3 unchanged sentences
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.
−Removed: 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 by Regeneron and/or its collaborators (collectively, "Regeneron’s Products"), and the global economy;
−Removed: the nature, timing, and possible success and therapeutic applications of Regeneron's Products and our 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, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, REGN-COV2, Regeneron's oncology programs (including its costimulatory bispecific portfolio), Regeneron's earlier-stage programs, and the use of human genetics in Regeneron's research programs;
+Added: 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;
+Added: the nature, timing, and possible success and therapeutic applications of Regeneron's Products and our 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, Inmazeb TM (atoltivimab, maftivimab, and odesivimab-ebgn), REGN-COV2, fasinumab, evinacumab, garetosmab, pozelimab, Regeneron's oncology programs (including its costimulatory bispecific portfolio), Regeneron's 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 product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and product candidates in clinical trials;
−Removed: 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 EYLEA, Dupixent, Libtayo, Praluent, Kevzara, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, REGN-COV2, and REGN1979;
+Added: 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 EYLEA, Dupixent, Libtayo, Praluent, Kevzara, Inmazeb, REGN-COV2, fasinumab, evinacumab, garetosmab, pozelimab, and odronextamab;
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;
5 unchanged sentences
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 product candidates;
−Removed: the availability and extent of reimbursement of Regeneron’s Products from third-party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;
−Removed: coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers;
+Added: 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;
+Added: coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors;
unanticipated expenses;
2 unchanged sentences
the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd.
−Removed: (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success;
+Added: (or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to REGN-COV2, 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, and Praluent 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.
10 unchanged sentences
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions, except per share data) 2020 2019 *
2 unchanged sentences
Net income per share - diluted $ 7.39 $ 5.86 $ 20.36 $ 11.54
−Removed: * Certain revisions have been made to the previously reported June 30, 2019 revenues.
+Added: * Certain revisions have been made to the previously reported revenues for the periods ended September 30, 2019.
See Note 1 to our Condensed Consolidated Financial Statements for further details.
−Removed: Marketed Products
−Removed: We currently have seven products that have received marketing approval, which are currently marketed by us, Bayer, and/or Sanofi:
Product Disease Area (1)
9 unchanged sentences
- Atopic dermatitis (in adults and adolescents) (7)
−Removed: - Atopic dermatitis (in pediatrics 6–11 years of age) a
+Added: - Atopic dermatitis (in pediatrics 6–11 years of age) a a
- Asthma (in adults and adolescents) a a a a
2 unchanged sentences
- Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a a
+Added: Product (continued)
+Added: Disease Area (1)
+Added: EU Japan ROW (6)
Praluent (alirocumab) Injection (5)
3 unchanged sentences
- Rheumatoid arthritis ("RA") (in adults) a a a a
+Added: Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection - Infection caused by Zaire ebolavirus
ARCALYST ® (rilonacept) Injection for Subcutaneous Use
2 unchanged sentences
- Metastatic colorectal cancer ("mCRC") a a a a
+Added: 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, Bayer, or Sanofi
(1) Refer to label information in each territory for specific indication
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Pursuant to the April 2020 agreement, Sanofi pays us a royalty on net product sales of Praluent outside the United States.
−Removed: Refer to "Collaboration and License Agreements" section below for further details.
+Added: Refer to "Collaboration, License, and Other Agreements" section below for further details.
(6) Rest of world.
5 unchanged sentences
Net Product Sales Recorded by Regeneron Three Months Ended
+Added: September 30,
2020 2019 % Change
6 unchanged sentences
Kevzara (b) $ 33.2 $ 36.8 $ 70.0 $ 36.5 $ 18.3 $ 54.8 28 %
+Added: REGN-COV2 (d)
+Added: $ 40.2 — $ 40.2 — — — (e)
ZALTRAP (b) $ 1.7 $ 22.5 $ 24.2 $ 3.1 $ 25.3 $ 28.4 (15 %)
1 unchanged sentence
$ 3.6 — $ 3.6 $ 3.0 — $ 3.0 20 %
−Removed: Net Product Sales Recorded by Regeneron Six Months Ended
+Added: Net Product Sales Recorded by Regeneron Nine Months Ended
+Added: September 30,
2020 2019 % Change
6 unchanged sentences
Kevzara (b) $ 105.0 $ 93.4 $ 198.4 $ 91.4 $ 55.6 $ 147.0 35 %
+Added: REGN-COV2 (d)
+Added: $ 40.2 — $ 40.2 — — — (e)
ZALTRAP (b) $ 4.9 $ 74.0 $ 78.9 $ 4.9 $ 74.6 $ 79.5 (1 %)
11 unchanged sentences
Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such sales.
−Removed: Refer to "Marketed Products" section above and "Collaboration and License Agreements - Sanofi" section below for further details.
+Added: Refer to "Products" section above and "Collaboration, License, and Other Agreements - Sanofi" section below for further details.
+Added: (d) Regeneron records net product sales of REGN-COV2 in connection with our agreement with the U.S.
+Added: Refer to "Agreements Related to COVID-19 - BARDA " below for further details.
+Added: (e) Percentage not meaningful
Programs in Clinical Development
3 unchanged sentences
We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, manufacture, and commercialize new product candidates.
−Removed: 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.
+Added: 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
+Added: 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.
1 unchanged sentence
The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and will continue to impact our clinical development programs.
−Removed: We continue to evaluate the impact of the COVID-19 pandemic on an individual trial basis and are
−Removed: working to ensure patient safety, provide sufficient supply of product candidates for the studies, and oversee trial management.
+Added: 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.
At this time, we expect fully enrolled clinical studies to remain generally on track.
−Removed: While the COVID-19 pandemic and the resulting constraints on healthcare resources and local or regional restrictions initially adversely impacted new clinical studies and recruitment of new patients into open studies, enrollment in both new and ongoing clinical studies started to resume as regions relaxed their restrictions and healthcare resources started to become more available for non-COVID-19 activities.
−Removed: However, there has been a resurgence of COVID-19 cases in many regions across the world, and any resurgence of COVID-19 cases in the regions in which we or our collaborators conduct clinical trials may require our expectations relating to the impacted studies to adjust.
−Removed: The ultimate impact (including possible delays) resulting from the COVID-19 pandemic will depend, among other factors, on the extent of the pandemic in the areas with study sites for our or our collaborators' clinical programs.
+Added: However, the ongoing pandemic continues to impact clinical trial execution in many regions across the world for us and our collaborators.
+Added: 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.
