Xvivo Perfusion AB (publ) (XVIVO) Earnings Call Transcript & Summary

Welcome to Xvivo Q3 Report for 2026. [Operator Instructions] Now I will hand the conference over to the CEO, Christoffer Rosenblad, and the CFO, Kristoffer Nordstrom. Please go ahead.

Thank you so much. Good morning and good afternoon, everyone, and welcome to Xvivo's earnings call for the third quarter of 2026. We can go to Slide #2. Joining me today is Kristoffer Nordstrom, our CFO, calling in from Denver, Colorado, and myself, Christopher Rosenblad, CEO, joining from Stockholm, Sweden, today. And with that, we can go to Slide #3, which is the Q3 financial at a glance. We delivered another solid quarter with sales in line with the first half of the year and organic growth of 32% compared with the third quarter of 2025. EBITDA remained strong, supporting healthy operating cash flow. For the fourth consecutive quarter, total cash flow was close to neutral, resulting in a stable cash position. Our CFO will later in this call provide more details on sales, gross margin, and EBITDA later in the presentation. Looking at the business, [Thoracic] continued to perform very well across both North America and Europe. The positive market trends we saw towards the end of last year continued through the quarter, supported by strong growth in the lung market and our expanding commercial presence. Kidney also delivered strong growth driven by increased commercial coverage in Europe and growing interest in the U.S. market. Against this backdrop, sales developed this quarter and over the coming quarters will be impacted by the transition to updated core components. While this creates a temporary headwind, it does not change our positive view on the underlying market opportunity and business momentum. Turning to Slide 4, which is the year-to-date performance. The first 9 months of the year show a similar picture to the quarter. We continue to deliver strong and consistent growth driven by robust performance in Thoracic and healthy growth in abdominal. Throughout the year, we have continued to invest in our commercial organization, scalable production capabilities, and regulatory approvals to support future growth. Sales amounted to SEK 730 million, corresponding to an organic growth of 30%. The key takeaway from the past 2 years is that we have demonstrated the scalability of our business model. With only a few months remaining in 2026, we are now increasingly focused on the opportunities ahead. The next 2 years will be important for XVIVO to continue building the company toward our ambition of becoming the preferred partner in the transplant process. Among the most exciting commercial opportunities are the launch of XVIVO Heart Assist Transport in Europe and our planned expansion into Canada and Australia. In Australia, XVIVO Heart Assist Transport has already established a strong position through compassionate use and has now become standard of care, which took only 3 years. With that, we move over to the next slide, Slide 5, and the key business highlights from the quarter on the following slides, 6 and 7. So, turning to Slide 6 and the key highlights from the quarter. Q3 was an important quarter for XVIVO, marked by several milestones across our business. First, with the EU approval of XVIVO Heart Assist Transport, we can now begin supplying this life-saving technology to patients across Europe. The approval covers all heart donors and all heart transplant recipients, including all age groups as well as both DBD and DCD donors. Clinical data demonstrated a 76% risk reduction in severe PGD, the leading cause of early mortality following heart transplantation. As a result, 6 additional patients per 100 survived to their 1-year follow-up date. This represents a significant benefit for this vulnerable patient population. In addition, XVIVO Heart Assist has also demonstrated the ability to safely extend preservation and transportation times. This gives transplant teams greater flexibility in planning procedures, enabling surgery to be performed under more controlled conditions with the rest of the transplant teams while also having the potential to reduce overall cost of the transplant process. Second, we reached another important milestone with the submission of the PMA application for XVIVO Heart Assist Transport in the United States. We are equally committed to patients with end-stage heart failure in the U.S. and to enabling heart transplant teams to perform surgery with investor teams and in a less stressful and more controlled environment. By extending transportation capabilities, XVIVO Heart Assist has the potential to make more donor hearts available for transplantation while reducing transportation costs, ultimately lowering the overall cost of the transplant procedure. Third, our OPO EVLP hub pilot is now successfully up and running, contributing to the strong lung sales development we have seen this year. We are now seeing 3 distinct EVLP models emerging in the U.S. market: advanced transplant centers, centralized EVLP providers, and OPO-based programs. Our strategy is to support all 3 models, helping more donor lines reach transplantation and ultimately ensure that nobody dies waiting for a lung. To support this development, we continue to invest in our commercial organization and strengthen relationships with an expanding network of EVLP partners across the United States. And finally, despite making significant investments in scalable manufacturing, regulatory initiatives, and commercial expansion, we continue to maintain a healthy financial position. We believe this is the right time to invest in the long-term growth opportunity ahead of us and continue building XVIVO for the future. And with that, we're turning to Slide 7. An update on the European heart launch of XVIVO Heart Assist Transport. During the quarter, our primary focus was on preparing the market launch country by country and clinic by clinic across Europe. We are executing a structured 3-tier launch strategy. The first phase is now in place, enabling active transplant centers to begin using the X-HAT under derogation or compassionate use while local listing processes are completed. We now