Moderna Advances Next-Gen COVID Vaccine in EU, but Transition Challenges Persist

What happened

Moderna's mNEXSPIKE, a next-generation COVID-19 vaccine, received a positive opinion from the EMA's CHMP, recommending authorization in the EU. This milestone aligns with the DeepValue report's note on encouraging early data for next-gen COVID vaccines, such as mNEXSPIKE's efficacy against current lineages. However, Moderna remains in a transition trough, with 2024 revenue falling to ~$3.2B and 2025 guidance of $1.5-$2.5B due to COVID normalization, RSV market contraction, and CMV discontinuation. The company faces heavy cash burn, negative EPS, and reliance on successful launches of flu and RSV vaccines to stabilize finances. Thus, while mNEXSPIKE's progress is a step forward, it does not resolve broader execution risks in Moderna's respiratory portfolio and cost management.

Implication

This news confirms Moderna's ability to advance regulatory milestones for next-gen COVID vaccines, supporting its platform agility and potential for strain updates. However, mNEXSPIKE's contribution to 2025 sales is likely modest and uncertain, given the guided revenue range of $1.5-$2.5B and competitive dynamics. The DeepValue report emphasizes that key swing factors—like flu approval, RSV traction, and cost cuts—are more critical for revenue recovery and cash flow improvement. Investors should remain cautious, as persistent negative earnings and high burn rates require successful execution across multiple products, not just regulatory wins. Therefore, while incrementally positive, this development does not justify a shift from the current HOLD stance without clearer progress on watch items such as flu milestones and RSV performance.

Thesis delta

The positive CHMP opinion for mNEXSPIKE reinforces the tailwind for next-gen COVID vaccines noted in the DeepValue report, highlighting Moderna's continued pipeline advancement. However, the core thesis of a transition trough with revenue declines, cash burn, and reliance on flu and RSV execution remains unchanged. Investors should still prioritize monitoring regulatory milestones for flu and combo vaccines, RSV market share gains, and cost management as primary drivers for any future thesis shift.