Regeneron Pharmaceuticals Inc Q2 2026 Earnings Call

Welcome to the Regeneron Pharmaceuticals second quarter 2026 Earnings Conference call. My name is Michelle and I'll 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 Crowe, Senior Vice President, Investor Relations. You may begin.

Thank you Michelle. 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 2020 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, Co-Founder, board co-chair, president and Chief Executive Officer. Doctor George Yancopoulos, co-founder, board co-chair, president and chief scientific officer Marion McCourt, executive vice president, commercial, and Chris Fenimore, executive vice president, finance and chief financial officer. For our call to. Today, Glenn will briefly review key second quarter performance drivers highlight important upcoming pipeline catalysts and provide a few comments on capital allocation. George will then detail our recent pipeline progress, followed by Marion, who will review our commercial portfolio. And finally, Chris will discuss our financial results and outlook. After our prepared remarks, the remaining time will be available for Q&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 forecasting guidance. Development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement changes to drug pricing regulations and requirements, and our drug pricing strategy, 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-q for the quarter ended June 30th, 2026, 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 Investors 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. Leonard. Thanks.

Ian, and thanks to everyone for joining today's call. Before we begin, I would like to acknowledge with deep sadness the passing earlier this week of financial industry luminary and longtime Regeneron director Arthur. Art. Ryan Art served on our board for more than two decades and was a trusted advisor whose judgment, integrity and business insight helped guide the company through many important milestones. Prior to joining Regeneron's board, he built a distinguished career in financial services, including serving as chairman and CEO of Prudential Financial and previously as president and CEO of Chase Manhattan Bank. In addition, Art left an enduring legacy of civic engagement and philanthropy throughout Newark and Essex County, new Jersey. On behalf of everyone at Regeneron. I want to express our gratitude for art's many contributions and years of service. We joined his family and all who knew him in celebrating his life and legacy. We will miss his wisdom and unparalleled support of Regeneron's mission. Turning now to our business. We delivered another strong quarter with total revenues up 17% and non-GAAP earnings per share up 11% compared to the second quarter of 2025. Making our second consecutive quarter of double digit growth on both the top and bottom lines Dupixent, Eylea HD and Libtayo all set.

New all time highs for quarterly net sales and are carrying strong momentum into the second half of the year. Dupixent global net product sales, as reported by Sanofi, were $6 billion, up 38% compared to the second quarter of last year. On a constant currency basis Demand trends across all approved indications remained robust and accounted for the majority of the year over year growth. We and Sanofi continue to see a long runway for Dupixent growth, driven by further penetration of existing indications, expansion into additional age groups and international growth opportunities beyond Dupixent, we are rapidly advancing a broad portfolio of next generation programs that we believe can build on the foundation we've established with Dupixent to. Excuse me, George will discuss some of our recent progress in this area, including encouraging early clinical data from our long acting interleukin 13 antibody. Our collaboration with Sanofi spans nearly two decades and has been one of the most successful in the biopharmaceutical industry. Together, we have built a highly productive development and commercialization engine and the continued success of Dupixent in nine FDA approved indications across specialties ranging from dermatology. Pulmonology. Gastroenterology. ENT, and allergy highlights the value that this model can create.

Given that success. I can report that we have had productive early discussions with Sanofi to identify potential opportunities for further collaboration, including for several of Regeneron's, Dupixent follow on programs. Ali HD in the US continued to gain momentum with net product sales in the second quarter of nearly 600 million, up 52% compared to the prior year. Importantly, this quarter marked the first time. Eylea HD net sales exceeded Eylea, highlighting the continued strength of the conversion to a next generation product. Physician unit demand for Eylea HD in the second quarter increased 24% sequentially, reflecting continued strong uptake following recent FDA label expansions and growing prescriber appreciation for Eylea HD differentiated profile and dosing flexibility. We continue to work towards obtaining approval for yet another product enhancement for HD, the HD Pre-filled Syringe We expect launch of this enhancement to drive even further adoption of Eylea HD, and we are continuing to work closely with the FDA and multiple contract manufacturers with a goal of approval before the end of the year. All in all, Eylea HD has performed extremely well, and we look forward to continuing to grow this product. The only thing that's strong growth trajectory in the second quarter, global net product sales reached nearly 500 million, up 29% compared to last year.

