KORU Medical Systems (KRMD) Piper Sandler 37th Annual Healthcare Conference summary

Strategic growth drivers

• Achieved over 20% year-to-date growth, driven by international expansion and prefill technology adoption.

• U.S. business outperformed the market, with primary immune deficiency patient growth of 8%-10% and U.S. revenue up 10%-15%.

• Four new drugs expected to be added to the label between early and mid-2026, expanding patient reach.

• Oncology pilot study showed 97% nurse preference, with a 510(k) submission by year-end and market launch in H2 2026.

• New pump filing anticipated in H1 2026, targeting incremental share and higher ASP in both U.S. and international markets.

Market outlook and opportunities

• U.S. SCIg market projected to grow 8%-10%, with only 20% of patients on subcutaneous therapy, leaving significant room for conversion.

• Secondary immunodeficiency trials by all major players expected to conclude in 2027, potentially doubling the addressable patient population.

• European market growth driven by prefill expansion, with five new markets expected to convert in 2026, two of which are larger than the initial converted market.

• International segment projected to grow over 30% in 2026, with prefill expansion as a key lever.

Competitive landscape

• U.S. competition centers on a single mechanical pump competitor, while Europe is dominated by electronic pumps that lack compatibility with prefills.

• In the large-volume subcutaneous space, the main competitor is Enable, but the platform offers lower cost per use and a larger installed base.

• More competitors are seen as positive for driving adoption of subcutaneous therapy.