Hansa Biopharma AB (publ) (HNSA) Earnings Call Transcript & Summary

Hello, everyone, and welcome to the Hansa Biopharma Q2 2024 Conference Call. Today's call is being recorded. [Operator Instructions] I'll now hand the call over to CEO, Søren Tulstrup. Please begin.

Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the first half and Q2 results for 2024. I'm Søren Tulstrup, President and CEO of Hansa Biopharma. Joining me today is Evan Ballantyne, Chief Financial Officer; Matt Shaulis, Chief Commercial Officer and U.S. President; and Hitto Kaufmann, Chief R&D Officer. Please turn to Slide 2. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Now please turn to Slide 3 and an overview of today's agenda. Today we'll discuss the progress we made during the first half of 2024 and review our near-term [ milestones ]. The presentation should take roughly 15 to 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to Slide 4 and an overview of our Q2 highlights. I'm pleased to announce we have delivered our third consecutive quarter of solid sales with total revenue of SEK 54.2 million, of this, SEK 47.1 million can be attributed to Idefirix sales. The strong sales performance we saw in the second quarter is a result of the team's successful efforts to expand access to Idefirix for highly sensitized kidney patients across Europe. During the quarter, we secured our first commercial sales in Italy, following achievement of reimbursement status in key regions. Today, we have had commercial sales of Idefirix in all of the top 5 European markets. We're also seeing strong momentum in our pipeline and clinical development efforts. In May, we announced that ConfIdeS, our pivotal Phase III U.S. trial in kidney transplantation, had been fully randomized. This marks an important milestone for Hansa and following data readout in the second half of 2025, we expect to submit a biologics license application to the U.S. FDA seeking accelerated approval. Matt will cover the status and next steps for the trial in more detail during this section of the call. Our postauthorization efficacy start in Europe is progressing at a good pace in parallel with the continued commercialization of Idefirix and as part of our obligation to EMA. [indiscernible] data that could further support the adoption of Idefirix as desensitization therapy to enable incompatible kidney transplants, this study offers additional opportunities for important transplant centers to gain experience with Idefirix. Data readout is expected in 2025. Looking beyond kidney transplantation, we have advanced several trials in autoimmune diseases. Our Phase III anti-GBM disease trial continues with more than 70% of patients enrolled in the trial. Completion of enrollment is expected in 2025, as previously guided. And based on the strong momentum in enrolling patients, we now also expect data from the study in 2025. Our Phase II trial in Guillain-Barré syndrome also remains on track, and we expect to share additional efficacy data later this year, following promising high-level data communicated in 2023. Our efforts to advance HNSA-5487, the lead candidate from our next-generation [ NiceR ] program, continue as planned, and we look forward to sharing further analysis on endpoint in the Phase I trial and the development path forward during the second half of this year. Finally, I'd like to congratulate our partners Sarepta on the recent achievement of FDA's full approval and expanded label for ELEVIDYS in Duchenne Muscular Dystrophy. While this approval enables more patients the opportunity to benefit from the therapy, some patients remain ineligible due to anti-AAV antibodies, and we're excited to continue our collaboration with Sarepta to determine the potential for imlifidase to enable gene therapy in these patients. With this, I'll hand it over to Matt for a business and operational update. Please turn to Slide 5.

