Protagonist Therapeutics, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 5 May 2026: press release. Guidance figures: 6 new, 2 kept. The quarter’s numbers.

Key takeaways

Revenue rose on ICOTYDE milestone: License and collaboration revenue was $56.4 million, against $28.3 million a year earlier. It included a $50.0 million milestone from Johnson & Johnson tied to FDA approval of ICOTYDE. Source
Net income against prior-year loss: Net income was $3.8 million, or $0.05 per diluted share, compared with a net loss of $11.7 million, or $0.19 per share, in the first quarter of 2025. Source
Rusfertide FDA decision set for August: The FDA set a PDUFA goal date in August 2026. The headline gives the target action date as the third quarter of 2026. Source
Opt-out payment terms as stated: The headline calls the $200 million an opt-out fee. The body describes a $200 million payment plus a separate $200 million opt-out fee and a $75 million approval milestone. Source
ICOTYDE approved for plaque psoriasis: Johnson & Johnson received FDA approval for ICOTYDE on March 18, for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 and older. Source
PN-881 Phase 1 finishing, Phase 2 by year-end: The PN-881 oral IL-17 antagonist peptide is expected to complete Phase 1 by mid-2026, with a Phase 2 study to start by end of 2026. Source
Cash and securities of $620.3 million: Cash, cash equivalents and marketable securities were $620.3 million at March 31, down from $646.0 million at December 31, 2025. Source

“The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE”
Dinesh V. Patel, Ph.D., the Company’s President and Chief Executive Officer

Guidance

Area	Period	Figure	Against last quarter
Rusfertide regulatory decision Source	2026	PDUFA goal date in August 2026	New
Rusfertide opt-out payments Source	Following the April 28, 2026 opt-out	$200 million payment; additional $200 million opt-out fee; $75 million milestone on FDA approval	New
Rusfertide sales milestones and royalties Source	Following opt-out	up to $775 million in sales milestones; tiered worldwide royalties of 14% to 29%	New
ICOTYDE milestones and royalties Source	Future	up to $580 million in additional milestones; royalties of 6% to 10% on global net sales
PN-881 Phase 1 completion Source	By mid-2026	mid-2026	Kept
PN-881 Phase 2 initiation Source	By end of 2026	by end of 2026	New
PN-477sc Phase 1 initiation Source	Mid-2026	mid-2026	New
PN-477o Phase 1 initiation Source	Q1 2027	Q1 2027	New
Cash runway Source	Through at least 2028	at least 2028	Kept

What changed from last quarter

New: FDA approved ICOTYDE for moderate-to-severe plaque psoriasis, in a period the prior release described as pending a 2026 decision. Source
New: FDA accepted the rusfertide NDA and granted Priority Review, after the prior release reported the NDA submission in December 2025. Source
New: Protagonist exercised its opt-out from the U.S. profit and loss sharing arrangement for rusfertide on April 28, which the prior release had expected in Q2 2026. Source
New guidance: A PN-881 Phase 2 study start by end of 2026 was added to the pipeline timing, which the prior release did not give. Source
New guidance: Phase 1 timing for the PN-477 sc and oral formulations was added: mid-2026 and Q1 2027 respectively. Source

Quarter results and revenue

Revenue rose on ICOTYDE milestone: License and collaboration revenue was $56.4 million, against $28.3 million a year earlier. It included a $50.0 million milestone from Johnson & Johnson tied to FDA approval of ICOTYDE. Source
Net income against prior-year loss: Net income was $3.8 million, or $0.05 per diluted share, compared with a net loss of $11.7 million, or $0.19 per share, in the first quarter of 2025. Source
Income tax benefit recorded: Income tax benefit was $1.5 million, including a discrete credit for stock-based compensation expense specific to the current quarter. Source

Rusfertide NDA and Takeda opt-out

Rusfertide NDA accepted with Priority Review: The FDA accepted the rusfertide New Drug Application and granted Priority Review. The application is supported by the Phase 3 VERIFY study and the Phase 2 REVIVE study. Source
Rusfertide FDA decision set for August: The FDA set a PDUFA goal date in August 2026. The headline gives the target action date as the third quarter of 2026. Source
Opt-out payment terms as stated: The headline calls the $200 million an opt-out fee. The body describes a $200 million payment plus a separate $200 million opt-out fee and a $75 million approval milestone. Source
Higher economics and royalty rate: At $1.5 billion in annual net sales, the weighted-average royalty rate is about 21%, with the 29% tier applying to sales above $1.5 billion. Source

“These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide”
Dinesh V. Patel, Ph.D., the Company’s President and Chief Executive Officer

