Protagonist Reports Third Quarter 2026 Financial Results and Provides Corporate Update
MIMRYLO approval triggered $275 million in payments, while both commercial partnerships offer royalties and potential future milestones.
Sentiment and the balance of points
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Rhea-AI Summary
Protagonist Therapeutics (Nasdaq: PTGX) reported third-quarter 2026 net income of $220.015 million, reversing a loss in the prior-year quarter. License and collaboration revenue reached $274.410 million versus $4.712 million a year earlier; diluted earnings were $3.07 versus a $0.62 loss per share.
FDA approval of MIMRYLO for erythrocytosis in adults with polycythemia vera triggered $275 million in payments, received in October. Takeda holds exclusive worldwide rights. ICOTYDE gained psoriasis approvals in China, Japan and the European Union. Cash, cash equivalents and marketable securities totaled $834.621 million at September 30, versus $646.002 million at year-end 2025.
The board authorized up to $300 million in share repurchases. Protagonist plans to start PN-881 Phase 2b testing in early Q1 2027 and expects three other clinical study starts during 2027. Research and development expenses are expected to rise for the remainder of 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointQ3 license and collaboration revenue rose to $274.410 million from $4.712 million a year earlier.
- Moderate pointQ3 net income reached $220.015 million, versus a $39.339 million loss a year earlier.
- Moderate pointCash, equivalents and marketable securities rose to $834.621 million at September 30, from $646.002 million at year-end.
- Moderate pointMIMRYLO gained FDA approval for erythrocytosis in adults with polycythemia vera and approval in the United Arab Emirates.
- Moderate pointMIMRYLO approval triggered $275 million: a $200 million opt-out payment and $75 million milestone, received in October.
- Moderate point. Forward-looking: it has not happened yet and may not happen.MIMRYLO offers 14%–29% tiered royalties and eligibility for up to an additional $875 million in potential milestones.
- Moderate pointICOTYDE gained psoriasis approvals in China, Japan and the European Union during Q3.
- Moderate point. Forward-looking: it has not happened yet and may not happen.ICOTYDE offers 6%–10% tiered royalties and eligibility for up to an additional $580 million in potential milestones.
- Moderate point. Forward-looking: it has not happened yet and may not happen.The board authorized repurchases of up to $300 million of common stock.
15 minor points
- Minor pointQ3 basic/diluted earnings were $3.32/$3.07 per share, versus losses of $0.62/$0.62 a year earlier.
- Minor pointNine-month revenue rose to $544.253 million, versus $38.579 million in 2025.
- Minor pointNine-month net income reached $386.647 million, versus an $85.765 million loss in 2025.
- Minor pointNine-month basic/diluted earnings reached $5.88/$5.43, versus losses of $1.35/$1.35 per share in 2025.
- Minor pointOperating income reached $218.332 million in Q3 and $373.450 million year-to-date, reversing prior-year operating losses.
- Minor pointWorking capital rose to $1,045.595 million at September 30, versus $532.133 million at year-end 2025.
- Minor pointStockholders’ equity rose to $1,084.910 million at September 30, versus $614.707 million at year-end 2025.
- Minor pointICOTYDE Phase 3 results showed sustained responses through Week 112 and a continued favorable safety profile.
- Minor pointICOTYDE development continues for psoriatic arthritis, ulcerative colitis and Crohn’s disease.
- Minor pointPN-881 completed Phase 1, achieving targeted exposure with once-daily dosing and no serious adverse events.
- Minor point. Forward-looking: it has not happened yet and may not happen.PN-881 Phase 2b dose range-finding testing in plaque psoriasis is planned for early Q1 2027.
- Minor pointPN-477sc Phase 1 showed dose-related pharmacokinetic, pharmacodynamic and clinical activity; Protagonist is prioritizing oral PN-477o.
- Minor point. Forward-looking: it has not happened yet and may not happen.PN-477o Phase 1 initiation is anticipated in the first half of 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.PN-458o preparatory studies continue, with Phase 1 initiation anticipated in the second half of 2027.
- Minor point. Forward-looking: it has not happened yet and may not happen.PN-8047 preparatory studies continue, with Phase 1 initiation anticipated in Q1 2027.
