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.

Collectively, the ranked companies produced a three-year average shareholder return of 19%, vs. 11% for the S&P 500.

Fastest Growing Companies 2020 90. Regeneron

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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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Q4 2024

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

legacy

Regeneron Pharmaceuticals

regeneron pharmaceuticals

Hello, and welcome to Regeneron Pharmaceuticals 4th Quarter 2024 Earnings Conference Call. My name is Towanda, 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 is being recorded.

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

Thank you, Towanda. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our Q4 2024 earnings conference call. An archive and transcript of this call will be available on the Regeneron Investor Relations website shortly after the call ends. Joining me on today's call are Doctor.

Leonard Schleifer, Board Co Chair, Co Founder, President and Chief Executive Officer Doctor. George Yancopoulos, 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 your questions. 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 forecasting 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 that 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 ks for the year ended December 31, 2024, which we expect to file with the SEC tomorrow, February 5. 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 accessed on the Regeneron Investor Relations website.

Once our call concludes, Chris and 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. Leonard?

Thank you, Ryan, and thank you to everyone for joining today's call. Regeneron CAP 2024 with a strong 4th quarter highlighted by 10% revenue growth, reflecting the strength and durability of our key franchises, primarily Dupixent, Libtayo and EYLEA HD. 2024 was also a year in which we made significant investments across our broad pipeline, which yielded notable progress across several key programs. For my remarks today, I will review some of our key performance drivers, then briefly discuss a few of our more differentiated pipeline opportunities and close with a few comments on capital allocation. After my remarks, George will provide further updates on our pipeline.

Marin will then review our commercial performance. And finally, Chris will detail our financial results for the Q4 of 2024 and our guidance for the current year. To start, I would like to share my perspective on the current state of Regeneron. From the beginning, our focus has been on science and innovation, developing cutting edge technology platforms that repeatedly yield scientific breakthroughs. These efforts have led to 13 products that have been approved or authorized worldwide, several of which are driving revenue growth and hold significant future potential.

Our approach has already delivered 5 blockbuster drugs, a leading pipeline of approximately 40 product candidates across various therapeutic areas and a world class DNA sequence linked healthcare database, providing us with unparalleled insights into key drivers of disease. At the JPMorgan conference last month, we detailed 10 differentiated mid and late pipeline opportunities that could collectively address a total market opportunity of over $220,000,000,000 Given these opportunities, the strength of our early stage pipeline and our turnkey technology platforms, we have never been more confident in Regeneron's future and we are incredibly excited about what lies ahead. Moving to our quarterly results. Dupixent continues to be a transformative medicine with over 1,000,000 patients on treatment around the world across 7 approved indications. In the U.

S, Dupixent remains the leader in new to brand prescription share across all of its approved indications and continues to be well positioned for future growth given the potential for further penetration in approved indications, the ongoing launch in COPD and potential 2025 launches in chronic spontaneous urticaria and bullous pimplargoid. Regarding the ongoing launch in COPD, where Dupixent is the 1st and only biologic approved, we and our partner Sanofi have made great progress securing broad payer coverage and reimbursement, positioning us to drive uptake over the course of this year and beyond. EYLEA HD and EYLEA continue to lead the anti veg of category and our commercial efforts remain focused on driving EYLEA HD uptake, while preserving share for EYLEA in an increasingly competitive category. Over the course of this year, we expect continued competitive pressure on EYLEA while strengthening the profile of EYLEA HD by offering it in a more convenient prefilled syringe administration, broadening its label to include macular edema following retinal vein occlusion or RVO and adding more dosing flexibility, including every 4 week dosing as well as extended dosing intervals of up to every 24 weeks for certain indications. With these anticipated label enhancements, EYLEA HD will offer the broader set of retinal disease indications with the greatest dose and flexibility of any product in the NMEDGEV category, positioning it to become the new standard of care in the category.

