Q4 2023 Earnings Summary
- Moderna's RSV vaccine offers ease of use with a prefilled syringe presentation, providing significant advantages over competitors and reducing burden on pharmacies facing labor shortages.
- The Individualized Neoantigen Therapy (INT) program is progressing well, with rapid enrollment in Phase III trials and manufacturing scale-up, positioning Moderna for potential accelerated approval in melanoma.
- Potential upside in European COVID-19 vaccine sales due to a new EU tender allowing Moderna to participate, and efforts to increase vaccination rates in the U.S., could boost revenues beyond 2024 guidance.
- Declining COVID-19 vaccine sales and lower vaccination rates are projected to reduce 2024 revenues. Moderna expects net sales of approximately $4 billion in 2024, down from $6.7 billion in 2023. The company acknowledges that vaccination rates in the U.S. were lower than last year, which could be a downside risk to sales.
- Potential delays and uncertainties in regulatory approvals and product launches for RSV and flu vaccines amid strong competition. Contracting for the RSV vaccine cannot start until approval is received, and timing of RSV launch could be delayed due to regulatory approvals. There is also competition from Pfizer and GSK, with similar products already in the market.
- Significant net loss and cash burn raise financial concerns. Moderna reported a net loss of $4.7 billion in 2023 compared to income of $8.4 billion in 2022. The company expects to end 2024 with approximately $9 billion in cash, down from $13.3 billion at the end of 2023, indicating continued cash burn. Additionally, they established a valuation allowance against deferred tax assets due to projected losses.
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2024 Revenue Guidance Upside/Downside
Q: What could be the upside or downside for your 2024 revenue guidance of $4 billion?
A: Stéphane Bancel highlighted that upside could come from participating in the new COVID vaccine tender in Europe, increasing vaccination rates in the U.S., and the RSV vaccine launch and market share gains. Downside risks include lower vaccination rates and potential delays in the RSV launch due to regulatory approvals. -
Melanoma Vaccine Accelerated Approval
Q: What's your latest thinking on accelerated approval for the melanoma vaccine?
A: Stephen Hoge expressed excitement about the data and mentioned they are discussing accelerated approval with regulators. Key criteria include demonstrating durability, substantial enrollment in the confirmatory Phase III study, and establishing a commercial manufacturing facility. Recent data showed durability, and they're making progress on the other criteria. -
CMV Vaccine Efficacy Expectations
Q: What vaccine efficacy would be clinically meaningful for the CMV Phase III trial?
A: Stephen Hoge stated that a vaccine efficacy of around 50% would be significant, as no current vaccine prevents CMV infection. Anything above that would be incredibly exciting. They're enrolling both seropositive and seronegative participants, aiming to launch the product for both groups without needing a diagnostic test. -
CMV Trial Readout Timelines
Q: When can we expect a readout from the CMV trial, and what's the statistical plan?
A: Stephen Hoge explained they are fully enrolled and accruing cases, needing approximately 80 cases for the first interim analysis. They expect to have enough cases this year, anticipating a readout from the interim analysis, possibly even the final analysis for efficacy in 2024. -
RSV Vaccine Market Dynamics
Q: How will your RSV vaccine compete in the market, given existing competitors?
A: Stéphane Bancel is optimistic about their RSV vaccine's potential, emphasizing the convenience of a prefilled syringe and the importance of simplifying pharmacy workflows amid labor shortages. He believes their product will be a meaningful tool for customers. Additionally, Stephen Hoge expects public health officials to view their product similarly to competitors, leading to consistent recommendations. -
Manufacturing Scale-Up for Melanoma Vaccine
Q: What's the status of manufacturing scale-up for the melanoma vaccine, and when will the facility be ready?
A: Stephen Hoge mentioned they've made significant progress in scaling up manufacturing for clinical supply and are rapidly enrolling patients in Phase III studies. The Marlborough facility is being built as a purpose-built commercial site for the individualized neoantigen therapy, with the goal to establish it for clinical supply this year. -
Flu Vaccine Discussions with FDA
Q: Can you provide an update on discussions with FDA for your seasonal flu vaccine?
A: Stephen Hoge stated they are in ongoing conversations with the FDA and global regulators about the data package required for submission of their mRNA-1010 influenza vaccine. They are discussing the total submission data package and duration of follow-up in studies. -
RSV Vaccine in Pediatrics
Q: What's the status of evaluating the RSV vaccine in the pediatric population?
A: Stéphane Bancel said they haven't started the pediatric Phase III study yet. The vaccine is in Phase I/II trials, and they're waiting for data before moving into the pediatric setting. -
Correlate of Protection for RSV
Q: When will you have a correlate of protection for RSV, and how important is this for competition?
A: Stephen Hoge believes they've identified a strong candidate in neutralizing antibodies as a correlate of protection. They plan to publish data and include it in regulatory submissions this year. Once established, it will guide public health recommendations on revaccination and boosting, impacting competitive dynamics. -
Australia's Impact on RSV Launch
Q: How integral will Australia be for your RSV launch and COVID vaccination trends?
A: Stéphane Bancel noted that Australia is different commercially compared to the U.S., more akin to European markets. While they have a strong presence in Australia and are building a plant in Melbourne, he doesn't think events there will directly correlate with U.S. market outcomes for RSV or COVID vaccines.