These companies use the creative forces of capitalism to solve big problems—and do well by doing good.

Regeneron studies the root causes of diseases and identifies new therapies for rare and ultrarare conditions at its genetics center. For example, the company has been studying conditions such as fibrodysplasia ossificans progressiva (FOP), a disabling disease that transforms muscles, ligaments, and other tissue into bone, and is conducting late-stage trials of a FOP treatment. Regeneron is also testing a novel approach to treating lipodystrophy, a rare disorder that leads to low levels of body fat and its abnormal distribution, plus reduced leptin levels, disrupting metabolism.

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GPTW New York Large 2022-Regeneron Pharmaceuticals Inc

Employees say: 
 
“When I joined as a temp, I was made to feel a full member of the team, my suggestions and opinions were appreciated. I also love the willingness by the company to adapt and progress and to provide flexible working arrangements post-COVID. The extra freedom provided by flexible working arrangements has changed the way I view working a 9-5 and has made this company really stand out in a great way.” 
 
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Employees say: 
 
“The culture and energy of the people in Regeneron make it a great place to work. I am proud of our science and ethics. Each employee makes a difference in patients' lives and that is what is truly important. It fuels me to be the best.”

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Regeneron’s anti-coronavirus cocktail REGEN-COV was provisionally approved in November 2020 to treat COVID-19 symptoms, and may also reduce its spread. But to develop the important therapy, the biotechnology and pharmaceuticals firm had to keep its own researchers and other staff safe as one of the first U.S. hotspots exploded just miles from its Tarrytown, N.Y., headquarters. The company sent nonessential workers home while implementing safety measures in its research labs. By spring of 2020 Regeneron was providing regular COVID testing for employees, and indefinite paid leave for those infected to recover and quarantine. The firm donated coronavirus-testing components to its home state, with hundreds of staff voluntarily working overtime and weekends to produce them. Regeneron also rolled out a new five-year responsibility strategy organized around stakeholders, including new diversity and inclusion measures after the summer’s wave of protests against anti-Black police brutality. Says one employee: “As an African American male, it’s nice to know that I work for a company that really puts its money where its mouth is regarding making changes in underserved communities.”

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The biotechnology company produces medicines and treatments for allergic and inflammatory diseases, eye diseases, cancers, and more. Regeneron became a household name in 2020 when the U.S. government granted it a $450 million federal contract to develop an antibody drug to treat COVID-19. Former U.S. President Donald Trump reportedly received the treatment while hospitalized with the illness in October 2020.

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The biopharmaceutical company develops and manufactures medicines designed to treat a range of illnesses, including asthma, chronic pain, cancer, and infectious diseases. In the latter category, Regeneron is deeply involved in the pursuit of treatments for COVID-19.

As we face unprecedented collective challenges, cooperation has become a business superpower.

08.CTW20.Regeneron

The world has battled Ebola since 1976, but only late last year did it get therapies that should meaningfully reduce the virus’s death toll. In a randomized clinical trial conducted during an outbreak in Africa, one such drug—Regeneron’s antibody cocktail, EB3—proved so clearly effective in reducing mortality that the trial was ended early. Regeneron is now racing to develop a comparable cocktail for COVID-19.

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F500 2018-Regeneron Pharmaceuticals

Employees say: 
 
&nbsp; 
 
"Regeneron is all about innovation. Whether it is in our scientific endeavors, employee recognition programs, or seasonal celebrations we are always finding new and exciting ways to do things." 
 
&nbsp; 
 
"The thing I love most about working at Regeneron is that when they say data is king, they mean it. Our work and projects are always changing based on what the data shows us. This allows us to work as equals with senior management. When you are presenting or discussing projects, it doesn't matter your role— if you have a good idea, and good data to support it, then you are taken seriously. This removes a lot of the bureaucracy and politicking that happens in other companies." 
 