turn to Tier 2, and our current focus is targeting 33 transplant centers across 4 priority markets where reimbursement is already established. These centers, together with the first 8, represent almost 40% of all heart transplant clinics in Europe. In parallel, in Phase III, our commercial and market access teams are working closely together to identify patient segments where the clinical value proposition is particularly strong, including DCD hearts, long-distance organ transplantation, pediatric transplantation, and complex patients with prior LVAD support. With a very strong clinical evidence base already established, the focus is increasingly shifting towards health economics and reimbursement in Europe. From our perspective, the question is no longer whether the XVIVO Heart Assist can become the gold standard of future heart transplantation. The key question is how quickly reimbursement can be established to ensure broader patient access across Europe. Ultimately, our ambition is clear: to make this technology available to more patients, enabling more heart transplants and bringing us one step closer to the future where nobody actually dies waiting for a heart. So that was the key milestone of this quarter. And as customary, we turn to Slide 8 and the regulatory and clinical update. As more products receive approval and enter the market, the list of ongoing regulatory milestones continues to get shorter. And with that, we can turn to Slide 9 to show that picture. So the CE Mark for XVIVO Heart Assist in Europe serves as a foundation for our regulatory application in both Australia and Canada. In addition to the clinical data generated in Australia, the European clinical trial provides strong supporting evidence. It was the first randomized controlled trial with a superiority endpoint conducted in the field of heart transplantation. Beyond the strong clinical outcome, the trial was also the first to establish a link between preservation method, which is the risk reduction of severe PDD, which was 76%, and the improved 1-year survival of 6 percentage points. For heart in the U.S. and liver in the U.S., I will return to a deeper dive into the following slide. And with that, we turn to Slide 10, which is the regulatory status of Xvivo heart disease transport in the United States. The U.S. heart trial was fully enrolled in record time, completing enrollment in 13 months compared to the written plan of 30 months and delivering results consistent with those we've seen in Europe. The study met its predefined safety and efficacy endpoints, while the analysis of secondary endpoints showed a severe PGD rate of only 7.9%. We also reached an important milestone with the submission of the PMA application for Xvivo Heart Assist Transport. The submission was accepted by the FDA in September, and the review process is now ongoing. During the quarter, the extension of the continuous access protocol of the CAP was also approved, providing access to this really innovative and life-saving technology for an additional 60 patients at the participating trial centers in the United States. The breakthrough device designation supports an efficient PMA review process, and we are targeting commercial launch in late 2027. This is subject to FDA review time as well as approval. It should be mentioned that the breakthrough device designation allows us to have a dialogue with the FDA during the process. So that should facilitate the process. Though I have to mention, as always, FDA review timelines are determined by the agency itself and remain difficult to predict. We will continue to provide regular updates to the investor community on the progress of the Xvivo Heart review process during quarterly calls. And with that, we turn to Slide 11 and the U.S. liver regulatory opportunity. But before I go in there, let me start with an overview of the clinical evidence supporting vivo Liver Assist. Xvivo Liver Assist is approaching the standard of care for liver transplantation in several European markets and is supported by one of the largest bodies of clinical evidence in the transplant field, if not the largest body of evidence we have seen in the transplant field so far. The evidence base includes more than 100 peer-reviewed publications and covers a broad range of outcomes from improved patient outcomes in both DCD and DBD liver transplantation to meaningful operational economic benefits for transplant. Clinical studies have demonstrated improved utilization of donor livers, improved post-transplant outcome and reduce complication. At the same time, machine perfusion has enabled transplant centers to work with great flexibility and predictability, supporting both the teams and the hospital operations. Taken together, we believe Xvivo Liver Assist has established one of the strongest clinical and health economic evidence bases in transplantation and provides a solid foundation for our regulatory and commercial ambitions in the United States. And with that, we go to Slide 12 for a more specific update on the U.S. regulatory pathway for the Liver Assist. Following a reevaluation of our U.S. regulatory strategy last year, interest in the Liver Assist has continued to grow among transplant centers in the United States. We are increasingly being approached by centers and clinics that would like to get access to Liver Assist, recognizing both its clinical benefits and its potential to improve workflow and quality of life for transplant teams. There's a clear demand in the United States for a cost-efficient solution that can improve outcomes while supporting a more sustainable transplant practice. Against this backdrop, our regulatory team is actively preparing the submission package for the FDA. We are targeting a 510(k) submission in the first half of 2027 and, subject again to regulatory timelines, commercial launch in early 2028. We believe the U.S. represents a significant long-term opportunity for Liver Assist, supported by both the strong clinical evidence base we have just shown you and the growing market interest. And with that, I turn over to Slide 13 and hand over to our CFO, Kristoffer Nordstrom, for the next segment of this quarterly call.

