Moderna has vowed to cut R&D spending by $1.1 billion by 2027. The decision to shrink the budget by more than 20% follows commercial setbacks that have persuaded the biotech to take a “more selective and paced approach” to drug development.
The mRNA specialist expects to spend $4.8 billion on R&D this year. That figure is a problem for a company that wants to turn a profit in the foreseeable future. During the COVID-19 vaccine boom, Moderna generated enough cash to defuse concerns about spending. However, with Pfizer sewing up the European COVID-19 vaccine market for now and contracts stopping Moderna’s respiratory syncytial virus (RSV) vaccine from making a mark on the U.S. this year, the biotech is contending with falling sales.
Moderna set out its response ahead of an R&D day on Thursday. The headline change is the reduction in R&D spending, which the biotech wants to get down to $3.6 billion to $3.8 billion in 2027. Moderna aims to generate the savings through portfolio reprioritizations and cost efficiencies.
Cutting the budget will take time, with Moderna forecasting R&D spending of $4.2 billion to $4.5 billion in 2025.
The biotech disclosed a raft of pipeline changes as part of the announcement. Moderna has axed a plan to file for accelerated approval of its standalone flu vaccine mRNA-1010. The biotech was aiming to seek approval this year but has decided to focus on its flu-COVID combination shot.
Moderna plans to file for approval of the combination vaccine this year and use a priority review voucher. The biotech will start a confirmatory trial of mRNA-1010 this year, using cash from its deal with Blackstone Life Sciences.
Moderna also discontinued five programs. A vaccine designed to prevent endemic human coronaviruses, pathogens that Moderna has previously said cause 1 million outpatient visits a year in the U.S., will stop development before entering the clinic.
The other deprioritized candidates made it into human testing. “Emerging clinical data” has derailed the company's plans to advance a pediatric RSV program and triplet oncology candidate mRNA-2752 beyond phase 1. The cancer asset encodes a T cell co-stimulator and two pro-inflammatory cytokines. A
KRAS antigen-specific therapy, mRNA-5671, and heart failure prospect, mRNA-0184, also failed to make the cut.
Meanwhile, Moderna is continuing development of its Merck & Co.-partnered cancer prospect mRNA-4157 but has hit a regulatory obstacle.
“Initial feedback from FDA has not been supportive of accelerated approval based on the current data,” Moderna said. Talks are ongoing but plans to seek approval may be put back until the partners have data from a “substantially enrolled” phase 3 trial in adjuvant melanoma, the company said.
The biotech needs to get more products to market to hit the $6 billion in sales it believes are needed to break even. The goal is to secure 10 approvals over the next three years. Based on the forecasts, the biotech now expects to break even in 2028, two years later than previously planned.