NVS Novartis AG

93.13
-0.78  -1%
Previous Close 93.91
Open 93.3
52 Week Low 77.04
52 Week High 98.52
Market Cap $209,085,120,782
Shares 2,245,088,809
Float 2,245,088,809
Enterprise Value $243,463,468,261
Volume 1,273,624
Av. Daily Volume 1,879,259
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Upcoming Catalysts

Drug Stage Catalyst Date
Inclisiran
Hypercholesterolemia
NDA Filing
NDA Filing
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BEOVU (Brolucizumab) - KINGFISHER
Diabetic macular edema (DME)
Phase 3
Phase 3
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KYMRIAH (tisagenlecleucel) - BELINDA
Diffuse large B-cell lymphoma (DLBCL) - 2nd line
Phase 3
Phase 3
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KISQALI (ribociclib) - MONALEESA-2
Breast cancer
Phase 3
Phase 3
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ZOLGENSMA (AVXS-101) - SPRINT
Pre-symptomatic patients with spinal muscular atrophy (SMA) Types 1, 2 and 3
Phase 3
Phase 3
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Canakinumab (ACZ885) - CANOPY-1
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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COSENTYX (secukinumab) - SUNRISE
Hidradenitis Suppurativa (HS)
Phase 3
Phase 3
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Remibrutinib (LOU064)
Chronic spontaneous urticaria (CSU)
Phase 2
Phase 2
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ECF843
Dry Eye Disease
Phase 2
Phase 2
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Sabatolimab (MBG453)
Myelodysplastic syndromes (MDS)
Phase 2
Phase 2
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Ligelizumab (QGE031) - Pearl 1
Chronic spontaneous urticaria
Phase 3
Phase 3
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ENTRESTO (Sacubitril/valsartan) - PERSPECTIVE
Heart failure
Phase 3
Phase 3
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ENTRESTO (Sacubitril/valsartan) - Panorama
Heart failure
Phase 3
Phase 3
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COSENTYX (secukinumab) - SURPASS
Ankylosing spondylitis (AS)
Phase 3
Phase 3
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Kisqali (NATALEE)
Adjuvant breast cancer
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Iptacopan (LNP023) - APPLAUSE-IgAN
IgA nephropathy (IgAN)
Phase 3
Phase 3
Phase 3 trial ongoing.
Iptacopan (LNP023)
C3 glomerulopathy (C3G)
Phase 2
Phase 2
Phase 3 trial to commence mid-2021.
ENTRESTO (Sacubitril/valsartan) - PARADISE-MI
Post-acute myocardial infarction
Phase 3
Phase 3
Phase 3 data be presented at ACC meeting May 2021.
KENGREAL (cangrelor)
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
Approved
Approved
CRL April 30 2014. Approved June 22 2015
VABOMERE (meropenem and vaborbactam)
Complicated urinary tract infections (cUTI)
Approved
Approved
Approved August 29, 2017.
ORBACTIV (Oritavancin)
ABSSSI
Approved
Approved
Approved August 6 2014 under priority review.
PROMACTA (eltrombopag)
Severe aplastic anemia (SAA)
Approved
Approved
sNDA approval announced November 16, 2018.
HUMIRA (adalimumab)
Rheumatoid Arthritis
Approved
Approved
FDA approval announced October 31, 2018.
ARZERRA (ofatumumab)
Relapsing multiple sclerosis
Approved
Approved
FDA approval announced August 20, 2020.
EGATEN (triclabendazole)
Fascioliasis
Approved
Approved
FDA Approval announced February 13, 2019.
MAYZENT (siponimod)
Secondary progressive multiple sclerosis
Approved
Approved
FDA approval announced March 26, 2019.
BEOVU (brolucizumab)
Wet age-related macular degeneration (AMD)
Approved
Approved
FDA Approval announced October 8, 2019.
ADAKVEO (crizanlizumab)
Sickle cell disease
Approved
Approved
FDA Approval announced November 15, 2019.
GILENYA (Fingolimod)
Multiple Sclerosis (MS)
Approved
Approved
Approval announced May 11, 2018.
KYMRIAH (tisagenlecleucel)
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
Approval announced May 1, 2018.
TAFINLAR (dabrafenib) + MEKINIST (trametinib)
Melanoma with BRAF V600E or V600K mutations
Approved
Approved
Approval announced April 30, 2018.
LUTATHERA (lutetium Lu 177)
Inoperable progressive midgut NETs
Approved
Approved
Approved January 26, 2018. Acquired from Advanced Accelerator Applications (NASDAQ: AAAP).
KISQALI (ribociclib)
HR+/HER2- advanced breast cancer
Approved
Approved
Priority review granted November 1, 2016. Approval announced March 13, 2017.
RYDAPT (midostaurin)
Acute myeloid leukemia (AML)
Approved
Approved
Priority review granted November 14, 2016. Approval announced April 28, 2017.
ZYKADIA (ceritinib)
First-line use in patients with ALK+ metastatic NSCLC
Approved
Approved
Priority review granted February 22, 2017. Approval announced May 26, 2017.
KYMRIAH (tisagenlecleucel)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Approved
Approved
Approval announced early - August 30, 2017.
TAFINLAR (dabrafenib) + MEKINIST (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
Approved
FDA Approval announced June 22, 2017.
ZOLGENSMA (AVXS-101)
Spinal muscular atrophy (SMA) Type 1
Approved
Approved
FDA Approval announced May 24, 2019.
TABRECTA (capmatinib)
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
Phase 3
Phase 3
Phase 3 trial met both primary endpoints of overall survival and radiographic progression-free survival.
Alpelisib + FASLODEX (fulvestrant)
HR + Metastatic breast cancer (MBC)
Approved
Approved
FDA Approval announced May 24, 2019.
AIMOVIG (Erenumab)
Migraine
Approved
Approved
Approval announced May 17, 2018.
COSENTYX (secukinumab)
Psoriatic arthritis
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - October 31, 2019.
COSENTYX (secukinumab)
Psoriasis
Approved
Approved
FDA approval announced February 8, 2018.
COSENTYX (secukinumab) - PREVENT
Non-radiographic axial spondyloarthritis
Approved
Approved
FDA Approval announced June 16, 2020.
Canakinumab (ACZ885) - CANOPY-2
Non-small cell lung cancer (NSCLC) - 2nd/3rd line
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 9, 2021.
Zolgensma AVXS-101 STR1VE EU
Spinal muscular atrophy (SMA) Type 1
Phase 3
Phase 3
Phase 3 trial completed.
Asciminib (ABL001)
Chronic myeloid leukemia
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
PDR001
Metastatic melanoma
Phase 3
Phase 3
Phase 3 trial completed.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
IONSYS
Acute postoperative pain
Approved
Approved
Approved April 30, 2015.
QAW039 (fevipiprant) - LUSTER-1
Asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 16, 2019.
Biosimilar pegfilgrastim
Pegfilgrastim biosimilar
Approved
Approved
FDA Approval announced November 5, 2019.
QAW039 (fevipiprant) - ZEAL
Asthma
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - noted October 22, 2019.
ACZ885 (canakinumab)
CV risk reduction
CRL
CRL
CRL announced October 18, 2018.
Biosimilar rituximab
Various blood cancers, rheumatoid arthritis.
CRL
CRL
CRL issued May 2, 2018.
RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
Phase 3
Phase 3 data released March 22, 2017 - primary endpoints not met.