12 unchanged sentences
Antibody to IL-4R alpha subunit
−Removed: - Peanut allergy - Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d)
+Added: - Grass allergy - Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d)
- Atopic dermatitis in pediatrics (6–11 years of age) (EU) (d)
−Removed: - Approved by FDA for expanded atopic dermatitis indication in pediatrics (6–11 years of age) - EC decision for expanded atopic dermatitis indication in pediatrics (6–11 years of age) (second half 2020)
−Removed: - Asthma in pediatrics (6–11 years of age) - Auto-injector for 300 mg dose (Japan) - Approved by National Medical Products Administration ("NMPA") in China for adults with atopic dermatitis - Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)
+Added: - Approved by FDA for expanded atopic dermatitis indication in pediatrics (6–11 years of age) - EC decision for expanded atopic dermatitis indication in pediatrics (6–11 years of age) (fourth quarter 2020)
+Added: - Peanut allergy
+Added: - Asthma in pediatrics (6–11 years of age) - Approved by National Medical Products Administration ("NMPA") in China for adults with atopic dermatitis - Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022)
- Eosinophilic esophagitis
−Removed: ("EoE") (c) in adults, adolescents, and pediatrics
−Removed: - Approved by MHLW for CRSwNP in Japan - Report results from Phase 3 study for asthma in pediatric patients (6–11 years of age) (second half 2020)
−Removed: - Chronic obstructive pulmonary disease ("COPD") - Approved by FDA for 300 mg auto-injector
+Added: ("EoE") (c) in adults (d) , adolescents (d) , and pediatrics
+Added: - European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") recommended approval for an additional indication in children aged 6 to 11 with atopic dermatitis - Submit supplemental Biologics License Application ("sBLA") and Marketing Authorization Application ("MAA") for asthma in pediatrics (6–11 years of age) (first quarter 2021)
+Added: - Chronic obstructive pulmonary disease ("COPD")
- Bullous pemphigoid (Phase 2/3) (c)
−Removed: - Reported that Part A of the Phase 3 trial in adult and adolescent patients with EoE met both co-primary endpoints - Resubmit supplemental Biologics License Application ("sBLA") for 200 mg auto-injector (second half 2020)
−Removed: - Chronic spontaneous urticaria
−Removed: - Prurigo nodularis - Presented results from Phase 2a trial in grass allergy - Report results from Phase 2 study in peanut allergy (second half 2020)
−Removed: - Initiated second confirmatory Phase 3 trial in COPD - Report results from Part B of the Phase 3 study in adults and adolescents with EoE (2022)
+Added: - Chronic spontaneous urticaria - Reported that Phase 3 trial for asthma in children aged 6 to 11 years met its primary and key secondary endpoints - Report results from Part B of the Phase 3 study in adults and adolescents with EoE (2022)
+Added: - Prurigo nodularis
+Added: - Allergic bronchopulmonary aspergillosis ("ABPA") - Report results from Phase 2 study in peanut allergy (fourth quarter 2020)
+Added: - Approved by MHLW for CRSwNP in Japan
+Added: - Approved by FDA and MHLW for 300 mg auto-injector - Resubmit sBLA for 200 mg auto-injector (fourth quarter 2020)
Clinical Program (continued)
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2020 Events to Date Select Upcoming Milestones (k)
−Removed: - Allergic bronchopulmonary aspergillosis ("ABPA") - Initiate Phase 3 study in hand and foot atopic dermatitis (second half 2020)
+Added: - Reported that Part A of the Phase 3 trial in adult and adolescent patients with EoE met both co-primary endpoints - Report results from Phase 3 chronic spontaneous urticaria and prurigo nodularis studies (second half 2021)
+Added: - Presented results from Phase 2a trial in grass allergy - Initiate Phase 3 studies in chronic inducible urticaria, chronic sinusitis without nasal polyposis, and allergic fungal rhinosinusitis (fourth quarter 2020)
+Added: - Initiated second confirmatory Phase 3 trial in COPD
+Added: - Initiate Phase 3 study in hand and foot atopic dermatitis (first half 2021)
Kevzara (sarilumab) (a)
Antibody to IL-6R
−Removed: - Polyarticular-course juvenile idiopathic arthritis ("pcJIA") - Hospitalized "critical" COVID-19 patients (outside the United States) - Stopped Phase 3 U.S.
−Removed: trial in COVID-19 patients due to study not meeting its primary and key secondary endpoints - Report results from Phase 3 study outside the United States in COVID-19 (second half 2020)
+Added: - Polyarticular-course juvenile idiopathic arthritis ("pcJIA") - Reported that Phase 3 studies in COVID-19 patients did not meet primary and key secondary endpoints
- Systemic juvenile idiopathic arthritis ("sJIA")
- Discontinued clinical development in polymyalgia rheumatica and giant cell arteritis
+Added: Itepekimab (a) (REGN3500)
Antibody to IL-33
−Removed: Studied as monotherapy and in combination with Dupixent.
−Removed: - Asthma - Discontinued further clinical development in atopic dermatitis due to lack of efficacy
+Added: - Asthma - Discontinued further clinical development in atopic dermatitis due to lack of efficacy - Initiate Phase 3 study in COPD (fourth quarter 2020)
REGN1908-1909 (f)
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Antibody to Betv1
−Removed: - Birch allergy
−Removed: Libtayo (cemiplimab) (a)(h)
−Removed: Antibody to PD-1
−Removed: - Solid tumors and advanced hematologic malignancies - Basal cell carcinoma ("BCC")
−Removed: (potentially pivotal study) - First-line non-small cell lung cancer ("NSCLC"), monotherapy - Reported that Phase 3 monotherapy trial in first-line NSCLC met its primary endpoint.
−Removed: The Independent Data Monitoring Committee ("IDMC") recommended stopping the trial early due to highly significant improvement in overall survival.
−Removed: - Submit sBLA and Marketing Authorization Application ("MAA") for first-line NSCLC, monotherapy (second half 2020)
+Added: - Birch allergy - Initiate Phase 3 study in birch allergy (first half 2021)
+Added: Antibody to IL2Rg
+Added: - Aplastic anemia
Clinical Program (continued)
1 unchanged sentence
2020 Events to Date Select Upcoming Milestones (k)
+Added: Libtayo (cemiplimab) (a)(h)
+Added: Antibody to PD-1
+Added: - Solid tumors and advanced hematologic malignancies - Basal cell carcinoma ("BCC")
+Added: (potentially pivotal study) - First-line non-small cell lung cancer ("NSCLC"), monotherapy - First-line NSCLC, monotherapy (U.S.
+Added: and EU) - Reported that Phase 3 monotherapy trial in first-line NSCLC met primary endpoint.
+Added: Independent Data Monitoring Committee ("IDMC") recommended stopping the trial early due to highly significant improvement in overall survival.
+Added: - FDA decision on sBLA (target action date of February 28, 2021) and EC decision on regulatory submission (mid-2021) for first-line NSCLC, monotherapy
- Metastatic or locally advanced CSCC (d)
−Removed: - First-line NSCLC, chemotherapy combination - Reported that Phase 2 study in BCC demonstrated clinically-meaningful and durable responses - Complete patient enrollment in Phase 3 first-line NSCLC chemotherapy combination study (second half 2020)
−Removed: - Neoadjuvant CSCC
−Removed: - Second-line cervical cancer (e)
−Removed: - Submit sBLA and MAA for BCC (second half 2020)
−Removed: - Adjuvant CSCC
−Removed: - Interim analysis from Phase 3 study in cervical cancer (2021)
+Added: - First-line NSCLC, chemotherapy combination - Advanced BCC (U.S.
