KalVista Pharmaceuticals (KALV) 25th Annual Needham Virtual Healthcare Conference summary

Commercial launch and product uptake

• EKTERLY, the first oral on-demand therapy for HAE, launched in the US in July and generated nearly $50 million in revenue in under six months, with over 20% of patients receiving prescriptions.

• The product also launched in Germany and Japan, with strong initial uptake and high satisfaction among patients and physicians in all markets.

• Uptake has been especially strong among high-need patients, with about one-third of this group in the process of switching to EKTERLY.

• Over 700 physicians had prescribed EKTERLY by the end of February, representing a significant portion of the addressable market.

• The sales force effectively covers the concentrated prescriber base, with most high-volume prescribers already engaged.

Market dynamics and competitive landscape

• The HAE market is stable, with about 70% of patients using both prophylaxis and on-demand therapies, and nearly all patients receiving on-demand prescriptions.

• EKTERLY is the only oral on-demand option, while the prophylactic segment has seen multiple new entrants and innovations in dosing schedules.

• Another oral on-demand competitor is expected to enter the market next year, but is not seen as meaningfully differentiated.

• EKTERLY is not yet considered the standard of care but is positioned to become the foundational therapy for new patients.

Access, reimbursement, and patient journey

• Initial access to EKTERLY has been primarily through medical exception, with formulary negotiations underway and broader coverage expected within a few quarters.

• All HAE therapies require prior authorization, and a step-through process with generic icatibant is anticipated for most payers.

• The Quickstart program allows patients to begin therapy immediately while commercial approval is processed, streamlining the patient experience.

• No significant issues with refills or payer restrictions have emerged, though quantity limits may be implemented in the future.