On a constant currency basis, growth was driven by continued strong adoption in its approved nonmelanoma Skin Cancer indications and further penetration in non-small cell lung cancer. With the now captures 20% of new to brand prescriptions in the U.S. beyond its growing patient impact and commercial contribution, the tie remains the strategic backbone of our ongoing efforts to expand and strengthen our oncology portfolio. Turning to the rest of the pipeline, I firmly believe that one generates core. Strengths is that we do not rely on any single program or platform. Our pipeline is broad, diversified, and highly productive, and while that. Not every program will succeed, we are confident that it will create many substantial value for patients and shareholders with approximately 50 active clinical programs and many rapidly advancing preclinical candidates, we have one of the largest R&D portfolios in the entire industry. George will. Have more details on our pipeline progress in his remarks, but I want to highlight a few important programs where we expect near-term regulatory and clinical milestones. We anticipate multiple milestones for our C5 complement programs, including an FDA decision in November for a new drug application for Andres Sirulnik and siRNA that targets C5 in generalized myasthenia gravis, which we believe has the potential to offer a differentiated profile for patients living with this serious autoimmune disease.

We also continue to make meaningful progress across several longer term value drivers, including factor 11 for coagulation disorders, lymphocytoma for multiple myeloma, and premalignant conditions, and our obesity portfolio, where we expect multiple phase three study initiations later this year. Now to a few comments on capital allocation. Where our framework remains consistent First and foremost, we believe the highest return opportunities to continue from investing in our own science. At the same time, we remain active in evaluating external opportunities. We are casting a wide net across the universe of business development options with particular interest in areas where we can leverage Regeneron's differentiated expertise in genetics, antibody engineering, clinical development, manufacturing, and product commercialization. While we remain disciplined on valuation and strategic fit, we believe our financial strength, scientific capabilities, operational infrastructure and long term perspective. Position us well to capitalize on compelling opportunities as they emerge in. Our ability to repeatedly discover, develop and deliver important medicines has been a defining strength of Regeneron for decades. This quarter's performance, together with the important milestones ahead, reinforces our confidence in the company's long term outlook. We have a thriving commercial business, a deep and diverse pipeline, and a talented team committed to improving patients lives through science Together, these strengths position us well to continue delivering meaningful innovation for patients and sustainable value for our shareholders.

With that, let me turn the call over to George.

Thanks, Lynn. Today, I'll focus on the key updates from our development pipeline for comprehensive summary of our mid and late stage pipeline, please refer to the programs and clinical development section of our 10-q I'll start with our complement mediated disease franchise. Beginning with some district. Our. C5 siRNA regulatory submissions for some destroying monotherapy in generalized myasthenia gravis, or GMG, have been accepted for review by both the FDA and the EMA. The FDA Target action date is in November of this year. While a European Commission decision is anticipated in the second half of 2027. If approved, some decision would represent a highly differentiated treatment option in GMG and be the first Shrna approved for this disease. We believe some efficacy, safety and convenient four times per year subcutaneous dosing profile highly differentiated from C5 antibodies and other modalities approved for GMG. For some district in combination with Pozelimab, our C5 antibody, we continue to expect Registrational data in paroxysmal nocturnal hemoglobinuria or PNH in the fourth quarter of this year. Our phase three lead in cohort that compared this combination with Ravulizumab, an FDA. Approved antibody to C5 for the treatment of PNH suggested that our combination could provide a more convenient monthly subcutaneous regimen that could also improve disease control based on LDL measures and support our hypothesis that complete complement blockade.

