Regeneron Corporate Presentation
M A Y 2 0 2 4
This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially.
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 events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products") and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA® HD (aflibercept) Injection 8 mg, EYLEA® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Veopoz® (pozelimab), odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713- 5714-5715,NTLA-2001, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of the anticipated milestones discussed or referenced in this presentation; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, including those listed above and/or otherwise discussed in this presentation; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; Regeneron's ability to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; unanticipated expenses; the costs of developing, producing, and selling products; Regeneron's ability to meet any of its financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on Regeneron's business; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
This presentation includes or references non-GAAP net income per diluted share, revenues excluding Ronapreve, and net product sales growth on a constant currency basis for certain of Regeneron's Products, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles ("GAAP"). These and other non-GAAP financial measures are computed by excluding certain non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated income tax effect of reconciling items. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. Management uses this and other non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations. However, there are limitations in the use of such non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the non-GAAP financial measures used in this presentation is provided on slide 31.
2
Executing on our
core competencies
#1 prescribed | Now FDA approved |
FDA approved anti- | Aspire to become |
VEGF treatment | new standard- |
for retinal disease | of-care |
~$3.1B net product | Emerging portfolio of |
sales in 1Q24† | immuno-oncology |
antibodies |
Investing in
Regeneron
- Investing ~$5B into R&D in 2024*
- New $3B share repurchase program authorized in April 2024
- Repurchased over $12B of shares since Nov 2019§
Looking ahead
to the future
- Over 35 therapeutic candidates in various stages of clinical development
- Pioneering novel therapeutic approaches including in genetic medicines
- Expanding partnerships with leading companies in new technologies
Advancing a best-in-class, diversified pipeline based on innovation and strategic partnerships
driving new breakthroughs and target discovery
3 *Based on midpoint of most recent GAAP R&D guidance. † Sanofi records global net product sales of Dupixent. §~$1.2 billion in the aggregate remaining under the February 2023 share repurchase program as of March 31, 2024. Note: Definitions for all abbreviations and acronyms in this presentation can be found on page 32. All trademarks mentioned are the property of their respective owners.
Continued execution driving strong results
Notable R&D PipelineAdvancements
1Q 2024 Total Revenues*†
+7% YoY
1Q 2024 Non-GAAP EPS†
- EYLEA HD (known as EYLEA 8 mg outside of U.S.) approved in EU and Japan for wAMD and DME
- sBLA accepted for priority review for COPD with evidence of Type 2 inflammation (PDUFA June 27, 2024)
- Approved in Japan for CSU in patients age 12+; regulatory application submitted in EU
- Approved for pediatric (1 -11 years) EoE in US; under review in EU
- BLA for linvoseltamab for MM accepted by FDA for Priority Review (PDUFA Aug 22, 2024); Phase 3 confirmatory study currently enrolling
- Positive pivotal data for linvoseltamab presented at
American Association for Cancer Research (AACR)
- Praluent approved by FDA for pediatric (8+ year) HeFH
- Acquired clinical and preclinical programs from 2seventy bio
$9.55
4 | *Excluding contributions from Ronapreve |
†See reconciliation of non-GAAP measure on slide 31. |
- Initiated Phase 2 study of ALN-APP in cerebral amyloid angiopathy
- Initiated Phase 2 study of itepekimab in non-cystic fibrosis bronchiectasis
This slide contains investigational drug candidates and indications that have not been approved by any regulatory authority.
EYLEA HD approved in U.S. for wAMD, DME, and DR
has the potential to become the next-generation
standard-of-care anti-VEGF treatment
1Q 2024 U.S. Net Product Sales:
$200 million
achieved in second full quarter following launch
5
1Q 2024 combined EYLEA HD + EYLEA U.S. net product sales of $1.4 billion
FDA approval for wAMD, DME and DR received in August 2023
Early indicators suggest broad initial uptake across treatment landscape
Strong 2-yeardata from pivotal PULSAR and PHOTON studies presented in 2023, supporting best-in-class efficacy, safety, and durability profile
>80% of eligible lives have coverage; vast majority of covered lives have first-line or single-step-edit access to Eylea HD
CMS-assignedpermanent J-Code took effect on April 1, 2024
Maintaining U.S. anti-VEGF category leadership with Eylea HD launch
Building on 12+ years of safety and efficacy experience, breadth of indications, and flexible dosing regimens
U.S. Net Product Sales, in $ Millions
$43 | $123 | |||
$200 | ||||
$1,434 | $1,500 | $1,448 | ||
$1,338 | ||||
$1,202 | ||||
1Q 2023 | 2Q 2023 | 3Q 2023 | 4Q 2023 | 1Q 2024 |
EYLEA | EYLEA HD |
Q1 2024 combined revenues of $1.4 billion
Eylea HD launched in late August 2023
- 1Q 2024 U.S. net product sales of $200M
- U.S. net product sales of $366M since launch
Eylea remains #1 anti-VEGF treatment for retinal diseases
- 1Q 2024 U.S. net product sales of $1.2B
