Moderna (MRNA) is on its way to getting a third mRNA-based vaccine approved by the FDA if the regulatory agency likes the data released Monday for a combination flu-COVID shot.
The company said the new combo vaccine provided better protection against both diseases than separate shots. It marks the first positive late-stage results of a combination vaccine.
The company's stock was trading slightly up on the news early Monday before falling after market open. Moderna is up almost 20% in the last month after the company received approval from the FDA for its RSV vaccine for older adults.
The biotech firm has enjoyed the spotlight as its brand-new platform became a frontrunner, and ultimately one of the two key vaccines, in addressing the pandemic. Since the multibillion-dollar COVID windfall, investors have been anxious about the near-term prospects of Moderna.
In a note to investors in March, JPMorgan analysts said, "While we continue to struggle with MRNA’s goal of break-even in 2026 based on our current top-line expectations over the next few years, we remain impressed with the platform’s versatility and see the company laying the groundwork for the future."
That wariness has persisted.
In a note to investors Monday, JPMorgan analysts said that the news opens the door for incremental revenue in the 2025-2026 flu season, but they do not view the product as a way to renew a focus on COVID amid the waning interest in the vaccines post-pandemic.
"While we don’t necessarily see the existence of a COVID/flu combo expanding the COVID opportunity, we do think having non-inferior data to FluZone HD could enable MRNA to capture some revenue in what we view as the more attractive segment of the flu market," the analysts wrote.
Moderna president Stephen Hoge knows investors are waiting to see the company grow in a big way and regain the momentum lost following outsized COVID-19 vaccine revenues.
"What we're kind of settling into now is what feels like more of the normal operations. It's actually been comforting, stabilizing. There was a lot of work last year to come down the mountain in terms of scaling the size of business. Making 2 billion doses per year is not the same as making 200 million per year," Hoge told Yahoo Finance at the Goldman Sachs annual healthcare event in Miami Beach Monday.
"I think all that work's paid off," he said.
But can Moderna convince investors to stay long-term as it works to avoid sinking back into "small biotech" territory?
Hoge said the company is already up to three vaccines in two years and has late-stage trial data expected for three more in the near term. But it's also important to note that Moderna's current pipeline is mainly respiratory vaccines, which will not provide the type of profits to make up for the loss in the COVID portfolio.
In terms of volume in vaccination, flu impacts 150 million Americans every year, while COVID affects 50 million, Hoge said. The respiratory vaccines are priced lower than other vaccines, like Merck's (MRK) HPV vaccine, Gardasil, which has a list price of $300 or more. (List price for Moderna's COVID vaccine: $110.)
So while the Moderna vaccines "are good for public health, it means you have to sell more to get to the same revenue," Hoge said.
Still, he noted that much of the company's investment is now in clinical trials, and he expects the newer products to add to the company's revenues sooner rather than later.
"It will take a lot more time and maybe 10 products to get there, and that's appropriate," Hoge said.
Anjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. Follow Anjalee on all social media platforms @AnjKhem.
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