Earnings Call: H2 2020

Mar 2, 2021

Thank you, Bernard. Good day, everyone, and thank you for joining us. With me today from Orthozyme are Anders Baschol, Interim Chief Executive Officer and Chief Financial Officer Thomas Laitler, Chief Medical Officer and Molly Painter, President of Orthozyme U. S. Officer. The slides for this call are available for download on the Investors section of our website. Please note that the Q and A will take place at the end of the presentation via conference call. Officer. Before we begin, I would like to remind you that during today's call, we will be making certain forward looking statements. Various remarks Officer we make during this call about the company's future expectations, plans and prospects constitute forward looking statements. The forward looking statements are subject to a number of risks, of Uncertainties and Assumptions. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties, Officer nor can we assess the impact of all factors on our business or the extent to which any factors or combination of factors may cause actual results to differ materially from those contained in or implied by any forward looking statements. In light of these risks, uncertainties and assumptions, Officer. The forward looking events and circumstances may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. Officer. In addition, any forward looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date. Officer. While we may elect to update these forward looking statements in the future, we specifically disclaim any obligation to do so even if our views change. Officer. Now I'll turn the call over to Anders. Thank you, Molly. Welcome and everyone. Thank you for joining us. Officer. On today's call, I'll be making the introduction remarks. Molly Painter will review our commercialization strategy and then I'll review our financials. Officer. And then we'll move into Q and A where Thomas Sleddler also will be available for questions. So Officer. On the slide, as you may have read yesterday, we announced very exciting news for Orthozyme. We appointed Christophe Rodin as our new Chief Executive Officer. Officer, who will officially begin his follow on April 1 to give him and his family enough time to relocate to Copenhagen from the United States. Officer. Christoph is a global recognized leader with 25 years of experience in building successful diverse cross functional teams in 3 continents. Officer. Christoph is the ideal CEO for us, as he shares our commitment to delivering therapies to patients and he has Officer with significant experience in commercializing rare disease drugs. He joins us from an outstanding career at Amgen, where he most recently served as Senior Vice President and General Manager for the U. S. Oncology Business. He previously worked at Alexion, where he left the development of ultra orphan diseases, Officer. And I must say personally, but also we as a team look forward Officer. If we then look on the next slide, Officer. The 2020 building momentum slide. I'll provide a summary of 2020, which was an important momentum building year for Orthozyme. Officer. We accomplished many goals against an extremely challenging backdrop due to the ongoing global pandemic. During 2020, we Officer. We significantly advanced our pipeline in our product, IMOsmo, a first class heat job protein amplifier that we believe is a potential game changer in certain Officer. We established a commercial organization in the U. S. Based in Chicago, Illinois, and we expand our commercial footprint here in Europe Officer, to support the potential drug launch. To secure the achievement of these aggressive goals during 2020, we chose to strengthen our balance sheet globally. Officer. We raised capital both in Europe and the U. S. And in the U. S, we also did a U. S. Public offering in Q3. And in total, we raised more than DKK 1 point Officer DKK 2,000,000,000. Overall, we're very pleased with the progress in 2020. Importantly, Officer. And as it's based on the FDA approval, we are ready for the potential launch of our model for NDC in the United States. We're also very excited about the Officer for our investigation products to provide therapeutic benefits in the ALS, IBM and GOCEAK communities. Officer. And then the next slide, which is the pipeline in the product. Officer. So we are developing IMOCTMO for several rare diseases where limited or no suitable therapeutic options, Officer. We believe we can create high value impact to those patients, population and the families. Our pipeline is organized Officer. By the type of disease that we're pursuing and bringing in hematolysomythoid diseases, which include MDC and Roche, Officer. In purple, we have pneumoscular diseases Officer. Protein aggregation may occur as a consequence of protein distorting and is a hallmark in many new innovative Officer. Our leading patient with a disease and ultra rare metastatic genetic disorder Officer. That is life limiting conditions with high unmet medical needs. We have reported the pivotal data and completed our initiation mission Officer in the U. S. Where we received the priority review with the proof of data June 17 this year. We've also filed the biotin appreciation in Europe in November 2020. In both cases, our Phase 2 data show clinical meaningful effect as early as 6 months regarding liver and spleen. Officer. And we are excited about these data and look forward to providing updates on our FORTShift program in the coming months. With MiMOS disease, we are looking forward to top line data from our registration trials in both IBM and ALS in the first half of this year. As a reminder, Officer. We have received both orphan and fast track designation for those two indications. And with that overview of our target and significant milestones Officer. We have achieved this year and also anticipate this year. I'll then turn the call over to Malteita, who will review our commercialization strategy for an optimal. Officer. Yes. Thank you, Anders. And I'm really excited to talk today about the enormous potential we have with aramaximol. Officer. And in the next slide, it will go over our commercial overview. And as you know, we're driving the program Officer, towards the market in both U. S. And Europe and for 4 rare neurodegenerative Officer of Diseases that Anders highlighted in his opening remarks. So our lead indication, Niemann Pick Disease Type C or otherwise known as NTC, Officer. We estimate that there are about 2,000 patients in the U. S. And Europe combined with a diagnosis rate around 40% to 70%. Officer. MPC typically starts for many patients in their childhood with around half of the patients today under 15 years old. Officer. Some children have very aggressive phenotypes. And as you see very, very quickly that they lose Officer. If they have a very aggressive phenotype, Officer. They are unlikely to survive beyond their teenage years, which is very devastating for families. There are currently no Officer, approved drugs for the treatment of MPC in the U. S. Beyond MPC, we are investigating aramachamol for ALS, Officer. We believe that ALS and IBM have the potential to be