AMGN Amgen Inc.

227.52
-2.47  -1%
Previous Close 229.99
Open 229.99
52 Week Low 177.05
52 Week High 276.69
Market Cap $131,407,903,460
Shares 577,566,383
Float 576,165,949
Enterprise Value $156,600,081,392
Volume 2,769,561
Av. Daily Volume 2,540,668
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Upcoming Catalysts

Drug Stage Catalyst Date
KYPROLIS (ARROW)
Multiple Myeloma
Approved
Approved
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Tezepelumab - NAVIGATOR
Asthma
Phase 3
Phase 3
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AMG 510 (Sotorasib)
Colorectal cancer
Phase 2
Phase 2
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AMG 510 - sotorasib (CodeBreak 100)
Non-small cell lung cancer (NSCLC)
PDUFA priority review
PDUFA priority review
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Drug Pipeline

Drug Stage Notes
CK-136 (AMG 594)
Healthy volunteers
Phase 1
Phase 1
Phase 1 trial has been completed.
Omecamtiv mecarbil METEORIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 enrollment to be completed 1H 2021.
OTEZLA
Plaque psoriasis
sNDA Filing
sNDA Filing
sNDA filing announced February 22, 2021.
Efavaleukin alfa (AMG 592)
Chronic Graft Versus Host Disease
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
AMG 570
Systemic Lupus Erythematosus (SLE)
Phase 2
Phase 2
Phase 2 trial is enrolling.
AMG 701
Multiple Myeloma
Phase 1
Phase 1
Phase 1 enrollment has been paused to discuss changes to safety monitoring and mitigation, expects to resume patient enrollment in 1H 2021.
AMG 510 (Sotorasib)
Non-small cell lung cancer (NSCLC) first line including STK11 mutations
Phase 2
Phase 2
Phase 2 trial to commence 1H 2021.
Nplate
Hematopoietic Syndrome of Acute Radiation Syndrome
Approved
Approved
FDA approval announced in earnings release - February 2, 2021.
AMG 592
Systemic Lupus Erythematosus
Phase 1/2
Phase 1/2
Phase 1b/2 trial is enrolling - noted July 28, 2020.
Tezepelumab - SOURCE
Oral corticosteroid dependent asthma.
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 22, 2020.
RIABNI (rituximab-arrx)
RITUXAN biosimilar - non-Hodgkin lymphoma
Approved
Approved
FDA approval announced December 17, 2020.
Tezepelumab
Chronic obstructive pulmonary disease (COPD)
Phase 2
Phase 2
Phase 2 trial is enrolling.
AMG 510
Solid tumors
Phase 1
Phase 1
Phase 1 update at ASCO May 29, 2020. Objective response rate (ORR) was 12% (3/25) in 960 mg once-daily target dose cohort.
AMG 757
Small Cell Lung Cancer
Phase 1
Phase 1
Phase 1 data presented at SITC November 9-14, 2020. Partial response 6/38.
Omecamtiv mecarbil GALACTIC-HF
Acute heart failure
Phase 3
Phase 3
Phase 3 top-line data met primary composite endpoint of reduction in cardiovascular death or heart failure but did not meet secondary endpoint of reduction in cardiovascular death - October 8, 2020.
MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved
Approved September 14, 2017.
AMG 420
Relapsed. Refractory (R/R) Multiple Myeloma (MM)
Phase 1
Phase 1
Phase 1 data ASCO June 2, 2019. Overall response rate 70% (7/10) in high dose, 13/42 response across all cohorts.
AMG 890
Cardiovascular disease / Elevated Lipoprotein
Phase 2
Phase 2
Phase 2 trial has commenced - noted July 28, 2020.
Cenicriviroc + Otezla (apremilast) + Firazyr (icatibant)
COVID-19 (severe)
Phase 2
Phase 2
Phase 2 trial initiation announced August 3, 2020.
AMG 510 CodeBreaK 200
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial is enrolling.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
OTEZLA
Scalp Psoriasis
Approved
Approved
FDA approval announced April 2020.
ABP 710
REMICADE biosimilar - rheumatoid arthritis
Approved
Approved
FDA Approval announced December 6, 2019.
OTEZLA - PSA-006
Psoriatic Arthritis
Phase 3
Phase 3
Phase 3 - primary endpoint met.
OTEZLA
Behçet’s Disease
Approved
Approved
FDA Approval announced July 19, 2019.
BLINCYTO
Acute lymphoblastic leukemia (ALL) - pediatric
Phase 3
Phase 3
Phase 3 enrolment terminated due to treatment benefit over chemo. Primary endpoint of event-free survival met.
Nplate (Romiplostim)
Immune thrombocytopenia (ITP)
Approved
Approved
FDA Approval announced October 18, 2019.
ABP 980 (Kanjinti; trastuzumab-anns)
Herceptin biosimilar
CRL
CRL
FDA approval announced June 13, 2019.
EVENITY (Romosozumab)
Osteoporosis
Approved
Approved
FDA Approval announced April 9, 2019.
Nplate (Romiplostim)
Immune Thrombocytopenia (Pediatric)
Approved
Approved
FDA approval announced December 14, 2018.
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approval announced June 11, 2018.
Prolia (denosumab)
Glucocorticoid-induced osteoporosis (GIOP)
Approved
Approved
Approval announced May 21, 2018.
Erenumab
Migraine
Approved
Approved
Approval announced May 17, 2018.
KYPROLIS (ENDEAVOR)
Relapsed Multiple Myeloma
Approved
Approved
sNDA approved January 17, 2018.
Repatha
Cardiovascular disease
Approved
Approved
Approval announced December 1, 2017.
Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved
Approved February 7, 2017.
BLINCYTO
Ph+ R/R ALL
Approved
Approved
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
XGEVA
Multiple Myeloma
Approved
Approved
sBLA approval announced January 5, 2017.
Corlanor
Chronic Heart Failure
Approved
Approved
Approved April 15, 2015.
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
Approved
Approved
sBLA approval announced June 29, 2017.