And we anticipate these enhancements will lead to acceleration in EYLEA HD uptake starting in the second half of this year. Leptina became Regeneron's latest blockbuster product in 2024 and we are looking to build on that by expanding shared metastatic non melanoma skin cancers along with making further inroads in lung cancer. We also plan to seek regulatory approval for high risk adjuvant cutaneous squamous cell carcinoma in setting in which KEYTRUDA failed and over the longer term could represent a blockbuster opportunity globally in and of itself. Moving to our pipeline and focusing on the upcoming year, we expect regulatory approvals for limbocetimab in relapsedrefractory multiple myeloma, ogenestimab in late lung follicular lymphoma and the aforementioned Libtayo indication in adjuvant CSCC. In addition, we expect to read out pivotal or proof of concept data this year from several other programs, including our pivotal ARIFY studies for idepicamab, our IO-thirty three antibody in former smokers with COPD.

Pivotal data for the fialumab Libtayo combination in first line metastatic melanoma are also anticipated in 2024. We also expect pivotal data for our C5 antibody siRNA combination in generalized myasthenia graviton. Finally, we expect to learn more about our potential opportunity to improve the quality of weight loss in obese patients on semaglutide by blocking myostatin in active NA. George will soon discuss these programs in more detail and provide updates on many of the other programs in our broad and differentiated pipeline. Finally, regarding capital allocation, this morning we were pleased to announce the initiation of a quarterly cash dividend program and an additional $3,000,000,000 share repurchase authorization, increasing our total current buyback capacity to approximately $4,500,000,000 These decisions reflect our Board and management's ongoing commitment to returning capital to shareholders, but this does not change the core of our capital allocation framework.

Importantly, our dividend will not impact the way we plan to heavily invest in our business and pipeline going forward, does not impair our ability to do business development in the future and we anticipate that share repurchases will remain the primary means of returning capital to shareholders. However, initiating the dividend reflects our continued confidence in the future cash flows from our business, provides more balance to our approach to capital returns, gives us flexibility in how we return capital in the future and expands the pool of potential Regeneron shareholders to include funds with a dividend mandate. In closing, Regeneron remains in a very strong position scientifically, commercially and financially, enabling us to invest heavily in R and D and deliver tremendous innovation from our pipeline, maximize the growth opportunities from our in line brands, initiate a quarterly dividend and significantly increase our capacity to repurchase shares. We look forward to keeping you updated in these innovations throughout 2025 beyond. With that, I'll now turn the call over to George.

Thank you, Len. At last month's JPMorgan Healthcare Conference, we showcased our robust R and D efforts and the promising opportunities within our pipeline that have the potential to revolutionize the practice of medicine across several different disease areas. This year holds the potential to be transformative for Regeneron as we hope to capitalize on several of our scientific and technological breakthroughs. We anticipate reporting pivotal or proof of concept data from multiple programs across diverse therapeutic areas, including in oncology, COPD and obesity, while also rapidly advancing our Factor XI antibodies to multiple Phase III trials. These programs represent significant opportunities for Regeneron to address substantial unmet needs across large commercial categories, positioning Regeneron for long term growth.

Let me highlight some of these opportunities and recent pipeline advancements. Starting with EYLEA HD, In December, we and Bayer reported positive data from the Phase 3 QUASAR study in retinal vein occlusion, where EYLEA HD demonstrated non inferior vision gains within every 8 week dosing regimen compared to the standard of care 2 milligram EYLEA dosed every 4 weeks. Additionally, approximately 90% of EYLEA HD patients were able to maintain 8 week dosing intervals throughout the 36 weeks. These data together with our recently presented long term follow-up data from the PULSAR and PHOTON studies in wet AMD and DME respectively continue to support EYLEA HD's best in class clinical profile. We remain on track to submit a supplementary BLA for this indication later in Q1.

We also plan to seek approval from the FDA to potentially include every 4 week dosing, maximizing EYLEA HD's dosing flexibility for physicians. Along with the submission for a prefilled syringe and the potential FDA approval in April to extend dosing intervals to up to 24 weeks, the longest intervals in the category, EYLEA HD is set to provide the greatest dosing flexibility across the broadest indication set of any anti VEGF therapy all in a convenient prefilled syringe. Next immunology and starting with DUPIXENT. In November, DUPIXENT was approved in Europe to treat eosinophilic esophagitis in children as young as 1 year old, making it the 1st and only medicine indicated for these young patients in the U. S.

