The first quarter of 2025 was a tough one. The S&P 500 lost 4.6%, and the Nasdaq Composite lost 10.4%. Following the trend, shares of Moderna (MRNA +15.99%) slid 31.8% in the first three months of the year.
The vaccine maker's sales continue to struggle years after its top line exploded during the COVID-19 pandemic. More recently, the conspicuous exit of a top Food and Drug Administration (FDA) official has darkened investor sentiment.
NASDAQ: MRNA
Key Data Points
Another report fails to impress
The company's revenues have cratered now that the coronavirus pandemic no longer rages. Moderna's 2022 sales of $19.3 billion seem like a distant memory. The company delivered just $3.2 billion in 2024, as its year-end and Q4 earnings released in early January showed a more than 50% decline year over year. Results across the board disappointed investors by failing to meet expectations.
On top of the poor performance, the company's guidance shocked investors. Moderna lowered its target sales for 2025 to $1 billion. Where it had expected sales for the coming year to fall between $2.5 billion to $3.5 billion, it now expects a range of $1.5 billion and $2.5 billion. Demand for its coronavirus and RSV vaccines is significantly weakened, more so than the company expected.
To address the drop in projected revenue, Moderna is accelerating previously announced cost-cutting plans, aiming to reduce expenses by $1 billion this year. That means some pretty significant shakeups at the company that could impact its ability to operate effectively.
The FDA ousts a key player
Recently, Moderna investors got more bad news. Peter Marks, who led the FDA's Center for Biologics Evaluation and Research (CBER), resigned. As the head of CBER, Marks was critical in the rapid approval of coronavirus vaccines during the pandemic and, more recently, was heavily involved in the regulator's oversight of cutting-edge cell and gene therapies.
The resignation came amid pressure from Donald Trump's Health and Human Services Secretary Robert F. Kennedy Jr., a known vaccine skeptic. Marks stated in his resignation letter that it was "clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies."
It's not a good sign for the industry
BMO Capital Markets analyst Evan David Seigerman called the resignation a "significant negative" for biotech and biopharma companies, especially vaccine manufacturers like Moderna. He explained that the "politicization of FDA runs counter to the agency's mission" and introduces major uncertainty for drug makers. Moderna could see its vaccine development programs delayed as the FDA takes a less friendly or possibly hostile stance. I would avoid Moderna until it can right the ship.
