Cytosorbents Corp Q3 FY2024 earnings call

• Q3 2024 product sales reached $8.6 million, an 11% year-over-year increase, exceeding the guided range.
• Product gross margins were 61% for the quarter, expected to return to normalized levels in the current quarter after addressing production issues.
• Operating expenses decreased 25% year-over-year, reducing the operating loss and cash burn to approximately $2.7 million.
• DrugSorb ATR achieved significant regulatory milestones, including submission to the FDA and Health Canada, and MDSAP certification.
• The PuriFi hemoperfusion pump was launched, with ~60 devices received, aimed at enabling early treatment with CytoSorb.
• Data from the COSMOS registry presented at the EACTAIC conference showed positive clinical outcomes for CytoSorb in critical care indications.

In Q3 2024, product sales were $8.6 million, surpassing the guided range of $8.3 million to $8.5 million and marking an 11% year-over-year growth. The gross margin for the quarter was 61%, which was above the guided range but down year-over-year due to a planned production slowdown and a short-term manufacturing issue. The flagship product, CytoSorb, generates high-margin sales, and the investigational DrugSorb ATR is a key focus in the regulatory and clinical trial phases.

• Expect to return to normalized production levels and product gross margins in the current quarter.
• Cash burn was reduced to ~$2.7 million in Q3, with a focus on cash conservation.
• Anticipate regulatory decisions from the FDA and Health Canada for DrugSorb ATR in 2025.
• The PuriFi pump is part of the strategy to expand the usage of CytoSorb therapies.

• Potential regulatory delays in the approval process for DrugSorb ATR from the FDA and Health Canada.
• Risks associated with manufacturing issues that could impact production volumes.
• Market adoption risks for new products like DrugSorb ATR and the PuriFi pump.

Q: On the FDA submission, the substantive review process.

A: The main review process for the De Novo submission, with an expected decision in 2025. The breakthrough device designation allows for priority review, facilitating more interactive review with the agency.

Q: Update on Taiwan launch.

A: Regulatory approval in Taiwan was recent, and the launch is anticipated to accelerate in the next year or so, with a motivated distributor in the region.

Q: PuriFi pump program.

A: The PuriFi pump is designed to build infrastructure for CytoSorb usage in areas without extensive dialysis infrastructure, is user-friendly, and aims to encourage early treatment with CytoSorb.

Q: Gross margins normalization.

A: Returning to normalized levels, with the long-term goal to get back to a 75%-80% gross margin range, and more details to be provided in future calls regarding guidance and outlook.