By Mariam Sunny and Christy Santhosh
July 31 (Reuters) – Moderna beat Wall Street estimates for second-quarter revenue on Friday, helped by vaccine partnership payments and international sales of its COVID-19 shot, as investors await a key U.S. decision on its flu vaccine.
The biotech is betting on partnerships with the governments of the UK, Canada and Australia, alongside cost cuts and the expansion of its vaccine portfolio, to support growth amid an uncertain U.S. regulatory environment for vaccines.
The U.S. FDA is set to decide on Moderna’s flu vaccine by August 5, after the agency initially declined to review the application under former Commissioner Marty Makary before later accepting a revised filing.
Last month, a panel of external advisers to the FDA backed the vaccine’s approval. If approved, it would be the first seasonal flu shot in the U.S. made with mRNA technology.
An approval would mark an important milestone for Moderna as it seeks to prove its mRNA platform can succeed beyond COVID-19 and build a broader respiratory vaccine business.
“Looking across the three-year horizon, we are building toward a broader and more diversified portfolio … while continuing to expand our global commercial footprint,” Stephen Hoge, president of Moderna, said on a call with analysts.
R&D expenses for the quarter fell 7% year-over-year to $651 million, driven by the wind-down of several late-stage programs.
It expects full-year research and development expenses to be about $2.9 billion, down from its previous forecast of about $3 billion.
Bernstein analysts welcomed Moderna’s efforts to reduce costs and its “cautious approach” to advancing its pipeline, but said several key milestones still lie ahead.
NOROVIRUS SETBACK, EYES ON MELANOMA
Moderna’s experimental norovirus vaccine candidate missed the statistical benchmark for early success in an interim analysis of a late-stage study.
Moderna will run the norovirus vaccine trial through another winter season, Hoge said, as cases meeting the study’s main goal accumulated more slowly than anticipated.
Moderna is also advancing intismeran autogene, an individualized cancer therapy being developed with Merck, across different types of cancer.
Barclays analysts said positive melanoma data could “bring meaningful credit” to the company’s oncology pipeline, while a miss could weigh on the shares. They estimate the therapy could generate about $3 billion in adjuvant melanoma by 2035.
The company expects late-stage data for the therapy in skin cancer later this year.
Moderna continues to expect 2026 revenue growth of up to 10% from a year earlier, with roughly half of its revenue coming from the U.S.
Total revenue came in at $145 million, topping analysts’ estimate of $103 million.
The company’s second-quarter loss of $1.97 per share came in smaller than expectations of $2.08.
(Reporting by Christy Santhosh and Mariam Sunny in Bengaluru; Editing by Maju Samuel)
Comments