+Added: - Neoadjuvant CSCC - Second-line cervical cancer (e)
+Added: - FDA decision on sBLA (target action date of March 3, 2021) and EC decision on regulatory submission (mid-2021) for advanced BCC
+Added: - Adjuvant CSCC - Completed patient enrollment in Phase 3 first-line NSCLC chemotherapy combination study
+Added: - Reported that Phase 2 study in BCC demonstrated clinically-meaningful and durable responses - Interim analysis from Phase 3 study in cervical cancer (2021)
+Added: - Presented positive data from pivotal NSCLC and BCC studies at the European Society for Medical Oncology ("ESMO") Virtual Congress 2020
+Added: Odronextamab (REGN1979)
Bispecific antibody targeting CD20 and CD3
- Certain B-cell malignancies (c)
−Removed: - B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) - Expanded potentially pivotal Phase 2 program with different subtypes of NHL - Report updated results from initial study in certain B-cell malignancies (second half 2020)
+Added: - B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) - Expanded potentially pivotal Phase 2 program with different subtypes of NHL - Report updated results from initial study in certain B-cell malignancies (fourth quarter 2020)
Bispecific antibody targeting BCMA and CD3
−Removed: - Multiple myeloma - Report updated results from initial study in multiple myeloma (second half 2020)
+Added: - Multiple myeloma - Report updated results from initial study in multiple myeloma (fourth quarter 2020)
Bispecific antibody targeting BCMA and CD3
2 unchanged sentences
- Platinum-resistant ovarian cancer
+Added: Clinical Program (continued)
+Added: Phase 1 Phase 2 Phase 3 Regulatory Review (i)
+Added: 2020 Events to Date Select Upcoming Milestones (k)
Bispecific antibody targeting PSMA and CD28
4 unchanged sentences
- Solid tumors and advanced hematologic malignancies
−Removed: Clinical Program (continued)
−Removed: Phase 1 Phase 2 Phase 3 Regulatory Review (i)
−Removed: 2020 Events to Date Select Upcoming Milestones (k)
+Added: Antibody to GITR
+Added: - Solid tumors
Cardiovascular/Metabolic Diseases
1 unchanged sentence
Antibody to PCSK9
−Removed: - Homozygous familial hypercholesterolemia ("HoFH") (c) in adults and pediatrics
−Removed: - HoFH in adults (U.S.) (c)
−Removed: - Reported results from Phase 3 study in adult patients with HoFH - FDA decision on sBLA for HoFH in adults (target action date of April 4, 2021)
+Added: - Homozygous familial hypercholesterolemia ("HoFH") (c) in pediatrics
+Added: - HoFH in adults (U.S.) - Reported results from Phase 3 study in adult patients with HoFH - FDA decision on sBLA for HoFH in adults (target action date of April 4, 2021)
- HeFH in pediatrics
1 unchanged sentence
Antibody to ANGPTL3
−Removed: - Refractory hypercholesterolemia (both HeFH and non-FH) - HoFH (U.S.) (c)(d)
−Removed: - Submitted MAA for HoFH - FDA decision on BLA and EC decision on MAA for HoFH (first half 2021)
+Added: - Refractory hypercholesterolemia (both HeFH and non-FH) - HoFH (U.S.
+Added: and EU) (c)(d)
+Added: - New England Journal of Medicine published positive results from Phase 3 trial in HoFH
+Added: - FDA decision on BLA (target action date of February 11, 2021) and EC decision on MAA for HoFH (first half 2021)
- Severe hypertriglyceridemia
2 unchanged sentences
- Paroxysmal nocturnal hemoglobinuria ("PNH") (c)
−Removed: - Initiate combination program with Alnylam's cemdisiran (second half 2020)
+Added: - Initiate combination program with Alnylam's cemdisiran (fourth quarter 2020)
- CD55-deficient protein-losing enteropathy (c)
4 unchanged sentences
("FOP") (c)(d)(e) (potentially pivotal study)
−Removed: - Reported results from Phase 2 study in FOP - Submit BLA and MAA for FOP (first half 2021)
−Removed: - Initiate Phase 3 study for FOP in pediatrics (first half 2021)
+Added: - Reported results from Phase 2 study in FOP - Further review trial data and determine next steps for the program
+Added: - Paused dosing in the open-label portion of the Phase 2 study in FOP based on reports of serious adverse events
+Added: Clinical Program (continued)
+Added: Phase 1 Phase 2 Phase 3 Regulatory Review (i)
+Added: 2020 Events to Date Select Upcoming Milestones (k)
Agonist antibody to leptin receptor ("LEPR")
- Generalized lipodystrophy (e)
+Added: Agonist antibody to NPR1
+Added: - Heart failure
Fasinumab (l)(f) (REGN475)
2 unchanged sentences
- Reported top-line results from Phase 3 trials in osteoarthritis pain of the knee or hip - Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (first half 2021)
−Removed: Antibody to GFRα3
−Removed: - Osteoarthritis pain of the knee (e)
−Removed: - Report results from Phase 2 study in osteoarthritis pain of the knee (second half 2020)
−Removed: Clinical Program (continued)
−Removed: Phase 1 Phase 2 Phase 3 Regulatory Review (i)
−Removed: 2020 Events to Date Select Upcoming Milestones (k)
+Added: - Discontinued actively treating patients following recommendation from the IDMC that the program should be terminated - Continue discussions with regulatory authorities and determine next steps for the program (first half 2021)
Infectious Diseases
−Removed: REGN-EB3 (f)(g) (REGN3470-3471-3479)
−Removed: Multi-antibody therapy to Ebola virus infection ("Ebola")
−Removed: - Ebola (U.S.) (c)(d)
−Removed: - FDA decision on BLA for Ebola (target action date of October 25, 2020)
−Removed: REGN-COV2 (g) (REGN10933-10987)
+Added: REGN-COV2 (g) (n) (REGN10933-10987)
Multi-antibody therapy to SARS-CoV-2 virus
−Removed: - COVID-19 multi-dose safety study - COVID-19 treatment (Phase 2/3) - COVID-19 prevention (m)
+Added: - COVID-19 multi-dose safety study - COVID-19 treatment in non-hospitalized patients (Phase 2/3) - COVID-19 prevention (m)
+Added: - Adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes - Reported that Phase 2/3 trial in non-hospitalized patients with COVID-19 met primary and key secondary endpoints - FDA decision on EUA for COVID-19 (fourth quarter 2020)
+Added: - COVID-19 treatment in hospitalized patients (Phase 2/3) - COVID-19 treatment in hospitalized patients (RECOVERY trial) - Submitted request to FDA for an Emergency Use Authorization ("EUA") for COVID-19 - Complete Phase 3 portion of COVID-19 study in non-hospitalized patients and submit BLA (first half 2021)
+Added: - IDMC recommended further enrollment of hospitalized patients requiring high-flow oxygen or mechanical ventilation be placed on hold
- Two papers published in Science describing REGN-COV2
−Removed: - Report initial virology and biomarker results from treatment trials (September 2020)
−Removed: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruiting for the corresponding study or studies has commenced
+Added: 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
+Added: We have discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee
(a) In collaboration with Sanofi
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(g) We and the Biomedical Advanced Research Development Authority ("BARDA") of the U.S.
−Removed: Department of Health and Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research and development of these antibodies.
+Added: 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
2 unchanged sentences
Effective April 2020, 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.
−Removed: Refer to "Collaboration and License Agreements" section below for further details.
+Added: Refer to "Collaboration, License, and Other Agreements" section below for further details.
(k) As described in the section preceding the table above and Part II, Item 1A.
1 unchanged sentence
(l) In collaboration with Teva and Mitsubishi Tanabe Pharma
−Removed: (m) Conducted jointly with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health ("NIH")
+Added: (m) Conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health ("NIH")
+Added: (n) In collaboration with Roche
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.
15 unchanged sentences
The REGN-COV2 clinical program consists of the following separate study populations:
−Removed: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate).
+Added: hospitalized COVID-19 patients, non-hospitalized symptomatic and asymptomatic COVID-19 patients, uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate), and healthy volunteers.
+Added: In October 2020, we submitted a request to the FDA for an EUA for REGN-COV2 in patients with mild-to-moderate COVID-19 who are at high risk for poor outcomes.