Negative
- Moderate point. Forward-looking: it has not happened yet and may not happen.Protagonist expects higher research and development expenses for the remainder of 2026 versus prior 2026 quarters.
- Minor pointQ3 research and development expense rose to $41.274 million, from $40.003 million a year earlier.
- Minor pointNine-month research and development expense rose to $130.074 million, from $112.932 million in 2025.
- Minor point. Forward-looking: it has not happened yet and may not happen.Planned clinical manufacturing investments include at-risk expenditures to prepare additional programs for clinical development.
- Minor pointQ3 general and administrative expense rose to $13.704 million, from $11.130 million a year earlier.
4 minor points
- Minor pointNine-month general and administrative expense rose to $39.629 million, from $33.419 million in 2025.
- Minor pointCost of revenue was $1.100 million in Q3 and year-to-date, versus none in the corresponding 2025 periods.
- Minor pointIncome tax expense reached $6.556 million in Q3 versus none; nine-month expense reached $7.319 million versus $0.172 million.
- Minor pointNine-month interest income declined to $20.558 million, from $22.028 million in 2025.
News Explained
The release details sales-linked terms: Protagonist is eligible for tiered royalties on global net sales of
Key Figures
- Takeda payments triggered
- $275 million
- $200 million opt-out payment and $75 million approval milestone
- MIMRYLO royalties
- 14%–29%
- Tiered royalties on worldwide net sales
- Potential future MIMRYLO milestones
- Up to $875 million
- Additional potential payments to Protagonist
- Q3 license and collaboration revenue
- $274.4 million
- Third quarter 2026
- Q3 net income
- $220.0 million
- Third quarter 2026
- Cash, cash equivalents and marketable securities
- $834.6 million
- As of September 30, 2026
- Share repurchase authorization
- Up to $300 million
- Authorized by the board
Previous Earnings Reports
-
Outlined Takeda opt-out fee and milestone economics later triggered by MIMRYLO FDA approval.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
hepcidin mimetic medical
new drug application regulatory
pharmacokinetic medical
pharmacodynamic medical
ind-enabling regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
NEWARK, CA / ACCESS Newswire / November 5, 2026 / Protagonist Therapeutics (Nasdaq:PTGX) ("Protagonist" or "the Company") today reported financial results for the third quarter ended September 30, 2026, and provided a corporate update.
"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, and the continued strong commercial launch of ICOTYDE under our collaboration with Johnson & Johnson," said Dinesh V. Patel, PhD, President and Chief Executive Officer of Protagonist Therapeutics. "MIMRYLO reflects years of disciplined scientific dedication and clinical execution, and together with ICOTYDE, provides immensely important validation both of our innovative expertise in peptide therapeutics and of the successful pharma-biotech partnership model we have built around these two approved drugs. 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."
Third Quarter 2026 Recent Developments and Upcoming Milestones
MIMRYLO™ (rusfertide): Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera
- On August 28, Protagonist announced that its partner Takeda received U.S. Food and Drug Administration (FDA) approval of MIMRYLO for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is the first and only hepcidin mimetic peptide therapy approved for this indication. On September 30, 2026, MIMRYLO was also approved in the United Arab Emirates. Protagonist discovered MIMRYLO and had primary responsibility for its clinical development through its New Drug Application ("NDA") filing in December 2025.
- The FDA approval of MIMRYLO triggered
$275 million in payments to Protagonist, consisting of a$200 million opt-out payment and a$75 million approval milestone.
- Following Protagonist's April 2026 opt-out election, Takeda holds exclusive worldwide development and commercialization rights to MIMRYLO. Protagonist is eligible to receive tiered royalties ranging from
14% to29% on worldwide net sales, corresponding to an approximately21% weighted-average royalty rate at$1.5 billion in annual net sales. Protagonist is eligible for up to an additional$875 million in potential future milestone payments.
- On October 13, 2026, results from the pivotal Phase 3 VERIFY study were published in the Journal of Clinical Oncology. The article is available here.
