After the biotech company reported a larger-than-expected fourth-quarter loss and provided modest outlook for 2025, Moderna Inc.’s stock overcame early losses to recover 3.4% on Friday, offsetting a sales beat.
Moderna, a company based in Cambridge, Massachusetts, reported a net loss of $1.1 billion for the quarter, or $2.91 per share, following $217 million in earnings, or 55 cents per share, for the same time last year.
Revenue dropped from $2.8 billion to $1 billion in the previous year. The FactSet consensus predicted $943 million in revenue and a $2.68 per share loss.
The early release of the revised COVID-19 vaccination in the United States, which moved sales into the third quarter, was mostly to blame for the drop in sales.
“The U.S. Food and Drug Administration (FDA) approval granted three weeks earlier than in the previous year enabled the company to meet demand more effectively ahead of the fourth quarter,” the business stated in a statement.
The COVID-19 vaccination Spikevax and mRESVIA, a vaccine against respiratory syncytial virus, or RSV, are two of Moderna’s authorized products.
The majority of the quarterly total was made up of $923 million in sales of Spikevax and $15 million in sales of mRESVIA. Although the Spikevax figure was higher than the $909 million FactSet expectation, it still falls well short of the pandemic era’s highest sales.
The business reached $25 million in full-year sales after beginning to promote mRESVIA in the third quarter. Although the company is seeking approval for high-risk adults aged 18 to 59, the approval is limited to U.S. adults aged 60 and above, rather than younger patients.
Additionally, Canada, the European Union, the United Arab Emirates, Iceland, Qatar, Taiwan, and Liechtenstein have approved the RSV vaccination.
According to early January guidance, the company now projects 2025 sales to be between $1.5 billion and $2.5 billion, with a midpoint of $2 billion. FactSet projects $2.4 billion. Because the company’s respiratory business is seasonal, the majority of that will occur in the second half.
In prepared remarks, Chief Executive Stéphane Bancel stated, “In 2025, we remain focused on driving sales, delivering up to 10 product approvals through 2027, and expanding cost efficiencies across our business.”
Bancel stated during an analyst call that the ten items cover a market worth over $30 billion. According to him, the business will also improve its cost structure to make sure it breaks even on a cash cost basis by 2028 at the latest.
Once it starts providing Phase 3 data readouts this year, the business anticipates receiving several approvals and cutting expenses by over $1 billion.
During the quarter, research and development expenses decreased by 20% to $1.1 billion. This was partly offset by increased spending on norovirus and personalized neoantigen treatment (INT) projects, but primarily resulted from lower expenses associated with the COVID, RSV, seasonal flu, and combo vaccine programs.
In addition to its respiratory portfolio, Moderna is developing a treatment for cytomegalovirus, a virus that poses a special risk to expectant mothers since it can be transferred to the fetus and result in symptoms like convulsions, enlarged liver, and low birth weight.
Data from a fully enrolled Phase 3 trial is anticipated this year.
Additionally, the business is working on a norovirus vaccine, and a Phase 3 trial is reliant on case accruals. Moderna is getting ready for a second-season enrollment in the southern hemisphere, while the trial is fully enrolled in the northern hemisphere.
Moderna is developing personalized neoantigen therapy in oncology, which customizes treatment for each patient’s unique malignancy. With trials in different phases of recruitment, the business is collaborating with Merck and its popular cancer medication Keytruda on treatments for non-small-cell lung cancer and melanoma. Additionally, it is conducting research on an INT for renal and invasive bladder cancer.
Treatments for methylmalonic acidemia (MAA) and propionic acidemia (PA), two uncommon metabolic diseases that impair the body’s capacity to metabolize specific proteins and fats, are part of the company’s rare-disease portfolio.
Moderna was awarded $211 million by the U.S. Department of Health and Human Services in January to improve the capabilities of mRNA platforms in order to better respond to new infectious diseases like bird flu in the United States.
Because there haven’t been enough cases in the United States for a complete clinical study, there isn’t an approved vaccination for human bird flu. Some vaccines that were previously developed and tested on volunteers are part of the national stockpile.
According to Moderna, research and development expenses will total around $4.1 billion in 2025, while marketing, general, and administrative expenses will total approximately $1.1 billion. It is anticipated that the cost of sales will be around $1.2 billion.
Over the past 12 months, Moderna’s stock has down 62.7%, while the S&P 500 SPX has increased 22.2%.
