REGENERON PHARMACEUTICALS, INC. This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance ofRegeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), 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 (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 (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA® (aflibercept) Injection, Dupixent® (dupilumab) Injection, Libtayo® (cemiplimab) Injection, Praluent® (alirocumab) Injection, Kevzara® (sarilumab) Injection, Evkeeza® (evinacumab), InmazebTM (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™ (casirivimab and imdevimab), fasinumab, garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909, 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 our anticipated development milestones referenced in this report; 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 our late-stage product candidates and new indications for Regeneron's Products, including without limitation those listed above; the extent to which the results from the research and development programs conducted by us and/or our 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 our 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; our ability to manufacture and manage supply chains for multiple products and product candidates; the ability of our 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; our ability to meet any of our 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 our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to the casirivimab and imdevimab antibody cocktail (known as REGEN-COV inthe United States and Ronapreve™ in other countries), to be cancelled or terminated; 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, Dupixent, Praluent, and REGEN-COV described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition. These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part II, Item 1A. "Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise. 24 --------------------------------------------------------------------------------
Table of Contents
Overview
Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases. Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases. Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to be an integrated, multi-product biotechnology company that provides patients and medical professionals with important options for preventing and treating human diseases. Selected financial information is summarized as follows: Three Months Ended
Six Months Ended
June 30 ,
(In millions, except per share data) 2021 2020
2021 2020
Revenues $ 5,138.5 $ 1,952.0 $ 7,667.2 $ 3,780.2
Net income $ 3,098.9 $ 897.3 $ 4,214.1 $ 1,521.9
Net income per share - diluted $ 27.97 $ 7.61
For purposes of this report, references to our products encompass products
marketed or otherwise commercialized by us and/or our collaborators and
references to our product candidates encompass product candidates in development
by us and/or our collaborators (in the case of collaborated products or product
candidates under the terms of the applicable collaboration agreements), unless
otherwise stated or required by the context.
Products
Products that have received marketing approval are summarized in the table
below.
Territory
Product Disease Area U.S. EU Japan ROW(4)
EYLEA (aflibercept) - Neovascular age-related macular a a a a
Injection(1) degeneration ("wet AMD")
- Diabetic macular edema ("DME") a a a a
- Macular edema following retinal a a a a
vein occlusion ("RVO"), which
includes macular edema following
central retinal vein occlusion
("CRVO") and macular edema
following branch retinal vein
occlusion ("BRVO")
- Myopic choroidal neovascularization a a a
("mCNV")
- Diabetic retinopathy a
- Neovascular glaucoma ("NVG") a
Dupixent (dupilumab) - Atopic dermatitis (in adults and a a a a
Injection(2) adolescents)(5)
- Atopic dermatitis (in pediatrics a a a
6-11 years of age)
- Asthma (in adults and adolescents) a a a a
- Chronic rhinosinusitis with nasal a a a a
polyposis ("CRSwNP")
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Table of Contents
Territory
Product (continued) Disease Area U.S. EU Japan ROW(4)
Libtayo (cemiplimab) - Metastatic or locally advanced a a
Injection(2) first-line non-small cell lung cancer
("NSCLC")
- Metastatic or locally advanced basal a a a
cell carcinoma ("BCC")
- Metastatic or locally advanced a a a
cutaneous squamous cell carcinoma
("CSCC")
Praluent (alirocumab) - LDL-lowering in heterozygous familial a a (7) a
Injection(3) hypercholesterolemia ("HeFH") or
clinical atherosclerotic
cardiovascular disease ("ASCVD")
- Cardiovascular risk reduction in a a a
patients with established
cardiovascular disease
- Homozygous familial a
hypercholesterolemia ("HoFH")
REGEN-COV(9) - COVID-19 treatment aKevzara (sarilumab) Solution for - Rheumatoid arthritis ("RA")
a a a a
Subcutaneous Injection(2)
Evkeeza (evinacumab) Injection - HoFH (in adults and adolescents) a a
Inmazeb (atoltivimab, - Infection caused by Zaire ebolavirus a
maftivimab, and odesivimab-ebgn)
Injection
ARCALYST® (rilonacept) Injection - Cryopyrin-associated periodic a
for Subcutaneous Use(8) syndromes ("CAPS"), including
familial cold auto-inflammatory
syndrome ("FCAS") and Muckle-Wells
syndrome ("MWS") (in adults and
adolescents)
- Deficiency of interleukin-1 receptor a
antagonist ("DIRA") (in adults and
pediatrics)
- Recurrent pericarditis (in adults and a
adolescents)
ZALTRAP® (ziv-aflibercept) - Metastatic colorectal cancer ("mCRC") a a a a
Injection for Intravenous
Infusion(6)
Note 1: Refer to "Net Product Sales of Regeneron-Discovered Products" section below for information regarding whether net product sales for a
particular product are recorded by us or others
Note 2: Product is approved for use in adults, unless otherwise noted, in the disease area described above
(1) In collaboration with Bayer outside the United States
(2) In collaboration with Sanofi
(3) Pursuant to a 2020 agreement, the Company is solely responsible for the development and commercialization of Praluent in the United
States , and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States (and Sanofi pays
us a royalty on net product sales of Praluent outside the United States ).
(4) Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the
United States , European Union ("EU"), or Japan .
(5) Approval in Japan is for adults and adolescents 15 years of age and older
(6) Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net
product sales of ZALTRAP
(7) No longer marketed by Sanofi in Japan
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(8) Pursuant to a 2017 license agreement with Kiniksa Pharmaceuticals, Ltd., we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST. InMarch 2021 , Kiniksa received marketing approval for its first new indication of ARCALYST inthe United States ; consequently we grantedU.S. commercial rights to ARCALYST for all previously approved indications and Kiniksa pays us a share of ARCALYST profits. Refer to "Collaboration, License, and Other Agreements - Kiniksa" section below for further details. (9) Known as REGEN-COV inthe United States and Ronapreve™ in other countries REGEN-COV - Emergency and Temporary Use AuthorizationsUnited States InNovember 2020 , the antibody cocktail casirivimab and imdevimab administered together, known as REGEN-COV inthe United States , received Emergency Use Authorization ("EUA") from theU.S. Food and Drug Administration ("FDA") for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. InJune 2021 , the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (which is half the dose originally authorized) and allowing for subcutaneous injections as an alternative when intravenous ("IV") infusion is not feasible and would lead to a delay in treatment. InJuly 2021 , the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons). For people who are not expected to mount an adequate immune response to vaccination, REGEN-COV can also now be administered monthly for the duration of ongoing exposure to SARS-CoV-2. The EUA is temporary and does not replace a formal Biologics License Application ("BLA") submission review and approval process. This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner. See information regarding ongoing clinical trials of REGEN-COV in the "Programs in Clinical Development" section below. Outsidethe United States InFebruary 2021 , theEuropean Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") issued a positive opinion, recommending that the casirivimab and imdevimab antibody cocktail be used to treat COVID-19 patients who do not require supplemental oxygen and are at high risk of progressing to severe COVID-19. The CHMP's positive opinion can be used by EU member states when making decisions on the possible use of the antibody cocktail at a national level prior to a market authorization. Emergency or temporary pandemic use authorizations are currently in place in certain other countries outsidethe United States , including within theEuropean Union ,India ,Switzerland , andCanada . 27 --------------------------------------------------------------------------------