ICOTYDE® (Icotrokinra): Oral IL-23 Receptor Antagonist
- During the third quarter, ICOTYDE received regulatory approvals in China, Japan and the European Union for the treatment of psoriasis, following U.S. FDA approval in March 2026. ICOTYDE is the first and only targeted oral peptide designed to precisely block the IL-23 receptor.
- On October 14, 2026, results from the Phase 2 ANTHEM-UC study were published in the New England Journal of Medicine. The article is available here.
- The third quarter of 2026 represents ICOTYDE's second full quarter of U.S. commercial sales. Under the collaboration with Johnson & Johnson, Protagonist receives tiered royalties ranging from
6% to10% on global net sales, with an approximate7.25% weighted-average royalty rate at$4 billion in annual net sales and a10% tier applying to incremental annual sales above$4 billion . Protagonist is eligible for up to an additional$580 million in potential future milestone payments.
- In September and October 2026, Johnson & Johnson presented two-year Phase 3 results from the ICONIC-TOTAL and ICONIC-LEAD studies. The results demonstrated sustained responses through Week 112 and a continued favorable safety profile in adults and adolescents with plaque psoriasis, including patients with disease affecting high-impact and difficult-to-treat areas.
- ICOTYDE is also in development for additional immune-mediated diseases, including psoriatic arthritis, ulcerative colitis and Crohn's disease.
Wholly-Owned Clinical and Discovery Programs
- PN-881 (oral IL-17 antagonist peptide for immune-mediated disease): The Phase 1 study of PN-881 has been completed. PN-881 achieved 24-hour trough concentrations several-fold above prospectively targeted IC90 values for IL-17AA, IL-17FF and IL-17AA+FF with once-daily oral dosing and was generally well tolerated, with no serious adverse events. Protagonist plans to initiate a comprehensive Phase 2b dose range-finding study in patients with plaque psoriasis in early Q1 2027. Phase 1 data are expected to be presented at a future medical meeting.
- PN-477 (triple GLP-1/GIP/GCG agonist peptide for obesity): In the subcutaneously administered PN-477sc Phase 1 SAD study we observed positive dose-related pharmacokinetic, pharmacodynamic and clinical activity. Based on these highly encouraging findings, the Company has made a strategic decision to prioritize the orally administered PN-477o clinical development program. Initiation of a Phase 1 study of oral PN-477o is anticipated in the first half of 2027.
- PN-458o (dual GLP-1/GIP agonist peptide for obesity): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in the second half of 2027.
- PN-8047 (oral small molecule hepcidin functional mimetic for PV): IND-enabling studies are ongoing, with Phase 1 initiation anticipated in Q1 2027.
- Discovery: The Company continues to advance high-priority discovery programs for oral peptides, including an oral IL-4Rα antagonist and amylin-based mono- and poly-agonists.
Share Repurchase Program
- On September 8, Protagonist announced that its Board of Directors authorized a share repurchase program under which the Company may repurchase up to
$300 million of its outstanding common stock. The Company intends to fund repurchases from its cash, cash equivalents and marketable securities, as well as royalties and other payments received under its collaboration arrangements with Takeda related to MIMRYLO and Johnson & Johnson related to ICOTYDE. The timing and amount of any repurchases will depend on market conditions, alternative capital deployment opportunities and other factors.
Third Quarter 2026 Financial Results
- Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2026, were
$834.6 million as compared to$646.0 million as of December 31, 2025.
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
(in thousands, except per share amounts) | 2026 | 2025 | 2026 | 2025 | ||||||||||||
License and collaboration revenue | $ | 274,410 | $ | 4,712 | $ | 544,253 | $ | 38,579 | ||||||||
Research and development expense | $ | 41,274 | $ | 40,003 | $ | 130,074 | $ | 112,932 | ||||||||
General and administrative expense | $ | 13,704 | $ | 11,130 | $ | 39,629 | $ | 33,419 | ||||||||
Income tax expense | $ | 6,556 | $ | -- | $ | 7,319 | $ | 172 | ||||||||
Net income (loss) | $ | 220,015 | $ | (39,339 | ) | $ | 386,647 | $ | (85,765 | ) | ||||||
Basic earnings (loss) per share | $ | 3.32 | $ | (0.62) | $ | 5.88 | $ | (1.35) | ||||||||
Diluted earnings (loss) per share | $ | 3.07 | $ | (0.62) | $ | 5.43 | $ | (1.35) | ||||||||
- License and Collaboration Revenue: License and collaboration revenue was
$274.4 million for the third quarter of 2026. This revenue was primarily driven by the proportional recognition of$266.6 million related to the$275.0 million earned from Takeda during the quarter. These payments, which were received in cash in October 2026, consisted of a further$200.0 million opt-out fee and a separate$75.0 million milestone triggered by the FDA approval of MIMRYLO. The remaining$7.8 million was derived from ongoing development services provided by us under the Takeda Collaboration Agreement, and other revenues.
