Protagonist Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• License and collaboration revenue was $274.4 million for the three months ended September 30, 2026, compared to $4.7 million in the same period of 2025.
• License and collaboration revenue totaled $544.3 million for the nine months ended September 30, 2026, compared to $38.6 million in the same period of 2025.
• Net income was $220.0 million ($3.32 basic, $3.07 diluted per share) for the third quarter of 2026, reversing a net loss of $39.3 million ($0.62 per share) in the prior year period.
• Net income was $386.6 million ($5.88 basic, $5.43 diluted per share) for the nine months ended September 30, 2026, reversing a net loss of $85.8 million ($1.35 per share) in the prior year period.
• Research and development expense was $41.3 million for the three months ended September 30, 2026, up from $40.0 million in 2025, and $130.1 million for the nine months ended September 30, 2026, up from $112.9 million in 2025.
• General and administrative expense was $13.7 million for the three months ended September 30, 2026, up from $11.1 million in 2025, and $39.6 million for the nine months ended September 30, 2026, up from $33.4 million in 2025.
• Cash, cash equivalents, and marketable securities were $834.6 million as of September 30, 2026, compared to $646.0 million as of December 31, 2025.
• Working capital was $1.05 billion as of September 30, 2026, compared to $532.1 million as of December 31, 2025.
• Total assets were $1.15 billion as of September 30, 2026, compared to $668.2 million as of December 31, 2025.
• Deferred revenue was $16.3 million as of September 30, 2026, compared to $9.6 million as of December 31, 2025.
• Accumulated deficit was $(84.0) million as of September 30, 2026, compared to $(470.7) million as of December 31, 2025.
• Total stockholders' equity was $1.08 billion as of September 30, 2026, compared to $614.7 million as of December 31, 2025.
• Stock-based compensation expense was $14.4 million for the three months ended September 30, 2026, compared to $10.6 million in 2025, and $42.9 million for the nine months ended September 30, 2026, compared to $35.3 million in 2025.

Business Segments and Product Lines:

• MIMRYLO (rusfertide) received FDA approval on August 28, 2026, for the treatment of erythrocytosis in adults with polycythemia vera, triggering $275 million in payments to Protagonist ($200 million opt-out payment and $75 million approval milestone).
• MIMRYLO was also approved in the United Arab Emirates on September 30, 2026.
• Protagonist is eligible for tiered royalties on MIMRYLO ranging from 14% to 29% on worldwide net sales, with an approximate 21% weighted-average royalty rate at $1.5 billion in annual net sales, and up to $875 million in potential future milestone payments.
• ICOTYDE (icotrokinra) received regulatory approvals in China, Japan, and the European Union during the third quarter of 2026, following U.S. FDA approval in March 2026.
• ICOTYDE represents its second full quarter of U.S. commercial sales under the collaboration with Johnson & Johnson.
• Protagonist receives tiered royalties on ICOTYDE ranging from 6% to 10% on global net sales, with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier for incremental sales above $4 billion.
• Protagonist is eligible for up to $580 million in potential future milestone payments related to ICOTYDE.
• A comprehensive Phase 2b program for PN-881 (oral IL-17 antagonist for psoriasis) is planned to initiate in early Q1 2027.
• Development of PN-477o (oral triple GLP-1/GIP/GCG agonist for obesity) is prioritized over the subcutaneous version, with Phase 1 initiation anticipated in the first half of 2027.
• IND-enabling studies are ongoing for PN-458o (dual GLP-1/GIP agonist for obesity) with Phase 1 initiation anticipated in the second half of 2027.
• IND-enabling studies are ongoing for PN-8047 (oral small molecule hepcidin functional mimetic for PV) with Phase 1 initiation anticipated in Q1 2027.
• Results from the pivotal Phase 3 VERIFY study for MIMRYLO were published in the Journal of Clinical Oncology on October 13, 2026.
• Results from the Phase 2 ANTHEM-UC study for ICOTYDE were published in the New England Journal of Medicine on October 14, 2026.
• Johnson & Johnson presented two-year Phase 3 results from the ICONIC-TOTAL and ICONIC-LEAD studies in September and October 2026, demonstrating sustained responses and a favorable safety profile.

Management Commentary and Tone:

• CEO Dinesh V. Patel described the third quarter as a "defining period" driven by FDA approval of MIMRYLO and the strong commercial launch of ICOTYDE.
• Management stated that partnerships are fueling an "accelerating revenue engine" that provides flexibility to fund wholly owned programs and return capital to shareholders.
• Management expects R&D expenses to increase for the remainder of 2026 compared to prior quarters in 2026, driven by the advancement of PN-881, clinical manufacturing investments, and increased headcount and stock-based compensation.

Other Key Points:

• On September 8, 2026, the Board of Directors authorized a share repurchase program allowing the Company to repurchase up to $300 million of its outstanding common stock.
• Repurchases are intended to be funded from cash, cash equivalents, marketable securities, and royalties received from collaboration arrangements with Takeda and Johnson & Johnson.
• ICOTYDE is in development for additional immune-mediated diseases including psoriatic arthritis, ulcerative colitis, and Crohn's disease.
• The Company continues to advance discovery programs for oral peptides, including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.