Protagonist Therapeutics (PTGX) Q4 2025 earnings summary

Executive summary

• NDA for rusfertide submitted to FDA; potential approval and launch expected this year.

• Anticipated opt-out of 50:50 profit/loss sharing for rusfertide with Takeda in Q2 2026.

• U.S. regulatory decision for ICOTYDE expected in 2026, with potential launch this year.

• Multiple Phase 3 outcomes and two NDA filings achieved in 2025.

• Expanded preclinical pipeline with new wholly owned candidates targeting obesity and iron disorders.

Financial highlights

• Cash, cash equivalents, and marketable securities totaled $646 million as of December 31, 2025, up from $559.2 million a year earlier.

• License and collaboration revenue dropped to $7.4 million in Q4 2025 from $170.6 million in Q4 2024; full year revenue fell to $46.0 million from $434.4 million year-over-year.

• Net loss of $44.4 million ($0.69 per share) in Q4 2025 vs. net income of $131.7 million ($2.11 per share) in Q4 2024.

• Full year net loss of $130.1 million ($2.05 per share) in 2025 vs. net income of $275.2 million ($4.47 per share) in 2024.

• Research and development expenses increased by $11.5 million in Q4 and $21.2 million for the full year, driven by drug discovery and preclinical research.

Outlook and guidance

• Cash runway expected through at least the end of 2028.

• Phase 1 study of PN-881 expected to complete by mid-2026.

• Regulatory and commercial milestones for ICOTYDE and rusfertide anticipated in the next 12–24 months.