ICOTYDE approval and royalties

ICOTYDE approved for plaque psoriasis: Johnson & Johnson received FDA approval for ICOTYDE on March 18, for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 and older. Source
Milestones and royalties remaining: Up to $580 million in additional regulatory and sales milestones remains eligible, plus tiered royalties of 6% to 10% on global net sales. Source
Royalty rate at $4 billion sales: At $4 billion in annual net sales the weighted-average royalty is about 7.25%, with a 10% tier applying to incremental sales above $4 billion. Source

Pipeline and discovery programs

PN-881 Phase 1 finishing, Phase 2 by year-end: The PN-881 oral IL-17 antagonist peptide is expected to complete Phase 1 by mid-2026, with a Phase 2 study to start by end of 2026. Source
PN-477 Phase 1 starts in 2026 and 2027: Phase 1 of the injectable PN-477sc is anticipated in mid-2026, and of oral PN-477o in Q1 2027. Source
PN-458 and PN-8047 in IND-enabling work: IND-enabling studies are in progress for PN-458 sc and oral forms and for the oral small molecule hepcidin mimetic PN-8047. Source
One-year Phase 3 ICOTYDE data presented: New one-year Phase 3 ICOTYDE results from the ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies were presented at the 2026 American Academy of Dermatology meeting. Source
Discovery programs added for IL-4Rα and amylin: Oral IL-4Rα antagonist and amylin oral mono and poly agonist programs are named as high-priority discovery programs. Source

“In addition, we look forward to implementing an efficient capital return strategy at the appropriate time.”
Dinesh V. Patel, Ph.D., the Company’s President and Chief Executive Officer

Costs and operating expenses

R&D expense rose on PN-881 and obesity: R&D expense was $46.7 million, up from $35.9 million, driven by the PN-881 Phase 1 study and obesity preclinical and discovery work, partly offset by lower rusfertide Phase 3 spend. Source
G&A rose on personnel costs: G&A expense was $13.3 million, up from $11.7 million, mainly from personnel-related expenses including wages, benefits and stock-based compensation. Source

Cash, balance sheet and capital return

Cash and securities of $620.3 million: Cash, cash equivalents and marketable securities were $620.3 million at March 31, down from $646.0 million at December 31, 2025. Source
Cash runway through at least 2028: Cash is anticipated to provide runway through at least 2028, the same period given in the prior release, reworded from end of 2028. Source
Capital return strategy planned: Management said it expects to implement a capital return strategy at the appropriate time. The release gives no amount or timing for it. Source

Coming up, as management said on 5 May 2026

Rusfertide FDA target action date: The target action date for rusfertide is in the third quarter of 2026, with the body giving a PDUFA goal date in August 2026. Source
PN-881 Phase 1 completion and Phase 2 start: Phase 1 completion is expected by mid-2026, and Phase 2 initiation by end of 2026. Source
PN-477 Phase 1 start dates: PN-477sc Phase 1 is expected to start in mid-2026, and PN-477o Phase 1 in Q1 2027. Source
Rusfertide approval milestone payment: A $75 million milestone is payable to Protagonist on FDA approval of rusfertide. Source

Figures management reported

Figure	Reported
Approvals Source	ICOTYDE FDA approval, March 18, 2026, moderate-to-severe plaque psoriasis
Pipeline milestones Source	Rusfertide NDA accepted; Priority Review granted
Trial readouts Source	One-year Phase 3 ICOTYDE results presented, AAD 2026
R&D spend Source	$46.7 million in Q1 2026, up from $35.9 million in Q1 2025

Earlier plans management reported on

Not stated: The prior release expected the opt-out in Q2 2026. The current release reports it was exercised on April 28.
Not stated: The prior release expected PN-881 Phase 1 completion by mid-2026, informing later clinical plans. The current release repeats mid-2026 timing.
Not stated: The prior release anticipated a 2026 decision and launch. The current release reports FDA approval on March 18 and a U.S. launch in March 2026.

Other quarters

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.

As filed with the SEC

Open the filing on EDGAR

Protagonist Reports First Quarter 2026 Financial Results and Provides Corporate Update

ICOTYDE™ (icotrokinra) approved by FDA in March for moderate-to-severe plaque psoriasis, triggering a $50 million milestone payment; Protagonist receives tiered royalties of 6% to 10% and is eligible for up to $580 million in future milestone payments

Rusfertide NDA accepted and granted Priority Review by FDA, with a Prescription Drug User Fee Act target action date in the third quarter of 2026

Protagonist exercised its rusfertide opt-out right under the Takeda collaboration on April 28, triggering a $200 million opt-out fee payable to the Company; eligible for additional $200 million opt-out and $75 million milestone payments upon NDA approval, sales milestones of up to $775 million and worldwide royalties ranging from 14% to 29%

