R e g e n e r o n C o r p o r a t e P r e s e n t a t i o n
A u g u s t 2 0 2 2
This non-promotional presentation is intended for the investor audience and contains investigational data as well as forward-looking statements; actual results may vary
materially
Note regarding forward-looking statements & 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 impact of SARS- CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators' ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of 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® (aflibercept) Injection, Dupixent® (dupilumab), Libtayo® (cemiplimab), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab), Inmazeb® (atoltivimab, maftivimab, and odesivimab-ebgn),REGEN-COV® (casirivimab and imdevimab), aflibercept 8mg, fasinumab, pozelimab, odronextamab, itepekimab, fianlimab, REGN5458, REGN5713-5714-5715,REGN1908-1909, Regeneron's and its collaborators' 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; 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 without limitation those listed above; the likelihood and timing of achieving any of the anticipated milestones described in this presentation; the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees 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; 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; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron's collaborators, licensees, 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; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; 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, Dupixent, Praluent, and REGEN-COV), other litigation and other proceedings and government investigations relating to the Company and/or its operations, 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; and the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated. 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 uses total revenues excluding REGEN-COV and non-GAAP net income per share, or non-GAAP EPS, 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 other items from the related GAAP financial measure. Non-GAAP adjustments also include the 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. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company's control, such as the Company's stock price on the dates share-based grants are issued. Management uses 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, 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 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 21.
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Executing on Our
Core Competencies
#1 prescribed FDA | ||
approved anti-VEGF | Advancing a | |
treatment for retinal disease | ||
best-in-class, | ||
diversified | ||
pipeline based on | ||
~$2.1B net product sales in 2Q 2022† | in-house | |
innovation and | ||
with 2 additional U.S. approvals in 2Q | ||
strategic | ||
partnerships | ||
Emerging portfolio of immuno- | ||
oncology antibodies | ||
3 | * Based on midpoint of most recent GAAP R&D guidance | |
† Sanofi records global net product sales of Dupixent |
Investing in Regeneron
Expect to
invest ~$3.6
billion into
Research
and
Development
in 2022*
Announced $3
billion share
repurchase
program in Nov
2021
(over $8 billion
shares
repurchased since
Nov 2019**)
Looking Ahead | |
to the Future | |
30+ therapeutic | |
candidates in various stages | |
of clinical development | |
Acquired full rights to Libtayo | |
driving new | from Sanofi and completed |
breakthroughs | acquisition of Checkmate |
and target | Pharmaceuticals |
discovery | Expanding partnerships |
with leading companies in | |
new technologies |
** As of June 30, 2022
~$2.1 billion remaining in authorization
Delivering Results Across the Organization
2Q 2022 | +20% YoY |
Total Revenues | |
excluding REGEN-COV* |
2Q 2022 | $9.77 per share | ||
Non-GAAP EPS* | Includes $1.71 impact of Acquired | ||
IPR&D charge | |||
PN - Prurigo Nodularis; EoE - Eosinophilic Esophagitis AD - Atopic Dermatitis; | |||
DR - Diabetic Retinopathy; FL - Follicular Lymphoma; DLBCL - Diffuse Large | |||
4 | * See reconciliation of non- | B-Cell Lymphoma; EC - European Commission; EoE - Eosinophilic Esophagitis; | |
ATTR - Transthyretin Amyloidosis; mCRPC - metastatic Castration-resistant | |||
GAAP measure on slide 22 | |||
Prostate Cancer | |||
Notable R&D PipelineAdvancements
sBLA accepted for 16-week dosing regimen in DR
FDA approval for pediatric AD (6 mo - 5 yr) FDA approval for EoE (12 yr+)
EC approval for pediatric asthma (6 - 11 yr)
FDA acceptance of sBLA for PN with priority review (PDUFA 9/30/2022)
Positive Ph3 data in pediatric EoE (1 - 11 yr)
Data for LAG-3+Libtayo, MUC16xCD3, and METxMET at ESMO 2022
First-in-human data for REGN5678 in mCRPC
Updated Phase 1 data for NTLA-2001 in
ATTR presented by Intellia
This slide contains investigational products not yet approved by regulatory authorities
EYLEA®: 10+ Years of Patient Impact
Extending leadership position based on efficacy and safety that has transformed millions of lives; 55+ million doses administered worldwide since launch
Developed using our proprietary Trap technology, development on aflibercept began in 2004 and became
Regeneron's second FDA-approved treatment in November 2011 as EYLEA
$4.6
$4.1
$3.7
$3.3
$2.7
$1.7
$1.4
$0.8
$0.0
$5.8
$4.9
The #1 prescribed FDA approved anti-VEGF treatment for retinal disease
- 2Q22 U.S. net product sales of $1.62Bn (+14% YoY)
Well-established leadership based on safety/efficacy experience
- ~75% share of U.S. branded category; ~50% share of total category
- Breadth of indications, flexible dosing regimens, with established real-world safety
Continuing to drive future growth
▪ Diabetic eye disease remains a significant growth opportunity |
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021
U.S. Net Product Sales, $Billion
▪ Ph3 readouts for Aflibercept 8mg expected Late Q3/ Early Q4 |
5
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Regeneron Pharmaceuticals Inc. published this content on 03 August 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 August 2022 12:38:10 UTC.