Thank you, Søren. Please turn to Slide 6 for an update on Idefirix launch in Europe. As mentioned, this marks the third quarter of strong commercial sales for Idefirix. We attribute the continued commercial utilization of Idefirix to several things. The first is that we have seen additional centers come onboard throughout Europe and continue to progress reimbursement in key European markets. As Søren mentioned, we secured our first commercial sale in Italy in Q2. As of today, we have reimbursement in 14 European markets, including the top 5 markets, and we have access to approximately 75% of the European transplant market. By Q2, 28 centers gained clinical experience with Idefirix. This is an increase from last quarter with 3 additional centers gaining experience with Idefirix. Importantly, 60% of those centers have used Idefirix more than once. And there are over 50 transplant centers in Europe that have the capability to perform kidney transplants in highly sensitized patients. Repeat utilization underscores the growing clinical confidence in Idefirix and clinician's ability and willingness to identify Idefirix-appropriate patients. Given that we see increased uptake in new clinics in new markets, we believe that repeat utilization could happen in several clinics in the remainder of 2024. While we have full confidence that our strategy is the right one, we recognize the volatility of the transplantation market, particularly with respect to organ allocation and therefore, we'll continue to broaden our base of opportunity, including the progression of health technology assessment processes in several countries to ensure ongoing expansion of Idefirix availability and reimbursement to even more markets and patients. The second reason we believe we are seeing good progress in Europe is the desensitization strategies within the clinical community continue to advance. In fact, the European Society of Transplantation, ESOT, published a consensus paper in April entitled European Consensus on the Management of Sensitized Kidney Transplant Recipients: A Delphi Study. The paper recommends imlifidase as a desensitization strategy for deceased kidney transplantation in selected patients for whom no other treatment options are available. This follows the organization's publication of the first ever guidelines on desensitization in 2022, which resulted in Idefirix specific guideline implementation at the national level in key European markets. And finally, Eurotransplant’s desensitization program is helping identify patients eligible for Idefirix. To date, the program has identified and treated 5 patients with Idefirix, including in Germany, the largest market in Eurotransplant footprint. This validates that participating transplant centers are now receiving Idefirix-designated kidneys. Eurotransplant is an international allocation system responsible for the allocation of donor organs across 8 countries, including Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, the Netherlands, and Slovenia. Please turn to Slide 7. Advancing the science of imlifidase in kidney transplantation is also important. To that end, there are 2 key studies we continue to progress, including a long-term follow-up study. The 17-HMedIdeS-14 study and the postauthorization efficacy study, PAES. As we have communicated previously, the long-term study has demonstrated that for important endpoints such as graft survival and overall survival, imlifidase treated highly sensitized patients achieve similar outcomes as nonsensitized patients. Both studies are on track, and Hitto will share more about them in just a moment. Additionally, a real-world evidence study has been initiated in France to evaluate outcomes in 9 imlifidase-treated patients. Through the initial follow-up period, there has been no graft failure and no death and these real-life data demonstrate that the use of imlifidase to desensitize highly sensitized patients and have an accessible short-term efficacy and safety profile in selected patients. Additionally, a real-world evidence study has been initiated in France to evaluate outcomes in 9 imlifidase treatment patients. Through the initial follow-up period, there has been no graft failure and no death and these real-life data demonstrate that the use of [indiscernible] to desensitize, highly sensitized patients and have an accessible short-term efficacy and safety profile in selected patients. Please turn to Slide 8. Finally, we are happy to announce that ConfIdeS, the pivotal U.S. Phase III trial is now fully randomized. As a reminder, the ConfIdeS study is evaluating imlifidase as a potential desensitization therapy compared to treatment according to standard of care to enable kidney transplantation in highly sensitized patients waiting for a deceased donor kidney. A total of 64 highly sensitized patients on the waitlist for kidney transplantation were randomized on a one-to-one basis to either desensitization with imlifidase or standard of care. What's important to know about the study is the total of 23 sites were enrolled in the trial and consented over 140 patients. Approximately half of these sites, about 11, were responsible for randomizing 2 or more patients. The sites in the trial represents about 20% of the total transplantation volumes in the U.S. Currently, 13 sites have treated patients with imlifidase thus far, which is very encouraging, and we believe it further validates the clinicians are recognizing the clinical value and patient benefit imlifidase in highly sensitized patients. Following full randomization, all patients will be followed for 12 months per the study protocol, and we expect data readout in second half 2025 and followed by submission of a BLA to the U.S. FDA to seek accelerated approval. I will now turn to Hitto for an update on the pipeline.