In this disease is required for sustained disease control As a reminder, the Registrational study is evaluating Noninferiority of C5 combination versus eculizumab. The other C5 antibody that is FDA approved for the treatment of PNH using co-primary endpoints of intravascular hemolysis control, as well as transfusion avoidance in ophthalmology. Our C5 approach in geographic atrophy or GA, remains on track to read out 26 week data. From our exploratory cohort in the fourth quarter of 2026, which will help inform our pivotal strategy. As a reminder, we are evaluating systemic administration of Andres Sirulnik with or without Pozelimab with the goal of slowing the rate of GA lesion growth and associated declines in visual acuity while avoiding the ocular safety issues that have been observed with certain FDA approved therapies. We are also evaluating Intravitreal Pozelimab in GA to. Provide optionality and are actively developing Co-formulations of this with other agents such as Aflibercept to address comorbid retinal disease settings. In immunology and inflammation. To follow on on Dupixent success, we continue to advance a series of next generation, fully human antibodies and bispecifics designed to build. On Dupixent by extending duration enhancing target coverage and potentially improving efficacy.

We have enrolled initial healthy subjects in our first in human trial for a long acting IL 13 antibody, and expect to begin dosing patients with atopic dermatitis later this quarter. With plans to execute an expedited path to starting registration, enabling studies potentially by the end. Of next year or early 2028. Our initial clinical data indicate that this antibody has a prolonged half life that has the potential to extend the dosing interval well beyond those achieved with currently approved products in this category. First, in human studies of our other next generation long acting antibodies are planned with next generation Dupixent or soupy Doopy, expected to be clinic ready by early 2027, and additional candidates, including our panel for IL 13 bispecific next year. Briefly. Onto oncology. Madam AB. Our muck 16 by CD3 bispecific continues to demonstrate promising monotherapy activity in low grade serous ovarian cancer, a subset of advanced ovarian cancers, and we plan to present detailed data in this setting at a medical meeting this fall. We also continue to advance pivotal studies for our Bcma. By CD3 bispecific in multiple myeloma and premalignant conditions, including a newly initiated pivotal study in high risk smoldering multiple myeloma.

We expect results next year from the linker MM3 study. Our confirmatory trial of monotherapy. Versus standard of care in patients who have received at least one, but no more than four lines of therapy in. 2028, we expect minimal residual disease, or MRD negativity results from our first in line from our first line study in transplant ineligible myeloma patients, as well as our. Carfilzomib combination study in myeloma patients who have received one or more prior lines of therapy. At the American Society of Clinical Oncology, or the Asco meeting, we presented first results from the phase one two linker al two trial of. Therapy in patients with second line plus systemic light chain or Al amyloidosis. Normalization of free light chain occurred by day 15 across all doses and 100% of patients achieved. A hematologic complete response at the highest dose tested. The majority of patients with renal or cardiac involvement demonstrate improvement in organ function despite short follow up. The phase two portion of the study, which has registrational intent, is now ongoing. A phase three study in first line light chain amyloidosis is planned to start early next year. Moving to anticoagulation. We are on track to initiate the remaining phase three studies from our comprehensive factor 11 program this year.

Featuring our catalytic antibody, formerly known as region seven, 508 and and reservoir are two antibody formerly known as region 9933. Funeral results from our studies in venous thromboembolism, or VTE prevention, following total knee replacement surgery, are expected in the first half of 2027. Also, in 2027. We anticipate results from the phase two Roxy Atlas study, which evaluates both factor 11 antibodies against apixaban in stroke prevention in patients with atrial fibrillation or Spaf, which is expected to provide us with important insights into bleeding risks after three months of observation. We have also begun enrolling patients in our phase three Spaf trial. Roxy Incline, that will evaluate both of our antibodies against placebo in patients who are not candidates for conventional anticoagulant therapy. Remain excited about our program and favor. Antibodies as opposed to a small molecule approach. As we believe antibodies enable greater and more specific inhibition of factor 11, leading to improved antithrombotic activity without increased bleeding risk or other off target safety issues. Turning to. The obesity. R dual GLP, GIP receptor agonist in-licensed from Hansoh continues to advance data from phase three study of peptide in Chinese patients with obesity, which. Top line in March will be presented as a late breaker at the European Society for the Study of Diabetes Conference, or Easd, in October.

