsed or refractory multiple myeloma, exciting emerging data from the lead-in cohorts of our pivotal programs in myeloma and lymphoma, as well as positive pivotal data supporting a potential upcoming FDA approval for Libtayo in adjuvant CSCC. Dupixent continues to be the world-leading treatment for diseases driven by type 2 inflammation, adding recent FDA approvals for bullous pemphigoid and chronic spontaneous urticaria, the seventh and eighth distinct indications for this important medicine. We are confident in the near- and long-term potential of our diverse pipeline and look forward to additional data and regulatory milestones later this year."

Financial Highlights

($ in millions, except per share data) Q2 2025 Q2 2024 % Change
Total revenues $ 3,676 $ 3,547 4 %
GAAP net income $ 1,392 $ 1,432 (3 %)
GAAP net income per share – diluted $ 12.81 $ 12.41 3 %
Non-GAAP net income(a) $ 1,424 $ 1,351 5 %
Non-GAAP net income per share – diluted(a) $ 12.89 $ 11.56 12 %

"We are pleased with our second quarter financial performance, which reflects strong momentum across our business, highlighted by 4% revenue growth and 12% non-GAAP earnings growth," said Christopher Fenimore, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "While we continue to prioritize internal investments, we also returned over $2.3 billion of capital to shareholders through share repurchases and dividends and committed over $7 billion to U.S. manufacturing investments, capital expenditures, and business development since the start of 2025, underscoring our commitment to deploy capital with the goal of driving long-term value creation."

Business Highlights

Key Pipeline Progress
Regeneron has approximately 45 product candidates in clinical development, including a number of marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent (dupilumab)

In June 2025, the FDA approved Dupixent for the treatment of adults with bullous pemphigoid. Regulatory applications are under review in the European Union (EU) and Japan.
In April 2025, the FDA approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment. Regulatory applications were submitted to the FDA and in the EU for CSU in children aged 2 to 11 years.
EYLEA HD (aflibercept) 8 mg

The European Commission (EC) approved EYLEA 8 mg with extended dosing intervals of up to 6 months (24 weeks) for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).
The Company now expects regulatory approvals to be delayed for its currently pending FDA applications for EYLEA HD (pre-filled syringe, every-four-week dosing, and for the treatment of macular edema following retinal vein occlusion), which have PDUFA dates in August 2025. The anticipated delay is related to observations from an FDA general site inspection at the filler for EYLEA HD in these regulatory applications, Catalent Indiana LLC (recently acquired by Novo Nordisk A/S). This inspection was completed in mid-July and was not specific to EYLEA HD. Novo has been in communication with the FDA and expects to submit its response next week. Based on the Company’s review of the observations and Novo’s proposed response to the FDA, along with the progress the Company has made with alternate third-party fillers, the Company anticipates an expeditious resolution of the filling issues for EYLEA HD.
Oncology Programs

In July 2025, the FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Additionally, the EC granted conditional marketing approval of Lynozyfic to treat adults with relapsed or refractory multiple myeloma who have received at least three prior therapies.
In July 2025, Lynozyfic was added to the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of multiple myeloma.
The FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab) in adjuvant CSCC, with a target action date in October 2025.
The Company announced detailed analyses from a Phase 3 trial of Libtayo in adjuvant CSCC. The results, presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in the New England Journal of Medicine, included additional data for the primary endpoint of disease-free survival (DFS) and the first presentation of key secondary endpoint outcomes.
On July 30, 2025, the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy, which was also impacted by the Catalent Indiana LLC site inspection (as described above).
Other Programs

