KORU Medical Systems (KRMD) investor relations material

Q3 performance and outlook

• Q3 growth was 11%; EBITDA-positive results marked a second consecutive quarter of positive EBITDA. Over 90% of revenue supports immunoglobulin patients.

• New international agreements and progress on execution helped position the business for a solid Q4 close.

• FY2026 revenue guidance was raised at the low end to $48 million–$48.5 million.

• No specific 2027 financial guidance was given; management cited domestic growth in the mid-teens versus market growth of 8%–10%, alongside international expansion.

Growth strategy and market expansion

• Priorities include expanding immunoglobulin use domestically and internationally and bringing the delivery system onto additional therapies, including rare diseases and potentially oncology.

• International market share was estimated at ~20%; management aims to grow through tender wins and account-level distribution, with patient starts creating recurring revenue over therapy duration.

• A pan-European agreement provides access through a partner spanning drug wholesaling, pharmacy and home care; a new African partner extends access for immunoglobulin patients, with other adjacencies under exploration.

• Tender markets are won with pharmaceutical partners bidding by geography; competitive markets are developed account by account through pharmacies, home care, wholesalers and distributors.

New therapies and pipeline

• Three specialty pharmacies completed clinical evaluations and selected the delivery system for UCB’s RYSTIGGO; revenue could reach $1 million over the next few years as patient starts grow.

• An enzyme replacement therapy partner advanced a Phase III trial and dosed patients with the Freedom Infusion System; commercialization is anticipated toward late 2028 or 2029, subject to trial and regulatory progress.

• A nephrology asset is starting Phase III; if successful, commercial treatment could begin in 2030–2031. An additional statement of work supports international expansion.

• A revised oncology entry path is being pursued with a partner after the PHESGO route did not proceed because the partner did not want label updates; further details are planned for H1 2027.

• Management sees RYSTIGGO’s clinic and home-care administration as a potential model for oncology, including possible future home administration.