Regeneron's Growth Strategy: Eylea and Beyond

Eylea's Market Performance and Future Prospects

Eylea HD has shown strong market performance, generating $304 million in its third full quarter and outperforming recent anti-VEGF launches. Regeneron aims to establish Eylea HD as the new standard-of-care for retinal disease, with expectations of stable category share and continued market growth around 10% year-over-year.

"In summary, we're pleased with our second quarter performance for EYLEA HD and EYLEA and remain on track to achieve our goal of establishing EYLEA HD as the new standard-of-care for retinal disease.Next to DUPIXENT, which delivered 29% growth in the second quarter on a constant currency basis with global net sales of $3.56 billion." --- (REGN, earning call, 2024/Q2)

"So do you believe that EYLEA HD is reaching a stage and maturity of its launch, where it will allow the overall category share to be relatively stable in the coming quarters that will allow you to participate in the retinal disease market growth and is the market still growing around 10% year-over-year?" --- (REGN, earning call, 2024/Q2)

"Our performance demonstrates the ongoing strength and diversity of our product portfolio with continued growth opportunities powered by existing and upcoming product and indication launches across multiple geographies. I'll start with EYLEA HD and EYLEA in the US." --- (REGN, earning call, 2024/Q2)

"Higher Sanofi collaboration revenues reflecting the continued strong performance of DUPIXENT as well as robust growth for LIBTAYO. EYLEA HD generated $304 million in its third full quarter on the US market and continues to outperform recent launches in the anti-VEGF category." --- (REGN, earning call, 2024/Q2)

"So do you believe that EYLEA HD is reaching a stage and maturity of its launch, where it will allow the overall category share to be relatively stable in the coming quarters that will allow you to participate in the retinal disease market growth and is the market still growing around 10% year-over-year? Ryan Crowe: Marion?" --- (REGN, earning call, 2024/Q2)

Pipeline of New Drugs

Regeneron's pipeline includes diverse drugs targeting eye diseases, allergic and inflammatory conditions, cancer, and more. Key developments include EYLEA HD's FDA submission, late-stage trials for Dupixent, itepekimab, fianlimab, and Libtayo, and promising opportunities with Dupixent and linvoseltamab.

"Heading into 2H 2024, we take pride in the expanding impact of our medicines, our thriving pipeline, and exciting technologies that sustain our approach to drug development and manufacturing." --- (REGN, twitter, 2024/08/01)

"Updates from the clinical pipeline include: EYLEA HD (aflibercept) 8 mg In June 2024, a supplemental Biologics License Application (sBLA) with two-year data for wet age-related macular degeneration (wAMD) and diabetic macular edema (DME) was submitted to the U.S. Food and Drug Administration (FDA)." --- (REGN, press release, 2024/08/01)

"Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases and rare diseases." --- (REGN, press release, 2024/04/29)

"As always, we remain focused on driving forward our diverse clinical pipeline, progressing late-stage trials for Dupixent in chronic spontaneous urticaria and other dermatologic indications; itepekimab, our IL-33 antibody in COPD; fianlimab, our LAG-3 antibody in metastatic melanoma; and Libtayo in adjuvant cutaneous squamous cell carcinoma." --- (REGN, press release, 2024/08/01)

"In a moment, George will describe another key opportunity in our pipeline involving Dupixent in combination with our BCMAxCD3 bispecific antibody, linvoseltamab, which we believe has the potential to address any severe allergy and allow the millions of severe allergy sufferers to stop living in fear of an accidental exposure." --- (REGN, earning call, 2024/Q1)

Strategic Partnerships and Collaborations

Regeneron actively pursues strategic partnerships and collaborations to enhance its growth strategy. These include reducing collaboration expenses, exploring acquisitions, and forming alliances like the one with Alnylam Pharmaceuticals for RNAi therapeutics and expanding CRISPR/Cas9-based treatments. Their business development team also seeks complementary technologies to improve therapeutic approaches.

