EPS of $-1.12 decreased by 9.8% from previous year
Gross margin of 58.6%
Net income of -60.10M
""FDA approved EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. This approval has positioned EKTERLY to transform the treatment paradigm globally for people living with HAE."" - Benjamin Palleiko
KalVista Pharmaceuticals Inc (KALV) QQ1 2026 Results Analysis — Early US Launch of EKTERLY Drives Modest Revenue but Funds Global Commercial Expansion Amid Material Operating Losses
Executive Summary
KalVista reported its QQ1 2026 results (three months ended July 31, 2025) with US commercial launch of EKTERLY (oral on-demand therapy for acute HAE attacks) generating first net revenue of $1.4 million. Revenue was modest relative to operating costs as the company advances its EKTERLY launch and global expansion plans. Key takeaways include: (1) EKTERLY achieved early commercial traction post-approval, with 460 patient start forms in the 8 weeks ended Aug 29 and >4,000 patient community members in KalVista’s database, suggesting meaningful demand and payer/physician interest; (2) operating expenses remained elevated at $60.4 million for the quarter, driven by launch-related SG&A (~$44.7 million) and R&D (~$15.2 million), resulting in a quarterly EBITDA of approximately -$59.0 million and a net income of -$60.1 million; (3) the company ended the period with substantial liquidity (~$191 million in cash and investments) and signaled funding through 2027 on the basis of EKTERLY revenue and operating plan, with a calendar-year reporting shift planned later in 2025; (4) management emphasized EKTERLY’s potential to redefine HAE care, ongoing regulatory progress overseas, and the need to manage payer access and rapid uptake efficiently. The combined effect is a high-burn but strategically oriented launch with meaningful near-term revenue visibility and a clear runway to 2027, contingent on continued adoption and international expansion.
Operating expenses: $59.845 million (R&D $15.162 million; SG&A $44.683 million)
EBITDA: -$59.009 million; EBITDAR: -$41.381 million; Operating income: -$59.009 million; Net income: -$60.096 million
Net income margin: -42.14%; EPS: -$1.12; Weighted average shares: 53.497 million
Interest expense: -$3.522 million; Income before tax: -$57.939 million; Tax expense: $2.158 million
Financial Highlights
Revenue and profitability highlights:
- Revenue: $1.426 million; Gross profit: $0.836 million; Gross margin: 58.6%
- Operating expenses: $59.845 million (R&D $15.162 million; SG&A $44.683 million)
- EBITDA: -$59.009 million; EBITDAR: -$41.381 million; Operating income: -$59.009 million; Net income: -$60.096 million
- Net income margin: -42.14%; EPS: -$1.12; Weighted average shares: 53.497 million
- Interest expense: -$3.522 million; Income before tax: -$57.939 million; Tax expense: $2.158 million
- Revenue YoY: +18.24%; Gross profit YoY: -15.30%; Operating income YoY: -21.78%; Net income YoY: -34.59%; EPS YoY: -9.80%
Balance sheet and liquidity:
- Cash and cash equivalents: $124.3 million; Total cash & short-term investments: $191.5 million
- Total assets: $215.5 million; Total current assets: $205.9 million
- Total liabilities: $136.3 million; Total stockholders’ equity: $40.8 million; Retained earnings: -$713.3 million
- Long-term debt: ~$4.0 million; Net debt: -$118.2 million (net cash position)
Cash flow and liquidity:
- Net cash provided by operating activities: -$54.5 million; Free cash flow: -$54.5 million
- Net cash used in investing activities: -$21.3 million; Net cash provided by financing activities: $23.2 million; FX impact: +$2.7 million
- Net change in cash: -$7.3 million; Ending cash: ~$$124.96 million
Strategic implications:
- EKTERLY launch is in its early days with strong signals of demand and adoption, but profitability remains distant as the company pursues a capital-intensive global rollout. Management views EKTERLY as potentially foundational for HAE care, with regulatory momentum in Europe and planned launches in the UK (2026) and Japan (2026) implying meaningful near- to mid-term expansion opportunities.
