Q1 2024 Earnings Summary
- Moderna is expanding their oncology pipeline through their partnership with Merck, with multiple new adjuvant cancer indications for their Individualized Neoantigen Therapy (INT), based on positive Phase II melanoma results, demonstrating strong potential in their cancer vaccine platform.
- Moderna is progressing towards regulatory approval of their RSV vaccine, confirming that the PDUFA date remains on track, potentially adding significant revenue and expanding their respiratory vaccine portfolio.
- Moderna is actively participating in an EU tender process for up to 36 million doses of their COVID vaccine annually, indicating continued demand and potential significant revenue in Europe.
- Uncertainty in revenue projections due to lack of specific guidance on RSV vaccine sales and competition from existing approved vaccines . The company stated, "we haven't guided any specific guidance or number for RSV" and acknowledged that competitors "have a head start, timing-wise" .
- Potential delays in regulatory approvals for key products like the flu vaccine, which may impact revenue growth projections. The company mentioned that they are "engaged right now...with regulators on the process for submission of the flu vaccine" and that "those discussions are ongoing," indicating potential uncertainty in approval timelines.
- Oncology programs face significant hurdles before commercialization, including lengthy confirmatory studies and manufacturing scale-up, delaying potential returns on investment . The company admitted that for the INT (Individualized Neoantigen Therapy) program, they have "not consulted with the agency on that yet" and that "it could be several years" before the confirmatory study matures. Additionally, they are "not prepared to disclose" the actual R&D cost for the cancer program.
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RSV Approval and ACIP Recommendation
Q: Is the RSV PDUFA date still May 12, and what's the expected ACIP recommendation?
A: We're working towards the same PDUFA date with no changes. We hope for a parity ACIP recommendation based on our data, including durability and immunogenicity, but the final decision rests with ACIP. -
INT Phase III and Accelerated Approval
Q: How critical is INT Phase III progress before FDA engagement, and is Merck on board?
A: Substantial enrollment in the confirmatory study is crucial for accelerated approval. We're making great progress but haven't consulted FDA yet. While we defer to regulators, we believe both we and Merck would want to make the product available if supported. -
Flu Vaccine Filing and 1083 Data
Q: When will you file the flu vaccine, and how does 1083 data affect it?
A: We expect to file the flu product this year, pending considerations and data from our flu-COVID combo vaccine, mRNA-1083. The 1083 data is expected imminently and will inform our regulatory strategy and submission sequencing. -
CMV Data Timing and Vaccination Strategy
Q: When is CMV interim data expected, and will you vaccinate seropositives?
A: We expect the CMV readout this year with no delays. While transmission risk is highest in seronegatives, seropositives can also benefit due to reactivation; thus, we see potential in vaccinating both groups. -
INT Manufacturing Capacity
Q: Update on INT manufacturing capacity and expansion plans?
A: We've sized our plant to meet the melanoma market needs and future indications. We acquired a facility and are building modular capacity that can be quickly expanded as needed. -
RSV Revenue and Contract Strategy
Q: How much RSV revenue is in guidance, and how will you compete?
A: We haven't provided specific RSV revenue guidance. We can't contract until FDA approval but are actively engaging pharmacies about our product's efficacy, safety, and PFS (prefilled syringe) benefits. -
IP Litigation Impact
Q: Thoughts on recent IP ruling and impact on COVID sales?
A: We believe our COVID-19 vaccine technology doesn't infringe on asserted patents. We're confident in our position and look forward to presenting our case. -
Refrigerator Stable Vaccines
Q: Will your flu and combo vaccines be refrigerator stable?
A: All our respiratory vaccines, including the flu-COVID combo mRNA-1083, are being developed as refrigerator stable prefilled syringes, facilitating global delivery. -
EU COVID Vaccine Tender
Q: Under what scenario can you get 36 million EU doses, and pricing?
A: The EU tender for up to 36 million doses depends on participating countries; we'll know after the process. We won't disclose pricing due to competitive reasons. -
Cancer Program Costs and Indications
Q: Can you disclose cancer program R&D costs and indications pursued?
A: We're not disclosing R&D costs at this time. We will continue adding more indications in partnership with Merck but can't provide specifics now.
Research analysts covering Moderna.