Krystal Biotech’s Contradictory Claims on KB111 Trial and NK Study Timelines Don’t Match

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Date of Call: Aug 3, 2026

Financials Results

• Revenue: $119.2M, a 24% increase from the second quarter of 2025
• EPS: $1.79 per diluted share, an increase compared to the prior year's second quarter EPS of $1.33
• Gross Margin: 95%, improved from 93% in the second quarter of 2025

Guidance:

• Expect to complete enrollment for the KB801 (NK) study before year-end, with readout soon thereafter.
• Expect to start registrational studies in 2027 for both cystic fibrosis and Haley-Haley disease programs.
• Expect to complete enrollment for the KB407 (CF) study and report interim results before year-end.
• Expect to start a registrational study for KB707 in second-line NSCLC in 2027.
• Expect non-GAAP R&D and SG&A expenses in the range of $190 million to $195 million for the full year 2026.

Business Commentary:

Revenue Growth and Market Expansion:

• Crystal Biotech reported net revenue from global sales of Vijuvec at $119.2 million for the quarter, representing a 24% increase from the second quarter of 2025.
• The growth was driven by strong commercial momentum across Europe and Japan, with increasing patient inclusion and treatment volumes, despite challenges such as pricing negotiations in Germany impacting revenue accruals.

Clinical Pipeline Advancements:

• The company is nearing readouts for its registrational studies for KB803 and KB801, with enrollment completed in April and expected results later in the year.
• The progress is attributed to the unique HSV-1 vector approach that is well-tolerated and effective for ocular indications, with strong patient engagement and repeat dosing capabilities.

U.S. Commercial Performance and Patient Penetration:

• U.S. net revenue for the quarter was $91.6 million, with over 730 reimbursement approvals for Revizuvac, surpassing the initial target of 60% patient penetration.
• Success in patient outreach and education programs, along with partnerships with patient advocacy groups, contributed to increased patient starts and continued penetration of the diagnosed patient pool.

Financial Strength and Strategic Investment:

• Crystal Biotech reported a 95% gross margin and net income of $54.8 million, with EPS of $1.85 per basic share and $1.79 per diluted share, indicating improved financial performance.
• The strong financial position allows for continued investment in global commercial strategy and pipeline development, with a focus on expanding treatment access and advancing clinical trials.

Sentiment Analysis:

Overall Tone: Positive

• Management expressed being 'very encouraged by the recent progress' and reported 'another strong quarter of commercial performance.' They noted 'strong underlying demand,' 'commercial momentum...is strong and building,' and are 'confident' in the 'longer-term opportunity.' Pipeline advancements are described as 'on track' and 'rapidly approaching two registry exciting implications.'

Q&A:

• Question from Roger Song (Jefferies): For the commercial side, seeing the European selection, maybe one for commercial, one for pipeline. I was down a little bit from the first quarter understanding some pricing dynamic. Can you just give us some color around the demand side and then maybe the compliance between Germany and France? That would be very helpful. And then on the pipeline, Haiti-Haiti seems, so given you will have phase one data by year end, so how should we, you know, very interesting indication and appreciated right now. What should we expect from that data redial? And then market opportunity for Haiti-Haiti. Thank you. also what the current thinking about the epidemiology and then overall.
  Response: Demand is strong with growth in patient numbers and treatment volumes. Compliance has been strong in Germany and France, similar to the U.S. launch. For Haley-Haley disease, the phase 1 study is nearly complete, with data expected by year-end; enrollment is on track for completion by year-end, and the pipeline is positioned for a registrational study start in 2027.

• Question from Alex Stranahan (Bank of America): I guess first, maybe on NK, could you talk a bit about the patient treated with KB801 that had a complete closure demographic compared to the population that's being enrolled in? And is this patient still being followed? And I guess, how does their disease stage or done Emerald 1? And then on CS, Just on the five-patient follow-up study, could you maybe just remind us what kind of functional metrics the study is designed to show, or is it maybe more around the dosing PK side?
  Response: The single-patient complete closure data from the past is not representative and was disclosed for patent support; the ongoing study has a different design. The NK study aims to enroll patients with chronic wounding to maximize efficacy. The CF follow-up study is a repeat dosing safety study measuring FEV1 and FEV2 to assess functional improvement.

• Question from Yigal Natramovic (Citigroup): With respect to the progress in Germany in terms of the view for taking the questions, I'm just wondering if you could be perhaps a little more specific quarter over quarter vial growth, the demand growth relative to the accrual process and what the headwind is on the accrual given that starting in 2Q, I believe that's There was a cruel throughout the quarter. And then on NK, if you could just clarify, it sounds like you're going to finish enrollment before the end of the year and then eight weeks to the end point. But it appears, if I'm correct, that the data will be likely in early 27 or could it still be in this year?
  Response: Vial growth in Germany is solid. The pricing negotiation in Germany is expected to conclude in Q3; successful completion would allow for a move from accrual to actual net revenue in Q4. For the NK program, enrollment is on track for completion by year-end, with data expected soon thereafter, and the BLA could be submitted in early 2027.

