Xspray Pharma (XSPRAY) Q3 2024 earnings summary

Executive summary

• Focused on resubmitting NDA for DasynocⓇ after FDA's complete response letter; launch now expected in 2025 pending approval.

• Positive clinical data for XS003 nilotinib, showing bioequivalence to TasignaⓇ at over 50% reduced dose.

• Reduced negative cash flow from operating activities due to postponed commercialization activities.

• Announced SEK 135 million rights issue and SEK 100 million loan to fund launch preparations and further development.

Financial highlights

• Net sales were SEK 0 thousand for Q3 and Jan–Sep 2024 (unchanged year-over-year).

• Loss before tax for Q3 was SEK -82,272 thousand (vs. -38,942), and for Jan–Sep SEK -203,672 thousand (vs. -125,171).

• Earnings per share before dilution for Q3 was SEK -2.44 (vs. -1.59); Jan–Sep was SEK -6.24 (vs. -5.11).

• Cash and cash equivalents at period end were SEK 74,759 thousand (vs. 132,480).

• Equity/assets ratio was 87.7% (vs. 93.9%).

Outlook and guidance

• NDA resubmission for DasynocⓇ planned for Q4 2024; FDA decision expected within 2–6 months post-resubmission.

• Launch of DasynocⓇ in the US anticipated in Q1 or Q2 2025, depending on FDA review class.

• Application for XS003 nilotinib approval expected in H1 2025.

• Rights issue and loan proceeds to fund launch and ongoing development.