KalVista's Q3 2026: Contradictions Emerge on Access/Reimbursement Dynamics and Patient Burden/Adoption Trends

Date of Call: November 11, 2025

Financials Results

• Revenue: $13.7M for the launch period through September 30, 2025 (includes $1.4M recorded in July)

Guidance:

• SG&A expected to remain relatively consistent for the remainder of 2025.
• Cash position sufficient to fund operations through profitability following convertible note financing.
• Pediatric NDA submission for sebetralstat expected in Q3 2026.
• U.K. launch planning with NICE for H1 2026; Japan PMDA approval and launch expected in Q1 2026 with partner Kaken.
• Formal payer policies anticipated early 2026 while medical exceptions are used now.
• Gross-to-net expectations: upper teens to low-20s.

Business Commentary:

* EKTERLY Launch and Adoption: - KalVista Pharmaceuticals reported $13.7 million in sales for EKTERLY in Q3, reflecting its launch period. - The product has seen strong adoption, with over 937 start forms representing more than 10% of the HAE community within four months of launch. - The high-burden patients have been the early adopters, accounting for about 46% of these start forms and experiencing more than 2 attacks per month on average. - The strong uptake is attributed to patient satisfaction with EKTERLY's oral on-demand therapy, which offers a convenient alternative to injectable treatments.

• Patient Satisfaction and Switching Trends:
• EKTERLY has shown high patient satisfaction, with 84% of attacks treated rated as satisfied or extremely satisfied by participants in the KONFIDENT-S trial.
• The majority of switches to EKTERLY have been from injectable therapies like FIRAZYR and icatibant.

• The high satisfaction rates and the shift from injectables to EKTERLY are driven by the convenience, efficacy, and safety benefits of the oral on-demand therapy.

• Financial Performance and Gross-to-net:

• KalVista's gross to net came in at the low end of the expected range, primarily due to lower co-pay utilization this quarter.
• The company's total operating expenses were $59.7 million, with $12 million in R&D expenses and $46.5 million in SG&A expenses.

• The financial performance is being influenced by the initial launch costs and the ongoing investment in EKTERLY's global expansion, alongside the current healthcare landscape impacting co-pay utilization.

• Global Expansion and Market Access:

• KalVista is expanding EKTERLY's reach globally, with initial success in the German market following its launch in mid-October.
• In the U.S., EKTERLY policies are being established by multiple payers, with 100% awareness among Tier 1 HCPs and 95% among all-target HCPs.
• The global expansion and market access are supported by favorable pricing in Germany and ongoing negotiations with other countries, leveraging the strong clinical data and patient demand for EKTERLY.
  

  Sentiment Analysis:

  Overall Tone: Positive

  • Management: "We are highly encouraged" and "Demand for EKTERLY is strong." Reported $13.7M in sales for initial launch period and stated the company is "fully financed through profitability." Multiple commercialization and regulatory milestones (Germany launch, U.K./Japan progress, pediatric NDA timing) were presented as validating early momentum.

Q&A:

• Question from Maurice Raycroft (Jefferies LLC): Congrats on the great quarter. Maybe to start off, wondering if you could talk more about trends for types of patients who are switching to EKTERLY early on, particularly the high-burden patients? Are you putting percentages on how the 937 start forms break down? And how could these trends change over time?
  Response: About half of switchers self-report ≥2 attacks/month (high‑burden); they refill more and drive early utilization, and this share and intensity should decline as adoption broadens.

• Question from Maurice Raycroft (Jefferies LLC): For the 937 new starts, are you seeing more on what proportion is converting to drug? And are you breaking down paid versus free drug at this time?
  Response: Paid utilization is increasing week‑to‑week, medical exceptions are working consistently, and start forms correspond to active prescriptions.

• Question from Stacy Ku (TD Cowen): Are you willing to talk about refill rates/average number of doses for high‑burden patients, expected normalization versus claims data, quantity limits seen from payers, and comfort versus consensus given 937 start forms?
  Response: Early adopters show much higher refill frequency (around monthly) versus the typical 3–4 months; quantity limits are consistent with other on‑demand products and have not impeded access; rates should normalize over time.

• Question from Stacy Ku (TD Cowen): A carton is 2 doses, correct?
  Response: Yes.