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Net Product Sales of Regeneron-Discovered Products
Three Months Ended
June 30,
2021 2020 % Change
(In millions) U.S. ROW Total U.S. ROW Total (Total Sales)
EYLEA(a) $ 1,424.7 $ 903.8 $ 2,328.5 $ 1,113.7 $ 641.0 $ 1,754.7 33 %
Dupixent(b) $ 1,146.6 $ 352.4 $ 1,499.0 $ 770.4 $ 174.6 $ 945.0 59 %
Libtayo(c) $ 78.0 $ 38.9 $ 116.9 $ 63.3 $ 16.7 $ 80.0 46 %
Praluent(d) $ 41.9 $ 57.5 $ 99.4 $ 47.2 $ 39.4 $ 86.6 15 %
REGEN-COV(e) $ 2,591.2 $ 470.2 $ 3,061.4 - - - (h)
Kevzara(b) $ 30.7 $ 36.0 $ 66.7 $ 36.5 $ 31.8 $ 68.3 (2 %)
Evkeeza(f) $ 2.0 - $ 2.0 - - - (h)
ARCALYST(g) $ 7.7 - $ 7.7 $ 2.7 - $ 2.7 185 %
ZALTRAP(b) $ 1.3 $ 22.2 $ 23.5 $ 1.7 $ 25.0 $ 26.7 (12 %)
Six Months Ended
June 30,
2021 2020 % Change
(In millions) U.S. ROW Total U.S. ROW Total (Total Sales)
EYLEA(a) $ 2,771.7 $ 1,728.1 $ 4,499.8 $ 2,285.7 $ 1,322.7 $ 3,608.4 25 %
Dupixent(b) $ 2,108.1 $ 653.8 $ 2,761.9 $ 1,449.4 $ 350.8 $ 1,800.2 53 %
Libtayo(c) $ 147.1 $ 70.6 $ 217.7 $ 125.0 $ 29.8 $ 154.8 41 %
Praluent(d) $ 85.2 $ 118.8 $ 204.0 $ 82.3 $ 84.1 $ 166.4 23 %
REGEN-COV(e) $ 2,853.4 $ 654.4 $ 3,507.8 - - - (h)
Kevzara(b) $ 61.4 $ 74.4 $ 135.8 $ 71.8 $ 56.6 $ 128.4 6 %
Evkeeza(f) $ 2.5 - $ 2.5 - - - (h)
ARCALYST(g) $ 9.9 - $ 9.9 $ 5.7 - $ 5.7 74 %
ZALTRAP(b) $ 2.7 $ 45.2 $ 47.9 $ 3.2 $ 51.5 $ 54.7 (12 %)
(a) Regeneron records net product sales of EYLEA in the United States . Bayer records net product sales of EYLEA outside the United States . The Company records
its share of profits/losses in connection with sales of EYLEA outside the United States .
(b) Sanofi records global net product sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses in connection with global sales
of Dupixent and Kevzara, and Sanofi pays the Company a percentage of net sales of ZALTRAP.
(c) Regeneron records net product sales of Libtayo in the United States and Sanofi records net product sales of Libtayo outside the United States . The parties
equally share profits/losses in connection with global sales of Libtayo.
(d) Effective April 1, 2020 , Regeneron records net product sales of Praluent in the United States . Also effective April 1, 2020 , Sanofi records net product
sales of Praluent outside the United States and pays the Company a royalty on such sales. Previously, Sanofi recorded global net product sales of Praluent and
the Company recorded its share of profits/losses in connection with such sales. Refer to "Collaboration, License, and Other Agreements - Sanofi" section below
for further details.
(e) Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government. Roche records net product sales of the
antibody cocktail outside the United States and the parties share gross profits from global sales. Refer to "Agreements Related to COVID-19" below for further
details.
(f) Regeneron records net product sales of Evkeeza in the United States .
(g) Effective April 1, 2021 , Kiniksa records net product sales of ARCALYST in the United States and pays us a share of ARCALYST profits, if any. Prior to
April 1, 2021 , Regeneron recorded net product sales of ARCALYST in the United States . Refer to "Products" section above and "Collaboration, License, and Other
Agreements - Kiniksa" section below for further details.
(h) Percentage not meaningful
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Programs in Clinical Development
Product candidates in clinical development, which are being developed by us
and/or our collaborators, are summarized in the table below. We believe that our
ability to develop product candidates is enhanced by the application of
our VelociSuite® technology platforms. We continue to invest in the development
of enabling technologies to assist in our efforts to identify, develop,
manufacture, and commercialize new product candidates.
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. The planning, execution, and results of our clinical programs are
significant factors that can affect our operating and financial results.
We and our collaborators conduct clinical trials in multiple countries across
the world. The COVID-19 pandemic and the restrictions adopted around the globe
to reduce the spread of the disease have impacted and may continue to impact our
clinical development programs. We continue to evaluate the impact of the
COVID-19 pandemic on an individual trial basis and oversee trial management
while also working to ensure patient safety and provide sufficient supply of
product candidates for the studies. The ultimate impact (including possible
delays in recruiting and/or obtaining data) resulting from the COVID-19 pandemic
will depend, among other factors, on the extent of the pandemic in the areas
with study sites and patient populations. It is possible that the COVID-19
pandemic may cause clinical disruptions beyond those we have described. In
addition, there may be delays in the timing of regulatory review and other
projected milestones discussed in the table below.
Refer to Part II, Item 1A. "Risk Factors" for a description of these and other
risks and uncertainties that may affect our clinical programs, including those
related to the COVID-19 pandemic.
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Regulatory Select Upcoming
Clinical Program Phase 1 Phase 2 Phase 3 Review(i) 2021 Events to Date Milestones(j)
Ophthalmology
EYLEA(b) -High-dose -Retinopathy of -Initial results from -Submit supplemental BLA
formulation in wet prematurity National Institutes of ("sBLA") for
AMD ("ROP")(c) Health ("NIH")-sponsored every-16-weeks dosing
Protocol W trial in regimen in patients with
-High-dose non-proliferative diabetic NPDR (Q4 2021)
formulation in wet retinopathy ("NPDR") were
AMD announced; data confirmed -Report results from
results from Phase 2 study for
-High-dose Company-sponsoredPANORAMA high-dose formulation in
formulation in DME trial and demonstrated wet AMD (second half
reduced risk of developing 2021)
vision-threatening
complications with
every-16-weeks dosing
regimen
-Completed enrollment in
Phase 3 study for ROP
-Completed enrollment in
Phase 3 studies for
high-dose formulation in
wet AMD and DME
Immunology & Inflammation
Dupixent (dupilumab)(a) -Peanut allergy -Atopic dermatitis in -Asthma in -Reported that Phase 2 -Report results from
Antibody to IL-4R alpha pediatrics (6 pediatrics (6-11 trial of Dupixent in Phase 3 study for atopic
subunit -Grass allergy months-5 years of years of age) combination with Aimmune dermatitis in pediatric
age) (Phase 2/3)(d) (U.S. and EU) Therapeutics' AR101, an patients (6 months-5
oral immunotherapy, in years of age) (Q3 2021)
-Asthma in pediatrics -Asthma longer pediatric patients with
(6-11 years of age) term efficacy and peanut allergy met its -FDA decision on sBLA
safety in adults primary and key secondary (target action date of
-Eosinophilic and adolescents endpoint October 21, 2021) and
esophagitis (U.S.) European Commission
("EoE")(c) in -Initiated Phase 3study ("EC") decision on
adults(d), in hand and foot atopic regulatory submission
adolescents(d), and dermatitis (first half 2022) for
pediatrics asthma in pediatrics
(6-11 years of age)
-Chronic obstructive
pulmonary disease -FDA decision on sBLA
("COPD") for asthma longer term
efficacy and safety
-Bullous pemphigoid label update (Q4 2021)