Latest News

  1. Attralus, backed by venBio Partners, recruits new leadership team to support advancement of its pipeline to bring transformational pan-amyloid removal therapies to the systemic amyloidosis field

    Attralus Therapeutics today announced the appointment of Mark Timney as the company's Chief Executive Officer and a member of its Board of Directors. Timney brings to Attralus more than 30 years of leadership experience at publicly traded and global biopharmaceutical companies, including his most recent role as CEO of The Medicines Company (NASDAQ:MDCO) until its sale for $9.7 billion to Novartis AG (NYSE:NVS) which was completed in 2020. Timney joins Attralus to accelerate clinical development of its product pipeline and expand the company's business…

    Attralus, backed by venBio Partners, recruits new leadership team to support advancement of its pipeline to bring transformational pan-amyloid removal therapies to the systemic amyloidosis field

    Attralus Therapeutics today announced the appointment of Mark Timney as the company's Chief Executive Officer and a member of its Board of Directors. Timney brings to Attralus more than 30 years of leadership experience at publicly traded and global biopharmaceutical companies, including his most recent role as CEO of The Medicines Company (NASDAQ:MDCO) until its sale for $9.7 billion to Novartis AG (NYSE:NVS) which was completed in 2020. Timney joins Attralus to accelerate clinical development of its product pipeline and expand the company's business plan. Spencer Guthrie, the co-founder who led the company during early development, will continue at Attralus as Chief Operating Officer.

    The company also expanded the Board of Directors with the appointment of Rahul Kakkar, MD as an independent director who brings 20 years of experience founding and building biotechnology companies and as a practicing physician. In addition, the company announced the appointment of four additional executives to its leadership team: Gregory Bell, MD, Chief Medical Officer; Glen Firestone, Chief Business Officer; Krishna Gorti, MD, Head of Corporate Development; and Michael Klein, PhD, Head of Chemistry, Manufacturing and Controls (CMC). Each of these executives brings more than 20 years of experience in the biopharmaceutical industry in their respective areas of expertise.

    "We are pleased to welcome Mark Timney as CEO of Attralus, as he brings a track record for delivering value for patients, health care systems and investors. His leadership will guide Attralus to realize the potential of its transformative therapies for systemic amyloidosis which address a wide range of unmet needs for patients with all forms of this disease," said Richard Gaster, MD, PhD, Attralus Board member and Partner at venBio Partners.

    Mark Timney, Chief Executive Officer

    Mark Timney stated, "I am excited to lead Attralus, a company built on deep fundamental research in the field of amyloidosis with a strong commitment to delivering life-changing therapies for patients. I see an extraordinary opportunity for Attralus to advance novel pan-amyloid removal therapies that open the potential to treat and reverse disease in patients with all types of systemic amyloidosis. There are extensive, unmet medical needs that can be addressed by diagnosing and therapeutically removing toxic, disease-causing amyloid in patients with systemic amyloidosis. I look forward to working with the very talented team at Attralus to make a significant difference in the lives of these patients."

    In leadership roles at publicly traded and global biopharmaceutical companies, Timney has successfully managed companies through stages of growth and transition, launched numerous breakthrough medicines, and led high-value strategic transactions. Most recently, Timney served as CEO and Board member of The Medicines Company where he led the company through late-stage clinical development and maximized the potential for inclisiran, a first-in-class siRNA cholesterol-lowering therapy. These actions increased shareholder return more than three-fold within one year and culminated in the company's acquisition by Novartis. Previously, he held senior roles in biopharmaceutical companies that include Merck & Co., Purdue Pharmaceuticals, Zeneca Group, ICI Pharmaceuticals and Roussel Labs, and has led markets that include the United States, Japan, South Korea, Australia and New Zealand. Timney received a bachelor's degree from Newcastle Polytechnic (now Northumbria University) in Newcastle in the United Kingdom.

    New Board Member

    • Rahul Kakkar, MD, Independent Board Director: Dr. Kakkar is a biotech entrepreneur and physician-scientist with nearly 20 years of professional experience, spanning founding and building biotechnology companies, as well as working as a practicing physician. Most recently, he was Chief Executive Officer at Pandion Therapeutics, a company developing innovative modular therapeutics autoimmune and inflammatory diseases, which he led to reach the stage as a clinical-stage company and successfully completed an initial public offering prior to Pandion's acquisition by Merck for $1.9 billion. Prior to joining Pandion, he served as an executive at Corvidia Therapeutics where he was a founder, Chief Medical Officer and Chief Strategy Officer, guiding the company from seed stage through Series B and its lead asset through clinical proof of concept. Corvidia was acquired by Novo Nordisk for $2.1 billion. Corvidia was a "spin-out" from AstraZeneca, where Dr. Kakkar had served as Director for Emerging Innovations, responsible for preclinical through Phase 2 clinical studies both for compounds within the AstraZeneca pipeline and in support of compound out-licensing efforts. He continues to practice medicine as Associate Physician at Brigham and Woman's Hospital and is a Lecturer in Medicine at Harvard Medical School. Dr. Kakkar is dual-trained via the American Board of Internal Medicine Fast Track program in molecular biology and clinical cardiology, and he is a fellow of the American College of Cardiology.

    New Executive Leaders

    Attralus has appointed these veteran biopharmaceutical leaders who bring deep clinical, manufacturing and business expertise to support the company's growth and clinical advancement of its pipeline.