Latest News

  1. The new report by Expert Market Research titled, ‘Global Anaemia Drugs Market Report and Forecast 2021-2026', gives an in-depth analysis of the Global Anaemia Drugs market, assessing the market based on its segments like iron deficiency, CKD (chronic kidney disease), sickle cell, aplastic and major regions.

    The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porter’s Five Forces models.

    Note 1: For a snapshot of the primary and secondary data of the market (2015-2025), along with business strategies and detailed market segmentation, please click on the request

    The new report by Expert Market Research titled, ‘Global Anaemia Drugs Market Report and Forecast 2021-2026', gives an in-depth analysis of the Global Anaemia Drugs market, assessing the market based on its segments like iron deficiency, CKD (chronic kidney disease), sickle cell, aplastic and major regions.

    The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porter’s Five Forces models.

    Note 1: For a snapshot of the primary and secondary data of the market (2015-2025), along with business strategies and detailed market segmentation, please click on the request sample report. The sample report shall be delivered to you within 24 hours.

    Request a free sample copy in PDF or view the report  https://www.expertmarketresearch.com/reports/anaemia-drugs-market/requestsample

    The key highlights of the report include:

    Market Overview (2016-2026)

    • Forecast CAGR (2021-2026): 8%

    The rising prevalence of the CKD anaemia segment over the forecast period is driving the global demand for anaemia drugs as chronic kidney diseases are becoming prevalent across many regions. In addition, due to consumer convenience, the exponential growth of the e-commerce segment as a distribution channel is projected to promote the market growth of anaemic drugs. The market depends on many factors that are expected to drive the overall growth of the market, such as the increasing geriatric population, rapid R&D operations, and better healthcare infrastructure. The market is further motivated by the ongoing development of key players in the industry.

    Industry Definition and Major Segments

    Anaemia is a medical disorder where the number of red blood cells (RBC) or haemoglobin is below average. The results of anaemia are shortness of breath, tiredness, palpitations, and dizziness. In the treatment of this disease, anaemic medicines are used.

    Explore the full report with the table of  https://www.expertmarketresearch.com/reports/anaemia-drugs-market

    On the basis of anaemia type, the market is divided into:

    • Iron Deficiency
    • CKD (Chronic Kidney Disease)
    • Sickle Cell
    • Aplastic
    • Others

    Based on drugs, the industry can be segmented into:

    • Dietary Supplements
    • Medicines

    The dietary supplements are further divided on the basis of types:

    • Iron supplements
    • Vitamin supplements
    • Others

    Medicines are further divided into:

    • Antibiotics
    • Hormones (erythropoietin)
    • Chelation therapy (lead poisoning)
    • Others

    By distribution channel, the industry is categorised into:

    • Hospital Pharmacy
    • Store Pharmacy
    • Online
    • Others

    Latest Global News on Anaemia Drugs  https://www.expertmarketresearch.com/pressrelease/global-anaemia-drugs-market

    On the basis of regional markets, the industry is divided into:

    1 North America
    1.1 United States of America
    1.2 Canada
    2 Europe
    2.1 Germany
    2.2 United Kingdom
    2.3 France
    2.4 Italy
    2.5 Others
    3 Asia Pacific
    3.1 China
    3.2 Japan
    3.3 India
    3.4 ASEAN
    3.5 Others
    4 Latin America
    4.1 Brazil
    4.2 Argentina
    4.3 Mexico
    4.4 Others
    5 Middle East & Africa
    5.1 Saudi Arabia
    5.2 United Arab Emirates
    5.3 Nigeria
    5.4 South Africa
    5.5 Others

