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KalVista Pharmaceuticals, Inc. (KALV)·Q2 2026 Earnings Summary

Executive Summary

  • EKTERLY launch momentum accelerated: net product revenue rose to $13.692M in Q2 2026 (quarter ended Sep 30, 2025), up from $1.426M in Q1 2026, as patient starts and prescriber activation scaled quickly .
  • Adoption KPIs were strong: 937 patient start forms and 423 unique prescribers through Oct 31; repeat prescribers drove 75% of start forms, supporting sustainability of demand .
  • Cash increased to $309.158M with recent convertible notes; management expects funding “through profitability,” reducing near-term financing risk .
  • No formal revenue/EPS guidance; management flagged seasonal demand moderation into holidays and variability from high-burden patient refills; investors should expect quarterly revenue lumpiness near-term .
  • Potential stock catalysts: payer coverage policies formalizing in early 2026, continued ex-U.S. launches (Germany underway; U.K. and Japan targeted 1H/early 2026) and pediatric NDA submission planned for Q3 2026 .

What Went Well and What Went Wrong

What Went Well

  • “US launch of EKTERLY is progressing with significant momentum” with $13.7M net product revenue and rapid adoption (937 start forms, 423 prescribers) .
  • Management emphasized “accelerating utilization, repeat prescribing, and growing favorable access,” positioning EKTERLY as foundational HAE therapy; prescriber awareness at 100% of tier-one and 95% of target HCPs .
  • Ex-U.S. execution: Germany launch recorded first-day commercial sales; approvals in EU, Switzerland, UK, and Australia broadened footprint .

What Went Wrong

  • Operating loss widened on commercialization investment: Q2 total operating expenses $59.742M vs $43.480M y/y; SG&A $46.517M vs $24.800M y/y, reflecting launch costs .
  • Near-term demand volatility expected: management cautioned holiday season softness, inventory build dynamics at specialty pharmacies, and higher refill quantities among high-burden early adopters .
  • No quantitative revenue/EPS guidance and S&P Global consensus data unavailable; management noted wide sell-side dispersion (over “threefold gap”), complicating modeling and expectations .

Financial Results

Consolidated P&L and Balance Metrics (USD Millions unless noted)

MetricQ1 2026 (Jul 31, 2025)Q2 2026 (Sep 30, 2025)Q2 2025 (Sep 30, 2024)
Product Revenue, net$1.426 $13.692 $0.000
Cost of Revenue$0.590 $1.232 $0.000
Research & Development$15.162 $11.993 $18.680
SG&A$44.683 $46.517 $24.800
Total Operating Expenses$60.435 $59.742 $43.480
Operating Loss$(59.009) $(46.050) $(43.480)
Net Loss$(60.096) $(49.482) $(39.084)
EPS (basic & diluted)$(1.12) $(0.92) $(0.84)
Cash, Cash Eq. & Mkt. Sec.$191.465 $309.158 $268.345

Estimates vs Actuals

MetricQ1 2026Q2 2026
Revenue ConsensusN/A (S&P Global consensus unavailable)N/A (S&P Global consensus unavailable)
EPS ConsensusN/A (S&P Global consensus unavailable)N/A (S&P Global consensus unavailable)

Note: S&P Global consensus data was unavailable for this period; values would otherwise be retrieved from S&P Global.

Segment Breakdown

SegmentQ1 2026 RevenueQ2 2026 Revenue
EKTERLY (net product revenue)$1.426 $13.692

Commercial KPIs

KPIQ1 2026Q2 2026
Patient Start Forms (cumulative)460 (through Aug 29) 937 (through Oct 31)
Unique Prescribers253 (activated) 423
Repeat Prescribers Share38% (early) 75% of start forms
HCP Awareness96% tier-one reached 100% tier-one, 95% target aware
Typical Refill FrequencyEarly stocking; not disclosed 3–4 weeks among early high-burden patients

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SG&A ExpenseRemainder of 2025N/ASG&A “to remain relatively consistent” as global launch investment continues Maintained spending run-rate
Cash RunwayThrough profitability$191M cash expected to fund into 2027 (FY25 context) $309M cash “expected to fund through profitability” Improved liquidity and duration
Payer Coverage PoliciesEarly 2026Policies take ~6 months to establish post-approval “Aim to formalize access in early 2026” with PBMs and national payers Timeline affirmed
Ex-U.S. Launches1H/early 2026Germany launch expected; UK/MHRA approval; CHMP positive Germany launched; UK pricing/reimbursement for 1H 2026; Japan approval/launch targeted early 2026 Executed Germany; timelines reiterated
Revenue/EPS2025–2026NoneNoneNo formal guide

