Protagonist Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 5 November 2026: press release. Guidance figures: 1 new, 4 kept. The quarter’s numbers.

Read the filing

Key takeaways

• Revenue rose on Takeda payments: License and collaboration revenue was $274.4 million, against $4.7 million a year earlier. Most of it was $266.6 million of proportional recognition from the $275.0 million Takeda payments. Source
• Net income reversed to a profit: Net income was $220.0 million, or $3.07 per diluted share, against a net loss of $39.3 million, or $0.62 per share, in the third quarter of 2025. Source
• MIMRYLO approved for polycythemia vera: Takeda received FDA approval for MIMRYLO (rusfertide) for erythrocytosis in adults with polycythemia vera on August 28. MIMRYLO was also approved in the United Arab Emirates on September 30, 2026. Source
• PN-881 Phase 1 completed, Phase 2b next: The PN-881 Phase 1 study is complete, with 24-hour trough levels several-fold above targeted IC90 values and no serious adverse events. A comprehensive Phase 2b psoriasis study is planned for early Q1 2027. Source
• PN-477 shifted to oral form: After Phase 1 results for the subcutaneous PN-477sc, the company prioritized the oral PN-477o program, with Phase 1 start expected in the first half of 2027. Source
• Cash rose to $834.6 million: Cash, cash equivalents and marketable securities were $834.6 million at September 30, 2026, against $646.0 million at December 31, 2025. Source
• $300 million buyback authorized: The Board authorized repurchases of up to $300 million of common stock, announced on September 8, 2026. Source

“The third quarter was a defining period for Protagonist, with FDA approval of MIMRYLO, our second approval this year for a first-in-class peptide drug”

Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics

Guidance

What changed from last quarter

• New: FDA approved MIMRYLO for erythrocytosis in adults with polycythemia vera. Source
• New: Share repurchase program of up to $300 million authorized. Source
• New: Development priority moved from subcutaneous PN-477sc to oral PN-477o. Source
• New: ICOTYDE received approvals in China, Japan and the European Union in the quarter. Source
• New: PN-881 Phase 1 study completed. Source

Results and growth drivers

• Revenue rose on Takeda payments: License and collaboration revenue was $274.4 million, against $4.7 million a year earlier. Most of it was $266.6 million of proportional recognition from the $275.0 million Takeda payments. Source
• Net income reversed to a profit: Net income was $220.0 million, or $3.07 per diluted share, against a net loss of $39.3 million, or $0.62 per share, in the third quarter of 2025. Source
• Nine-month revenue and income: Nine-month revenue was $544.3 million and net income was $386.6 million, or $5.43 per diluted share, against a net loss of $85.8 million a year earlier. Source
• Takeda cash received in October: The $275.0 million Takeda payments were received in cash in October 2026, after quarter end. The remaining $7.8 million of quarterly revenue came from development services and other revenues. Source

Partnered products and royalties

• MIMRYLO approved for polycythemia vera: Takeda received FDA approval for MIMRYLO (rusfertide) for erythrocytosis in adults with polycythemia vera on August 28. MIMRYLO was also approved in the United Arab Emirates on September 30, 2026. Source
• Takeda royalty terms and milestones: Protagonist is eligible for tiered royalties of 14% to 29% on worldwide MIMRYLO net sales, about 21% weighted-average at $1.5 billion in annual sales. It is also eligible for up to an additional $875 million in potential future milestones. Source
• ICOTYDE approved in three more regions: ICOTYDE received approvals in China, Japan and the European Union during the third quarter, following U.S. FDA approval in March 2026. Johnson & Johnson leads commercialization under the collaboration. Source
• J&J royalties on ICOTYDE sales: Protagonist receives tiered royalties of 6% to 10% on ICOTYDE global net sales, about 7.25% weighted-average at $4 billion in annual sales. It is eligible for up to $580 million in further milestones. Source

“The partnerships are fueling an accelerating revenue engine, which provides the flexibility to fund the next generation of wholly owned programs emerging from our platform, and to return meaningful capital to shareholders through a share repurchase program.”

Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics

Trial data and publications

• VERIFY results published in journal: Results from the pivotal Phase 3 VERIFY study were published in the Journal of Clinical Oncology on October 13, 2026. Source
• ANTHEM-UC results in NEJM: Phase 2 ANTHEM-UC results for ICOTYDE were published in the New England Journal of Medicine on October 14, 2026. Source
• Two-year ICOTYDE psoriasis data: Johnson & Johnson presented two-year Phase 3 ICONIC-TOTAL and ICONIC-LEAD results in September and October 2026, covering responses through Week 112 and safety in adults and adolescents. Source

Wholly owned pipeline and strategy

• PN-881 Phase 1 completed, Phase 2b next: The PN-881 Phase 1 study is complete, with 24-hour trough levels several-fold above targeted IC90 values and no serious adverse events. A comprehensive Phase 2b psoriasis study is planned for early Q1 2027. Source
• PN-477 shifted to oral form: After Phase 1 results for the subcutaneous PN-477sc, the company prioritized the oral PN-477o program, with Phase 1 start expected in the first half of 2027. Source
• PN-8047 and PN-458o timelines: PN-8047, an oral hepcidin functional mimetic for PV, is in IND-enabling studies with Phase 1 start in Q1 2027. PN-458o is in IND-enabling studies with Phase 1 start in the second half of 2027. Source
• Discovery work on oral peptides: Discovery programs continue for an oral IL-4Rα antagonist and for amylin-based mono- and poly-agonists. Source

“MIMRYLO reflects years of disciplined scientific dedication and clinical execution, and together with ICOTYDE, provides immensely important validation”

Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics

Costs, margins and operating income

• R&D expense rose to $41.3 million: Quarterly R&D expense was $41.3 million, against $40.0 million a year earlier. Clinical and discovery spending increases were partly offset by lower rusfertide VERIFY trial expense. Source
• R&D expected to rise through year-end: R&D expense is expected to rise for the rest of 2026. Drivers named include PN-881 Phase 2 work, clinical manufacturing and CMC activities, discovery programs and headcount. Source
• G&A and stock compensation rose: G&A expense was $13.7 million, against $11.1 million a year earlier, mainly from stock-based compensation and personnel costs. Stock-based compensation totaled $14.4 million in the quarter. Source
• Income tax expense appeared this quarter: Income tax expense was $6.6 million in the third quarter of 2026, against none in the third quarter of 2025. Source

Capital, cash and share repurchase

• Cash rose to $834.6 million: Cash, cash equivalents and marketable securities were $834.6 million at September 30, 2026, against $646.0 million at December 31, 2025. Source
• $300 million buyback authorized: The Board authorized repurchases of up to $300 million of common stock, announced on September 8, 2026. Source
• Buyback funding sources named: Repurchases are to be funded from cash and marketable securities, plus royalties and other payments under the Takeda and Johnson & Johnson collaborations. Source
• Diluted share count increased: Weighted-average diluted shares were 71.7 million in the quarter, against 63.8 million in the third quarter of 2025, a period with a net loss. Source

Coming up, as management said on 5 November 2026

• PN-881 Phase 2b study to start: Comprehensive Phase 2b dose range-finding study in plaque psoriasis is planned to initiate in early Q1 2027. Source
• PN-881 Phase 1 data at a meeting: Phase 1 PN-881 data are expected to be presented at a future medical meeting. No date is given. Source
• PN-477o Phase 1 to start: Phase 1 study of the oral PN-477o is anticipated to start in the first half of 2027. Source
• PN-8047 Phase 1 to start: Phase 1 initiation for PN-8047 is anticipated in Q1 2027, following ongoing IND-enabling studies. Source
• Future Takeda milestone payments: Protagonist is eligible for up to an additional $875 million in potential future milestone payments under the Takeda arrangement. Source
• Repurchase timing set by conditions: Timing and amount of any repurchases will depend on market conditions and other factors. No repurchase amounts are given. Source

Figures management reported

Risks management discussed

• Financial: Planned R&D includes at-risk manufacturing and CMC spending to be ready for PN-477o, PN-458 and PN-8047 before they enter clinical development. Source
• Financial: Timing and amount of share repurchases depend on market conditions and other factors. Source

Earlier plans management reported on

• Not stated: FDA approval of MIMRYLO was announced on August 28, 2026, in the month of the PDUFA goal date given in the prior release.
• Not stated: The prior release expected PN-881 Phase 2 initiation in early Q1 2027. This release again plans the Phase 2b start for early Q1 2027.
• Not stated: The prior release expected R&D to increase significantly in the second half of 2026. This release states R&D will increase for the remainder of the year.

Other quarters

• Q2 FY2026 earnings call
• Q1 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.