    Market Trends

    The demand is further influenced by the continuing growth of key players in the industry, such as Pfizer Inc. and Amgen Inc. (NASDAQ:AMGN). On 15 May 2018, Pfizer Inc. reported that RETACRIT® (epoetin alfa-epbx), which is biosimilar to Epogen® and Procrit® (epoetin alfa)1, has been approved by the US Food and Drug Administration (FDA) for all indications of the product listed. RETACRIT® is believed to provide more access to high-quality, lower-cost alternative treatment options for anaemia and a reduction in RBC allogeneic transfusions in some patients for patients and their physicians. Such advances in the field of anaemia drugs are expected to support market growth over the forecast period to meet the advancing needs of patients and the large healthcare population.

    Key Market Players

    The major players in the market are Amgen Inc, Pieris Pharmaceuticals, Inc., Pfizer Inc., Akebia Therapeutics, Inc., and Takeda Pharmaceutical Company Limited. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

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    Note 2: As the novel coronavirus (COVID-19) continues to spread across the world, our analysts are constantly tracking the impact of this rapidly evolving situation on the markets and the consumer purchase behaviours. Thus, our latest estimates and analysis about the current market trends and forecast will exhaustively reflect the effects of this emerging pandemic.

    About Us:

    Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

    At Expert Market Research, we tailor our approach according to our clients’ needs and preferences, providing them with valuable, actionable and up-to-date insights into the market, thus, helping them realize their optimum growth potential. We offer market intelligence across a range of industry verticals which include Pharmaceuticals, Food and Beverage, Technology, Retail, Chemical and Materials, Energy and Mining, Packaging and Agriculture.

    We also provide state-of-the-art procurement intelligence through our platform, https://www.procurementresource.com. Procurement Resource is a leading platform for digital procurement solutions, offering daily price tracking, market intelligence, supply chain intelligence, procurement analytics, and category insights through our thoroughly researched and infallible market reports, production cost reports, price analysis, and benchmarking.

    Informes de Expertos (https://informesdeexpertos.com), the Spanish variant of Expert Market Research, is a platform that offers market research and consultancy services to a broad clientele base across Spanish speaking countries. With our primary focus on the Latin America and Spain markets, our research experts provide relevant and actionable insights into the markets and track major trends, economic developments, and global trade data.

    Determined to bring client satisfaction, we make sure that our tailored approach meets the client’s unique market intelligence requirements. Our syndicated and customized research reports cover a wide spectrum of industries ranging from pharmaceuticals and food and beverage to packaging, logistics, and transportation.

    Media Contact
    Company Name: Expert Market Research
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    Press Release Distributed by ABNewswire.com

    To view the original version on ABNewswire visit: Global Anaemia Drugs Market to be Driven by Growing Prevalence of CKD Anaemia in the Forecast Period of 2021-2026

    View Full Article Hide Full Article
  2. 2021 Vaccine Manufacturing: Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; manufacturing is still working to supply up to 1 billion doses for 2021

    2022 Vaccine Manufacturing: Based on the high demand from around the world for our COVID-19 vaccine and variant-based boosters, making new capital investments to increase capacity up to 1.4 billion doses in 2022

    Commercial Subsidiaries: Company established 8 commercial subsidiaries in 2020 in North America and Europe and plans to expand in 2021 to Japan, South Korea and Australia

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business…

    2021 Vaccine Manufacturing: Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; manufacturing is still working to supply up to 1 billion doses for 2021

    2022 Vaccine Manufacturing: Based on the high demand from around the world for our COVID-19 vaccine and variant-based boosters, making new capital investments to increase capacity up to 1.4 billion doses in 2022

    Commercial Subsidiaries: Company established 8 commercial subsidiaries in 2020 in North America and Europe and plans to expand in 2021 to Japan, South Korea and Australia

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the fourth quarter and fiscal year 2020 and highlighted pipeline progress.

    "2020 was a historic year for Moderna. The team rose to the challenge to address the devastating COVID-19 pandemic in less than one year with our authorized vaccine. It is encouraging and humbling that more than 32 million doses of our vaccine have been administered in the U.S. and that millions of people around the world have been vaccinated with our vaccine to date. 2020 demonstrated the power of harnessing mRNA to make medicines and also demonstrated the speed and scalability of the Moderna platform that we have built over the last 10 years," said Stéphane Bancel, Chief Executive Officer of Moderna. "I believe that 2021 will be an inflection year for Moderna. We previously believed that mRNA would lead to approved medicines, and we were limited in our ambitions by the need for regular capital raises and keeping several years of cash to manage financing risk. We now know that mRNA vaccines can be highly efficacious and authorized for use, and we are a cash-flow generating commercial company. We opened commercial subsidiaries in 8 countries in 2020 and plan to add Japan, South Korea and Australia in 2021. We plan to accelerate and significantly increase our investments in science and grow our development pipeline faster. By executing on our 2021 priorities, we will advance our mission of delivering on the promise of mRNA science to create a new generation of transformative medicines for patients. This is just the beginning."

