管理層發言
Thank you for standing by, and welcome to the Krystal Biotech 2Q 2026 Conference Call. As a reminder, today's conference is being recorded. I would now like to hand the conference over to your host, Stephane Paquette, Senior Vice President of Corporate Development. Please begin.
Good morning, and thank you all for joining today's call. Earlier today, we released our financial results for the second quarter of 2026. The press release is available on our website at www.krystalbio.com. We also filed our earnings 8-K and 10-Q with the SEC earlier today. Joining me today will be Krish Krishnan, Chairman and Chief Executive Officer; Suma Krishnan, President of Research and Development; Laurent Goux, Executive Vice President and General Manager for Europe; Christine Wilson, Senior Vice President and Head of U.S. Commercial; and Kate Romano, Chief Accounting Officer. This conference call and our responses to questions may contain forward-looking statements. You are cautioned not to rely on these forward-looking statements, which are based on current expectations using information available as of the date of this call and are subject to certain risks and uncertainties that may cause the company's actual results to differ materially from those projected. A description of these risks, uncertainties and other factors can be found in our SEC filings. With that, I will turn the call over to Krish.
Good morning, and thank you for joining us. We were focused on execution in Q2, making solid progress across both our commercial and clinical programs. Internationally, strong underlying demand and high patient excitement underpin our launch. We're working diligently to meet that demand and broaden access for DEB patients around the world. We're advancing pricing and reimbursement discussions in Germany, France, Italy, Spain and the U.K., while working through the country-specific requirements associated with each launch. In the United States, demand continues to grow, supported by our increasing focus on reaching patients and physicians in the community setting. Laurent and Christine will provide additional detail on our commercial performance and international launch progress. Our clinical pipeline is also advancing across multiple important programs. We currently have two registrational studies underway, our study in neurotrophic keratitis and our study of ocular lesions in patients with dystrophic epidermolysis bullosa.
In addition, our repeat dose studies in cystic fibrosis and Hailey-Hailey disease are progressing. Assuming supportive data, we believe both programs have the potential to advance into registrational development in 2027. We're also making great progress with our KB707 program in oncology. Our inhaled 707 formulation for the treatment of NSCLC is on track for a registrational study next year. And we are now evaluating our intratumoral KB707 formulation in Gorlin syndrome, a rare skin indication that fits in well with our therapeutic focus and growing commercial footprint. Suma will provide a more comprehensive update on our clinical programs shortly. Finally, we remain in a very strong financial position. Our continued financial strength reflects both the growing performance of our commercial business and the operating discipline we have maintained over the past 12 quarters. This allows us to invest confidently in global expansion and pipeline development while continuing to manage the business responsibly. With that, let's get into the details. Laurent?
Thank you, Krish. We are very encouraged by the recent progress in our VYJUVEK launch. Commercial momentum across Europe and Japan is strong and building, supported by growing physician familiarity, high engagement from leading treatment centers and sustained interest across the dystrophic epidermolysis bullosa community. In July, Krystal had a strong presence at the third World Congress on Rare Skin Diseases in France, including a well-attended symposium. This was another important step in building awareness and advancing our ambition to establish VYJUVEK as an essential treatment for DEB patients. Demand is high in France, Germany and Japan and driving growth in both treated patients and treatment volumes. This growth also reflects the excellent work of our country teams as they navigate the access and operational dynamics unique to each market. In Germany, for example, the care landscape is fragmented and only a limited proportion of DEB patients are routinely seen at established specialist centers.
Our team is, therefore, engaging a broader network of physicians and supporting patients in continuing treatment at home. In France, VYJUVEK is available through the early access pathway where administration is currently concentrated in hospital settings due to the requirements associated with its GMO classification. Our team is working closely with centers to facilitate access and treatment continuity while exploring solutions that could support home administration over time. And in Japan, an important nuance is the requirement for intensive prescription renewal, which can put a heavy burden on patients in the first year of launch. We are working closely with prescribers and patients to ensure all stakeholders understand the importance of consistent weekly administration and minimize potential disruptions. Turning to revenues, reported revenue in Europe and Japan was broadly flat in the quarter, primarily due to a reserve provision related to the ongoing pricing process in Germany.