    • Gregory Bell, MD, Chief Medical Officer: Dr. Bell has extensive expertise in the development of investigational therapies, having recently served as Vice President, Safety Risk Management of the Immunology, Infectious Disease and Ophthalmology portfolio at Genentech. Previously, he was Senior Vice President, Development and Chief Medical Officer at KAI Pharmaceuticals where he led the global development of Parsabiv® until Amgen acquired KAI in 2012. Earlier in his career, Bell served as Vice President of Clinical Development, Biometrics and Clinical Operations at Abgenix with responsibilities across all clinical programs including Vectibix®; at Merck, he contributed to several products that received regulatory approval including Vioxx®, Etoricoxib® and Cancidas®. Prior to joining Attralus, Greg was Senior Vice President of Development at Global Blood Therapeutics.
    • Glen Firestone, Chief Business Officer: Mr. Firestone has a distinguished 25-year career as an executive leader and has utilized his deep strategic and commercial expertise to build businesses, launch breakthrough therapies, improve patients' lives and create value. Firestone recently led a consulting business advising biotech companies on corporate growth strategies, commercialization, product development, market access, and business development. Previously, he served as a strategic advisor to Valo Health and was Head of Commercialization at Tmunity Therapeutics. Earlier, Firestone spent 20 years as a commercial executive at Merck with responsibility for leading many global and U.S. franchises, including the cardiovascular business, launching innovative medicines, building blockbuster product portfolios, negotiating business development deals and building partnerships.
    • Krishna Gorti, MD, Head of Corporate Development: Dr. Gorti has a rich and diverse background including roles in corporate development and investor relations, as an investment analyst covering biotechnology companies, as a physician trained in otolaryngology and head and neck surgery, and as a clinical and translational researcher. In his previous tenure with The Medicines Company, he served as Senior Vice President of Investor Relations and played an integral role in value-building initiatives, as well as working in earlier roles in business development and strategy. Prior to roles with biopharmaceutical companies, Gorti was a biotechnology industry equity research analyst with leading financial institutions, including JP Morgan, Piper Jaffray and Rodman & Renshaw.
    • Michael Klein, PhD, Head of Chemistry, Manufacturing and Controls (CMC): Dr. Klein has more than 30 years of experience in the biotechnology industry, having spent his career working in various aspects of CMC development of therapeutic proteins, including monoclonal antibodies, Fc fusions, bispecific and multifunctional therapeutics. Most recently, Klein served as Vice President of Analytical Development at Nektar Therapeutics and was a member of the leadership team of the company's Product Development and Manufacturing group. Previously, he was CMC scientific leader at Agenus, Atara Bio, Xencor, Protein Design Labs and Amgen.

    About Systemic Amyloidosis

    Systemic amyloidosis encompasses a diverse group of rare diseases that occur due to accumulation of toxic amyloid fibrils in tissues and organs, which is triggered by aberrant protein misfolding. These diseases are progressive, debilitating and often fatal. Systemic amyloidosis is significantly underdiagnosed due to low awareness, lack of specific symptoms, and no current disease-specific diagnostics. The two most common forms of systemic amyloidosis are transthyretin amyloidosis (ATTR) and amyloid light-chain (AL) amyloidosis.

    About Attralus

    Attralus is a clinical stage biopharmaceutical company focused on creating transformative medicines to improve the lives of patients with systemic amyloidosis. The company's proprietary pan-amyloid removal (PAR) therapeutic product candidates are designed to directly bind to and remove toxic amyloid in organs and tissues. By targeting the universal disease-causing pathology in all systemic amyloidosis diseases, PAR therapeutics have the potential to treat and reverse disease in patients with all types and stages of systemic amyloidosis. Attralus was founded by scientific experts in the field of amyloidosis and is headquartered in South San Francisco, California.

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  2. SARS-CoV-2 Variant Booster Program Update: Single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two Variants of Concern (B.1.351, P.1) in previously vaccinated clinical trial participants

    TeenCOVE Study Update: Initial analysis of the Phase 2/3 TeenCOVE study of mRNA-1273 showed vaccine efficacy against COVID-19 of 96%; mRNA-1273 was generally well tolerated with no serious safety concerns identified to date

    2021 and 2022 Vaccine Manufacturing: Company increased its 2021 supply forecast to between 800 million and 1 billion doses; Company making investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022

    Company plans to initiate rolling submission

    SARS-CoV-2 Variant Booster Program Update: Single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two Variants of Concern (B.1.351, P.1) in previously vaccinated clinical trial participants

    TeenCOVE Study Update: Initial analysis of the Phase 2/3 TeenCOVE study of mRNA-1273 showed vaccine efficacy against COVID-19 of 96%; mRNA-1273 was generally well tolerated with no serious safety concerns identified to date

    2021 and 2022 Vaccine Manufacturing: Company increased its 2021 supply forecast to between 800 million and 1 billion doses; Company making investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022

    Company plans to initiate rolling submission for BLA in the U.S. this month

    First patient dosed in Phase 1/2 study of propionic acidemia (PA) candidate (mRNA-3927); Company now has infectious disease, cardiovascular, oncology and rare disease programs in the clinic

    Company increases R&D investments in infectious diseases and other therapeutic areas to increase new development candidates from the lab to the clinic

    First GAAP profitable quarter in Company history

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the first quarter 2021 and highlighted pipeline progress.

    "In the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people. This accomplishment translated into our first profitable quarter in the company's history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality," said Stéphane Bancel, Chief Executive Officer of Moderna. "Based on these first quarter accomplishments and our current manufacturing scale-up trajectory, we were pleased to again increase our base plan for 2021 to 800 million doses. The Moderna team and our manufacturing partners are working hard to get as close to 1 billion doses in 2021 as we can. The feedback from governments around the world requesting high-efficacy mRNA vaccines and variant boosters is overwhelming. We are now actively engaged in discussions and agreements for 2022 with all of the governments we are currently supplying for 2021. On top of that, new partnerships, like COVAX, for up to 466 million doses in 2022 and discussions with new governments in Asia, Middle East, Africa and Latin America, make us believe that our total advance purchase agreements for 2022 should be higher than those in 2021."

    New updates and recent progress include:

    COVID-19 Vaccine Development

    • Increased 2021 supply forecast to between 800 million and 1 billion doses; making additional investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022 (depending on the mix)
    • Company recently announced data supporting 3-month refrigerated (2-8°C) stable formulation
    • New data shows a single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants
    • Initial analysis of Phase 2/3 TeenCOVE study of mRNA-1273 in adolescents ages 12 to 17 years showed vaccine efficacy against COVID-19 of 96%; mRNA-1273 was generally well tolerated with no serious safety concerns identified to date
    • Phase 3 study of mRNA-1273 in adults with a kidney or liver transplant is ongoing
    • Company plans to initiate rolling submission for BLA in the U.S. this month

    Infectious Diseases

    • Positive interim data from Phase 1 study of RSV vaccine candidate (mRNA-1345) in younger adults (ages 18-49 years)
    • Positive seven-month interim data from Phase 2 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647) announced during Vaccines Day on April 14; Moderna preparing for pivotal Phase 3 study expected to begin in 2021

    Rare Diseases

    • First patient dosed in Propionic Acidemia (mRNA-3927) Phase 1/2 Paramount study

    Moderna currently has 24 mRNA development programs in its portfolio with 14 having entered clinical studies. The Company's updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 65 peer-reviewed papers.