(Phase 2/3)(c)
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Select Upcoming
Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review(i) 2021 Events to Date Milestones(j)
Dupixent (dupilumab)(a) -Chronic spontaneous -Presented additional -Report results from Part B
(continued) urticaria ("CSU") positive results from Phase of the Phase 3 study in
3 trial for asthma in adults and adolescents with
-Prurigo nodularis pediatrics (6-11 years of EoE (Q4 2021)
age) at American Thoracic
-Allergic Society International -Report results from Phase
bronchopulmonary Conference 2 study in peanut allergy
aspergillosis ("ABPA") (first half 2022)
-Reported that Phase 3
-Chronic inducible trial in CSU met its -Report results from
urticaria primary and key secondary additional Phase 3 CSU
endpoints study (first half 2022)
-Chronic rhinosinusitis
without nasal polyposis -Approved by FDA for 200 mg -Report results from
auto-injector prurigo nodularis study
-Allergic fungal (second half 2021)
rhinosinusitis
Kevzara (sarilumab)(a) -Polyarticular-course
Antibody to IL-6R juvenile idiopathic
arthritis ("pcJIA")
-Systemic juvenile
idiopathic arthritis
("sJIA")
Itepekimab(a) (REGN3500) -COPD
Antibody to IL-33
REGN1908-1909(f) -Cat allergy -Reported that Phase 2
Multi-antibody therapy to Fel d study in cat allergic
1 patients with mild asthma
met its primary and key
secondary endpoints
REGN5713-5714-5715 -Birch allergy -Report results from
Multi-antibody therapy to Bet v initial Phase 3 study in
1 birch allergy (Q4 2021)
REGN6490 -Palmo-plantar pustulosis
Antibody to IL-36R
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Select Upcoming
Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review(i) 2021 Events to Date Milestones(j)
Solid Organ Oncology
Libtayo (cemiplimab)(a)(h) -Metastatic or -First-line NSCLC, -Approved by FDA and EC -Submit sBLA and Marketing
Antibody to PD-1 locally advanced chemotherapy combination for first-line NSCLC, Authorization Application
CSCC(d) monotherapy ("MAA") for cervical cancer
-Second-line cervical (second half 2021)
-Neoadjuvant CSCC cancer(e) -Approved by FDA and EC
for BCC
-Second-line -Adjuvant CSCC
cervical cancer, -Reported Phase 3
ISA101b combination chemotherapy combination
trial in NSCLC met its
overall survival primary
endpoint; trial stopped
early based on Independent
Data Monitoring Committee
("IDMC") recommendation
-Reported positive results
from Phase 3 trial in
cervical cancer,
demonstrating an overall
survival benefit; trial
stopped early based on
IDMC recommendation
REGN4018(f) -Platinum-resistant ovarian cancer -Report results from Phase 1
Bispecific antibody targeting study in platinum-resistant
MUC16 and CD3 ovarian cancer (2022)
REGN5668 -Ovarian cancer
Bispecific antibody targeting
MUC16 and CD28
REGN5678 -Prostate cancer -Report results from Phase 1
Bispecific antibody targeting study in prostate cancer
PSMA and CD28 (2022)
REGN5093 -MET-altered advanced NSCLC
Bispecific antibody targeting two
distinct MET epitopes
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Clinical Program Select Upcoming
(continued) Phase 1 Phase 2 Phase 3 Regulatory Review(i) 2021 Events
to Date Milestones(j)
Fianlimab(f) -Solid tumors and -Presented positive -Initiate Phase 3 study
(REGN3767) advanced data from Phase 1 in first-line
Antibody to LAG-3 hematologic trial in combination metastatic melanoma
malignancies with Libtayo in (2022)
advanced melanoma at
American Society of
Clinical Oncology
Annual Meeting
REGN6569 -Solid tumors
Antibody to GITR
REGN7075 -Solid tumors
Bispecific antibody
targeting EGFR and
CD28
Hematology
Odronextamab -Certain B-cell -B-cell non-Hodgkin -Resumed enrollment -Initiate Phase 3
(REGN1979) malignancies(c) lymphoma ("B-NHL") of patients with program
Bispecific antibody (potentially pivotal follicular lymphoma
targeting CD20 and CD3 study) ("FL") and diffuse
large B-cell lymphoma
("DLBCL") following
protocol amendments
REGN5458(f) -Multiple myeloma -Expand into earlier
Bispecific antibody (potentially pivotal lines of multiple
targeting BCMA and CD3 study) myeloma therapy (second
half 2021)
REGN5459(f) -Multiple myeloma
Bispecific antibody
targeting BCMA and CD3
Pozelimab(f) -CD55-deficient -Initiate Phase 3 study
(REGN3918) protein-losing in PNH, cemdisiran
Antibody to C5; enteropathy(c), combination (2022)
studied as monotherapy monotherapy
and in combination (potentially pivotal -Initiate Phase 3 study
with cemdisiran study) in myasthenia gravis,
cemdisiran combination
-Paroxysmal nocturnal (Q4 2021)
hemoglobinuria
("PNH"), cemdisiran
combination(c)(o)
Cemdisiran(o) -Immunoglobulin A
siRNA therapeutic nephropathy
targeting C5
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Select Upcoming
Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review(i) 2021 Events to Date Milestones(j)
REGN7257 -Aplastic anemia
Antibody to IL2Rg
NTLA-2001(n) -Hereditary -Reported positive interim
TTR gene knockout using CRISPR/Cas9 transthyretin data from Phase 1 trial in
amyloidosis with ATTRv-PN
polyneuropathy
("ATTRv-PN")
General Medicine
REGEN-COV (casirivimab and -COVID-19 multi-dose -COVID-19 dose-ranging -COVID-19 treatment in -COVID-19 treatment -Reported that Phase 3 trials -Complete rolling BLA and imdevimab)(e)(g)(l)(m)
safety study virology study in non-hospitalized patients and
prevention (
non-hospitalized patients and EU) patients met primary and key treatment and prevention
SARS-CoV-2 virus -COVID-19 treatment in secondary endpoints (second half 2021)
hospitalized patients -EUA amendment to
add COVID-19 -NIH COVID-19 Treatment
-COVID-19 treatment in treatment for Guidelines updated to strongly
hospitalized patients hospitalized recommend REGEN-COV be used in
(UK-based RECOVERY trial) patients and non-hospitalized COVID-19
pre-exposure patients at high risk of
-COVID-19 prevention prophylaxis clinical progression
-Reported that all tested
doses in Phase 2 dose-ranging
study in non-hospitalized
patients met the primary
endpoint
-FDA updated EUA, lowering
dose to 1,200 mg, allowing for
subcutaneous injections in
certain circumstances, and to
include post-exposure
prophylaxis
-Approved by Ministry of
Health, Labour and Welfare
("MHLW") for COVID-19
treatment in Japan
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Select Upcoming
Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review(i) 2021 Events to Date Milestones(j)
REGEN-COV (casirivimab and -Reported that Phase 3
imdevimab)(e)(g)(l)(m) prevention trial in
(continued) uninfected household
contacts of SARS-CoV-2
infected individuals met
primary and key secondary
endpoints
-Positive results reported
from Phase 3 RECOVERY
trial in hospitalized
patients
Praluent (alirocumab) -HeFH in pediatrics -Approved by FDA for HoFH
Antibody to PCSK9
Fasinumab(k)(f) (REGN475) -Osteoarthritis pain of -Report additional
Antibody to NGF the knee or hip(e) longer-term safety results
from Phase 3 studies in
osteoarthritis pain of the
knee or hip (second half
2021)
-Continue discussions with
regulatory authorities and
determine next steps for
the program (second half
2021)
Evkeeza (evinacumab)(f)
-Severe hypertriglyceridemia
-Approved by FDA and EC
Antibody to ANGPTL3 for HoFH
Garetosmab(f) (REGN2477)
-Fibrodysplasia ossificans
-Further review trial data
Antibody to Activin A progressiva and determine next steps
("FOP")(c)(d)(e) (potentially
for the program (second
pivotal study) half 2021)
REGN4461(f) -Generalized lipodystrophy(e)
Agonist antibody to leptin receptor
("LEPR")
REGN5381 -Heart failure
Agonist antibody to NPR1
ALN-HSD(o) -Nonalcoholic steatohepatitis
RNAi therapeutic targeting HSD17B13 ("NASH")
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Note: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after
recruitment for the corresponding study or studies has commenced
(a) In collaboration with Sanofi
(b) In collaboration with Bayer outside of the United States
(c) FDA granted orphan drug designation
(d) FDA granted Breakthrough Therapy designation
(e) FDA granted Fast Track designation
(f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate. Under the terms of
our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate.