"That makes a ton of sense. Maybe going back to Doopie, Chris, I find one of the areas that people are either confused about or don't have a full appreciation of is the step down in collaboration expenses or the step up in collaboration revenue through the partnership that you'd be expecting once the development balance is paid off." --- (REGN, conference, 2024/05/14)

"1st and foremost, we will always invest in our internal R and D, but we are always open to acquisitions or collaborations that further our long term strategy, particularly those that are complementary to our science and platforms or otherwise synergistic." --- (REGN, event transcript, 2024/06/14)

"Alnylam In 2019, we and Alnylam Pharmaceuticals, Inc. entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver." --- (REGN, sec filing, 2024/Q1)

"The collaboration was expanded in 2020 to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities." --- (REGN, sec filing, 2024/Q1)

"Looking beyond internal projects that we're financing, we also have a business development team that's out there looking at complementary technologies that might enhance the way we look at different therapeutic areas where maybe antibodies might not be the best way to approach those." --- (REGN, conference, 2024/06/11)

Market Expansion and New Therapeutic Areas

Regeneron is accelerating growth and market leadership across numerous therapeutic areas, including lung cancer with LIBTAYO and international expansion. Their pipeline, with over 35 programs, spans distinct therapeutic areas, including innovative efforts like the COSTIM program and partnerships for hearing loss therapeutics.

"I'm energized by our strong momentum as we continue to accelerate growth and market leadership of our commercialized products across numerous therapeutic areas." --- (REGN, event transcript, 2024/06/14)

"In lung cancer, LIBTAYO is recognized by physicians as an important therapy for their lung cancer patients and continues to gradually gain market share. Outside the US, our teams are delivering excellent results with net product sales of $115 million as Regeneron continues its international expansion." --- (REGN, earning call, 2024/Q2)

"The FDA has not informed us of any approvability issues for linvoseltamab related to safety, efficacy or the status of our ongoing confirmatory trial. More broadly on our pipeline, we are excited about several upcoming readouts later this year or in 2025 to further inform programs that could support significant long-term growth opportunities which George will discuss in a moment. In closing, our pipeline continues to generate innovative and differentiated opportunities and now has over 35 programs in clinical development spanning several distinct therapeutic areas." --- (REGN, earning call, 2024/Q2)

"And I think our COSTIM program is an example where we are trying to expand the combinatorial potential that is available for therapeutic regimens to engage the immune response." --- (REGN, conference, 2024/06/05)

"Decibel In 2017, we entered into an agreement with Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is currently in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss)." --- (REGN, sec filing, 2024/Q1)

R&D Investments and Innovation

Regeneron is set to invest $4.4-$4.6 billion in R&D for 2024, focusing on internal innovation rather than external transactions. Their oncology franchise, bolstered by Libtayo and potential approvals for linvoseltamab, exemplifies their commitment to advancing their R&D portfolio.

"earlier this morning. We now expect 2024 R&D expense to be in the range of $4.4 billion to $4.6 billion." --- (REGN, earning call, 2024/Q1)

"We're always looking at opportunities that are out there. We don't feel compelled to do any sort of a transaction just based on, as you heard from Ryan, the breadth and depth of what we have in our own internal R and D portfolio." --- (REGN, conference, 2024/06/11)

"Okay. Chris, I'd be remiss if I didn't ask about capital deployment and R and D investment." --- (REGN, conference, 2024/05/14)

"Our promising oncology franchise is strengthening, driven by strong global growth in Libtayo sales and potential regulatory approvals later this year for linvoseltamab in relapsed/refractory multiple myeloma. Financial Highlights ($ in millions, except per share data) Q1 2024 Q1 2023 % Change Total revenues $3,145 $3,162 (1%) Total revenues excluding Ronapreve(a)(b) $3,145 $2,940 7% GAAP net income $722 $818 (12%) GAAP net income per share -" --- (REGN, press release, 2024/05/02)

Competitive Positioning in the Biopharmaceutical Industry

Regeneron faces manufacturing challenges in the biopharmaceutical space but remains competitive with key products like Dupixent and promising candidates like limvoseltamab. Competitors like Gilead and Bristol-Myers Squibb also navigate competitive markets, highlighting the dynamic landscape Regeneron operates within.