Income Statement
Metric
Value
YoY Change
QoQ Change
Revenue
1.43M
18.24%
N/A
Gross Profit
836.00K
-15.30%
N/A
Operating Income
-59.01M
-21.78%
-37.42%
Net Income
-60.10M
-34.59%
-23.89%
EPS
-1.12
-9.80%
-21.74%
Key Financial Ratios
Net Income vs. Revenue
Expense Breakdown
Management Commentary
Theme: Launch progress and strategic positioning
- Quote 1 (CEO Ben Palleiko): "FDA approved EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. This approval has positioned EKTERLY to transform the treatment paradigm globally for people living with HAE." This underscores KalVista’s strategic thesis that EKTERLY could redefine standard of care in HAE.
- Quote 2 (CCO Nicole Sweeny): "In the 8-week period ending August 29, we received 460 patient start forms. Early demand has largely come from patients previously on Firazyr and icatibant as expected, but also from all other on-demand therapies... we are seeing patients on all prophylactic therapies adopt EKTERLY at similar rates." This highlights robust early demand and a broad-addressable market, including patients on various prophylaxis regimens.
Theme: Commercial execution and KPIs
- Quote 3 (CCO Nicole Sweeny): "From launch through August 29, we have activated 253 unique prescribers with 38% of those starting multiple patients on EKTERLY. Our field team has reached over 72% of the total physician base, including 96% of Tier 1 physicians." This indicates strong early payer/provider engagement and solid field execution.
Theme: Financials and runway
- Quote 4 (CFO Brian Piekos): "The first sale of EKTERLY reporting $1.4 million in net revenue for the launch period... We expect operating expenses to remain relatively consistent as we continue to invest in the EKTERLY launch."
- Quote 5 (CEO Ben Palleiko): "We expect EKTERLY to redefine the standard of care... the rapid adoption reinforces our belief that EKTERLY can redefine the standard of care for people living with HAE."
Theme: Access and payer dynamics
- Quote 6 (CCO Nicole Sweeny): "Quickstart provides immediate access to EKTERLY at no charge... medical exception approvals drive paid access over time. If medical exception is approved, shipments proceed without delay to payer-funded channels." This captures the payer access trajectory and operational mechanics embedded in the launch plan.
"FDA approved EKTERLY as the first and only oral on-demand therapy for acute HAE attacks in adults and pediatric patients aged 12 and older. This approval has positioned EKTERLY to transform the treatment paradigm globally for people living with HAE."
— Benjamin Palleiko
"In the 8-week period ending August 29, we received 460 patient start forms. Early demand has largely come from patients previously on Firazyr and icatibant as expected, but also from all other on-demand therapies, and we are seeing patients on all prophylactic therapies adopt EKTERLY at similar rates."
— Nicole Sweeny
Forward Guidance
Summary: Management signaled a funding runway into 2027 anchored by EKTERLY revenue and ongoing cash generation from the US launch, with no formal full-year revenue targets disclosed. Key points include:
- The company expects operating expenses to remain relatively stable in 2025 as EKTERLY launch investments continue, indicating a controlled burn in the near term while ramping commercial activities.
- Funding stance: KalVista stated cash and investments (~$191 million) plus forecast EKTERLY revenue are expected to support operations into 2027, implying a multi-year liquidity runway provided the uptake trajectory remains on plan.
- Regulatory and geographic expansion: Ongoing regulatory progress in Europe (CHMP positive, EC decision anticipated in Oct; UK MHRA marketing authorization; potential Japan approval late 2025 with launch in 2026) supports a multi-country growth path that could materially alter the revenue mix if successful.
- Metrics to monitor: progression of paid access vs. Quickstart, payer approvals by market, replenishment/refill rates, repeat prescriptions, and dose utilization per patient as adoption matures.
Assessment: The near-term outlook hinges on the pace of payer coverage and geographies entering commercial mode. If EKTERLY achieves sustained payor coverage across major territories and a meaningful portion of the HAE population converts to paid prescriptions, revenue could scale meaningfully toward the latter part of 2025 into 2026. However, given the current burn rate and lack of profitability, the investment case remains contingent on successful international expansion and a durable, scalable reimbursement path.