Thank you, Christoffer. So, coming to the financial performance of the third quarter, this was another stable quarter for XVIVO, as Christoffer already mentioned. Net sales reached SEK 253 million, corresponding to an organic growth of 32% in local currencies. Growth was led by thoracic, our largest business area, while abdominal also continued to show positive momentum. EBITDA amounted to SEK 52 million, corresponding to a margin of 21% compared with 19% last year. This improvement was supported primarily by strong sales, but also somewhat seasonally lower activity levels on the cost side over the summer months. Gross margin is worth a comment. So gross margin was 70% compared with 75% last year. The year-on-year decrease reflects the lower margins in services primarily, as well as product mix and some inventory write-down within thoracic. Excluding services, where we have made deliberate investments over P&L for some time now, the product gross margin was 75%, both in the quarter and year-to-date. Moving over to our largest business area, Thoracic. Thoracic delivered a very strong quarter with net sales of SEK 177 million and organic growth of 51%. Lung sales amounted to SEK 155 million, and EDP disposable growth was 67% in the quarter, reflecting the continued adoption that we see and the strong activity amongst our larger customers. We mentioned it in the report. So Thoracic also benefited from approximately SEK 19 million from tailwinds towards the end of the quarter. So we had a SEK 8.5 million adjustment, you could say, based on IFRS and the treatment of lease contracts, and that refers to the 3 OPOs where we delivered XPS earlier in the year. And now, when you do that, you need to take the revenue and the cost upfront, and that's the lesson we learned in the quarter. So that's why you see that bit of a one-time effect in this quarter isolated. And that's how we're going to treat those contracts going forward as well when we onboard new customers. There was also approximately SEK 10 million of inventory buildup by our largest customer in the U.S. Heart sales were positive, amounting to SEK 22 million compared with SEK 10 million last year. The CAP study has started. It has 3 patients included in Q3, so it contributed with SEK 1 million, which means that the rest, the SEK 21 million comes from Europe and it comes from Australia, where we continue to see a very strong interest and good adoption of the technology. Gross margin was 80% compared with 89% last year. And as I mentioned, the decrease is mainly explained by the product mix, hence a larger portion of this [Xvivo PS] revenue, and also the inventory write-downs. Excluding these events, the gross margin would have been 85%; that's the level we recognized from earlier quarters as well. Moving over to Abdominal. Net sales were SEK 62 million, corresponding to an organic growth of 12%. Liver sales were SEK 40 million and grew 9% in local currencies. Growth was somewhat lower than last year, reflecting temporary implications from the manufacturing transfer that has been going on and somewhat softer activity in a few European markets over the summer. We remain encouraged by the long-term opportunity, supported by continued adoption in our core markets and the broader DCD utilization that continues, but also by longer-term reimbursement development and those opportunities. Kidney sales amounted to SEK 22 million and grew 19% in local currencies. Our growth in the quarter was affected by seasonality and implications from the manufacturing transfer as well, and we believe that will continue into Q4. We do expect growth at current customers and with the current design to continue to return to higher levels of growth from the beginning of 2027. Gross margin was 61% compared to 60% last year. Turning to Services, our final business area. So net sales were SEK 14 million -- that means a negative growth of 28%. The decline was again primarily explained by lower organ recovery volumes. We remain optimistic about the pipeline of prospective customers. We have several contract processes currently underway, which is very encouraging. However, these processes continue to take longer time than we anticipated to convert into revenue. Gross margin was negative 19% compared with 37% last year. And the decrease reflects the lower recovery volumes, combined with our investment in expanding the surgical team to position us for winning new contracts in new geographies and for building capacity ahead of the U.S. heart launch later on. So as recovery volumes increase and the new capacity is utilized, we expect the gross margins to recover significantly. EBITDA looking at SEK 52 million in EBITDA in Q3 compared with SEK 36 million last year, and the EBITDA margin improved to 21% from 19%. Year-to-date EBITDA was SEK 148 million, and the margin was 20% compared to 17% last year, so an improvement there. Rolling 12 were at 21%. The margin improvement in the quarter was supported by strong sales, but also by the seasonally lower summer activity. While we continue to invest in commercial expansion, we talked about regulatory activities and also the infrastructure to support future growth. Final slide: cash flow. Cash flow from operating activities was strong, SEK 53 million positive in the quarter compared with SEK 21 million last year. The improvement was primarily driven by the strong sales development. And for the first 9 months, our operating cash flow amounted to SEK 182 million compared with only SEK 14 million last year. So a significant improvement on the cash flow this year, which I am very proud of. Cash flow from investing activities was minus SEK 49 million, where SEK 39 million of those were invested in our regulatory approval processes and trials, primarily related to heart. So over the past 3 quarters, we have generated positive operating cash flows that have been sufficient to fund both our operating and our investing activities. And we ended the quarter with a cash position of SEK 313 million. In addition, we have an unutilized part of our credit facility of EUR 12 million. So we believe that we will enter next year with a solid cash position. And with those comments, Christoffer, I will hand over to you again. Thank you.

