Moderna (MRNA) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Everyone, thank you. Good morning, and thank you for joining us on our next discussion here at the Jefferies Healthcare Conference. I have the pleasure of having the President of Moderna, Stephen Hoag, up here with us. Obviously, timely. A lot's going on in the world, both from a regulatory administrative standpoint. We had Marty Makary here yesterday. Obviously, a lot going on with your commercial business, the pipeline, all of that. So I lo ...

Moderna (MRNA) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the Moderna first quarter '20 '20 '5 conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Pl ...

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]