The Company announced interim 26-week results from the ongoing Phase 2 COURAGE trial investigating combinations of semaglutide and trevogrumab (myostatin antibody) with or without garetosmab (Activin A antibody) for the treatment of obesity. The trial demonstrated that approximately 35% of semaglutide-induced weight loss was due to loss of lean mass, and further demonstrated that combining semaglutide with trevogrumab with or without garetosmab preserved lean mass while increasing loss of fat mass. Final 26-week efficacy and safety results were consistent with the interim data and will be presented at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2025.
A Phase 3 study for REGN7508, an antibody to Factor XI (catalytic domain), was initiated to evaluate the prevention of venous thromboembolism after total knee replacement surgery. Initiation of additional Phase 3 studies is planned for later this year and the first half of 2026.
The Company and Sanofi announced that a Phase 3 trial, AERIFY-1, for itepekimab, an antibody to IL-33, in adults who were former smokers with inadequately controlled chronic obstructive pulmonary disease (COPD) met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, a clinically meaningful benefit. A second Phase 3 trial, AERIFY-2, did not meet the same primary endpoint, although a benefit was seen earlier in the trial. The Company and Sanofi continue to evaluate the data to inform next steps for potential future COPD development.
Corporate and Business Development Updates

In July 2025, the Company’s license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside of mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China) became effective. In-licensing a late-stage GLP1/GIP agonist enables the Company to study combinations with its products and product candidates in order to address muscle loss and potentially other comorbidities of obesity, such as cardiovascular diseases, diabetes, and liver conditions.
A jury verdict in the U.S. District Court for the District of Delaware found that Amgen Inc. violated antitrust and tort laws by creating an anticompetitive bundling scheme which was designed to exclude Praluent from the market.
In June 2025, the Company announced the launch of a matching program for donations to Good Days, an independent national non-profit charitable organization, to support their Retinal Vascular and Neovascular Disease Fund. The Company has committed to matching donations up to a total of $200 million at a one-to-one rate through the end of 2025, with the goal of enabling more patients to affordably access essential medicines that help protect their vision.
The Company acquired an FDA Rare Pediatric Disease Priority Review Voucher from a third party for $155 million.
Second Quarter 2025 Financial Results

Revenues

($ in millions) Q2 2025 Q2 2024 % Change
Net product sales:
EYLEA HD – U.S. $ 393 $ 304 29 %
EYLEA – U.S. 754 1,231 (39 %)
Total EYLEA HD and EYLEA – U.S. 1,147 1,535 (25 %)
Libtayo – U.S. 248 182 36 %
Libtayo – ROW* 129 115 12 %
Total Libtayo – Global 377 297 27 %
Praluent – U.S. 66 56 18 %
Evkeeza – U.S. 41 31 32 %
Total net product sales 1,631 1,919 (15 %)

Collaboration revenue:
Sanofi 1,444 1,146 26 %
Bayer 415 375 11 %
Other 2 3 (33 %)
Other revenue 184 104 77 %
Total revenues $ 3,676 $ 3,547 4 %

* Rest of world (ROW)

Net product sales of EYLEA HD increased in the second quarter of 2025, compared to the second quarter of 2024, due to higher sales volumes driven by increased demand.

Net product sales of EYLEA in the second quarter of 2025, compared to the second quarter of 2024, were negatively impacted by (i) lower sales volumes as a result of continued competitive pressures, loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.

Sanofi collaboration revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in the Company’s share of profits from the commercialization of antibodies, which were $1.282 billion and $988 million in the second quarter of 2025 and 2024, respectively. The change in the Company’s share of profits from commercialization of antibodies was driven by higher profits associated with an increase in Dupixent sales.

Refer to Table 4 for a summary of collaboration revenue.

Other revenue increased in the second quarter of 2025, compared to the second quarter of 2024, due to an increase in royalties and share of profits earned in connection with license agreements, which were $118 million and $69 million for the second quarter of 2025 and 2024, respectively.

Operating Expenses

GAAP %
Change
Non-GAAP(a) %
Change
($ in millions) Q2 2025 Q2 2024 Q2 2025 Q2 2024
Research and development (R&D) $ 1,422 $ 1,200 19% $ 1,283 $ 1,072 20%
Acquired in-process research and
development (IPR&D) $ 10 $ 24 (58%) * * n/a
Selling, general, and administrative
(SG&A) $ 634 $ 759 (16%) $ 542 $ 667 (19%)
Cost of goods sold (COGS) $ 276 $ 258 7% $ 222 $ 214 4%
Gross margin on net product sales(c) 83% 87% 86% 89%
Cost of collaboration and contract
manufacturing (COCM)(d) $ 255 $ 222 15% * * n/a
Other operating expense (income), net $ — $ 15 (100%) * $ — —%