And the European Union and further highlighting Dupixent's exceptional safety profile. The supplementary BLA resubmission for chronic spontaneous urticaria was recently accepted by the FDA with a target action date of April 18, potentially making it the 1st new target therapy for CSU in a decade. Finally, our supplementary BLA was submitted for bulluspendicoid late last year, marking another first as Dupixent is the only biologic to achieve significant improvements in disease remission and symptoms for this indication. While Mary will discuss the ongoing launch of Dupixent in COPD, I want to remind you of another potentially significant opportunity in COPD with idepikumab, our interleukin-thirty three antibody discovered by Regeneron. We anticipate reporting pivotal results in former smokers from the ARFI program in the second half of this year, a partially overlapping and distinct population from that treated with Dupixent.

As part of our long term commitment to improving the lives of patients with allergic conditions, I would also like to highlight the compelling initial data from our ongoing Dupixent plus limvosertimab trial for severe food allergy. These two agents have the potential to eliminate immunoglobulin E or IgE, the key driver allergic reactions and prevent IgE from returning, thereby reversing severe allergies. Last month, we shared initial clinical data from the first patient in our proof of concept study, which showed greater than 90% reductions in both total and food specific IgE levels following initial treatments at low doses. This trial is continuing to enroll patients and we plan to provide updates throughout 2025. Turning now to oncology, where we continue to break new ground.

Last month, we announced positive data for Libtayo in high risk adjuvant CSCC, becoming the 1st immunotherapy to show a benefit in this high risk population. At the 1st pre specified interim analysis for disease free survival, adjuvant Libtayo demonstrated 68% reduction in the risk of disease recurrence or death compared to placebo with no new safety signals identified. This is the same setting in which Merck reported last year that KEYTRUDA had failed highlighting that antibodies even within the same class do not always produce the same treatment effect. We plan to submit these data to the FDA in the first half of twenty twenty five and present these results at a medical meeting later this year. This data set reinforces our belief that Libtayo provides a best in class foundation for combinations with our other oncology assets.

Data from early clinical trials in melanoma suggests that cienlumab, our LAG-three antibody, when combined with Libtayo, might be first combination to demonstrate meaningful additive benefit compared to PD-one monotherapy without exacerbating safety. This combination is being studied in an ongoing randomized Phase 3 trial versus KEYTRUDA monotherapy in first line metastatic melanoma with results expected in the second half of this year. If these data confirm best in class activity in melanoma, it will increase our confidence for this combination in other cancer settings. Turning to our CD3 bispecifics. We are pleased to announce that we have recently resubmitted the BLA for limvacelitimab, our BCMAxCD3 bispecific for relapsed refractory multiple myeloma following the resolution of third party manufacturing issues.

Limvoseltamab has the potential to be the best in class BCMA by CD3 bispecific due to its differentiated clinical profile dosing and administration with nearly double the reported complete response rates at similar duration of follow-up. Given the strength of the data in late lines of therapy, including the observed level of efficacy and favorable safety profile of viloboseltumab, we are pursuing a differentiated approach in earlier lines of therapy, emphasizing monotherapy and novel limited combination approaches. For otranexamab, our CD20xCD3 bispecific, we are pleased to announce that we have resubmitted the BLA for relapsedrefractory follicular lymphoma, where odraneximab has also demonstrated potentially best in class efficacy and we expect an FDA decision in the second half of twenty twenty five. In December at the American Society of Hematology meeting, we presented initial results from the safety lead in portion of the confirmatory Phase 3 OLYMPIA trial. Ogenximab monotherapy delivered complete responses in all 12 patients evaluable for efficacy with previously untreated follicular lymphoma.

