KORU Medical Systems, Inc. Q4 FY2025 earnings call

1. Pre-fill is a driver of international market momentum, with step-up expected in back half of year. U.S. growth is slow and steady with consistent growth on PST side. 2. In 2026, strong SCIG market expected to continue growing, and growth from new drug approvals on label. 3. Signed two new deals with pharmaceutical companies: one nephrology drug in phase three and one multi-indication molecule in early phase one, representing approx 3 million annual infusions. 4. Ristigo has potential for growth in infusion clinics, with off-label sales already present and on-label promotion to come. 5. Strategic priorities include protecting and growing core domestic business, expanding internationally, and enabling more drugs to reach more patients. 6. Japan has approved pumps and consumables, with pre-filled syringes being important and expected growth with them.

1. Guidance range is influenced by prefill conversions, new drug clearances, timing of Middle East factor, and oncology opportunities. 2. Prefill conversions faster and new drugs getting traction sooner can move towards high end. 3. If prefill conversions and new drug clearances slip into 2027, it can be towards low end. 4. Expect to be positive adjusted EBITDA again and cash flow positive for full year, with continuing operating leverage due to business model.

Q: How to think about the go-to-market model in infusion clinics and penetration of oncology opportunity?

A: Ristigo has potential for growth in infusion clinics with entry into this channel, which gives a head start and broader opportunity for oncology.

Q: Walk through guidance range detail?

A: Guidance range varies with prefill conversions, new drug clearances, Middle East timing, and oncology opportunities.

Q: Thoughts on Japan for 2026 guidance?

A: Japan has approved pumps and consumables, with pre-filled syringes important and expected growth with them.