Please turn to Slide 9. Thank you, Matt. Slide 10 -- please turn to Slide 10. During the second quarter, we have made progress across our 3 key therapeutic areas with all trials. Let me [ go ] into the slide and talk through the progress as well as what's to come in the second half of 2024 and beyond. Importantly, Matt mentioned that we've completed full randomization in the Phase III U.S. trial ConfIdeS. We now look to follow all patients for the next 12 months for the study protocol and begin to prepare for BLA submission to the U.S. FDA in the second half of 2025. In parallel, we are also advancing additional trials in kidney transplantation. The long-term follow-up study, 15-HMedIdeS-14 is a prospective observational long-term follow-up study of patients treated with the imlifidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after imlifidase administration. The data shows sustained positive outcomes out of 5 years in the majority of highly sensitized patients, who received imlifidase-enabled kidney transplant. Data were presented at the American Transplant Congress in June, and we expect it to be published in a peer review journal later this year. And the postauthorization efficacy study, PAES, continues to progress as part of our obligation under the European conditional marketing authorization. The study will support full marketing authorization and data readout is expected in 2025. In autoimmune, we are progressing 3 trials. Earlier this year, we reported initial data for our Phase II study in GBS, the 15-HMedIdeS-09 study, an exploratory single-arm study with several efficacy endpoints. We plan to share contextualized efficacy data later this year based on a comparison between the data of the study and the matched cohort from the IGOS database. The International Guillian-Barré Syndrome outcome study, or IGOS, is a large-scale global research initiative that collects extensive clinical and biological data from GBS patients to enhance understanding and treatment of the disease. GBS is an acute rare paralyzing inflammatory disease of the peripheral nervous system, usually preceded via an infection or other immune stimulation. 2/3 of patients have severe symptoms, resulting in the inability to walk unaided. The GOOD-IDES-12 (sic) [ GOOD-IDES-02 ] Phase II trial in anti-GBM disease has enrolled over 70% of mutations in the trial, 36 of total of 50. We anticipate full enrollment in 2025 and data readout later [ the same year ]. The trial is an open-label, controlled randomized multicenter trial across Europe in the U.S. and is evaluating renal function at the need of dialysis at 6 months in patients with severe anti-GBM disease. We believe imlifidase can have significant potential in improving the outcome for these patients and address the unmet medical need. Anti-GBM diseases are serious, an ultrarare acute monophasic autoimmune disease affecting approximately 1.6 people in 1 million. In anti-GBM disease, antibodies are directed against the patient's own organs causing acute injury to kidney and/or lung function and in worst case organ failure. Rounding out in autoimmune, the Phase II trial in AMR has been submitted to a peer-reviewed channel, and we anticipate publication at the same time in 2024. Moving now to gene therapy. I'm pleased to share that we continue to progress our collaborations with all 3 partners. AskBio, Genethon and Sarepta. These collaborations will help determine the potential for imlifidase as a pretreatment to gene therapy in those patients with anti-AAV antibody. With both AskBio and Genethon, we continue to progress preclinical efforts. In May at the American Society of Gene and Cell Therapy, ASGCT, annual meeting, AskBio delivered an oral presentations on preclinical data as part of the Hansa-AskBio partnership. The data evaluated the potential use of imlifidase as pretreatment to gene therapy and demonstrated that imlifidase can keep AAVs in circulation for a longer time period, thus allowing a longer window for gene therapy transduction. Together with Genethon, we are finalizing our preclinical work and have plans to commence the clinical study later this year, evaluating imlifidase as pretreatment to GNT-0003 for patients with Crigler-Najjar syndrome. GNT-0003 is currently being evaluated in a pivotal clinical study in France, Italy and the Netherlands and has received PRIME status from the EMA. I'm also pleased to share that we continue to collaborate with Sarepta and DMD. A Phase Ib trial was initiated last December, and we anticipate initial data from this trial will be available in 2025. This is a slight change in the timing to allow for protocol amendment. In June, Sarepta communicated that it is putting a strategic focus on making their AAV-based therapies available for antibody positive patients. Finally, we are making good progress with next-generation molecules as part of the NiceR program. Previously, we announced high-level results related to safety and tolerability from the NICE-01 trial with HNSA-5487, the company's lead candidate in the NiceR program. The trial included a total of 36 healthy male and female adult participants. Further analysis or other endpoints will be completed in 2024, including a decision on the clinical development pathway. Hansa is developing novel IgG-degrading enzymes with the objective of enabling redosing in autoimmune conditions, oncology, gene therapy and transplantations, where patients may benefit for more than 1 dose of an IgG-modulating enzyme. I will now turn over to Evan to cover financial performance.

