Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q3 2024 Earnings Presentation
33 slides from Regeneron Pharmaceuticals's earnings presentation, Oct 31, 2024
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation O C T O B E R 2 0 2 4 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially.
Slide 2: Note regarding forward-looking statements and non-GAAP financial measures
Note regarding forward-looking statements and non-GAAP financial measures This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual even
Slide 3: Executing on our core competencies; Investing in the future; Looking ahead
Executing on our Investing in Looking ahead core competencies Regeneron to the future • Investing $5B+ into R&D • ~40 therapeutic candidates in various stages of clinical development in 2024* #1 prescribed FDA approved • Pioneering novel therapeutic FDA approved anti- VEGF treatment Aspire to become
Slide 4: Continued execution driving strong results
Continued execution Notable R&D Pipeline Advancements driving strong results • Long-term data in diabetic macular edema patients who switched to EYLEA HD consistently achieved longer dosing intervals and slower retinal fluid re-accumulation • Pre-filled Syringe (PFS) approved in EU • FDA approval fo
Slide 5: EYLEA HD approved in U.S. for wAMD, DME, and DR
EYLEA HD approved in U.S. for wAMD, DME, and DR 3Q 2024 combined EYLEA HD + EYLEA U.S. net product sales of $1.54 billion (+3% y/y) Broad utilization across treatment landscape driving conversion from EYLEA to EYLEA HD Strong 3-year data from pivotal and PHOTON has the potential to become the next-g
Slide 6: Maintaining U.S. anti-VEGF category leadership with EYLEA HD launch
Maintaining U.S. anti-VEGF category leadership with EYLEA HD launch Building on 13 years of safety and efficacy experience, breadth of indications, and flexible dosing regimens U.S. Net Product Sales, in $ Millions Q3 2024 combined revenues of $1.54 billion $304 $392 $43 $123 $200 EYLEA HD launched
Slide 7: Dupixent global net sales grew 24% to $3.82 billion
3Q24 Dupixent global net sales grew 24%* to $3.82 billion Incremental market penetration, new indications, and younger populations represent significant opportunity for continued growth >1 million patients on therapy globally +24%* Approved in SIX indications in the U.S., positive pivotal results in
Slide 8: Delivering on "pipeline in a product" potential
Delivering on “pipeline in a product” potential Dupixent clinical trials have demonstrated that IL-4 and IL-13 are two of the key drivers of multiple Type 2 allergic diseases Atopic Dermatitis Asthma Atopic Dermatitis CRSwNP Atopic Dermatitis Asthma Adults 18+ Adults/Adolescents 12+ Adolescent 12+ A
Slide 9: Dupixent & itepekimab: Potential to change the COPD treatment paradigm
Dupixent & itepekimab†: Potential to change the COPD treatment paradigm (anti-IL4/13) Itepekimab (anti-IL-33) Positive results in Phase 3 BOREAS and NOTUS studies in Positive data in former smokers in Phase 2 COPD study eosinophilic COPD reported during 2023 informed Phase 3 trial design Approved in
Slide 10: Two opportunities to address high unmet need in COPD
Dupixent & itepekimab†: Two opportunities to address high unmet need in COPD Itepekimab Type 2 Non-Type 2 (anti IL-33) (70% of COPD patients) Former Smokers • Addressing COPD with an • Potential to address COPD in eosinophilic phenotype (eos ≥300/μl) Dupixent or Itepekimab former smokers, regardless
Slide 11: Novel treatment approach for reversing severe allergy: Linvoseltamab plus Dupixent
Novel treatment approach for reversing severe allergy: Linvoseltamab (BCMAxCD3) plus Dupixent (anti-IL4Rα) Transient plasma cell depletion with BCMAxCD3 Myeloma patients treated with plus sustained IL-4Rα blockade durably eliminated linvoseltamab rapidly reduced IgE levels1 IgE production in cynomol
Slide 12: Strong commercial execution with opportunities for future growth
