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Protagonist Therapeutics, Inc (PTGX)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 printed license and collaboration revenue of $28.321M and diluted EPS of -$0.19, cycling an unusually strong prior-year quarter that recognized $254.953M from the Takeda upfront, driving a YoY decline and GAAP net loss of $11.655M .
  • Versus S&P Global consensus, PTGX missed: revenue $28.321M vs $30.444M* and EPS -$0.19 vs -$0.002* (9 estimates each); lumpy license recognition timing appears to be the primary driver of the variance .
  • Operationally, the quarter was strong: rusfertide Phase 3 VERIFY met the primary and all key secondary endpoints (p<0.0001), selected for ASCO plenary; icotrokinra delivered positive Phase 2b UC topline and Phase 3 psoriasis presentations; cash reached $697.9M with runway through at least end-2028 .
  • Near-term stock catalysts: ASCO plenary (June 1) and investor call (June 2) to discuss rusfertide, plus NDA filings targeted by year-end for late-stage partnered assets .

What Went Well and What Went Wrong

What Went Well

  • Rusfertide VERIFY met its primary endpoint and all four key secondary endpoints with highly significant p-values (p<0.0001), and was selected for ASCO plenary—strong clinical validation and visibility .
  • Icotrokinra showed positive topline in ANTHEM-UC Phase 2b and delivered late-breaking Phase 3 ICONIC-LEAD psoriasis data at AAD and pediatric cohort at WCPD, reinforcing breadth across immunology indications .
  • Management emphasized momentum toward year-end NDA filings and highlighted robust liquidity to independently advance preclinical assets (including PN-881 IL-17) into PoC studies: “Protagonist is off to a very strong 2025… progressing to NDA filings by year end… strong cash position” .

What Went Wrong

  • Revenue and EPS both missed consensus (revenue $28.321M vs $30.444M*; EPS -$0.19 vs -$0.002*), reflecting the absence of last year’s large upfront license recognition and partial milestone proportional recognition in Q1 2025 .
  • GAAP net loss of $11.655M contrasts with Q1 2024’s GAAP net income of $207.340M; operating margin compressed sharply on lower license recognition this quarter .
  • R&D rose YoY (to $35.893M from $33.734M) on increased preclinical/discovery spend, while rusfertide VERIFY costs tapered; G&A normalized from prior-year legal/advisory fees but higher stock-based comp partially offset the decline .

Financial Results

P&L comparison (oldest → newest)

MetricQ1 2024Q4 2024Q1 2025
License & Collaboration Revenue ($USD Millions)$254.953 $170.638 $28.321
Net Income ($USD Millions)$207.340 $131.674 $(11.655)
EPS (Basic, $)$3.41 $2.11 $(0.19)
EPS (Diluted, $)$3.26 $1.98 $(0.19)

Margins (computed from reported figures; oldest → newest)

MetricQ1 2024Q4 2024Q1 2025
EBIT Margin %80.9% (206.309 / 254.953) 74.3% (126.780 / 170.638) -68.2% (-19.310 / 28.321)
Net Income Margin %81.4% (207.340 / 254.953) 77.2% (131.674 / 170.638) -41.1% (-11.655 / 28.321)

Revenue composition (Q1 2025)

ComponentQ1 2025
Milestone proportional recognition (of $25M earned in Q1, payable post VERIFY CSR)$22.8M
Development services$5.5M
Total License & Collaboration Revenue$28.3M

Balance sheet KPIs

KPI ($USD Millions)Dec 31, 2024Mar 31, 2025
Cash, Cash Equivalents & Marketable Securities$559.165 $697.877
Working Capital$544.243 $570.748
Deferred Revenue$30.567 $25.071
Total Stockholders’ Equity$675.295 $689.052

Estimates comparison (Q1 2025)

MetricConsensus (Q1 2025)Actual (Q1 2025)Result
Revenue ($USD Millions)$30.444*$28.321 MISS
Primary EPS ($)-$0.002*-$0.19 MISS
# of Estimates (Revenue / EPS)9* / 9*——

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious Guidance (Q4 2024)Current Guidance (Q1 2025)Change
Cash runwayThrough end-2028“Cash…$559.2M; combined with $165.0M milestone, anticipated runway through at least end of 2028” “Cash…$697.9M, anticipated runway through at least end of 2028” Maintained
Rusfertide VERIFY (PV) timingReadout“Topline VERIFY expected in March 2025” Positive topline announced (Mar 3), ASCO plenary June 1; investor call June 2 Updated (achieved)
Icotrokinra ANTHEM-UCReadout“Topline expected in Q1 2025” Positive topline announced Mar 10; full dataset later in 2025 Updated (achieved)
NDA filings (rusfertide, icotrokinra)2025“NDA submissions potentially in 2025” “Progressing to NDA filings by year end” Maintained/clarified timeline

Earnings Call Themes & Trends

Note: No Q1 2025 earnings call transcript available in our document set; company will host an investor call June 2 to discuss ASCO plenary rusfertide data .

