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- **Breakout Launch**: 937 start forms in 3 months, with 50% of adopters being high-burden patients (≥2 attacks/month) achieving 1-2 cartons/month refill rates.
- **Financial Strength**: $13.7M in Q3 sales, fully funded through profitability with $150M convertible notes.
- **Global Momentum**: Commercial launches in Germany and Japan (Q1 2026), with U.K. NICE discussions advancing.
- **Clinical Validation**: 84% patient satisfaction among switchers; KONFIDENT-KID trial validates EKTERLY's efficacy in children (0.8 attacks/month).

**【CEO Summary】**
- EKTERLY achieved strong early adoption with 937 start forms in the first 3 months, representing ~10% of the U.S. HAE community. High-burden patients (≥2 attacks/month) account for 50% of adopters, with refill rates of 1-2 cartons/month.
- Global expansion underway: Germany launched commercially in October, U.K. approval pending NICE pricing discussions, and Japan set for Q1 2026 with Kaken Pharmaceutical.
- Clinical data highlights: 84% of patients switching from injectables rated EKTERLY as 'satisfied' or better; KONFIDENT-KID trial shows 0.8 attacks/month in children aged 2-11.

**【CFO Financial Commentary】**
- Q3 2025 revenue: $13.7M (includes $1.4M from July launch). Gross to net ratio at low end of expected range (15-20%), driven by lower co-pay utilization.
- Operating expenses: $59.7M (R&D: $12M, SG&A: $46.5M). Fully funded through profitability via $150M convertible note offering.
- Cash position: Sufficient to support U.S. launch and global expansion without additional capital needs.

**【CCO Commercial Update】**
- Prescriber engagement: 423 unique prescribers, 75% of starts from repeat prescribers. 95% of target HCPs aware of EKTERLY.
- Payer access: All major PBMs and payers approve medical exceptions. Formal policies expected to roll out Q1 2026.
- Utilization trends: High-burden patients refill every 3-4 weeks, aligning with clinical trial data. Average cartons per refill aligns with guideline-recommended 2-3 attacks coverage.

**【Q&A Highlights】**
- **Patient Segmentation**: 50% of adopters are high-burden (≥2 attacks/month), 30% moderate (1-2 attacks/month), 20% low-burden. Refill rates expected to normalize to 1-2 refills/month as adoption broadens.
- **International Pricing**: German launch pricing confidential; U.S. gross to net ~15-20% vs. 20-25% for peers. Japan pricing TBD with partner.
- **Payer Dynamics**: 90%+ of policies allow immediate access; step edits for icatibant generics resolved quickly. No material quantity limits observed to date.
- **2026 Outlook**: U.S. growth to moderate as high-burden penetration saturates; Europe (U.K., Germany) and Japan to drive incremental growth. Global EKTERLY adoption expected to exceed 30% of addressable market by year-end.

KalVista Pharmaceuticals, Inc. (KALV) Q3 2026 Earnings Call Transcript

- **FDA Approval Success**: EKTERLY launched with 5% of U.S. HAE patients submitting prescriptions, exceeding expectations.
- **Global Expansion**: Regulatory approvals in Europe, UK, and Japan, with launches planned in Germany, UK, and Japan by early 2026.
- **Financial Stability**: $1.4M in initial revenue, $191M cash, and sufficient funding through 2027.
- **Market Growth Potential**: Updated market size reflects higher pricing, driven by EKTERLY's oral, on-demand advantage over injectables.
- **Access Progress**: 460 start forms processed, with paid access growing via medical exceptions and first refills completed.

**【Management Opening Remarks】**
- Ryan Baker provided an overview of the call, highlighting the FDA approval of EKTERLY and the initiation of the U.S. launch. He introduced the executive team and outlined the agenda, emphasizing the company's progress in regulatory approvals and commercial readiness.

**【CEO Summary Section】**
- **FDA Approval and Launch Success**: EKTERLY received FDA approval for acute HAE attacks, with 5% of the U.S. HAE population submitting prescriptions within weeks. The CEO highlighted the therapy's oral administration, rapid onset, and safety profile as key differentiators.
- **Global Regulatory Milestones**: Positive CHMP opinion in Europe, UK MHRA approval, and anticipated Japanese approval by year-end. Staged launches in Europe (starting with Germany) and Japan in early 2026. Progress with Canadian and other international partners.
- **Commercial Infrastructure**: Praise for the commercial team's execution, including partnerships and distribution networks, supporting the rapid launch.

**【CFO Financial Commentary】**
- **Revenue**: $1.4 million in net revenue from EKTERLY, primarily from specialty pharmacy stocking orders.
- **Operating Expenses**: $60.4 million for the quarter, with $45 million in SG&A driven by launch activities. Expect steady expenses through 2025.
- **Cash Position**: $191 million in cash, sufficient to fund operations into 2027.

**【Q&A Highlights】**
- **Access Dynamics**: Quickstart program provided immediate therapy access, with 460 start forms processed. Paid access via medical exceptions is growing, with first refills already occurring.
- **Patient Demographics**: Broad adoption across attack frequency and prophylaxis use, with 38% of prescribers starting multiple patients.
- **Market Growth**: Updated market size reflects higher branded pricing expectations, driven by EKTERLY's unique benefits over injectables.
- **Regulatory and Commercial Strategy**: Focus on securing orphan drug exclusivity in Europe and navigating step-through requirements with generics.


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