&nbsp;

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Regeneron Pharmaceuticals is a major pharmaceutical company that develops and sells drugs covering areas of immunology, oncology, ophthalmology, and rare diseases. During the COVID-19 outbreak it developed a widely used monoclonal antibody treatment. Other flagship products include Eylea, an injection to treat age-related macular degeneration and other eye conditions; Dupixent, a therapy for inflammatory diseases like atopic dermatitis, asthma, and chronic rhinosinusitis; and Libtayo, for certain types of cancer. The company was incorporated in 1988.

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Regeneron Pharmaceuticals (REGN): Company Profile, Stock Price, News, Rankings

legacy

Regeneron Pharmaceuticals

regeneron pharmaceuticals

Welcome to the Regeneron Pharmaceuticals Second Quarter twenty twenty five Earnings Conference Call. My name is Shannon, and I will be your operator for today's call. At this time, all participants are in a listen only mode. Later, we will conduct a question and answer session. Please note that this conference call is being recorded.

I will now turn the call over to Ryan Crow, Senior Vice President, Investor Relations. You may begin.

Thank you, Shannon. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our second quarter twenty twenty five earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after our call concludes. Joining me on today's call are Doctor.

Leonard Schleifer, Board Co Chair, Co Founder, President and Chief Executive Officer Doctor. George Yankopoulos, Board Co Chair, Co Founder, President and Chief Scientific Officer Marion McCourt, Executive Vice President of Commercial and Chris Fenimore, Executive Vice President and Chief Financial Officer. After our prepared remarks, the remaining time will be available for Q and A. I would like to remind you that remarks made on today's call may include forward looking statements about Regeneron. Such statements may include, but are not limited to, those related to Regeneron and its products and business, financial forecast and guidance, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement, intellectual property, pending litigation and other proceedings, and competition.

Each forward looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in the statement. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10 Q for the quarter ended 06/30/2025, which was filed with the SEC this morning. Regeneron does not undertake any obligation to update any forward looking statements, whether as a result of new information, future events or otherwise. In addition, please note that GAAP and non GAAP financial measures will be discussed on today's call. Information regarding our use of non GAAP financial measures and a reconciliation of those measures to GAAP is available in our quarterly results press release and our corporate presentation, both of which can be found on the Regeneron Investor Relations website.

Once our call concludes, the IR team will be available to answer any further questions. With that, let me turn the call over to our President and chief executive officer, doctor Leonard Schleifer. Len, please go ahead.

Thanks, Ryan. Thanks for you and everybody else who's joining today's call. For my remarks today, I will review some of our key performance drivers from the second quarter, then briefly discuss some pipeline advances we have made this year and close with some comments on our capital allocation principles. I will then hand the call over to George, who will provide more details on our pipeline progress, while also highlighting some exciting emerging data from leading cohorts for our pivotal programs in myeloma and lymphoma.

From there, Marion will review our commercial performance. And finally, Chris will detail our quarterly financial results and provide an update on our 2025 financial guidance. Return On delivered a strong second quarter, driven by durable growth drivers across our commercial portfolio. Worldwide net product sales for Dupixent increased by 21% and Libtayo by 25% at constant exchange rates, while EYLEA HD in The US grew by 29% compared to the second quarter of last year. With respect to EYLEA, second quarter twenty twenty five U.

S. Net product sales were $754,000,000 down 39% compared to the second quarter of last year. Sequentially, compared to the 2025, physician unit demand declined by 10%, but net product sales were favorably impacted by prior period inventory dynamics. We expect ongoing switches to EYLEA HD, competitive pressures, patient affordability issues, and pricing to continue to negatively impact EYLEA U. S.