This does not change our assessment of the underlying launch trajectory or our confidence in the longer-term opportunity across Europe and worldwide as we continue to grow patient and treatment volumes in our overseas markets. Turning to market access, pricing and reimbursement work continue across the EU. In Germany, Italy and Spain, we continue to expect key outcomes before the end of 2026, subject to each country's process. In France, formal pricing and reimbursement discussions are expected to progress into 2027. Our engagement with authorities remains constructive, and we believe VYJUVEK's clinical evidence and potential value to patients provide a strong foundation for these discussions. In the United Kingdom, we also achieved two important milestones. On May 15, the MHRA granted marketing authorization for VYJUVEK, making it the first genetic medicine approved in the U.K. for DEB.
This was followed in June by VYJUVEK receiving the 2026 Prix Galien UK Award for Best Product for Orphan Disease. This is the third Prix Galien for VYJUVEK following similar recognitions in France and Italy last year. Together, these milestones reinforce the strength of the evidence supporting VYJUVEK and its significance for patients and families living with DEB. Our ultimate objective is sustainable patient access. NICE's appraisal in the U.K. remains ongoing, and our team is engaging constructively to address NICE's questions and showcase the transformational benefit achievable with VYJUVEK. Finally, we are planning multiple additional regulatory submissions in the coming months, including Switzerland and Australia, representing another step towards bringing VYJUVEK to more DEB patients globally. Overall, we are pleased with the momentum across our international business. We remain focused on disciplined execution, navigating market-specific challenges, securing sustainable reimbursement and converting strong physician engagement and patient demand into durable patient-centered access. With that, I will hand the call over to Christine.
Thank you, Laurent. I am pleased to report another strong quarter of commercial performance. U.S. net revenue was $91.6 million for the quarter. Our field team continues to perform exceptionally well as we extend our reach deeper into the community and across the country. Working in close partnership with health care providers nationwide, they are filling education gaps, raising awareness and helping us reach more patients through the DEB community. To that end, I am also very happy to report that we have achieved more than 730 U.S. reimbursement approvals for VYJUVEK. We have now surpassed our initial penetration target of 60% and have no plans of stopping there. With a strong pace of approvals over the last year and a growing prescriber base, we expect continued penetration of the diagnosed DEB patient pool in the quarters to come. In addition to driving new patient starts, we continue to strengthen our patient engagement efforts to help patients and caregivers successfully incorporate VYJUVEK into their long-term wound care routines.
Based on ongoing feedback from the DEB community, we know that virtual education and peer-to-peer connection remain preferred ways to access information and support. As a result, we continue to invest in scalable community-driven programs that educate, engage and empower patients through their treatment journey. During the second quarter, we partnered with debra of America to host a virtual education webinar focused on recent VYJUVEK label updates and practical bandaging techniques presented by our Krystal Connect team. The program was developed in direct response to questions from the patient community as treatment needs continue to evolve. As more patients achieve complete wound closure in larger wound areas and transition to managing smaller or more anatomically challenging wounds, including the scalp, ears and other sensitive locations, the educational needs of patients and caregivers continue to change.
The webinar attracted more than 100 live attendees and remains available on demand, extending its impact across the DEB community. Our VYJUVEK Voices program continues to provide peer-to-peer education and support by connecting patients and caregivers with trained ambassadors who share firsthand experience, practical insights and ongoing encouragement through the treatment journey. During the quarter, we also launched VYJUVEK Connections, a virtual discussion series that brings together patients, caregivers and VYJUVEK ambassadors to discuss topics selected by the community. These sessions foster meaningful peer engagement while addressing the real-world questions that arise as patients gain experience with therapy. Collectively, these initiatives support patients as they adopt greater self-administration at home following our recent label expansion and further integrate VYJUVEK into their long-term treatment routines.
These programs also provide Krystal with valuable real-world insights into the evolving needs of the DEB community, enabling us to continuously refine and strengthen our patient engagement strategy. Just a few weeks ago, we were also proud to serve as a diamond sponsor of the debra of America Care Conference, one of the largest gatherings of the EB community. The conference provided an important opportunity to engage directly with patients, caregivers, health care professionals and advocacy leaders. These interactions not only strengthen our connection with the community, but also allow us to see firsthand the meaningful impact VYJUVEK continues to have on patients' lives. These advancements, combined with our continued investment in patient support, education and community engagement further strengthen our reach and impact as we establish VYJUVEK as the long-term standard of care for patients living with DEB. I will now hand the call off to Suma to share pipeline highlights.