As a reminder, the standard of care regimen in this setting rituximab plus chemotherapy has historically achieved complete responses in approximately 67% of patients. Based on this impressive monotherapy efficacy for otranexamab in both late line and first line patients, we are once again exploring a differentiated program in early lines of therapy, highlighted by our head to head evaluation of ojraneximab monotherapy compared to rituxan plus chemotherapy in our Phase 3 OLYMPIA-one trial, which has already achieved over 40% enrollment. Our CD28 co stimulatory bispecifics for solid tumors are also progressing. We're working to mitigate safety concerns related to their combination with PD-one blockade, while prioritizing combination with CD3 bispecifics. The science suggests that this approach may enhance efficacy with fewer immune mediated adverse events.

We will provide updates on these innovative combinations later this year. Moving now to a rapidly advancing Factor XI program. We're employing a 2 pronged approach to anticoagulation that offers a potential for improved blood clot prevention and lower bleeding risk. Supported by genetic data from the Regeneron Genetics Center, our approach has delivered 2 antibodies with unique profile to meet different market needs. Regeneron 708 which targets the catalytic domain of Factor XI may provide improved efficacy compared to standard of care options, offering patients who need significant anticoagulation activity a potentially more effective option.

On the other hand, REGEN-nine thousand nine hundred and thirty three which targets the A2 domain is expected to carry a lower risk of bleeding, potentially making it a viable option for patients with the highest bleeding risk who would otherwise not be candidates for currently available anticoagulants. Late this year, we reported positive proof of concept data for the prevention of venous thromboembolism following total knee replacement with both antibodies demonstrating robust antithrombotic effects. Regeneron 7,508 was superior to enoxaparin and non inferior opixaban, while REGEN-nine thousand nine hundred and thirty three was numerically better than enoxaparin. These data support the advancement of both antibodies into broad pivotal programs across multiple indications and patient types, with initial Phase 3 studies expected to begin enrolling this year. Moving briefly to obesity, where we are progressing early clinical programs in an expansive pipeline of preclinical assets.

Our muscle sparing Phase 2 COURAGE study is investigating the addition of terivagrumab to semaglutide with and without garatizumab to improve the quality of weight loss and evaluate the maintenance of weight loss after discontinuing semaglutide. This trial is fully enrolled with data expected in the second half of the year. Moving to our Regeneron Genetics Medicine pipeline, starting with our differentiated siRNA plus antibody approach, we have the potential to address multiple complement mediated diseases. In December at the ASH Annual Meeting, we presented compelling updated results from an exploratory cohort in our Phase 3 program for paroxysmal maternal hemoglobinuria. Our combination achieved greater disease control compared to the standard current of care, revolizumab and only our combination lowered mean LDH levels to the normal range.

When revolizumab patients were switched to our combination, their mean LDH levels, which remained higher than normal, also became normalized. We are also evaluating this combination in generalized myasthenia gravis with pivotal results expected in the second half of this year. In addition, we recently initiated our Phase 3 program exploring this combination in geographic atrophy in dry age related macular degeneration, where we believe our systemic approach has several advantages over currently approved intravitreal agents. For DB oto, our otoferlin gene therapy program for genetic hearing loss, We announced data last month from the ongoing clinical program. GB auto is an AAV based dual vector gene therapy delivered to the inner ear to enable hearing in children suffering from profound genetic hearing deficit.

We reported that 10 out of 11 treated children with at least 1 post treatment assessment showed a notable increase in hearing with some reaching the normal range. We look forward to continue to share additional data later this year. Regarding our collaboration with Alnylam, we are advancing several new siRNA CNS programs including synuclein for Parkinson's and tau for Alzheimer's and other neurodegenerative diseases with trials initiating later this year. And finally, I would like to highlight 2 recent advances that extend our leadership position in the field of structured big data that will be necessary to allow computational approaches to revolutionize the healthcare industry. Over the past decade, we have become the leader in high throughput human DNA sequencing, enabling us to create the world's largest DNA sequence linked healthcare database encompassing nearly 3,000,000 individuals, all with DNA sequence linked to de identified healthcare records.

