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X4 Pharmaceuticals, Inc (XFOR)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 delivered a decisive upside versus Street: revenue $28.81M and EPS $0.04, driven by $27.87M license revenue from the Norgine partnership and a $10.8M non-cash gain on Class C warrants; XOLREMDI product revenue was $0.94M .
  • Revenue and EPS both materially beat S&P Global consensus (revenue $7.03M*, EPS -$3.75*), reflecting the timing of upfront license recognition and warrant mark-to-market; prior two quarters showed mixed results amid early U.S. launch and higher operating spend .
  • Operationally, 4WARD Phase 3 CN trial is ~90% site-initiated, with full enrollment guided for Q3/Q4 2025 and top-line in 2H 2026; EU WHIM MAA validation and ex‑U.S. partnerships (Norgine, taiba rare) expand global optionality .
  • Strategic restructuring announced in February is expected to cut annual spend by $30–35M; cash and marketable securities totaled $87.7M at 3/31/25, with runway into 1H 2026 .
  • Stock-relevant catalysts include: CN Phase 3 enrollment/milestones, EU WHIM review/launch preparations via Norgine, and U.S. WHIM commercial progress; reverse split (1-for-30) effected April 28, 2025 to cure Nasdaq bid-price deficiency .

What Went Well and What Went Wrong

What Went Well

  • License monetization and ex-U.S. strategy execution: $27.9M license/other revenue recognized in Q1 from the Norgine agreement; two ex‑U.S. commercialization deals (Norgine in EU/ANZ; taiba rare in MENA) enhance geographic leverage .
  • CN Phase 3 (4WARD) pacing and design rigor: ~90% of planned sites initiated; trial powered >90% for co-primary endpoints; management reiterated full enrollment Q3/Q4 2025 and topline 2H 2026; CEO: “extremely productive and value‑adding period” .
  • WHIM launch traction signals: cumulative U.S. XOLREMDI sales reached $3.5M since May 2024; new patient share rising, supported by HCP/patient education; CCO noted adherence “higher than you would expect” for daily oral therapy .

What Went Wrong

  • Product revenue still small and lumpy: XOLREMDI Q1 product revenue $0.94M (lower than Q4 due to inventory resupply timing and small-population dynamics), underscoring early-stage commercial adoption .
  • Continued operating cost intensity: Q1 R&D $18.5M and SG&A $15.0M, though both declined y/y; Q4 2024 R&D/SG&A elevated with pre-commercial scale-up and CN development .
  • Prior-quarter estimate misses on revenue/EPS amid launch ramp and spending: Q3 2024 revenue and EPS missed consensus, highlighting near-term variability before license revenue inflection [functions.GetEstimates]*.

Financial Results

Consolidated P&L and EPS vs prior quarters

MetricQ3 2024Q4 2024Q1 2025
Total Revenue ($USD)$0.56M $1.43M $28.81M
License & Other Revenue ($USD)$0.00M $0.00M $27.87M
Product Revenue, net ($USD)$0.56M $1.43M $0.94M
Cost of Revenue ($USD)$0.23M $0.30M $4.72M
Research & Development ($USD)$19.17M $21.70M $18.51M
Selling, General & Admin ($USD)$15.66M $15.15M $15.02M
Loss from Operations ($USD)$(34.50)M $(35.72)M $(9.44)M
Other (Income) Expense, net ($USD)$(2.18)M $(3.85)M $9.76M
Net Income (Loss) ($USD)$(36.70)M $(39.82)M $0.28M
EPS Basic ($USD)$(0.18) $(0.20) $0.04
EPS Diluted ($USD)$(0.18) $(0.20) $0.04

Notes: Q1 2025 EPS reflects split-adjusted share count (weighted diluted 6.87M) . Historical EPS prior to the April 28, 2025 1-for-30 reverse split would equate to split-adjusted figures of approximately $(5.40) for Q3 2024 and $(6.00) for Q4 2024 for estimate comparability .

