Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — J.P. Morgan Healthcare Conference 2023
37 slides from Regeneron Pharmaceuticals's conference presentation, Jan 9, 2023
Slide 1: J.P. Morgan Healthcare Conference January 9, 2023
J.P. Morgan Healthcare Conference January 9, 2023 This non - promotional presentation contains investigational data as well as forward - looking statements; actual results may vary m aterially.
Slide 2: Strategy & Business Update
J.P. Morgan Healthcare Conference 2023 Strategy & Business Update 2 Leonard S. Schleifer, MD, PhD Co - Founder, President & Chief Executive Officer
Slide 3: Note regarding forward-looking statements and non-GAAP financial measures
3 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 ac
Slide 4: 2022 progress across key strategic priorities positions Regeneron to deliver long-term shareholder value
2022 progress across key strategic priorities positions Regeneron to deliver long - term shareholder value 4 Potential upcoming regulatory submissions, approvals and data readouts Positive aflibercept 8 mg data position retinal franchise for prolonged leadership Exceptional Dupixent clinical profile
Slide 5: Maintaining U.S. leadership with 2022 revenue growth continuing to outpace anti-VEGF category growth
Maintaining U.S. leadership with 2022 revenue growth continuing to outpace anti - VEGF category growth 5 $0.0 $0.8 $1.4 $1.7 $2.7 $3.3 $3.7 $4.1 $4.6 $4.9 $5.8 $6.3 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 U.S. Net Product Sales, in $ Billions #1 anti - VEGF treatment for retinal
Slide 6: Reducing treatment burden for patients with wAMD and DME remains a high unmet need
Reducing treatment burden for patients with wAMD and DME remains a high unmet need If approved, patients eligible for aflibercept 8 mg could benefit from extended dosing intervals Aflibercept 8 mg has potential to shift treatment paradigm; positions Regeneron’s retinal franchise for prolonged leader
Slide 7: Aflibercept 8 mg DME dosing intervals and safety
Q8W* 7% Pooled Aflibercept 8 mg (N=456^) Q8W* 4% Q12W* 7% Q16W 89% Aflibercept 8 mg Q16W (N=156^) 93% of aflibercept 8 mg DME patients maintained dosing intervals ≥12 weeks through week 48 7 Q8W* 9% Q12W 91% Aflibercept 8 mg Q12W (N=300^) Safety of aflibercept 8 mg comparable to that of aflibercept
Slide 8: Aflibercept 8 mg wAMD dosing intervals and safety
Q8W* 13% Q12W* 11% Q16W 77% Aflibercept 8 mg Q16W (N=312^) Q8W* 17% Pooled Aflibercept 8 mg (N=628^) 83% of aflibercept 8 mg wAMD patients maintained dosing intervals ≥12 weeks through week 48 8 Q8W* 21% Q12W 79% Aflibercept 8 mg Q12W (N=316^) ≥Q12W 83% Mean # of injections in first 48 weeks † Aflib
Slide 9: Cross-trial comparison of aflibercept 8 mg and faricimab in DME patients
7% remained on Q4W dosing throughout Year 1 Cross - trial comparison of aflibercept 8 mg and faricimab in DME patients 9 Dosing intervals of DME patients randomized to aflibercept 8 mg Q16W arm (N=156) in PHOTON study, through 48 weeks Dosing intervals of DME patients randomized to faricimab 6 mg PT
Slide 10: Cross-trial comparison of aflibercept 8 mg and faricimab in wAMD patients
10 77% maintained Q16W dosing through week 48 11% achieved Q12W dosing through week 48 45% assigned to Q16W dosing at week 24 33% assigned to Q12W dosing at week 24 22% assigned to Q8W dosing at week 20 Dosing intervals of wAMD patients randomized to faricimab 6 mg in TENAYA and LUCERNE studies (n=6
Slide 11: Dupixent global net product sales grew 41% in first nine months of 2022
In first 9 months of 2022, Dupixent global net product sales grew 41% and exceeded $6.2 billion Incremental market penetration, new indications, and younger populations represent significant opportunity for continued grow th 11 2022 regulatory progress across 5 diseases: Atopic Dermatitis Approved b
Slide 12: Delivering on 'pipeline in a product' potential indications for dupilumab
Delivering on “pipeline in a product” potential 12 This slide contains investigational indications for dupilumab that have not been approved by any regulatory authority. Under regulatory review/submitted Investigational indications Approved by FDA and/or EC Dupixent’s differentiated mechanism of act
Slide 13: Dupixent & itepekimab: two opportunities to address high unmet need in COPD