Thank you for that. And we now, at the last section of the presentation, the outlook session, looking into the next couple of years, we can turn to Slide 21, our outlook for the remainder of '26 and the next 2 years. Over the past 4 years, we have invested heavily in building XVIVO into the company we are today. Today, we are #1, second to none in innovation. We are #1 in customer support and clinical evidence within transplantation. So we've built a strong position. Combining those with the close partnership with transplant teams around the world, this has created a strong foundation for very high continued growth into the future. All of our major product platforms are now improved in Europe, and we are making good progress towards achieving the same in the U.S. As we look ahead, our focus increasingly shifts from building capabilities to expand access and driving adoption of our products. Our ambition is to become the preferred partner in the transplant process. To achieve that, we have identified 4 key pillars or 4 key priorities. And number one is to secure market access for heart and liver in the U.S. through regulatory approval, reimbursement, continued generation of U.S. clinical evidence, and further development of decision support parameters for both heart and liver with HOPEMed. Number two, the exciting Xvivo Heart launch in Europe. Our aim is to establish the Xvivo Heart Assist Transport as the standard of care for modern transplantation. Third, we continue to strengthen our leadership position in EVLP for lungs. We will continue to work closely with transplant centers to advance the science of lung transplantation. We'll continue to support pump centers, and we continue to support OPOs and centralized evaluation hubs in increasing access to donor lines for transplant products across the United States. And finally, we continue to invest in the robust and scalable supply chain, maintaining the highest standards of quality across our products and processes. We are growing very fast, and we have to make sure that our supply chain runs equally fast. In addition, to maintain our #1 position in perceived quality of customer support, we will continue investing in our commercial capability and in the partnerships that are critical to the success of transplant programs across the world. The opportunities we see ahead of us are significant. We have a strong product portfolio, growing clinical evidence, and dedicated teams around the world. We believe that XVIVO is well positioned for the next phase of our growth journey. And with that, we can turn to Slide 22 and our longer-term outlook. Because if we look at the longer term, the fundamental picture remains unchanged. And in many ways, this is also the reason we're all here today. According to WHO, the demand for organ transplantation remains approximately 10x greater than the available supply of donor organs. At the same time, the value created through machine perfusion is significantly higher than with traditional aesthetic cold storage. Clinical evidence and real-world experience have demonstrated that machine perfusion and a service model can increase organ utilization, particularly within the rapidly growing DCD donor pool. The key drivers are superior clinical outcomes, increased utilization of donor organs, and simplified workflows for the transplant center. As a result, we believe machine perfusion and a service-based model for both DBD and DCD organs will continue to drive growth in transplantation for many years to come. At XVIVO, our ambition is to change the paradigm of transplantation through innovation. We are committed to improving life after transplantation, making more organs available for patients in need, and providing transplant teams with technology that enables surgery to perform under the best possible conditions. And therefore, our vision remains unchanged: nobody should die right in front of the team. And with that, we can turn to Slide 23. And before we open up for questions, I just want to touch base on our dream and what we have been working on in the last 10 years to achieve: for transplantation to become a standard procedure and for organ transplantation to be performed using ordinary mode of transportation. And that should be done by the rest of the transplant teams with the best possible patient outcome. So again, next time, when you are flying, I hope that you are seated next to one of our devices on a flight. And remember that it's not just a device being transported. It's a donor heart going to a patient whose life is about to change. And I want to thank you all for supporting this journey with us. With that, I want to also thank you for listening today, and we will now open up the line for question.

