Moderna reported a strong second-quarter Wednesday, citing revenues of $4.7 billion for a half-year total of $10.8 billion. The company’s strong position is bolstered by recently signed advanced purchase agreements with the U.S. government and others for its mRNA-based COVID-19 vaccine, equaling approximately $21 billion.
Moderna CEO Stéphane Bancel expressed unreserved confidence about his company’s prospects.
“Despite the slowing economy and challenges in the biotech industry, Moderna is in a unique position: a platform to drive scale and speed in research of new medicines, a strong balance sheet with $18 billion cash and an agile, mission-driven team of over 3,400 people and growing,” he said. “We will continue to invest and grow as we have never been as optimistic about Moderna’s future.”
The company currently has four Phase III trials underway for infectious diseases and is projecting proof-of-concept data later this year from its rare disease and immuno-oncology programs. While the company’s sole marketable product remains the COVID-19 vaccine, Bancel noted, “Our teams are actively working to prepare these new product launches to help patients and drive growth. This is an exciting time for Moderna as we continue to see significant scientific and business momentum.”
Moderna has 46 programs in development with 43 candidates, 31 of which are in active clinical trials. Although its original COVID-19 vaccine is still going strong and a two-dose series for children six months to 17 years of age recently received emergency use authorization from the U.S. Food and Drug Administration, it is also developing a bivalent vaccine that contains the original and a modified formulation to target the Omicron variants. Moderna expects this vaccine to be authorized in the fall.
The four Phase III trials are for two different flu shots, a COVID-19 and flu vaccine combination and an mRNA-based treatment for glycogen storage disease type 1 (GSDA1). Additional programs include vaccines for cytomegalovirus, Epstein-Barr virus, HIV, HSV, Zika virus and Nipah virus and therapeutics for methylmalonic acidemia (MMA) and cystic fibrosis.
Anticipating a Fragmented Booster Market
On the investor call, Chief Medical Officer Dr. Paul Burton, M.D., Ph.D. focused on COVID-19. “The top of mind is who should get boosted and when to get boosted (for COVID-19). Boosting is highly effective, reducing the risk of infection,” he said, describing a Spanish study of more than 3 million people.
He also presented U.S. and U.K. studies supporting the effectiveness of the Moderna vaccine booster shots compared to the Pfizer-BioNTech vaccines. “Results show higher antibody levels with three Moderna shots compared to three Pfizer-BioNTech” shots, including against Omicron BA.1. “Taken together, these data demonstrate the strong performance of the Moderna vaccine in a real-world model, including against variants of concern.”
That said, the company believes the booster market will become increasingly fragmented and is planning accordingly to develop its bivalent vaccine and strike commercial agreements for it.
Shares Anyone?
Flush with cash, Moderna’s board of directors approved a new share buyback program for $3 billion. Prior to the fourth quarter of 2021, the company did not run share repurchases. It had put aside $1.9 billion in cash for stock buybacks for the months that ended June 30, 2022. From the end of the third quarter of 2021 to the close of Q2 2022, Moderna repurchased 16 million shares. The board authorized a repurchase program for $3 billion in August 2022 as a way to “return excess capital to shareholders.”
https://www.biospace.com/article/flush-with-cash-and-expectations-moderna-plans-3b-stock-buyback-/
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