Protagonist Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance

• License and collaboration revenue for the three months ended September 30, 2026, was $274.4 million, compared to $4.7 million in the same period in 2025.
• License and collaboration revenue for the nine months ended September 30, 2026, was $544.3 million, compared to $38.6 million in the same period in 2025.
• Net income for the three months ended September 30, 2026, was $220.0 million ($3.32 basic EPS, $3.07 diluted EPS), compared to a net loss of $39.3 million ($0.62 basic and diluted EPS) in 2025.
• Net income for the nine months ended September 30, 2026, was $386.6 million ($5.88 basic EPS, $5.43 diluted EPS), compared to a net loss of $85.8 million ($1.35 basic and diluted EPS) in 2025.
• Research and development expense for the three months ended September 30, 2026, was $41.3 million, compared to $40.0 million in 2025.
• Research and development expense for the nine months ended September 30, 2026, was $130.1 million, compared to $112.9 million in 2025.
• General and administrative expense for the three months ended September 30, 2026, was $13.7 million, compared to $11.1 million in 2025.
• General and administrative expense for the nine months ended September 30, 2026, was $39.6 million, compared to $33.4 million in 2025.
• Cash, cash equivalents, and marketable securities totaled $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.
• Total stockholders' equity was $1.08 billion as of September 30, 2026, compared to $614.7 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.
• Stock-based compensation expense for the three months ended September 30, 2026, was $14.4 million, compared to $10.6 million in 2025.
• Stock-based compensation expense for the nine months ended September 30, 2026, was $42.9 million, compared to $35.3 million in 2025.

Guidance and Future Outlook

• R&D expenses are expected to increase for the remainder of 2026 compared to prior quarters in 2026.
• The increase in R&D expenses is driven by the advancement of PN-881 into a Phase 2 psoriasis program, planned investments in clinical manufacturing and CMC activities, additional pre-clinical discovery programs, and increases in headcount and stock-based compensation.
• Phase 2b dose range-finding study for PN-881 is planned to initiate in early Q1 2027.
• Phase 1 study of oral PN-477o is anticipated in the first half of 2027.
• Phase 1 initiation for PN-458o is anticipated in the second half of 2027.
• Phase 1 initiation for PN-8047 is anticipated in Q1 2027.

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 holds tiered royalties on MIMRYLO ranging from 14% to 29%, with an approximate 21% weighted-average royalty rate at $1.5 billion in annual net sales, and is eligible for up to $875 million in additional 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.
• Protagonist receives tiered royalties on ICOTYDE ranging from 6% to 10%, with an approximate 7.25% weighted-average royalty rate at $4 billion in annual net sales and a 10% tier for incremental annual sales above $4 billion.
• Protagonist is eligible for up to $580 million in additional potential future milestone payments for ICOTYDE.
• ICOTYDE is in development for psoriatic arthritis, ulcerative colitis, and Crohn's disease.
• PN-881, an oral IL-17 antagonist, achieved 24-hour trough concentrations several-fold above targeted IC90 values in Phase 1 and was generally well tolerated with no serious adverse events.
• PN-477o (oral triple GLP-1/GIP/GCG agonist) showed positive dose-related pharmacokinetic, pharmacodynamic, and clinical activity in Phase 1; the Company is prioritizing the oral program over the subcutaneous version.
• PN-458o (dual GLP-1/GIP agonist) is in IND-enabling studies.
• PN-8047 (oral small molecule hepcidin functional mimetic) is in IND-enabling studies.
• Discovery programs include an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.

Market and Competitive Landscape

• MIMRYLO is the first and only hepcidin mimetic peptide therapy approved for polycythemia vera.
• ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor.
• Johnson & Johnson presented two-year Phase 3 results (ICONIC-TOTAL and ICONIC-LEAD) in September and October 2026 demonstrating sustained responses through Week 112 and a favorable safety profile in adults and adolescents with plaque psoriasis.
• 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.

Risks and Challenges

• Forward-looking statements regarding future royalty and milestone payments, clinical development timing and results, and development expense levels are subject to risks and uncertainties.
• Risks include the ability to develop and commercialize product candidates, obtain regulatory approvals, operate in a competitive industry, compete against competitors with greater resources, and obtain and protect intellectual property rights.
• Actual results may differ materially from anticipated results due to these risks.

Management Commentary and Tone

• CEO Dinesh V. Patel described the third quarter as a "defining period" for the company.
• Management highlighted FDA approval of MIMRYLO and the strong commercial launch of ICOTYDE as validation of their innovative peptide therapeutics expertise and pharma-biotech partnership model.
• Management stated that partnerships are fueling an accelerating revenue engine, providing flexibility to fund next-generation programs and return capital to shareholders.

Other Key Points

• On September 8, 2026, the Board of Directors authorized a $300 million share repurchase program.
• Repurchases will be funded from cash, cash equivalents, marketable securities, and royalties/payments from Takeda (MIMRYLO) and Johnson & Johnson (ICOTYDE).
• The timing and amount of repurchases depend on market conditions, alternative capital deployment opportunities, and other factors.
• Takeda holds exclusive worldwide development and commercialization rights to MIMRYLO following Protagonist's April 2026 opt-out election.
• Johnson & Johnson assumed responsibility for further clinical and regulatory development and commercialization of ICOTYDE after Phase 1.