KalVista Pharmaceuticals, Inc. Q3 FY2025 earnings call

Ben Palleiko:

• EKTERLY's U.S. launch has steady adoption with strong demand, treating significant HAE attacks. German launch underway, with initial uptake validating ex-U.S. interest. Regulatory approvals in Australia, U.K., EU, Switzerland. Hired Bilal Arif as COO and Linea Aspesi as CPO. Convertible note offering fully finances through profitability.

Paul Audhya:

• KONFIDENT-KID trial for sebetralstat in pediatric HAE (2-11) fully recruited ahead of schedule, with high attack rate and rapid treatment. KONFIDENT-S trial has over 2,700 attacks treated, with reduced second dose use and high patient satisfaction from switching to sebetralstat.

Nicole Sweeny:

• U.S. launch has 937 start forms, 423 unique prescribers, high awareness. Broad uptake across HAE segments, including prophylaxis users and adolescents. German launch in mid-October with first-day sales, U.K. and Japan progress towards launches.

Brian Piekos:

• Financial highlights: $13.7M sales for EKTERLY launch, operating expenses $59.7M, SG&A expenses around $46.5M, R&D around $12M. Sufficient cash to fund operations through profitability.

For the 3-month period ending September 30, sales of EKTERLY were $13.7 million. EKTERLY's U.S. launch has seen 937 start forms in less than 4 months, representing over 10% of the HAE community. Revenue contribution from EKTERLY is a key segment performance metric.

Brian Piekos:

• Fully financed through profitability, allowing focus on EKTERLY launch and growth opportunities.

Nicole Sweeny:

• Expect refill patterns to normalize as adoption expands beyond high-burden patients, with lower refill frequency and volume.

Q: Congrats on the great quarter. 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?

A: Maury, thanks for joining today... Roughly half of all the patients who have switched to EKTERLY to date self-report an attack rate of 2 or more attacks per month, which we consider to be high burden. In the longer run, expect that number to decline as EKTERLY's reach broadens.

Q: 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?

A: Nicole Sweeny: Yes. So from an access standpoint, we are very encouraged by the continued increase in paid. Week-to-week, we see the paid rate continue to grow. And we've seen successful use of the medical exception...

Q: Congrats on a great quarter. The first is just a follow-up. Are you willing to talk a little bit more about these refill rates or maybe disclose on average number of doses for these high-burden patients? And maybe help us compare that to where you would expect things to normalize, especially given your work with claims data? And of course, as it relates to payer willingness to treat these high-burden patients, maybe talk about the quantity limits that you're seeing for chronic use of EKTERLY?

A: Benjamin Palleiko: Our presumption going into this when you look at claims data is that the average person with HAE is refilling about once every 3 to 4 months... Nicole Sweeny: Quantity limits are certainly the norm for the current branded on-demand treatment...

Q: It's great to see that according to our math, the rate of PSF has stayed fairly constant through your first couple of updates so far. Do you expect this relatively linear PSF growth rate to continue? At what point, either months into the launch or overall penetration-wise, do you expect PSF growth to taper off? And then ex-U.S., it was great to see the German launch is underway. What is the price you agreed upon in Germany, and how does that compare to the U.S.?

A: Benjamin Palleiko: The PSF rates have been quite consistent... We would expect some slowing in Q4 due to seasonality. Nicole Sweeny: German price not disclosed at this time, early in launch there...

Q: Congrats on the progress. When you guys talk about kind of normalization of these rates, wondering if you could talk a little bit about your expectations for how many patients do you expect to ultimately be trialing EKTERLY because the high burden makes sense now, but do you think that this is going to be broad across people with low burden as well? Or is it going to be a majority of these high-burden patients over time? And then in the prepared remarks, you mentioned that gross net towards the low end of your expected range. I was hoping you could just remind us of what that expected range is?

A: Benjamin Palleiko: We do fundamentally expect orals to displace injectables... Brian Piekos: Like other specialty medicines, we expect to see gross to net to be on average, upper teens, low-20s...

Q: Congrats on the quarter. When you guys talk about kind of normalization of these rates, wondering if you could talk a little bit about your expectations for how many patients do you expect to ultimately be trialing EKTERLY because the high burden makes sense now, but do you think that this is going to be broad across people with low burden as well? Or is it going to be a majority of these high-burden patients over time? And then in the prepared remarks, you mentioned that gross net towards the low end of your expected range. I was hoping you could just remind us of what that expected range is?

A: Benjamin Palleiko: We do fundamentally expect orals to displace injectables... Brian Piekos: Like other specialty medicines, we expect to see gross to net to be on average, upper teens, low-20s...

Q: Congrats on the quarter. First question, I wanted to go back to your initial focus on high-burden patients. Is that just a function of the market or the docs that you -- prescribers that you have initially targeted? And are they using these higher burden patients as leveraging them to get experience with the product and familiarity? Secondly, when prescribers are writing patient start forms or prescriptions, are these PRNs or are they limiting them to a certain number of boxes or cartons?

A: Nicole Sweeny: These are patients with high disease burden on prophylaxis. Prescriptions are typically written for PRN, allowing flexibility for refills...

Q: Congrats on the quarter. So, can you talk a little bit more about how your insurance negotiations are progressing and how we should think about the cadence of payers coming online in the first half of next year?

A: Nicole Sweeny: Leading into launch, we anticipated 6 months for payers to assess. We're leveraging medical exception, and seeing some regional and national payers create favorable policies. Planning to wrap up discussions with larger payers and PBMs early in 2026.

Q: Congrats on the quarter. So, can you talk a little bit more about how your insurance negotiations are progressing and how we should think about the cadence of payers coming online in the first half of next year?

A: Nicole Sweeny: Leading into launch, we anticipated 6 months for payers to assess. We're leveraging medical exception, and seeing some regional and national payers create favorable policies. Planning to wrap up discussions with larger payers and PBMs early in 2026.

Q: Congrats on the quarter. So, can you talk a little bit more about how your insurance negotiations are progressing and how we should think about the cadence of payers coming online in the first half of next year?

A: Nicole Sweeny: Leading into launch, we anticipated 6 months for payers to assess. We're leveraging medical exception, and seeing some regional and national payers create favorable policies. Planning to wrap up discussions with larger payers and PBMs early in 2026.