(g) We and the Biomedical Advanced Research Development Authority ("BARDA") of the U.S. Department of Health and
Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research and
development of this product candidate
(h) Studied as monotherapy and in combination with other antibodies and treatments
(i) Information in this column relates to U.S. , EU, and Japan regulatory submissions only
(j) As described in the section preceding the table above and Part II, Item 1A. "Risk Factors," development
timelines may be further subject to change as a result of the impact of the COVID-19 pandemic
(k) In collaboration with Teva and Mitsubishi Tanabe Pharma
(l) Certain trials conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the
NIH
(m) In collaboration with Roche
(n) In collaboration with Intellia
(o) In collaboration with Alnylam
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General
Our ability to generate profits and to generate positive cash flow from
operations over the next several years depends significantly on the continued
success in commercializing EYLEA and Dupixent. We expect to continue to incur
substantial expenses related to our research and development activities, a
portion of which we expect to be reimbursed by our collaborators. Also, our
research and development activities outside our collaborations, the costs of
which are not reimbursed, are expected to expand and require additional
resources. We also expect to incur substantial costs related to the
commercialization of our marketed products. Our financial results may fluctuate
from quarter to quarter and will depend on, among other factors, the net sales
of our marketed products; the scope and progress of our research and development
efforts; the timing of certain expenses; the continuation of our collaborations,
in particular with Sanofi and Bayer, including our share of collaboration
profits or losses from sales of commercialized products and the amount of
reimbursement of our research and development expenses that we receive from
collaborators; and the amount of income tax expense we incur, which is partly
dependent on the profits or losses we earn in each of the countries in which we
operate. We cannot predict whether or when new products or new indications for
marketed products will receive regulatory approval or, if any such approval is
received, whether we will be able to successfully commercialize such product(s)
and whether or when they may become profitable.
Additional Information - Clinical Development Programs
REGEN-COV (casirivimab and imdevimab)
Treatment Study - Non-Hospitalized Patients
In February 2021 , the IDMC for the REGEN-COV Phase 3 trial in non-hospitalized
patients with COVID-19 found clear clinical efficacy for reducing the rate of
hospitalization and death with both the 1,200 mg and 2,400 mg doses of REGEN-COV
compared to placebo, and recommended stopping enrollment in the placebo group.
In March 2021 , we announced positive top-line results from the Phase 3 trial in
non-hospitalized COVID-19 patients. The trial met its primary endpoint, showing
that REGEN-COV reduced the risk of hospitalization or death by 70% (1,200 mg
dose IV) and 71% (2,400 mg dose IV) compared to placebo. The trial also met key
secondary endpoints, including the ability to reduce symptom duration.
In March 2021 , the Company also announced that all tested doses (IV: 2,400 mg,
1,200 mg, 600 mg and 300 mg; subcutaneous injections: 1,200 mg and 600 mg) in
the Phase 2 dose-ranging trial in non-hospitalized COVID-19 patients met the
primary endpoint.
In April 2021 , the Company announced positive data from the Phase 3 treatment
trial in recently infected asymptomatic COVID-19 patients. The trial was being
jointly run with the NIAID and met all primary and key secondary endpoints. The
trial demonstrated that the 1,200 mg subcutaneous injection of REGEN-COV reduced
the risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and
by 76% after the third day.
Treatment Study - Hospitalized Patients
In June 2021 , positive results were reported from the Phase 3 UK-based RECOVERY
trial in hospitalized patients with severe COVID-19. The trial found that adding
REGEN-COV to usual care reduced the risk of death by 20% in patients who had not
mounted a natural antibody response on their own against SARS-CoV-2, compared to
usual care alone. We have shared these data with regulatory authorities and
requested that the EUA be expanded to include COVID-19 treatment for appropriate
hospitalized patients. We were subsequently notified by the sponsor of the
RECOVERY trial of a Good Clinical Practices ("GCPs") inspection of the trial by
the UK Medicines and Healthcare Products Regulatory Agency ("MHRA"), which found
certain deviations from GCP compliance. The MHRA report stated that it found no
evidence that the identified issues had impacted the overall data integrity to
such an extent that the data would be unreliable based on those findings.
However, it noted that certain aspects of data quality could not be fully
assured and requested that certain corrective and preventative actions be taken;
the sponsor of the trial has been in discussions with the MHRA and is responding
to these findings. We have shared this information with the FDA.
In the Phase 2/3 portion of the treatment study in hospitalized patients being
run by the Company, REGEN-COV met the primary virologic endpoint, showing that
REGEN-COV reduced viral load in these hospitalized patients, but did not achieve
statistical significance in the pre-specified primary clinical endpoint:
reduction in mechanical ventilation or death from day 6 to day 29 in patients
with high viral load at baseline. However, four out of five secondary clinical
endpoints of the study were nominally significant including an endpoint
preferred by the FDA: reduction in mechanical ventilation or death from day 1 to
day 29 in all patients who were SARS-CoV-2 PCR-positive at baseline. The
relative risk reduction with REGEN-COV versus placebo ranged from approximately
24% to 47% on these various clinical endpoints. In addition, an approximately
36% reduction in all-cause mortality was seen from day 1 to day 29, supporting
the results of the RECOVERY trial.
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Prevention Study
In April 2021 , we announced positive results from the Phase 3 COVID-19
prevention trial in household contacts of SARS-CoV-2 infected individuals. The
trial, which was jointly run with the NIAID, part of the NIH , met its primary
and key secondary endpoints, showing that REGEN-COV 1,200 mg subcutaneous
injection reduced the risk of symptomatic infections by 81% in those who were
not infected.
Agreements Related to COVID-19
U.S. Government
In the first quarter of 2020, the Company announced an expansion of its Other
Transaction Agreement with BARDA, pursuant to which HHS was obligated to fund
certain of our costs incurred for research and development activities related to
COVID-19 treatments.
In July 2020 , the Company also announced an agreement with entities acting at
the direction of BARDA and the U.S. Department of Defense to manufacture and
deliver filled and finished drug product of REGEN-COV to the U.S. government.
In January 2021 , the Company announced an agreement with an entity acting on
behalf of the U.S. Department of Defense and HHS to manufacture and deliver
additional filled and finished drug product of REGEN-COV to the U.S. government.
Pursuant to the agreement, the U.S. government was obligated to purchase all
filled and finished doses of drug product delivered by June 30, 2021 , up to 1.25
million doses, at the lowest treatment dose authorized or approved by the FDA
for the indication authorized under the EUA (as described under "Products -
REGEN-COV - Emergency and Temporary Use Authorizations" above).