    New updates and recent progress include:

    COVID-19 Vaccine Development

    • Raises lower end of global manufacturing plan for 2021 from 600 million doses to 700 million doses; making capital investments to increase capacity up to an expected 1.4 billion doses in 2022
    • Phase 2/3 study of mRNA-1273 in adolescents has completed enrollment of 3,000 participants

    Infectious Diseases

    • First cohort in the Phase 1 study of hMPV/PIV3 vaccine candidate (mRNA-1653) fully enrolled
    • First older adult in the Phase 1 study of RSV vaccine candidate (mRNA-1345) has been dosed
    • First 3 cohorts in age de-escalation study of RSV vaccine candidate (mRNA-1345) for the pediatric population fully enrolled

    Rare Diseases

    • Study start-up activities for Phase 1/2 study of PA candidate (mRNA-3927) ongoing

    Cardiovascular Diseases

    • Regained all rights to the Relaxin development candidate from AstraZeneca

    Moderna currently has 24 mRNA development programs in its portfolio with 13 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: On December 30, 2020, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the National Institutes of Health (NIH). All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Today, the Company is sharing an update on the Phase 3 COVE study. An updated total of adjudicated COVID-19 cases among baseline seronegative participants in the COVE study starting two weeks following the second dose showed 690 cases to date, of which 639 cases of COVID-19 were observed in the placebo group versus 51 cases observed in the Moderna COVID-19 Vaccine group. Participants in the Phase 3 COVE study are in the process of being unblinded and cases will continue to accrue. On December 18, 2020, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age and older. 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 and Qatar. Moderna is working with additional health agencies and with the World Health Organization 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.
    • 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: Letter to the editor in the New England Journal of Medicine published February 17, 2021, showed vaccination with the Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant relative to prior variants.
    • 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 of 3,000 participants in the U.S.
      • 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 will start in the near-term.
      • 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.
    • Next-generation vaccine against COVID-19 (mRNA-1283): 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 interim data from the Phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. 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. On January 11, Moderna announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults (greater than 50 years), in addition to the pediatric population, who are also at risk of significant RSV disease. In the pediatric population, the first three cohorts of younger adults in the Phase 1 age de-escalation study of mRNA-1345 are fully enrolled. The age range of toddlers in this de-escalation Phase 1 study has been amended to 12-59 months (from 12-36 months). In the older adult population, the first participant in the Phase 1 study of mRNA-1345 in the adult RSV vaccine has been dosed. 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 WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of seasonal influenza is approximately $11 billion per year. 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 Phase 1 clinical trials for this 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 (BMGF), 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 new 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 new 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): Study start-up activities for the Phase 1/2 study of PA candidate (mRNA-3927) have resumed following COVID-19 related pause and protocol amendment. mRNA-3927 uses the same LNP formulation as mRNA-1944. 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.

    Fourth Quarter and Full Year 2020 Financial Results (Unaudited)

    • Cash Position: Cash, cash equivalents and investments as of December 31, 2020 and 2019 were $5.25 billion and $1.26 billion, respectively.
    • Net Cash Provided by (Used in) Operating Activities: Net cash provided by operating activities was $2.03 billion for the year ended December 31, 2020 compared to net cash used in operating activities of $(459) million for the year ended December 31, 2019.
    • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $67 million for the year ended December 31, 2020 compared to $32 million for the same period in 2019.
    • Revenue: Total revenue was $571 million for the fourth quarter of 2020 compared to $14 million for the fourth quarter of 2019. Total revenue was $803 million for the year ended December 31, 2020 compared to $60 million for the year ended December 31, 2019. The increases in both periods in 2020 were driven by increases in grant revenue and product sales. The increase in grant revenue was primarily due to the BARDA award to accelerate development of our COVID-19 vaccine. We began to recognize revenue in December 2020 from our COVID-19 vaccine subsequent to its authorization for emergency use by the FDA and Health Canada.
    • Cost of Sales: Costs of sales were $8 million, or 4% of Moderna's product sales, in 2020, primarily comprised of third-party royalties as the associated inventory costs were expensed previously. If inventory sold during 2020 was valued at cost, Moderna's cost of sales for 2020 would have been $62 million, or 31% of Moderna's product sales.
    • Research and Development Expenses: Research and development expenses were $759 million for the fourth quarter of 2020 compared to $118 million for the fourth quarter of 2019. Research and development expenses were $1.37 billion for the year ended December 31, 2020 compared to $496 million for the year ended December 31, 2019. The increases in 2020 were largely attributable to mRNA-1273 clinical development, pre-launch inventory buildup prior to the emergency use authorization from the FDA and to a lesser extent, an increase in personnel related costs, primarily driven by an increase in the number of employees supporting our mRNA-1273 development activities.
    • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $79 million for the fourth quarter of 2020 compared to $26 million for the fourth quarter of 2019. Selling, general and administrative expenses were $188 million for the year ended December 31, 2020 compared to $110 million for the year ended December 31, 2019. The increases in 2020 were mainly due to an increase in personnel costs, and outside services, primarily attributable to increased headcount and mRNA-1273 vaccine candidate commercialization-related activities.
    • Net Loss: Net loss was $272 million for the fourth quarter of 2020 compared to $123 million for the fourth quarter of 2019. Net loss was $747 million for the year ended December 31, 2020 compared to $514 million for the year ended December 31, 2019.