Thank you, Christine, and good morning, everyone. I'm happy to share today's update on our progress. Thanks to the tireless commitment of our team, we are rapidly approaching two registrational study readouts in the front of the eye. These readouts have exciting implications both for the patients we aim to serve as well as our platform. Due to the rapid cell turnover and protein clearance, the front of the eye has historically been a difficult-to-treat target with gene therapies and biologics. Our HSV-1 vectors, which we easily and repeatedly administer as an eye drop, are uniquely positioned to fill this treatment gap. In sentinel patient cases, repeat dosing of our vectors has been well tolerated and delivered profound clinical improvement, underscoring the therapeutic potential of our HSV-1-based approach. With our registrational programs for KB803 and KB801 nearing readouts, we are on the cusp of validating that potential.
Our registrational IOLITE study evaluating KB803 in DEB patients was fully enrolled in April and is on track for a readout later this year. On success, we expect to move rapidly to BLA submission, leveraging the extensive CMC work already completed for VYJUVEK. Our registrational EMERALD-1 study evaluating KB801 in NK patients is also progressing well. We expect to complete enrollment before year-end. And given the short eight-week primary endpoint, we expect a readout soon thereafter. Our KB407 and KB111 programs are advancing on similar timelines to deliver clinical data this year and registrational study starts in 2027. Dosing is underway in our open-label single-arm study evaluating the safety of repeat dose KB407 in patients with cystic fibrosis who are either ineligible or refractory to modulator therapy. We expect to enroll approximately five patients and report interim results before year-end.
We are also working with the FDA, the Cystic Fibrosis Foundation and the CF Therapeutic Development Network Coordinating Center or TDN on our innovative registrational study design. We are making good progress on the details of our design and statistical analysis plan. We expect study design alignment later this year and registrational study start in 2027. Dosing is also underway in our open-label single-arm study evaluating the safety of repeat dose KB111 in patients with Hailey-Hailey disease. We expect to enroll approximately seven patients and report interim results before year-end. We have completed development of our HHD assessment scale and validations are now underway. Altogether, we are on track to discuss our repeat dosing safety results, scale and study design with the FDA before the end of the year, again, enabling a registrational study start in 2027. We look forward to sharing clinical updates on both programs in the coming months as we work to deliver meaningful benefits to the tens of thousands of patients with untreated cystic fibrosis or Hailey-Hailey disease.
In addition to our work in rare disease, we continue to advance our broader pipeline, which leverages the flexibility of HSV-1 to target more common diseases of the lung, skin and eye. The most advanced of these programs is our inhaled KB707 program for the treatment of non-small cell lung cancer or NSCLC. Inhaled KB707 is currently under investigation in our Phase I/II dose escalation and expansion study KYANITE-1. Last year, we disclosed the inhaled KB707 monotherapy achieved a 36% response rate in heavily treated late-line NSCLC patients. Inhaled KB707 was also generally well tolerated with a safety profile amenable to outpatient management. At ASCO this year, we provided a clinical update on our dose expansion cohort evaluating KB707 in combination with pembrolizumab. We again saw strong response in late-line NSCLC patients with an objective response rate of 31% and encouraging durability.
Responses were achieved in a diverse array of tumor types, including those with driver mutations, squamous histology and low PD-L1 expression. The combination regimen was also well tolerated, a positive indicator for KB707 combination potential with checkpoint inhibitors and immunotherapies more broadly. We expect to complete enrollment in our final dose expansion cohort evaluating inhaled KB707 in combination with chemotherapy later this year. Once data from this cohort is available, we expect to have full information needed to finalize and initiate a registrational study in second-line NSCLC expected in 2027. We are also moving intratumoral KB707 forward. Building on early signals of efficacy in patients with basal cell carcinoma from our Phase I/II OPAL-1 study, we expanded the scope of OPAL-1 to evaluate intratumoral KB707 in patients with Gorlin syndrome. Gorlin syndrome is a rare genetic disease, which imposes a heavy burden on patients, dramatically increasing the risk of developing basal cell carcinomas.
Patients with Gorlin syndrome can suffer from hundreds of BCCs over their lifetimes, requiring frequent and potentially disfiguring surgeries. There is no specific therapy approved for Gorlin and as a result, there exists a clear and urgent need for a safe and effective therapy that reduces BCC burden for these patients. We have now enrolled three patients with Gorlin syndrome and expect to provide a clinical update on these patients as well as our development plan in Gorlin later this year. With multiple registrational study readouts and starts upcoming as well as growing momentum in our oncology pipeline, we are uniquely positioned to deliver transformational impact to patients. This is in addition to our ongoing work on alpha-1 antitrypsin lung disease and other earlier-stage preclinical programs. We look forward to sharing many updates in the months ahead. With that, I'll hand the call over to Kate.