+Added: In October 2020, we announced positive results from the ongoing Phase 2/3 seamless trial in non-hospitalized patients with COVID-19, showing that REGN-COV2 significantly reduced viral load and patient medical visits (hospitalizations, emergency room, urgent care visits, and/or physician office/telemedicine visits).
+Added: The trial met the primary and key secondary endpoints.
+Added: In September 2020, we had announced initial data from the trial showing that REGN-COV2 reduced viral load and time to alleviate symptoms.
+Added: In October 2020, the IDMC for the REGN-COV2 treatment trials for COVID-19 recommended that the current hospitalized patient trial be modified.
+Added: Specifically, based on a potential safety signal and an unfavorable risk/benefit profile at this time, the IDMC recommended that further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data on patients already enrolled.
+Added: The IDMC also recommended continuing enrollment of hospitalized patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable in these cohorts.
+Added: Finally, the IDMC recommended continuation of the outpatient trial (described further above) without modification.
+Added: In September 2020, we and the University of Oxford announced that the RECOVERY trial in the UK will evaluate REGN-COV2.
+Added: The RECOVERY trial, which is a Phase 3 open-label trial in patients hospitalized with COVID-19, will compare the effects of adding REGN-COV2 to the usual standard-of-care versus standard-of-care on its own.
+Added: The trial is being coordinated by researchers at the University of Oxford.
+Added: The RECOVERY IDMC is aware of the IDMC recommendations made in connection with the REGN-COV2 treatment trials (described above), and will be discussing the impact, if any, on the RECOVERY trial.
+Added: In October 2020, the FDA approved Inmazeb for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.
+Added: In connection with this approval, we were also granted a material threat medical countermeasure priority review voucher by the FDA.
In August 2020, we announced that two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively.
3 unchanged sentences
In a sub-group of patients from one Phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date.
−Removed: Additional longer-term safety data from the ongoing trials are being collected and are expected to be reported early next year.
−Removed: Agreements with BARDA
−Removed: In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement ("OTA") with BARDA, pursuant to which HHS is obligated to fund 80% of our costs incurred for certain research and development activities related to COVID-19 treatments.
+Added: In August 2020, we also announced that we discontinued actively treating patients with fasinumab, which at such time only involved dosing in an optional second-year extension phase of one trial.
+Added: This followed a recommendation from the fasinumab program's IDMC that the program should be terminated, based on available evidence to date.
+Added: We will continue to gather long-term safety data, which we expect to report in 2021, along with our decision on next steps for the program.
+Added: In October 2020, we notified clinical investigators to pause dosing of garetosmab in the ongoing Phase 2 LUMINA-1 trial in patients with the ultra-rare genetic disorder FOP.
+Added: The decision was based on reports of fatal serious adverse events in the trial during the open-label portion during which all patients received active treatment.
+Added: These deaths are being further investigated to understand if they are related to garetosmab treatment.
+Added: During the 28-week double-blind treatment period, there were no deaths in the trial.
+Added: We also shared this update with the trial's IDMC and relevant regulatory authorities, and will conduct a review of the trial data to date to better understand the benefit/risk profile of garetosmab in people with FOP.
+Added: The Company announced top-line 28-week results from the LUMINA-1 trial earlier this year;
+Added: this is the only active trial evaluating garetosmab.
+Added: Agreements Related to COVID-19
+Added: In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement ("OTA") with BARDA, pursuant to which HHS is obligated to fund 80% of certain of our costs incurred for certain 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 REGN-COV2 to the U.S.
−Removed: This agreement could result in payments to the Company of up to $450.2 million in the aggregate for bulk manufacturing of the drug substance, beginning in the summer of 2020, as well as fill/finish and storage activities starting in the third quarter of 2020.
−Removed: In 2015, we and BARDA entered into an agreement pursuant to which HHS provides certain funding to develop, test, and manufacture a treatment for Ebola virus infection.
−Removed: In July 2020, HHS exercised its option under the existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of REGN-EB3.
−Removed: Contingent upon FDA approval of REGN-EB3, we expect to deliver an established number of treatment doses over the course of approximately six years.
−Removed: Collaboration and License Agreements
+Added: This agreement could result in payments to the Company of up to $450.2 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish and storage activities.
+Added: See "Results of Operations - Revenues " below for REGN-COV2 net product sales recognized in connection with this agreement during the three months ended September 30, 2020.
+Added: In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute REGN-COV2.
+Added: We will continue to lead global development activities for REGN-COV2, and the parties will jointly fund the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as any mutually agreed additional new global studies to evaluate further the potential of REGN-COV2 in treating or preventing COVID-19.
+Added: Roche will be responsible for securing regulatory approvals outside the United States, following the initial EMA approval (if any), and conducting any additional studies specifically required for approval by regulators outside the United States.
+Added: Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to REGN-COV2 each year.
+Added: We will distribute the product in the United States and Roche will distribute the product outside of the United States.
+Added: The parties will share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product delivered by each party.
+Added: Any profit sharing will commence after product manufactured by Roche receives regulatory approval and is supplied to the market.
+Added: Collaboration, License, and Other Agreements
In May 2020, a secondary offering of 13,014,646 shares of our Common Stock held by Sanofi was completed.
We also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $5 billion.
−Removed: Pursuant to the offering and purchase, Sanofi disposed of all of its shares of common stock in Regeneron, other than 400,000 shares that it retained as of the closing of these transactions (which Sanofi has used, and may continue to use, for the funding of certain development costs as described below).
−Removed: As of June 30, 2020, we were collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and REGN3500 (the "Antibody Collaboration").
+Added: Pursuant to the offering and purchase, Sanofi disposed of all of its shares of common stock in Regeneron, other than 400,000 shares that it retained as of the closing of these transactions (see further details below regarding Sanofi's use of these shares for the funding of certain development costs).
+Added: As of September 30, 2020, we were 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.
3 unchanged sentences
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.
−Removed: In 2018, we and Sanofi entered into a letter agreement (the "Letter Agreement") amending the LCA in connection with, among other matters, the allocation of additional funds to certain proposed activities relating to dupilumab and REGN3500 (collectively, the "Dupilumab/REGN3500 Eligible Investments").
−Removed: Pursuant to the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/REGN3500 Eligible Investments for the quarterly periods commencing on January 1, 2018 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.
+Added: In 2018, we and Sanofi entered into a letter agreement (the "Letter Agreement") amending the LCA in connection with, among other matters, the allocation of additional funds to certain proposed activities relating to dupilumab and itepekimab (collectively, the "Dupilumab/Itepekimab Eligible Investments").
+Added: Pursuant to the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/Itepekimab Eligible Investments for the quarterly periods commencing on January 1, 2018 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.
Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement and this funding arrangement.
1 unchanged sentence
We have exercised our option to co-commercialize Dupixent in the United States and in certain countries outside the United States.
−Removed: We currently anticipate commencing co-commercialization of Dupixent in such countries outside the United States at the end of 2020 or early 2021.
+Added: We currently anticipate commencing co-commercialization of Dupixent in such countries outside the United States in 2021.
We supply certain commercial bulk product to Sanofi.
1 unchanged sentence
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).
−Removed: In addition to profit and loss sharing, we are entitled to receive up to an aggregate of $250.0 million in milestone payments upon achievement of specified aggregate annual sales of antibodies outside the United States (including Praluent) on a rolling twelve-month basis.
−Removed: The Company will be entitled to receive the first sales milestone payment from Sanofi, in the amount of $50.0 million, when such sales outside the United States exceed $1.0 billion.