Thank you very much, Hitto. Let's walk through the company's financial performance in Q2 and for the first half of 2024. Revenue for the second quarter of 2024 was SEK 54.2 million, including SEK 47.1 million in product sales before a SEK 19.9 million provision. Revenue included approximately SEK 4.6 million in contract revenue, mainly from the agreement with Sarepta, including the provision, product sales for the quarter totaled SEK 27.2 million. The provision is associated with cumulative sales since the launch of Idefirix in Europe. What's important to remember is that as the new market entrant, establishing the provision reflects ongoing price and volume discounts. And this is not unique to Hansa nor is it unique to the transplantation market. Excluding the provision, we've delivered our third consecutive quarter a strong Idefirix sales. As we continue to expand our commercial footprint in Europe and other key markets, we expect this to increase. SG&A expense -- please go to the next slide, on Slide 13. SG&A expense totaled SEK 88 million in Q2 2024 and SEK 179 million in the first half of the year. SG&A expense have been affected by restructuring reserve of approximately SEK 3.5 million. Restructuring activities have reduced total SG&A expense compared to prior quarters. Noncash expense for the company's long-term incentive program, the LTIP program, were included in SG&A costs and totaled SEK 16 million for the first 6 months of 2024. Additionally, R&D expense for the second quarter of 2024 totaled SEK 92 million and SEK 195 million for the first half of 2024. R&D expense included our restructuring reserve totaling SEK 6.6 million. Compared to the same period a year ago in 2023, the decrease in expenses was primarily driven by restructuring activities, as Hitto mentioned, R&D expense, including costs associated with the U.S. ConfIdeS study, EMA postauthorization commitment and anti-GBM Phase III studies as well as the CMC development for HNSA-5487. Noncash expenses for the company's LTIP program were included in the R&D expenses and totaled SEK 6.5 million for the first half of 2024. The operating loss for the quarter was SEK 187 million and was driven by lower SG&A expenses and lower R&D expenses, offset by higher cost of goods sold. The operating loss for the first half of 2024 totaled SEK 347 million and was driven by lower SG&A expense and lower R&D expense. If we go -- please go to the next slide on cash flow on Slide 14. In Q2, our company completed a direct share offering of approximately SEK 372 million or USD 34.6 million. This helped extend the company's cash runway into 2026. Operating cash flow for the second quarter of 2024 totaled SEK 189 million and SEK 378 million for the first half of 2024. The decrease in Hansa's operating loss compared to the first half of 2023 was driven by increased sales and a reduction in overall expenses. At June 30, 2024, cash and cash equivalents totaled SEK 705 million compared to SEK 732 million at the end of December 2023. I'd like to turn the discussion back to Søren for Q&A in this portion of the call. Søren?

Thanks, Evan. Please turn to Slide 15. With this overview, our presentation is now concluded, and we'd like to open the call for questions. Operator, please begin.

[Operator Instructions] The first question will be from the line of Alexander Krämer from ABG.

I have 2 questions. One about the sales development in Q2. In light of the additional markets that you have gained in the quarter and also in relation to the postapproval study, could you comment the postapproval study did not recruit much many -- additional -- many additional patients, could you comment on how you see the patient numbers like evolving based on [indiscernible] postapproval study? That's the first question. And the second question is about the 5487 program, which maybe I will ask later.

Okay. Well, thanks for those questions or the first question, Alexander. So the postapproval efficacy study continues, right? In the last quarter, we had a few additional patients added. Some centers are reaching our caps and so on. So that plays into that. But we're on track to have that study completed by the end of 2025 per the commitment we have to the EMA. And obviously, as these postapproval efficacy study centers reach the caps, they will convert into commercial use of Idefirix, and so that's going to benefit our sales going forward. As to patient numbers and so on, [ expect this. ] I can't be more precise, as you know. You had a second question as well around 5487.

Yes, 5487, and that's a question I guess, Evan to you so or to Hitto. The 5487, so we will see data soon. So I'm looking forward to that. And my question here would be -- when it comes to the announcement of the first indication, if this will come together with the data announcement or if it will come later. And also, like [indiscernible] that's the question basically.

So once we get the data in the second half of this year from the healthy volunteer study, when we have the full data set, including the 12-month follow-up. We'll, of course, make an assessment, and then we will chart out the path forward, including selection of indications and so on. We're currently looking at a number of different indications that we find attractive and potentially feasible and so that decision will be taken also in the second half of this year. Whether we will communicate the path forward together with the data or we will first communicate the data and then subsequently, the path, I can't say at this point in time. I don't know, Hitto, if you have additional comments to this.

No additional comments, sir. And as you outlined, there's a certain likelihood that we will initially talk about the data and then digesting the data further, we will inform later about the clinical development.

The next question will be from the line of Matt Phipps from William Blair.

Congrats on continued execution in the quarter. Can you guys give us a little detail on why the Sarepta trial results moved into 2025? I think previously, there have been some update later this year. And then on 5487, why do you feel the need to have 12 months of follow-up, if I recall from early imlifidase data, the immunogenicity responses fairly soon and short half-life of the molecule. Just curious what do you hope to see by 12 months that you wouldn't see by 6 months.