We are now emerging also as the leaders in high throughput proteomics as reflected by the selection of the Regeneron Genetics Centre to generate the proteomics data for the U. K. Biobank Pharma Proteomics project, building on our previous selection to provide the sequence data for the U. K. Biobank.

Importantly, our new strategic collaboration with Truveta is expected to dramatically expand our database to include up to an additional 10,000,000 individuals from Truveta's network of leading U. S. Health system with the opportunity to generate both DNA sequence and proteomics information. While our leadership position in this big data space has already proven invaluable for our drug discovery and development efforts, we believe it can ultimately help us contribute to revolutionizing the field of healthcare analytics and management. In summary, I have never been more excited about the future of Regeneron and our potential to transform the practice of medicine and revolutionize the healthcare industry.

Our pipeline is more innovative and exciting than ever and we anticipate several pivotal or proof of concept data readouts throughout 2025 positioning Regeneron for long term success. Let me now turn the call over to Marian.

Thank you, George. Regeneron's 4th quarter performance demonstrates our ongoing leadership across therapeutic categories. Our commercial team is well positioned to optimize our 2025 growth opportunities, driven by new indications, new product enhancements and new product approvals. Turning to Q4 results, starting with EYLEA HD and EYLEA. In January, we announced combined 4th quarter U.

S. Net sales of $1,500,000,000 for EYLEA HD and EYLEA, capturing over 46% of the total anti vegiv category. For the full year, net product sales grew by 1.4 percent to 4 percent to approximately $6,000,000,000 despite increasing competition in the category. EYLEA HD net sales were $305,000,000 in the 4th quarter and $1,200,000,000 for the full year, representing 20% of the combined net sales for Eylea HD and Eylea. 4th quarter net sales for Eylea HD were affected by elevated wholesaler inventory levels at the end of Q3, which were absorbed over the course of the Q4.

In 2025, our team is laser focused on growing Eylea HD adoption. Physicians tell us that Eylea HD has the potential to be the new standard of care for retinal diseases and several catalysts occurring this year will put us in a position to grow our competitive share. The team is ready to launch the prefilled syringe and our 2 year label updates, both of which are anticipated to occur in the Q2. Physicians eagerly await the prefilled syringe, which has been described as game changing by clinical trial participants. Further, our 2 year long term follow-up data from the PULSAR and PHOTON studies in wet AMD and DME, respectively, clearly illustrate EYLEA HD's ability to extend dosing beyond any other competitor in the anti VEGF category.

2 other potential FDA approvals are also expected later this year, the RVO indication and additional dosing flexibility. In RVO clinical trials, Eylea HD dosing could be extended to every 12 weeks following loading doses, making it the only medicine with durability beyond 4 weeks and also the only medicine to show a numeric improvement in vision for RVO patients compared to EYLEA dosed every 4 weeks. In terms of additional dosing flexibility across all of our approved indications, we look forward to the potential FDA approval of every 4 week dosing for the subset of patients who need it, which would mean EYLEA HD has the most flexible dosing schedule of any anti VEGF medicine. 4th quarter EYLEA net sales were $1,200,000,000 primarily driven by persistent physician demand in spite of a recent offlibercept 2 milligram biosimilar launch. Wholesale inventory levels were elevated at the end of the 4th quarter and we expect EYLEA net sales will be negatively impacted in the Q1 of 2025 as this increase in inventory is absorbed.

We also expect ongoing market dynamics will put downward pressure on EYLEA business. We continue supporting existing and new patients who benefit from EYLEA, while prioritizing uptake of EYLEA HD, which has the clinical profile to potentially become the new standard of care in the anti VEGF category. Turning now to Libtayo, which achieved blockbuster status in 2024 with global net sales of $1,200,000,000 In the Q4, global net sales grew by 50% year over year to $367,000,000 with U. S. Net sales reaching 2.51,000,000 Libtayo's strong performance was based on growth in non melanoma skin cancers and steady gains in lung cancer.