    Summary of Program Highlights by Modality

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.

    COVID-19 Vaccine Development

    • Moderna COVID-19 Vaccine: The Company shared an update on the Phase 3 COVE study of the Moderna COVID-19 Vaccine (mRNA-1273) at its annual Vaccines Day on April 14, 2021. An updated review of adjudicated cases identified over 900 cases of COVID-19 in the COVE study as of April 9th, including over 100 cases of severe COVID-19, as defined in the protocol, with a median follow-up of approximately 6 months post dose 2. Vaccine efficacy starting two weeks following the second dose and based on the updated adjudicated cases remains consistent with prior updates, including greater than 90% efficacy against all cases of COVID-19, and greater than 95% efficacy against severe cases of COVID-19. The COVE study is ongoing and reported results remain preliminary. Throughout the year, Moderna will be sharing updated data from the Phase 3 COVE study including efficacy against asymptomatic infection, genotyping data, additional antibody persistence data and information regarding potential correlates of protection. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the World Health Organization (WHO), and the Philippines. The Company plans to initiate rolling submission for a Biologics License Application (BLA) for the vaccine in the U.S. this month. Moderna is working with additional health agencies on the authorization of its vaccine in additional jurisdictions. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of the Moderna COVID-19 Vaccine with federal funding under Contract no. 75A50120C00034. Moderna retains worldwide rights to develop and commercialize the Moderna COVID-19 Vaccine.



    • Temperature Stability Update: Moderna recently announced that ongoing development data related to the current formulation of the Moderna COVID-19 Vaccine (mRNA-1273) could support a 3-month refrigerated (2-8°C) shelf life for the vaccine in alternative formats to facilitate easier distribution to doctor's offices and other smaller settings, if authorized. Currently, the Moderna COVID-19 Vaccine is approved for storage up to 1 month at refrigerated temperatures (2-8°C) and up to 7 months in a standard freezer (-20°C). The Moderna COVID-19 Vaccine is also the only authorized mRNA vaccine that does not require on-site dilution. The Company also announced that it is working on formulations of mRNA-1273 and a next generation vaccine (mRNA-1283) that it believes will extend refrigerated shelf life even further.
    • Publication of Note: Antibody persistence data out to 6 months following the second dose of the Moderna COVID-19 Vaccine were recently published in The New England Journal of Medicine. This study analyzed 33 healthy adult participants in the NIH-led Phase 1 study of Moderna's COVID-19 Vaccine at 6 months following the second 100 μg dose (day 209). As detected by three distinct serologic assays, antibodies elicited by the Moderna COVID-19 Vaccine persisted through 6 months after the second dose. Antibody decay was estimated using two approaches and was consistent with published observations of convalescent patients with COVID-19 through 8 months after symptom onset.



      • Addressing Variants of Concern: On February 24, Moderna announced that it completed manufacturing of clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351 first identified in the Republic of South Africa and has shipped doses to the NIH for a Phase 1 clinical trial that will be led and funded by the NIH's NIAID. The Company also provided an update on its strategy for addressing SARS-CoV-2 variants of concern.

    • Publication of Note: Initial data from Moderna's Phase 2 study showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company's strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies.
    • Publication of Note: Preclinical data on the Company's variant booster vaccine candidates have been submitted as a preprint to bioRxiv showed that both mRNA-1273.351 and mRNA-1273.211 increase neutralizing titers against SARS-CoV-2 variants of concern in mice. Specifically, this preclinical data confirms improved neutralizing titers with the mRNA-1273.351 vaccine primary series. The multi-valent vaccine provided the broadest level of immunity. A boost at 6 months with mRNA-1273.351 closed the neutralizing titer gap for the variants of concern. Following the mRNA-1273.351 boost, neutralizing titers were comparable between the ancestral strain (Wuhan) and the new B.1.351 variant.

    • Further Clinical Studies of mRNA-1273

      • Phase 2/3 "TeenCOVE" study of mRNA-1273 in adolescents: The Phase 2/3 study of mRNA-1273 in adolescents ages 12-17 years has completed enrollment in the U.S. An initial analysis of 3,235 participants randomized 2:1 in TeenCOVE Study showed a vaccine efficacy rate of 96% in seronegative participants who received at least one injection. The analysis included 12 cases starting 14 days after first dose and based on the CDC definition of COVID-19, which requires one COVID-19 symptom and paired with a nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2 by RT-PCR. Because the incidence rate of COVID-19 is lower in adolescents, the case definition is less stringent than for COVE, resulting in vaccine efficacy against milder disease. The median duration for follow-up in this initial analysis was 35 days following the second dose. mRNA-1273 was generally well tolerated. The majority of adverse events were mild or moderate in severity. No serious safety concerns have been identified to date. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills. The Company is continuing to collect data in TeenCOVE and is in discussions with regulators about a potential amendment to its regulatory filings.
    • Phase 2 "KidCOVE" study of mRNA-1273 in young children: The Phase 2 study of mRNA-1273 in pediatric population ages 6 months to 11 years is ongoing.



    • Phase 1/2 study of mRNA-1273 in Japan: The Phase 1/2 study of Moderna's vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan, led by Takeda Pharmaceutical Co., Ltd is ongoing.



    • Phase 3 "COVE Transplant" study of mRNA-1273: The Phase 3 study of mRNA-1273 in adults with a kidney or liver transplant is ongoing.

    • Next-generation vaccine against COVID-19 (mRNA-1283): The Phase 1 study of mRNA-1283 is ongoing. mRNA-1283 is a next-generation vaccine candidate against COVID-19 that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). The encoded mRNA-1283 antigen is shorter than mRNA-1273 and is being developed as a potential refrigerator stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers. mRNA-1283 is intended to be evaluated for use as a booster dose for previously vaccinated or infected individuals as well as in a primary series for seronegative individuals.



    Vaccines requiring complex antigens and against highly prevalent infections

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive seven-month data from the Phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels (50 μg, 100 μg and 150 μg) of mRNA-1647 were presented at Moderna's annual Vaccines Day on April 14, 2021. mRNA-1647 was generally well tolerated. The most common solicited local adverse reaction (AR) was injection site pain and the most common solicited systemic ARs were headache, fatigue, myalgia, arthralgia and chills. Rates of Grade 3 solicited ARs after the third vaccination were similar to, or lower than the rates of Grade 3 solicited ARs after the second vaccination. In CMV-seronegative participants in mRNA-1647 treatment groups after the third vaccination, neutralizing antibody geometric mean titers (GMTs) against epithelial cell infection were at least 20-fold higher than the baseline GMT of the CMV-seropositive group and neutralizing antibody GMTs against fibroblast infection approximated the baseline GMT of the CMV-seropositive group. In CMV positive participants in mRNA-1647 treatment groups after the third vaccination: neutralizing antibody GMTs against epithelial cell infection increased to at least 6.8-fold over baseline and neutralizing antibody GMTs against fibroblast infection increased to approximately 2-fold over baseline. Based on the interim analysis of the Phase 2 study, the 100 μg dose has been chosen for the Phase 3 pivotal study, which is expected to begin in 2021. Moderna owns worldwide commercial rights for mRNA-1647.



    • Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. Moderna is planning to begin a Phase 1 study of mRNA-1189 in 2021. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.

    Vaccines against respiratory infections

    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Moderna is enrolling seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653). The first cohort in this study has been fully enrolled. Moderna owns worldwide commercial rights to mRNA-1653.



    • Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. RSV is the leading cause of respiratory illness in young children. Older adults (65+) are at high risk for severe RSV infections. mRNA-1345 uses the same lipid nanoparticle (LNP) as Moderna's authorized COVID-19 vaccine and contains optimized protein and codon sequences. The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, older adults and children is ongoing. All four cohorts of younger adults (ages 18-49 years) are fully enrolled. Dosing in the older adult cohort (ages 65-79 years) is ongoing. The age range of toddlers in this de-escalation Phase 1 study is 12-59 months. The Company shared the first interim analysis of the Phase 1 study of mRNA-1345, through 1-month post-vaccination, of the younger adult cohorts at its annual Vaccines Dayon April 14, 2021. The Company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.
    • Seasonal influenza vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The World Health Organization (WHO) estimates approximately 3-5 million severe cases of flu each year globally, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. Current flu vaccines are only approximately 40-60% effective and their formulation is decided 9 months before the vaccines are intended to be used. Egg-based vaccine production also has the potential to cause unintended antigenic change to the vaccine virus. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin a Phase 1 clinical trial for the program in 2021.

    Public health vaccines

    • Zika virus vaccine (mRNA-1893):Moderna is preparing for a Phase 2 study of mRNA-1893, which is expected to begin in 2021. mRNA-1893 is being developed in collaboration with BARDA. Moderna owns worldwide commercial rights to mRNA-1893.



    • HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation, is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the NIH and includes multiple native-like trimer antigens. The Company expects to begin Phase 1 studies for both mRNA-1644 and mRNA-1574 in 2021.



    • Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).
    • Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.



    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day in September and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.



    • IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a long-acting tolerizing IL-2. This autoimmune development candidate is designed to preferentially activate and expand the regulatory T cell population. The Company plans to conduct a Phase 1 study of mRNA-6231 in healthy adult volunteers. mRNA-6231 uses the same LNP formulation as mRNA-1944. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Moderna owns worldwide commercial rights to mRNA-6231.



    • PD-L1 (mRNA-6981): mRNA-6981 is an mRNA encoding for PD-L1. This autoimmune development candidate is designed to augment cell surface expression of PD-L1 on myeloid cells to provide co-inhibitory signals to self-reactive lymphocytes. As an initial step to addressing a range of autoimmune indications, the Company intends to pursue proof-of-concept in a Phase 1 study of mRNA-6981 in type 1 autoimmune hepatitis (AIH), a condition that involves liver inflammation and can lead to cirrhosis and liver failure. mRNA-6981 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-6981.



    • Relaxin (AZD7970): Moderna has regained all rights to the Relaxin development candidate from AstraZeneca. Moderna now owns worldwide commercial rights to this development candidate.



    Exploratory Modalities

    Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

    • Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. Phase 1 in multiple cohorts is ongoing. The upsized head & neck cohort is recruiting additional patients. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.



    • Mutant KRAS vaccine (mRNA-5671 or V941): The Phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.



    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L (mRNA-2416): The Phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The Phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.
    • OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The Phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.



    • IL-12 (MEDI1191): The Phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

    Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

    • VEGF-A (AZD8601): The Phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.



    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Propionic acidemia (PA) (mRNA-3927): The first patient in the Phase 1/2 Paramount studyof mRNA-3927 has been dosed. mRNA-3927 uses the same LNP formulation as mRNA-1944. This is the Company's first development candidate in its systemic intracellular therapeutics modality to enter the clinic. Moderna owns worldwide commercial rights to mRNA-3927.



    • Methylmalonic acidemia (MMA) (mRNA-3705): Moderna received rare pediatric designation for its next generation MMA candidate (mRNA-3705). The Company plans to file new IND and CTA applications for mRNA-3705 and will focus development efforts on that candidate going forward. mRNA-3705 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3705.



    • Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU have a deficiency in phenylalanine hydroxylase (PAH) resulting in a reduced or complete inability to metabolize the essential amino acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to restore the deficient or defective intracellular enzyme activity in patients with PKU. mRNA-3283 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3283.
    • Glycogen storage disease type 1a (GSD1a) (mRNA-3745): Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV-administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. mRNA-3745 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3745.

    Information about each development candidate in Moderna's pipeline can be found on the investor relations page of its website: investors.modernatx.com.

    First Quarter 2021 Financial Results

    • Revenue: Total revenue was $1.9 billion for the three months ended March 31, 2021 compared to $8 million for the same period in 2020. Total revenue increased in the first quarter of 2021, resulting from a full quarter of commercial sales of the Company's COVID-19 vaccine in the U.S. and an initial ramp up of international sales. A total of 102 million doses were recognized as revenue. Product sales were $1.7 billion for the three months ended March 31, 2021 from sales of the Company's COVID-19 vaccine. The increase in grant revenue of $190 million was primarily driven by an increase in revenue from BARDA related to the Company's COVID-19 vaccine development.



    • Cost of Sales: Costs of sales were $193 million, or 11%, of product sales the three months ended March 31, 2021, including third-party royalties of $84 million. A portion of the inventory costs associated with the Company's products sales for the three months ended March 31, 2021 was expensed as pre-launch inventory costs in 2020. If inventory sold in the three months ended March 31, 2021 was valued at cost, the Company's cost of sales for the quarter would have been $377 million, or 22% of product sales.



    • Research and Development Expenses: Research and development expenses were $401 million for the three months ended March 31, 2021 compared to $115 million for the same period in 2020. The growth in spending was mainly due to increases in clinical trial expenses, manufacturing expenses, personnel related costs, and consulting and outside services, largely driven by mRNA-1273 clinical development and increased headcount.



    • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $77 million for the three months ended March 31, 2021 compared to $24 million for the same period in 2020. The growth in spending was mainly due to increases in consulting and outside services, personnel-related costs, legal and other licensing expenses, and marketing and other expenses, primarily attributable to increased headcount and the Company's COVID-19 vaccine commercialization-related activities.



