Sept 12 (Askume) – Moderna (MRNA.O) on Thursday pushed back its breakeven target by two years as the company pushed back development timelines for several key products and forecast 2025 sales that would be lower than this year’s expectations, sending its share price near a four-year low.

    By midday, shares of the vaccine maker were down 17.1% to $65.88.

    According to LSEG, the company expects sales to be between $2.5 billion and $3.5 billion in 2025, below analysts’ estimates of $3.74 billion. The midpoint was also below its forecast of $3 billion to $3.5 billion in sales in 2024 .

    The company, which is struggling to ramp up production of its COVID-19 vaccine, said at an investor conference in New York that the regulatory process for flu and cancer vaccines would take longer than it said.

    Moderna expects to have $6 billion in cash on hand by the end of 2024, which Jefferies analyst Michael Yee said is at the low end of his previous forecast of $6 billion to $7 billion.

    Its cost savings will include cutting $1.1 billion in R&D expenses starting in 2026, with the major action taking place in 2027.

    “I hope you can understand … why we were so intimidated by the business challenges of launching all of these products over the next three years is that we really wanted to push ourselves,” Moderna President Stephen Hoge said.

    The company expects to achieve balance on an operating cash cost basis by 2028, two years later than previously expected.

    Chief Financial Officer James Mock said in an interview that the forecast for next year reflects uncertainty in the U.S. coronavirus and respiratory syncytial virus (RSV) markets. Moderna says adoption of its RSV vaccine has been slower than expected.

    He said the forecast also takes into account Moderna’s forecast that each of the 10 new products approved by 2027 will begin generating significant revenue in the second year after approval.

    “By 2025, we can assume that some new products have been approved, but we don’t expect them to bring in much revenue,” Mock said.

    The company said new product launches will drive revenue growth of an average of 25% annually from 2026 to 2028.

    Moderna said it plans to submit an application to the FDA this year to expand approval of its RSV vaccine to high-risk adults under age 60, based on new data from a late-stage trial.

    Last May, regulators approved Moderna’s MRESVA vaccine to treat RSV-related lower respiratory tract disease in adults aged 60 and older , joining forces with rival vaccines from GSK.L and Pfizer PFE.N.

    The company said it has dropped its request for fast-track approval as part of a standalone flu vaccine application from the FDA. Instead, it will focus on its application for a combination vaccine to protect against COVID-19 and influenza , which it plans to submit this year.

    Moderna said mRESVIA met all immune response targets and was found to be safe and well-tolerated in adults 18 years of age and older with weakened immune systems, but did not provide further details about the results of the new study.

    Pfizer said in August that its Abrisvo vaccine, approved last year for adults over 60, produced strong immune responses in high-risk adults 18 and older .

    In June the FDA expanded the use of GSK’s ArexV vaccine in adults ages 50 to 59. Get vaccinated against RSV .

    Moderna said the FDA’s initial response does not support accelerated approval based on interim study data for the cancer vaccine it is developing with Merck Co (MRK.N) .

    Last Update: September 12, 2024