KalVista Pharmaceuticals, Inc. (KALV)·Q1 2026 Earnings Summary

Executive Summary

• First commercial quarter post-FDA launch: net product revenue $1.426M, driven primarily by specialty pharmacy stocking; net loss widened to $(60.1)M on SG&A launch spend; cash and marketable securities $191.5M with runway into 2027 .
• Rapid early demand for EKTERLY: 460 patient start forms in eight weeks (~5% of U.S. HAE population), 253 unique prescribers activated (38% writing for multiple patients), and >4,000 patients/caregivers in the database; first paid shipments and refills began in August .
• Ex‑U.S. catalysts: UK MHRA approval secured; EMA CHMP positive opinion with EC decision expected early October; Japan approval anticipated by year-end with early 2026 launch via Kaken .
• Outlook/guardrails: management expects operating expenses to remain relatively consistent as launch investments continue; reporting transitions to calendar quarters beginning with 9/30/25; runway intact through 2027 .

What Went Well and What Went Wrong

What Went Well

• “Defining moment” launch momentum: “Approval and launch on the same day…In just eight weeks…460 patient start forms…almost five percent of the reported HAE patient population in the US” (CEO) .
• Broad prescriber and patient engagement: 253 unique prescribers activated; field team reached 72% of physician base and 96% of tier‑one physicians; >4,000 individuals in the patient database .
• Ex‑U.S. regulatory positioning: UK approval, CHMP positive opinion, and EMA orphan status maintained; EC decision expected early Oct; UK NICE decision anticipated 1H26 .

What Went Wrong

• Heavy launch OpEx and financing costs drove wider loss: SG&A $44.7M (vs $17.6M YoY) and interest expense $3.5M linked to royalty financing; net loss $(60.1)M vs $(40.4)M YoY .
• Access still normalizing: 100% of start forms used Quick Start as intended; payer policies still forming with occasional step‑through of generic icatibant, though most patients qualify due to prior use .
• Early revenue mostly channel build: $1.426M revenue “primarily from stocking orders by specialty pharmacies,” creating near‑term variability in shipment-to-use dynamics .

Financial Results

Core P&L vs prior periods

Notes: Gross margin % is calculated from reported revenue and cost of revenue. Company noted cost of revenue does not yet include full manufacturing cost until pre‑launch inventory is exhausted .

Balance sheet liquidity trend

Operating expense breakdown (launch mix shift)

Launch KPIs (operational)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “This quarter marked a defining moment…Approval and launch on the same day…In just eight weeks…460 patient start forms…almost five percent of the reported HAE patient population in the US.” — Benjamin Palleiko, CEO .
• “We are observing encouraging signs…activated 253 unique prescribers…our field sales team has reached over 72% of the total physician base, including 96% of the tier one physicians.” — Nicole Sweeny, CCO .
• “We are pleased to announce the first sales of ECTERLEET, reporting $1.4 million in net revenue…Total operating expenses…$60.4 million…We expect operating expenses to remain relatively consistent as we continue to invest in the ECTERLEET launch.” — Brian Piekos, CFO .
• “We anticipate a staged launch in Europe over the next 12 to 18 months…UK commercial launch in the first half of 2026…approval in Japan at the end of this year and launch…in early 2026.” — Benjamin Palleiko, CEO .

Q&A Highlights

• Access conversion mechanics: 100% of start forms concurrently enroll in Quick Start; KalVista pursues medical exceptions to transition to paid; second free shipment provided if needed during exception processing .
• Early payer experience: first paid shipments and first paid refills began within weeks; occasional step‑through of generic icatibant seen but often satisfied given 80% prior use among patients .
• Utilization details: initial prescriptions typically two boxes; refills often “p.r.n.” based on attack burden; re‑dose rates in low‑20% range in OLE, not seen as a concern; minimal AE signals post‑launch .
• Demand drivers: growth not a one‑time bolus from OLE rollover (only “dozens” of U.S. OLE patients); trajectory linear and broad across prophylaxis backgrounds .
• Channel/inventory: specialty pharmacies expected to carry 2–4 weeks on average, with some variability early in launch .

Estimates Context

• S&P Global consensus for Q1 2026 (revenue/EPS) was unavailable at the time of analysis; as such, we cannot provide beat/miss comparisons to Street estimates for this quarter [GetEstimates returned no data].
• Implications: near‑term estimate updates likely to focus on (i) pace of conversion from start forms to paid scripts/refills, (ii) payer policy parity and potential step‑edits, (iii) ex‑U.S. approval timing (EU, Japan) and contribution phasing, and (iv) SG&A/interest expense run‑rate through 2025 based on launch investment and royalty financing .

Key Takeaways for Investors

• Early adoption is strong and broad: 460 start forms (~5% U.S. HAE population) with 253 prescribers and high tier‑one reach; monitor paid conversion and refill cadence as primary revenue drivers over next 1–2 quarters .
• Access normalizing as expected: Quick Start bridging to medical exceptions, with first paid shipments and refills underway; limited step‑through headwinds mitigated by prior generic icatibant use in most patients .
• Ex‑U.S. catalysts are near‑term: EC decision early October, UK NICE decision 1H26, Japan approval by year‑end with early 2026 launch—potential step‑ups to consensus trajectories once timing is confirmed .
• Expense and cash guardrails: SG&A remains elevated to support launch; royalty financing adds interest expense; cash/securities $191.5M supports runway into 2027, reducing near‑term financing risk .
• Modeling note: Q1 revenue primarily channel stocking; specialty pharmacy inventory targets 2–4 weeks; expect some early variability between shipments and patient use .
• Margin construction: initial gross margin reflects partial cost of revenue due to pre‑launch inventory accounting; gross margin should normalize as manufactured inventory sold post‑approval flows through COGS .
• Reporting shift: transition to calendar quarters starting with 9/30/25 improves comparability vs peers; watch the first full calendar quarter (Q3CY25) for clean directional reads on paid utilization .

Appendix: Primary Source Documents

• Q1 2026 8‑K (Ex. 99.1 press release, financial tables) .
• Q1 2026 10‑Q (financial statements, MD&A, accounting notes) .
• Q1 2026 earnings call transcript (prepared remarks and Q&A) .
• Prior quarter references: Q3 2025 8‑K/PR (Jan 31, 2025) ; FY2025 release (Apr 30, 2025) .
• Regulatory press releases: UK MHRA approval ; EMA CHMP positive opinion .