    • Net Income (Loss): Net income was $1.2 billion for the three months ended March 31, 2021 compared to a net loss of $(124) million for the same period in 2020.
    • Cash Position: Cash, cash equivalents and investments as of March 31, 2021 and December 31, 2020 were $8.2 billion and $5.2 billion, respectively.



    • Net Cash Provided by (Used in) Operating Activities: Net cash provided by operating activities was $3.0 billion for the three months ended March 31, 2021 compared to $(106) million used in operating activities for the same period in 2020. Net cash provided by operating activities increased significantly in 2021, mainly due to net income of $1.2 billion and additional customer deposits received in the first quarter for supply of the Company's COVID-19 vaccine.



    • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $35 million for the three months ended March 31, 2021 compared to $6 million for the same period in 2020.

    2021 Updated Financial Framework

    • Advance Purchase Agreements (APAs): The Company has already signed APAs for scheduled delivery in 2021, for a total of $19.2 billion in anticipated product sales, including sales already recorded in the three months ended March 31, 2021.
    • Q2 Delivered Doses: The Company expects doses delivered in the second quarter 2021 to be in the range of 200-250 million doses.
    • Cost of Sales: Cost of sales as percentage of product sales are expected to be approximately 20% for fiscal year 2021.
    • 2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: Expect quarter over quarter cost increases in R&D and SG&A expenses during 2021 as commercial and research and development activities and expenses ramp up.
    • Tax Rate: Effective tax rate expected in the low-teens as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of $2.3 billion, based on current tax rates.
    • Capital Expenditures: $450-550 million of capital investments currently planned for 2021 including the planned capacity expansion.

       

    2022 and 2023 Vaccine Access Discussions

    • The Company has already signed APAs with Israel and Switzerland for 2022, and Switzerland has options for further deliveries in 2023. Through its recent agreement with COVAX, the Company has committed up to 466 million doses to COVAX for 2022. The Company is having ongoing discussions for 2022 APAs with all governments that have 2021 APAs. The Company is also having ongoing discussions to supply new geographies in Asia, Latin America and Africa in 2022 that it could not supply in 2021 due to manufacturing supply constraints. In response to feedback from governments for their desire to procure more high efficacy mRNA vaccines, the Company recently announced manufacturing investments to facilitate supply of up to 3 billion doses in 2022. The Company is also engaged in discussions with some governments for supply in 2023.



    Management Updates

    • Shannon Thyme Klinger will join the Company as Chief Legal Officer and Corporate Secretary, effective June 1, 2021. Ms. Klinger joins Moderna from Novartis (NYSE:NVS), where she served as Chief Legal Officer and a member of the Novartis Executive Committee since 2018. Previously, she served as Chief Ethics, Risk & Compliance Officer. During her ten-year tenure at Novartis, she held other roles of increasing responsibility, including as Chief Ethics and Compliance Officer and Global Head of Litigation, General Counsel and Global Head of Legal at Sandoz, a Novartis division.

    Corporate Updates

    • Full-Time Employees: Over the last year, the Company nearly doubled the size of its workforce. As of March 31, 2021, Moderna had approximately 1,500 employees, compared to approximately 830 employees as of March 31, 2020.
    • Vaccines Day: Moderna hosted its annual Vaccines Day on April 14, 2021.
    • Corporate Social Responsibility (CSR): Moderna CEO Stéphane Bancel published a letter on the Company's commitment to CSR on April 27, 2021.
    • Company Recognition: Moderna was named as a top company on Fast Company's annual list of the World's Most Innovative Companies for 2021 and was named to TIME's inaugural list of the TIME100 Most Influential Companies.

       

    Key 2021 Investor and Analyst Event Dates

    • Science Day – May 27
    • R&D Day – September 9

    Investor Call and Webcast Information

    Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, May 5, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 7487119. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    MODERNA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, in millions, except per share data)

     

     

    Three Months Ended March 31,

     

    2021

     

    2020

    Revenue:

     

     

     

    Product sales

    $

    1,733

     

     

    $

     

    Grant revenue

    194

     

     

    4

     

    Collaboration revenue

    10

     

     

    4

     

    Total revenue

    1,937

     

     

    8

     

    Operating expenses:

     

     

     

    Cost of sales

    193

     

     

     

    Research and development

    401

     

     

    115

     

    Selling, general and administrative

    77

     

     

    24

     

    Total operating expenses

    671

     

     

    139

     

    Income (loss) from operations

    1,266

     

     

    (131)

     

    Interest income

    4

     

     

    8

     

    Other expense, net

    (10)

     

     

    (1)

     

    Income (loss) before income taxes

    1,260

     

     

    (124)

     

    Provision for income taxes

    39

     

     

     

    Net income (loss)

    $

    1,221

     

     

    $

    (124)

     

     

     

     

     

    Earnings per share

     

     

     

    Basic

    $

    3.05

     

     

    $

    (0.35)

     

    Diluted

    $

    2.84

     

     

    $

    (0.35)

     

     

     

     

     

    Weighted average common shares used in calculation of earnings per share

     

     

     

    Basic

    400

     

     

    353

     

    Diluted

    430

     

     

    353

     

    MODERNA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

    (Unaudited, in millions)

     

     

    March 31,

     

    December 31,

     

    2021

     

    2020

    Cash, cash equivalents and investments

    $

    8,203

     

     

    $

    5,247

     

    Total assets

    12,694

     

     

    7,337

     

    Total liabilities

    8,856

     

     

    4,776

     

    Total stockholders' equity

    3,838

     

     

    2,561

     

    Total liabilities and stockholders' equity

    12,694

     

     

    7,337

     

     

    Three Months Ended March 31,

     

    2021

     

    2020

    Net cash provided by (used in) operating activities

    $

    2,971

     

     

    $

    (106)

     

    Cash used for purchases of property and equipment

    (35)

     

     

    (6)

     

     

     

