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**Modest but Encouraging Launch Progress**: 280+ ORLYNVAH prescriptions in first 10 weeks, 100+ unique prescribers.
- **2026 Revenue Guidance**: $5-15M with lean field team of 10 reps + virtual support.
- **Critical Capital Need**: $25-30M operating expenses; must raise funds to sustain growth.
- **Payer Momentum**: 16% insured lives covered, signed Medicare rebate agreement.
- **Physician Engagement**: 60% prescribers wrote multiple scripts; 40% scripts filled via payer process.

**【CEO Summary Section】**
- Launched ORLYNVAH in August 2025, generating 280+ prescriptions through November 12, 2025, with 100+ unique prescribers.
- 2026 net product revenue guidance: $5-15 million, achieved with a reduced field team of 10 reps (originally planned 20 reps).
- Operating expenses for 2026: $25-30 million; current cash runway extends into Q2 2026.
- Must raise capital to continue commercialization; seeking shareholder approval for additional share issuance.

**【CFO Financial Commentary】**
- Q3 2025 net product sales: $400,000 (includes specialty pharmacy stocking).
- Total operating expenses: $8.1 million (Q3 2025) vs. $4.9 million (Q3 2024), driven by commercialization costs.
- Net loss: $9 million (GAAP) / $7.3 million (non-GAAP) for Q3 2025.
- Cash on hand: $11 million as of September 30, 2025; AT-the-market offering raised $2.6 million through November 13, 2025.

**【Q&A Highlights】**
- **Sales Metrics**: 280+ prescriptions, 100+ prescribers, 40% fill rate through specialty pharmacy.
- **Payer Coverage**: 16% of insured lives covered; signed rebate agreement with top Medicare PBM.
- **Field Team Strategy**: 10 in-person reps + virtual reps to cover 20+ high-value territories efficiently.
- **Capital Needs**: Must raise funds to expand into new territories and maintain commercial momentum.
- **Physician Feedback**: 60% of prescribers wrote >1 script; 40% of scripts filled via payer approval process.


Iterum Therapeutics plc (ITRM) Q3 2025 Earnings Call Transcript

- **Accelerated Launch**: ORLYNVAH set to launch August 20, 2025, targeting 26 million at-risk UTI patients in a $40M+ market.
- **Strong Financial Position**: $13M cash on hand, with $2.2M raised in Q3 2025, supporting operations into 2026.
- **Strategic Flexibility**: Proposed 80M share increase (100% of current authorized) to fund commercial expansion.
- **Long-Term IP Protection**: 10-year market exclusivity and patents expiring 2039-2041, ensuring dominance in the UTI space.

**【CEO Opening Remarks】**
- **ORLYNVAH Launch Update**: Expected to launch on August 20, 2025, ahead of the previously announced timeline. This will make it the first new branded oral treatment for uncomplicated urinary tract infections (UTIs) in the U.S. in over 25 years.
- **Market Opportunity**: The U.S. UTI market generates ~40 million annual prescriptions, with ~26 million for at-risk patients (elderly women, those with comorbidities). ORLYNVAH targets this underserved population.
- **Commercial Strategy**: 
  - Initial launch in 20 high-prescription territories across 7 states, covering ~2,300 high-value physicians (primarily PCPs, OB/GYNs, urologists).
  - Specialty pharmacy partnerships to optimize speed to therapy (e.g., overnight delivery, prior authorization support).
- **Manufacturing & Supply**: 
  - Signed a commercial supply agreement with ACS Dobfar for long-term production.
  - Current U.S. inventory sufficient for demand through mid-2026.
  - Shelf life of 6 years, providing competitive advantage over shorter-dated products.
- **Intellectual Property**: 
  - 10 years of market exclusivity (expiring 2034) and patents expiring 2039-2041, ensuring a strong competitive moat.

**【CFO Financial Commentary】**
- **Q2 2025 Financials**: 
  - Total operating expenses: $5.5 million (vs. $4 million in Q2 2024).
  - Net loss (GAAP): $6.5 million (vs. $5 million in Q2 2024).
  - Non-GAAP net loss: $5.1 million (vs. $3.8 million in Q2 2024).
- **Cash Position**: $13 million as of June 30, 2025, plus $2.2 million raised in July-August 2025. Sufficient to fund operations into 2026.
- **Share Authorization Proposal**: 
  - Requesting shareholder approval to increase authorized shares by 80 million (100% increase), enabling flexibility for future financings.
  - Seeking waiver of pre-emption rights to access less dilutive funding options.


