mNEXSPIKE

By channeling proceeds from its commercial products into late-stage oncology and rare disease programs, Moderna believes it can “set the stage for additional growth in 2027 and 2028." With much of Moderna’s rise in this decade tied to its COVID-19 vaccine, the company has struggled in recent years to match the sales highs it experienced during the pandemic.Now, in an effort to correct course, the Cambridge, Massachusetts-based mRNA specialist is laying out a three-year business strategy, highlighting promising avenues for growth and setting out a goal to lift revenue by up to 10% in 2026. The new game plan debuted at Moderna’s analyst day event on Thursday.On the commercial front, Moderna plans to build a “large seasonal vaccine franchise for at-risk populations” over the next three years, CEO Stéphane Bancel said in a statement. The company will then reinvest revenues into its roster of experimental cancer and rare disease therapeutics, the helmsman explained."We plan to deliver up to 10 percent revenue growth in 2026 while continuing to reduce our R&D investments and diversify further into oncology,” Bancel explained. “Our financial outlook remains strong, and we are focused on disciplined execution as we advance our pipeline and bring innovative mRNA medicines to patients around the world."Digging deeper into Moderna’s seasonal vaccine ambitions, the company figures that sales from products like COVID shot Spikevax and its next-generation sibling mNEXSPIKE, plus its respiratory syncytial virus (RSV) prophylactic mRESVIA and potential launches in norovirus and beyond, should allow it to break even by 2028 and continue to fund development activities.By channeling proceeds from its commercial products into late-stage oncology and rare disease programs, Moderna aims to “set the stage for additional growth in 2027 and 2028, with early-stage pipeline investments expected to mature" starting in 2029, the company said in the release.The company further expects a financial boost next year from long-term partnerships in countries such as the United Kingdom, Canada and Australia focused on R&D investment, national security and domestic manufacturing. Over that same span, Moderna is banking on “continued strong uptake” of its next-generation COVID vaccine mNEXSPIKE in the U.S., with sales likely to be buoyed by launches in other countries as well, according to the company.Additionally, the European market presents an enticing opportunity come 2027, when an existing supply contract for Pfizer’s COVID shot, Comirnaty, is slated to expire, Moderna noted. The company stressed that it has the commercial infrastructure in place to support the up to six seasonal vaccine products it hopes to have approved by 2028 and added that it will make “targeted investments” in its European commercial infrastructure “as needed.” With regards to potential approvals beyond seasonal inoculations, Moderna has put its chips behind four key assets in cancer and rare diseases. On the oncology front, the company is now in late-stage testing with its Merck-partnered cancer vaccine mRNA-4157, also known as intismeran autogene, which is running through the clinical gauntlet in potential indications such as melanoma, non-small cell lung cancer (NSCLC), bladder cancer and renal cell carcinoma.The company also has high hopes for mRNA-4359, a cancer antigen therapy designed to elicit T-cell immune responses against tumor and immunosuppressive cells. That asset is currently engaged in a phase 1/2 study, with the midstage portion including cohorts in first-line metastatic melanoma and first-line metastatic NSCLC, Moderna said.In rare diseases, Moderna is prioritizing the propionic acidemia asset, mRNA-3927, and prospective methylmalonic acidemia treatment, mRNA-3705. A registrational trial for the first asset has now reached target enrollment, while the second is slated to begin registrational testing next year, according to the company.The company’s slimmed-down clinical focus comes on the heels of several pipeline purges. Besides its recent high-profile cytomegalovirus discontinuation, the company revealed that programs for herpes simplex virus, varicella zoster virus and glycogen storage disease type 1a will not move to the next stages of development.Moderna will tighten its belt under the strategy as well, noting that it will reduce its expected 2026 and 2027 cash costs to roughly $4.2 billion and a range of $3.5 billion to $3.9 billion, respectively. To get there, the company says it will enforce “disciplined cost management and R&D prioritization.”Meanwhile, helping pad the company’s coffers as it waits for new growth spigots to open, Moderna said Thursday that it has also closed a five-year loan from Ares Management worth $1.5 billion.“The non-dilutive financing bolsters the company's strong balance sheet and provides increased flexibility,” Moderna explained in its release. As of Thursday, the mRNA drugmaker now projects that it will have a higher year-end cash and investment balance of $7.1 billion to $7.6 billion, which it linked “to the $0.6 billion initial loan draw.” The new strategy follows a rough third-quarter for Moderna, during which the company reported $1 billion in revenue, down some 45% from the sum its products generated for the same period in 2024. Notably, almost all of the company’s sales were linked to its COVID vaccines at $971 million, while RSV immunization mRESVIA—approved last May—generated just $2 million in the quarter.With the results in hand, Moderna narrowed its guidance range for the year to 2025 sales of $1.6 billion to $2 billion, moving the high end of its range down $200 million from its previous forecast.