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been recorded

GAAP and non-GAAP R&D expenses increased in the second quarter of 2025, compared to the second quarter of 2024, driven by the advancement of the Company’s mid- and late-stage clinical pipeline.
GAAP and non-GAAP SG&A expenses decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to lower charitable contributions to an independent not-for-profit patient assistance organization.
GAAP and non-GAAP gross margin on net product sales decreased in the second quarter of 2025, compared to the second quarter of 2024, partly due to ongoing investments to support the Company’s manufacturing operations and higher inventory write-offs and reserves in the second quarter of 2025 compared to the second quarter of 2024.
Other Financial Information

GAAP other income (expense), net included the recognition of net unrealized gains on equity securities of $250 million in the second quarter of 2025, compared to $393 million in the second quarter of 2024.

In the second quarter of 2025, the Company’s GAAP effective tax rate (ETR) was 8.4%, compared to 12.0% in the second quarter of 2024. The GAAP ETR decreased in the second quarter of 2025, compared to the second quarter of 2024, primarily due to the net change in uncertain tax positions, partly offset by lower tax benefits from less stock option exercises. During the second quarter of 2025, the release of liabilities for uncertain tax positions recognized upon the effective settlement of an IRS audit reduced the Company’s GAAP ETR by 3.9%. In the second quarter of 2025, the non-GAAP ETR was 8.3%, compared to 10.8% in the second quarter of 2024.

A reconciliation of the Company’s GAAP to non-GAAP results is included in Table 3 of this press release.

Capital Allocation

During the second quarter of 2025, the Company repurchased shares of its common stock and recorded the cost of the shares, or $1.070 billion, as Treasury Stock. As of June 30, 2025, $2.814 billion remained available for share repurchases under the Company’s share repurchase programs.

In July 2025, the Company’s board of directors declared a cash dividend of $0.88 per share on the Company’s common stock and Class A stock, payable on September 3, 2025 to shareholders of record as of August 18, 2025.

2025 Financial Guidance(b)

The Company’s full year 2025 financial guidance consists of the following components:

2025 Guidance
Prior Updated
GAAP R&D $5.560–$5.795 billion $5.660–$5.790 billion
Non-GAAP R&D(a) $5.000–$5.200 billion $5.100–$5.200 billion
GAAP SG&A $2.910–$3.095 billion $2.810–$2.940 billion
Non-GAAP SG&A(a) $2.550–$2.700 billion $2.450–$2.550 billion
GAAP gross margin on net product sales 83%–84% Approximately 83%
Non-GAAP gross margin on net product sales(a) 86%–87% Approximately 86%
COCM* $1.000–$1.150 billion $1.000–$1.050 billion
Capital expenditures* $850–$950 million $880–$950 million
GAAP effective tax rate 9%–11% 11%–13%
Non-GAAP effective tax rate(a) 11%–13% Unchanged

* GAAP and non-GAAP amounts are equivalent as no non-GAAP adjustments have been or are expected to be recorded

A reconciliation of full year 2025 GAAP to non-GAAP financial guidance is included below:

Projected Range
($ in millions) Low High
GAAP R&D $ 5,660 $ 5,790
Stock-based compensation expense 560 590
Non-GAAP R&D $ 5,100 $ 5,200

GAAP SG&A $ 2,810 $ 2,940
Stock-based compensation expense 360 390
Non-GAAP SG&A $ 2,450 $ 2,550

GAAP gross margin on net product sales 83% 83%
Intangible asset amortization expense 2% 2%
Stock-based compensation expense 1% 1%
Non-GAAP gross margin on net product sales 86% 86%

GAAP ETR 11% 13%
Income tax effect of GAAP to non-GAAP
reconciling items <1% <1%
Non-GAAP ETR 11% 13%

Conference Call Information

Regeneron will host a conference call and simultaneous webcast to discuss its second quarter 2025 financial and operating results on Friday, August 1, 2025, at 8:30 AM Eastern Time. Participants may access the conference call live via webcast, or register in advance and participate via telephone, on the "Investors and Media" page of Regeneron’s website at www.regeneron.com. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.