Thank you, Suma, and good morning, everyone. I'll now provide some highlights from our second quarter financial results as reported in our press release and 10-Q filing earlier today. Net revenue from global sales of VYJUVEK was $119.2 million for the quarter, which included sales from our commercial launches in Europe and Japan as compared to $96 million or a 24% increase from the second quarter of 2025. Note that this quarter also included a full quarter of accrued pricing for Germany as we started our pricing negotiations mid last quarter, which contributed to reduced quarter-over-quarter net European revenue despite growth in related vial sales. Cost of goods sold for the quarter was $6.4 million compared to $7.2 million in the prior year second quarter. Gross margin for the quarter was 95%, improved from 93% in the second quarter of 2025. R&D expenses for the quarter were $14.5 million, which was essentially flat to the prior year of $14.4 million.
G&A expenses were $39.9 million compared to $35.1 million in the prior year. This $4.8 million increase was primarily due to increased head count and related compensation expense as well as commercial costs related to global sales of VYJUVEK. Operating expenses for the quarter included noncash stock-based compensation of $14.2 million compared to $14.1 million in the second quarter of last year. Net income for the quarter was $54.8 million, which represented $1.85 per basic and $1.79 per diluted share. This marks an increase compared to the prior year second quarter net income of $38.3 million and EPS of $1.33 per basic and $1.29 per diluted share. I'll also note that the guidance we previously issued relating to non-GAAP operating expenses remains unchanged. We continue to expect to incur in the range of $175 million to $195 million in non-GAAP R&D and SG&A expenses for the full year of 2026.
And finally, we continue to further strengthen our cash and investments foundation, now exceeding $1.1 billion in overall cash and investments. We remain committed to thoughtfully and efficiently deploying our capital as we execute on our upcoming pipeline milestones and continued global commercial strategy. And with that, I'd like to turn the call back over to Krish.
Thanks, Kate. To summarize, on the commercial side, we're working through typical overseas launch dynamics, including accruals and pricing negotiations as we build the foundation to sustain our launch for years to come. We're confident that the work we're doing this year will put us in a position to provide access to thousands of patients worldwide and provide a clear path for VYJUVEK to reach its full commercial potential. On the clinical side, we're focused on completing the ongoing registrational trials and initiating at least two more registrational trials in 2027. When we do that in the next 12 to 18 months, Krystal has the potential to transition from a commercial success story into a multiproduct genetic medicines company. Thank you, and we're now ready to answer questions.
分析師問答
Your first question for today is from Roger Song with Jefferies.
Great. Congrats for the quarter. Maybe one for commercial, one for pipeline. For the commercial side, seeing the European sales 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, Hailey-Hailey seems very interesting indication, underappreciated right now. So given you will have Phase I data by year-end, so what should we expect from that data readout? And then also, what's the current thinking about the epidemiology and then overall market opportunity for Hailey-Hailey?
Roger, thanks for the question. Laurent, do you want to take a first stab at the European question?
Yes. As we said earlier, the market dynamics are pretty strong. We are facing strong growth in both patient inclusion and volume. And the overall revenues reflect the full quarter of the German reserve for the future...
Laurent, do you want to make any comment on demand because there was a question on demand?
The demand is strong. Yes, we still estimate over 180 patients have been treated in Western Europe and Japan so far. As we are expanding in more centers and countries, it is increasingly difficult to have a precise estimation in Europe, so we might not have explicitly given a number.
And I will add, Roger, just to close on that. I think compliance in the early days of launch in any country tends to be really good as we start off treating severe patients. So your question on compliance in Germany and France, we see pretty strong compliance, similar to what we saw in the U.S.
I can take the Hailey-Hailey question. Hailey-Hailey is an interesting disease and not well studied. The beauty of this program is we have done a natural history study over five months and have over 60 to 70 patients already enrolled in this natural history because we use these patients to understand the disease. We've been collecting data over the past four to five months, so we have extensive knowledge and understanding now about the disease, its cycle time and other characteristics. We've also used these patients to validate our scale. We are nearing the end of scale validation and feel confident that we understand the disease and what endpoints we should go after. We have also convened scientific experts and KOLs in the space to develop the scale and the endpoints. The Phase I study is based on what we learned from the natural history. Most patients are excited to be part of this trial, and we have no problem enrolling.
