Moderna says the flu vaccine is missing the bar for early success, but it projects revenue in 2024

BOSTON (Reuters) – Moderna Inc (mRNA) said on Tuesday that its experimental influenza vaccine did not meet criteria for “early success” in a late-stage trial, and its shares fell 3 percent.

Also at the Vaccine Day meeting in Boston, the US biotechnology company said it expects to bring six major vaccines to market in the next few years. Its COVID-19 shot is currently the company’s only marketed product.

The company is banking on its respiratory vaccine candidates to help offset the expected sharp drop in revenue from its hugely successful COVID-19 vaccine. Analysts expected sales of the Moderna COVID vaccine for 2023 to be about $7 billion, much less than the $18.4 billion in 2022, due to lower demand.

This has led to increased investor scrutiny of experimental mRNA-based shots for influenza and respiratory syncytial virus (RSV).

The company is testing whether its experimental influenza vaccine, mRNA-1010, can compare with an approved influenza vaccine in preventing disease.

Moderna said there isn’t enough data available to determine whether the flu vaccine will work, and it’s not clear if it will gather enough information from the trial during the current flu season.

“We haven’t included enough cases yet in the interim analysis to declare early success,” said Raphael Nakbagauer, CEO of our director at the meeting.

Moderna President Stephen Hogg said in an interview that he expects to start generating revenue from the flu vaccine in 2024, though the amount will depend on the timing of the launch.

Moderna’s decision to continue the trial comes months after data from an earlier trial showed that the shot generated a strong immune response against strains of influenza A, but failed to generate a response similar to the approved vaccine for less common influenza B.

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Oppenheimer analyst Hartaj Singh said Tuesday’s update removes some of the near-term optimism about Moderna’s flu vaccine.

Shares of Moderna were down nearly 3% at $155.60 after dropping as low as $149.32 earlier in the day.

Moderna’s pipeline includes an RNA-based cancer vaccine, which was shown to work against skin cancer in a mid-stage study. The company is expected to share full data for this vaccine later this week at a medical conference.

The company’s RSV vaccine has been shown to be 84% effective in preventing at least two symptoms in older adults. Moderna expects to launch an RSV vaccine next year, the first of several that it hopes will be approved in the coming years.

Chief Financial Officer James Mok said he expects Moderna to form one or two partnerships every quarter to help the company grow its mRNA platform, bring partner products to market or break into new therapeutic areas.

“We want to continue investing in our platform, and that means partnerships,” he told Reuters.

Moderna forecasts sales in the range of $8 billion to $15 billion in 2027 from RSV and next-generation influenza vaccines for COVID-19.

“We remain skeptical about the company’s ability to reach franchise guidelines for the announced respiratory vaccine,” SVB Securities analyst Mani Forouhar said in a note.

Moderna estimates that the COVID-19 booster vaccine market will be about $15 billion globally, assuming the same vaccination rate as annual flu vaccines in the elderly.

Additional reporting by Bhanvi Satija in Bengaluru and Patrick Wingrove in Boston, Additional reporting by Aditya Samal in Bengaluru; Editing by Chingini Ganguly and Bill Berkrot

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