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KalVista Pharmaceuticals, Inc. (KALV)·Q4 2025 Earnings Summary

Executive Summary

  • EKTERLY launch momentum drove $13.7M in net product revenue in the quarter ended September 30, 2025, with refill behavior at the high end of expectations among high-burden patients; gross-to-net landed toward the low end of management’s anticipated range .
  • 937 patient start forms and 423 unique prescribers through October reflect broad uptake; repeat prescribers account for 75% of start forms, signaling rising confidence and utilization depth .
  • Cash, cash equivalents, and marketable securities of ~$309.2M; management expects this, plus EKTERLY revenues, to fund operations through profitability; recent $144M convertible notes bolster flexibility .
  • Ex-U.S. launch began in Germany with first-day commercial sales; approvals also secured in EU, Switzerland, and Australia, with U.K. pricing/reimbursement underway and Japan launch planned with partner Kaken in early 2026 .
  • Wall Street consensus (S&P Global) for the reported quarter was unavailable; dispersion acknowledged by management, implying potential estimate recalibration as utilization normalizes beyond high-burden cohorts .

What Went Well and What Went Wrong

What Went Well

  • “US launch of EKTERLY is progressing with significant momentum…sustained uptake and confidence,” supported by $13.7M net product revenue and strong early demand .
  • Broad adoption across patient segments: 937 start forms, 423 prescribers, high awareness and repeat prescribing (75% of start forms from repeat prescribers) .
  • Ex-U.S. commercialization: Germany launch recorded first-day sales; approvals added in EU, Switzerland, Australia; management sees EKTERLY “on its way to becoming the foundational therapy for HAE” .

What Went Wrong

  • SG&A expanded materially with commercialization ($46.5M vs $24.8M YoY); operating loss widened ($46.1M) and net loss deepened ($49.5M) with EPS of $(0.92) vs $(0.84) YoY .
  • Near-term revenue cadence may be “bumpy” as refill rates and quantities normalize; holiday season expected to slow start form growth; specialty pharmacies still building inventory .
  • Formal payer coverage still maturing—access relies on medical exceptions; some policies require step-through icatibant (minority), though patients generally progress quickly given prior exposure .

Financial Results

MetricQ3 2024Q1 2026 (Quarter Ended Jul 31, 2025)Q3 2025 (Quarter Ended Sep 30, 2025)
Product Revenue, Net ($MM)$0.0 $1.426 $13.692
Cost of Revenue ($MM)$0.0 $0.590 $1.232
Operating Expenses ($MM)$43.480 $60.435 $59.742
Operating Loss ($MM)$(43.480) $(59.009) $(46.050)
Interest Income ($MM)$1.580 $1.849 $1.875
Interest Expense ($MM)$0.000 $(3.522) $(4.757)
FX Gain/(Loss) ($MM)$1.072 $1.925 $(0.884)
Other Income, Net ($MM)$1.744 $0.818 $2.491
Total Other (Expense)/Income ($MM)$4.396 $1.070 $(1.275)
Net Loss ($MM)$(39.084) $(60.096) $(49.482)
Diluted EPS ($)$(0.84) $(1.12) $(0.92)
Weighted Avg Shares (MM)46.591 53.497 53.884

Balance Sheet and Liquidity

MetricDec 31, 2024Jul 31, 2025Sep 30, 2025
Cash, Cash Equivalents & Marketable Securities ($MM)$268.345 $191.465 $309.158
Total Assets ($MM)$294.816 $215.505 $339.931
Total Liabilities ($MM)$130.457 $174.715 $322.932
Stockholders’ Equity ($MM)$164.359 $40.790 $16.999

KPIs

KPIValueContext/Period
Patient Start Forms (PSFs)937 Through Oct 31, 2025
Unique Prescribers423 Through Oct 31, 2025
Repeat Prescriber Share75% of PSFs Launch to date
Refill FrequencyEvery 3–4 weeks (early cohort) High-burden patients; expected to normalize
Gross-to-NetLow end of expected range Q3 2025
Cartons/ShipmentHigh end of expected range Q3 2025
Medical ExceptionsApproved across all PBMs & large payers Since approval
Policy StatusMajority PA to label; minority step-through icatibant In progress, formalization targeted early 2026

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
SG&A ExpensesRemainder of 2025Operating expenses to remain relatively consistent SG&A to remain relatively consistent as investment in global launch continues Maintained
Access PoliciesEarly 2026Formal coverage typically takes ~6 months post-approval Advancing with PBMs/national payers; aim to formalize early 2026 Maintained (timeline reaffirmed)
Cash RunwayThrough profitability~$191.5M cash funds operations into 2027 (pre-convert) ~$309.2M cash; plus EKTERLY revenues expected to fund through profitability (post-convert) Raised confidence (financing + revenue trajectory)
Ex-U.S. Launch2026EU approval decision expected Oct; Germany first Germany launched (Oct); U.K. launch 1H26; Japan Q1 2026 via Kaken Progressed to execution

