Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q1 2023 Earnings Call Transcript
Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) Q1 2023 Earnings Call Transcript May 4, 2023
Regeneron Pharmaceuticals, Inc. beats earnings expectations. Reported EPS is $10.09, expectations were $9.56.
Operator: Welcome to the Regeneron Pharmaceuticals First Quarter 2023 Earnings Conference Call. My name is Josh, 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 Crowe, Vice President, Investor Relations. You may begin.
Ryan Crowe: Thank you, Josh. Good morning, good afternoon and good evening to everyone listening around the world. Thank you for your interest in Regeneron and welcome to our first quarter 2023 earnings conference call. An archive of this webcast will be available on our Investor Relations website shortly after the call ends. Joining me today are Dr. Leonard Schleifer, Co-Founder, President and Chief Executive Officer; Dr. George Yancopoulos, Co-Founder, President and Chief Scientific Officer; Marion McCourt, Executive Vice President and Head of Commercial; and Bob Landry, Executive Vice President and Chief Financial Officer. After our prepared remarks, we will open the call 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 forecast and guidance, revenue diversification, development programs and related anticipated milestones, collaborations, finances, regulatory matters, payer coverage and reimbursement issues, 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 quarterly period ended March 31, 2023, 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 measures will be discussed in today's call. Information regarding our use of non-GAAP financial measures and a reconciliation of those measures to GAAP is available in our financial results press release and our corporate presentation, which can be accessed on our website. Once our call concludes, Bob Landry and the IR team will be available to answer further questions. With that, let me turn the call over to our President and Chief Executive Officer, Dr. Len Schleifer. Len?
Leonard Schleifer: Thank you, Ryan, and thank you to everyone joining today's call. Following our significant achievements in 2022, Regeneron is off to a good start in 2023, highlighted by important regulatory and pipeline advances, commercial execution and prudent capital allocation, all of which position better the company to deliver sustainable long-term growth and shareholder value over time. George, Mary and Bob will cover details of our first quarter performance in a few moments. In the meantime, I would provide an update on our goal of continuing to grow our business while simultaneously diversifying our revenue and earnings streams, which is part of our long-term vision for Regeneron. We have made substantial progress toward achieving that goal.
Over the past four years, while total revenues have nearly doubled, EYLEA accounted for only 57% of total revenues in the first quarter of 2023 compared to 88% of total revenues for the year 2019. Driven primarily by the growth of DUPIXENT, our Sanofi collaboration accounted for 25% of our total revenues in the first quarter of 2023 compared to only 6% of our total revenues in 2019. We expect this trend of revenue growth, along with diversification to continue. For example, assuming the approval and successful launch of aflibercept 8 milligrams, which has a June 27 PDUFA date, EYLEA 2 milligrams is expected to become a smaller share of our revenues, while aflibercept 8 milligrams is expected to contribute to overall revenue growth. In addition, DUPIXENT remains in a high-growth mode, with global net product sales up 40% on a constant currency basis compared to the prior year quarter, driven by growth across all 5 approved indications.
We believe the positive Phase III results for DUPIXENT in the subpopulation of COPD patients with evidence of type 2 inflammation, as well as the promising results for our IL-33 antibody itepekimab in former smokers represent additional significant opportunities to accelerate revenue growth as well as diversification. Our oncology portfolio is also starting to make a meaningful contribution to our top line, with last year's acquisition of full global rights to Libtayo and the recent launch of Libtayo in combination with chemotherapy in advanced non-small cell lung cancer. Moreover, we believe that fianlimab, our LAG-3 antibody, in combination with Libtayo, has the potential to become an important therapy in both melanoma and non-small cell lung cancer, where we have already advanced to pivotal studies.
We are also quite excited about the emerging clinical profile for linvoseltamab, our BCMAxCD3 bispecific. Updated data for which will be presented at the upcoming ASCO Annual Meeting. We remain on track to submit a BLA seeking accelerated approval in late-stage myeloma later this year. We continue to invest in our research and development engine and expect it will deliver new differentiated medicines that will drive organic growth over time. Our broad development pipeline of nearly 3 dozen programs spans many different therapeutic areas and modalities, notably: Our co-stimulatory bispecifics in cancer; our early pipeline in cardiovascular and metabolic diseases; as well as our collaborations with Alnylam, Intellia, Decibel and others are expected to drive medium- and long-term revenue growth, profitability and diversification.
