April 30, 2023 Source: drugdu 142
Moderna on Tuesday said it expects to see between $8 billion and $15 billion in sales from its Covid, RSV, flu and other respiratory vaccines in 2027.
The biotech company said it sees a corresponding operating profit in the range of $4 billion to $9 billion. Those respiratory product estimates are supported by additional research investments of $6 billion to $8 billion “over the next few years,” Moderna added.
The announcement came ahead of Moderna’s Vaccine Day on Tuesday. At the annual event, the company presented updates on its vaccine portfolio to investors and analysts eager to see how the company will navigate its post-pandemic boom.
Moderna said earlier this year it expects $5 billion in mRNA Covid vaccine sales in 2023, a steep drop from the $18 billion the shot raked in last year. The Cambridge, Massachusetts-based company’s Covid vaccine remains its only commercially available product.
Moderna’s highly anticipated flu vaccine did not meet the criteria for early success in a late-stage clinical trial, the company said.
Moderna highlighted efforts to beef up its pipeline, saying it expects to launch six major vaccine products “in the next few years.”
The new 2027 guidance “represents an upside to the low profitability expected this year given the smaller” Covid market, Jefferies Analyst Michael Yee wrote in a Tuesday note.
But Yee said to expect investors to debate the guidance because it’s unclear “where seasonal viruses are going especially COVID for now.”
RSV vaccine
Moderna said its experimental RSV vaccine is among the “big three” respiratory products that will contribute to the company’s lofty 2027 guidance.
The company expects to file for full approval of the shot for adults ages 60 and older this quarter. The “best case scenario” is getting a decision from the Food and Drug Administration around the end of this year or early 2024, according to Christine Shaw, Moderna’s portfolio head of respiratory vaccines.
Moderna is racing closely behind drugmakers Pfizer
and GSK
to launch the world’s first vaccine against the deadly virus, which infects the lungs and respiratory tract and usually causes mild, cold-like symptoms. Most people recover in a week or two, but RSV kills 6,000 to 10,000 seniors and a few hundred children, younger than 5, each year.
Moderna’s RSV vaccine received Breakthrough Therapy Designation from the FDA in late January. That designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, and was based on positive topline data from Moderna’s phase three clinical trial on the vaccine.
Moderna’s vaccine was 83.7% effective in preventing RSV with two or more symptoms in people ages 60 and older, and 82.4% effective at preventing lower respiratory tract disease with three or more symptoms. No safety concerns were identified during the trial.
Notably, Shaw said, no cases of Guillain-Barre Syndrome were reported. Cases of the nervous system disorder have dogged shots from Pfizer and GSK, a key concern of the FDA advisors who recommended those vaccines.
Shaw noted that Moderna also has a “very active” pediatric program studying its RSV shot in children. She said the company recently initiated a pediatric study in children five months to two years old. The study evaluates the RSV shot in those children as well as a new combination vaccine that targets RSV and another common respiratory virus called human metapneumovirus.
Reference:
https://www.cnbc.com/2023/04/11/moderna-2027-covid-rsv-flu-shot-sales-guidance.html
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