Dupixent & itepekimab: two opportunities to address high unmet need in COPD 13 • Potential to address Type 2 COPD in both current and former smokers • Two Phase 3 studies ongoing: x BOREAS fully enrolled x NOTUS enrolling • BOREAS achieved pre - specified interim efficacy threshold , triggering init
Slide 14: Meaningful advances in oncology in 2022
Tumor Type Initial Indication Data Disclosures 2H 2022 Hematology Lymphoma Multiple myeloma Dermato - oncology Neoadjuvant CSCC First - line advanced melanoma Other Solid Tumors MET - altered advanced NSCLC Advanced NSCLC Ovarian cancer (2L+) Metastatic castration - resistant prostate cancer Meaning
Slide 15: Research & Pipeline Update
J.P. Morgan Healthcare Conference 2023 Research & Pipeline Update 15 George D. Yancopoulos, MD, PhD Co - Founder, President & Chief Scientific Officer
Slide 16: Evolution of Regeneron's turn-key technologies powering our science and pipeline
Evolution of Regeneron’s turn - key technologies powering our science and pipeline Biologicals: Turn - Key Therapeutic Platforms Genetic Medicines: Turn - Key Therapeutic Platforms Antibodies Traps Gene Therapy siRNA Genome editing (insertion/knockout) CRISPR/Cas9 Tech | RNAi | Next - Gen Editing |
Slide 17: Meaningful advances across therapeutic areas in 2022
Meaningful advances across therapeutic areas in 2022 17 Ophthalmology Immunology Oncology Broader Pipeline EYLEA (VEGF Trap) • Received six months of pediatric exclusivity • sBLA accepted for Priority Review in Retinopathy of Prematurity AFLIBERCEPT 8 MG (VEGF Trap) • Positive pivotal data in wet Ag
Slide 18: Tumor-Targeted Biparatopics and bispecific approaches
Tumor - Targeted Biparatopics Designed to disrupt cellular signaling and/or deliver a cytotoxic drug to tumor cells Unique flexibility of internally developed pipeline drives potential for novel and differentiated combinations 18 CD3 Bispecifics : “Signal 1” Designed to bridge tumor - associated ant
Slide 19: Unique flexibility of internally developed pipeline drives novel combinations
Unique flexibility of internally developed pipeline drives potential for novel and differentiated combinations 19 Odronextamab (CD20xCD3) Linvoseltamab (BCMAxCD3) MUC16xCD3 (REGN4018) PSMAxCD3 (REGN4336) R/R B - NHL, CLL R/R Multiple Myeloma Metastatic prostate cancer Recurrent ovarian cancer Cemipl
Slide 20: Unique flexibility of internally developed pipeline drives novel combinations
Unique flexibility of internally developed pipeline drives potential for novel and differentiated combinations Odronextamab (CD20xCD3) Linvoseltamab (BCMAxCD3) MUC16xCD3 (REGN4018) PSMAxCD3 (REGN4336) R/R B - NHL, CLL R/R Multiple Myeloma Metastatic prostate cancer Recurrent ovarian cancer Cemiplima
Slide 21: Costim bispecifics may allow 'cold' tumors to respond to immunotherapy
08006 01003 05007 '09001 05012 09002 02001 05006 08001 05002 05003 055001 05008 08005 05009 -100 -80 -60 -40 -20 0 20 40 60 80 100 01008 17001 07001 01007 07002 09003 05014 09004 01009 05016 07003 02004 02003 -100 -80 -60 -40 -20 0 20 40 60 80 100 Costim bispecifics may allow “cold” tumors to respon
Slide 22: PSMAxCD28 + Libtayo demonstrated profound anti-tumor activity
PSMAxCD28 + Libtayo demonstrated profound anti - tumor activity in tumor type historically resistant to anti - PD - 1 monotherapy 22 Key takeaways from initial PSMAxCD28 data • Minimal PSMAxCD28 anti - tumor activity at lower doses, as predicted by preclinical models • Anti - tumor activity amplifie
Slide 23: Costimulatory bispecifics platform: status and next steps
Costimulatory bispecifics platform: status and next steps 23 *Skokos, D., Wei, J., et al. (2022 ). Science Translational Medicine . https://doi.org/10.1126/scitranslmed.abn1082 Prostate Cancer Ovarian Cancer EGFR + Solid Tumors Hematology PSMAxCD28 (REGN5678) + Libtayo x Share initial Phase 1 data •
Slide 24: Dual LAG-3 and PD-1 blockade may provide enhanced immune activation
Dual LAG - 3 and PD - 1 blockade may provide enhanced immune activation vs. anti - PD - 1 alone 24 This slide contains investigational drug candidates that have not been approved by any regulatory authority. Fianlimab (anti - LAG - 3) + Libtayo (anti - PD - 1) Melanoma • Two metastatic melanoma coho
Slide 25: Fianlimab + Libtayo: competitive efficacy in 1L metastatic melanoma
Fianlimab + Libtayo: competitive efficacy in 1L metastatic melanoma Data from second anti - PD - (L)1 - naïve metastatic melanoma cohort confirmed strong efficacy signal observed in first cohort 25 Tumor response waterfall plot by investigator assessment (melanoma anti – PD - (L)1 - naïve patients,
