Kyntra Bio (KYNB) Q3 2024 earnings summary

Executive summary

• Q3 2024 revenue rose 15% year-over-year to $46.3M, driven by 57% growth in China Roxadustat sales and 34% volume growth, while net loss narrowed to $17.1M from $63.6M due to significant cost reductions and a 75% U.S. workforce reduction.

• Focused on advancing FG-3246 and FG-3180 in metastatic castration-resistant prostate cancer (mCRPC), with positive Phase 1 data and upcoming Phase 2 trials.

• Regained U.S. and ROW rights to Roxadustat, opening new development and partnership opportunities.

• Roxadustat remains the primary value driver, maintaining category leadership in China and ongoing global commercialization through partnerships.

• Cost reduction plan in the U.S. is on track for substantial completion by year-end 2024.

Financial highlights

• Q3 2024 total revenue was $46.3M, up 15% year-over-year; Roxadustat China net product revenue was $46.2M, up 57% year-over-year; total Roxadustat net sales in China (including JV/JDE) reached $96.6M, a 25% increase year-over-year.

• Net loss for Q3 2024 was $17.1M ($0.17/share), a significant improvement from $63.6M ($0.65/share) in Q3 2023.

• Operating costs and expenses dropped 39% year-over-year to $63.1M; excluding restructuring, $44.5M.

• R&D expenses fell 65% to $21.7M; SG&A expenses decreased 31% to $17.6M.

• Cash, cash equivalents, investments, and accounts receivable totaled $160.0M at quarter end.

Outlook and guidance

• Full-year 2024 China net product revenue guidance reiterated at $135–$150M (U.S. GAAP); Roxadustat China net sales guidance raised to $330–$350M for 2024.

• Cash, cash equivalents, and accounts receivable of $160M expected to fund operations into 2026, assuming additional repatriation from China.

• Approval decision for Roxadustat in chemotherapy-induced anemia in China anticipated in early 2025, with a potential $10M milestone.

• Topline results from Phase 2 FG-3246/enzalutamide study in mCRPC expected 1H 2025; Phase 2 monotherapy trial to start 1Q 2025.

• Substantial doubt exists about ability to continue as a going concern within 12 months unless additional U.S. capital is raised or China cash is repatriated.