Looking forward, we eagerly await the submission and potential approval of Libtayo in high risk adjuvant CSCC. Beginning in the U. S, where we estimate there are approximately 10,000 patients who may benefit from treatment. And next to Dupixent, which continues to deliver exceptional results in type 2 inflammatory diseases, approved in 7 indications worldwide, more than 1,000,000 patients are currently benefiting from Dupixent treatment. 3 of these indications, atopic dermatitis, asthma and nasal polyps have achieved blockbuster status, each generating over $1,000,000,000 in annual net sales.

In the Q4, DUPIXENT Worldwide net sales grew 15% year over year to $3,700,000,000 with increasing volume across all indications, age groups and geographies. In the U. S, net sales grew 10% year over year to $2,700,000,000 driven by a 24% increase in total prescriptions, including the recent COPD launch. As Sanofi noted, 4th quarter results were negatively impacted by onetime items. We continue to see broad growth across all blockbuster indications of atopic dermatitis, asthma and nasal polyps.

Despite new entrants in atopic dermatitis, Dupixent continues to be first choice for physicians who now understand that IL-four and IL-thirteen are crucial drivers of Type 2 inflammation. Additionally, there is robust uptake in our recent U. S. Launches for acyenophilic esophagitis, paragumodularis with current trends suggesting that these indications will likely also achieve blockbuster status. We are off to a promising start in COPD following approvals in more than 30 countries.

In the U. S, the FDA approved Dupixent in September of last year and we are very encouraged by our progress in early market adoption. Together with our partner Sanofi, we've made significant strides in securing U. S. Access and reimbursement for commercial and Medicare patients.

At the start of this year, nearly 85% of commercial patients and nearly 90% of Medicare patients have coverage. Additionally, we are pleased that global gold treatment guidelines for COPD now include Dupixent as the only recommended biologic medicine for these patients. We look forward to accelerating the launch of this important indication and to make a significant difference in the lives of 100 of 1000 of COPD patients worldwide. Our teams are also preparing for a potential April launch in chronic spontaneous urticaria pending FDA approval. We believe Dupixent offers a compelling treatment option and if approved would be the 1st new targeted therapy in the U.

S. In over a decade for the estimated 300,000 CSU patients. In conclusion, we continue to deliver solid performance across our commercial portfolio in the Q4. We also see significant growth opportunities in 2025 and beyond with near and medium term catalysts to drive growth. 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 ended 2024 with strong financial performance in the 4th quarter, delivering growth on both the top and bottom line. Total revenues grew 10% year over year to $3,800,000,000 primarily reflecting higher Sanofi collaboration revenue driven by Dupixent growth, strong global net sales growth for Libtayo and modest growth for combined net sales of EYLEA HD and EYLEA in the U. S.

4th quarter diluted net income per share was $12.07 on net income of $1,400,000,000 up 2% from the prior year. On a full year basis, total revenues were $14,200,000,000 representing growth of 10% when excluding revenues from RonaPreve. 20.24 earnings per share grew 4% from the prior year to $45.62 Turning to collaboration revenue in the 4th quarter, revenues from the Sanofi collaboration were $1,200,000,000 of which $1,000,000,000 related to our share of collaboration profits. Regeneron share of profits grew 18% versus the prior year, driven by volume growth through Dupixent and higher collaboration margins. For the year, our share of profit, net of development balance reimbursement, increased to the highest level since initiation of the collaboration reaching approximately 20% of total antibody net sales.

The Sanofi development balance was approximately $1,600,000,000 at the end of 2024, reflecting a reduction of approximately $175,000,000 from the end of the 3rd quarter and approximately $700,000,000 from the end of 2023. We continue to expect this balance to be fully reimbursed by the end of 2026, which is expected to result in a significant increase in Sanofi collaboration revenue and cash flow thereafter. Moving to Bayer. 4th quarter ex U. S.

Net sales of EYLEA and EYLEA 8 mg were $888,000,000 up 2 percent on a constant currency basis versus the prior year. Total buyer collaboration revenue was $377,000,000 of which $349,000,000 related to our share of net profits outside the U. S. Now to our operating expenses. R and D expense was $1,200,000,000 in the 4th quarter.