Acknowledging the inherent limitations of Cross-trial comparisons. Although appetite generated weight loss that was comparable to the weight loss observed in a similar study of tirzepatide in China, while demonstrating a favorable gastrointestinal tolerability profile, including meaningful, meaningfully lower rates of diarrhea, nausea, and vomiting remain on track to commence phase three studies later this year. In addition, in. In patients with obesity as well as patients with obesity and type two diabetes, in addition to the peptide monotherapy. We also continue to advance our combination of Ola and Praluent. Our Pcsk9 antibody to address patients with obesity or type two diabetes that have comorbid hypercholesterolemia. Also, at, we will present 52 week results from the current study, including accompanying MRI findings in a subset of patients adding a group AB to semaglutide did not drive. Additional weight loss, but did show encouraging skeletal muscle mass preservation versus semaglutide alone. These findings reinforce our belief that presenting preventing muscle mass loss may become increasingly important as obesity treatment involves, particularly in older patients with sarcopenic obesity in rare disease, we expect an FDA decision in August for pertuzumab, our active in blocking antibody in fibrodysplasia Ossificans, Progressiva, or FOP. If approved Daratumumab would be the first treatment shown to reduce the number of new abnormal bone formation lesions, as well as clinician assessed flare ups in FOP patients from our earlier stage pipeline, we are planning to present a medical meetings this fall.

Some promising clinical data from our pipeline of siRNAs for metabolic dysfunction associated steatohepatitis, or Nash, and for our Npr1 antagonist antibody balancer bark for the treatment. Of postural orthostatic tachycardia syndrome or Pots. Finally, we continue to work with the US government and international health organizations to deliver potential new treatments for the devastating recent Ebola virus epidemic that is driving the current outbreak in the Democratic Republic of the Congo. Regeneron developed antibodies are now being tested in non-human primates with early data showing they can prevent mortality when administered even after clinical symptoms have already appeared. We are talking with the International Health organizations to see whether we will be able to once again. Help with the current Ebola outbreak, as we have in previous outbreaks. In summary, we remain focused on rapidly advancing our broad, diverse pipeline, which we firmly believe has the potential to change the practice of medicine across many diseases with high unmet need. And with that, I'll turn it over to Marion.

Thanks, George. Our second quarter results reflect strong commercial execution across our portfolio, delivering meaningful growth from our market leading brands in multiple therapeutic categories. Starting with our retinal franchise in the second quarter, I lead and Eylea delivered just over 1 billion in combined U.S. net sales, up 7% quarter over quarter. We also achieved an important milestone in the second quarter, with more than 100 million doses of lead in Eylea administered to patients. Since Ilia's launch in 2011. Second quarter. Net sales in the U.S. were 596 million, representing a 52% year over year increase and 27% growth quarter over quarter. These results reflect strong physician demand, which grew 24% from the prior quarter. Eylea HD has the broadest label in greatest dosing flexibility of any anti-VEGF medicine. Following last year's label enhancements to include retinal vein occlusion and additional dosing options that range from every four weeks through to every 20 weeks. I lead now comprises approximately 60% of U.S. franchise net sales, compared to 34% in the second quarter of last year. Within the innovative branded category, I, HD and Eylea captured 57% share in the second quarter, and I. HD was the only innovative brand that achieved quarter over quarter share growth.