Strong commercial execution with opportunities for future growth Libtayo on-track to become Regeneron’s next internally-discovered drug to reach >$1B in annual net sales Strong and Consistent Growth +24% • 3Q24 WW net sales of $288M (+24% YoY)* Growth vs. 2Q23* • Expanding global commercial footprin
Slide 13: Innovative assets and rational combinations across 30+ solid and blood cancers
Innovative assets and rational combinations in clinical development across 30+ solid and blood cancers Accomplishments: Upcoming regulatory Leader in immuno- Initial approvals, novel submissions, potential oncology and hematology platform validation and approvals and data by investigating the power
Slide 14: Harnessing the immune system to fight cancer
Harnessing the immune system to fight cancer Deploying our deep understanding of biology, genetics, and the immune system, Regeneron has validated several independent classes of internally-developed immuno-oncology agents in clinical trials Checkpoint Inhibitors CD3 Bispecifics CD28 Costimulatory Ce
Slide 15: Unique flexibility of internally-developed pipeline drives novel combinations
Unique flexibility of internally-developed pipeline drives potential for novel and differentiated combinations Bispecifics and Checkpoint Inhibitor Combos Immunomodulatory Combos Ch oth eck dies Odronextamab Linvoseltamab PSMAxCD3 Ubamatamab Cemiplimab Fianlimab Melanoma & other (CD20xCD3) (BCMAxCD3
Slide 16: Fianlimab + Libtayo: broad pipeline across metastatic and perioperative cancer settings
Fianlimab + Libtayo: advancing a broad pipeline across several metastatic and perioperative cancer settings Combining two potentially “best-in-class” checkpoint inhibitors: fianlimab (anti-LAG-3) + cemiplimab (anti-PD-1) – potential for differentiated efficacy and safety vs. current standard-of-care
Slide 17: Fianlimab + Libtayo: potentially differentiated option for 1L metastatic melanoma
Fianlimab + Libtayo: emerging as a potentially differentiated treatment option for 1L metastatic melanoma* Table depicts randomized Phase 3 data for four FDA-approved treatments as well as pooled, post-hoc data from three independent cohorts from initial trial of fianlimab + cemiplimab Pembrolizumab
Slide 18: Regeneron's leading CD3 bispecifics
Regeneron’s leading CD3 Linvoseltamab (BCMAxCD3) – MM bispecifics Linvoseltamab has the potential to be FDA and EC decisions on the best-in-class BCMAxCD3 bispecific with its clinical profile, dosing, and regulatory applications pending administration resolution of a third-party fill/finish manufact
Slide 19: Linvoseltamab emerging differentiated clinical profile in r/r multiple myeloma
Within the BCMA bispecific class, linvoseltamab emerging to have differentiated and compelling clinical profile in r/r multiple myeloma Teclistamab - FDA Approved Elranatamab - FDA approved Linvoseltamab - Not FDA approved (per U.S. FDA Prescribing Information§; n=110) (per U.S. FDA Prescribing Info
Slide 20: Progressing CD28 costimulatory bispecifics
Progressing CD28 costimulatory bispecifics Dose Proof-of- Dose Escalation Mechanism Expansion Status / Next Steps Combined with: Nezastomig Enrolling monotherapy cohort; (PSMAxCD28) combo with PSMAxCD3 now enrolling Cemiplimab PSMAxCD3 Prostate Cancer Expansion cohorts now enrolling; EGFRxCD28 Prese
Slide 21: Regeneron's approach to obesity: combinations to improve quality of weight loss
Regeneron’s approach to obesity: combinations with leading medicines aim to improve quality of weight loss GLP-1 based therapies, such as semaglutide (sema) and tirzepatide, are emerging as standards of care for weight loss; however, up to 40% of weight loss from these agents is due to decreases in
Slide 22: Obesity clinical program now enrolling
Obesity clinical program now enrolling Phase 2 study to investigate if addition of trevogrumab (anti-myostatin) to semaglutide with and without garetosmab (anti- activin A) improves the quality of weight loss and/or improves maintenance of weight loss post semaglutide discontinuation • Safety and to