Net product sales going forward. EYLEA HD had a very encouraging performance in the second quarter with US net product sales reaching $393,000,000 an all time high, driven by a notable step up in physician unit demand. Future product enhancements, including prefilled syringe administration and every four week dosing interval for approved indications and the addition of macular edema following retinal vein occlusion, or RVO, are expected to help further realize the EYLEA HD commercial opportunity. These EYLEA HD enhancements are now likely to be delayed from their August 2025 PDUFA dates as a result of observations from an FDA general site inspection at the filler for these regulatory applications, Catalent Indiana LLC, which was recently acquired by Novo Nordisk AS. Prior to its acquisition, this site was owned and operated by Catalent Inc, a leading contract manufacturer that in their fiscal year 2024 produced nearly 70,000,000,000 unit doses and did business with the vast majority of the top biopharmaceutical companies in the world.

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 file its comprehensive and robust response next week. Based on our review of the observation and Novo's proposed response, along with the progress we have made with alternate third party fillers, we anticipate an expeditious resolution of our filling issues for EYLEA HD. The BLA for ogeneximab, a bispecific antibody targeting CD20 and CD3 for relapsedrefractory follicular lymphoma, was also impacted by the Catalent, Indiana LLC site inspection and resulted in the FDA issuing a CRL earlier this week. Moving to DUPIXENT, second quarter twenty twenty five global net product sales were $4,300,000,000 up 21% on a constant currency basis versus the 2024.

Now annualizing at over 17,000,000,000, Dupixent global growth continues across all approved indications in all approved age groups and across geographic regions. In The US, DUPIXENT net product sales grew 23% to the second quarter of last year and continues its leadership position in both Nunibrand prescription share and total prescription share across all indications approved prior to this year. Over the past ten months, three new indications, chronic obstructive pulmonary disease or COPD, chronic spontaneous urticaria or CSU, and Bulleys pemphigoid or BP were approved by the FDA, enabling DUPIXENT to potentially treat more than six hundred thousand additional biologic eligible patients. These approvals bring the total addressable population for Dupixent in The US to over four million patients, of which only a small fraction are being actively treated, positioning Dupixent to remain a strong growth driver over the near, medium, and long term. Global Libtayo net product sales grew 25% on a constant currency basis compared to the second quarter of last year and are now annualizing at 1,500,000,000.0 In The US, where net product sales grew 16%, Libtayo continues to be the market leading immunotherapy for advanced non melanoma skin cancers while building share in the lung cancer market.

We are looking forward to the FDA decision and potential launch later this year of Libtayo in high risk adjuvant cutaneous squamous cell carcinoma, where Libtayo has the potential to become the standard of care. If approved, Libtayo will be the first and only PD-one antibody for this setting, and would represent a significant advance for the up to ten thousand addressable patients in The US who could benefit from this treatment. Moving to our pipeline, which now includes approximately 45 product candidates in various stages of clinical development. We continue to make significant investments in R and D that have yielded notable progress across several key programs so far this year, which George will discuss in just a moment. Over the next six months, we anticipate phase three data for our C5 program in generalized myasthenia gravis for fianlimab, our LAG-three antibody in combination with Libtayo in advanced melanoma.

For Garitosumab, our Actin A antibody in fibrodysplasia osfocans progressivare, or FOP, and our programs for birch and cat allergies. We also expect to make a decision on next steps for itapacumab in COPD. Several differentiated early clinical and preclinical programs spanning hematology, genetic medicines, ophthalmology, oncology, and immunology represent an exciting next wave of innovations at Regeneron. Finally, I'd like to provide an update on how we think about allocating shareholder capital. At our core, we firmly believe that internal investment offers the greatest potential return for shareholders.

Therefore, we plan to continue investing heavily in our internal R and D programs, while also making significant capital investments in The United States to support anticipated future growth. We are investing over $7,000,000,000 in The US over the coming years to expand our research and development capabilities and our manufacturing network, including a brand new state of the art fillfinish manufacturing facility in Rensselaer, New York. We also believe that these critical investments should be complemented by direct returns of capital to shareholders through share repurchases and dividends. And we remain committed to funding both for the foreseeable future. Given the strength of our balance sheet, we also have the flexibility to engage in business development and our focus remains on opportunities that can accelerate or strengthen our existing R and D capabilities.