+Added: In addition to profit and loss sharing, we are entitled to receive sales milestone payments from Sanofi.
+Added: In the third quarter of 2020, the Company earned, and 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.
+Added: 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 will share profits and losses for Praluent under the LCA.
−Removed: The parties also entered into a Praluent
−Removed: Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, is 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.
+Added: 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, is 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.
1 unchanged sentence
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.
−Removed: 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).
+Added: 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
+Added: 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.
−Removed: In December 2019, the Company and Sanofi also announced their intent to restructure their antibody collaboration for Kevzara.
−Removed: The companies continue to assess potential terms of this restructuring in light of the clinical program evaluating Kevzara in patients hospitalized with COVID-19 infection.
Immuno-Oncology
11 unchanged sentences
and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) we will lead the development of such MUC16xCD3 Program antibody and commercialization of such MUC16xCD3 Program antibody within the United States and (y) Sanofi will lead the commercialization of such MUC16xCD3 Program antibody outside of the United States.
−Removed: In connection with the IO License and Collaboration Agreement, Sanofi made a $375.0 million non-refundable up-front payment to us.
If Sanofi exercises its option to license rights to a BCMAxCD3 Program antibody or MUC16xCD3 Program antibody thereunder, it will co-develop these drug candidates with us through product approval under the terms of the IO License and Collaboration Agreement.
4 unchanged sentences
We are obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured.
−Removed: Under the terms of the IO License and Collaboration Agreement, the parties are also co-developing and co-commercializing Libtayo (cemiplimab), an antibody targeting PD-1.
+Added: Under the terms of the IO License and Collaboration Agreement, the parties are also 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.
−Removed: Under the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for the quarterly periods commencing on October 1, 2017 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.
−Removed: As of June 30, 2020, 279,766 shares of our Common Stock remained eligible for sale by Sanofi in order to satisfy its funding obligations with respect to Libtayo development costs and/or, as noted above, Dupilumab/REGN3500 Eligible Investments.
−Removed: If Sanofi desires to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or, as noted above, Dupilumab/REGN3500 Eligible Investments, we may elect to purchase, in whole or in part, such shares from Sanofi.
+Added: Under the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for the quarterly
+Added: periods commencing on October 1, 2017 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi.
+Added: As of September 30, 2020, 279,766 shares of our Common Stock remained eligible for sale by Sanofi in order to satisfy its funding obligations with respect to Libtayo development costs and/or, as noted above, Dupilumab/Itepekimab Eligible Investments.
+Added: If Sanofi desires to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or, as noted above, Dupilumab/Itepekimab Eligible Investments, we may elect to purchase, in whole or in part, such shares from Sanofi.
If we do not elect to purchase such shares, Sanofi may sell the applicable number of shares (subject to certain daily and quarterly limits) in one or more open-market transactions.
−Removed: Refer to the "Antibody" section above for a description of share transactions related to Dupilumab/REGN3500 Eligible Investments.
+Added: Refer to the "Antibody" section above for a description of share transactions related to Dupilumab/Itepekimab Eligible Investments.
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.
12 unchanged sentences
We lead global development activities, and the parties share equally, on an ongoing basis, development costs under a global development plan.
−Removed: As of June 30, 2020, 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.
+Added: As of September 30, 2020, 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.
1 unchanged sentence
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).
−Removed: In April 2020, we entered into an agreement with Zai Lab Limited to develop and commercialize REGN1979 in mainland China, Hong Kong, Taiwan, and Macau (the "Zai Territories").
+Added: Odronextamab (REGN1979)
+Added: In April 2020, we entered into an agreement with Zai Lab Limited to develop and commercialize odronextamab in mainland China, Hong Kong, Taiwan, and Macau (the "Zai Territories").
In connection with the agreement, Zai made a $30.0 million non-refundable up-front payment to the Company.
−Removed: We will continue to lead global development activities for REGN1979, and Zai will be responsible for funding a portion of the global development costs for certain clinical trials.
−Removed: We are responsible for the manufacture and supply of clinical and commercial product of REGN1979 to Zai.
−Removed: If REGN1979 is commercialized in the Zai Territories, we will supply the product to Zai at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive up to $160.0 million in additional regulatory and sales milestone payments.
+Added: We will continue to lead global development activities for odronextamab, and Zai will be responsible for funding a portion of the global development costs for certain clinical trials.
+Added: We are responsible for the manufacture and supply of clinical and commercial product of odronextamab to Zai.
+Added: If odronextamab is commercialized in the Zai Territories, we will supply the product to Zai at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive up to $160.0 million in additional regulatory and sales milestone payments.
In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc.
4 unchanged sentences
In connection with the 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.
−Removed: The amount paid in excess of the fair market value of the shares purchased , or $15.0 million, was recorded to Research and development expense.
+Added: 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.
+Added: In 2015, we and BARDA entered into an agreement pursuant to which HHS provides certain funding to develop, test, and manufacture a treatment for Ebola virus infection.
+Added: In July 2020, HHS exercised its option under the existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of Inmazeb.
+Added: We expect to deliver a pre-specified number of Inmazeb treatment doses over the course of approximately six years.
+Added: See "Agreements Related to COVID-19 - BARDA" section above for information related to our COVID-19 agreement.
Corporate Information
6 unchanged sentences
Results of Operations
−Removed: Three and Six Months Ended June 30, 2020 and 2019
−Removed: Certain revisions have been made to the previously reported June 30, 2019 amounts below in connection with changing the presentation of certain amounts earned from collaborators;
+Added: Three and Nine Months Ended September 30, 2020 and 2019
+Added: Certain revisions have been made to the previously reported September 30, 2019 amounts below in connection with changing the presentation of certain amounts earned from collaborators;
see Note 1 to our Condensed Consolidated Financial Statements for further details.
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions, except per share data) 2020 2019 2020 2019
2 unchanged sentences
Income from operations 1,053.1 738.5 2,409.6 1,534.1
−Removed: Other income (expense), net 262.5 (90.9) 231.0 (24.8)
+Added: Other (expense) income, net (54.8) 30.0 176.2 5.2
Income before income taxes 998.3 768.5 2,585.8 1,539.3
3 unchanged sentences
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 $ Change *
4 unchanged sentences
Praluent 48.5 *
+Added: REGN-COV2 40.2 — 40.2 40.2 — 40.2
ARCALYST 3.6 3.0 0.6 9.3 10.7 (1.4)
6 unchanged sentences
Net Product Sales
−Removed: Net product sales of EYLEA in the United States decreased for the three months ended June 30, 2020, compared to the same period in 2019, due to lower sales volume primarily attributable to the COVID-19 pandemic and an increase in sales-related deductions primarily due to higher discounts.
−Removed: Net product sales of EYLEA in the United States increased for the six months ended June 30, 2020, compared to the same period in 2019, due to higher sales volume partly offset by an increase in sales-related deductions, primarily due to higher rebates and discounts, as well as the impact of the COVID-19 pandemic.
−Removed: EYLEA demand was lower in April 2020 compared to the same period of 2019.
+Added: Net product sales of EYLEA in the United States increased for the three and nine months ended September 30, 2020, compared to the same periods in 2019, due to higher sales volume partly offset by an increase in sales-related deductions primarily due to higher rebates and discounts.
+Added: EYLEA demand was lower in April 2020 due to the impact of the COVID-19 pandemic compared to the same period of 2019.
While we observed an increase in U.S.
