Xspray Pharma (XSPRAY) investor relations material

Executive summary

• Q3 remained pre-commercial, with net sales of SEK 0 and continued losses; focus stayed on regulatory resubmissions and launch readiness for Dasynoc and Nilopki.

• FDA review raised no questions on Dasynoc clinical data, bioequivalence or stability; remaining issues center on commercial batch data and the third-party manufacturing facility.

Financial highlights

• Q3 2026 operating loss was SEK 36.625m, loss before tax SEK 39.323m and net loss SEK 39.312m, versus SEK 42.651m, SEK 47.332m and SEK 47.308m, respectively, in Q3 2025.

• Q3 EPS was SEK -0.83 versus SEK -1.25; 9M net loss was SEK 114.454m versus SEK 134.455m, with EPS of SEK -2.54 versus SEK -3.60.

• 9M operating expenses declined 15% YoY; R&D expenditure totaled SEK 26.748m, of which SEK 6.871m was expensed and SEK 19.877m capitalized.

• Cash and cash equivalents were SEK 88.840m at September 30, 2026, versus SEK 197.984m a year earlier; total assets were SEK 718.884m.

Outlook and guidance

• Both NDAs are targeted for resubmission in Q4 2026; company-controlled work includes additional consecutive commercial-scale batches and related analytical work.

• FDA clearance of the manufacturing facility remains required for approval; subject to resubmission, FDA review and resolution of facility matters, launch is planned for the quarter immediately following approval.

• Nilopki work includes dose correspondence with Tasigna at the relevant dose for a defined patient subgroup, plus product information and manufacturing documentation.