[Operator Instructions] The next question comes from Simon Larsen from Danske Bank. The next question comes from Jakob Lembke from SEB.

My first question is on the heart. And maybe, briefly, if you could share the split between Europe and Australia for the Q3 sales? And then also, if you could comment, yes, if you are already starting to drive adoption among the Tier 1 compassionate centers, and also when you will start to onboard new customers in that sort of Tier 2 category.

I will start with the second question. We are listing the product. So we are targeting to onboard new customers in December of this year. We know the listing process is 3 to 4 months. So right now, the sales we see on Heart are still coming from irrigation compassionate use, et cetera.

I can follow up on the first question. So in Q3, Heart sales were as follows. So Australia, New Zealand, SEK 9 million; Europe, SEK 11 million; and U.S., SEK 1 million. Okay.

And if I understand, are you growing your volumes with these existing customers right now? Or are those stable right now?

That's a good question. The majority of centers are growing, but we still believe that the real growth from both new centers and existing centers would come with the listing of the product and selling on the CE mark, and with reimbursement kicking in as of December.

Then on Liver in the U.S., I mean, very good that you are targeting a faster launch here. I'm wondering how you see the long-term prospects in the U.S. market. On the one hand, you're very strong in Europe, but the U.S. market is also more crowded than you are, with already 2 warm perfusion players and fusion. So yes, it would be interesting to hear what you think about the long term in the U.S.

That is a great question. I mean, from customer feedback, it has been very clear that they need an alternative in the U.S. And when they all meet or transplant surgeons and transplant coordinator all meet on the larger global conference, it is clear that when they see Europe, it's clear that they see an extremely good product, very stable product with the best clinical results in the world. So of course, they want to get their hands on that one. We are realizing it's a more crowded field. And I think the success rate of it will depend partly on how fast we can afford to scale up sales and support functions to deliver Assist, which will be key to being successful in the United States as well as partnership within the, let's call it, logistics/perfusionist area, so we can support OPOs in pumping the greatest number of livers as possible. So there will be some investment needed and some partnership discussions needed to have the greatest possible success.

And do you think that you will mainly sort of convert customers that today are on warm perfusion solutions? Or will it be those that don't use perfusion at all, or converting those now maybe on cold perfusion? Do you have any sense of that, which will be your main opportunity?

We are doing that job right now to look at what will be the main opportunity. I think that we will see opportunities in all of the above. Then depending on how fast we can change current behavior, that will be the leading cost to where we will get the highest uptake of our technology. But as always, when we launch a product, I think the majority of sales in the beginning will come from KOLs, divisions, the ones who want to change. And over time, that will trickle down to the majority market.

Then I also have a question about this stocking you mentioned to your large customer in the U.S. Just to understand, is this an order you otherwise would have expected in Q4 that now came in in Q3? Or is it that stands out as unusually high to the customer? Just some more color on that, please.

Yes. So it's given our insight into the volumes, this was more of a pop up as we see it. So we are afraid that could mean that the sales in Q4 might be slightly less than we expected, but still solid and contribute to growth in Q4.

Short comment on that one. Sometimes when we get an order, it can fall on the last day in 1 quarter or the first day in 1 quarter. This fell on the last day. It happens. It's not unusual. We just want to be very transparent.

Then, the final question from my end is on the kidney. And if you can elaborate a bit on what you mean by more moderate growth. As, let's say, do you still see some growth? Will you go with existing accounts? Or will you also take some new accounts? Or how should you look at that?