The Company has completed its final deliveries of drug product under the
agreements described above. See "Results of Operations - Revenues" below for
REGEN-COV net product sales recognized during the three and six months ended
June 30, 2021 in connection with these agreements.
Roche
In August 2020 , we entered into a collaboration agreement with Roche to develop,
manufacture, and distribute the casirivimab and imdevimab antibody cocktail. We
lead global development activities for casirivimab and imdevimab, and the
parties jointly fund certain on-going studies, as well as any mutually agreed
additional new global studies to evaluate further the potential of casirivimab
and imdevimab in treating or preventing COVID-19.
Under the terms of the agreement, each party is obligated to dedicate a certain
amount of manufacturing capacity to casirivimab and imdevimab each year. We
distribute the product in the United States and Roche distributes the product
outside of the United States . The parties share gross profits from worldwide
sales based on a pre-specified formula, depending on the amount of manufactured
product supplied by each party to the market.
Collaboration, License, and Other Agreements
Sanofi
Antibody
We are collaborating with Sanofi on the global development and commercialization
of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration"). See
discussion below for updates related to the development and commercialization of
Praluent effective April 1, 2020 . Under the terms of the Antibody License and
Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding
80%-100% of agreed-upon development costs. We are obligated to reimburse Sanofi
for 30%-50% of worldwide development expenses that were funded by Sanofi based
on our share of collaboration profits from commercialization of collaboration
products. However, we are only required to apply 10% of our share of the profits
from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for
these development costs
Under our collaboration agreement, Sanofi records product sales for
commercialized products, and Regeneron has the right to co-commercialize such
products on a country-by-country basis. We co-commercialize Dupixent in the
United States and have exercised our option to co-commercialize Dupixent in
certain countries outside the United States . We currently anticipate commencing
co-commercialization of Dupixent in such countries outside the United States
later this year. We supply certain commercial bulk product to Sanofi. We and
Sanofi equally share profits and losses from sales within the United States . We
and Sanofi share profits outside the United States on a sliding scale based on
sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us), and
share losses outside the United States at 55% (Sanofi)/45% (us). In addition to
profit and loss sharing, we are entitled to receive sales milestone payments
from Sanofi. In the third quarter of 2020, the Company earned, and
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recognized as revenue, the first $50.0 million sales-based milestone from
Sanofi, upon aggregate annual sales of antibodies outside the United States
(including Praluent) exceeding $1.0 billion on a rolling twelve-month basis. We
are entitled to receive up to an aggregate of $200.0 million in additional
milestone payments from Sanofi, including the second sales milestone in the
amount of $50.0 million , when such sales outside the United States exceed $1.5
billion on a rolling twelve-month basis.
In April 2020 , the Company and Sanofi entered into an amendment to the LCA in
connection with, among other things, the removal of Praluent from the LCA such
that (i) effective April 1, 2020 , the LCA no longer governs the development,
manufacture, or commercialization of Praluent and (ii) the quarterly period
ended March 31, 2020 was the last quarter for which Sanofi and the Company
shared profits and losses for Praluent under the LCA. The parties also entered
into a Praluent Cross License & Commercialization Agreement (the "Praluent
Agreement") pursuant to which, effective April 1, 2020 , the Company, at its sole
cost, became solely responsible for the development and commercialization of
Praluent in the United States , and Sanofi, at its sole cost, is solely
responsible for the development and commercialization of Praluent outside of the
United States . Under the Praluent Agreement, Sanofi will pay the Company a 5%
royalty on Sanofi's net product sales of Praluent outside the United States
until March 31, 2032 . The Company will not owe Sanofi royalties on the Company's
net product sales of Praluent in the United States . Although each party will be
responsible for manufacturing Praluent for its respective territory, the parties
have entered into definitive supply agreements under which, for a certain
transitional period, the Company will continue to supply drug substance to
Sanofi and Sanofi will continue to supply finished product to Regeneron. With
respect to any intellectual property or product liability litigation relating to
Praluent, the parties have agreed that, effective April 1, 2020 , Regeneron and
Sanofi each will be solely responsible for any such litigation (including
damages and other costs and expenses thereof) in the United States and outside
the United States , respectively, arising out of Praluent sales or other
activities on or after April 1, 2020 (subject to Sanofi's right to set off a
portion of any third-party royalty payments resulting from certain patent
litigation proceedings against up to 50% of any Praluent royalty payment owed to
Regeneron). The parties will each bear 50% of any damages arising out of
Praluent sales or other activities prior to April 1, 2020 .
Immuno-Oncology
We are collaborating with Sanofi on the development and commercialization of
antibody-based cancer treatments in the field of immuno-oncology (the "IO
Collaboration").
Effective December 31, 2018 , the Company and Sanofi entered into an Amended and
Restated Immuno-oncology Discovery and Development Agreement (the "Amended IO
Discovery Agreement"), which narrowed the scope of the existing discovery and
development activities conducted by the Company ("IO Development Activities")
under the original 2015 Immuno -oncology Discovery and Development Agreement (the
"2015 IO Discovery Agreement") to developing therapeutic bispecific antibodies
targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the
"MUC16xCD3 Program") through clinical proof-of-concept. The Amended IO Discovery
Agreement provided for, among other things, Sanofi's prepayment for certain IO
Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program.
Under the terms of the Amended IO Discovery Agreement, the Company was required
to conduct development activities with respect to (i) the BCMAxCD3 Program
through the earlier of clinical proof-of-concept or the expenditure of $70.0
million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program
through the earlier of clinical proof-of-concept or the expenditure of $50.0
million (the "MUC16xCD3 Program Costs Cap"). We are obligated to reimburse
Sanofi for half of the development costs they funded that are attributable to
clinical development of antibody product candidates under the Amended IO
Discovery Agreement from our share of profits from commercialized IO
Collaboration products.
With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when the
applicable Program Costs Cap was reached, Sanofi had the option to license
rights to the product candidate and other antibodies targeting the same targets
for, with regard to BCMAxCD3, immuno-oncology indications, and with regard to
MUC16xCD3, all indications, pursuant to the Immuno -oncology License and
Collaboration Agreement (the "IO License and Collaboration Agreement"), as
amended. During the first quarter of 2021, Sanofi did not exercise its options
to license rights to these product candidates; as a result, we retain the
exclusive right to develop and commercialize such product candidates and Sanofi
will receive a royalty on sales (if any).
Under the terms of the IO License and Collaboration Agreement, the parties are
co-developing and co-commercializing Libtayo, an antibody targeting PD-1. We
have principal control over the development of Libtayo, and the parties share
equally, on an ongoing basis, development and commercialization expenses for
Libtayo.
With regard to Libtayo, we lead commercialization activities in the United
States , while Sanofi leads commercialization activities outside of the United
States and the parties equally share profits from worldwide sales. Sanofi has
exercised its option to co-commercialize Libtayo in the United States . We will
be entitled to a milestone payment of $375.0 million in the event that global
sales of Libtayo equal or exceed $2.0 billion in any consecutive twelve-month
period.
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Bayer
EYLEA outside the United States
We and Bayer are parties to a license and collaboration agreement for the global
development and commercialization outside the United States of EYLEA. Under the
agreement, we and Bayer collaborate on, and share the costs of, the development
of EYLEA. Bayer markets EYLEA outside the United States , where, for countries
other than Japan , the companies share equally in profits and losses from sales
of EYLEA. In Japan , we are entitled to receive a tiered percentage of between
33.5% and 40.0% of EYLEA net sales through 2021, and thereafter, the companies
will share equally in profits and losses from the sales of EYLEA.
