Moderna Files for Global Approval of Seasonal Flu Vaccine Amid Deepening Financial Woes

What happened

Moderna has submitted its investigational seasonal influenza vaccine, mRNA-1010, for marketing authorization in the U.S., EU, Canada, and Australia, targeting adults aged 50 and older. This move is part of the company's effort to diversify beyond COVID-19 vaccines, which have seen revenue collapse from $18.4 billion in 2022 to a ~$2.2 billion annual run-rate. However, the DeepValue report reveals Moderna is structurally loss-making, with persistent negative free cash flow and rising financial risk from a $1.5 billion loan. The regulatory filing follows past delays, such as the withdrawn flu/COVID combo submission, and faces intense competition in a crowded respiratory vaccine market. Investors should view this as a necessary but uncertain step in Moderna's risky pivot, which requires roughly tripling sales to $6 billion by 2028 for breakeven.

Implication

In the near term, the submission may provide a minor sentiment boost, but it does not alter Moderna's financial trajectory of sustained losses and negative operating cash flow. The success of mRNA-1010 is critical for diversifying revenue, but approvals are not guaranteed, and commercial uptake faces headwinds from established competitors and potential safety concerns. Even if approved, the vaccine must overcome manufacturing overcapacity and fixed costs that could erode margins, as highlighted by recurring inventory write-downs. Long-term, Moderna's investment case remains binary, hinging on multiple pipeline successes, including oncology and norovirus programs, to achieve its 2028 breakeven target. Investors should await clearer evidence from regulatory decisions and sales performance before considering a shift from the current 'WAIT' rating.

Thesis delta

The regulatory submissions for mRNA-1010 represent progress in Moderna's respiratory franchise but do not materially reduce the execution risk or financial pressures outlined in the DeepValue report. The thesis remains unchanged: Moderna is a high-risk, binary investment dependent on successful approvals and commercial launches across its pipeline to offset declining COVID revenues and achieve profitability. Until more definitive data on efficacy, approvals, and cash flow stabilization emerge, the 'WAIT' stance is prudent.