    Moderna's COVID-19 Vaccine Supply Agreements & Regulatory Updates

    Moderna has confirmed the following supply agreements of committed orders:

    • United States: 300 million doses with options to purchase an additional 200 million doses; the U.S. Food and Drug Administration (FDA) has authorized emergency use in individuals 18 years of age and older
    • European Union: 310 million doses with option to purchase an additional 150 million doses in 2022; the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna in individuals 18 years of age and older1
    • Japan: 50 million doses
    • Canada: 44 million doses; Health Canada authorized COVID-19 Vaccine Moderna for the immunization of people 18 years of age and older under an Interim Order
    • Republic of Korea: 40 million doses
    • United Kingdom: 17 million doses; the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the COVID-19 Vaccine Moderna for use under Regulation 174, a temporary authorization
    • Switzerland: 13.5 million doses; Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland
    • Colombia: 10 million doses
    • Israel: 6 million doses; Israel's Ministry of Health (MOH) has given authorization to import the COVID-19 Vaccine Moderna
    • Taiwan: 5 million doses
    • Singapore: (undisclosed); the Singapore Health Sciences Authority (HSA) approved the interim authorization of the COVID-19 Vaccine Moderna for use under the Pandemic Special Access Route (PSAR)
    • Qatar (undisclosed); the Qatar Ministry of Public Health issued an emergency use authorization for the COVID-19 Vaccine Moderna

    Management Updates

    • Moderna's Chief Medical Officer (CMO), Tal Zaks, M.D., Ph.D., will be leaving the Company in late September after six years of service. The Company has retained Russell Reynolds to recruit for a new CMO with global and commercial experience as the Company scales up the launch of its COVID-19 Vaccine and prepares to file several biologics license applications (BLAs) over the next few years.

    "I would like to thank Tal for his tremendous impact on Moderna's success over the last six years. Tal joined us when we were a pre-clinical company. His guidance and contributions were important in helping Moderna get to where we are today. Through his leadership over the past year in Moderna's response to the COVID-19 pandemic, Tal has made a contribution that extends beyond Moderna to all of society. I have enjoyed having him as my partner and wish him all the best as he embarks on the next leg of his career," said Stéphane Bancel.

    • Corinne Le Goff, Pharm.D., M.B.A., joined Moderna as the Company's first Chief Commercial Officer on January 19, 2021. Dr. Le Goff previously served as SVP and President U.S. Business Organization at Amgen (NASDAQ:AMGN). During her nearly 6-year tenure at Amgen, she also served as SVP of the Europe Region and oversaw 48 markets. Dr. Le Goff was actively engaged with the policy community and advocates for innovative, high-quality and affordable healthcare.

    2020 Commercial Network

    The Company started to build a global commercial network. This infrastructure will enable Moderna's entire portfolio, which means that Moderna can commercialize its entire pipeline without a large pharmaceutical partner. The Company now has subsidiaries, distributors or partners in the following geographies:

    • Moderna USA
    • Moderna Canada
    • Moderna France
    • Moderna Germany
    • Moderna Italy
    • Japan (Partner: Takeda)
    • Moderna Spain
    • Moderna UK
    • Moderna Switzerland

    Corporate Updates

    • Shareholder letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.
    • Annual Meeting of Shareholders: The Moderna Annual Meeting of Shareholders will be held on April 28, 2021 at 8:00 a.m. ET. The meeting will be held virtually at www.virtualshareholdermeeting.com/MRNA2021. The record date for voting or attendance as a stockholder is 4:00 p.m. ET on March 1, 2021.