We are obligated to reimburse Bayer for 50% of the development costs that it has
incurred under the agreement from our share of the collaboration profits
(including payments to us based on sales in Japan ). The reimbursement payment in
any quarter will equal 5% of the then outstanding repayment obligation, but
never more than our share of the collaboration profits in the quarter unless we
elect to reimburse Bayer at a faster rate.
Within the United States , we retain exclusive commercialization rights to EYLEA
and are entitled to all profits from such sales.
Teva
Fasinumab
We and Teva are parties to a collaboration agreement to develop and
commercialize fasinumab globally, excluding certain Asian countries that are
subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation
("MTPC"). In connection with the agreement, Teva made a $250.0 million
non-refundable up-front payment. We lead global development activities, and the
parties share equally, on an ongoing basis, development costs under a global
development plan. As of June 30, 2021 , we had earned an aggregate of $120.0
million of development milestones from Teva and we are entitled to receive up to
an aggregate of $340.0 million in additional development milestones and up to an
aggregate of $1.890 billion in contingent payments upon achievement of specified
annual net sales amounts. We are responsible for the manufacture and supply of
fasinumab globally.
Within the United States , we will lead commercialization activities, and the
parties will share equally in any profits or losses in connection with
commercialization of fasinumab. In the territory outside of the United States ,
Teva will lead commercialization activities and we will supply product to Teva
at a tiered purchase price, which is calculated as a percentage of net sales of
the product (subject to adjustment in certain circumstances).
Alnylam
In 2018, we and Alnylam Pharmaceuticals, Inc. entered into a collaboration to
discover RNA interference ("RNAi") therapeutics for NASH and potentially other
related diseases, as well as to research, co-develop and commercialize any
therapeutic product candidates that emerge from these discovery efforts
(including ALN-HSD, which is currently in Phase 1 clinical development). ALN-HSD
is being co-developed with Alnylam with terms generally consistent with the form
of a Co-Commercialization Collaboration Agreement in connection with the 2019
collaboration agreement as described below. Alnylam is conducting the Phase 1
clinical trial for ALN-HSD and Regeneron will be responsible for all other
development as the lead party. The parties share equally, on an ongoing basis,
development expenses for ALN-HSD.
In 2019, we and Alnylam 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. Under the terms of the agreement, we made an up-front
payment of $400.0 million to Alnylam. For each program, we will provide Alnylam
with a specified amount of funding at program initiation and at lead candidate
designation, and Alnylam is eligible to receive up to an aggregate of $200.0
million in clinical proof-of-principle milestones for eye and CNS programs.
In addition, during 2019, the parties entered into a Co-Commercialization
Collaboration Agreement for a silencing RNA ("siRNA") therapeutic targeting the
C5 component of the human complement pathway being developed by Alnylam, with
Alnylam as the lead party, and a License Agreement for a combination product
consisting of cemdisiran and pozelimab, with us as the licensee. Under the C5
siRNA Co-Commercialization Collaboration agreement, the parties share costs
equally and will split profits (if commercialized); and under the License
Agreement, the licensee is responsible for its own costs and expenses. The C5
siRNA License Agreement contains a flat low double-digit royalty payable to
Alnylam on our potential future net sales of the combination product only
subject to customary reductions, as well as up to $325.0 million in commercial
milestones.
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Intellia
In 2016, we entered into a license and collaboration agreement with Intellia
Therapeutics, Inc. to advance CRISPR/Cas9 gene-editing technology for in vivo
therapeutic development. NTLA-2001, which is in clinical development, is subject
to a co-development and co-commercialization arrangement pursuant to which
Intellia will lead development and commercialization activities and the parties
share an agreed-upon percentage of development expenses and profits (if
commercialized).
In May 2020 , we expanded our existing collaboration with Intellia Therapeutics,
Inc. 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. In addition, we also
received non-exclusive rights to independently develop and commercialize ex vivo
gene edited products. In connection with the May 2020 agreement, we made a $70.0
million up-front payment and purchased 925,218 shares of Intellia common stock
for an aggregate purchase price of $30.0 million . The up-front payment and the
amount paid in excess of the fair market value of the shares purchased, or $15.0
million , were recorded to Research and development expense in the second quarter
of 2020.
BARDA
We and BARDA are parties to agreements pursuant to which HHS provided certain
funding to develop, test, and manufacture a treatment for Ebola virus infection.
In July 2020 , HHS exercised its option under an existing agreement to provide up
to $344.6 million of additional funding for the manufacture and supply of
Inmazeb. We expect to deliver a pre-specified number of Inmazeb treatment doses
over the course of approximately six years.
See "Agreements Related to COVID-19 - U.S. Government " section above for
information related to our COVID-19 agreements.
Kiniksa
As described under "Products" above, pursuant to a 2017 license agreement, we
granted Kiniksa the right to develop and commercialize certain new indications
for ARCALYST. During the first quarter of 2021, Kiniksa received marketing
approval in the United States for a new indication of ARCALYST, recurrent
pericarditis, and, as a result, we received a $20.0 million milestone payment
from Kiniksa. The quarterly period ended March 31, 2021 was the last quarter for
which the Company recorded net product sales of ARCALYST.
Following this approval, Kiniksa is solely responsible for the U.S. development
and commercialization of ARCALYST in all approved indications, and Regeneron
will continue to supply clinical and commercial product to Kiniksa. Kiniksa will
pay Regeneron 50% of its profits from sales of ARCALYST and the parties will not
share in any losses incurred by Kiniksa in connection with commercialization of
ARCALYST.
Corporate Information
We were incorporated in the State of New York in 1988 and publicly listed in
1991. Our principal executive offices are located at 777 Old Saw Mill River
Road , Tarrytown, New York 10591, and our telephone number at that address is
(914) 847-7000.
We make available free of charge on or through our Internet website
(http://www.regeneron.com) our Annual Report on Form 10-K, Quarterly Reports on
Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those
reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange
Act, as soon as reasonably practicable after we electronically file such
material with, or furnish it to, the Securities and Exchange Commission ("SEC").
Investors and other interested parties should note that we use our media and
investor relations website (http://newsroom.regeneron.com) and our social media
channels to publish important information about Regeneron, including information
that may be deemed material to investors. We encourage investors and other
interested parties to review the information we may publish through our media
and investor relations website and the social media channels listed on our media
and investor relations website, in addition to our SEC filings, press releases,
conference calls, and webcasts.
The information contained on our websites and social media channels is not
included as a part of, or incorporated by reference into, this report.