We have already got patients on the study and started dosing them. Over three months, using imaging and investigators' evaluations, similar to what we did with VYJUVEK, we will look at treated versus untreated areas. We'll also have biopsies at baseline and look for evidence of correction in treated areas. I think we will have enough data to discuss endpoints with the agency because the FDA has limited prior guidance here. We plan to propose endpoints based on our generated data and we expect to start a registrational trial early next year. As I said, we have over 60 to 70 patients already in our natural history, and new patients continue to enroll into that study.
Your next question is from Alec Stranahan with Bank of America.
Good to see all the progress in the quarter. I guess, first, maybe on NK. Could you talk a bit about the patient treated with KB801 that had a complete closure? Is this patient still being followed? And I guess, how does their disease stage or demographic compare to the population that's being enrolled in EMERALD-1? And then on CF, just on the five-patient follow-up study, could you remind us what kind of functional metrics the study is designed to show? Or is it maybe more around the dosing PK side? Hoping to link CFTR expression to improved lung function, but possibly this is something we see more with the pivotal study.
Alec, before Suma gets into the comment on NK patients, I want to say it was a legal requirement that made us disclose that one patient data stemming from some of the patent disclosures that ensued as we were supporting the patent with clinical information. We have always said and expressed to not have the investment community read too much into a single patient data. The data was fantastic on a single patient, but it is one-patient data and the new study that we are working on is a different design. With that, I'll turn it over to Suma.
Correct. This patient had chronic wounding in the eye based on his records. We treated the patient and observed complete closure, and we monitored this patient for a couple of weeks after with durable wound healing. That study has been closed out for this patient. Previously we changed the dosing regimen to daily dosing because it made more sense for consistency and for administration into the eye for older patients, and there were no safety concerns. We want to ensure that we enroll patients with chronic wounds to better separate from placebo. We opened this trial globally, filed our CTAs and have identified several sites across the EU. We want to expand because our intent is a global trial and potentially global approval, not just in the U.S. but worldwide. On the CF study, as we have said in previous calls, the intent of this study is to provide the FDA with repeat dosing data. We have enrolled and dosed patients already and expect to enroll five patients. This is a weekly repeat dosing study. Patients come in monthly and we check FEV1 and other safety outcomes. We'll measure FEV1 monthly over six months and hope to have data on the impact of repeat dosing. We are enrolling very sick patients with low FEV1 who have no other options, so it is a high-need population.
Your next question for today is from Yigal Nochomovitz with Citigroup.
I'm just wondering if you could be perhaps a little more specific with respect to the progress in Germany in terms of the quarter-over-quarter vial growth, demand growth relative to the accrual process and what the headwind is on the accrual given that starting in 2Q, I believe there was an accrual 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 endpoint, but it appears I'm correct that the data will be likely in early '27? Or could it still be in this year?
Laurent, do you want to take the German question?
We don't provide country-by-country details for number of patients and revenues, but the dynamics in terms of patient inclusion and vial increases are very solid in Germany.
And Yigal, on the accrual process, we expect to complete negotiations in Q3 for pricing in Germany. Our objective is to be conservative in the accrual and complete that once pricing is established. We experienced some accrual in the first half, fully in Q2 and possibly partial in Q3. Hopefully by Q4 we'll return to actual net revenue recognition in Germany. On NK, Suma?
NK is being conducted globally. We are activating sites in EU countries and regions because we want to do a global filing. We expect to enroll all patients by the end of the year, so the data could be early 2027 after database lock and cleaning. Keep in mind the CMC and other filing components; given our platform and readiness, once the data is out we expect to be prepared to file the BLA.
Your next question is from Ritu Baral with TD Cowen.
Suma, I just want to clarify on NK enrollment. Are you pushing out the enrollment completion and the data just slightly in order to include European patients? I wanted to ask how enrollment rate was going overall as a reflection of interest in the therapy. Also, are you upsizing the trial at all to include these European patients? And then a commercial question on VYJUVEK in the U.S.: you mentioned going more to the community setting. What commercial opportunity or patient number opportunity is left in the community setting for DEB? Is it mostly dominant DEB? What market research trends have you seen to drive that interest?
We are going global to include Europe to support global filing. There is a need in Europe since competitor products are not available there, so KOLs in Europe want to participate. We are not upsizing the trial; the study design and patient numbers remain the same. The intent is to increase recruitment through additional sites while keeping design constant for a global filing.
On the commercial side, Christine?