    2021 Financial Considerations

    • Advance Purchase Agreements (APAs): Already signed APAs for scheduled delivery in 2021, reflecting a total of $18.4 billion in anticipated product sales. Additional discussions ongoing with several governments relating to APAs for scheduled deliveries in 2021 and 2022. Moderna responded to a tender to UNICEF to supply COVAX in 2021 and 2022 and discussions are ongoing with COVAX/UNICEF.
    • Cost of Sales: Expected at approximately 20% of product sales for fiscal year 2021.
    • 2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: For the first quarter 2021, expect low double-digit percent increase versus adjusted fourth quarter 2020 results of $0.5 billion. The fourth quarter 2020 reported expense was $0.8 billion. Adjusted Q4 expense, totaling $0.5 billion, excludes $0.3 billion of reported expenses, which are now capitalized and expensed through cost of sales, based on our change from a research and development to a commercial organization.
    • Tax Rate: Effective tax rate expected in the mid-teen percentage level as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of $2.3 billion.
    • Capital Expenditures: $350-400 million of capital investments currently planned for 2021.

    2021 New Commercial Networks

    In 2021, the Company plans to further expand its commercial network to enable Moderna's entire portfolio.

    • Moderna Australia
    • Moderna Japan
    • Moderna South Korea

    Key 2021 Investor and Analyst Event Dates

    • Vaccines Day – April 14
    • 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, February 25, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 4066945. 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 thousands)

     

     

    Three Months Ended December 31,

     

    Years Ended December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Revenue:

     

     

     

     

     

     

     

    Grant revenue

    $

    341,370

     

     

    $

    3,502

     

     

    $

    528,905

     

     

    $

    12,173

     

    Product sales

    199,872

     

     

     

     

    199,872

     

     

     

    Collaboration revenue

    29,503

     

     

    10,553

     

     

    74,618

     

     

    48,036

     

    Total revenue

    570,745

     

     

    14,055

     

     

    803,395

     

     

    60,209

     

    Operating expenses:

     

     

     

     

     

     

     

    Cost of sales

    7,933

     

     

     

     

    7,933

     

     

     

    Research and development

    758,860

     

     

    117,954

     

     

    1,370,339

     

     

    496,309

     

    Selling, general and administrative

    78,990

     

     

    25,707

     

     

    188,267

     

     

    109,620

     

    Total operating expenses

    845,783

     

     

    143,661

     

     

    1,566,539

     

     

    605,929

     

    Loss from operations

    (275,038

    )

     

    (129,606

    )

     

    (763,144

    )

     

    (545,720

    )

    Interest income

    4,200

     

     

    7,984

     

     

    24,715

     

     

    38,530

     

    Other expense, net

    (174

    )

     

    (1,837

    )

     

    (6,084

    )

     

    (7,526

    )

    Loss before provision for (benefit from) income taxes

    (271,012

    )

     

    (123,459

    )

     

    (744,513

    )

     

    (514,716

    )

    Provision for (benefit from) income taxes

    1,473

     

     

    (169

    )

     

    2,551

     

     

    (695

    )

    Net loss

    $

    (272,485

    )

     

    $

    (123,290

    )

     

    $

    (747,064

    )

     

    $

    (514,021

    )

    Net loss per share, basic and diluted

    $

    (0.69

    )

     

    $

    (0.37

    )

     

    $

    (1.96

    )

     

    $

    (1.55

    )

    Weighted average common shares used in net loss per share, basic and diluted

    396,697,168

     

    334,392,128

     

    381,333,059

     

    330,802,136

    MODERNA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

    (Unaudited, in thousands)

     

     

    December 31,

     

    2020

     

    2019

    Cash, cash equivalents and investments

    $

    5,246,456

     

     

    $

    1,262,987

     

    Total assets

    7,336,750

     

     

    1,589,422

     

    Total liabilities

    4,775,375

     

     

    414,612

     

    Total stockholders' equity

    2,561,375

     

     

    1,174,810

     

     

     

    Years Ended December 31,

     

    2020

     

    2019

    Net cash provided by (used in) operating activities

    $

    2,026,971

     

     

    $

    (458,968

    )

    Cash used for purchases of property and equipment (1)

    (67,448

    )

     

    (31,554

    )

    (1)

    Includes $41.7 million and $14.6 million for the years ended December 31, 2020 and 2019, respectively, related to our Moderna Technology Center facilities.

    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; the Company's establishment of additional subsidiaries and development of its commercial network; 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 efficacy of mRNA vaccines and their potential for regulatory approval or authorization; expected timing of execution of the Purchase Agreement by the European Commission for additional vaccine doses; future research and development expenses; 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 the associated dollar amounts to be received, which should not be construed as expected 2021 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 Quarterly Report on Form 10-Q 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.

