Summary of Moderna (MRNA) 2025 Conference Call Company Overview - **Company**: Moderna, Inc. (MRNA) - **Event**: Jefferies Healthcare Conference - **Date**: June 5, 2025 Key Points Industry and Market Outlook - The discussion highlighted the evolving landscape of the healthcare industry, particularly in relation to COVID-19 vaccines and other vaccine developments [1][2] - There is a significant focus on the impact of the current administration's policies on vaccine approvals and recommendations, which has created uncertainty in the market [3][8] Financial Performance and Guidance - Moderna reaffirmed its revenue guidance for 2025, projecting revenues between $1.5 billion and $2.5 billion [53] - The company expects a cash burn of approximately $5.5 billion for the year, with an end-of-year cash position of around $6.6 billion [54][60] - Cost reductions have been a consistent theme, with a reported 20% decrease in operational costs year-over-year [58][59] COVID-19 Vaccine Developments - Moderna is awaiting efficacy data for its flu-COVID combination vaccine, with plans to resubmit for approval later this year [6][9] - The FDA has provided clearer guidelines on the populations recommended for COVID vaccinations, indicating a potential market of 100-200 million Americans for boosters, compared to 40 million last year [9][10] - The company has withdrawn its Biologics License Application (BLA) for the flu-COVID combo vaccine and is focusing on generating the necessary efficacy data [6][8] Pipeline and Future Products - Moderna is actively pursuing approvals for several vaccines, including norovirus and cytomegalovirus (CMV), with ongoing placebo-controlled studies [33][34] - The company is also exploring new cancer therapies, having shifted resources from respiratory vaccines to a promising cancer immunotherapy [78][84] - The anticipated launch of multiple products, including RSV and flu vaccines, is expected to contribute to revenue growth by 2027-2028 [70][74] Strategic Focus - Moderna is committed to maintaining a disciplined approach to R&D spending, with a focus on completing existing projects rather than initiating new phase three trials [61][62] - The company aims to align its cost structure with revenue growth, emphasizing the importance of managing expenses while expanding its product portfolio [75][76] Regulatory Environment - The recent clarity from the FDA regarding vaccine approvals is seen as a positive development for Moderna, allowing for more predictable planning and execution of its business strategy [85] Investor Sentiment - There is a cautious sentiment among investors regarding Moderna's ability to achieve significant revenue growth in the near term, with concerns about cash burn and market competition [56][66] Additional Insights - The company is focusing on a broad definition of comorbidities to expand the eligible population for COVID vaccinations, which could significantly increase market potential [16][18] - Moderna's strategy includes a pivot towards cancer therapies, indicating a shift in focus from respiratory vaccines to broader therapeutic areas [84] This summary encapsulates the key discussions and insights from the Moderna conference call, highlighting the company's strategic direction, financial outlook, and market opportunities.

Financial Data and Key Metrics Changes - Q1 revenues were $100 million, with a net loss of $1 billion, reflecting the seasonal nature of the respiratory vaccine business [6][12] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - R&D expenses decreased by 19% year over year to $856 million, driven by lower clinical development spending [14][19] - SG&A expenses were $212 million, down 23% year over year, reflecting broad-based cost reductions [15] Business Line Data and Key Metrics Changes - Net product sales were $86 million, primarily from COVID vaccine sales, with the U.S. accounting for about one-third of total sales [12][13] - Total revenue for the quarter was $108 million, a decrease of 35% year over year [13] - Cost of sales was $90 million, representing 104% of net product sales, up from 58% in the prior year [14] Market Data and Key Metrics Changes - Lower vaccination rates were observed compared to Q1 last year, indicating a transition of COVID into routine seasonal vaccination patterns [13] - The company expects total revenue in 2025 to be in the range of $1.5 billion to $2.5 billion, with first-half sales of approximately $200 million [17] Company Strategy and Development Direction - The company is focused on three priorities: expanding markets for commercial products, advancing its pipeline to drive sales growth, and executing with financial discipline [7][39] - The oncology portfolio is being expanded with the Checkpoint Medicine program, and the company aims to drive sales for approved products [8][39] - A commitment to achieve a breakeven target on a cash cost basis by 2028 has been established, with plans for significant cost reductions by 2027 [21][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in the upcoming fall season, despite the competitive market environment [52] - The company remains engaged with the FDA and anticipates continued productive exchanges regarding its product approvals [51] - The management is optimistic about the potential for new product approvals and the impact on sales growth [41][42] Other Important Information - The company plans to reduce annual GAAP expenses by over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The Phase III FRU program has exceeded the required number of case accruals for an interim vaccine efficacy analysis [9] Q&A Session Summary Question: Comments on FDA interactions and potential risks to the vaccine business outlook - Management noted that interactions with the FDA have been productive and ongoing, with a focus on providing necessary data for product reviews [51][52] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable, pending event accruals [56][58] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38%, and they are focused on managing working capital effectively [100][101] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis, stating that they will conduct the analysis once the season is over [105]