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 2026, FY25)Current Period (Q2 2026)Trend
Product Performance & Adoption460 PSFs; 253 prescribers; strong KOL engagement 937 PSFs; 423 prescribers; repeat prescribers 75% of PSFs; broad switching from injectables Improving
Payer AccessQuick Start + medical exceptions; formal policies ~6 months Policies forming; PA to label common; minority step-through icatibant; aim to formalize early 2026 Improving
International ExpansionEU CHMP positive; UK MHRA approval; Germany expected; Japan/Canada partnerships Germany launched; UK NICE in process (1H 2026 target); Japan approval/launch targeted early 2026 Improving
R&D: Pediatrics (KONFIDENT-KID)Interim scale and timelines (CHMP orphan, pediatrics development) Median dosing 30 min; symptom relief 1.5 hours; higher attack frequency; pediatric NDA planned Q3 2026 Advancing
Inventory & Refill DynamicsSpecialty pharmacy stocking; 2–4 weeks typical inventory average Multiple cartons per refill among high-burden; expect normalization over time Normalizing over time
Estimates DispersionN/A“Over a threefold gap” across consensus; fiscal-year change complicates modeling Persistent

Management Commentary

  • CEO: “US launch of EKTERLY is progressing with significant momentum… We also recently launched EKTERLY in Germany… we now hold five regulatory approvals… With the successful closing of our recent $144 million convertible note offering, we have the financial resources to continue advancing our global launch strategy” .
  • CCO: “In less than four months since launch, we have received 937 start forms… 423 unique prescribers… Awareness levels are exceptionally high… repeat prescribers account for 75% of all start forms” .
  • CMO: Pediatrics interim data show median 30 minutes to dosing and median 1.5 hours to symptom relief; no treatment-related AEs reported, reinforcing EKTERLY’s potential to expand to younger populations .
  • CFO: “Sales of EKTERLY were $13.7 million… gross-to-net toward low end of expected range… operating expenses $59.7M… cash sufficient to fund operations through profitability” .
  • CEO closing: “With strong execution, a clear strategic runway, and a fully funded path through profitability, we believe we are well on our way to establishing EKTERLY as the foundational therapy for HAE” .

Q&A Highlights

  • Refill rates and quantity limits: High-burden patients refilling ~monthly with multiple cartons; quantity limits consistent with branded on-demand therapies and not impeding access; expect normalization as adoption broadens .
  • PSF trajectory: Linear growth to date; anticipated holiday season slowdown; longer-term penetration expected to broaden beyond high-burden cohort .
  • Stockpiling: Some evidence of higher refill quantities; guidelines encourage patients to keep treatment for 2–3 attacks on hand; utilization expected to moderate as base broadens .
  • Ex-U.S. pricing: Germany price not disclosed; U.K. launch targeted for 1H 2026; broader EU rollout toward late 2026 .
  • Consensus modeling: Management noted >3x dispersion across sell-side estimates post fiscal-calendar change, highlighting early-stage uncertainty .

Estimates Context

  • Wall Street consensus from S&P Global was unavailable for Q1 and Q2 2026; management emphasized wide dispersion (“over a threefold gap”) in sell-side models given early launch, refill dynamics, and fiscal-year change .
  • Implication: Expect near-term estimate revisions to track payer policy formalization, refill frequency normalization, and ex-U.S. revenue contribution; investors should anchor scenarios on observed PSF growth, repeat prescribing, and access trends .

Key Takeaways for Investors

  • EKTERLY adoption is broadening beyond early high-burden users; repeat prescribers and high awareness underpin persistent demand and support sustained PSF growth into 2026 .
  • Near-term revenue may be volatile due to holiday season effects, inventory builds, and higher refill quantities among early adopters; avoid over-extrapolating Q2 run-rate .
  • Liquidity inflection: $309M cash with expectation to fund through profitability reduces financing overhang and supports global launch execution .
  • Access milestones: Majority of emerging policies are PA-to-label; minority require icatibant step-through, typically surmountable; formalization targeted early 2026 .
  • Ex-U.S. growth drivers: Germany launch underway; U.K. reimbursement and Japan approval/launch in early 2026 can add multi-region revenue legs .
  • Pediatrics upside: KONFIDENT-KID interim data are favorable; pediatric NDA planned Q3 2026, potentially expanding addressable market and reinforcing “foundational therapy” positioning .
  • Modeling caution: With S&P Global consensus unavailable and sell-side estimates dispersed, triangulate with operational KPIs (PSFs, prescribers, refills) and management commentary on GTN and SG&A run-rate .