−Removed: EYLEA demand during the remainder of the second quarter of 2020 relative to April 2020, we are unable to predict whether there will be additional adverse impact on net product sales if shelter-in-place and social distancing orders are reintroduced or imposed in additional geographies.
+Added: EYLEA demand during the subsequent months of the second and third quarters of 2020 relative to April 2020, we are unable to predict whether there will be additional adverse impact on net product sales if shelter-in-place, social distancing, and other similar measures are reintroduced or imposed in additional geographies.
Effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States.
−Removed: Refer to "Collaboration and License Agreements - Sanofi - Antibody " section above for further details.
+Added: Refer to "Collaboration, License, and Other Agreements - Sanofi - Antibody " section above for further details.
+Added: During the three months ended September 30, 2020, net product sales of REGN-COV2 were recorded in connection with our agreement with the U.S.
+Added: Refer to "Agreements Related to COVID-19 - BARDA " section above for further details.
Sanofi Collaboration Revenue
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 2020 2019
1 unchanged sentence
$ 212.8 $ 94.2 $ 555.6 $ 105.2
+Added: Sales-based milestone earned 50.0 — 50.0 —
Reimbursement for manufacturing of commercial supplies (1)
7 unchanged sentences
Total Sanofi collaboration revenue $ 353.3 $ 175.0 $ 869.3 $ 232.8
−Removed: (1) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing.
+Added: (1) Corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing
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.
−Removed: During the three and six months ended June 30, 2020, the change in our share of profits in connection with commercialization of antibodies, compared to the same period in 2019, was primarily driven by higher Dupixent profits as well as our new agreement with Sanofi under which, effective April 1, 2020, we are no longer sharing in losses with Sanofi in connection with the commercialization of Praluent (see further information below).
+Added: During the three and nine months ended September 30, 2020, the change in our share of profits in connection with commercialization of antibodies, compared to the same periods of 2019, was driven by higher Dupixent profits and, to a lesser extent, our new agreement with Sanofi under which, effective April 1, 2020, we are no longer sharing in losses with Sanofi in connection with the commercialization of Praluent (see further information below).
The increase in reimbursements for manufacturing of commercial supplies is primarily driven by higher Dupixent sales, as revenue recognition for such cost reimbursements is deferred until the product is sold by Sanofi to third-party customers.
1 unchanged sentence
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 2020 2019
12 unchanged sentences
therefore, the quarter ended March 31, 2020 was the last quarter for which net product sales of Praluent were included in the table above.
−Removed: As described above under "Collaboration and License Agreements - Sanofi - Antibody ", effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States.
+Added: As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States.
Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States, and will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States.
+Added: In the third quarter of 2020, the Company earned, and 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.
Bayer Collaboration Revenue
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 2020 2019
4 unchanged sentences
Total Bayer collaboration revenue $ 299.9 $ 293.6 $ 825.5 $ 834.8
−Removed: (1) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing.
+Added: (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 the United States is summarized below:
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 2020 2019
13 unchanged sentences
Other Revenue
−Removed: Other revenue increased during the three and six months ended June 30, 2020, compared to the same periods of 2019, primarily due to:
−Removed: • recognition of revenue in connection with our agreements with BARDA related to funding of certain development activities for REGN-EB3 for the treatment of Ebola and antibodies for the treatment of COVID-19;
−Removed: • $30.0 million up-front payment received from Zai Lab in connection with our collaboration agreement;
+Added: Other revenue increased during the three and nine months ended September 30, 2020, compared to the same periods of 2019, primarily due to:
+Added: • recognition of revenue in connection with our agreements with BARDA related to funding of certain development activities for antibodies for the treatment of COVID-19 and Inmazeb for the treatment of Ebola;
• effective April 1, 2020, Sanofi's reimbursement for manufacturing commercial supplies of Praluent and royalties of 5% on Sanofi’s net product sales of Praluent outside the United States.
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions, except headcount data) 2020 2019 $ Change 2020 2019 $ Change
15 unchanged sentences
(3) Cost of collaboration and contract manufacturing includes costs we incur in connection with producing commercial drug supplies for collaborators and others
−Removed: Operating expenses included a total of $103.5 million and $105.8 million for the three months ended June 30, 2020 and 2019, respectively, and $209.3 million and $213.7 million for the six months ended June 30, 2020 and 2019, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans.
+Added: Operating expenses included a total of $101.2 million and $117.1 million for the three months ended September 30, 2020 and 2019, respectively, and $310.5 million and $330.8 million for the nine months ended September 30, 2020 and 2019, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans.
Research and Development Expenses
5 unchanged sentences
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions) 2020 2019 *
1 unchanged sentence
Direct research and development expenses:
−Removed: Fasinumab $ 43.2 $ 59.6 $ (16.4) $ 83.7 $ 109.7 $ (26.0)
Libtayo (cemiplimab) $ 46.9 $ 33.6 $ 13.3 $ 118.4 $ 112.0 $ 6.4
1 unchanged sentence
REGN-COV2 70.2 — 70.2 84.3 — 84.3
+Added: Fasinumab 39.9 57.0 (17.1) 123.6 166.7 (43.1)
EYLEA 19.7 16.3 3.4 48.5 41.6 6.9
Evinacumab 8.0 9.6 (1.6) 26.8 24.6 2.2
+Added: Kevzara (sarilumab) 6.9 4.6 2.3 66.3 11.0 55.3
Up-front payments related to license and collaboration agreements
18 unchanged sentences
* Certain prior year amounts have been reclassified to conform to the current year's presentation
−Removed: Research and development expenses for the three and six months ended June 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).
−Removed: 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).
−Removed: Research and development expenses for the three and six months ended June 30, 2019 included a $400.0 million up-front payment to Alnylam.
−Removed: Research and development expenses included non-cash compensation expense of $56.9 million and $59.3 million for the three months ended June 30, 2020 and 2019, respectively, and $113.6 million and $118.0 million for the six months ended June 30, 2020 and 2019, respectively.
+Added: Research and development expenses for the nine months ended September 30, 2020 included $85.0 million in aggregate up-front payments made in connection with our collaboration agreement with Intellia (see "Collaboration, License, and Other Agreements - Intellia " above).
+Added: Research and development expenses for the nine months ended September 30, 2019 included a $400.0 million up-front payment to Alnylam.
+Added: Research and development expenses included non-cash compensation expense of $55.9 million and $60.0 million for the three months ended September 30, 2020 and 2019, respectively, and $169.5 million and $178.0 million for the nine months ended September 30, 2020 and 2019, 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.
5 unchanged sentences
Selling, General, and Administrative Expenses
−Removed: Selling, general, and administrative expenses increased for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily due to higher headcount-related costs, additional accruals for loss contingencies associated with ongoing litigation, higher contributions to independent not-for-profit patient assistance organizations, and, effective April 1, 2020, no longer receiving Praluent-related cost reimbursements from Sanofi for Regeneron-incurred expenses.
−Removed: Selling, general, and administrative expenses also increased for the six months ended June 30, 2020, compared to the same period in 2019, due to an increase in commercialization-related expenses for EYLEA.
−Removed: Selling, general, and administrative expenses also included non-cash compensation expense of $38.2 million and $37.7 million for the three months ended June 30, 2020 and 2019, respectively, and $78.5 million and $81.5 million for the six months ended June 30, 2020 and 2019, respectively.