- License and collaboration revenue was
$544.3 million for the nine months ended September 30, 2026. This cumulative revenue consisted primarily of$460.5 million related to total proportional revenue recognized from Takeda during those nine months. Additionally, the nine-month revenue includes$33.8 million derived from ongoing development services provided by us under the Takeda Collaboration Agreement, a$50.0 million milestone earned from Johnson & Johnson in Q1 2026 upon FDA approval of ICOTYDE, and other revenues.
| License and collaboration revenue of |
- Research and Development ("R&D") Expense: The increases in R&D expense from the prior year periods were primarily due to our clinical development and pre-clinical discovery programs, partially offset by decreases in rusfertide expenses related to the Phase 3 VERIFY clinical trial. We expect our R&D expenses to increase for the remainder of the year as compared to the prior quarters in 2026. The increase is expected to be driven primarily by the advancement of PN-881 into a comprehensive Phase 2 psoriasis program, planned investments in clinical manufacturing and CMC activities, including at-risk expenditures to ensure readiness for other programs as they advance into clinical development (PN-477o, PN-458, PN-8047), additional pre-clinical discovery programs, as well as an increase in headcount and stock-based compensation expense.
- General and Administrative ("G&A") Expense: The increases in G&A expense from the prior year periods were primarily due to increases in stock-based compensation and other personnel-related expenses.
- Net Income (Loss): Net income was
$220.0 million , or$3.32 per basic share and$3.07 per diluted share, for the third quarter of 2026 as compared to net loss of$39.3 million , or$0.62 per basic and diluted share, for the third quarter of 2025. Net income was$386.6 million , or$5.88 per basic share and$5.43 per diluted share, for the nine months ended September 30, 2026, as compared to net loss of$85.8 million , or$1.35 per basic and diluted share, for the nine months ended September 30, 2025.
About Protagonist
Protagonist Therapeutics is a biopharmaceutical company built on a proprietary peptide technology platform that has now produced two FDA-approved, first-in-class medicines, generating royalties and milestones from global commercial partnerships with Johnson and Johnson and Takeda Pharmaceutical Company Limited. ICOTYDE® (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 (IL-23) receptor. ICOTYDE was launched in the U.S. in March 2026 for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older and is in Phase 3 development for psoriatic arthritis, ulcerative colitis and Crohn's disease. ICOTYDE was jointly discovered by Protagonist and Johnson & Johnson scientists, with Protagonist having primary responsibility for the development of ICOTYDE through Phase 1, and Johnson & Johnson assuming responsibility for further clinical and regulatory development and commercialization. Protagonist also discovered and led research and development through Phase 3 for MIMRYLO™ (rusfertide), a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceutical Company Limited for worldwide commercialization. MIMRYLO is approved in the U.S. for the treatment of erythrocytosis in adults with PV. The Company also has a number of clinical and preclinical programs based on clinically and commercially validated targets and addressing unmet medical needs, including an oral IL-17 antagonist peptide, anti-obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin discovery programs.
More information on Protagonist, its pipeline drug candidates, and clinical studies can be found on the Company's website at https://www.protagonist-inc.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the company's expectations related to future royalty and milestone payments pursuant to the Company's collaboration arrangements, the timing and results of our clinical development programs, and the level of our future development expenses. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events, or otherwise, after the date of this press release.
Investor Relations Contact
Corey Davis, Ph.D.
