KalVista Pharmaceuticals NASDAQ: KALV CEO Ben Palleiko told investors at Needham & Company’s 25th Annual Healthcare Conference that the company has seen a strong early commercial launch for EKTERLY, which he described as the “first and only oral on-demand therapy for treatment of HAE attacks.” Palleiko said the company launched EKTERLY immediately after FDA approval last July and generated “just under $50 million” in revenue in a slightly less-than-six-month period.
According to Palleiko, EKTERLY has reached “something over 20% of all patients in the space who’ve received prescriptions,” with uptake he characterized as “really strong” and “really consistent.” He also pointed to early international momentum, including launches in Germany and Japan.
What management attributes to EKTERLY’s early traction
Palleiko said EKTERLY’s adoption reflects both product attributes and what he called a uniquely large clinical data package in hereditary angioedema (HAE). He contrasted EKTERLY with historical on-demand options, which he said were limited to intravenous or subcutaneous delivery and often fit poorly with patients’ daily lives.
He cited icatibant (brand FIRAZYR) as an example of an efficacious injectable therapy that can be burdensome to carry, store, and administer, and noted injection-site reactions and pain as challenges. Palleiko said that, prior to EKTERLY, patients often did not treat attacks early or consistently despite guidelines, contributing to unnecessary suffering.
On the evidence base, he described KalVista’s development program as the largest conducted in HAE, saying the company treated “something like 2,700” attacks in clinical trials. He added that the program covered a wide range of patient circumstances, including ages 12 and up initially and now down to age two, as well as different attack severities, locations, and attack types. Palleiko said the breadth of data helped physicians feel comfortable prescribing at launch and has supported continued confidence as real-world experience accumulates.
Launch metrics: patient starts and prescriber breadth
Needham analyst Serge Bélanger asked Palleiko to highlight updated launch metrics the company discussed in a late-March fourth-quarter update. Palleiko said KalVista had expected patient starts to be “consistent and pretty linear,” and he said the launch has tracked that way so far.
Providing metrics through February, Palleiko said KalVista had “just around 1,700 start forms,” representing “a little bit over 20%” of what the company believes is the addressable market. He also reported approximately 724 prescribing physicians at that point and estimated there are about 2,500 physicians who have ever prescribed in the category. He added that KalVista’s penetration is higher among top prescribers, saying the company is “probably at 2/3 or more” of higher-tier physicians.
On seasonality, Palleiko said the company believes the end of the year can involve some pull-forward activity, including specialty pharmacy and patient behavior around re-authorizations and deductible resets. He also said weather-related disruptions in the first quarter affected starts, noting there were “days in the first quarter when we had zero starts because the physicians’ offices were closed,” which also slowed prior authorizations and conversions.
Coverage and access: medical exceptions today, formulary discussions beginning
Bélanger asked about payer coverage, particularly the shift from medical exception pathways to formulary access. Palleiko said that in rare diseases such as HAE it is difficult to secure formulary coverage immediately at launch, adding that large payers often require roughly six months of market experience before engaging.
He said EKTERLY was initially covered “effectively 100%” via medical exception, and that while some formularies were added over the course of last year, coverage remains “primarily medical exception.” He said large PBMs began engaging starting “last month,” and described the process as taking “a quarter or two” to work through, with the goal of improved access and a faster pathway for patients.
Palleiko outlined the company’s Quickstart process, in which patients submit a start form and prescription, and KalVista’s hub verifies insurance and sends an initial Quickstart carton so patients can gain experience while commercial approval is pursued. He said that once approval is in place, refills are typically managed directly through the pharmacy without repeated physician or insurance interaction.
Discussing long-run expectations, Palleiko said prior authorization is required across HAE therapies. He added that broader formulary access may involve step edits through generic icatibant, which he said the company views as “completely reasonable,” noting KalVista estimates about 80% of HAE patients have previously been or are currently on generic icatibant.
Market backdrop and competition in HAE
Palleiko provided context on the HAE market, stating that in the U.S. about 70% of patients use both prophylaxis and on-demand therapy, while about 30% use on-demand only, a split he said has been stable for years. He said nearly all HAE patients have an on-demand prescription because breakthrough attacks occur even with prophylaxis.
He described the prophylaxis market as crowded, citing seven approved therapies for what he called a “9,000-person disease,” with additional products potentially coming. He said differentiation in prophylaxis is often tied to dosing profiles rather than efficacy, referencing recent launches including ANDEMBRY and DANZALERA as examples of longer-interval dosing options.
For on-demand treatment, Palleiko reiterated that EKTERLY is currently the only oral option and said one other oral entrant could arrive next year, though he said he has not seen a pathway for that product to become predominant and added that “more choices is always good for people.”
International rollout and pediatric expansion plans
Palleiko said KalVista received seven approvals last year across the U.S., U.K., European Union, Japan, Switzerland, Singapore, and Australia. He said the company has launched in the U.S., Germany, and Japan, and described early German uptake as strong enough that the company “had to do a reforecast in January” after exceeding expectations.
He noted that additional European launches will depend on pricing negotiations and that some countries may not be economically viable given lower pricing relative to the U.S. When asked about ex-U.S. revenue potential, Palleiko said KalVista has “very consistently said” a long-run expectation of roughly 15% to 20% of the U.S. opportunity.
On pediatrics, Palleiko discussed an orally dissolving tablet (ODT) formulation designed for children ages 2–11 and said KalVista plans to file an NDA in the third quarter, with a goal of approval “earlier mid next year,” depending on review type. He described surprising findings from the pediatric study, including faster-than-expected enrollment and a much higher-than-expected number of attacks, saying the company had observed roughly 230 attacks in the cohort and an average of about 0.7 attacks per month. Palleiko said the data suggest attacks in younger children may be under-treated because approved options are limited and often require IV therapy.
Palleiko also said KalVista plans to initiate a small, open-label short-term prophylaxis study this year to provide physicians with additional guidance on scheduling around procedures that can trigger attacks, such as dental work or colonoscopies. He said the study is not intended to support a label change, and the company expects data next year.
On financial position, Palleiko said KalVista ended the fiscal year with about $300 million in cash and has stated it is “funded to profitability,” with an expectation of reaching cash-flow breakeven “within the first few years of launch.” Addressing questions about investor skepticism, he said he believes the market is primarily waiting for more quarters of sustained commercial data.
About KalVista Pharmaceuticals NASDAQ: KALV
KalVista Pharmaceuticals is a clinical‐stage biotechnology company focused on the discovery and development of small‐molecule protease inhibitors for orphan and specialty disease indications. The firm's scientific platform centers on selective inhibition of plasma kallikrein, a serine protease implicated in disorders characterized by vascular leak, edema and inflammation. KalVista's approach leverages oral and intravitreal delivery formats to target both systemic and ophthalmic conditions.
The company's lead programs include an oral plasma kallikrein inhibitor in clinical trials for the acute treatment of hereditary angioedema (HAE) attacks and an intravitreal kallikrein inhibitor being evaluated for diabetic macular edema.
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