Physicians increasingly recognized that HD for its efficacy, safety, and durability profile. Initial uptake of HD in Rvo has been strong, driven by its differentiated label and clinical data. Eylea HD is the only product that offers every eight week dosing. In this indication, and was the only product to demonstrate numerical improvement in visual acuity in clinical studies compared to Eylea, the prior gold standard in Rvo Eylea U.S. net sales in the second quarter were 412 million, representing a 45% year over year decline and a 13% decline quarter over quarter, primarily driven by ongoing conversion to Eylea, HD and competitive dynamics. Looking to the second half of 2026 for Eylea, we expect sequential quarterly demand declines in the low to mid teens due to the factors mentioned, as well as additional competition primarily from multiple Aflibercept two milligram biosimilar launches. With an Eylea HD label that now includes wet AMD, DME and Rvo, as well as the broadest dosing interval in the category. Retina specialists increasingly recognized a Li HD as the next standard of care in the anti-VEGF category. We expect this will drive sequential demand for Eylea HD in the low to mid teens, and the third and fourth quarters of 2026.

Turning to Dupixent, which continues to deliver significant patient benefit to patients globally with more than 1.5 million patients actively treated worldwide Dupixent has had a tremendous impact across its nine approved indications, and it's the number one biologic medicine prescribed by a dermatologist, pulmonologist, allergist and ents. Second quarter. Net sales were $6 billion, reflecting 38% growth on a constant currency basis in the U.S., sales grew 42% year over year to 4.6 billion, primarily driven by continued growth across our blockbuster indications and uptake in recent launches. In addition, as reported by Sanofi this morning, a favorable gross to net adjustment also boosted US net sales in the quarter. Dupixent continues to drive strong growth across blockbuster indications, including atopic dermatitis, asthma, nasal polyps, and acidophilic esophagitis. Supported by its clinical efficacy and safety profile. Uptake is also growing in our new indications of COPD. Chronic spontaneous urticaria. Bullous pemphigoid and allergic fungal sinusitis with significant opportunity to improve the lives of even more patients, Dupixent is well positioned for sustained growth over the near and long term across approved indications. In the second half of the year, we expect year over year global net sales growth to remain strong. But to moderate relative to the first half of 2026.

As we annualize recent indication launches and face stronger prior year comparisons Turning to Libtayo, which delivered worldwide net sales of $489 million, up 29% year over year on a constant currency basis in the U.S., sales grew 38% year over year to 343 million, with growth across both non-melanoma skin cancers and non-small cell lung cancer. The recent launch in adjuvant cutaneous squamous cell carcinoma has generated positive feedback on this paradigm changing treatment and has been accompanied by increasing use across all approved cscc settings in first line non-small cell lung cancer, Libtayo is now firmly established as the second most prescribed immunotherapy treatment in the U.S., where Lithia's share of new patient starts has doubled since early 2025 to 20%. As physicians increasingly recognize its strong clinical profile. We expect continued growth for Libtayo in the second half of 2026 as we strive to gain incremental share in lung cancer and drive uptake across all approved stages of cscc Until ozempic, which is now in its third full quarter on the market, physician feedback in this late line treatment setting is positive. Based on differentiated efficacy and safety profile. Lower hospitalization requirements and convenient dosing. Despite its strong profile, we expect growth to remain modest in this small late line setting as we work to advance into earlier lines of therapy.

Turning to rare disease where Regeneron is expanding our portfolio of life changing medicines for patients with significant unmet medical need, our homozygous familial hypercholesterolemia marked medicine of César delivered net sales of $53 million in the second quarter, representing 29% year over year growth. I'm also delighted to inform you that first patients have been dosed with harmony. The first. And only gene therapy for children born with genetic hearing loss. And our early launch efforts continue. We are looking forward to adding Daratumumab to our rare disease portfolio, with a potential FDA approval in August for FOP FOP is a serious, life threatening disease where would be the first treatment shown to reduce the number of new abnormal bone formation lesions, as well as clinician assessed flare ups in FOP patients? We are also excited about the potential FDA approval of some in generalized myasthenia gravis later this year. We see significant opportunity in a large and growing. Category based on some distinct clinical profile demonstrated in this pivotal study, including rapid, deep and sustained clinical benefit. Favorable safety profile, and convenient quarterly subcutaneous dosing. In closing, our second quarter results reflect focused commercial execution across therapeutic areas. We continue to drive growth for our in-line brands and are preparing for upcoming launches.

We remain well