Slide 23: Next-generation approach to anticoagulation via Factor XI inhibition
Next-generation approach to anticoagulation via Factor XI inhibition offers potential for blood clot prevention with minimal bleeding Two Factor XI antibodies potentially advancing to pivotal trials in early 2025: REGN9933 (A2 domain) and REGN7508 (catalytic domain) Intrinsic Coagulation Current sta
Slide 24: Regeneron Genetic Medicines: multiple investigational approaches
Regeneron Genetic Medicines: multiple investigational approaches for treatment of genetic diseases Established clinical proof-of-principle across several diseases with novel genetic medicine technologies siRNA CRISPR Gene Silencing AAV Knockout and Insertion (alone and antibody combos) Genome Editin
Slide 25: Regeneron Genetic Medicines pipeline
Regeneron Genetic Medicines pipeline Select Pre-IND Phase 1 Phase 2 Phase 3 Candidates ALN-SOD* ALN-PNP* Rapirosiran* Pozelimab + Cemdisiran* SOD1 siRNA PNPLA3 siRNA HSD17B13 C5 Antibody + C5 siRNA CIDEB* SOD1 ALS NAFLD CIDEB siRNA siRNA Myasthenia Gravis and MASH MASH Paroxysmal Nocturnal ALN-ANG3*
Slide 26: Geographic atrophy: extending C5 siRNA + antibody approach to ophthalmology
Geographic atrophy (in dry AMD): Extending our C5 siRNA + antibody approach to ophthalmology Current Geographic Regeneron Opportunity Atrophy Landscape (Pozelimab + Cemdisiran Combo) • ~1M diagnosed in U.S. • Increasing diagnosis and Market • Leadership in ophthalmology drug-treatment rates Opportun
Slide 27: Regeneron restores hearing in a profoundly deaf child
Regeneron restores hearing in a profoundly deaf child DB-OTO AAV-based dual-vector gene therapy delivered to the inner ear to rescue hearing in infants Preliminary results for first patient dosed: Gene therapy for genetic hearing loss Profoundly deaf child at baseline, demonstrates markedly improved
Slide 28: Regeneron-discovered, approved and investigational medicines across diverse diseases
Regeneron-discovered, approved and investigational medicines across a diverse set of diseases Phase 1 Phase 2 Phase 3 Approved † vonsetamig (BCMAxCD3) REGN9933 (Factor XI) pozelimab + cemdisiran‡ ° REGN5837 (CD22xCD28) REGN7508 (Factor XI) (anti-C5 + C5 siRNA) REGN7257 (IL-2Rγ) odronextamab (CD20xCD
Slide 29: 2024 key milestones
2024 key milestones Ophthalmology Solid Organ Oncology • EU decision for aflibercept 8 mg in wAMD and DME ✓ • Report potentially pivotal interim analysis of Libtayo in Adjuvant CSCC (4Q) • Japan decision for aflibercept 8 mg in wAMD and DME ✓ • Report results from Phase 3 study of fianlimab + cemipl
Slide 30: Continuing to deliver on capital allocation priorities
Continuing to deliver on capital allocation priorities to drive long-term growth Internal Business Investment Development Repurchase in our world-class R&D capabilities Shares to expand pipeline and maximize and capital expenditures to commercial opportunities • Deploy excess cash to support sustain
Slide 31: Three responsibility focus areas reflect our "doing well by doing good" ethos
Three responsibility focus areas all reflect our “doing well by doing good” ethos Improve the lives of people with serious diseases Our mission: • Pipeline innovation • Access to medicine and fair pricing Use the power of • Patient advocacy Foster a culture science to repeatedly of integrity and exc
Slide 32: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations 32
Slide 33: Abbreviations and Definitions
Abbreviations and Definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L First line EoG Eosinophilic gastroenteritis NAFLD Non-alcoholic fatty liver disease AAV Adeno-associated virus ESGCT European Society of Gene and Cell Therapy NEJM New England Journal of Medicine
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