Well, thanks for those 2 questions. So first on the Sarepta trial, as Hitto said, the reason why data will be forthcoming in 2025 is because Sarepta has guided that data will be available in 2025, and that follows the implementation of a protocol amendment, right, obviously, you can have a full data set. You can have a slice of the [ dataset, ] [ you can have data of ] The first patients and so on. We will let Sarepta continue to communicate around the time line here and also, say, the granular aspects of the trial. But we've certainly noted with satisfaction that Sarepta is clearly concluding that this is a priority for them and it's more [ important ] we'll get paid in 2025. On the second question, Matt, 5487, why are we waiting to get a 12-month data? I will let Hitto expand on this. But essentially, what we are -- what we want to see is the ability to do short interval redosing essentially extending the IgG-free window upfront and then also redose later, typically, when you have these flares and crisis in a range of autoimmune diseases. And they can appear several months after initiation of the disease or a year after or 2 years after. So we want to see over the 12-month period, the development of ADAS and also the development of IgG. But maybe Hitto you have some additional comments here.

Sure, Søren. Thanks, Matt, for this question. Søren you outlined it. Matt, what we're trying to do here in this study is an exploratory endpoint. We were taking samples of patients at the different time points and then we subject them to in [indiscernible] cleavage experiments, which will help us guide to the right indication. And typically in indications where you get reoccurring acute phases. That doesn't happen very shortly after the third acute phase. It happens sometimes say, 12, 18 months later. So what we're trying to do is to cover the relevant end point for the diseases that we currently have in mind. And at the same time, we want to get a nice complete FcRn profile to test the hypothesis that we have that overall FcRn levels will be lower compared to [indiscernible]

Can ask one quick follow-up? As you see some of the additional clinical data readout from both the FcRn class positive and negative trials and then also non-FcRn integrators, such as for [ Biohaven. ] Do those play a role as you're thinking about indications? Or do you feel you're in just a different class compared to those anyways as far as diseases that you're looking at?

Thanks for that question as well, Matt. So clearly, we think that FcRn inhibitors and also biodegraders are more complementary than to our [indiscernible] we feel we have a pretty unique profile and the ability to knock down IgG completely and immediately, right? And we don't see any data suggesting that FcRn inhibitors or biodegraders, should be able to do the same. So we're essentially playing in a different field. Our enzymes potentially could be ideal at the onset of a also a chronic autoimmune disease or when you have these crisis and flares. Hitto, do you have additional comments?

No, just to specify maybe the comparison with FcRn. So if you look at pathogenic IgG level, if you treat with an IgG cleaving enzyme, you bring them down to something below 5% within hours. For an FcRn type of treatment, you will only ever bring levels down to something like 30% or 40% within weeks after treatment. And that's why we think of it as complementary.

The next question will be from the line of Douglas Tsao.

In terms of 5487, I'm just curious that I understand the rationale for waiting over the 12 months to see potential formation of antidrug antibodies. But I'm just curious, I mean, given the relatively short half-life, I mean would we expect most of the ADAs to have been formed within the first few weeks of dosing?

Hitto, will you take this one?

Sure, of course. Yes. That's true. However, as I said, that's probably not the most relevant data point for what we have in mind therapeutically speaking. So we wanted to make sure we cover the data point that I'm probably most relevant for the indications that we currently have in mind.

I mean, can you -- I mean, I know you don't want to give too much because you don't want to sort of disclose the indication quite yet. But maybe just give us some examples of types of things that might be occurring in these latter months after dosing.

Again, Hitto, I'll pass it over to you.

Yes. So as we said, we will talk more about it at a later point in time. But I just wanted to point out that there are a number of diseases, for example, autoimmune diseases with a severe effect on the central nervous system, where, unfortunately, 90% of the patients have reoccurring acute phases within the first 5 years after the first occurrence. And that is one group of indications that we are currently having in mind, but there's certainly other as well.

Well, no, no. And I get the reoccurrence and the concept of the flares. I'm just curious in terms of the trial results or the data that you're analyzing. What -- is there any sort of biomarkers right now that you're particularly focused on that would be forming or sort of developing in the later stages after several months after dosing with 5487?

[indiscernible]. I don't know if you have additional...

Just as a reminder, we're talking about a study in healthy volunteers at the moment. So the markers that we're looking at are at [indiscernible] levels are -- and the cleavage experiments that I have alluded to before, where you basically take their samples of patients that have been dosed once with 5487 at the relevant dose for our Phase I study and then you subject them in the laboratory to [indiscernible] that we have [ established ].