Competitive Position
Company
Gross Margin
Operating Margin
Return on Equity
P/E Ratio
KALV Focus
58.63%
N/A
N/A
N/A
COGT
0.00%
0.00%
-32.90%
-2.36%
KNSA
55.30%
9.63%
1.87%
47.24%
KRYS
94.30%
41.00%
3.63%
36.35%
KURA
1.00%
-4.59%
-15.80%
-2.51%
Gross Profit Margin
Operating Profit Margin
Return on Equity
P/E Ratio Comparison
Investment Outlook
KalVista’s QQ1 2026 results present a high-burn but strategically driven launch narrative. The key investment question centers on EKTERLY’s ability to translate early demand into sustained, payer-paid prescriptions across the US and, subsequently, international markets. Strengths include a credible path to a foundational therapy in HAE, solid early demand signals (460 start forms in 8 weeks; >4,000 in database), and meaningful regulatory tailwinds abroad. The company projects funding through 2027 based on EKTERLY revenue and current cash, implying a multi-year investment horizon rather than an imminent profitability turnaround. Risks include: (1) timely payer approvals and parity access in Europe/UK/Japan, (2) competition from established oral on-demand therapies and generics, and (3) execution risk in scaling the commercial operation and managing working capital as inventory and refill dynamics evolve. If EKTERLY achieves a scalable, payor-supported revenue trajectory, KalVista could see meaningful multiple expansion as profitability emerges. In a base-case scenario, investors should model continued cash burn until revenue escalates meaningfully post-2026 with successful international launches and payer access. A bear-case would hinge on slower payer adoption and competitive pressures, while a bull-case would require rapid payor coverage expansion and a favorable pricing/rate of uptake in multiple geographies.
Key Investment Factors
Growth Potential
EKTERLY has potential to become the foundational oral on-demand therapy for HAE globally, with regulatory momentum in EU/UK/Japan and potential partnerships in Canada and other countries. If premium pricing assumptions hold and payer coverage expands, the addressable market could expand beyond the US once international launches scale.
Profitability Risk
Primary risks include: slow payer approvals and access in key markets, competition from Berotralstat (BioCryst) and icatibant generics/step-throughs, regulatory delays in EU/Japan, execution risk on the EKTERLY launch, inventory and supply-chain challenges, and potential safety/tolerability issues affecting uptake. Financial risk arises from continued operating losses and the need to generate sustainable cash flow to fund the launch.
Financial Position
Solid liquidity with approximately $192 million in cash and investments at period end; net cash position with a reported net debt of -$118.2 million suggests substantial liquidity to fund operations into 2027. However, quarterly EBITDA of -$59.0 million and net income of -$60.1 million indicate a high burn rate until meaningful revenue scale is achieved. Management’s guidance to fund operations into 2027 relies on continued EKTERLY revenue growth and cost discipline.
SWOT Analysis
Strengths
First-mover in oral on-demand HAE therapy (EKTERLY) with FDA approval and ongoing international regulatory momentum
Early signals of demand and broad-based adoption across prophylaxis types (460 start forms in 8 weeks; 4,000+ patient database)
Strong commercial readiness and field execution (253 prescribers activated; 72% of total physician base engaged; 96% of Tier 1 physicians)
Robust liquidity with cash and investments (~$191M) and a stated runway into 2027
Strategic potential for multi-country launches (EU, UK, Japan) and potential partnerships
Weaknesses
Material operating losses and negative cash flow in QQ1 2026 (EBITDA -$59.0M; net income -$60.1M)
Revenue concentration at launch stage; dependency on EKTERLY uptake and payer access to reach profitability
Limited near-term visibility into sustained dose consumption and refill rates; early-stage profitability remains unproven
International expansion risks including regulatory timelines, pricing, and reimbursement variability
Opportunities
Expansion of EKTERLY into Europe (Germany launch pending approval; CHMP positive; orphan designation maintained) and UK/Japan launches in 2026
Potential for partnerships in Canada and other regions to accelerate access and reimbursement
Growing HAE patient awareness and education programs may support broader adoption and payer engagement
Possible future indications or line extensions leveraging plasma kallikrein inhibitor platform
Threats
Competition from BioCryst’s Orladeyo (berotralstat) and icatibant-based therapies, including generics
Regulatory and reimbursement hurdles in major markets could temper uptake and revenue ramp
Operational execution risk during rapid international rollout and payer negotiations
Safety, tolerability, and real-world adherence challenges impacting long-term usage