The increase in R and D expense versus the prior year was driven by cost to support advancement of Regeneron's broad clinical pipeline, including our C5 and Factor 11 programs in hematology, certain oncology programs, inapacumab in COPD and our ongoing program in obesity. 4th quarter SG and A was 681,000,000 with growth from the prior year primarily reflecting investments to support the launch of EYLEA HD and our international expansion. 4th quarter 2024 gross margin and net product sales was 86%, up slightly from the prior year quarter. Now to cash flow and the balance sheet. Regeneron generated approximately $3,700,000,000 in free cash flow in 2024 and ended the year with cash and marketable securities less debt of approximately $15,200,000,000 In 2024, we deployed $2,600,000,000 towards share repurchases, including a meaningful step up in the 4th quarter, during which we repurchased nearly $1,000,000,000 of our shares.

Consistent with our capital allocation framework, we are investing heavily in our R and D capabilities to drive long term growth, exploring business development opportunities and returning capital to shareholders. This morning, we announced an additional share repurchase authorization of 3,000,000,000 dollars increasing our capacity for repurchases to approximately $4,500,000,000 as of today. In addition, we are enhancing our approach to returning capital to shareholders. As announced this morning, our Board of Directors has authorized the initiation of a quarterly dividend with the first dividend payable on March 20 to shareholders of record as of February 20. The dividend will be $0.88 per share, equivalent to $3.52 per share on an annual basis.

We are confident in the long term growth of our business, our innovative R and D engine, our differentiated pipeline and the durability of our cash flows, all of which support the initiation of our 1st quarterly dividend and the announcement of an additional share repurchase authorization. I'll conclude with a review of our 2025 financial guidance. We expect 2025 R and D spend to be in the range of $5,000,000,000 to $5,200,000,000 The increase versus 2024 is driven by cost to support our expanding late stage pipeline, including Phase III programs for our Factor XI antibodies and HemOnc bispecifics, as well as programs in obesity and genetic medicines and the advancement of multiple new assets into the clinic. We expect 2025 SG and A to be in the range $2,550,000,000 to $2,700,000,000 representing 3% growth at the midpoint of this range versus 2024, driven by investments to support multiple potential oncology launches. We expect our gross margin on net product sales to be in the range of 87% to 88 percent.

This guidance reflects a changing product mix as well as ongoing start up costs for our new fill finish facility and investments to drive future efficiencies across our manufacturing network. We expect cost of collaboration manufacturing to be in the range of $1,000,000,000 to $1,150,000,000 in 2025, primarily driven by higher Dupixent volumes. Recall that we are reimbursed for these costs as revenue, making them generally neutral to net income. We expect 2025 capital expenditures to be in the range of $850,000,000 to $975,000,000 primarily related to ongoing expansion of the R and D facilities at our Tarrytown headquarters and investments to increase bulk manufacturing capacity in the U. S.

And Ireland to support our expanding pipeline. Finally, we expect our 2025 effective tax rate to be in the range of 11% to 13%. In summary, Regeneron delivered solid financial results in 2024 and our strong financial position and prudent capital allocation enables Regeneron to deliver long term shareholder value. With that, I'll pass the call back to Ryan.

Thanks, Chris. This concludes our prepared remarks. We'll now open the call for Q and A. To ensure we are able to address as many questions as possible, we will answer only one question from each caller before moving to the next. Towanda, can we go to the first question, please?

Thank you. Please stand by for our first question. Our first question comes from the line of Brian Abrahams. Your line is open.

Hey guys, good morning. Thanks for taking my question. Consensus numbers suggest expectations for annual sales erosion of about 7% annually over the next few years for the EYLEA franchise. Just given what you've been seeing on the ground and some of the dynamics you described, including competitive pressure, but a potential acceleration in HD with some of those approvals, do you think that these expectations look reasonable? And I know you guys don't typically provide guidance, but I just I think any directionality might be helpful here just to understand whether folks are looking at dynamics here the right way or if expectations may be way off?

Regeneron Pharmaceuticals (REGN) Q4 2024 Earnings Call Transcript

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