Before handing over to George, I'd like to take a moment to recognize the contributions that Dr. Roy Vagelos has made to Regeneron over the nearly three decades that he has served as our Board Chair. Over the years, he has provided invaluable guidance and he continues to inspire us as we work to turn world-class science into medicines. Roy will retire from the Board after his current term ends next month. At that time, in addition to our current roles in the company, George and I will be appointed by the Board to serve as co-Chairs, and Christine Poon, a member of Regeneron board since 2010, will be appointed as the board's Lead Independent Director. With that, let me turn the call over to George.
George Yancopoulos: Thank you, Len. The first quarter of 2023 delivered multiple significant milestones for Regeneron and for our collaborations, from the positive DUPIXENT Phase III COPD data to progress in our oncology pipeline, as well as exciting new landmarks from our genetic medicines programs. Starting with DUPIXENT. In March, together with our Sanofi collaborators, we announced that DUPIXENT was the first immune mechanism of action treatment to produce statistically significant and clinically meaningful results in a Phase III trial for COPD in over a decade. Our BOREAS trial enrolled COPD patients with moderate to severe disease and evidence of type 2 inflammation. DUPIXENT-treated patients demonstrated a clinically meaningful 30% reduction in exacerbations, a significant improvement in lung function as well as quality of life benefits: an impressive trifecta in a potential paradigm-changing treatment for this deadly disease.
We are looking forward to presenting the detailed BOREAS results in a late-breaking presentation at the upcoming American Thoracic Society Meeting later this month. We also plan to discuss these exciting results with regulatory authorities and expect to report results mid next year for the replicate Phase III NOTUS study. I would remind you that we are also trying to address an overlapping COPD population with our IL-33 antibody, which is in Phase III studies based on positive Phase II proof-of-concept data. This approach is further supported by genetic analysis from our Regeneron Genetics Center, which demonstrated association of loss of function in IL-33 with reduced COPD risk. Similar genetic analysis supported the role for a DUPIXENT benefit in COPD.
The BOREAS COPD data indicates that DUPIXENT can help even more patients beyond the 5 current FDA-approved indications and diseases caused or exacerbated by type 2 inflammation, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis and prurigo nodularis. We are also expecting an FDA decision for DUPIXENT for chronic spontaneous urticaria on October 22, 2023, and we are continuing to tailor DUPIXENT development to patients with other type 2 inflammatory diseases, most likely to be responsive to this method. Moving to oncology. With the progress of our late and early stage pipeline, we are looking forward to several important milestones this year. Starting with Libtayo. In addition to expanded use in lung cancer, Libtayo was recently added to the NCCN guidelines for neoadjuvant treatment of CSCC.
The Libtayo U.S. label was also recently updated with more mature CSCC and BCC data, supporting its differentiated clinical profile in these tumor settings and satisfying all post-marketing commitments that require full approval in these indications. Regarding our exciting new combinations with Libtayo. Starting with fianlimab, our LAG-3 antibodies, for which we are planning a broad pivotal program spanning several cancer indications. These efforts were triggered by our robust and confirmed data in first-line metastatic melanoma patients, which will be presented in further detail at ASCO, suggesting that the fianlimab-Libtayo combination could produce about double the response rates with longer progression-free survival, the anti-PD monotherapy standard.
Based on this, we have already initiated pivotal trials in metastatic and adjuvant melanoma, and we will start a study in perioperative melanoma in the second half of the year. In addition, based on promising data in small patient cohorts, we started a seamless Phase II/III pivotal study for treatment of metastatic non-small cell lung cancer, and we will soon start a Phase II study in the perioperative setting. Next, the bispecifics for solid tumors, which are being investigated in combination with Libtayo. Earlier this year, ASCO's GU represented initial positive first-in-human data for our PSMAxCD28 costimulatory bispecific in combination with Libtayo in advanced prostate cancer, the tumor type considered immunologically cold and largely unresponsive to anti-PD-1 therapy alone.
Over the next 12 months we plan to present updated PSMAxCD28 data in more patients, some of which will have been prophylactically treated with our anti-IL-6 receptor antibody, sarilumab, to potentially reduce the severity of immune-mediated side effects while maintaining or improving antitumor activity. Also during this time frame, we plan to present data in advanced ovarian cancer for both our MUC16xCD3 bispecific in our MUC16xCD3 co-stimulatory bispecific as well as data in several tumor types from our EGFRxCD28 costimulatory bispecific, or in combination with Libtayo. Our hematology oncology pipeline continues to advance. In an oral presentation at the upcoming ASCO Annual Meeting, we will present updated data for linvoseltamab, our BCMAxCD3 bispecific tested in late-line multiple myeloma.