+Added: Selling, general, and administrative expenses increased for the nine months ended September 30, 2020, compared to the same period in 2019, primarily due to higher headcount-related costs, an increase in commercialization-related expenses for EYLEA and Libtayo, higher contributions to independent not-for-profit patient assistance organizations, additional accruals for loss contingencies associated with ongoing litigation, and, effective April 1, 2020, no longer receiving Praluent-related cost reimbursements from Sanofi for Regeneron-incurred expenses.
+Added: Selling, general, and administrative expenses also included non-cash compensation expense of $35.9 million and $40.8 million for the three months ended September 30, 2020 and 2019, respectively, and $114.4 million and $122.3 million for the nine months ended September 30, 2020 and 2019, respectively.
+Added: Cost of Goods Sold
+Added: Cost of goods sold increased for the nine months ended September 30, 2020, compared to the same period in 2019, primarily in connection with higher product sales including (i) our obligation to pay Sanofi its share of Libtayo U.S.
+Added: gross profits and (ii) third-party royalties.
+Added: These increases were partly offset by lower period costs for our Limerick commercial manufacturing facility.
Cost of Collaboration and Contract Manufacturing
−Removed: Cost of collaboration and contract manufacturing increased for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent, process validation costs in connection with manufacturing REGN-EB3 under our BARDA agreement, and recognition of costs in connection with manufacturing ex-U.S.
−Removed: commercial supplies of Praluent for Sanofi under our new agreement (see "Collaboration and License Agreements - Sanofi - Antibody " above for further details).
+Added: Cost of collaboration and contract manufacturing increased for the three and nine months ended September 30, 2020, compared to the same periods in 2019, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent and recognition of costs in connection with manufacturing ex-U.S.
+Added: commercial supplies of Praluent for Sanofi under our new agreement (see "Collaboration, License, and Other Agreements - Sanofi - Antibody " above for further details).
+Added: In addition, Cost of collaboration and contract manufacturing increased for the nine months ended September 30, 2020, compared to the same period in 2019, due to process validation costs in connection with manufacturing Inmazeb under our BARDA agreement.
Other Operating (Income) Expense
1 unchanged sentence
Other Income (Expense)
−Removed: Other income (expense), net, for the three and six months ended June 30, 2020, compared to the same periods in 2019, was positively impacted by the recognition of unrealized gains on equity securities.
+Added: Other income (expense), net, for the three months ended September 30, 2020, compared to the same period in 2019, was negatively impacted by the recognition of unrealized losses on equity securities.
+Added: In addition, interest expense for the three months ended September 30, 2020, compared to the same period in 2019, increased as a result of the 2020 bridge loan facility and issuance of senior notes (as described below).
+Added: Other income (expense), net, for the nine months ended September 30, 2020, compared to the same period in 2019, was primarily affected by the positive impact of the recognition of unrealized gains on equity securities.
Three Months Ended
−Removed: June 30, Six Months Ended
+Added: September 30, Nine Months Ended
+Added: September 30,
(In millions, except effective tax rate) 2020 2019 2020 2019
3 unchanged sentences
15.6 % 12.9 % 8.6 % 14.0 %
−Removed: Our effective tax rate for the three and six months ended June 30, 2020 was positively impacted, compared to the U.S.
+Added: Our effective tax rate for the three and nine months ended September 30, 2020 was positively impacted, compared to the U.S.
federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than the U.S.
federal statutory rate and federal tax credits for research activities.
−Removed: Our effective tax rate for the three and six months ended June 30, 2019 was positively impacted, compared to the U.S.
−Removed: federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S.
−Removed: federal statutory rate, stock-based compensation, federal tax credits for research activities, and, to a lesser extent, the foreign-derived intangible income deduction, partly offset by the taxation of certain global intangible low-taxed income and the non-deductible Branded Prescription Drug Fee.
+Added: Our effective tax rate for the three and nine months ended September 30, 2019 was positively impacted, compared to the U.S.
+Added: federal statutory rate, primarily by federal tax credits for research activities, the foreign-derived intangible income deduction, and income earned in foreign jurisdictions with tax rates lower than the U.S.
+Added: federal statutory rate, partly offset by the taxation of certain global intangible low-taxed income and the non-deductible Branded Prescription Drug Fee.
Liquidity and Capital Resources
Our financial condition is summarized as follows:
−Removed: June 30, December 31,
+Added: September 30, December 31,
(In millions) 2020 2019 $ Change
8 unchanged sentences
$ 6,759.8 $ 5,592.5 $ 1,167.3
−Removed: As of June 30, 2020, we also had borrowing availability of $750.0 million under a revolving credit facility.
−Removed: Sources and Uses of Cash for the Six Months Ended June 30, 2020 and 2019
−Removed: June 30, June 30,
+Added: As of September 30, 2020, we also had borrowing availability of $750.0 million under a revolving credit facility.
+Added: Sources and Uses of Cash for the Nine Months Ended September 30, 2020 and 2019
+Added: September 30, September 30,
(In millions) 2020 2019 $ Change
3 unchanged sentences
Cash Flows from Operating Activities
−Removed: Our net income for the six months ended June 30, 2020 included up-front payments of $85.0 million made to Intellia and a $30.0 million up-front payment received from Zai Lab pursuant to our collaboration agreements.
−Removed: Our net income for the six months ended June 30, 2020 also included $171.3 million related to unrealized gains (net) on equity securities (included in other non-cash items).
−Removed: Deferred taxes as of June 30, 2020 decreased by $118.0 million, compared to December 31, 2019, primarily due to non-cash compensation expense and unrealized gains (net) on equity securities as described above.
+Added: Our net income for the nine months ended September 30, 2020 included a $50.0 million sales-based milestone related to Sanofi sales of antibodies outside the United States (see "Collaboration, License, and Other Agreements - Sanofi - Antibody " above for further details) and $85.0 million up-front payments made to Intellia pursuant to our collaboration agreements.
+Added: Our net income for the nine months ended September 30, 2020 also included $133.8 million related to unrealized gains (net) on equity securities (included in other non-cash items).
+Added: As of September 30, 2020, Sanofi, trade, and other accounts receivables increased by $1.275 billion, compared to December 31, 2019, primarily as a result of extending payment terms to certain of our EYLEA customers due to the COVID-19 pandemic.
+Added: Deferred taxes as of September 30, 2020 decreased by $117.9 million, compared to December 31, 2019, primarily due to non-cash compensation expense and unrealized gains (net) on equity securities as described above.
Cash Flows from Investing Activities
−Removed: Sales of marketable securities during the six months ended June 30, 2020 included proceeds in connection with funding our stock repurchase from Sanofi (as described below).
−Removed: Capital expenditures during the six months ended June 30, 2020 included costs associated with (i) the expansion of our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, including construction of a fill/finish facility and related equipment, and (ii) laboratory expansion and renovations at our Tarrytown, New York facilities.
+Added: Sales of marketable securities during the nine months ended September 30, 2020 included proceeds in connection with funding our stock repurchase from Sanofi (as described below).
+Added: Capital expenditures during the nine months ended September 30, 2020 included costs associated with (i) the expansion of our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, including construction of a fill/finish facility and related equipment, and (ii) laboratory expansion and renovations at our Tarrytown, New York facilities.
We expect to incur capital expenditures of $570 million to $600 million for the full year of 2020 primarily in connection with these projects.
Cash Flows from Financing Activities
−Removed: During the six months ended June 30, 2020, we paid an aggregate of $5.4 billion to purchase shares of our Common Stock, a portion of which was funded with the proceeds from a $1.5 billion senior unsecured 364-day bridge loan facility.
