Wed, May 14, 11:01 AM (35 days ago)
**Milestone Pharmaceuticals Inc. (MIST) Q1 2025 Financial Summary** **Financial Health and Performance:** - **Revenue:** No revenue was recorded for Q1 2025, consistent with Q1 2024. - **Profit Margins:** The company reported a net loss of $20.8 million for Q1 2025, compared to a net loss of $10.4 million in Q1 2024. - **Cash Flow:** The company had $45.1 million in cash and cash equivalents and $10.9 million in short-term investments as of March 31, 2025. Net cash used in operating activities was $14.0 million for Q1 2025, compared to $8.9 million in Q1 2024. - **Earnings Changes:** The net loss per share increased to $0.31 for Q1 2025 from $0.21 in Q1 2024. **Operational Performance:** - **Operating Expenses:** Total operating expenses increased by 95.9% to $20.5 million in Q1 2025 from $10.5 million in Q1 2024. This increase was driven by higher research and development, general and administrative, and commercial expenses. - **Research and Development:** R&D expenses increased by 36.8% to $4.98 million, primarily due to higher consulting costs in drug manufacturing and regulatory activities. - **General and Administrative:** These expenses increased by 30.7% to $5.17 million, driven by higher outside service costs. - **Commercial:** Commercial expenses surged by 259.9% to $10.4 million, reflecting preparations for the potential launch of CARDAMYST (etripamil). **Trends and Uncertainties:** - **CRL Impact:** The company received a Complete Response Letter (CRL) from the FDA in March 2025, highlighting two key Chemistry, Manufacturing, and Controls (CMC) issues related to etripamil. This has led to a temporary pause in ramping up operational expenditures related to the launch. - **Future Operations:** The company expects to continue incurring significant losses and increased operating expenses for at least the next several years. Future financial performance will depend on the successful resolution of the CRL issues, regulatory approvals, and the commercialization of etripamil. **Future Outlook:** - **Regulatory and Commercialization:** The company is focused on addressing the CRL issues and preparing for the potential commercialization of etripamil. The success of these efforts will be crucial for the company's future financial performance. - **Funding:** The company has sufficient cash and cash equivalents to support its operations for at least the next 12 months. Future funding may come from equity or debt financing, collaboration arrangements, or selective partnering for clinical development and commercialization.