Moderna, Inc. Q4 FY2024 earnings call

• In 2024, Moderna recorded revenue of $3.2 billion and achieved $2.6 billion in cost savings. Ended the year with $9.5 billion in cash and investments. - Focused on 10 high-value programs for potential approvals over the next three years, including respiratory vaccines, next-gen COVID, RSV, flu, and others in oncology and rare diseases. - Pipeline progress: Approved mRESVIA, positive Phase 3 results in respiratory vaccine programs, filed for FDA approval on next-gen COVID and RSV vaccines, seasonal flu vaccine in Phase 3, and progress in oncology, rare diseases, and latent virus programs. - Reduced operating expenses by $2.6 billion in 2024, with projected $6.4 billion in GAAP expenses for 2025, excluding non-cash charges.

In the fourth quarter of 2024, net product sales were $0.9 billion, with $0.2 billion in the United States and $0.7 billion outside the United States. For the full year 2024, net product sales were $3.1 billion. US sales were $1.7 billion, benefiting from a $0.2 billion favorable adjustment related to a prior period return reserve reversal. Excluding this adjustment, sales volume declined due to lower vaccination rates, market share, and competition. Outside the US, product sales were $1.4 billion, aligning with the midpoint of guidance, including approximately $400 million from non-recurring advanced purchase agreements. Spikevax was the primary contributor, while mRESVIA, launched in Q3, had $25 million in full-year sales.

• 2025 revenue expected to be in the range of $1.5 billion to $2.5 billion. - Cost of sales projected at approximately $1.2 billion, R&D expenses at ~$4.1 billion, SG&A expenses at ~$1.1 billion. - Capital expenditures projected at ~$0.4 billion. - Expect to end 2025 with approximately $6 billion in cash and investments. - Guidance excludes revenue from new product approvals not yet finalized.

• Clinical trial holds, such as the norovirus vaccine program on clinical hold following a case of Guillain-Barre syndrome. - Regulatory delays in approvals of vaccines, including uncertainties around the flu-COVID combination vaccine and other programs. - Market competition and variability in vaccination rates impacting sales. - Inventory write-downs and excess manufacturing capacity issues.

Q: Can you help us understand the breakdown of the R&D spend across your program?

A: Jamey Mock mentioned there's still room to reduce R&D spend, guiding $4.1 billion for 2025, and over 50% of trial spend is related to respiratory trials which are expected to roll-off.

Q: Can you give any more detail around the clinical hold on Norovirus?

A: Stephen Hoge explained the clinical hold was due to proactively communicating the GBS case, updating study documents, and the FDA reviewing the information; no impact on Northern Hemisphere study conduct as it's fully enrolled.

Q: What would it take for the FDA to remove the clinical hold on Norovirus?

A: Stephen Hoge said the FDA needs to review materials, answer their questions; no re-enrollment in Northern Hemisphere as it's fully enrolled.

Q: What is the clinical bar for the Norovirus program?

A: Stephen Hoge stated they'll look for a meaningful reduction in the rate of moderate-to-severe acute gastroenteritis as a key endpoint.

Q: Have you talked to the Trump administration or their representatives?

A: Stephane Bancel said they look forward to working with the new team as they get confirmed by the Senate.

Q: What's the future look like for inventory write-downs?

A: Jamey Mock said inventory levels are down, working to match demand with supply, aiming to reduce inventory write-downs from $600 million on $3 billion sales.