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2: Q1 2026 call; Q-1: FY2025 update)Current Period (Q3 2025 call)Trend
Commercial Launch KPIs460 PSFs; 253 prescribers; early paid access via medical exceptions; inventory build; quick-start program 937 PSFs; 423 prescribers; 75% repeat prescribers; refills every 3–4 weeks among high-burden patients; cartons/shipment high end; gross-to-net low end Accelerating, deepening utilization
Payer CoverageFormal coverage ~6 months; parity expected; isolated step-through cases manageable Majority PA to label; minority step-through icatibant; broad medical exceptions success; formalization targeted early 2026 Progressing as expected
International ExpansionEU decision expected Oct; UK approved; partner deals (Japan, Canada) Germany launched; UK pricing/reimbursement ongoing for 1H26 launch; Japan launch Q1 2026 via Kaken Moving from regulatory to commercial
R&D ExecutionPediatric ODT program progressing; OLE showing low re-dose rates; safety favorable KONFIDENT-KID interim: median 30 min to dosing; 1.5h to symptom relief; high attack frequency unmasked; 84% satisfaction in KONFIDENT-S Strong data expanding TAM (adolescents; pediatrics)
Patient Satisfaction/BehaviorEarly anecdotal satisfaction; laryngeal attack treated successfully; minimal AEs 84% satisfied; median satisfaction score “2” (very satisfied); second dose use declines with experience Reinforcing stickiness and dosing confidence

Management Commentary

  • “We continue to see encouraging trends…sustained uptake and confidence in the clinical value of EKTERLY as the first and only oral on-demand treatment for hereditary angioedema.” – CEO Ben Palleiko .
  • “Acceleration in utilization, repeat prescribing, and growing favorable access provide a clear signal: EKTERLY is quickly on its way to becoming the foundational therapy for HAE treatment.” – CCO Nicole Sweeney .
  • “With our recent convertible note offering, we are fully financed through profitability, allowing us to remain sharply focused on executing the EKTERLY launch while evaluating additional growth opportunities.” – CEO Ben Palleiko .
  • “Interim results from KONFIDENT-KID…median time to dosing of 30 minutes and median time to symptom relief of 1.5 hours; no treatment-related adverse events.” – CMO Dr. Paul Audia .

Q&A Highlights

  • Early adopters skew high-burden: ~50% self-report ≥2 attacks/month; higher refill rates and quantities; expected to normalize as adoption broadens .
  • Quantity limits consistent with branded on-demand norms; not impeding access; holidays may slow PSF growth seasonally .
  • Stockpiling vs utilization: unknown proportion; guidelines encourage keeping enough for multiple attacks; refill volumes above initial expectations even for lower-burden patients .
  • Payer dynamics: majority policies PA to label; minority step-through icatibant; medical exceptions successful across PBMs and large payers; formalization targeted early 2026 .
  • Germany pricing undisclosed; U.K. launch targeted 1H26; broader EU rollouts late 2026; Japan Q1 2026 with Kaken .

Estimates Context

  • Wall Street consensus via S&P Global for the reported quarter was unavailable; estimate comparisons cannot be made reliably at this time. Values retrieved from S&P Global.
  • Management highlighted a wide dispersion (over threefold gap) in external models, reflecting early-stage uncertainty and fiscal-year transition; expect normalization as utilization patterns broaden beyond high-burden cohorts .

Key Takeaways for Investors

  • Launch quality is high: strong PSF momentum, high repeat prescribing, and early refills every 3–4 weeks among high-burden patients suggest meaningful real-world reliance; expect refill cadence to moderate as patient mix broadened .
  • Access is progressing as planned: medical exceptions working across PBMs/large payers; majority policies PA to label; minority step-throughs manageable given prior icatibant experience; formalization targeted early 2026 .
  • Financial flexibility improved: ~$309M cash plus ongoing EKTERLY revenues and $144M convertible notes support global launch through profitability; watch SG&A staying “relatively consistent” near term .
  • International optionality: Germany launch underway; U.K. and Japan expected in 1H/Q1 2026; EU approvals broaden addressable market, adding catalysts for volume and revenue ramp .
  • Pediatric expansion could enlarge TAM: KONFIDENT-KID interim results show rapid symptom relief, high attack frequency unmasked, and favorable tolerability; NDA planned Q3 2026 .
  • Trading implications: near-term seasonality may temper PSF cadence, while inventory builds and payer policy formalization could create quarterly revenue “noise”; medium term, broadened adoption and ex-U.S. launches should support sustained growth .
  • Monitor estimate revisions: lack of consensus data and management-noted dispersion suggest potential for recalibration as KPIs evolve and coverage formalizes; evidence of refill normalization should inform trajectory .