Revenue Breakdown (License vs Product)

MetricQ3 2024Q4 2024Q1 2025
License & Other Revenue ($USD)$0.00M $0.00M $27.87M
Product Revenue, net ($USD)$0.56M $1.43M $0.94M
Total Revenue ($USD)$0.56M $1.43M $28.81M

Key Balance Sheet KPIs

MetricQ4 2024 (12/31/24)Q1 2025 (3/31/25)
Cash & Cash Equivalents ($USD)$55.70M $40.26M
Marketable Securities ($USD)$46.36M $46.69M
Total Funds (Cash, CE, Restricted, Mkts) ($USD)$102.80M $87.70M
Total Debt ($USD)$75.43M $75.63M
Warrant Liability ($USD)$13.76M $2.93M
Stockholders’ Equity ($USD)$22.15M $22.94M

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
4WARD Phase 3 Full Enrollment (CN)2025Mid-2025 Q3/Q4 2025 Lowered (later)
4WARD Top-line Data (CN)20262H 2026 2H 2026 Maintained
EU WHIM MAA Review/Approval Window2026Submit early 2025; possible approval 1H 2026 MAA validated Jan 2025; possible approval 1H 2026 Maintained (status advanced)
Cash RunwayThroughInto 1H 2026 (pro forma Norgine upfront and restructuring) Into 1H 2026 Maintained
Annual Spend ReductionAnnual$30–35M savings expected $30–35M savings expected Maintained
Reverse Stock SplitEffective dateN/A1-for-30 effective Apr 28, 2025 Implemented

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024)Current Period (Q1 2025)Trend
CN Phase 3 Execution/PoweringSites authorized in ~85% countries; ~40% sites initiated; full enrollment mid-2025 ~90% sites activated; full enrollment mid-2025; protocol refined for high unmet need and ANC endpoint uniformity ~90% sites initiated; full enrollment Q3/Q4 2025; powering >90% for co-primary endpoints Steady operational progress; timing nudged later
WHIM U.S. CommercializationAwareness and screening rising; engagement with target HCPs; Q3 revenue $0.56M FY 2024 revenue $2.6M; building physician outreach Cumulative $3.5M since launch; Q1 $0.94M; adherence better than expected Gradual ramp; early-stage adoption
Ex‑U.S. Strategy (EU/ANZ, MENA)Anticipated EU MAA submission by early 2025 EU MAA validated Jan 2025; Norgine deal terms disclosed; taiba rare MENA distribution MAA validated; Norgine & taiba rare partnerships highlighted Advancing towards EU launch readiness
Regulatory/Patent——USPTO Notice of Allowance for CN use; patent expiry 2041 IP protection enhanced
R&D Execution (Phase 2 CN)Positive Phase 2 CN data: ANC increases; potential G-CSF reduction; functional neutrophil data Reinforced Phase 2 data for Phase 3 design Post‑hoc analyses align with 4WARD ANC responder criteria; bolster confidence Confidence increasing
Financial Discipline/Restructuring—Strategic restructuring $30–35M annual savings expected Majority actions completed; savings maintained Cost base optimized

Management Commentary

  • CEO Paula Ragan: “The first quarter of 2025 was an extremely productive and value‑adding period for X4… continued to support U.S. commercialization of XOLREMDI… and the announcement of two international commercialization partnerships” .
  • CFO Adam Mostafa: “We ended the first quarter… with just under $90 million in cash… small amount of net income… due to $28 million in license… and a gain of $10.8 million on… Class C warrants” .
  • CCO Mark Baldry on adherence: “Compliance and adherence rates are actually higher than you would expect with a daily oral medication” .
  • CMO Christophe Arbet‑Engels on label ambition: “We are anticipating a broad label [for CN]… we do have already data to support this” .