We believe these data will show that linvoseltamab has the best-in-class potential with differentiated efficacy, safety and a favorable dosing schedule in the competitive environment of relapsed/refractory multiple myeloma treatment candidates. We remain on track for a regulatory submission in the United States in the second half of this year for linvoseltamab. For odronextamab, our CD20xCD3 bispecific, we are on track to complete U.S. and EU regulatory submissions for both relapsed or refractory follicular lymphoma and diffuse large B-cell lymphoma in the second half of this year. Odronextamab in late-line relapsed or refractory follicular lymphoma has a potential best-in-class efficacy profile, and our optimized step-up dosing regimen has improved our generic safety profile without impacting efficacy.
Photo by National Cancer Institute on Unsplash
Also, we have initiated a first-in-human study of our CD20xCD28 costimulatory bispecific in combination with odronextamab in relapsed/refractory DLBCL, which we hope could further improve upon the anticancer benefit for these patients. Now to genetics medicines. Starting with our collaboration with Alnylam, and siRNA therapeutics. Just last week, we and Alnylam announced an important update for our Alnylam APP program in early onset Alzheimer's disease. For the first time, an siRNA therapeutic demonstrates sustained silencing of a pathological gene in the central nerve system in a clinical trial. In the earnings call this morning, our Alnylam collaborators provided additional details on these results. Our siRNA approach aims to prevent production of amyloid precursor protein as opposed to clearing existing amyloid plaques after they have already formed, providing a new way to potentially address Alzheimer's disease, which will still have a devastating impact on patients and their families even with the emergence of amyloid-clearing antibodies.
Patients treated with single dose of ALN-APP experienced dose-dependent, rapid and sustained reduction of up to 90% in APP production as assessed by biomarkers in cerebrospinal fluid. The safety and tolerability profile with single dosing is encouraging so far. While the multi-dose Part B portion of the study is on partial clinical hold in the United States due to finding reserved in prior nonclinical chronic toxicology studies, Part B has already received regulatory approval to proceed in Canada, where the majority of the part A clinical trial patients had been enrolled. Detailed results from the study will be presented in an upcoming medical meeting. We are looking forward to advancing additional development candidates for the many other neurodegenerative diseases that currently have few or no therapeutic options such as other targets for Alzheimer's as well as for ALS or Lou Gehrig's disease, Parkinson's and Huntington's.
In addition to these exciting developments in central nervous system diseases, we are continuing our progress with liver targeted medicines, including our broad and multipronged approach to develop treatments for NASH, or nonalcoholic steatohepatitis. We're enrolling a Phase II study of ALN-HSD in NASH patients with genetic risk factors, continuing in development of ALN-PNP, and we are planning to progress additional more recently genetically validated NASH targets as well. Finally, I would like to highlight our recently announced collaboration with Sonoma Biotherapeutics' discover, develop and commercialize regulatory T cell therapies for autoimmune and inflammatory diseases. This collaboration will bring together our industry-leading technologies for the discovery and characterization of fully human antibodies and T cell receptors, as well as our additional biologics candidates with Sonoma's pioneering approach to developing and manufacturing gene modified T reg cell therapies.
In conclusion, Regeneron's R&D engine truly continues its productivity in both late and early-stage pipeline. Before turning the call over to Marion, I would also like to thank Roy Vagelos for serving as a role model for all of us at Regeneron as well as for so many others across the industry. I hope that we can continue to live up to the high stage that Roy has set over his distinguished career. With that, I will turn the call over to Marion.
Marion McCourt: Thank you, George. Our first quarter performance demonstrates ongoing leadership across multiple therapeutic categories. Taken together, our in-market brands anticipated near-term launches and extensive development pipeline uniquely position Regeneron to expand our leadership across multiple disease areas. First quarter EYLEA U.S. net product sales declined 6% year-over-year to $1.43 billion. On a sequential quarter basis, EYLEA U.S. net product sales decreased 4%, reflecting the favorable impact of higher demand volume, offset by lower sequential wholesaler inventory levels, higher sales-related deductions and increasing competitive pressure. EYLEA captured approximately 70% branded share in the first quarter.