That's a good question. That needs some clarification. We see high growth opportunities in the U.S. coming from both existing and, primarily, new accounts in the United States as well as Europe. So we are talking about moderate growth, probably around 30%, but the opportunity is much higher if I look into the pipeline of new kidney customers, especially in the U.S. market, but also in Europe, where, so far, I think we had far above 60% growth here in Europe. But due to some component changes where there is a shortage situation, we need to allocate them wisely, and we will not be able to fulfill the full demand of the market next year in kidney. That's our best estimate. But we still have solid growth, still okay, but unfortunately, not to its true potential.

The next question comes from Simon Larsson from Danske Bank.

Hopefully, you can hear me better now. I would like to start on this big U.S. line customer, and you are, of course, mentioning in the report that they are planning to switch to at least partly to their own EV platform here in '27. Just for a benefit to help us think about the dynamics in that switch, will this be from one day to another? Will it be more of a gradual shift? Because I'm thinking that some of the customers stick maybe to your platform given that they have experience working with it. So any color on that dynamic would be helpful.

Thank you. We will try our best. But you have a point that there is an end customer who has to say in this one, and it's very clear that the end customer decides. Just to be very clear, we've been partners for more than 10 years. And we are in constant dialogue around how to increase the lung utilization rate in the United States. Today, it's around 25%; it should be 50%. The jump from 20% to 55% will be because that's what it's developed for. So we are looking into those at the same time. We are in a phase in the dialogue where we can't go into exactly how the dynamic pricing will develop. But as soon as we know, we will inform the investor community at the latest in the quarter report for Q4. That's clear.

And maybe a bit of a conceptual question, but when you're looking into next year and on Lung specifically, okay, we have this, let's call it, a headwind potentially from this customer, but you had a very strong placement year last year of Xpress systems. The OPO model is starting to bear fruit. Is it sort of plausible for those initiatives to counteract, to a full extent, the potential headwind from the biggest customer? Or is the magnitude too big to counteract, do you think? Or yes, how should we think about the whole lung franchise next year in terms of growth rates? Just maybe high-level takes from your end.

You will get a high-level answer to that one, and we need to come back with a more detailed answer. But we do see fast growth in our new customers, and we do believe that will hopefully cover any shortfall. So that is our strategy, and we need to, of course, come back and update you regularly every quarter next year on the case, but that is the working hypothesis right now.

Lovely. Maybe my final one on services: are you evaluating any type of restructuring of that business or any similar initiatives? Do you think it will be -- or is it crucial for XVIVO to have an in-house service capability over time? Would it maybe be better and more cost-effective to work with a partner instead? Or what's your thinking about that business area right now?

If I answer more generally, we are continuously evaluating our strategy and go-to-market strategy for all our products. And as we have mentioned many, many times, this was bought as an option for the U.S. heart launch, and we're now nearing the U.S. heart launch. So of course, we are looking into what the best possible way is. We have, I would say, the best quality organ recovery service, and it's a great asset that we will use in the heart launch either way. But of course, we are looking into any strategic opportunities constantly to see what is the best way forward.

I also want to comment that the restructuring, as you said, is what has happened, and that's also why we see we have invested in this business and that currently was weighing down the margins of that business, but it has been a deliberate decision, and the restructuring has been attracting very talented surgeons in strategic geographies to position us for winning new contracts and to be a good spot when we launched the heart launch. So I'm very excited about the contracting discussions we have at the moment. And I just wish it went faster, so to speak, but we will get there.

The next question comes from Filip Wiberg from Pareto Securities.

I got a few questions today. I think I'll start on liver. So I'm a bit curious about the submission now in the U.S. So what exactly does it take before you can do something that you've targeted on 27? What are you going to do until then? Is it mostly just writing it up? Or will you need to get any clinical data? I think you had on the slide that you're only going to submit based on data outside the U.S. So do you have everything you need currently? Yes.

Thank you for that question. There will, of course, setting up the file and the application will take some time and that will spend the time on. Our current strategy is that we will still have outside data; the usability validation needs to be done in the United States, but that's not a clinical trial; it's more of a usability trial. So that also takes some time. So that is what we will spend the majority of the time on until submission.

I think you've spoken before because the predicate device you're relying on now is just HOPE, but you have most of your data in dHOPE, but like you have sufficient data for a submission, it seems like that.