Release Date: May 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Moderna Inc (MRNA, Financial) reported substantial clinical progress with exciting data on EBV, VZV, and Norovirus vaccines.
- The company announced four significant business agreements and collaborations, enhancing its financial and strategic positioning.
- Moderna Inc (MRNA) has a strong cash position with $12.2 billion in cash and investments, providing substantial financial flexibility.
- The company has made significant advancements in its late-stage clinical programs, including the expansion of studies for Individualized Neoantigen Therapy (INT) into new indications.
- Moderna Inc (MRNA) demonstrated strong financial discipline with a reduction in operating expenses, contributing to a more efficient cost structure.
Negative Points
- Net product sales for Q1 were down 91% year-over-year, primarily due to lower sales volumes of the COVID-19 vaccine outside the United States.
- The cost of sales represented 58% of net product sales, up from 43% in the same quarter last year, indicating increased costs relative to sales.
- Moderna Inc (MRNA) reported a net loss of $1.2 billion for the period, compared to net income of $79 million last year.
- The company experienced a decrease in cash and investments from $13.3 billion at year-end 2023 to $12.2 billion, reflecting significant R&D and operational expenditures.
- Despite ongoing efforts, there are challenges in the regulatory and competitive landscape, particularly with the upcoming need for vaccine approvals and market positioning against competitors.
Q & A Highlights
Q: Could you discuss your strategy for pursuing contracts for the RSV vaccine given 2 approved vaccine sort of have a head start, timing-wise? And help us understand, as you've communicated with large retail pharmacy, how significant the PFS formulation is to them?
A: (Stephane Bancel - CEO & Director) We are actively engaging with retail pharmacies and hospital networks to discuss the efficacy, safety, and productivity benefits of our PFS RSV vaccine. We are awaiting FDA approval to proceed with contracts.
Q: With regard to moving into the 3 new indications for the INT program. Maybe help us understand signals or specific data points that support that?
A: (Stephen Hoge - President) The new INT indications are all adjuvant settings where we see an opportunity to improve outcomes by driving a specific T cell response with INT, similar to our encouraging Phase II results in melanoma.
Q: On RSV, what is your latest perspective on what the most likely ACIP recommendation will be? Will you get a parity recommendation to the competitors?
A: (Unidentified Company Representative) We expect a parity recommendation based on our data package, which includes durability through a second season and immunogenicity across other populations, but the final decision rests with ACIP.
Q: Any update on your ongoing conversations regarding filing your seasonal flu vaccine?
A: (Stephen Hoge - President) We are actively engaged with regulators on the submission process for our flu vaccine and expect to file this year, depending on several considerations including upcoming clinical data.
Q: On CMV, how are you thinking about the need or benefits of potentially boosting both from a clinical as well as a commercial perspective?
A: (Stephen Hoge - President) We are evaluating the durability of immunogenicity from our CMV vaccine. The need for boosting will depend on the long-term efficacy data, which is still under study.
Q: You're developing a refrigerator stable vaccine and flu vaccine. When could that get approved? Will the combo vaccine also be refrigerator stable?
A: (Stephen Hoge - President) All our respiratory vaccines, including the flu and flu-COVID combo, are being developed towards being refrigerator stable. We aim for these to be in prefilled syringes to facilitate easy administration.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
