Aug 13, 2026 earnings call — ZEVASKYN launch progress and reporting changes
Reported net ZEVASKYN revenue of $11.4 million and will now report patients treated and net revenue each quarter.
Revenue $0.0B (est $0.0B) · EPS $-0.35 (est $-0.23)
Key quotes
"With the recent addition of Cincinnati Children's, which is one of the largest epidermolysis bullosa treatment centers in the country, we now have 7 activated QTCs nationwide."
"These factors resulted in 1 low-yield batch in Q2 and 1 out of specification batch in Q3, for which no revenue was recognized."
"We will anchor future quarterly disclosures around completed operational achievements, specifically patients treated during the quarter and net revenue recognized."
Analyst Q&A 6
When centers reach 1 patient/month
Q (Jefferies): When will leading QTCs like Lurie and Stanford reach the near-term cadence of 1 patient per month? Also, given a low-yield batch and an out-of-spec batch, are these isolated incidents or likely to recur long-term?
A: Management said they expect about 1 patient per month once centers reach a steady state and that some leading centers have started treating while others are coming online. They also said it is early to judge long-term manufacturing success; the low-yield event is the first they have seen and may be rare, and the out-of-spec failure related to a Pan-CK identity test set on limited samples is being discussed with the agency.
"But once we are in the steady state is when we believe that 1 patient per month cadence is something that we continue to hear from the QTCs." — Madhav Vasanthavada
Average sheets produced per patient (manufacturing)
Q (Stephen Willey · Stifel): What average number of sheets are you manufacturing per patient in commercial use vs clinical trials? Also, what low-yield number prevents revenue recognition, and where are you with the pan-CK assay discussions with the agency?
A: They said commercial yields are higher than in the Phase III trial: clinical trial averaged about 5 sheets while commercial is averaging about 9 sheets per lot, with 12 as the maximum. Anything less than 4 sheets in a batch is considered a low-yield batch and will not be recognized for revenue. They have engaged the agency, treated the patient, are gathering GMP run data, and expect an update on spec revision by the next quarterly update though timing is TBD.
"Anything that is lesser than 4 sheets in a batch is a low-yield batch." — Vishwas Seshadri (CEO)
Last-minute patient cancellations and access/NTAP effects
Q (Raghuram Selvaraju · H.C. Wainwright): How often do patients withdraw or cancel late before treatment? How important is having a QTC in the same state and how many QTCs to reach most patients? And when will NTAP affect revenue cadence and margins?
A: They said they have recorded 2 such last-minute cancellations so far, and many cancellations relate to illness or health deterioration rather than refusal to be treated; often biopsies are rescheduled. Having an in-state QTC helps, especially for Medicaid, and about 40% of addressable patients are in-state by claims data, though many patients do travel; NTAP mainly affects Medicare beneficiaries (about 10% of their patient mix) and helps make centers whole and ease payer negotiations rather than directly changing company margins.
"Well, so far, we have had 2 such events, right, as we mentioned, that has happened in terms of our record." — Madhav Vasanthavada
More patients at top-of-funnel and screening to reduce cancellations
Q (Kristen Kluska · Cantor Fitzgerald): Which problems would having more patients at the top of the funnel mitigate, and which disruptions would remain? Also, can pre-screening at biopsy visits reduce last-minute cancellations?
A: They said more patients at the top of the funnel help mitigate factors outside their control by giving more opportunities to fill finite manufacturing slots, improving access, and spreading best practices across centers. Screening could help if issues are identified weeks in advance, but many cancellations occur within a day or two of biopsy, making late adjustments difficult.
"it's having more shots at filling those manufacturing slots, which are finite in number." — Madhav Vasanthavada
Who absorbs costs; normalized gross margin; patient funnel size
Q (David Bautz · Zacks Small-Cap): If revenue was not recorded for 2 treated patients, does the company absorb full manufacturing costs or can revenue be recognized later? Where will normalized gross margin settle as manufacturing stabilizes? Any current patient funnel numbers?
A: They said they will not recognize revenue for those 2 treatments and the company absorbs the COGS for such cases. Gross margins depend on patient volume because manufacturing costs are largely fixed, and they expect a steady-state gross margin of about 85% to 90% at full operating capacity. Management reiterated prior mention of more than 100 identified clinically eligible patients historically but did not provide updated funnel counts and said the rate-limiting step is QTC throughput.
"We will not be recognizing revenue for those 2 treatments because that is our agreement, right?" — Vishwas Seshadri (CEO)
If low-yield still allows treatment; QTC activation time
Q (Fanyi Zhong · Oppenheimer): When revenue was not recognized for low-yield cases, did the patient still receive treatment or only partial treatment? And how long does it typically take new QTCs to begin treating patients?
A: They clarified the two non-revenue cases were different (one low-yield, one out-of-spec) but in both cases the patients were treated with whatever sheets were produced; revenue was not recognized for those treatments. On QTC activation, they previously indicated an average of about 4 to 6 months but said variance is high: some sites activate and treat in a few months while others have taken 12 months with no treatments, driven by payer and paperwork factors, and they are learning to pre-line steps to shorten timing.
"So, they received treatment, and we're hoping that the patients receive the clinical benefit and that experience will grow with these treatments." — Vishwas Seshadri (CEO)