Moderna headquarters, exterior, Cambridge, Massachusetts, USA.
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Modern The company on Thursday said it plans to cut costs by about $1.1 billion by 2027 and seek approval for several new products as it looks to move forward after a steep decline in its coronavirus business.
The biotech company said it expects to have 10 new products approved by 2027. But Moderna said it will pause work on some products in its pipeline and scrap others to “accelerate” new research and development spending.
According to a company statement, the company plans to reduce its R&D spending to between $3.6 billion and $3.8 billion by 2027, down from an anticipated $4.8 billion by the end of this year.
“You’re going to see things get worse because some studies are basically going to stop and never start,” Moderna CEO Stephane Bancel told CNBC, adding that the company is “holding back” its portfolio of latent products, which refers to a category of viruses that can remain in a patient for long periods of time without causing symptoms but can later reactivate and cause serious health complications.
Also on Thursday, Moderna announced positive late-stage trial results for its vaccine against respiratory syncytial virus in high-risk populations. It plans to file for approval this year for adults ages 18 to 59. It also announced positive data from an experimental standalone flu vaccine for adults ages 65 and older.
The company released an update focused on its product pipeline and long-term business updates at its annual R&D investor event in New York on Thursday. It comes about four months after U.S. regulators approved Moderna’s RSV vaccine for seniors, the second of its kind to hit the market after its Covid vaccine.
The company said it currently has five respiratory vaccines in Phase 3 positive results and expects to submit three of them for approval this year. That includes Moderna’s combination vaccine targeting Covid and flu, which it expects to submit for approval in the US this year, as well as a new, more effective version of its Covid vaccine.
Moderna has five non-respiratory products for cancer, latent viruses and rare diseases that could be approved by 2027, according to a company statement.
The company projects revenues of $2.5 billion to $3.5 billion in 2025. Moderna expects a compound annual growth rate of more than 25% from 2026 to 2028 as new products are launched.
Bancel said the company’s success rate in getting a drug from Phase I to Phase III is “six times higher” than other areas of the biotechnology and pharmaceutical industries.
“What the team has done is truly remarkable, and they have left us with a lot of effective drugs, so we need to pace ourselves in terms of our R&D investments,” he told CNBC.
What’s in Moderna’s pipeline?
Moderna announced new data on mRESVIA, its RSV vaccine approved in the U.S. and European Union for adults 60 years of age and older.
The company said the vaccine met all of its primary efficacy objectives in an ongoing Phase 3 study of adults 18 to 59 years of age who are at high risk for severe illness from the virus. Moderna added that no safety concerns were observed.
Currently, there are no RSV vaccines approved worldwide for young, high-risk adults with weakened immune systems or underlying chronic diseases such as asthma and diabetes. Moderna’s main competitors in the RSV space include: Pfizer and GelskeWe are also seeking expanded approval for that age group.
Bancel said the company plans to use a “priority review voucher” when applying for approval for people ages 18 to 59, which would shorten the FDA’s review time from 10 months to six months. Moderna hopes the agency will approve mRESVIA for that age group in time for the 2025 RSV season.
“There are millions of people who could benefit… and we do it to stay competitive in the marketplace, because if you’re a big retail pharmacy, you want to be able to offer products to every customer that walks in,” Bancel said.
But the company also said it was discontinuing development of its RSV vaccine for children under 2 years of age, based on “new clinical data.”
Moderna recently announced that its experimental standalone flu vaccine, mRNA-1010, produced higher immune responses to the virus than traditional flu shots in a Phase 3 trial. The vaccine also demonstrated “consistently acceptable safety and tolerability” across three late-stage trials, the company added.
Meanwhile, Moderna said it plans to move its vaccine against norovirus, a highly contagious gastrointestinal illness that causes vomiting and diarrhea, into Phase 3 testing “very soon.” Bancel said if the data are positive, he believes the company could complete the study within a year and file for approval right away.
“This product may be two years away from being released, which is a good thing because there is nothing to treat norovirus today,” he said. “A lot of health care workers get infected from patients.”
Moderna is also working with Merck to develop a personalized cancer vaccine, which is being studied in combination with Keytruda in patients with a variety of forms of the disease.
The two companies are studying the vaccine in Phase 3 trials in people with advanced skin cancer, and are discussing approval with regulators based on interim study data from the vaccine.
But Moderna said the FDA “did not support” so-called accelerated approval based on existing data, a designation the FDA gives to drugs to be approved more quickly if they address an unmet medical need for a serious condition.
“We will continue to have discussions with regulators,” Bancel said, “and we are generating more data.”