- Negatively impacted by changing market dynamics, resulting in a lower net selling price and lower volumes
Net product sales of EYLEA and EYLEA HD in 1Q 2024 were negatively impacted by ~$40 million due to sequential net reduction in wholesaler inventory
45% category share for Eylea HD and Eylea in 1Q 2024*
6 | *Combined EYLEA + EYLEA HD share of anti-VEGF category (inclusive of branded, bevacizumab, & biosimilar ranibizumab agents); Projected Vestrum Category (Injection) Share - Q1'24 Update. April 2024. |
Dupixent global net product sales grew 25%*
In the first quarter of 2024, Dupixent global net sales grew 25%* to ~$3.1 billion
Incremental market penetration, new indications, and younger populations represent significant opportunity for continued growth
+25%*
$858.8
$586.9
$1,898.1$2,218.0
>850,000 patients on therapy globally
Approved in FIVEindications in the U.S., positive pivotal results in SEVENType 2 allergic diseases
NBRx - #1 prescribed biologic in all 5 approved indications TRx - #1 prescribed biologic in 4 of 5 approved indications
Pediatric Eosinophilic Esophagitis
FDA-approved in Jan 2024 in patients as young as 1 year old (≥15 kg)
1Q231Q24
U.S. ROW
$ Millions
Sanofi records global net product sales of Dupixent
7
Chronic Obstructive Pulmonary Disease
Reported positive results for pivotal BOREAS and NOTUS studies
Granted priority review by FDA (PDUFA June 27, 2024); EC decision expected 2H24
*On a Constant Currency basis | This slide contains investigational indications for dupilumab that have not been approved by any regulatory authority. |
Delivering on "pipeline in a product" potential
Dupixent clinical trials have demonstrated that IL-4 and IL-13 are key drivers of multiple Type 2 allergic diseases
Atopic Dermatitis | Asthma | Atopic Dermatitis | CRSwNP | Atopic Dermatitis | Asthma | |||||||||||||||
Adults 18+ | Adults/Adolescents 12+ | Adolescent 12+ | Adults 18+ | Ped 6-11 | Ped 6-11 | |||||||||||||||
CSU
Adults/
Adolescents 12+
Approved by
FDA and/or EC
Under regulatory review
Investigational indications
8
Atopic | |||||
BP | COPD | EoE | Prurigo Nodularis | Dermatitis | |
Adults 18+ | Ped 1-11 | Adults 18+ | Infant 6 mo-5Y | ||
Today | Adults 18+ | ||||
CSU | CPUO | Asthma | UC | EoG | Prurigo Nodularis | ||||||||||
Ped 2-11 | Adults 18+ | Ped 2-5 | Adults 18+ | Adults/Adol 12+ | Ped 6m-17 | ||||||||||
Potential new indications for Dupixent provide opportunity to add up to ~1 million additional eligible patients in the U.S.
EoE
Adults/
Adolescents 12+
This slide contains investigational indications for dupilumab that have not been approved by any regulatory authority.
Potential to change the COPD treatment paradigm with Dupixent and itepekimab
(anti-IL4/13) | Itepekimab | |
(anti-IL-33) | ||
Positive results in Phase 3 BOREAS and NOTUS studies in eosinophilic COPD reported during 2023
sBLA accepted for Priority Review (PDUFA June 27, 2024)
Positive data in former smokers in Phase 2 COPD study informed Phase 3 trial design
Phase 3 AERIFY studies passed interim futility analysis in 2023; studies nearing complete enrollment
BOREAS | NOTUS | |
Primary endpoint: | 30% | |
Significant reduction in moderate | 34% | |
or severe COPD exacerbations over | (p=0.0005) | (p=0.0002) |
52 weeks compared to placebo | ||
Key secondary endpoint: | +83 mL | +82 mL |
Significant improvement in lung | ||
function at week 12 compared | (p<0.0001) | (p=0.0001) |
to placebo* | ||
Lung function benefit vs. placebo observed at Week 12 sustained at Week 52 Safety findings generally consistent with known safety profile of Dupixent
- Demonstrated 42% reduction in exacerbations in former smokers vs. placebo in Phase 2 study
- RGC-generatedhuman genetics data support rationale for IL-33 blockade to treat COPD
- Pivotal results from both AERIFY studies expected in 2025
Phase 2 COPD Trial
Itepekimab led to 42% reduction in exacerbations in former smokers
2 | 42% |
reduction | |
1.5 | |
1 | |
1.55 | |
.5 | 0.89 |
0 | |
PLACEBO | ITEPEKIMAB |
9 * Results shown are placebo-adjusted improvements in pre-bronchodilator forced expiratory volume (FEV1).
This slide contains investigational drug candidates that have not been approved by any regulatory authority.
Dupixent & itepekimab: Two opportunities to address high unmet need in COPD
- Potential to address COPD with a Type 2 inflammatory phenotype (eos ≥300/μl) in both current and former smokers
- First and only biologic to achieve clinically meaningful and statistically significant reduction in COPD exacerbations and improvement in lung function vs. placebo*
- sBLA accepted for Priority Review (PDUFA June 27, 2024)
- Granted Breakthrough Therapy Designation by FDA
- EC decision expected 2H24
Former Smokers | (70% of COPD patients) |
Current Smokers | (30% of COPD patients) |
Type 2 | Non-Type 2 | |
Dupixent or | Itepekimab | |
itepekimab | only | |
>350K patients | ~600K patients | |
Dupixent | |
only | - |
~150K patients
Current U.S., EU and Japan addressable patient estimates
Itepekimab
(anti IL-33)
- Potential to address COPD in former smokers, regardless of eosinophilic phenotype
- Two Phase 3 studies ongoing:
- AERIFY-1enrolling
- AERIFY-2enrolling
- AERIFY studies passed interim futility analysis in 2023
- Enrollment nearly complete, results expected in 2025
- Includes patients with both high and low eosinophil counts
10 *Patients were randomized to receive Dupixent or placebo added to maximal standard-of-care inhaled triple therapy (LABA+LAMA+ICS)
This slide contains investigational drug candidates and indications that have not been approved by any regulatory authority.
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Regeneron Pharmaceuticals Inc. published this content on 02 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 12:58:13 UTC.