LifeSci Advisors
cdavis@lifesciadvisors.com
+1 212 915 2577
Media Relations Contact
Virginia Amann
ENTENTE Network of Companies
virginiaamann@ententeinc.com
+1 833 500 0061 ext 1
PROTAGONIST THERAPEUTICS, INC.
Consolidated Statements of Operations
(Amounts in thousands except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
License and collaboration revenue | $ | 274,410 | $ | 4,712 | $ | 544,253 | $ | 38,579 | ||||||||
Operating expense: | ||||||||||||||||
Cost of revenue | 1,100 | - | 1,100 | - | ||||||||||||
Research and development (1) | 41,274 | 40,003 | 130,074 | 112,932 | ||||||||||||
General and administrative (1) | 13,704 | 11,130 | 39,629 | 33,419 | ||||||||||||
Total operating expense | 56,078 | 51,133 | 170,803 | 146,351 | ||||||||||||
Income (loss) from operations | 218,332 | (46,421 | ) | 373,450 | (107,772 | ) | ||||||||||
Interest income | 8,253 | 7,049 | 20,558 | 22,028 | ||||||||||||
Other (expense) income, net | (14 | ) | 33 | (42 | ) | 151 | ||||||||||
Income (loss) before income tax expense | 226,571 | (39,339 | ) | 393,966 | (85,593 | ) | ||||||||||
Income tax expense | 6,556 | - | 7,319 | 172 | ||||||||||||
Net income (loss) | $ | 220,015 | $ | (39,339 | ) | $ | 386,647 | $ | (85,765 | ) | ||||||
Net income (loss) per share, basic | $ | 3.32 | $ | (0.62 | ) | $ | 5.88 | $ | (1.35 | ) | ||||||
Net income (loss) per share, diluted | $ | 3.07 | $ | (0.62 | ) | $ | 5.43 | $ | (1.35 | ) | ||||||
Weighted-average shares used to compute net income (loss) per share, basic | 66,362,300 | 63,772,332 | 65,799,973 | 63,418,522 | ||||||||||||
Weighted-average shares used to compute net income (loss) per share, diluted | 71,731,904 | 63,772,332 | 71,242,641 | 63,418,522 | ||||||||||||
Stock-based Compensation
(In thousands)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
Research and development | $ | 7,728 | $ | 6,019 | $ | 23,056 | $ | 20,301 | ||||||||
General and administrative | 6,635 | 4,540 | 19,864 | 14,972 | ||||||||||||
Total stock-based compensation expense | $ | 14,363 | $ | 10,559 | $ | 42,920 | $ | 35,273 | ||||||||
PROTAGONIST THERAPEUTICS, INC.
Selected Consolidated Balance Sheet Data
(In thousands)
| September 30, | December 31, | |||||||
| 2026 | 2025 | |||||||
Cash, cash equivalents and marketable securities | $ | 834,621 | $ | 646,002 | ||||
Working capital | 1,045,595 | 532,133 | ||||||
Total assets | 1,146,551 | 668,188 | ||||||
Deferred revenue | 16,311 | 9,550 | ||||||
Accumulated deficit | (84,024 | ) | (470,671 | ) | ||||
Total stockholders' equity | 1,084,910 | 614,707 | ||||||
SOURCE: Protagonist Therapeutics
View the original press release on ACCESS Newswire
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were Protagonist Therapeutics’ PTGX third-quarter 2026 earnings?
Protagonist reported $220.015 million in net income, or $3.07 per diluted share, for the quarter ended September 30, 2026. That compares with a $39.339 million net loss, or $0.62 per diluted share, a year earlier. License and collaboration revenue was $274.410 million versus $4.712 million.
How much can Protagonist receive from MIMRYLO and ICOTYDE royalties?
Protagonist is eligible for tiered royalties of 14%–29% on MIMRYLO worldwide net sales and 6%–10% on ICOTYDE global net sales. MIMRYLO’s approximately 21% weighted-average rate corresponds to $1.5 billion in annual net sales. ICOTYDE’s approximate 7.25% weighted-average rate corresponds to $4 billion in annual net sales; its 10% tier applies to incremental annual sales above $4 billion.