Based on presentations at scientific meetings, the retina community has expressed increasing enthusiasm about Regeneron's portfolio with the aflibercept 8-milligram PDUFA date, now 7 weeks away. EYLEA is the well-established gold standard anti-VEGF treatment and aflibercept 8-milligram has the potential to be as paradigm changing as EYLEA when it was introduced more than a decade ago. In clinical trials of aflibercept 8-milligram demonstrated improvements in visual acuity with less frequent injections and a safety profile comparable to EYLEA, exactly what retina specialists have told us they need in a next-generation medicine. Launch preparations are well underway, and we look forward to bringing this important treatment option to patients following FDA approval.
On Libtayo, which is foundational to Regeneron's oncology portfolio, first quarter global net product sales grew 49% on a constant currency basis, reaching $183 million, which includes $6 million from Sanofi transition sales in international markets. In the U.S., net sales grew 39% to $110 million. Libtayo continues to lead the market in both advanced CSCC and advanced BCC as demand volume increases. Following last November's FDA approval of Libtayo in combination with chemotherapy for first-line advanced non-small cell lung cancer, new patient starts have accelerated as physicians of Libtayo has an important new treatment option, initiatives to raise brand awareness and improve access have driven share gains in both the academic and community settings.
Outside the U.S., Libtayo net sales grew 67% on a constant currency basis to $73 million, driven by steadily increasing demand and additional country launches. The European Commission recently approved Libtayo in combination with chemotherapy for PD-L1 positive lung cancer, and we are in the process of securing access and reimbursement for this new indication. Turning to DUPIXENT. First quarter global net sales grew 40% on a constant currency basis to $2.49 billion. In the U.S., net sales grew 43% to $1.9 billion, with notable volume growth across all approved indications. Driven by its outstanding efficacy and safety profile, DUPIXENT is the number one prescribed biologic for new patients in all 5 of its approved indications. In atopic dermatitis, DUPIXENT is the leading systemic treatment based on its unique mechanism of action, clinical profile and real world experience.
Strong prescribing trends continue across moderate and severe disease and across approved age ranges. There's also significant opportunity to further increase market penetration as DUPIXENT is uniquely positioned to provide an effective, safe and convenient treatment for patients 6 months and older. In prurigo nodularis, DUPIXENT is the only FDA-approved systemic treatment. Launch update is progressing well, and we anticipate ongoing growth as we leverage our dermatology commercialization capabilities for patients in need. Across the competitive asthma space, DUPIXENT continues to gain market share as naive and biologic switch patients are initiated on treatment. DUPIXENT also continues to capture the majority of market demand in nasal polyps with increased prescribing from allergists and ENTs. Our cytosolic esophagitis launch is exceeding expectations.
In the first year following U.S. approval, more than 11,000 patients have initiated therapy, demonstrating extensive unmet patient need and our strong launch execution and collaboration with Sanofi. Both gastroenterologist and analogists have embraced DUPIXENTas the new standard of care setting meaningful improvements in disease symptoms and quality of life for those now on therapy. A new patient campaign is underway to raise awareness of the scientific advancements in treatment of eosinophilic esophagitis. Outside the U.S., DUPIXENTnet sales were $587 million, growing 30% on a constant currency basis, driven by growth across approved indications and launches in new geographies. Recent European approvals of eosinophilic esophagitis, prurigo nodularis and atopic dermatitis in young children are expected to contribute to DUPIXENT’s ongoing growth.
In summary, our commercial portfolio continues to diversify across many serious medical conditions and delivered solid results in the quarter. Moving forward, we are well positioned to serve even more patients driven by the strength of our existing portfolio, coupled with anticipated launches that have the potential to advance standards of care. With that, I'll turn the call to Bob.
Bob Landry: Thank you, Marion. My comments today on Regeneron's financial results and outlook will be on a non-GAAP basis unless otherwise noted. Regeneron performed well in the first quarter of 2023 with solid financial results. First quarter total revenues increased 7% year-over-year to $3.2 billion as DUPIXENT and Libtayo contribute to increasingly diversified revenue and earning streams. First quarter diluted net income per share was $10.09 on net income of $1.2 billion, which included a previously announced $0.42 impact of acquired IPR&D. Beginning with collaboration revenue and starting with Bayer. First quarter 2023 ex-U.S. EYLEA net product sales were $847 million, up 4% on a constant currency basis versus first quarter 2022.