We have historically focused mainly on early stage assets and innovative platform technologies with significant synergies to our internal R and D efforts, while also considering differentiated later stage opportunities in areas with high unmet medical need that complement our R and D focus. In closing, Regeneron's business remains sound with impressive commercial execution driving strong financial results in the second quarter. Our pipeline is poised to deliver scientific breakthroughs that can potentially help treat millions of patients and translate into meaningful commercial opportunities. The commercial team remains focused on maximizing growth drivers from our in line brands, while successfully launching new products and indications. Finally, we continue to prudently deploy capital with the goal of delivering long term value to shareholders.

With that, I'll now turn the call over to George.

Thanks, Len. I'll start with Dupixent, which continues to set a high bar across multiple type two allergic diseases. Dupixent achieved another recent milestone as the first and only FDA approved targeted medicine for bullous pemphigoid, a chronic debilitating and relapsing rare skin disease. DUPIXENT is now approved in The United States to treat eight distinct diseases driven by type two inflammation, including diseases affecting the skin, the gut, and respiratory system that can impact a broad range of patients from infants to elderly individuals. And as Len highlighted, DUPIXENT is the leading biologic treatment in its first six approved indications.

We also remain excited about the potential for DUPIXENT in the elimination and treatment of allergies, as well as a number of other approaches we are pursuing for allergies, such as our cat and birth specific allergy programs with updates on these programs expected later this year. As previously reported, itapicumab, our interleukin thirty three antibody evaluated for COPD in former smokers regardless of eosinophil levels met the primary endpoint in only one of two replicative studies. Together with Sanofi, we continue to evaluate the data to inform next steps for potential future COPD development. Itapicimab development continues in other respiratory diseases, most notably the ongoing phase three studies in chronic rhinosinusitis with nasal polyps, as well as phase two proof of concept studies in less validated clinical settings. Turning to our oncology efforts.

In high risk adjuvant CSCC, gorillip thio became the first immunotherapy to demonstrate a benefit where others had failed. The FDA accepted our supplemental BLA with priority review and assigned a PDUFA date in October. This dataset presented earlier this year at ASCO and published in the New England Journal of Medicine reinforces our belief that Libtayo provides a best in class foundation from combination therapies with our other oncology assets. And in this context, Libtayo is being tested in combination with Phelanoma, our LAG-three antibody, in a pivotal trial in first line advanced melanoma, a setting in which this combination has generated compelling preliminary efficacy data when compared cross trial to PD-one monotherapy. The primary endpoint for this study is progression free survival and KEYTRUDA monotherapy is the control.

Enrollment for the PFS cohort was completed in January as expected. The results are now anticipated in late twenty twenty five or early twenty twenty six, as the blinded PFS event rate accrual has slowed in recent months. Turning to our CD3 bispecifics. Linoxifix, our BCMA by CD3 bispecific, has now been approved in The United States for relapsed refractory multiple myeloma. Linosifix label is differentiated compared to other FDA approved BCMA bispecifics with nearly double the complete response rates.

Linus if it's label also includes a more favorable profile for cytokine release syndrome, shorter required hospitalization period, and a more convenient dosing regimen with longer intervals between doses for those patients that achieve at least very good partial responses after twenty four weeks on therapy. More broadly, we believe linosypic has the potential to become the backbone for therapeutic approaches across the myeloma treatment landscape. That is, from pre malignant settings through advanced disease, using both monotherapy and limited novel combination approaches. I've already summarized how linazific may have best in class activity in the most advanced myeloma patients where it was recently approved. Moving to the pre malignant settings, starting with high risk smoldering myeloma.

