Cytosorbents Corporation Q2 FY2025 earnings call

• Financial performance: Q2 product sales were $9.6 million, up 9% y-o-y and 4% constant currency. Gross margin held steady at approximately 71%.
• DrugSorb ATR regulatory update: Submitted de novo to FDA and medical device license to Health Canada late last year. FDA denied de novo in April, with an in-person hearing held last month and appeal process expected to conclude by end of August. Health Canada had a notice of refusal in June, with a request for reconsideration filed and awaiting further steps after FDA decision.
• Sepsis activities: Highlighting role in sepsis treatment, including World Sepsis Day Global webinar on Sept 10.
• German commercial team: Reorganization of German commercial team grew 22% y-o-y and sequentially in Q2, with distributor sales among the best ever.

In the second quarter of 2025, Cytosorbents reported product sales of $9.6 million, representing a 9% year-over-year increase and 4% on a constant currency basis compared to the same period last year. The core product, CytoSorb, had nearly 300,000 devices utilized to date in more than 70 countries worldwide, driving $35.6 million in core product sales last year. The second product, DrugSorb ATR, is an investigational FDA breakthrough designated medical device with ongoing regulatory activities in North America.

• Management aims to drive core business to near breakeven by end of 2025 with sufficient cash to fund initiatives.
• Anticipate final regulatory decisions on DrugSorb ATR from FDA and Health Canada by end of 2025.
• Plan purposeful rollout of DrugSorb ATR once approved in the US, focusing on clinical accounts.

• FDA denied de novo request for DrugSorb ATR in April, with ongoing appeal process.
• Health Canada issued notice of refusal in June, requiring a reconsideration/appeal process.
• Uncertainty in regulatory approvals for DrugSorb ATR impacting launch timeline.

Q: Michael Sarcone asked about regulatory denials and confidence in approval, and update on Germany.

A: Phil Chan discussed that the FDA appeal process was a good event to lay out DrugSorb ATR's story, with expectation of FDA response by end of August, and mentioned Germany reorganization is a work in progress with 22% growth but more work needed.

Q: Tom Kerr asked about Canada's reconsideration and commercial launch of DrugSorb ATR in US.

A: Phil Chan said Canada's request for reconsideration is like the FDA appeal process and will be pushed off until after FDA decision, and Peter Mariani said the launch would be a purposeful rollout focusing on clinical accounts