Total Bayer collaboration revenue was $357 million, of which $332 million related to our share of EYLEA net profits outside the U.S. Total Sanofi collaboration revenue was $798 million in the first quarter and grew 26% versus last year's first quarter, which included a $50 million sales milestone that did not recur this year. Our share of profits from the commercialization of DUPIXENT and KEVZARA was $637 million, an increase of 53% versus the prior year. We continue to see increasing profitability from our antibody collaboration and expect further margin expansion as we begin to realize drug substance yield improvements from a new Regeneron developed manufacturing process for DUPIXENT. Finally, we recorded Roche collaboration revenue of $222 million in the first quarter for our share of gross profits from ex U.S. sales of Ronapreve related to a previously signed contract.
We do not expect to record any additional revenue from Ronapreve in 2023, absent a new contract. Moving now to operating expenses. First quarter 2023 R&D expense increased 28% year-over-year to $960 million as we continue to invest in our pipeline to drive organic growth. The increase in R&D was primarily driven by higher headcount and related costs and funding of the company's growing pipeline, which now encompasses approximately 35 programs in clinical development in more than 15 ongoing late-stage studies with additional study starts expected this year. These late-stage programs include our expanding fianlimab development program, upcoming Phase III studies and early reliance for our hem/onc assets, as well as ongoing development programs for DUPIXENT and itepekimab for which we now record our full 50% share of development costs as a result of the Libtayo transaction.
SG&A expense increased 32% year-over-year to $515 million due to higher contributions to an independent, not-for-profit patient assistance organization, higher headcount and related costs, and the impact of the Libtayo transaction. First quarter 2023 COCM was $249 million, up 26% versus last year, due to increases in shipments of ex-U.S. commercial supplies of Praluent to Sanofi and manufacturing costs for Dupixent. Reimbursements for these production costs are recorded as part of other revenue in Sanofi collaboration revenue respectively. Shifting now to cash flow and the balance sheet. In the first quarter of 2023, Regeneron generated $1.2 billion in free cash flow. We ended the first quarter with cash and marketable securities, less debt, of $12.3 billion.
We have continued to strategically deploy our cash to deliver on our capital allocation priorities, which are focused on investing in innovation, both internal and external, as well as returning capital to shareholders. We purchased nearly $700 million of our shares in the first quarter with $3.1 billion remaining under our existing authorization as of March 31. Additionally, as George discussed, we announced the collaboration with Sonoma Biotherapeutics, investing $75 million through an upfront payment and equity investment to add a new approach to our scientific capabilities. I'd like to conclude with some select updates to our financial guidance and outlook for 2023. We are updating 2023 COCM guidance to be in the range of $820 million to $880 million, an increase of $90 million at the midpoint, reflecting increased shipments of ex-U.S. commercial supplies for Praluent and DUPIXENT to Sanofi.
Importantly, these anticipated incremental expenses will be reimbursed by Sanofi, generally resulting in a neutral impact to Regeneron's 2023 operating profit. Approximately half of the incremental $90 million of reimbursements from Sanofi are expected to be recorded as Sanofi collaboration revenue, with the balance recorded as other revenue. As a result, we now expect 2023 other revenue to be higher than 2022 other revenue. For modeling purposes, second quarter 2023 other revenue is expected to be the lowest of the 2023 quarters, with the vast majority of the remaining other revenue to be recorded in the second half of this year. We are also updating our 2023 gross margin to be between 89% to 91%. The change in expected gross margin is primarily driven by an unfavorable change in product mix, as well as an increase in the start-up costs associated with our new fill/finish facility located in upstate New York.
Finally, we are lowering our guidance for our effective tax rate to 10% to 12%, reflecting the benefit of higher than previously anticipated stock-based compensation deductions. In conclusion, Regeneron continued to deliver robust financial results in the first quarter of 2023, and the company remains well positioned to drive further growth in the remainder of the year and beyond. With that, I will now pass the call back to Ryan.
Ryan Crowe: Thank you, Bob. Josh, that concludes our prepared remarks. We'd now like to open the call for Q&A. To ensure we are able to address as many questions as possible, we will answer one question from each caller before moving to the next. Please go ahead, Josh.
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