• Question from Ritu (T.D. Cowan): Suma, I just want to clarify on NK enrollment. Are you pushing out the enrollment completion and the data just slightly in order to, for the sake of the European patients? I wanted to just ask how enrollment rate was going overall as far as, you know, a reflection of the interest in the therapy to include these European patients? And also, are you upsizing the trial at all? My second question was a commercial question just on Vajavek and you mentioned that you were going more to the community setting. In your remarks you mentioned, Chris, opportunity, what commercial opportunity or patient number opportunity is left in the community setting for Deb? Is it mostly dominant Deb and what sort of market research trends have you seen to sort of drive that interest?
  Response: The NK study is not being upsized but enrollment is being accelerated in Europe to facilitate a potential global filing; there is strong interest from European investigators. For Vajuvec, there remains significant opportunity in the U.S. community setting, with a healthy split between R-DEB and D-DEB patients, and demand continues to be strong with ongoing reimbursement approvals.

• Question from Lachlan Hanbury-Brown (William Blair): On access, I think over the past couple of weeks we've seen headlines out of Germany. Hey, guys, thanks for the questions. Maybe a couple that they're sort of passing some information reforms on drug pricing or health insurance. I know your negotiations are ongoing and this new law is still very early, but is there any thoughts on your side on how, if at all, that could impact either the negotiations or the ultimate outcome there? And then in the US, maybe negotiations on pricing and coverage And access is going through the PBA somewhat similar, but wondering how the sort of names for the at-home administration, given that's sort of earlier in the launch of that than the original HCP-administered product?
  Response: In Germany, negotiations are very constructive, and the company is focused on achieving sustainable reimbursement consistent with international reference pricing. In the U.S., access has been good with no major issues; the label expansion for at-home administration is a positive development that may enhance future access.

• Question from Kalpit Patel (Wolf Research): For the Ocular DEB program, can you remind us if that also includes global patients like you're planning for the NK program? And then what screening to enrollment rates are and what the demand looks like for the NK program itself? Can you comment on with this question, or your question, on a gross prep for the trial itself. And then finally, for the Germany-European Vigevec sales increased sequentially. Priceling, accrual basis, can you give us any color if, and if so, by approximately how much?
  Response: The ocular DEB study is initially a U.S.-based study, not global. Enrollment for the NK program is progressing well. The company does not quantify accrual headwinds but noted a prior quarter's impact was in the double digits.

Contradiction Point 1

Timeline for Hailey-Hailey (KB111) Phase One Data and Registrational Trial Start

Contradiction on when data will be ready to support a registrational study.

Roger Song (Jefferies) - Roger Song (Jefferies)

2026Q2: Based on this data, endpoints will be proposed to the FDA to support a registrational study start in 2027. - Suma Krishnan(President of R&D)

Could you provide insights on European demand and pricing dynamics, expectations from the phase one data for Haley-Haley disease (HD), and the associated market opportunity and epidemiology? - Matthew Guggenbiller (BofA Securities)

2026Q1: The goal is to complete scale validation and prepare for a registrational trial in 2027. - Suma Krishnan(President of R&D)

Contradiction Point 2

Timeline for NK (Haley-Haley) Study Data Readout

Contradiction on whether data readout is likely in 2027 or could occur earlier.

Yigal Natramovic (Citigroup) - Yigal Natramovic (Citigroup)

2026Q2: Data readout could potentially occur early in 2027, pending database cleaning. - Suma Krishnan(President of R&D)

Can you clarify the headwind from the accrual process on net revenue in Germany, the quarter-over-quarter dynamics, and the timeline for the NK study readout (2027 or this year)? - Matthew Guggenbiller (BofA Securities)

2026Q1: The goal is to complete scale validation and prepare for a registrational trial in 2027. - Suma Krishnan(President of R&D)

Contradiction Point 3

Germany Pricing Negotiation Timeline

Contradiction on when pricing negotiations with Germany will conclude.

Yigal Natramovic (Citigroup) - Yigal Natramovic (Citigroup)

2026Q2: Pricing negotiations in Germany are expected to conclude in Q3. - Laurent(CFO)

Can you provide more details on the headwind from the accrual process impacting net revenue in Germany and the quarter-over-quarter dynamics, as well as clarify the timeline for the NK study readout—is it likely in 2027 or this year? - Alec Stranahan (BofA Securities)

2025Q4: Expectation is to reach a pricing agreement with Germany in the second half of 2026 (Q3 or Q4). - Krish Krishnan(CEO)

Contradiction Point 4

NK Study (KB801) Enrollment and Data Readout Timeline

Contradiction on the expected timeline for the NK study's data readout.

Yigal Natramovic (Citigroup) - Yigal Natramovic (Citigroup)

2026Q2: NK study enrollment is on track to complete by year-end. Data readout could potentially occur early in 2027, pending database cleaning. - Suma(CFO)

Could you clarify the headwind's impact on Germany's net revenue accrual process, the quarter-over-quarter dynamics, and the timeline for the NK study readout (2027 or this year)? - Alec Stranahan (BofA Securities)

2025Q4: Enrollment is on track... completion expected by year-end and data before year-end. - Suma Krishnan(CEO)

Contradiction Point 5

NK (Haley-Haley) Trial Readout Timeline

Contradiction on when the key NK trial data will be available.

Yigal Natramovic (Citigroup) - Yigal Natramovic (Citigroup)

2026Q2: NK study enrollment is on track to complete by year-end. Data readout could potentially occur early in 2027, pending database cleaning. - Suma Krishnan(CEO)

Can you clarify the headwinds from the accrual process on net revenue in Germany, the quarter-over-quarter dynamics, and the timeline for the NK study readout—specifically, whether it is likely in 2027 or this year? - Ritu Baral (TD Cowen)

2025Q3: Interim data is targeted for mid-2026. - Suma Krishnan(CEO)

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