• Question from Matthew Ryan Tan (Stifel): With multiple cartons per shipment, do you think there's any stockpiling behavior within patients given oral convenience, and how do you see that evolving?
  Response: Cannot precisely separate stockpiling from usage today; high self‑reported attack rates support genuine utilization and guidelines encourage keeping supply for 2–3 attacks.

• Question from Joseph Schwartz (Leerink Partners LLC): Do you expect the relatively linear PSF growth rate to continue or taper, and what price did you agree upon in Germany versus the U.S.?
  Response: PSF growth has been steady but may slow seasonally in Q4 and moderate in 2026; German price has not been disclosed.

• Question from Joseph Schwartz (Leerink Partners LLC): What about plans for other European countries in 2026?
  Response: U.K. approval secured and NICE discussions are underway for an H1 2026 launch; broader launches in larger European countries planned toward late 2026.

• Question from Jonathan Wolleben (Citizens JMP Securities, LLC): How many patients do you expect to ultimately trial EKTERLY—will adoption be broad including low‑burden patients or remain concentrated in high‑burden? And what is your expected gross-to-net range?
  Response: Management expects oral therapies to displace injectables over time and adoption to broaden beyond high‑burden patients.

• Question from Serge Belanger (Needham & Company, LLC): Is the initial focus on high‑burden patients a function of the market or targeted prescribers, and are start forms written PRN or limited in boxes/cartons?
  Response: Early focus is driven by both high patient demand and prescriber targeting; prescriptions are typically written PRN to allow flexible refills.

• Question from Serge Belanger (Needham & Company, LLC): Out of the $13.7M reported this quarter, how much was inventory, and did you exit the quarter at steady state?
  Response: Specialty pharmacies built inventory into the launch (supporting sales); this is not steady state and inventory will continue building ahead of demand.

• Question from Debanjana Chatterjee (JonesTrading Institutional Services, LLC): How are insurance negotiations progressing and how should we think about the cadence of payers coming online in H1 2026?
  Response: Expect roughly six months for payers to assess and establish policies; aim to have formal policies in place early 2026 while using medical exceptions now.

• Question from Debanjana Chatterjee (JonesTrading Institutional Services, LLC): You've mentioned early revenues can be bumpy as refill rates stabilize—how should we think about revenue trajectory in the next couple of quarters?
  Response: Near‑term revenue trajectory is uncertain due to holiday season, evolving refill patterns and normalization of usage; difficult to precisely forecast quarter‑to‑quarter.

Contradiction Point 1

Access and Reimbursement Dynamics

It involves changes in the company's expectations regarding access and reimbursement dynamics, which are crucial for revenue forecasting and market penetration.

Can you clarify the conversion rate of new starts to drug therapy and the current breakdown between paid and free drug? - Maurice Raycroft (Jefferies LLC, Research Division)

2026Q3: We are encouraged by the increasing paid rate week-to-week, with consistency in medical exception use and clarity in access paths. The access dynamics are proceeding as expected. - Nicole Sweeny(CMO)

Can you provide details on the Quickstart program and the timeline expectations for paid drugs? - Stacy Ku (TD Cowen)

2026Q1: All 460 start forms received Quickstart, with some patients already transitioning to paid shipments. Refills have begun, indicating positive payer response and sustained product adoption. - Nicole Sweeny(CMO)

Contradiction Point 2

Patient Burden and Adoption Trends

It highlights shifts in the patient demographic most likely to adopt the new therapy, which could impact market penetration and revenue projections.

What are the trends for patient types switching to EKTERLY early, especially high-burden patients? - Maurice Raycroft (Jefferies LLC, Research Division)

2026Q3: The rapid adopters are high-burden HAE patients reporting an attack rate of 2 or more per month, accounting for a significant portion of prescriptions and refills. These patients are benefiting immensely from EKTERLY. Over time, this trend is expected to decline as EKTERLY expands beyond this subpopulation. - Benjamin Palleiko(CEO)

Can you provide details on the patient profile, including attack frequency and severity? - Will Soghikian (Leerink)

2026Q1: Demand is across a wide range of patient types, including those with severe disease burden. The product appeals to patients seeking more severe disease management, with adoption among high burden patients. The use of prophylaxis also lines up with market share, demonstrating broad uptake. - Nicole Sweeny(CMO)