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company's development of the Moderna COVID-19 Vaccine (mRNA-1273); the number of doses of the Moderna COVID-19 Vaccine that the Company anticipates being able to manufacture in 2021 and 2022 and on a quarterly basis, and investments to facilitate that manufacturing; the Company's efforts to continue developing vaccines against COVID-19, including efforts to develop vaccines against variant strains of SARS-CoV-2 and for booster doses, and the anticipated efficacy of those vaccines; the Company's plans to submit for a Biologics License Application for mRNA-1273; the Company's plans to share additional data regarding its COVE Study of the Moderna COVID-19 Vaccine and the conduct of ongoing and future clinical trials; the development of additional COVID-19 vaccine candidates that may be refrigerator stable; the conditions under which mRNA-1273 or future vaccine candidates can be shipped and stored; the efficacy of mRNA vaccines and their potential for regulatory approval or authorization; the ability of the Moderna COVID-19 Vaccine to provide protection against COVID-19 over time; the Company's investments in increased research and development for infectious diseases and other therapeutic areas; the potential efficacy of vaccines against RSV and CMV and future clinical trials for those vaccines; the status of developments for programs in the Company's pipeline, including with respect to the timing, enrollment and potential results of clinical trials; future growth prospects for the Company; the Company's commercial rights to its development candidates; future research and development expenses; future sales, general and administrative expenses, and capital expenditures, as well as other expenses; orders for the Company's Moderna COVID-19 Vaccine, both inside and outside the U.S.; anticipated doses to be delivered under advance purchase agreement in 2021 and 2022 and the associated dollar amounts to be received, which should not be construed as expected 2021 or 2022 revenue; the anticipated cost of sales associated with the Moderna COVID-19 Vaccine; the Company's future tax rate; and personnel recruitment efforts. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; the Moderna COVID-19 Vaccine may prove less effective against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or additional emergency use authorization applications may be filed in various jurisdictions and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

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  3. Moderna Inc., Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Shannon Thyme Klinger will join the Company as Chief Legal Officer, effective June 1, 2021. She will serve on Moderna's Executive Committee and as Corporate Secretary and report to Chief Executive Officer Stéphane Bancel.

    "Shannon's deep global experience in the pharmaceutical industry in both the general counsel and ethics and compliance roles are critical to Moderna as we pivot to a broad international and commercial footprint," said Stéphane Bancel, Chief Executive Officer of Moderna. "Her combination of skills across corporate, life sciences, pharmaceutical technology, commercial and multi-national…

    Moderna Inc., Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Shannon Thyme Klinger will join the Company as Chief Legal Officer, effective June 1, 2021. She will serve on Moderna's Executive Committee and as Corporate Secretary and report to Chief Executive Officer Stéphane Bancel.

    "Shannon's deep global experience in the pharmaceutical industry in both the general counsel and ethics and compliance roles are critical to Moderna as we pivot to a broad international and commercial footprint," said Stéphane Bancel, Chief Executive Officer of Moderna. "Her combination of skills across corporate, life sciences, pharmaceutical technology, commercial and multi-national sectors, and her passion for ESG and public health will help Moderna advance our core technology platform, engage critical partners across the globe and help us expand and capitalize on our growing international presence."

    Ms. Klinger joins Moderna from Novartis (NYSE:NVS), where she has served as Chief Legal Officer and a member of the Novartis Executive Committee since 2018. Previously, she served as Chief Ethics, Risk & Compliance Officer. During her ten-year tenure at Novartis, she held other roles of increasing responsibility, including as Chief Ethics and Compliance Officer and Global Head of Litigation, General Counsel and Global Head of Legal at Sandoz, a Novartis division.

    Across her career, Ms. Klinger's work has focused on driving long-term business performance and building trust with society, including ensuring access to medicine, protecting innovation with intellectual property, championing the responsible use of data, and enabling excellence in product launches. She is also a committed advocate for diversity, equity and inclusion.

    Ms. Klinger serves on the board of directors of SwissHoldings (the Swiss federation of industrial and service groups) in Switzerland. She previously served on the board of directors of the SIX Group in Switzerland from 2016 to 2020.

    "It is an honor to join Moderna and its leadership team at such a remarkable moment in the transformation of the company," said Ms. Klinger. "Moderna's mission and values are consistent with those on which I have sought to build my career, including a relentless focus on turning innovation into impact, every day. I look forward with enthusiasm to joining Moderna and helping continue to build an organization that supports the long-term demands of our evolving business, science, development programs and efforts to bring mRNA medicines to patients."

    Ms. Klinger received her Juris Doctorate with honors from the University of North Carolina at Chapel Hill and a bachelor's degree in psychology from the University of Notre Dame. She is a member of the State Bar of Georgia and the District of Columbia Bar.

    Late in 2020, Moderna's General Counsel and Corporate Secretary, Lori Henderson, J.D., announced her decision to retire later in 2021, while remaining with the Company to ensure a smooth transition with Moderna's next General Counsel.

    "As Shannon prepares to join us, I would like to thank Lori once again for her significant contributions during her time at Moderna. She helped us build a world class legal team even as we transitioned from a private to public company," said Mr. Bancel. "Lori has been a tireless champion for our people and advocate for our mission, and she has proven herself to be a wonderful partner to me and our leadership team. On behalf of our Executive Committee and our colleagues, I wish Lori all the best on her upcoming retirement."

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

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  4. EAST HANOVER, N.J., Sept. 16, 2020 /PRNewswire/ -- Today the Novartis US Foundation announced a total commitment of USD 25 million to develop partnerships and fund community organizations and programs that address health inequities, with a focus on diversity in clinical trials, in the United States. This commitment reinforces the Novartis US Foundation mission to improve health in underserved communities in the United States by creating innovative and sustainable solutions to expand access to healthcare and build trust within the healthcare system.

    "In the wake of the COVID-19 pandemic and heightened attention on racial injustice in the US, there has been new and significant recognition of disparities in care in minority communities. We have accelerated our commitment to create innovative and sustainable partnerships that have the potential to improve health equity in underserved communities, including African American/Black and Hispanic communities," said Tom Kendris, US Country President, Novartis Corporation, Chairman, Board of Trustees, Novartis US Foundation.

    Since re-focusing its mission last year, the Novartis US Foundation has committed more than USD 10 million to develop partnerships to enable healthcare systems to better meet the needs of their patients by addressing barriers to care, or by identifying changes needed to address the underlying causes of health disparities. This support included signature partnerships with New Jersey Primary Care Association, The CDC Foundation, Institute for Healthcare Improvement and USD 5 million to support COVID-19 response efforts, including 40 grants to support local communities.

    A key area of focus for the additional commitment will be in addressing the vast underrepresentation of minorities, including Black Americans, in clinical trials. In 2019, African Americans/Blacks made up 13.5% of the US population, but only 9% of clinical trial participants1,2. Diversity in clinical trials is critical to understanding how medicines will work in all patient populations impacted by the disease.

    "We believe the Novartis US Foundation can serve as a catalyst for change through a multi-year, multi-million dollar commitment. As part of this effort, we will collaborate with partners and support industry-wide programs to improve diversity in clinical trials through systemic and policy-driven solutions that go beyond calls to study sponsors to be more inclusive," continued Kendris.

    There are several barriers to clinical trial participation reflective of other systemic issues leading to disparities in health such as, mistrust of the healthcare system, a lack of comfort or understanding of health systems, including clinical trial processes, as well as time and resource constraints associated with participation3. The US Foundation is in the exploration phase to identify all dimensions of these issues and to identify new collaborators from the public, private and advocacy sectors. 

