Amid contract manufacturing wind-down, Moderna advances production efforts for cancer programs

To get a pulse on Moderna following its “year of transition” in 2023, look no further than the company’s manufacturing operations. The Cambridge, Massachusetts-based biotech has incurred a COVID-related wind-down charge on one hand, while it spends millions of dollars to bolster cancer vaccines at the same time.

Eyeing its post-COVID future, Moderna has started to build out its recently acquired manufacturing facility in Marlborough, Massachusetts. The project will be used to bring the company's Merck-partnered individualized neoantigen therapy program in multiple cancers up to commercial scale, the company said in a press release Thursday.

Merck and Moderna's personalized cancer vaccine, mRNA-4157, is currently being tested alongside Keytruda in several late stage trials. The partners, who are co-developing the vaccine, have decided to focus on resected high-risk melanoma and completely resected stage 2, 3A or 3B non-small cell lung cancer to start, with plans to “initiate clinical studies in additional tumor types in 2024,” Moderna said.

Moderna purchased the Marlborough facility last May. The company spent an initial $91 million for the empty 140,000-square-foot biomanufacturing building and the 24 acres on which it sits, telegraphing plans to expand the facility to 200,000 square feet for a total investment of at least $322 million.

Moderna has said it aims to employ at least 200 people at the site, with a focus on technicians to perform engineering, process management, maintenance and manufacturing.

Elsewhere, Moderna has been busy since last year’s third quarter right-sizing its manufacturing footprint as part of the transition from a pandemic to an endemic COVID-19 vaccine market. According to the company, the initiative involved scaling down capacity and commitments with contract manufacturers, reevaluating its inventory of raw materials and reducing purchase commitments tied to raw materials expected to expire before use.

As part of that process, the company incurred, “as expected,” additional charges of $169 million in the fourth quarter. The charges were primarily related to the wind-down of “certain contract manufacturing operations.”

“We applaud Moderna’s actions to reposition Spikevax, as the company transitioned to a seasonal endemic market, resized its manufacturing footprint and flattened its commercial structure," Lee Brown, global sector lead for healthcare at the research firm Third Bridge, said in an emailed note. "We view these efforts positively to allow for greater investment toward other promising growth drivers.”

COVID write-downs have become a common occurrence at Moderna and Pfizer following the steep decline of the pandemic vaccine market.

Back in 2023’s third quarter, Moderna took a hefty $1.3 billion inventory write-down attributed to “excess and obsolete” COVID vaccine stock. Further, the company paid $500 million for a contract manufacturing wind-down cost and $100 million for its cancellation during the period.

Around the same time, Pfizer recorded $5.6 billion in coronavirus-related inventory write-offs and other charges.