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
Rusfertide VERIFY (PV)Readout expected Q1 2025 Readout expected March 2025; PV Day held Feb 6 Positive topline; plenary ASCO; investor call June 2 Progressed to positive topline; high visibility
Icotrokinra (IL-23) PsoriasisPhase 3 readouts expected Q4 2024 Positive Phase 3 ICONIC-LEAD/TOTAL topline; late-breaking AAD Additional adolescent cohort at WCPD; continued visibility Continued positive momentum
Icotrokinra (IL-23) UCPhase 2b ANTHEM expected Q1 2025 Expected March 2025 Positive topline announced Mar 10; full dataset later in 2025 Achieved topline; awaiting full data
Cash/liquidity$583.3M at 9/30/24 $559.2M at 12/31/24 + $165M milestone received Jan 2025 $697.9M at 3/31/25; runway through 2028 Strengthened
Discovery pipeline (PN-881; oral programs)Candidate nomination expected Q4 2024 PN-881 nominated; more candidates expected in 2025 Focus on advancing PN-881 and oral hepcidin/obesity programs Advancing toward PoC

Management Commentary

  • “Protagonist is off to a very strong 2025 with multiple transformational events in the first quarter for our two late-stage partnered assets, rusfertide and icotrokinra which are progressing to NDA filings by year end… We are fortunate to be in a very strong cash position, allowing us to independently and rapidly progress our early-stage pipeline into value-creating clinical safety and proof-of-concept studies starting with PN-881 in 2025.” — Dinesh V. Patel, Ph.D., President & CEO .
  • VERIFY results summary: met primary endpoint (clinical responders weeks 20–32) and all four key secondary endpoints (EU phlebotomy rate, hematocrit control, PROMIS Fatigue, MFSAF TSS-7); safety consistent with prior studies; plenary selection at ASCO .
  • Icotrokinra: positive Phase 2b ANTHEM-UC topline and Phase 3 psoriasis data presentations; further data and conference disclosures expected later in 2025 .

Q&A Highlights

  • No formal Q1 2025 earnings call transcript available. Company scheduled an investor call on June 2 (8 AM EDT) to discuss rusfertide ASCO plenary data; dial-in details and webcast provided .
  • Anticipated focus areas: VERIFY efficacy endpoints and safety, NDA filing plans/timing, U.S. co-commercialization economics with Takeda, icotrokinra development plans in UC and psoriasis, and prioritization across preclinical oral programs .

Estimates Context

  • Q1 2025 revenue $28.321M vs consensus $30.444M* → MISS; Q1 2025 EPS -$0.19 vs consensus -$0.002* → MISS. Both variances are consistent with lumpy license recognition timing: Q1 included $22.8M proportional recognition of a $25M milestone (payable post VERIFY CSR) plus $5.5M of development services, versus Q1 2024’s large upfront recognition under the Takeda agreement .
  • Street models may need to recalibrate cadence of license/milestone recognition and expense trajectory (preclinical ramp, lower rusfertide trial costs post-readout), pending ASCO plenary details and NDA timelines .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Clinical catalysts are the dominant narrative: VERIFY plenary at ASCO and the June 2 investor call should shape near-term sentiment and regulatory expectations for rusfertide .
  • Icotrokinra’s expanding data set (UC positive topline; psoriasis Phase 3) supports multi-indication optionality with partner-led late-stage development; watch for full UC dataset later in 2025 .
  • Financials are inherently lumpy given license/milestone accounting; consensus misses reflect timing mechanics rather than demand—focus on total deal economics (Takeda/JNJ) and NDA path .
  • Liquidity is a strength: $697.9M cash provides runway through at least end-2028 and enables internal advancement of oral programs to PoC without near-term financing risk .
  • Expect operating expense mix to evolve: R&D up on preclinical/discovery; G&A normalized from prior advisory/legal fees but higher stock comp persists .
  • If ASCO plenary and subsequent disclosures are well-received, estimate revisions could shift from near-term GAAP cadence to medium-term commercialization scenarios—monitor partner decisions (e.g., profit-share vs opt-out economics) that affect value capture .
  • Near-term trading setup: elevated event risk around ASCO plenary and the June 2 call; position sizing should reflect binary headline risk and potential for narrative inflection tied to regulatory/label dynamics for PV .