Iterum Therapeutics plc (ITRM) Q2 2025 Earnings Call Transcript

- **ORLYNVAH Launch Target**: U.S. commercialization expected by Q4 2025 with product ready for launch.
- **Market Potential**: Addressable market of 26M high-risk patients could generate $250M+ in peak sales.
- **Financial Strength**: $17.9M cash runway post-recent equity raises, supporting operations into 2026.
- **Key Risk**: Reliance on internal commercialization without a strategic partner.

**【CEO Opening Remarks】**
- **Strategic Focus**: Iterum remains open to business development discussions but prioritizes the urgent commercialization of ORLYNVAH for U.S. patients with limited UTI treatment options.
- **Market Opportunity**: U.S. UTI market generates ~40M annual prescriptions, with 26M for high-risk patients (elderly, diabetic, recurrent infections). A 1% market share could yield $250M in peak year sales.
- **Commercialization Plan**: 
  - Phase 1: Launch in limited territories based on antibiotic resistance rates, prescribing physician volume, and managed care access.
  - Phase 2: Expand territories or deepen penetration in existing areas, contingent on capital availability.
- **Timeline**: Targeting a Q4 2025 launch with product already manufactured.
- **Financial Health**: Repaid $28M in exchangeable notes in January, extending cash runway into 2026.

**【CFO Financial Update】**
- **Q1 2025 Results**: 
  - Total operating expenses: $3.7M (down 40% YoY)
  - R&D costs: $0.6M (down 85% YoY due to REASSURE trial winding down)
  - G&A costs: $2.8M (up 27% YoY for pre-commercialization activities)
  - Net loss (GAAP): $4.9M (down 31% YoY)
  - Non-GAAP net loss: $3.3M (down 43% YoY)
- **Cash Position**: $12.7M as of March 31, plus $5.2M from recent equity raises, sufficient for operations into 2026.

**【Q&A Highlights】**
- **Partnership Progress**: No material updates on BD discussions; focus remains on internal commercialization with EVERSANA.
- **Launch Readiness**: No major hurdles identified; manufacturing complete and regulatory path clear.
- **Capital Needs**: Additional funding required for Phase 2 expansion, but current runway supports Q4 launch.

Iterum Therapeutics (ITRM)-13 May 25-2025 Q1 Earnings call transcript

- **Breakthrough Approval**: ORLYNVAH is the first oral penem in the U.S., addressing a $40B UTI market with 20-30% antibiotic resistance rates.
- **Strong Intellectual Property**: 10-year exclusivity + patents to 2039, safeguarding against generics.
- **Active Strategic Outreach**: Engaging ~dozens of potential partners; parallel pre-commercialization ensures 2025 launch readiness.
- **Financial Stability**: $29M cash runway into H2 2025; $20M Pfizer milestone deferred with 8% interest.


**【CEO Opening Remarks】**
- **FDA Approval Milestone**: ORLYNVAH (oral sulopenem) received FDA approval in October 2024, becoming the first and only oral penem in the U.S. for treating uncomplicated UTIs in high-risk adult women.
- **Market Opportunity**: U.S. UTI market generates ~40M annual prescriptions, with rising resistance rates (20-30%) in existing treatments. ORLYNVAH targets 1% of patients with no alternative oral options.
- **Exclusivity & Patent Protection**: 10-year marketing exclusivity (until 2034) and U.S. patents extending to 2039, providing robust protection against generics.
- **Strategic Process**: Actively engaging with ~dozens of potential partners (pharma, financial investors) for licensing/sale; parallel pre-commercialization activities underway.
- **Financial Position**: Cash of $24.1M as of Dec 2024, with sufficient funds to operate into H2 2025; $20M milestone payment to Pfizer deferred with 8% interest-bearing note.

**【CFO Financial Update】**
- **Q4 2024 Operating Expenses**: $3.7M (vs. $11.4M Q4 2023), driven by reduced R&D costs post-REASSURE trial completion.
- **Full Year 2024 Net Loss**: $24.8M (GAAP) / $17.6M (non-GAAP), down 46% vs. 2023 due to lower R&D spend.
- **Cash Position**: $24.1M + $4.8M ATM proceeds (Jan-Feb 2025) → ~$29M total liquidity.
- **Milestone Payment**: $20M Pfizer obligation deferred until 2026, accruing 8% interest.

**【Q&A Highlights】**
- **Partnering Strategy**: Engaging with pharma companies and financial investors; no definitive offers yet, but active dialogue continues.
- **Pre-Launch Activities**: Conducting payor/physician research, targeting analysis, and market readiness to enable direct launch if strategic deal fails.
- **Regulatory & Commercial Readiness**: All pre-commercial activities aligned with FDA requirements; commercial launch plan in development.


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