Okay. Great. That's helpful. And then just in terms of -- a question for Evan. So the adjustment to the product sales that we've done today, that's a onetime event to account for rebate levels? Or is that something that will happen on a somewhat regular basis, just to clarify that.

Yes. Go ahead, Søren.

I'll hand it over to you, Evan, just to say that [indiscernible] in Europe, getting market access is a complex multiyear effort. And we have a stellar team that has been able to achieve access now in for the majority of kidney transplant patients at a price point that we think reflects the value we're bringing to the table and they've actually been able to do that ahead of the typical kind of time line for this. Each country applies its own standards and models and so on. And in some countries, you benefit from special early access programs where you can actually charge a price upfront, that will not be the final price because you're negotiating in parallel. And then once you have achieved full reimbursement, it is with the obligation to then pay the delta between what you charge upfront and then what you have agreed to, that applies to certain situations. And in certain other situations, you have volume-based discounts and so on and so forth. And so we have been making provisions also in past periods, but now we have better and fuller insight as to what the outcome will be in certain specific situations. And that's why there is this material provision in this period. But Evan, I don't know if you have additional info here.

Yes. Yes. So, that was a great explanation. And we look at the provision every single quarter and as negotiations with various European authorities get closer to a final price, we will adjust the provision. So we didn't see anything unique in Q1. But in Q2, we felt we had to adjust it. And then volume discounts, we typically pay those at the end of the year. So if we pass a volume discount hurdle rate, and we realize that we're going to have to refund a European authority money, we will increase the provision and reflect that in the quarter. And that's what's happened here.

[Operator Instructions] The next question will be from Peter from Carnegie.

This is Erik Hultgård from Carnegie. Two, if I may. First, if you could comment on -- it's obviously very nice to see that you have sort of reached a new level for Idefirix sales in Europe. But I was wondering what our confidence level is in terms of ramping sales in the second half. And what would be the main driver of that, will it be retreatment? Or will it be new clinics coming on board? That's my first question. And what visibility you have on that progress? And then secondly, if you could comment on the gross margin in the quarter. And what the level will be in the coming quarters, that would be very helpful.

Well, thanks, Erik, for those questions. So yes, you're right. Obviously, it's nice to see that there is some level of stabilization of sales. We certainly do expect volatility to continue, given the specifics of the sales situation here. But we are seeing growing repeat usage across Europe, and that kind of will stabilize and increase the growth. So that's very reassuring. Looking forward, clearly, we expect countries like Italy and Spain that have come online recently to start to more meaningfully. We're happy that we've seen good progress in Germany and the Eurotransplant area. And France continues to be a growth engine. Hopefully, U.K. typically is also a relatively conservative market that will also start to contribute more meaningfully. It's, as you know, very, very difficult to predict, but we're certainly very pleased with the overall development, and we expect growth to continue. But Matt may have additional comments here.

Sure, happy to just provide some color commentary around that, Søren. And you have outlined the framework for growth quite well. So thank you. And the comments I would add are that in France, we certainly have a number of centers already, but we are actually seeing additional centers. So with each center, we have the opportunity for numerous patients on the waitlist and then it just becomes a matter of organ allocation. So we're pleased with France and believe that there are good prospects for the future there, and I would count that as a driver. Søren had mentioned and I had mentioned earlier in the call as well, Eurotransplant and Germany, in particular, we're pleased to see some momentum there, and we believe that, that will continue and that, that will very much be a source of growth, particularly given the size of Germany, but also other markets that fall within that Eurotransplant footprint. And then Søren had also mentioned that we are moving towards achieving regional reimbursement in both Spain and Italy. These will be opportunities both for additional centers as well as further identification of patients on waitlist. So we absolutely see that as a catalyst and then finally, I would say that there are continued opportunities in the U.K. We previously got some of our first sales there. And we continue to see patients get identified in that market. All of this bodes well, knowing that we've achieved some caps at some PAES centers. And we believe that in the future, we'll reach the completion of that study. That is another factor that across numerous markets is going to create an opportunity for further commercial sales. So overall, I would say that we're quite confident that we have prospects for growth in the second half of this year and also into next year. What we can never account for is the volatility associated with organ allocation and how that might impact a particular month or even a particular quarter. But suffice it to say, the base is getting broader, more markets, more centers, more patients on waitlist. So thanks for the question Erik.