Moderna disclosed that it has received $1.1 billion in cash payments for the supply of its COVID-19 vaccine candidate and set out a timeline for its launch. Shares are advancing 3.1% in early morning trading.
Moderna (MRNA) updated investors that it is preparing for the launch of mRNA-1273, its vaccine candidate, and has signed supply deals with a number of governments, including the US, Europe, Japan and Qatar. Enrollment of the 30,000 participants in the Phase 3 study of the COVID-19 vaccine candidate was completed last week and Moderna now expects first interim data analysis to be released in November. After that, upon positive efficacy and 2-month median safety data, it plans to file for emergence use authorization (EUA) with the US Food and Drug Administration (FDA).
Moderna’s candidate, mRNA-1273, is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein and is being co-developed with researchers from the National Institute of Allergy and Infectious Disease’s (NIAID) Vaccine Research Center.
The biotech company currently has 21 mRNA development candidates, in its portfolio with 13 in clinical studies. Across Moderna’s pipeline, more than 32,000 healthy volunteers and patients have been enrolled in clinical studies, including the Phase 3 study of mRNA-1273.
“We now have four programs in Phase 2 studies, in addition to the Phase 3 study of our COVID-19 vaccine, mRNA-1273, which is fully enrolled. Our CMV vaccine showed positive interim Phase 2 data and we are now preparing for the Phase 3 start in 2021,” said Moderna CEO Stéphane Bancel. “We are actively preparing for the launch of mRNA-1273. I believe that if we launch our COVID-19 vaccine, 2021 could be the most important inflection year in Moderna’s history.”
Bancel added that the company continues to work with regulators to advance the launch of mRNA-1273. “We will have the resources to scale Moderna to maximize the impact we can have on patients in the next 10 years through numerous new medicines,” Bancel commented.
For 2020, Moderna now expects positive net cash provided by operating activities to be between $0.1 billion and $0.3 billion, mainly due to customer deposits of about $1.2 billion received year-to-date as of September 30.
Shares in Moderna have dropped almost 7% over the past month but have exploded 236% so far this year. Wall Street analysts still have a Moderate Buy consensus on the stock’s outlook. Looking ahead, the $93.27 average price target suggests another 38% upside potential lies ahead.
Earlier this month, Needham analyst Alan Carr reiterated a Buy rating on the stock with a $94 price target as he expects positive catalysts in 4Q, particularly from the Phase 3 trial of the vaccine mRNA-1273.
“We assume an Emergency Use Authorization by YE20. Management has indicated that 20M doses will be produced by YE20,” Carr wrote in a note to investors. “We estimate $400M in 4Q20, $2.0B in 2021 and $1.0B in 2022 mRNA-1273 sales.” (See MRNA stock analysis on TipRanks).
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