The initial cohort of 19 evaluable patients with linazypic monotherapy, we observed a one hundred percent overall response rate with a favorable safety profile. Among the first six patients achieving one year follow-up, five were in complete response and all six were MRD negative. In this regard and recognizing the limitations of cross trial comparisons, DARZALEX was recently approved in The EU as a monotherapy with a complete response rate of only eight point eight percent in a similar setting. Based on this early data in high risk smoldering myeloma patients, which suggests that lenalzipid could prevent progression to malignant disease, we plan to initiate a Phase III head to head study against DARZALEX in the fourth quarter. In another pre malignant plasma cell disorder, light chain amyloidosis, exploratory data with linosypic monotherapy showed that the average light chain levels were normalized by two weeks in the first 11 treated patients, all of whom had failed prior therapies.

For context, while noting the limitations of cross trial comparisons, patients taking a four drug combination standard of care containing DARZALEX as one of the four components, in previously untreated light chain amyloidosis, it took more than five months for patients to approach without achieving normalization. Now moving to the second line multiple myeloma setting. For patients who have failed or progressed after the initial triplet or quadruplet regimen, usually containing DARZALEX and two and three other agents. We presented data at ASCO earlier this year showing that linezipic combined with Carfilzomam showed strong responses in relapsed or refractory myeloma patients, demonstrating a ninety percent response rate and a seventy six percent complete response rate. We think this novel doublet regimen could potentially offer an important new treatment option for second line patients who have failed their CD38 containing frontline regimens and anticipate initiating a registrational randomized phase three trial in the fourth quarter of this year to evaluate the lenoxifencarfilzumab doublet against standard of care in the second line setting.

Importantly, across all of these settings, no new or unexpected safety signals have emerged for Linacifix. Based on these collective data sets, suggesting that Linacifix may have unprecedented ability to address myeloma and premalignant disease, and become a new backbone for myeloma therapies, we anticipate conducting as many as 10 registrational trials for lenoxifix, including a broad registrational program in frontline myeloma for transplant eligible and ineligible patients. Onto adranextamab, our CD20xCD3 bispecific, which once again as with linacifix, we are looking to advance adranextamab into earlier lymphoma settings and enrollment in these trials is proceeding expeditiously. In first line follicular lymphoma, the Phase three Olympia odegeniximab monotherapy study has already completed enrollment. As previously reported in an FDA mandated lead in cohort ogenexumab monotherapy demonstrated an encouraging one hundred percent complete response rate in the first 12 evaluable patients with a favorable safety profile.

For reference, standard of care rituximab plus CHOP and rituximab plus lenalidomide are reported to demonstrate complete responses of approximately sixty five percent on average in these populations. In addition to the potential improved rate of complete responses, we believe a monotherapy chemo free approach could also provide a favorable safety profile in comparison to these other chemo based regimens. In first line diffuse large B cell lymphoma, the phase three OlympiA three study comparing ogenexumab plus CHOP or oCHOP to rituximab plus CHOP, the current standard of care has completed enrollment in the FDA mandated leading cohorts. In the first 13 patients treated at the intended odronextinib dose, oCHOP demonstrated once again a one hundred percent complete response rate with a favorable safety profile. For reference, R CHOP in first line DLBCL has historically demonstrated complete response rate of about seventy five percent in this setting.

Both linosific and oginexumab represent potential significant treatment advances in their respective disease areas, and we look forward to rapidly advancing these programs. We plan to present or publish many of these early datasets over the coming months. Turning now to thrombosis. Our factor 11 program continues to advance rapidly. The first pivotal study in postoperative venous thromboembolism following total knee replacement surgery evaluating our factor 11 catalytic domain antibody versus apixaban and exoparin has begun enrollment.

We anticipate data from the short duration study in 2027, which could support a fast to market regulatory pathway. Additional pivotal studies in thrombosis indications are set to launch by year end with more pivotal study starts expected early next year. Moving now to our obesity efforts. Our recently in licensed GLP-one GIP receptor agonist positions us well to expand into the growing obesity market. Regeneron has multiple opportunities in this large and growing therapeutic area, including GLP-one GIP receptor agonist monotherapy, a longer acting agent in preclinical development, as well as approaches to enhance the quality of GLP-one based weight loss through combination therapies with lean mass bearing agents.

