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Moderna (MRNA) 2021 Q1 Earnings. Should you Buy, Sell or Hold?

 

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.

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

 

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

CWEB Analyst’s have initiated a BUY Rating for  Moderna, Inc. (Nasdaq: MRNA) and potential upside of $199 in 2021. The fundamentals of the company are to strong and cash on hand has increased compare to previous quarter. Increased 2021 supply forecast between 800 million and 1 billion doses will factor in next quarter. We believe Q2 and Q3 will be the real break for the company.










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