Moderna experienced a solid start to 2024 with significant clinical progress in its pipeline, including vaccines for EBV, VZV, and Norovirus, and expanded studies in Individualized Neoantigen Therapy (INT).
Announced four major business agreements, including a nonexclusive IP licensing agreement in Japan and a contract to supply 4.5 million doses of COVID-19 vaccine to Brazil.
Net revenue for Q1 2024 was $167 million, a decrease primarily due to lower sales volumes of COVID-19 vaccines outside the United States.
Operating expenses significantly decreased, contributing to financial discipline, with a notable reduction in SG&A expenses.
Ended the quarter with $12.2 billion in cash and investments.
Clinical and Commercial Progress
Provided updates on respiratory vaccines, including regulatory progress for RSV and flu vaccines, and the initiation of Phase III studies for other vaccine candidates.
Highlighted advancements in oncology therapeutics, with ongoing Phase III studies and the initiation of new trials in various forms of cancer.
Outlined 2024 commercial priorities, focusing on increasing COVID-19 vaccination rates across different regions and preparing for the launch of the RSV vaccine.
Financial Outlook and Strategy
Q1 net product sales were $167 million, with a projected total of approximately $300 million for the first half of 2024.
Anticipate net sales of approximately $4 billion for 2024, expecting a return to growth in 2025.
Continued emphasis on financial discipline, with a decrease in R&D expenses and a focus on strategic investments to drive efficiency.
Upcoming Milestones
Awaiting approval for the RSV vaccine and discussion with regulators on the flu program, with plans to file in 2024.
Completion of enrollment for the Phase III adjuvant melanoma study and exploration of accelerated approval possibilities.
Initiating pivotal studies for additional vaccine programs, underscoring the commitment to leveraging the mRNA platform for broad impact.
Question and Answer
RSV Vaccine Contracting Strategy and Importance of PFS Formulation
Question
What is Moderna’s strategy for pursuing contracts for the RSV vaccine, considering competitors have a head start, and how significant is the PFS formulation to large retail pharmacies?
Answer
Moderna’s medical teams are actively engaging with retail pharmacies, IV, and hospital networks to discuss the efficacy, safety profile, and benefits of the PFS formulation, including its productivity advantages.
The company is not able to contract until FDA approval, but it is preparing by establishing relationships and sharing data with potential partners.
INT Program Expansion into Three New Adjuvant Indications
Question
What signals or specific data points support the expansion of the INT program into three new adjuvant settings?
Answer
The expansion is based on the encouraging Phase II results in melanoma, where Keytruda has a known benefit, but there is potential to improve by driving a specific T cell response with INT.
The Phase I trials explored multiple indications in the metastatic setting, but the focus has shifted to adjuvant indications where immunotherapy is approved and where there is an opportunity for improvement.
RSV Vaccine Revenue Guidance and Confidence Levels
Question
Can you comment on the RSV vaccine revenue guidance, the implied confidence levels, and how the guidance was adjusted?
Answer
Moderna has not provided specific financial guidance for RSV vaccine sales but has previously broken down its $4 billion guidance into three segments, including the U.S. market, APAs, and other COVID sales, which include RSV.
The company does not have a specific financial guidance number for RSV but is confident in the potential and is actively engaging with potential partners.
Importance of Phase III Enrollment Progress for INT Program and Accelerated Approval
Question
How important is the Phase III enrollment progress and the confirmatory study for the INT program’s accelerated approval, and what are the next steps in engaging with the FDA?
Answer
Substantial enrollment and demonstrating diligence in enrolling the confirmatory study are crucial for considering accelerated approval.
Moderna is making great progress with both the confirmatory study and the manufacturing facility and is optimistic about their availability in the near future.
Likely ACIP Recommendation for RSV Vaccine and Update on Flu Vaccine Filing
Question
What is the most likely ACIP recommendation for the RSV vaccine, and are there any updates on the ongoing conversations regarding filing the seasonal flu vaccine?
Answer
While the ultimate decision lies with ACIP, Moderna expects and hopes for a parity recommendation based on the data package, including durability through a second season, immunogenicity across populations, and additional data to be shared at the ACIP meeting.
The company is actively engaged with regulators on the process for submitting the flu vaccine and is closing in on clinical data from the combination flu COVID vaccine, which will be important for regulatory discussions.
Need for Boosting in CMV Vaccine and Disclosure of Interim Analysis
Question
How is Moderna thinking about the potential need or benefits of boosting in the CMV vaccine, and will the company disclose if it does not meet the interim analysis?
Answer
The potential need for boosting in the CMV vaccine will depend on the durability of immunogenicity data and the eventual efficacy data, which will provide insights into the need for additional protection.
Moderna has not committed to disclosing the results of the interim analysis, as it will depend on the data and the timing of the final analysis.
Approval Timeline and Stability of Refrigerator-Stable Vaccines
Question
When could the refrigerator-stable RSV and flu vaccines be approved, and will the combination vaccine also be refrigerator-stable?