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Results of Operations
Three and Six Months Ended June 30, 2021 and 2020
Net Income
Three Months Ended Six Months Ended
June 30 , June 30 ,
(In millions, except per share data) 2021 2020
2021 2020
Revenues $ 5,138.5 $ 1,952.0 $ 7,667.2 $ 3,780.2
Operating expenses 1,791.3 1,295.6 3,207.3 2,423.7
Income from operations 3,347.2 656.4 4,459.9 1,356.5
Other income (expense) 405.6 262.5 545.9 231.0
Income before income taxes 3,752.8 918.9
5,005.8 1,587.5
Income tax expense 653.9 21.6 791.7 65.6
Net income $ 3,098.9 $ 897.3 $ 4,214.1 $ 1,521.9 Net income per share - diluted$ 27.97 $ 7.61 $ 38.07 $ 13.03 Revenues Three Months Ended Six Months Ended June 30, June 30, (In millions) 2021 2020 $ Change 2021 2020 $ Change Net product sales in the United States: EYLEA$ 1,424.7 $ 1,113.7 $ 311.0 $ 2,771.7 $ 2,285.7 $ 486.0 Libtayo 78.0 63.3 14.7 147.1 125.0 22.1 Praluent 41.9 47.2 (5.3) 85.2 47.2 * * REGEN-COV 2,591.2 - 2,591.2 2,853.4 - 2,853.4 Evkeeza 2.0 - 2.0 2.5 - 2.5 ARCALYST - ** 2.7 ** 2.2 ** 5.7 ** Collaboration revenue: Sanofi 437.7 269.1 168.6 802.5 516.0 286.5 Bayer 349.1 244.2 104.9 671.9 525.6 146.3 Roche 167.9 - 167.9 234.7 - 234.7 Other revenue 46.0 211.8 (165.8) 96.0 275.0 (179.0) Total revenues$ 5,138.5 $ 1,952.0 $ 3,186.5 $ 7,667.2 $ 3,780.2 $ 3,887.0
* Net product sales of Praluent in
Net Product Sales Net product sales of EYLEA inthe United States increased for the three and six months endedJune 30, 2021 , compared to the same periods in 2020, primarily due to higher sales volume (including the adverse impact of the COVID-19 pandemic onU.S. EYLEA demand during the three months endedJune 30, 2020 ), partly offset by an increase in sales-related deductions. EffectiveApril 1, 2020 , the Company became solely responsible for the development and commercialization of Praluent inthe United States and records net product sales of Praluent inthe United States . Refer to "Collaboration, License, and Other Agreements - Sanofi - Antibody" section above for further details. 42 -------------------------------------------------------------------------------- Table of Contents During the three and six months endedJune 30, 2021 , net product sales of REGEN-COV were recorded in connection with our agreements with theU.S. government. Refer to "Agreements Related to COVID-19 -U.S. Government " section above for further details. EffectiveApril 1, 2021 , Kiniksa records net product sales of ARCALYST inthe United States . Prior toApril 1, 2021 , Regeneron recorded net product sales of ARCALYST inthe United States . Refer to "Collaboration, License, and Other Agreements - Kiniksa" section above for further details. Collaboration Revenue Sanofi Collaboration Revenue Three Months Ended Six Months Ended June 30, June 30, (In millions) 2021 2020 2021 2020 Antibody: Regeneron's share of profits in connection with commercialization of antibodies$ 327.6 $ 171.9 $ 588.2 $ 342.8 Reimbursement for manufacturing of commercial supplies(1) 110.9 100.6 216.5 180.7 Total Antibody 438.5 272.5 804.7 523.5 Immuno-oncology: Regeneron's share of losses in connection with commercialization of Libtayo outside the United States (3.5) (6.4) (9.6) (12.6) Reimbursement for manufacturing of commercial supplies(1) 2.7 3.0 7.4 5.1 Total Immuno-oncology (0.8) (3.4) (2.2) (7.5) Total Sanofi collaboration revenue$ 437.7
(1) Corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing
Antibody
Sanofi provides us with an estimate of our share of the profits or losses from commercialization of antibodies for the most recent fiscal quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits or losses is adjusted accordingly, as necessary. During the three and six months endedJune 30, 2021 , the change in our share of profits in connection with commercialization of antibodies, compared to the same periods of 2020, was driven by higher Dupixent profits. 43 -------------------------------------------------------------------------------- Table of Contents Regeneron's share of profits in connection with the commercialization of Dupixent, Praluent (throughMarch 31, 2020 ), and Kevzara is summarized below: Three Months Ended Six Months Ended June 30, June 30, (In millions) 2021 2020 2021 2020 Dupixent, Praluent, and Kevzara net product sales(1)$ 1,565.7
$ 364.5 $ 191.4 $ 654.4 $ 384.4 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation (36.9) (19.5) (66.2) (41.6) Regeneron's share of profits in connection with commercialization of antibodies$ 327.6 $ 171.9 $ 588.2 $ 342.8 Regeneron's share of collaboration profits as a percentage of Dupixent, Praluent, and Kevzara net product sales 21% 17% 20% 17%
(1) Global net product sales of Dupixent and Kevzara are recorded by Sanofi. The quarter ended
As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody", effectiveApril 1, 2020 , the Company became solely responsible for the development and commercialization of Praluent inthe United States . Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside ofthe United States , and pays the Company a 5% royalty on Sanofi's net product sales of Praluent outsidethe United States . Bayer Collaboration Revenue Three Months Ended Six Months Ended June 30, June 30, (In millions) 2021 2020 2021 2020 Regeneron's net profit in connection with commercialization of EYLEA outside the United States$ 335.4 $ 230.9 $ 644.3 $ 484.7 Reimbursement for manufacturing of commercial supplies(1) 13.7 13.3 27.6 40.9 Total Bayer collaboration revenue$ 349.1
(1) Corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing
Regeneron's net profit in connection with commercialization of EYLEA outside
Three Months Ended Six Months Ended
June 30, June 30,
(In millions) 2021 2020 2021 2020
EYLEA net product sales outside the United
States $ 903.8 $
641.0 $ 1,728.1
$ 350.4 $ 245.3 $ 674.1 $ 513.5 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (15.0) (14.4) (29.8) (28.8) Regeneron's net profit in connection with commercialization of EYLEA outside the United States$ 335.4 $ 230.9 $ 644.3 $ 484.7 Regeneron's net profit as a percentage of EYLEA net product sales outside the United States 37% 36% 37% 37% Bayer records net product sales of EYLEA outsidethe United States . Bayer provides us with an estimate of our share of the profit, including the percentage of sales inJapan that we earned, from commercialization of EYLEA outsidethe United States for the most recent fiscal quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profit is adjusted accordingly, as necessary. 44 -------------------------------------------------------------------------------- Table of Contents Roche Collaboration Revenue As described above under "Agreements Related to COVID-19 - Roche", Roche distributes and records net product sales of the casirivimab and imdevimab antibody cocktail outsidethe United States , and the parties share gross profits. During the three and six months endedJune 30, 2021 , Regeneron's share of gross profits in connection with sales of casirivimab and imdevimab outsidethe United States was$167.9 million and$234.7 million , respectively. Roche provides us with an estimate of our share of the gross profits for the most recent fiscal quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits is adjusted accordingly, as necessary. Other Revenue Other revenue decreased during the three and six months endedJune 30, 2021 , compared to the same periods of 2020, primarily due to lower amounts recognized in connection with our agreement with BARDA related to funding of certain development activities for antibodies for the treatment of COVID-19, and, to a lesser extent, Inmazeb. In addition, a$30.0 million up-front payment from Zai Lab was recorded in Other revenue in the second quarter of 2020 in connection with our collaboration agreement. This decrease in Other revenue for the six months endedJune 30, 2021 was partly offset by a$20.0 million milestone payment received from Kiniksa during 2021 in connection with our ARCALYST license agreement. Expenses Three Months Ended Six Months Ended June 30, June 30, (In millions, except headcount data) 2021 2020 $ Change 2021 2020 $ Change Research and development(1)$ 714.2 $ 722.0 $ (7.8) $ 1,457.1 $ 1,305.9 $ 151.2 Selling, general, and administrative(1) 414.7 348.3 66.4 820.3 715.6 104.7 Cost of goods sold(2) 539.4 102.5 436.9 722.6 181.3 541.3 Cost of collaboration and contract manufacturing(3) 154.3 173.0 (18.7) 279.1 311.5 (32.4) Other operating (income) expense, net (31.3) (50.2) 18.9 (71.8) (90.6) 18.8 Total operating expenses$ 1,791.3 $ 1,295.6 $ 495.7 $ 3,207.3 $ 2,423.7 $ 783.6 Average headcount 9,822 8,254 1,568 9,635 8,142 1,493 (1) Includes costs incurred as well as cost reimbursements from collaborators who are not deemed to be our customers (2) Cost of goods sold primarily includes costs in connection with producing commercial supplies for products that are sold by Regeneron inthe United States (i.e., for which we record net product sales), any royalties we are obligated to pay on such sales, and amounts we are obligated to pay to Sanofi for its share of LibtayoU.S. gross profits (3) Cost of collaboration and contract manufacturing includes costs we incur in connection with producing commercial drug supplies for collaborators and others Operating expenses included a total of$145.5 million and$103.5 million for the three months endedJune 30, 2021 and 2020, respectively, and$276.4 million and$209.3 million for the six months endedJune 30, 2021 and 2020, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans. Research and Development Expenses The following table summarizes our estimates of direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related external drug filling, packaging, and labeling costs. Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred. 45 --------------------------------------------------------------------------------
Table of Contents
Three Months Ended Six Months Ended
June 30, June 30,
(In millions) 2021 2020* $ Change 2021 2020* $ Change
Direct research and development
expenses:
REGEN-COV $ 97.2 $ 14.1 $ 83.1 $ 305.9 $ 14.1 $ 291.8
Libtayo (cemiplimab) 38.2 35.4 2.8 78.0 71.4 6.6
Dupixent (dupilumab) 37.0 31.7 5.3 64.4 66.2 (1.8)
EYLEA 26.7 11.2 15.5 54.8 28.8 26.0
Fasinumab 20.2 43.2 (23.0) 51.7 83.7 (32.0)
Up-front payments related to license
and collaboration agreements - 85.0 (85.0) - 85.0 (85.0)
Other product candidates in clinical
development and other research
programs 108.5 157.2 (48.7) 193.2 272.4 (79.2)
Total direct research and development
expenses 327.8 377.8 (50.0) 748.0 621.6 126.4
Indirect research and development
expenses:
Payroll and benefits 236.9 193.4 43.5 469.9 391.4 78.5
Lab supplies and other research and
development costs 33.4 30.6 2.8 66.8 65.5 1.3
Occupancy and other operating costs 98.5 80.8 17.7 193.6 162.7 30.9
Total indirect research and
development expenses 368.8 304.8 64.0 730.3 619.6 110.7
Clinical manufacturing costs 153.8 181.2 (27.4) 287.4 361.5 (74.1)
Reimbursement of research and
development expenses by collaborators (136.2) (141.8) 5.6 (308.6) (296.8) (11.8)
Total research and development
expenses $ 714.2 $ 722.0 $ (7.8) $ 1,457.1 $ 1,305.9 $ 151.2 * Certain prior year amounts have been reclassified to conform to the current year's presentation
Research and development expenses for the three and six months endedJune 30, 2020 included$85.0 million in aggregate up-front payments made in connection with our collaboration agreement with Intellia (see "Collaboration and License Agreements - Intellia" above). Direct research and development expenses in 2020 also include costs incurred in connection with Kevzara for the treatment of COVID-19 patients (included within "Other product candidates in clinical development and other research programs" in the table above). Reimbursement of research and development expenses by collaborators included$41.0 million and$127.8 million of reimbursements from Roche related to REGEN-COV for the three and six months endedJune 30, 2021 , respectively. There were no reimbursements of research and development expenses by collaborators related to REGEN-COV during the three and six months endedJune 30, 2020 . Research and development expenses included non-cash compensation expense of$70.9 million and$56.9 million for the three months endedJune 30, 2021 and 2020, respectively, and$140.6 million and$113.6 million for the six months endedJune 30, 2021 and 2020, respectively. There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A. "Risk Factors" (including those relating to the disruptions caused by the COVID-19 pandemic). There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects. The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially 46 -------------------------------------------------------------------------------- Table of Contents adversely affect our business. We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows. Selling, General, and Administrative Expenses Selling, general, and administrative expenses increased for the three and six months endedJune 30, 2021 , compared to the same periods in 2020, primarily due to higher headcount-related costs, and an increase in commercialization-related expenses for EYLEA and Libtayo. In addition, the three months endedJune 30, 2021 included costs associated with educational campaigns related to COVID-19. Selling, general, and administrative expenses also included non-cash compensation expense of$49.6 million and$38.2 million for the three months endedJune 30, 2021 and 2020, respectively, and$100.4 million and$78.5 million for the six months endedJune 30, 2021 and 2020, respectively. Cost of Goods Sold Cost of goods sold increased for the three and six months endedJune 30, 2021 , compared to the same periods in 2020, primarily due to the recognition of manufacturing costs in connection with product sales of REGEN-COV (refer to "Agreements Related to COVID-19 -U.S. Government " section above for further details). In addition, Cost of goods sold included inventory write-offs and reserves totaling$139.9 million and$149.3 million for the three and six months endedJune 30, 2021 , respectively, primarily related to REGEN-COV. For the three and six months endedJune 30, 2020 , such amounts were not material. Cost of Collaboration and Contract Manufacturing Cost of collaboration and contract manufacturing decreased for the three and six months endedJune 30, 2021 , compared to the same periods in 2020, primarily due to the recognition of process validation costs during 2020 in connection with manufacturing Inmazeb under our BARDA agreement; such costs did not recur during 2021. This decrease was largely offset by the recognition of manufacturing costs associated with higher sales of Dupixent. Other Operating (Income) Expense Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with Sanofi IO, Teva, and MTPC collaborative arrangements. Other Income (Expense) Other income (expense), net, for the three and six months endedJune 30, 2021 , compared to the same periods in 2020, was primarily impacted by the recognition of higher unrealized gains on equity securities. Income Taxes Three Months Ended Six Months Ended June 30, June 30, (In millions, except effective tax rate) 2021 2020 2021 2020 Income tax expense $ 653.9$ 21.6 $ 791.7$ 65.6 Effective tax rate 17.4 % 2.4 % 15.8 % 4.1 % Our effective tax rate for the three and six months endedJune 30, 2021 was positively impacted, compared to theU.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than theU.S. federal statutory rate and federal tax credits for research activities. In addition, the effective tax rate for the six months endedJune 30, 2021 was positively impacted by the reversal of liabilities related to uncertain tax positions. Our effective tax rate for the three and six months endedJune 30, 2020 was positively impacted, compared to theU.S. federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than theU.S. federal statutory rate and federal tax credits for research activities. 47 -------------------------------------------------------------------------------- Table of Contents Liquidity and Capital Resources Our financial condition is summarized as follows: June 30, December 31, (In millions) 2021 2020 $ Change Financial assets: Cash and cash equivalents$ 2,072.2 $ 2,193.7 $ (121.5) Marketable securities - current 1,838.6 1,393.3 445.3 Marketable securities - noncurrent 3,900.3 3,135.6 764.7$ 7,811.1 $ 6,722.6 $ 1,088.5 Borrowings: Long-term debt$ 1,979.2 $ 1,978.5 $ 0.7 Working capital: Current assets$ 13,337.6 $ 9,779.1 $ 3,558.5 Current liabilities 3,732.4 2,697.4 1,035.0$ 9,605.2 $ 7,081.7 $ 2,523.5 As ofJune 30, 2021 , we also had borrowing availability of$750.0 million under a revolving credit facility. Sources and Uses of Cash for the Six Months EndedJune 30, 2021 and 2020
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