Slide 26: Poised to advance oncology pipeline in 2023 and beyond
Tumor Type Initial Indication Upcoming Expected Data Disclosure 2023 2024+ Hematology Lymphoma Multiple myeloma Dermato - oncology Neoadjuvant CSCC Adjuvant CSCC Advanced CSCC (2L) Perioperative and adjuvant melanoma First - line advanced melanoma Other Solid Tumors MET - altered advanced NSCLC Peri
Slide 27: Next-gen COVID antibody neutralization activity against all known variants
Next - gen COVID antibody binds outside variable RBD and has demonstrated high neutralization activity against all known variants and lineages 27 Variant Lineage REGEN - COV* Xevudy † Evusheld ^ Bebtelovimab ¶ REGN14287 D614G xxx xx xxx xxx xxx Omicron BA.2 x x - xxx xxx BA.4/5 x x xx xxx xxx BA.4.6
Slide 28: Evolution of Regeneron's turn-key technologies: biologics to genetic medicines
Genetic Medicines: Turn - Key Therapeutic Platforms Gene Therapy siRNA Genome editing (insertion/knockout) CRISPR/Cas9 Tech | RNAi | Next - Gen Editing | Viral Vector Tech | AAV Biologicals: Turn - Key Therapeutic Platforms Antibodies Traps CD3 bispecifics Costimulatory bispecifics Evolution of Rege
Slide 29: Optimizing genetic medicines with antibody-targeted delivery
Optimizing genetic medicines with antibody - targeted delivery Improving delivery technologies to create the next generation of genetic medicines 29 Systemic delivery mostly targets the liver Local delivery Current options for genetics medicines delivery Our vision Specifically target any cell type
Slide 30: Regeneron-discovered, approved and investigational medicines across diverse diseases
Regeneron - discovered, approved and investigational medicines across a wide and diverse set of diseases 30 odronextamab (CD20xCD3) linvoseltamab (BCMAxCD3) REGN5459 (BCMAxCD3) REGN7257 (IL - 2Rg) REGN9933 (Factor XI) REGN7999 (TMPRS6) NTLA - 2001 # (TTR) REGN5381/REGN9035 (NPR1) ALN - HSD (HSD17B13
Slide 31: Multiple potential FDA submissions: 2022-2024+
EYLEA Retinopathy of Prematurity DUPIXENT* CINDU - Cold (2H) LIBTAYO Adjuvant CSCC Itepekimab* COPD DUPIXENT* Eosinophilic Esophagitis DUPIXENT* Pediatric EoE (mid) DUPIXENT* Type 2 COPD Fianlimab + LIBTAYO Advanced Melanoma DUPIXENT* Prurigo Nodularis PRALUENT Pediatric HeFH (mid) DUPIXENT* CRSsNP
Slide 32: 2023 key upcoming milestones
2023 key upcoming milestones 32 Ophthalmology • FDA decision for EYLEA in ROP (Q1) • BLA acceptance for aflibercept 8 mg in DME and wAMD (Q1) • FDA decision and potential U.S. launch of aflibercept 8 mg (Q3) • Two - year data for PHOTON (DME) and PULSAR ( wAMD ) (Q3) Dupixent • sBLA acceptance for C
Slide 33: 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 33 Our mission: Use the power of science to repeatedly bring new medicines to people with serious diseases Improve the lives of people with serious diseases Foster a culture of integrity and excellence Build sustaina
Slide 34: Q&A
Q&A 34 George D. Yancopoulos , MD, PhD Co - Founder, President & Chief Scientific Officer Marion McCourt EVP, Head of Commercial Leonard S. Schleifer, MD, PhD Co - Founder, President & Chief Executive Officer
Slide 35: Allocated ~$3.4 billion to business development and share repurchases in 2022
Allocated ~$3.4 billion* to business development and share repurchases in 2022 35 • $1.8 billion investment in Tarrytown R&D facilities announced in July 2021 • Continued investments in research and development and manufacturing capacity • Deploy excess cash to opportunistically repurchase shares •
Slide 36: Recast GAAP Income Statement including IPR&D for Q4 2021
Recast GAAP Income Statement including IPR&D for Q4 2021 36 In Q4 2022, Regeneron expects to record an acquired in - process research and development (IPR&D) charge of approximately $30 million ‡ related to an up - front payment in connection with the Company's collaboration with CytomX Therapeutics
Slide 37: Abbreviations and Definitions
Abbreviations and Definitions 37 Abbreviation Definition 1L Front line 2L+ Second line and beyond 3L+ Third line and beyond AD Atopic dermatitis AFRS Allergic fungal rhinosinusitis BCC Basal cell carcinoma BCMA B - cell maturation antigen BLA Biologics license application B - NHL B - cell non - Hodg
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