We also see an opportunity to address common obesity comorbidities with novel combinations. Results from our ongoing phase two COURAGE study, which is evaluating the combination of trivagrumab, a myostatin antibody with orthogartelsumab, an active an A antibody and semaglutide confirm the potential to enhance GLP-one mediated weight loss while preserving lean mass. At the interim analysis, our trial confirmed that approximately thirty five percent of semaglutide induced weight loss was due to lean mass loss. An average loss of seven to eight pounds of lean mass per patient. Once again highlighting a well documented concern associated with this therapeutic class.

Combining semaglutide with our muscle preserving antibodies reduced lean mass loss by 50 to 80%, while also increasing fat mass loss at the twenty six week time point. The combination of semaglutide with trivagrumab was generally well tolerated. The triplet combination semaglutide with both antibodies had a higher rate of discontinuations due to tolerability issues and other adverse events. Consistent with the safety profile previously observed with gartosumab monotherapy and other disease settings. Emerging data from across this class further validates our approach in this area.

Final twenty six week efficacy and safety results were consistent with the interim data and will be presented in the late breaking session at the sixty first annual meeting of the European Association for the Study of Diabetes in September 2025. Concluding with our Regeneron genetic medicines pipeline, our C5 siRNA and antibody combination has shown robust efficacy in patients with paroxysmal nocturnal hemoglobinuria or PNH. These data in PNH support our confidence in this regimen's potential to improve outcomes and reduce treatment burden in generalized myasthenia gravis, where pivotal results from an ongoing Phase III study are expected in the third quarter. This study will provide insights into the activity of both the C5 siRNA monotherapy and C5 siRNA antibody combination. Our ongoing Phase three studies in geographic atrophy and PNH, as well as preclinical efforts in this space further underscore our commitment to advancing this program.

In addition, we also continue to advance our genetic medicines programs in NASH, neurodegenerative disorders, and hearing loss, and expect to provide updates over the next few months. In summary, Regeneron continues to lead in scientific innovation, delivering results that redefine possibilities in medicine. Our R and expertise has enabled us to build one of the most dynamic and promising pipelines in the industry and we look forward to several important milestones in the coming months. With that, let me turn it over to Mary.

Thank you, George. Our second quarter performance highlights the strength and resiliency of Regeneron's commercial portfolio, demonstrating our ability to deliver important medicines to patients. We are well positioned to drive growth, fully realizing the potential of our leading brands and capitalizing on emerging opportunities. Recent launches include Linazypic, our first hematology product in The U. S, as well as two DUPIXENT dermatology launches in chronic spontaneous urticaria and bolus pemphigoid, further expanding its therapeutic reach.

Our robust pipeline also provides substantial opportunities to bring transformative treatments to even more patients. Starting with EYLEA HD and EYLEA, in the second quarter, total combined U. S. Net sales were 1,150,000,000.00 maintaining our leading position in the anti VEGF category. Notably, EYLEA HD U.

S. Net sales grew to $393,000,000 driven by strong unit demand, which increased 16% sequentially, making EYLEA HD the fastest growing innovative brand in the category. EYLEA HD has a solid foundation for future growth and now contributes onethree of total combined U. S. Net sales of our retina products.

Looking ahead, we expect stable demand and total potential inflection pending FDA approval of enhancement to EYLEA HD's profile. EYLEA's second quarter U. S. Net sales were $754,000,000 reflecting competitive dynamics from both branded and biosimilar competition as well as the ongoing conversion of patients to EYLEA HD. EYLEA unit demand declined 10% sequentially, and we anticipate comparable demand decline in the second half of the year.

