Xspray Pharma (XSPRAY) BioStock Life Science Summit 2026 summary

Lucentis biosimilar and U.S. launch

• Ximluci has been commercialized by STADA in 24 countries across Europe and MENA for three years; profit sharing is 50/50, with ~SEK 50m annually.

• The Lucentis biosimilar received FDA approval under the U.S. brand Lucamzi; launch with Valorum is targeted for mid-2027.

• U.S. launch preparations include applying for a Q code and producing commercial inventory; Medicare Part B reimbursement was cited as favorable for new entrants.

• ~SEK 150m of inventory is expected to convert to cash during the remainder of 2026 and through 2027.

Opdivo biosimilar

• Xdivane targets the Opdivo market, with U.S. patent expiration in December 2028; the broader Opdivo and Keytruda market was cited at $40bn in sales.

• The program was described as second in the race behind Amgen, with a goal of launching on day one after patent expiration; Intas and its Accord subsidiary are commercialization partners.

• The pivotal melanoma trial enrolled 340 patients and completed recruitment; readout is expected in Q2 2027, followed shortly by an FDA BLA submission.

• Manufacturing uses two European sites with a top-10 global contract manufacturer; prior FDA inspection experience was cited as reducing GMP-related approval risk.

• An external valuation indicated potential peak profit sharing above EUR 100m.

Darzalex biosimilar

• Xdarzane is in early development and targets the European patent expiration in 2031; the originator product was cited at $14bn.

• JOINN Biologics, a Chinese CMO, is supporting development with a targeted cost-competitive production process; a commercialization deal is being pursued over the next 12 months.