Release Date: November 07, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- CytoSorbents Corp (CTSO, Financial) reported Q3 2024 product sales of $8.6 million, exceeding their guidance range and reflecting an 11% year-over-year growth.
- The company achieved a product gross margin of 61% for the quarter, which was above their guided range.
- Operating expenses decreased by 25% year-over-year, leading to a 40% reduction in operating loss and a lower cash burn of $2.7 million for the quarter.
- CytoSorbents Corp (CTSO) has submitted its De Novo medical device marketing application for Drugsorb A TR to the FDA and Health Canada, with regulatory decisions expected in 2025.
- The company has received positive feedback on its newly launched purified hemoperfusion pump, which is expected to drive increased demand for its CytoSorb cartridges.
Negative Points
- Product gross margins decreased from 72% in the prior year's quarter due to a planned production slowdown and a short-term manufacturing issue.
- Grant revenue decreased to $800,000 from $1.1 million in the prior year due to the conclusion of several grants.
- The primary endpoint of the Star T trial was not met in the allcomers surgery population, although it was met in the isolated CABG population.
- The company has $12.2 million in cash, including $6.5 million of restricted cash, indicating limited liquidity.
- CytoSorbents Corp (CTSO) faces uncertainty regarding the timeline for FDA approval, with expectations set for sometime in 2025.
Q & A Highlights
Q: Can you explain the FDA's substantive review process for your De Novo submission?
A: Phillip Chan, CEO: The substantive review is the main process for our De Novo submission. Historically, the FDA's target has been a 150-day review, but post-pandemic, it's been about 11 months. We expect a decision sometime in 2025. Our breakthrough device designation makes us eligible for priority review, which can expedite the process through more interactive and collaborative discussions with the FDA.
Q: Could the FDA approval for Drugsorb A TR happen in the second quarter of 2025?
A: Phillip Chan, CEO: We expect approval sometime in 2025, but we cannot predict the exact timelines of the FDA.
Q: Is the Taiwan launch proceeding as planned?
A: Phillip Chan, CEO: We recently received regulatory approval in Taiwan and have been working closely with our distributor. We anticipate the launch will accelerate, likely in the next year.
Q: Regarding the $5 million in restricted cash, will it be released in the fourth quarter following the FDA application submission?
A: Peter Mariani, CFO: The restriction will be lifted once we raise $5 million in new equity, allowing us to free up $10 million in liquidity.
Q: Can you provide more details on the purified pump program? Is it in a trial phase or will it be marketed extensively?
A: Phillip Chan, CEO: The purified pump is designed to expand the use of our therapy in areas lacking dialysis infrastructure. It's user-friendly and encourages early treatment with Cytosorb, which is crucial for good outcomes. It's an enabling technology to drive demand for our cartridges, and while we sell it for profit in some regions, we subsidize it in others to promote cartridge sales.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