−Removed: See further descriptions under " Share Repurchase Program, " " Sanofi Funding of Certain Development Costs, " and " Dispositions of Regeneron Common Stock Held by Sanofi " below.
−Removed: Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $2.2 billion during the six months ended June 30, 2020 compared to $155.1 million during the six months ended June 30, 2019.
+Added: During the nine months ended September 30, 2020, we paid an aggregate of $5.5 billion to purchase shares of our Common Stock, a portion of which was funded with the proceeds from a $1.5 billion senior unsecured 364-day bridge loan facility.
+Added: See additional information under " Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi " below.
+Added: During the three months ended September 30, 2020, we issued and sold $2.0 billion aggregate principal amount of senior unsecured notes and used a portion of the net proceeds to repay in full the bridge loan facility.
+Added: See additional information under " Issuance of Senior Notes " below.
+Added: Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $2.5 billion during the nine months ended September 30, 2020, compared to $163.5 million during the nine months ended September 30, 2019.
Share Repurchase Program
5 unchanged sentences
We plan to finance the share repurchase program with available cash.
−Removed: During the six months ended June 30, 2020, we repurchased 719,167 shares of our Common Stock under the program and recorded the cost of the shares received, or $272.8 million, as Treasury Stock.
−Removed: As of June 30, 2020, the Company had $473.1 million which remained available for share repurchases under the program.
+Added: During the nine months ended September 30, 2020, we repurchased 898,991 shares of our Common Stock under the program and recorded the cost of the shares received, or $373.3 million, as Treasury Stock.
+Added: As of September 30, 2020, the Company had $372.7 million which remained available for share repurchases under the program.
Sanofi Funding of Certain Development Costs
−Removed: As described above in "Collaboration and License Agreements - Sanofi," effective January 7, 2018, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development and/or Dupilumab/REGN3500 Eligible Investments by selling shares (of which 279,766 shares remain available to be sold as of June 30, 2020) of our Common Stock directly or indirectly owned by Sanofi.
−Removed: During the six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 77,677 shares of the Company's Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs.
−Removed: Consequently, we recorded $41.7 million related to the shares received as Treasury Stock during the six months ended June 30, 2020.
−Removed: In addition, during the six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (in cash), 171,471 shares of the Company's Common Stock in connection with Sanofi's funding obligation for Dupilumab/REGN3500 Eligible Investments.
−Removed: Consequently, we recorded the cost of the shares received, or $93.3 million, as Treasury Stock during the six months ended June 30, 2020.
+Added: As described above in "Collaboration, License, and Other Agreements - Sanofi ," effective January 7, 2018, we agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development and/or Dupilumab/Itepekimab Eligible Investments incurred in periods through September 30, 2020 by selling shares (of which 279,766 shares remained available to be sold as of September 30, 2020) of our Common Stock directly or indirectly owned by Sanofi.
+Added: During the nine months ended September 30, 2020, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 77,677 shares of the Company's Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs.
+Added: Consequently, we recorded $41.7 million related to the shares received as Treasury Stock during the nine months ended September 30, 2020.
+Added: In addition, during the nine months ended September 30, 2020, Sanofi elected to sell, and we elected to purchase (in cash), 171,471 shares of the Company's Common Stock in connection with Sanofi's funding obligation for Dupilumab/Itepekimab Eligible Investments.
+Added: Consequently, we recorded the cost of the shares received, or $93.3 million, as Treasury Stock during the nine months ended September 30, 2020.
Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi
−Removed: As described above in "Collaboration and License Agreements - Sanofi," in May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed.
+Added: As described above in "Collaboration, License, and Other Agreements - Sanofi ," in May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed.
In connection with the Secondary Offering, we also purchased 9,806,805 shares of our Common Stock directly from Sanofi for an aggregate purchase amount of $5 billion (the "Stock Purchase").
−Removed: As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (which Sanofi has used, and may continue to use, for the funding of certain Libtayo development costs and/or Dupilumab/REGN3500 Eligible Investments as described above).
+Added: As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (which Sanofi has used, and may continue to use, for the funding of certain Libtayo development costs and/or Dupilumab/Itepekimab Eligible Investments as described above).
We funded the Stock Purchase with a combination of cash on hand, proceeds from the sale of marketable securities, and proceeds from loans under a $1.5 billion senior unsecured 364-day bridge loan facility (the "Bridge Facility") which was entered into in May 2020.
−Removed: The loans under the Bridge Facility bear interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varies with our debt rating and total leverage ratio.
−Removed: The Bridge Facility will mature, and all amounts outstanding thereunder will become due and payable, in May 2021.
−Removed: We intend to refinance the Bridge Facility prior to its maturity by entering into new debt financing arrangements.
−Removed: Amounts borrowed under the Bridge Facility may be prepaid at any time without premium or penalty.
−Removed: As of June 30, 2020, $1.5 billion remained outstanding under the Bridge Facility.
−Removed: The credit agreement governing the Bridge Facility (the “Bridge Credit Agreement”) contains financial and operating covenants, which are substantially similar to the covenants set forth in our existing $750.0 million senior unsecured five-year revolving credit facility.
−Removed: Financial covenants include a maximum total leverage ratio and a minimum interest expense coverage ratio.
−Removed: We were in compliance with all covenants of the Bridge Credit Agreement as of June 30, 2020.
+Added: The loans under the Bridge Facility bore interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varied with our debt rating and total leverage ratio.
+Added: As described below, the Bridge Facility was repaid in August 2020 following the issuance and sale of the Company's senior unsecured notes.
+Added: Issuance of Senior Notes
+Added: In August 2020, we issued and sold $1.250 billion aggregate principal amount of senior unsecured notes due 2030 (the "2030 Notes") and $750 million aggregate principal amount of senior unsecured notes due 2050 (the "2050 Notes" and, together with the 2030 Notes, the "Notes").
+Added: Net proceeds from the issuance and sale of the Notes (after deducting underwriting discounts and offering expenses) were used in part to repay in full the Bridge Facility described above, including accrued interest and related fees and expenses in connection therewith.
+Added: The 2030 Notes accrue interest at the rate of 1.750% per year and will mature on September 15, 2030.
+Added: The 2050 Notes accrue interest at the rate of 2.800% per year and will mature on September 15, 2050.
+Added: Interest on each series of Notes is payable semi-annually in arrears on March 15 and September 15 of each year, commencing on March 15, 2021, until their respective maturity dates.
+Added: The Notes may be redeemed at the Company’s option at any time at 100% of the principal amount plus accrued and unpaid interest, and, until a specified period before maturity, a specified make-whole amount.
+Added: The Notes contain a change-of-control provision that, under certain circumstances, may require the Company to offer to repurchase the Notes at a price equal to 101% of the principal amount plus accrued and unpaid interest.
+Added: The Notes also contain certain limitations on the Company’s ability to incur liens and enter into sale and leaseback transactions, as well as customary events of default.
Critical Accounting Policies and Use of Estimates
1 unchanged sentence
"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (filed February 7, 2020).
−Removed: Except as described in Note 1 to our Condensed Consolidated Financial Statements included in this report, there were no material changes to our critical accounting policies and use of estimates during the six months ended June 30, 2020.
+Added: Except as described in Note 1 to our Condensed Consolidated Financial Statements included in this report, there were no material changes to our critical accounting policies and use of estimates during the nine months ended September 30, 2020.
Future Impact of Recently Issued Accounting Standards
−Removed: As of June 30, 2020, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.
+Added: As of September 30, 2020, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.