PN-881 (oral IL-17 antagonist peptide) Phase 1 study completion by mid-2026 and Phase 2 initiation anticipated by year-end; PN-477sc and PN-477o (sc and oral triple GLP/GIP/GICG agonist) Phase 1 initiation expected in mid-2026 and Q1 2027, respectively

Cash, cash equivalents and marketable securities of $620 million as of March 31, 2026, anticipated to provide cash runway through at least 2028

NEWARK, Calif., May 5, 2026 - Protagonist Therapeutics (Nasdaq: PTGX) (“Protagonist” or “the Company”) today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“The first quarter of 2026 marked a series of landmark achievements for Protagonist, highlighted by the U.S. approval of ICOTYDE, FDA granting Priority Review for rusfertide, and advancement of our highly differentiated and fully-owned peptides PN-881 and PN-477,” said Dinesh V. Patel, Ph.D., the Company’s President and Chief Executive Officer. “These accomplishments, together with the additional financial resources afforded by our rusfertide opt-out election and future milestones and royalty payments from ICOTYDE and rusfertide, position Protagonist for meaningful near-, medium and long-term value creation through rapid progression of clinical stage assets and further expansion into new internal discovery programs. In addition, we look forward to implementing an efficient capital return strategy at the appropriate time.”

First Quarter 2026 Recent Developments and Upcoming Milestones

Rusfertide

On March 2, Takeda and Protagonist announced that the U.S. FDA accepted the New Drug Application for rusfertide and granted Priority Review. The application is supported by data from the positive 32-week primary analysis and 52-week results from the Phase 3 global randomized VERIFY study, as well as four-year efficacy and safety data from the Phase 2 REVIVE study and long-term extension THRIVE study. The FDA set a PDUFA goal date in August 2026.

On April 28, Protagonist announced that it exercised its right to opt out of the U.S. profit and loss sharing arrangement under the terms of its collaboration agreement with Takeda for rusfertide. The opt-out election triggers a $200 million payment to Protagonist, with an additional $200 opt-out fee and a separate $75 million milestone for FDA approval of rusfertide. The opt-out election also increases downstream economics payable to Protagonist, including up to $775 million in sales milestone payments and tiered worldwide royalties ranging from 14% to 29%. At $1.5 billion in annual net sales, the weighted-average royalty rate is approximately 21%, with the 29% tier applying to annual sales above $1.5 billion.

ICOTYDE™ (icotrokina)

On March 18, Protagonist announced that Johnson & Johnson received U.S. Food and Drug Administration approval for ICOTYDE for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg and are candidates for systemic therapy or phototherapy. The FDA approval triggered a $50 million milestone payment to Protagonist in the first quarter of 2026. Under the collaboration, Protagonist remains eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered royalties 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 applying to the incremental annual sales above $4 billion. ICOTYDE is the first and only FDA-approved targeted oral peptide for moderate-to-severe plaque psoriasis

On March 28, Protagonist announced presentation of new one-year Phase 3 ICOTYDE results at the 2026 American Academy of Dermatology Annual Meeting. Data from the Phase 3 ICONIC-ADVANCE 1 and 2 and ICONIC-LEAD studies further supported the potential of ICOTYDE as a differentiated oral therapy for patients with moderate-to-severe plaque psoriasis, demonstrating durable efficacy and a favorable safety profile in a once-daily pill.

Wholly-Owned Clinical and Discovery Programs

PN-881 (oral IL-17 antagonist peptide): The Company expects completion of Phase 1 study by mid-2026 and initiation of a Phase 2 study by end of 2026.
PN-477 (triple-G GLP/GIP/GCG agonist peptide): Phase 1 initiation of PN-477sc and PN-477o anticipated in mid-2026 and Q1 2027, respectively.
PN-458 (dual GLP/GIP agonist peptide): IND-enabling studies in progress with PN-458sc and PN-458o
PN-8047 (oral small molecule hepcidin functional mimetic): IND-enabling studies in progress
Discovery: Oral IL-4Rα antagonist and amylin oral mono/poly agonists are high-priority discovery programs.

First Quarter 2026 Financial Results

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2026, were $620.3 million as compared to $646.0 million as of December 31, 2025.