    About Social Determinants of Health and Health Disparities

    CDC defines social determinants of health as the conditions – social, economic and physical – in places where people live, learn, work and play that influence health outcomes of people2. These conditions may include safe and affordable housing, access to education, food security, and clean environments2. When health outcomes are better or worse from one population to the next, there is disparity. Health disparities have impacts reaching far beyond those directly affected by limiting advancements in care and resulting in avoidable costs3. For example, the American Public Health Association found racial disparities in health led to an estimated $93 billion in excess medical care costs and $42 billion in lost productivity4.

    About the Novartis US Foundation

    The Novartis US Foundation is a 501(c)(3) charitable foundation established by Novartis to support philanthropic efforts in the United States. The mission of the Novartis US Foundation is to improve health in underserved communities in the United States by creating innovative and sustainable solutions to expand access to healthcare and build trust within the healthcare system. We do this by supporting sustainable programs and partnerships that strengthen health systems, eliminate barriers to quality health services, and enhance local communities.

    About Novartis

    Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of Novartis – is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs about 15,000 people in the United States. For more information, please visit https://www.novartis.us.

    Novartis and Novartis US is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews and @NovartisUS at https://twitter.com/NovartisUS.

    For Novartis multimedia content, please visit https://www.novartis.com/news/media-library 

    For questions about the site or required registration, please contact .

    References

    1. US Food and Drug Administration. 2019 Drug Trials Snapshots Summary Report. Available at: https://www.fda.gov/media/135337/download. Accessed August 27, 2020.
    2. US Census Bureau. Quick Facts. Available at: https://www.census.gov/quickfacts/fact/table/US/RHI225219. Accessed August 27, 2020.
    3. Clark, LT, Watkins, L, Pina, IL, et al. Increasing Diversity in Clinical Trials. Current Problems in Cardiology. 2019; 44(5):148-175.
    4. Centers for Disease Control and Prevention. Social Determinants of Health: Know What Affects Health. Available at: https://www.cdc.gov/socialdeterminants/index.htm. Accessed August 20, 2020.
    5. Turner, A. The Business Case for Racial Equity. WK Kellogg Foundation. Available at: http://ww2.wkkf.org/2018/bcfre/BCRE-National-Report.pdf, Accessed February 13, 2020.
    6. American Public Health Association. Health Equity. Available at: https://www.apha.org/topics-and-issues/health-equity. Accessed February 13, 2020.

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  5. Industry Leader Joins Vasomune's Board of Directors as the Company Transitions to Clinical Development of AV-001 for the Treatment of COVID-19/pathogen-induced ARDS

    Vasomune Therapeutics, Inc., an early stage therapeutic biopharmaceutical company developing a novel first-in-class medicine for the treatment of COVID-19/pathogen-induced ARDS, today announced the appointment of Meenu Chhabra to the Company's Board of Directors. Ms. Chhabra is the President and Chief Executive Officer of Proteostasis Therapeutics, Inc. (NASDAQ:PTI).

    "Ms. Chhabra is an experienced highly regarded leader in the life sciences industry with particular expertise in operations, business development and finance," said Douglas A. Hamilton, President and Chief Executive…

    Industry Leader Joins Vasomune's Board of Directors as the Company Transitions to Clinical Development of AV-001 for the Treatment of COVID-19/pathogen-induced ARDS

    Vasomune Therapeutics, Inc., an early stage therapeutic biopharmaceutical company developing a novel first-in-class medicine for the treatment of COVID-19/pathogen-induced ARDS, today announced the appointment of Meenu Chhabra to the Company's Board of Directors. Ms. Chhabra is the President and Chief Executive Officer of Proteostasis Therapeutics, Inc. (NASDAQ:PTI).

    "Ms. Chhabra is an experienced highly regarded leader in the life sciences industry with particular expertise in operations, business development and finance," said Douglas A. Hamilton, President and Chief Executive Officer, Vasomune. "We are delighted to have Meenu join the Vasomune team as we transition to the clinic with our novel investigational medicine to treat ARDS."

    Ms. Chhabra has been serving as President and Chief Executive Officer and Director of Proteostasis Therapeutics Inc., since May 2014. From August 2007 to May 2014, Ms. Chhabra was President and Chief Executive Officer at Allozyne, Inc., a biopharmaceutical company. From December 2006 to August 2007, she served as Vice President of Business Development and Licensing at the Novartis Pharmaceuticals division of Novartis AG (NYSE:NVS). From July 2003 to November 2006, she served as Chief Business Officer at BioXell SpA, a spin-off from F. Hoffmann-LaRoche Ltd.'s Milan Research Institute (Italy), where she led corporate development and financing activities. Ms. Chhabra has also held management positions with Fresenius Kabi AG, Warner-Lambert Company, LLC, and Bristol-Myers Squibb Company (NYSE:BMY). She obtained her M.B.A. from York University and her B.Sc. from the University of Toronto. Ms. Chhabra is a member of the Biotechnology Industry Organization (BIO) Board and is a member of the Emerging Companies Section.

    "I'm excited to join Vasomune's Board and help build the company during this important transition and contribute to the company's mission of developing innovative medications for critically ill patients with ARDS and COVID-19 pneumonia," stated Ms. Chhabra.

    About AV-001

    AV-001 is an investigational medicine designed to activate the Tie2 receptor and restore normal barrier defense in the vasculature. Following trauma or infection, the body's host vascular response can become unchecked, leading to vascular leak and ultimately organ failure and death. Vasomune is developing AV-001 for the treatment of pathogen-induced moderate-to-severe ARDS. ARDS is a life-threatening condition that can develop after pneumonia, trauma, shock and sepsis, and is also the leading cause of death for patients infected with COVID-19. Prior to the onset of the coronavirus pandemic, the combined annual incidence of ARDS is approximately 370,000 patients per year in the US and EU with an average mortality rate of 40%. At present, there are no effective therapeutics to treat ARDS.

    About Vasomune Therapeutics

    Vasomune Therapeutics is a private early stage biopharmaceutical company developing the next generation of medicines to harness the body's ability to defend against illness by modifying the host vascular response. The company is transitioning in the near term to the clinic with a novel therapeutic approach to ARDS that involves targeting a signaling molecule in the vasculature responsible for regulating barrier defense. Vascular dysfunction is associated with the pathology of several disease states, including COVID-19 pneumonia, acute lung injury, acute kidney injury, hemorrhagic fever, sepsis and diabetic nephropathy. Vasomune's head office and laboratory is located in Toronto, Canada and US offices in San Mateo CA. For more information about the company and its product candidates, please visit www.vasomune.com or email the President and CEO of Vasomune at .

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