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IT

Iterum Therapeutics plc (ITRM)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was pivotal: FDA approved ORLYNVAH (oral sulopenem), extending exclusivity to October 2034 and bolstering IP protection into 2039, while management initiated outreach to strategic partners and began targeted pre-commercialization work .
  • Losses narrowed year over year: GAAP net loss of $6.6M vs. $12.4M in Q4 2023; non-GAAP net loss of $3.4M vs. $10.7M (drivers: sharp R&D decline post-REASSURE trial) .
  • Liquidity strengthened: Cash/equivalents of $24.1M at year-end plus $4.8M raised via ATM through 2/6/2025 support runway into H2 2025; exchangeable notes repaid in January 2025; Pfizer $20M milestone deferred (8% accrued interest) .
  • Stock catalysts: Strategic transaction potential; targeted launch readiness; ORLYNVAH’s first-in-class oral penem positioning in a large uUTI market facing rising resistance (estimated ~40M U.S. prescriptions annually) .

What Went Well and What Went Wrong

What Went Well

  • FDA approval of ORLYNVAH for adult women with uUTIs who have limited or no alternative oral options; “first and only oral penem approved in the U.S.” .
  • Exclusivity and IP: 10 years of marketing exclusivity under GAIN Act (to Oct 2034) and U.S. patents that provide protection into 2039; Orange Book listings submitted .
  • Cost discipline: R&D fell to $1.3M in Q4 (vs. $9.7M prior year) after completing REASSURE, materially improving non-GAAP results; management: “lower R&D expenses related to our REASSURE trial” drove improvement .
  • Quote: “ORLYNVAH will potentially be the first branded uUTI product to enter the U.S. market in over 25 years” – CEO Corey Fishman .

What Went Wrong

  • No product revenue yet; operations remain pre-commercialization, keeping bottom line negative; GAAP net loss $6.6M, driven by operating loss and non-cash derivative fair value changes post-approval .
  • Non-cash increase in fair value of Royalty-Linked Notes upon approval and passage of time added $2.0M to Q4 derivative adjustments, dampening GAAP earnings optics .
  • G&A rose to $2.1M in Q4 (vs. $1.7M prior year) on higher legal fees, and milestone economics: $20M Pfizer note accrues 8% interest until paid .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Total Operating Expenses ($USD Millions)$4.0 $4.9 $3.7
R&D Expense ($USD Millions)$2.1 $3.1 $1.3
G&A Expense ($USD Millions)$1.9 $1.8 $2.1
Cost of Sales ($USD Millions)N/A N/A $0.3
GAAP Net Loss ($USD Millions)$(5.0) $(6.1) $(6.6)
Non-GAAP Net Loss ($USD Millions)$(3.8) $(4.8) $(3.1)
GAAP EPS (Basic/Diluted, $USD)$(0.30) $(0.30) $(0.25)
Non-GAAP EPS (Basic/Diluted, $USD)$(0.23) $(0.24) $(0.12)
Cash & Equivalents at Period End ($USD Millions)$11.7 $14.5 $24.1
Weighted Avg Shares (Basic/Diluted)16,552,214 20,044,270 26,687,281

Notes:

  • FY comparisons: Q4 2024 GAAP net loss $6.6M vs. $12.4M in Q4 2023; non-GAAP net loss $3.1–$3.4M vs. $10.7M prior year quarter .
  • Shares outstanding increased to ~34.6M by Feb 6, 2025 (post ATM), from ~27.5M as of Nov 4, 2024 .

Segment breakdown: Not applicable (single-product pre-commercialization) .

KPIs

KPIQ2 2024Q3 2024Q4 2024
Marketing ExclusivityN/AConfirmed +5 yrs under GAIN Act (10 yrs total to Oct 2034) Reiterated Oct 2034
Patent Protection HorizonNotices of Allowance incl. 2039–2041 assets U.S. patents listed in Orange Book submitted U.S. portfolio extends into 2039; AU allowance; more pending
Debt ActionsExchangeable notes outstanding; Pfizer $20M milestone to be deferred upon approval ~$11.1M exchangeable notes with potential share exchange; plan to repay by Jan 31, 2025 Exchangeable notes repaid Jan 2025; Pfizer $20M note accrues 8%

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash Runway2025Into 2025 incl. through exchangeable notes repayment date (Jan 31, 2025) Into H2 2025 including $4.8M ATM proceeds; incorporates exchangeable note repayment and pre-commercialization activities Raised runway
Commercialization Readiness2024–2025Focus on strategic options and regulatory milestones Parallel pre-commercialization activities for a targeted launch, contingent on strategic outcome/capital Added pre-commercial plan
Revenue/Margins/OpEx/Tax2024–2025Not provided Not provided (no quantitative guidance) Maintained (no guidance)
DebtJan 2025Plan to repay exchangeable notes by maturity Exchangeable notes repaid Jan 2025 Achieved event