Financial Data and Key Metrics Changes - Q1 revenues were $100 million with a net loss of $1 billion, reflecting the seasonal nature of the respiratory vaccine business [7] - Cash and investments at the end of the quarter totaled $8.4 billion, down from $9.5 billion at the end of Q4 [16] - Net product sales were $86 million, primarily driven by COVID vaccine sales, with total revenue for the quarter at $108 million, a 35% decrease year over year [13][16] - R&D expenses were $856 million, a 19% decrease year over year, while SG&A expenses were $212 million, down 23% year over year [14][15] Business Line Data and Key Metrics Changes - The U.S. accounted for about one-third of total sales, with lower vaccination rates compared to Q1 last year due to the transition of COVID into routine seasonal vaccination patterns [12][13] - Cost of sales represented 104% of net product sales this quarter, up from 58% in the prior year, driven by lower volume and revenue mix [14] - The oncology portfolio was expanded with the Checkpoint Medicine program, which is expected to drive future sales growth [10][26] Market Data and Key Metrics Changes - The company received approvals for its vaccines in multiple international markets, including Australia, Taiwan, the UK, and Switzerland, enhancing its competitive position [9] - The company anticipates a total addressable market of over $30 billion for its upcoming product approvals [40] Company Strategy and Development Direction - The company is focused on three priorities: driving sales for approved products, advancing its late-stage pipeline, and delivering cost efficiency across the business [39] - The company plans to achieve significant cost reductions, targeting a cash cost of approximately $4.2 billion by 2027 to meet its breakeven target by 2028 [21][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for COVID vaccination, particularly in light of recent data showing high efficacy rates for their updated vaccine [53] - The company remains engaged with the FDA and continues to have productive exchanges regarding its ongoing product reviews [52] Other Important Information - The company is planning a total reduction in annual GAAP expenses of over $6 billion from 2023 to 2027, representing a 55% reduction [22] - The company is actively monitoring for additional cases of Guillain-Barré syndrome (GBS) in its trials and has lifted the clinical hold on its norovirus study [92] Q&A Session Summary Question: Comments on FDA interactions and potential risks to the vaccine business outlook - Management noted that interactions with the FDA have been productive and that they continue to see a need for COVID vaccination, especially among older Americans [52][53] Question: Update on INT Phase III data expectations - Management believes that a 2026 readout for the Phase III melanoma study is still reasonable based on historical event rates [57] Question: COVID strain selection process moving forward - The strain selection process will depend on guidance from regulatory bodies, with updates expected within the next month [75] Question: Concerns about future market share changes in COVID revenue - Management indicated that script data shows a consistent market share of around 38% and that inventory levels are being managed by customers [100] Question: Flu vaccine interim data expectations - Management did not provide specific guidance on total events for the flu vaccine analysis but indicated that a large number of cases are expected [105]

Financial Data and Key Metrics Changes - In 2024, the company recorded revenue of $3.3 million from an optional license agreement with MSD, with expectations for future income from this agreement [44] - The net loss for 2024 was $10.6 million, an improvement from a loss of $22 million in 2023, driven by increased revenue and reduced R&D and G&A expenses [48][49] - Cash and cash equivalents at the end of December 2024 were $6 million, up from $5.6 million at the end of 2023, with sufficient funds projected to last into mid-2026 [46][51] Business Line Data and Key Metrics Changes - The ongoing EBX01 Phase II trial showed a 69% overall response rate at the one-year readout, with 15 out of 16 patients showing a reduction in tumor target lesions [8][33] - The company has established a new precision cancer vaccine concept targeting non-conventional endogenous retroviruses, broadening the potential of cancer vaccines [9][35] Market Data and Key Metrics Changes - The partnership with MSD, established in September 2024, is expected to generate significant future income, with a potential option exercise in the second half of 2025 [6][15] - The company aims to generate at least two new agreements in 2025, focusing on a multi-partner approach to build its pipeline [17][19] Company Strategy and Development Direction - The company is focused on deriving value from both its platform and pipeline, emphasizing a dual focus on platform and pipeline development [18][20] - The strategy includes entering into high-value, low-risk partnerships around target discovery and the development of novel vaccine candidates [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong position, highlighting the successful execution of the pipeline and the transformative agreement with MSD [55][56] - The company is well-positioned for strong execution in 2025, with key milestones and value triggers identified [56] Other Important Information - The company extended the EVX01 trial from two to three years to collect three-year outcome data, which will provide a strong data package [27][34] - The company has raised $17 million through public offerings and other capital market activities, extending its cash runway to mid-2026 [12][21] Q&A Session Summary Question: How does the company ensure new pipeline candidates are partnerable assets? - The company emphasizes unmet medical needs and commercial potential as primary criteria, engaging in early dialogues with potential partners to shape preclinical programs accordingly [62][64] Question: What is the status of the CMV vaccine program after Expression Biotech returned rights? - The decision was made by Expression Biotech, and the company is confident in its plan to drive the program forward independently, exploring alternative solutions for antigen production [68][70] Question: What data should be expected at the upcoming AACR meeting regarding EBX01? - The company will present biomarker data and additional T cell data from patients, providing a more in-depth analysis than previously shared [80] Question: What types of cancers could the ERV vaccines target? - The company has identified specific cancer indications with a high burden where ERV sequences are shared across patients, with plans to share more information by the end of the year [85][86] Question: Will any data be released ahead of submitting to MSD for their decision on exercising the option for EVX B2 and B3? - No additional data will be released for B2, as MSD is conducting confirmatory work, while B3 is finalizing the current work plan [88][89]