Retina practices continue to report a negative impact on the branded anti VEGF category due to ongoing funding gaps at not for profit patient assistance foundations that provide co pay support for eligible patients with retina diseases. Next to DUPIXENT. In the second quarter, global net sales were $4,300,000,000 and grew 21% on a constant currency basis compared to the prior year. This growth was driven by broad demand across existing and recently launched indications, geographies and age groups. In The U.

S, DUPIXENT net sales were $3,200,000,000 representing 23% year over year growth and continuing DUPIXENT's strong performance and market leading position. DUPIXENT is a leader in new to brand and total prescriptions for seven of its eight FDA approved indications with our recently launched CSU indication being the only exception. In atopic dermatitis, DUPIXENT continues to strengthen its position as a standard of care. Competitor promotional spend has further accelerated overall market growth, and DUPIXENT remains the primary beneficiary of this expansion. Recent launches in chronic spontaneous urticaria and bolus pemphigoid are off to a fast start.

The CSU launch has gained significant traction with both dermatologists and allergists who are actively prescribing DUPIXENT and embracing it as a trusted and effective treatment option. The BP launch in late June has also provided another opportunity for DUPIXENT as the first and only FDA approved treatment for this debilitating disease. Early launch indicators have been positive with DUPIXENT as a critical therapeutic option for this previously underserved patient population. Dupixent's respiratory indications including COPD asthma and nasal polyps continue to drive growth. The COPD launch is progressing very well with rapid physician uptake.

Turning to oncology and hematology. In the second quarter, Libtayo delivered global net sales of $377,000,000 growing 25% on constant currency basis compared to the prior year. In The U. S, Libtayo net sales grew 36% year over year to $248,000,000 driven by growth across the non melanoma skin and lung cancer indications. The quarter was also favorably impacted by the timing of customer shipments by approximately $20,000,000 which we expect to adversely impact third quarter U.

S. Net product sales. We continue to see robust demand and market leadership Libtayo in non melanoma skin cancer. We're encouraged by strong key opinion leader interest in the clinical results for our adjuvant CSCC program. Regulatory applications were recently accepted in both The U.

S. And EU, and preparations are underway for a potential launch in The U. S. Later this year and in Europe in 2026. If approved, Libtayo has the potential to help more than ten thousand patients in The U.

S. And EU in this setting. In lung cancer, Libtayo is steadily increasing new patient share in The U. S. With more physicians prescribing Libtayo as a preferred treatment option for their patients and solidifying its position as the number two most prescribed IO treatment in newly diagnosed patients.

Outside The U. S. Libtayo net sales reached $129,000,000 growing 8% year over year on a constant currency basis supported by ongoing launches and sustained demand in international markets. Nadalimazypic, which was FDA approved in July in relapsedrefractory multiple myeloma, marking a significant milestone for Regeneron. Since then, we've made early launch progress.

Importantly, linezivik was already added to the NCCN treatment guidelines as a preferred product on par with other bispecifics in its class. Key opinion leaders recognize Lumazypic's potential to be best in class BCMA bispecific based on its impressive clinical efficacy, safety, and convenient response adapted dosing. At this stage, we expect modest revenue contributions in the 2025 as physicians must satisfy REMS requirements before administering linezivic, and formulary and pathway decisions need to be made. As George highlighted, Regeneron is advancing linezivic into earlier lines of therapy through our differentiated development program aiming to establish linezivic as a leading agent in the rapidly growing $30,000,000,000 market for multiple myeloma and precursor conditions. In summary, the quarter has been defined by growth across EYLEA HD, Dupixent and Libtayo, as well as important progress in several launches including linezipic.

Our commercial portfolio is well positioned to capitalize on many near term growth opportunities, enabling us to deliver treatments to more patients. And with that, I'll turn the call to Chris.

Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non GAAP basis unless otherwise noted. Regeneron's second quarter results demonstrate the strength of our commercial portfolio, which enables us to continue investing in our robust pipeline and returning capital to shareholders. Second quarter twenty twenty five total revenues of $3,700,000,000 grew 4% compared to the prior year, reflecting higher Sanofi collaboration revenue, primarily driven by Dupixent, higher U. S.

Net sales of EYLEA HD and growth in global net sales of Libtayo. Second quarter diluted net income per share grew 12% from the prior year to $12.89 on net income of 1,400,000,000.0 Beginning with the Sanofi collaboration, revenues were approximately $1,400,000,000 of which $1,300,000,000 related to our share of collaboration profits. Regeneron's share of profits grew 30% versus the prior year, driven by volume growth for DUPIXENT and improving collaboration margins. The Sanofi development balance was approximately $1,200,000,000 at the end of the second quarter, reflecting a reduction of approximately $430,000,000 since the start of the year. We continue to expect the balance to be fully reimbursed by the end of the year.

Moving to Bayer. Second quarter net sales of EYLEA and EYLEA eight mg outside The U. S. Were $978,000,000 up 4% versus the prior year on a constant currency basis and inclusive of $242,000,000 of EYLEA eight mg sales. Total buyer collaboration revenue grew 11% to $415,000,000 of which $383,000,000 related to our share of net profits outside The U.

S. Other revenue in the second quarter was $184,000,000 This included $118,000,000 of profit share and royalties associated with license agreements, which were up 70% from the prior year. This increase was driven by growth in our share of profits from Arcalist and higher royalty income from Alaris. Now to our operating expenses. R and D expense was $1,300,000,000 in the second quarter, reflecting continued investments to support Regeneron's innovative mid to late stage pipeline, including our obesity, hematology and thrombosis efforts.

Second quarter SG and A was $542,000,000 down 19% from the prior year. The decline was driven by lower general and administrative expenses. Second quarter twenty twenty five gross margin on net product sales was 86%. The lower gross margin versus the prior year reflects ongoing investments to support our manufacturing operations and higher inventory write offs in the 2025. Our effective tax rate in the second quarter was 8.3%, inclusive of a favorable settlement of an IRS audit, which lowered our tax rate by approximately four percentage points.

Regeneron generated $1,700,000,000 in free cash flow through the 2025 and ended the quarter with cash and marketable securities of $17,500,000,000 and debt of approximately $2,700,000,000 We repurchased approximately $1,100,000,000 worth of our shares in the second quarter and approximately $2,200,000,000 so far in 2025, resulting in a net reduction in our common shares outstanding of 3,200,000.0 shares from the 2024. With approximately $2,800,000,000 still available for share repurchases as of June 30, we remain opportunistic buyers of our shares. We have made some updates to our 2025 financial guidance. Changes in guidance ranges for SG and A, R and D and COCM expenses result in a combined net decrease of $125,000,000 at the respective midpoints, partially offset by slightly lower gross margin guidance. Importantly, the change to our gross margin guidance is unrelated to recent tariff announcements.

While many details from The US EU trade agreement have yet to emerge, including when a tariff may go into effect, we do not currently expect a 15% tariff on non generic pharmaceutical products to have a material impact on our financial results in 2025. As we gain clarity on important details from the trade agreement and other potential tariffs, we will be in a better position to evaluate the financial impact of tariffs in 2026 and over the longer term. Finally, while we are continuing to evaluate the impact of recently enacted tax legislation, we currently anticipated limited impact to our effective tax rate in the long term and continue to expect this rate to trend towards the mid teens over time. A full summary of our latest guidance can be found in our press release issued earlier this morning. In conclusion, Regeneron's second quarter results demonstrate the strength of our business and enable us to continue to invest in our differentiated pipeline to deliver breakthroughs for patients and long term value for shareholders. With that, I'll pass the call back to Ryan.

Regeneron Pharmaceuticals (REGN) Q2 2025 Earnings Call Transcript

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