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Regulatory/LegalPreparing for AdComm (stewardship, patient population); PDUFA 10/25 FDA approval achieved; exclusivity to 2034; Orange Book submissions Reiterated exclusivity; outlined IP protection into 2039 Progressed from review to approval and protection
Strategic AlternativesFunding outreach; plan to maximize sulopenem value Renewed outreach to partners post-approval “Outreach to dozens of companies” ongoing; evaluating direct commercialization option Intensifying post-approval
Market OpportunityEmphasis on large uUTI market and rising resistance Detailed resistance challenges; at-risk patient segments “First branded uUTI in 25+ years”; elevated-risk focus; ~1% pan-resistant isolates Consistent, sharpening positioning
Commercial PrepN/AEarly considerations; IP/exclusivity as enabler Payor/physician research, targeting geographies, analytics for launch foundation From concept to groundwork
R&D ExecutionREASSURE completed; strong safety profile across trials Reduced R&D costs post-REASSURE R&D minimal; cost of sales amortization begins Transitioned from development to pre-commercial
Ex-U.S. PathwaysN/AEU may use FDA package; China/Japan likely need local study Reiterated U.S.-centric focus; patent expansion AU Clarified regional requirements

Management Commentary

  • “ORLYNVAH will potentially be the first branded uUTI product to enter the U.S. market in over 25 years and the first and only oral penem approved for use in the U.S.” – Corey Fishman, CEO .
  • “We have conducted outreach to dozens of companies… include both pharma companies as well as financial investors and that process is ongoing.” – Corey Fishman .
  • “We plan to engage in pre-commercial activities in order to develop the foundation for a highly targeted launch of ORLYNVAH with a commercial partner or directly…” – Corey Fishman .
  • “Total operating expenses were $3.7M in the fourth quarter and $18.7M for the full year 2024…” – Judy Matthews, CFO .
  • “Based on our current operating plan… cash and cash equivalents, including $4.8M… will be sufficient to fund operations into the second half of 2025.” – Judy Matthews .

Q&A Highlights

  • Partnering updates: Management confirmed broad outreach and ongoing discussions with pharma and financial investors; specific counterparties not disclosed .
  • Commercial preparation: Active payor/physician research, targeting and geographic analytics to lay groundwork for a targeted launch if strategic process doesn’t conclude favorably .
  • Ex-U.S. regulatory: EU could leverage current FDA package; China and Japan likely require local studies; expands optionality for global strategy .
  • Label breadth and safety: Team “very pleased” with competitive label; standard post-marketing work; avoids unusual restrictions; aligns with elevated-risk patients narrative .
  • Future indications: Potential interest in complicated UTI step-down; one additional study could pursue formal indication; viewed as attractive to some counterparties .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was not retrievable at query time (tool error). As such, estimate comparisons are unavailable. We attempted to fetch “Primary EPS Consensus Mean,” “Revenue Consensus Mean,” and estimate counts for Q4 2024, but received a daily limit error from SPGI (IQ_EPS_EST_CIQ, FQ42024).
  • Implication: Absent Street numbers, we cannot mark beats/misses versus consensus; investors should monitor near-term updates from coverage initiations post-approval [functions.GetEstimates error].

Key Takeaways for Investors

  • FDA approval and 10-year exclusivity materially de-risk regulatory path; IP extends into 2039, supporting durable branded economics in an underserved, resistance-challenged uUTI market .
  • Liquidity runway into H2 2025, bolstered by $4.8M ATM and repayment of exchangeable notes, supports strategic transaction timeline and pre-commercial groundwork; monitor cash burn and timing of Pfizer milestone repayment accruals at 8% .
  • Near-term stock drivers: Evidence of partner interest/transaction terms; clarity on commercialization path (partnered vs. direct); payer access and pricing positioning as the “first oral penem” .
  • Financial trajectory improved YoY on R&D normalization post-REASSURE; watch G&A/legal spend and non-cash derivative adjustments tied to approval-related valuation changes .
  • Expansion optionality: EU pathway may proceed without new trials; China/Japan need local studies; potential cUTI step-down indication could expand TAM with one additional study .
  • Operational focus: Targeted launch planning (physician targeting, geography analytics, patient services) aims to accelerate early adoption within elevated-risk patient segments .
  • Actionable: Position around strategic alternatives and commercialization inflection; scrutinize balance sheet flexibility, capital raising cadence, and any guidance on launch timing/scale from subsequent updates .