    1 On February 18, 2021, the European Commission advised Moderna it had successfully tendered for the provision of 150 million doses of COVID-19 Vaccine Moderna in 2021 and an option to purchase an additional 150 million doses in 2022; this tender is subject to execution of the Purchase Agreement, which is expected February 26, 2021, following an opt out period for individual Member States.

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  3. THOUSAND OAKS, Calif., Feb. 24, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 41st Annual Virtual Healthcare Conference at 12:50 p.m. ET on Thursday, March 4, 2021. Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event.

    About Amgen 
    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing…

    THOUSAND OAKS, Calif., Feb. 24, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Cowen 41st Annual Virtual Healthcare Conference at 12:50 p.m. ET on Thursday, March 4, 2021. Murdo Gordon, executive vice president of Global Commercial Operations and Peter H. Griffith, executive vice president and chief financial officer at Amgen will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen's website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen's website for at least 90 days following the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-to-present-at-the-cowen-41st-annual-healthcare-conference-301234981.html

    SOURCE Amgen

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  4. THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Friday, Feb. 26, at 1:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with clinical trial investigators, will discuss the results of the tezepelumab Phase 3 NAVIGATOR study in patients with severe asthma.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business…

    THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will host a webcast call for the investment community in conjunction with the 2021 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on Friday, Feb. 26, at 1:00 p.m. ET. David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with clinical trial investigators, will discuss the results of the tezepelumab Phase 3 NAVIGATOR study in patients with severe asthma.

    Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

    The webcast, as with other selected presentations regarding developments in Amgen's business given at certain investor and medical conferences, can be accessed on Amgen's website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

    About Amgen 

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.  

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.  

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.  

    CONTACT: Amgen, Thousand Oaks 

    Megan Fox, 805-447-1423 (media)

    Trish Rowland, 805-447-5631(media) 

    Arvind Sood, 805-447-1060 (investors) 

    Amgen Logo. (PRNewsFoto/Amgen) (PRNewsFoto/)

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/amgen-to-webcast-investor-meeting-at-aaaai-virtual-annual-meeting-301232764.html

    SOURCE Amgen

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  5. THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.

    "Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing…

    THOUSAND OAKS, Calif., Feb. 22, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Otezla® (apremilast) for the treatment of adults with mild-to-moderate plaque psoriasis who are candidates for phototherapy or systemic therapy. The sNDA is based on data from the Phase 3 ADVANCE trial that demonstrated oral Otezla 30 mg twice daily achieved a statistically significant improvement in the primary endpoint of the static Physician's Global Assessment (sPGA) response at week 16 compared to placebo.

    "Despite treatment advances, there remains an unmet need for people with clinically mild-to-moderate plaque psoriasis who use existing topical therapies and still have challenges managing their disease, particularly those with disease in hard-to-treat locations. Results from the ADVANCE trial demonstrated the potential of Otezla to provide an oral, non-biologic option for these patients," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to working with the FDA to potentially expand access to Otezla and deliver on our commitment to improve outcomes for people living with mild-to-moderate plaque psoriasis."

    Otezla also demonstrated statistically significant improvements in key secondary endpoints compared to placebo, including achieving at least a 75% improvement from baseline in the percent of affected body surface area (BSA), change in BSA total score from baseline and change in Psoriasis Area and Severity Index (PASI) total score from baseline at week 16. Adverse events observed in the ADVANCE trial were consistent with the known safety profile of Otezla. The most commonly reported adverse events that occurred in at least 5% of patients in either treatment group were diarrhea, headache, nausea, nasopharyngitis and upper respiratory tract infection.

    Detailed results will be submitted for presentation at an upcoming medical meeting.

    In the U.S., Otezla is approved for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adult patients with active psoriatic arthritis and for adult patients with oral ulcers associated with Behçet's Disease. Since its initial FDA approval in 2014, Otezla has been prescribed to more than 250,000 patients with moderate-to-severe plaque psoriasis or active psoriatic arthritis in the U.S.1

    About ADVANCE (PSOR-022)

    ADVANCE (PSOR-022) is a Phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of Otezla in patients with mild-to-moderate plaque psoriasis (defined as BSA involvement of 2% to 15%, Psoriasis Area and Severity Index (PASI) score of 2 to 15, sPGA score of 2 to 3). The study randomized 595 patients 1:1 to receive Otezla (n=297) 30 mg twice daily or placebo (n=298) for the first 16 weeks. All patients then received Otezla during an open-label extension phase through week 32.

    The primary endpoint was the percentage of patients with sPGA response [defined as a sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline] at week 16.