Answer
Moderna’s entire respiratory portfolio, including RSV, flu, COVID, and the flu COVID combo, is being developed as refrigerator-stable prefilled syringes, which the company views as the ideal presentation for healthcare providers.
RSV Vaccine Supply Scenarios, Pricing, and INT Program Randomized Trial in Head and Neck Cancer
Question
What scenarios could enable the supply of up to 36 million RSV vaccine doses in the EU, and what are the potential prices in Brazil and the EU? Additionally, is Merck fully on board with submitting for accelerated approval in melanoma?
Answer
The supply of up to 36 million RSV vaccine doses in the EU will depend on the number of countries that apply to the tender through the EU, and the price in specific markets will not be shared for competitive reasons.
Moderna believes that both the company and Merck would make the product available for melanoma patients if accelerated approval is appropriate and regulators are supportive, but the ultimate decision rests with regulators.
RSV Vaccine PDUFA Date and Impact of Recent IP Decisions
Question
Can you confirm the RSV vaccine PDUFA date, and can you comment on the recent decision by Judge Goldberg regarding IP and its potential impact on COVID vaccine sales?
Answer
Moderna is working towards the same RSV vaccine PDUFA date, and there is no change reported at this time.
The company believes that its COVID-19 vaccine technology, including the lipid nanoparticle delivery system, does not infringe on the patent asserted by Arbutus and is confident in its position.
INT Program Randomized Trial in Head and Neck Cancer and Zoster Vaccine Development
Question
What is holding back the initiation of the randomized trial for the INT program in head and neck cancer, and when can we expect updates on the pivotal strategy for the zoster vaccine?
Answer
Moderna and Merck have not yet decided on the priority of head and neck cancer compared to other indications and opportunities, and it will take some time to determine the next steps.
Moderna is currently finalizing the pivotal strategy for the zoster vaccine, including dose selection, number of doses, and study design, and will consult with regulators before finalizing the plan.
Manufacturing Scale-up for INT Program and Timing of Data Availability
Question
Can you provide a status update on the manufacturing scale-up for the INT program and the number of patients supported currently and in the future, and when will the 1083 immunogenicity data be available, and how will this data impact the regulatory talks for 1010?
Answer
Moderna has not provided specific capacity numbers for the Marlborough plant but has sized it according to the melanoma market and the potential for multiple indications. The plant is being built in modules for rapid scaling as more indications become available.
The 1083 immunogenicity data is imminent, and the company is independently looking to submit both the flu and flu COVID combo programs. The timing of the submissions will depend on the data and the regulatory strategy.
While the 1083 and 1010 programs can stand alone, there may be a logical sequencing of submissions in some regulatory geographies, and the company will assess the best approach once the 1083 data is available.
CMV Vaccine and Risk in Seropositive versus Seronegative Individuals
Question
Can you remind us how the risk of CMV in pregnancy compares between seropositive and seronegative individuals and how this influences the strategy for pursuing vaccination in different populations?
Answer
While the risk of vertical transmission of CMV to the fetus is highest in seronegative individuals, it can also occur in seropositive individuals, particularly in cases of reactivation or reinfection.
Moderna believes there is potential benefit for a CMV vaccine in seropositive populations and is evaluating this through safety studies and by looking at data from other viruses like EBV, where control was demonstrated even in seropositive individuals.
Zoster Vaccine Pivotal Strategy and MMA and PA Program Safety
Question
When can we expect updates on the zoster vaccine pivotal strategy and any color on the Phase III design, and can you provide thoughts on the nature of editorial and comments on safety for the PA and MMA programs advancing into pivotal trials?
Answer
Moderna is currently finalizing the pivotal strategy for the zoster vaccine, including dose selection, number of doses, and study design, and will consult with regulators before finalizing the plan.
The clinical data for the MMA and PA programs shows a compelling benefit-risk profile with a good safety profile, and the company is encouraged by the data.
There are no specific or new safety concerns based on the clinical data at this time.
1083 Program Data Update and CMV Interim Data Timing
Question
How comprehensive will the 1083 program data update be, what is the potential need for longer-term follow-up, and are there parallels from the 1010 program that can inform the regulatory filing speed for 1083? Additionally, is there a slight delay in the timing of the CMV interim data?
Answer
The 1083 program data update will depend on the data and the timing of the final analysis, and the need for longer-term follow-up will be assessed based on the results.
It’s important not to draw direct correlations between the 1010 and 1083 programs in terms of timing for regulatory submissions due to differences in study structures.
There is no change in the expectations for the timing of the CMV interim data readout, which is expected by the end of this year.
HSV Vaccine and Potential Implications for Alzheimer’s Disease
Question
What are your thoughts on the potential utility of the HSV vaccine in Alzheimer’s disease, considering the hypothesis implicating HSV in its development?
Answer
The studies for the HSV vaccine will initially focus on improving outcomes in seropositive individuals, such as reducing shedding days or lesion-based measures.
While the neuroinflammatory aspects of HSV are interesting and potentially relevant to Alzheimer’s disease, it is still early to draw connections from a vaccine perspective, and further research is needed.
