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MW Moderna aims to prove it's 'more than a COVID company'

By Eleanor Laise

As COVID vaccine sales fall, Moderna releases positive results from mRNA flu vaccine, adds new development programs

As it looks to expand its horizons beyond COVID-19 vaccines, Moderna Inc. $(MRNA)$ on Wednesday released positive results from a late-stage trial of an mRNA flu vaccine and signaled progress across a range of investigational treatments for cancer and rare, latent and infectious diseases.

"I hope that people realize that we are more than a COVID company now," Moderna Chief Financial Officer Jamey Mock told MarketWatch. The company is looking to launch up to 15 drugs by 2028, he said, which are expected to generate an additional $10 billion to $15 billion in annual revenue about five years after launch.

The new flu-shot data, released ahead of Moderna's research-and-development day Wednesday, showed the company's investigational mRNA vaccine met primary endpoints across four flu strains in a late-stage analysis.

With the late-stage study of the flu vaccine, combined with previous results from COVID and RSV vaccines, "we are now three-for-three on advancing respiratory-disease programs to positive Phase 3 data," Moderna Chief Executive Stephane Bancel said in a statement.

The company said it will release additional data in the fourth quarter on the closely watched personalized cancer vaccine it is developing with Merck & Co. Inc. $(MRK)$.

Moderna shares are down more than 40% in the year to date, while the S&P 500 SPX has gained 16%.

As Moderna faces a drop-off in COVID vaccinations, the company is looking to speed other products to market. Up to four new product launches could come by 2025, the company said. Moderna now has six programs in late-stage development and expects to double the number of programs in Phase 3 studies by 2025.

Up 50 new drug candidates could enter clinical trials over the next five years, and Moderna expects to invest about $25 billion in R&D from 2024 through 2028, the company said.

"We always knew that if mRNA was going to be successful, it could be very successful across many different therapeutic areas," Mock said, "and I think that's what the data is showing us right now."

Moderna last month reported a second-quarter net loss of $1.38 billion, after income of $2.2 billion in the year-earlier period.

Post-pandemic, respiratory products still play a central role in Moderna's plans. The company expects to generate respiratory-product sales of $8 billion to $15 billion in 2027.

Moderna's next-generation, refrigerator-stable COVID vaccine, mRNA-1283, has now completed enrollment of its Phase 3 trial, the company said.

The company is expecting an FDA decision on its RSV vaccine for adults age 60 and older by next April, but it faces stiff competition, as Pfizer Inc. $(PFE)$ and GSK PLC (GSK.LN)already have FDA-approved RSV vaccines for older adults. Mock said the efficacy, safety and ease of use of Moderna's product will help the new shot compete well.

Moderna is also studying various combination respiratory shots, including a combined COVID and flu vaccine and a shot that would combine COVID, flu and RSV protection. Moderna said it expects to release data in the fourth quarter on its next-generation COVID and flu combination vaccine, mRNA-1083.

Beyond respiratory products, Moderna is developing vaccines for cytomegalovirus, Epstein Barr virus, herpes simplex, varicella zoster, norovirus and HIV.

The FDA earlier this week approved Moderna's Spikevax COVID vaccine for ages 12 and above and granted emergency-use authorization for the company's COVID shot for children 6 months through 11 years old. Advisers to the Centers for Disease Control and Prevention on Tuesday recommended Moderna's shot as well as Pfizer's new vaccine for everyone age 6 months and older.

As the vaccines transition to the commercial market, "we're prepared and ready from a supply perspective," Mock said, although demand has lately been tougher to predict. "We really didn't know what we were getting into this year, and we still don't know exactly what the vaccination rate will actually be, particularly in the United States but also across the globe. And so therefore, we didn't know exactly how much to make." The company prepared for higher demand than now appears likely, he said, but "that's the one hiccup."

Moderna's cancer vaccine partnership with Merck is set to expand to additional tumor types. Currently being studied in high-risk melanoma, the companies expect to launch a late-stage trial of the therapy in non-small cell lung cancer later this year. A top investing priority, Mock said, is building out Moderna's manufacturing footprint to ensure the company is ready to serve as many cancer patients as possible.

-Eleanor Laise

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September 13, 2023 06:33 ET (10:33 GMT)

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