Q&A Highlights

  • CN enrollment profile and demand: Investigators report strong interest and waitlists; enrolled patients are “very sick” to enrich infection endpoint success; market research shows concentrated CN caseloads among hematologists .
  • CN label scope: Management aims for a broad CN label beyond severe cases, leveraging Phase 2 and WHIM data; payer value proposition centers on refractory patients with recurrent infections .
  • Norgine license breadth: Agreement covers WHIM and CN across EU/ANZ; WHIM expected first commercially .
  • WHIM adherence and supply: Adherence above typical daily oral benchmarks; prescriptions currently dispensed as 30‑day supply .
  • 4WARD dropout and assumptions: 150‑patient target includes screen failures/dropouts; early blinded event rates support powering; timeline intact for Q3/Q4 2025 full enrollment .

Estimates Context

MetricQ3 2024Q4 2024Q1 2025
Revenue Actual ($USD)$560,000 $1,434,000 $28,807,000
Revenue Consensus Mean ($USD)$1,686,430*$1,064,670*$7,030,500*
EPS Actual ($USD)$(0.18) $(0.20) $0.04
Primary EPS Consensus Mean ($USD)$(5.16)*$(4.73)*$(3.75)*
SurpriseRevenue: Miss; EPS: Miss [functions.GetEstimates]*Revenue: Beat; EPS: Miss [functions.GetEstimates]*Revenue: Bold Beat; EPS: Bold Beat [functions.GetEstimates]*

Notes: EPS consensus and actuals for Q3/Q4 2024 reflect split-adjusted comparability in SPGI (e.g., $(0.18) pre‑split ≈ $(5.40) post‑split); Q1 2025 EPS $0.04 is split-adjusted. Values retrieved from S&P Global.*

Drivers:

  • Q1 beats were primarily driven by $27.9M license revenue from Norgine; EPS further benefited from a $10.8M warrant fair value gain, offsetting operating loss .
  • Prior quarter misses reflect early-stage WHIM launch revenue scale and elevated R&D/SG&A supporting CN development and commercialization .

Guidance Changes

(See table above for specifics.) Key clarifications:

  • 4WARD enrollment timing shifted from “mid-2025” to “Q3/Q4 2025,” reflecting real-time screening cadence while maintaining topline 2H 2026 .
  • EU WHIM pathway advanced to MAA validation; launch preparation underway with Norgine .
  • Cost savings from restructuring and runway into 1H 2026 reaffirm investor visibility .

Earnings Call Themes & Trends

(See table above.) Narrative evolution:

  • Confidence in CN success increased via post‑hoc ANC responder analyses mapping to infection rate reduction; Phase 3 powering emphasized .
  • WHIM commercialization focus continues on disease education, screening, and patient advocacy to drive new patient starts .
  • Global expansion underpinned by EU review and partnerships, diversifying future revenue beyond U.S. .

Key Takeaways for Investors

  • Q1 prints are not purely recurring—license revenue recognition was the principal driver—yet demonstrate X4’s ability to monetize assets while funding CN Phase 3; model product revenue ramp conservatively near term .
  • CN Phase 3 4WARD remains the core value inflection; watch site activation and enrollment cadence in H2 2025; design/powering and cross‑trial ANC/infection correlation support probability of success .
  • WHIM U.S. trajectory is building via education and adherence; expect variability (“lumpiness”) near term due to inventory resupply and small patient base .
  • EU WHIM optionality via Norgine and MENA via taiba rare expand TAM and de‑risk ex‑U.S. execution; MAA validation sets up 1H 2026 approval window .
  • Balance sheet runway into 1H 2026 and restructuring savings ($30–35M) reduce financing pressure before CN data, but monitor debt covenants and warrant liability volatility .
  • Near-term stock catalysts: CN enrollment milestones/Q3–Q4 2025, EU WHIM regulatory updates, WHIM commercial KPIs; reverse split cured Nasdaq bid-price deficiency, aiding listing compliance .