	Three Months Ended
	March 31,
	2026	2025
(in thousands, except per share amounts)	(Unaudited)
License and collaboration revenue	$56,368	$28,321
Research and development expense	$46,739	$35,893
General and administrative expense	$13,277	$11,738
Income tax benefit	$1,502	$-
Net income (loss)	$3,783	$(11,655)
Basic earnings (loss) per share	$0.06	$(0.19)
Diluted earnings (loss) per share	$0.05	$(0.19)

License and Collaboration Revenue: License and collaboration revenue of $56.4 million for the period ended March 31, 2026 consisted of (i) a $50.0 million milestone earned from JNJ in Q1 26 upon FDA approval of ICOTYDE, (ii) $3.3 million allocated to development services provided by us under the Takeda agreement during the period and (iii) $3.1 million cost reimbursement from Takeda for rusfertide clinical trial supplies. License and collaboration revenue of $28.3 million for the period ended March 31, 2025 consisted of (i) $22.8 million related to proportional recognition of a $25.0 million milestone earned in Q1 2025, and (ii) $5.5 million allocated to development services provided by us under the agreement during the period.
Research and Development ("R&D") Expense: The increase in R&D expense from the prior year period was primarily due to increases related to our Phase 1 study for PN-881 and pre-clinical and drug discovery research expenses, including our obesity product candidates, partially offset by a decrease in rusfertide expenses related to the Phase 3 VERIFY clinical trial.
General and Administrative ("G&A") Expense: The increase in G&A expense from the prior year period was primarily due to an increase in personnel-related expenses, including wages and benefits and stock-based compensation.
Income Tax Benefit: Income tax benefit was $1.5 million for the period ended March 31, 2026 and included a discrete credit for stock-based compensation expense specific to the current quarter.
Net Income (Loss): Net income was $3.8 million, or $0.06 per basic share and $0.05 per diluted share, for the first quarter of 2026 as compared to net loss of $11.7 million, or $0.19 per basic and diluted share, for the first quarter of 2025.

About Protagonist

Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company with a proprietary technology platform that enables de novo discovery of peptide therapeutics. Two novel peptides derived from Protagonist's proprietary discovery platform are at or near commercialization. ICOTYDE™ (icotrokinra), licensed to Johnson & Johnson company Janssen Biotech, Inc., is the first and only targeted oral peptide that precisely blocks the Interleukin-23 receptor. ICOTYDE was launched in the U.S. in March 2026, is approved 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 development and commercialization. Protagonist also discovered and led development through Phase 3 of rusfertide, a first-in-class hepcidin mimetic peptide licensed to Takeda Pharmaceuticals. An NDA for rusfertide for the treatment polycythemia vera is under priority review with the FDA. The Company also has a number of clinical and preclinical programs addressing clinically and commercially validated targets, including an oral IL-17 antagonist peptide, obesity dual and triple agonists, an oral hepcidin functional mimetic, and the recently announced IL-4 and amylin 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

Forward-looking statements notice

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 potential revenue from the Company's collaborations with Johnson & Johnson and Takeda, timing of regulatory actions and clinical trial completion, and advancement of the Company’s discovery and clinical pipeline. 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 and royalty 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, 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. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. 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.

Consolidated Statements of Operations

(Amounts in thousands except share and per share data)

	Three Months Ended
	March 31,
	2026	2025
License and collaboration revenue	$56,368	$28,321
Operating expense:
Research and development	46,739	35,893
General and administrative	13,277	11,738
Total operating expense	60,016	47,631
Loss from operations	(3,648)	(19,310)
Interest income	5,876	7,573
Other income, net	53	82
Income (loss) before income tax benefit	2,281	(11,655)
Income tax benefit	1,502	-
Net income (loss)	$3,783	$(11,655)
Net income (loss) per share, basic	$0.06	$(0.19)
Net income (loss) per share, diluted	$0.05	$(0.19)
Weighted-average shares used to compute net income (loss) per share, basic	65,087,847	62,963,806
Weighted-average shares used to compute net income (loss) per share, diluted	70,492,618	62,963,806

(1) Amount includes non-cash stock-based compensation expense.

Stock-based Compensation

(In thousands)

	Three Months Ended
	March 31,
	2026	2025
Research and development	$7,769	$7,991
General and administrative	6,750	5,811
Total stock-based compensation expense	$14,519	$13,802

PROTAGONIST THERAPEUTICS, INC.

Selected Consolidated Balance Sheet Data

(In thousands)

	March 31,	December 31,
	2026	2025
Cash, cash equivalents and marketable securities	$620,334	$646,002
Working capital	578,906	532,133
Total assets	697,459	668,188
Deferred revenue	6,282	9,550
Accumulated deficit	(466,888)	(470,671)
Total stockholders' equity	655,473	614,707

Contacts
Corey Davis, Ph.D.
LifeSci Advisors cdavis@lifesciadvisors.com
+1 212 915 2577
Virginia Amann ENTENTE Network of Companies virginiaamann@ententeinc.com +1 833 500 0061 ext 1
PROTAGONIST THERAPEUTICS, INC.