Yes, we continue to believe there's opportunity in the community setting. While we've made a lot of great progress on finding these patients wherever they may be located across the U.S. and as mentioned, we have surpassed our initial penetration target of 60% of the diagnosed patient population. We're continuing to see opportunities, which supports the demand growth that you're seeing. In addition, you asked about the DDEB population. We're continuing to see patients come in that are both RDEB and DDEB. As the launch has gone on, we're seeing the DDEB patient population grow as they sit more on that mild-to-moderate spectrum, but we're still also seeing RDEB patients coming in. So it is still a healthy split of the opportunity that's being found in that community setting.
There are about 1,200 identified patients in our initial target. Once we get close to that number, we'll expand efforts to go after the roughly 3,000 more who are likely undiagnosed. The number of reimbursement approvals we generate every quarter demonstrates continued healthy demand; we are still seeing somewhere between 35 and 50 reimbursement approvals almost every quarter.
Your next question for today is from Lachlan Hanbury-Brown with William Blair.
Maybe a couple on access. Over the past couple of weeks we've seen headlines out of Germany about reforms on drug pricing or health insurance. I know negotiations are ongoing and this new law is still early, but any thoughts on how, if at all, that could impact either the negotiations or the ultimate outcome there? And then in the U.S., how are pricing and coverage negotiations going through PBMs and the shift to at-home administration, given that's earlier in the launch than the original ACP-administered product?
I'll answer the U.S. quickly and turn it to Laurent for Germany. In the U.S., since the beginning of the launch we've had very good access and haven't had substantive issues to date. There is some annual churn in January as people transition insurances, but in terms of pricing and rebates we've had productive relationships with payers. Laurent, on Germany?
Each market has its own pricing and reimbursement framework and specificities, so outcomes will vary from one country to another. Our focus is on achieving sustainable reimbursement that reflects VYJUVEK's clinical value, the high unmet medical need, while providing access to expanding groups of patients and being consistent with international reference pricing frameworks. News and policy in Germany are evolving, but we are aware of it and our negotiations are constructive.
Your next question for today is from Debjit Chattopadhyay with Guggenheim Securities.
I have a couple. First on NK: our channel checks suggest patients who have undergone prior corneal surgeries or vision correction procedures might be at risk for NK. If that's correct, how are you thinking about the commercial opportunity? Second, the ocular DEB program will read out prior to NK. How are you thinking about the read-through from DEB to NK?
Thanks, Debjit. On NK market opportunity and potential incident forces like surgeries, we're looking at claims data and OXERVATE's performance. It's clear diagnoses and treated patients have increased dramatically, likely from both awareness and incident forces. NK is a large and growing market in the U.S. and underserved globally. There's plenty of opportunity for 801.
The advantage for 801 is our CMC and manufacturing readiness. Mechanistically, NK and ocular DEB programs are different. For NK, you need an open wound and demonstrate complete wound healing via physician imaging and independent review. For the ocular DEB program, it's more prophylactic and relies on patient-reported outcomes; patients complete scales assessing pain and abrasion, so it's a different endpoint and evaluation. Because of these differences, read-through from one program to the other is limited and not the right approach.
If I may follow up, our channel checks found many competitor sales reps in the market supporting OXERVATE. Assuming a successful outcome of EMERALD-1, how are you thinking about sales force in 2027 to prepare for a launch and address the market opportunity there?
It's a bit early to discuss Phase IV or detailed post-approval plans. We recognize the significant unmet need and patient opportunity. If EMERALD-1 is successful, we would plan to pursue a dominant position in the U.S. and worldwide and will prepare accordingly.
Your next question for today is from Kalpit Patel with Wolfe Research.
For the ocular DEB program, can you remind us if that is also planned to include global patients like NK? And for the NK program itself, can you comment on screening-to-enrollment rates and what the demand looks like for the trial? Finally, on Europe, on a gross pre-pricing accrual basis, can you give any color if European VYJUVEK sales increased sequentially, and if so, by approximately how much?
The ocular DEB study is currently focused on the U.S. because patient-reported outcomes are not as widely accepted in Europe for regulatory purposes. NK is different; it's driven by physician imaging and is more accepted globally. Regarding enrollment, we are picking up pace as more sites become active, and adding European sites should accelerate recruitment. For the Europe sequential sales question, while we avoid country-by-country disclosure, I can say European vial utilization increased sequentially in the quarter and the increase was in the double digits.
Thank you. We have reached the end of the question-and-answer session and today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.