    About Psoriasis

    Psoriasis is a serious, chronic inflammatory disease that causes raised, red, scaly patches to appear on the skin, typically affecting the outside of the elbows, knees or scalp, though it can appear on any location.2 Approximately 125 million people worldwide have psoriasis, including around 14 million people in Europe and more than 7.5 million people in the United States.3,4 About 80% of those patients have plaque psoriasis.5 



    About Otezla® (apremilast)

    OTEZLA® (apremilast) is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which Otezla exerts its therapeutic action in patients is not well defined.

    Otezla® (apremilast) U.S. INDICATIONS 

    Otezla® (apremilast) is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

    Otezla is indicated for the treatment of adult patients with active psoriatic arthritis.

    Otezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

    Otezla® (apremilast) U.S. IMPORTANT SAFETY INFORMATION

    Contraindications

    • Otezla® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

    Warnings and Precautions

    • Diarrhea, Nausea, and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of Otezla. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider Otezla dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting
    • Depression: Carefully weigh the risks and benefits of treatment with Otezla for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on Otezla. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes, and they should contact their healthcare provider if such changes occur
      • Psoriasis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo. Depression was reported as serious in 0.1% (1/1308) of patients exposed to Otezla, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on Otezla, compared to 0.2% (1/506) on placebo. One patient treated with Otezla attempted suicide; one patient on placebo committed suicide
      • Psoriatic Arthritis: Treatment with Otezla is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on Otezla, compared to none in placebo-treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to Otezla, compared to none in placebo-treated patients (0/495). Two patients who received placebo committed suicide compared to none on Otezla
      • Behcet's Disease: Treatment with Otezla is associated with an increase in depression. During the phase 3 clinical trial, 1% (1/104) reported depression or depressed mood compared to 1% (1/103) treated with placebo. No instances of suicidal ideation or behavior were reported in patients treated with Otezla or treated with placebo
    • Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of Otezla
      • Psoriasis: During clinical trials, body weight loss of 5-10% occurred in 12% (96/784) of patients treated with Otezla and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with Otezla compared to 1% (3/382) of patients treated with placebo
      • Psoriatic Arthritis: During clinical trials, body weight loss of 5-10% was reported in 10% (49/497) of patients taking Otezla and in 3.3% (16/495) of patients taking placebo
      • Behçet's Disease: During the phase 3 clinical trial, body weight loss of >5% was reported in 4.9% (5/103) of patients taking Otezla and in 3.9% (4/102) of patients taking placebo
    • Drug Interactions: Apremilast exposure was decreased when Otezla was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of Otezla efficacy may occur. Concomitant use of Otezla with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

    Adverse Reactions

    • Psoriasis: Adverse reactions reported in ≥5% of patients were (Otezla%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)
    • Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (Otezla%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)
    • Behçet's Disease: Adverse reactions reported in at least ≥5% of patients taking Otezla, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 12 weeks, were (Otezla%, placebo%): diarrhea (41.3, 20.4); nausea (19.2, 10.7); headache (14.4, 10.7); upper respiratory tract infection (11.5, 4.9); upper abdominal pain (8.7, 1.9); vomiting (8.7, 1.9); back pain (7.7, 5.8); viral upper respiratory tract infection (6.7, 4.9); arthralgia (5.8, 2.9)

    Use in Specific Populations

    • Pregnancy: Otezla has not been studied in pregnant women. Advise pregnant women of the potential risk of fetal loss. Consider pregnancy planning and prevention for females of reproductive potential. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Otezla during pregnancy. Information about the registry can be obtained by calling 1-877-311-8972 or visiting https://mothertobaby.org/ongoing-study/otezla/
    • Lactation: There are no data on the presence of apremilast or its metabolites in human milk, the effects of apremilast on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Otezla and any potential adverse effects on the breastfed child from Otezla or from the underlying maternal condition
    • Renal Impairment: Otezla dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min) for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

    Please click here for Otezla® Full Prescribing Information.

    About Amgen

    Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

    Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

    For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

    Forward-Looking Statements

    This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration to manufacture therapeutic antibodies against COVID-19, or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

    No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

    Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

    The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

    CONTACT: Amgen, Thousand Oaks 

    Trish Rowland, 805-447-5631 (Media) 

    Megan Fox, 805-447-1423 (Media)

    Arvind Sood, 805-447-1060 (Investors) 

    1 Data on File at Amgen Inc.

    2 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed September 22, 2020.

    3 National Psoriasis Foundation. Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed September 22, 2020.

    4 Ortonne JP, Prinz JC. Alefacept: a novel and selective biologic agent for the treatment of chronic plaque psoriasis. Eur J Dermatol. 2004;14(1):41–45.

    5 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed September 22, 2020.

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