"There's been a lot of third-party filler type and manufacturing issues with lots of CRLs across our, the biopharmaceutical space." --- (REGN, earning call, 2024/Q2)

"Our portfolio today is anchored by Trodelbi, which is the only approved Trob2 direct ADC available in market and our industry leading cell therapies Yescarta and TECARDAS.In second line metastatic non small cell lung cancer, while our EVOCO-one study did not meet its primary endpoint, we did observe improvements in certain subgroups and continue to believe in Firdelby's potential in lung cancer." --- (GILD, event transcript, 2024/05/08)

"As it relates to Zeposia, Zeposia has really been a tale of two launches. We entered the market in multiple sclerosis and we've seen good uptake there over time and we're doing that in a market that continues to contract based on the kind of the increases in the products like Ocrevus and Kesimpta and we continue to grow our share in a competitive market." --- (BMY, earning call, 2024/Q2)

"Help us understand how you're thinking about this in terms of positioning commercially in light of Regeneron, Dupixent among other drugs that are on the market as well as the safety and tolerability profile to date." --- (AMGN, conference, 2024/06/10)

"very, very exciting. We're also very encouraged with limvoseltamab, which not necessarily on the data front, but just the prospect of what that might look like in terms of the competitive profile for lenvaceltenab." --- (REGN, conference, 2024/06/11)

Regulatory Approvals and Challenges

Regeneron faces significant regulatory challenges, including milestone payment obligations, uncertainties in drug development, FDA re-inspections, and additional efficacy analyses requested during priority reviews. These hurdles highlight the complexities and financial commitments involved in achieving regulatory approvals for new products.

"In addition, we are obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product; and, with respect to any approved product, a low single-digit percent royalty on sales. General" --- (REGN, sec filing, 2024/Q1)

"There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate." --- (REGN, sec filing, 2024/Q2)

"Although this third-party fill/finish provider communicated to us and the FDA that they believe these findings have been successfully remediated, the FDA has indicated that a re-inspection will be required before these issues are considered resolved and any new products filled on this line can be approved, including linvoseltamab." --- (REGN, sec filing, 2024/Q2)

"accepted by the FDA for priority review with the June 27 PDUFA date. During its review of our submission, the FDA has requested additional efficacy analyses, including an information request received earlier this week regarding subpopulations from the BOREAS and NOTUS pivotal studies." --- (REGN, earning call, 2024/Q1)

"Recall, we filed for approval at the end of 2023 and were given a priority review said on our most recent earnings call that an information had request an information request came from the FDA asking for all of these various subgroups." --- (REGN, conference, 2024/05/14)

Patient and Market Access Initiatives

Regeneron is focusing on enhancing patient convenience, reducing hospital stays, and ensuring rapid establishment of clinical benefits for new treatments like Dupixent. They aim to activate physician adoption, motivate patients, and improve access and affordability, indicating a comprehensive strategy to expand patient and market access.

"With access and infrastructure progressing and patient volume accelerating, we believe this is also the right time to expand the field force." --- (BIIB, earning call, 2024/Q1)

"If you look at patient convenience in terms of differentiation, we really think there's an opportunity for lower days in the hospital." --- (REGN, conference, 2024/06/11)

"In the US given payers support across all market segments commercial, Medicaid and Medicare, I'm pleased to report that we do not see coverage as a significant obstacle to patient access." --- (VRTX, earning call, 2024/Q2)

"Other countries will come online as we go through the individual country reimbursement processes, but our objective is actually build up the patients." --- (BIIB, earning call, 2024/Q1)

"If approved, we will rapidly -- we'll work to rapidly establish the unique clinical benefits of Dupixent, activate physician adoption, motivate patients to seek treatment and also advance access and affordability." --- (REGN, earning call, 2024/Q1)