blockbuster market opportunities Officer with about 50,000 patients for ALS and 40,000 patients for IBM. These are two indications Officer with patient populations that are looking for answers and new treatment options. Currently, no approved therapies exist for IBM in the U. S. Officer. In the next slide, we talk about our established platform. We've worked Officer. We're very hard in 2020 to build our organization for the launch. And as it stands today, we're ready for the potential launch of aramaximol in Episease this year. Officer. We now have a fit for purpose commercial model that is scalable for NTC and additional indications. Officer. We have established our U. S. Headquarters in Chicago, where I'm located, and we're putting together a strong Officer, a multidisciplinary team in the U. S. With experience of more than 15 ultrarare or rare disease launches. Officer. Our key account managers and national account directors are in place and ready. As part of this work, we made sure to keep our manufacturing and supply on track to be sure we meet anticipated demand given our narrow window of approval. Our commercial organization is very Strong across all these disciplines and we're poised and ready to go upon approval. Until sometime, we will continue to enroll patients into our early access program Officer now expanded to 12 sites in the U. S. We are actively engaging with U. S. Payers to support patient access Officer and have completed and scheduled presentations representing 77% of managed lives nationally and 55% of the total NPC community. Officer. This is all happening despite COVID-nineteen and much of this is work that is happening virtually. Officer. Outside the U. S, we've established EAPs in France and Germany, and we're building our European commercial infrastructure Officer with the hiring of General Managers in France, DOC region, Spain and the UK. Officer. For the next slide, we'll start talk we can talk about how we have talked about our commercial readiness. Officer. So let's talk about our global strategy and how we'll work to drive adoption upon approval. There's a 3 pronged approach for the U. S, Europe and the rest of the world. Officer. In the U. S, we expect for aramaximol to be the first to market for MPC. Officer. Our research shows that payers will prioritize approved treatments as first line therapy, which is very positive for us. Officer. In Europe, we expect arimacamole to become an add on therapy to miglostat, which is approved in the EU for MPC and is used Officer, off label in the U. S. In about 40% to 50% of patients. For the rest of the world, we Officer, plan to position aramocamal as a first line therapy in all territories, including U. S. And Europe to hopefully transition patients who are currently Officer on off label therapies to aramoclimal. On this Slide 10, which we'll transition to, I want to emphasize our exciting and near term opportunity with aramachromal to become standard of care for MPC. Officer. There's been a lot of movement in the MPT development space lately with 2 key programs from large pharma being closed, which has caused tremendous disappointment Officer, to this well informed patient community. In addition, it's worth noting that Zabeska became generic in 2020, which we believe Officer. With these recent events and the MPC development landscape, we are more confident Officer. Than ever in our ability to deliver the 1st novel disease modifying treatment to patients suffering with MPC and we believe that Officer Mal is well positioned to become standard of care in this indication. Officer. In the next slide, I'll talk about one of the reasons that we feel so strongly that aramachamol and MPC Officer, is the extensive physician survey work that we conducted and the outcomes and feedback that we've received. Officer. The KOL feedback suggests that patients would receive aramachamol as an important part of their treatment regimen, whether it's first line or add on. Officer. This feedback is incredibly encouraging not only for Orpazyme, but for the MTC patients that we serve. Officer. I'd like to point out a specific quote here from Doctor. Mark Patterson, who's a leading expert on MPC from the Mayo Clinic in the U. S. Officer and globally recognized neurological expert. He reinforces, the MCC community Officer that has been waiting for decades for an approved therapy for this disease and the availability, excuse me, Officer of Arimakramal, will offer an important treatment option to clinicians and great hope for affected individuals and their families. Officer. We are very pleased to have the support of these key opinion leaders as we prepare for a potential launch. Next slide, please. Officer. A key part of Orthozyme's approach since inception has been the emphasis on partnering and our strong relationships with scientific collaborators Officer and Patient Advocacy Group. We have established relationships with specialist centers and are building our steering committees and advisory boards. Officer. For example, key opinion leaders and treatment teams to build out our medical education in Congress program. Officer. This slide really shows our partnerships with all 4 rare disease indications, including recently formed partnerships with Check Rare, Officer, a learning platform for healthcare professionals that is helping to educate on MPC. Our partners continue to inform our approach, Officer, elevate how we show up for patient communities we aim to serve and remain a key component to our strategy in all four indications moving forward. Officer. In the next slide, I'll talk about how I'll Officer. I'll close my remarks here as I'm proud to announce the brand name for Aramacamole, which is My Sleep Spa. We've been working very hard on this campaign and we look forward to sharing additional details when we are able. Officer. To reiterate, we have a huge opportunity to make a real difference in patients' lives. This work is very important to me. Officer. I've dedicated my career to helping people and their families living with rare diseases. And I really am deeply moved by the patient community Officer and their drive and their push for innovation. We have a tremendous responsibility to these patients and Officer. I hope that we're able to deliver on their expectations. With that, I'll turn the call back over to Anders to review financials for 2020. Outsiders. The floor is yours. Thanks, Molly. During 2020, we laid the foundation for our future with investments in our commercial infrastructure in preparation for the potential launch of our modular NPC. As you heard Mollie describe, we have established a fit for purpose commercial business Officer. And we are now well positioned to bring the product to the patients if approved and further maximize the potential of thiamogimov should it be Officer. Successful in other indications. So let me go through the figures. Here you can see the figure as a summary for Officer. Our net loss widened from minus $337,000,000 to a minus of $6.33 for 2020 Officer. As a result of the increased operating expenses associated with our pre launch activities and to support our growth. Officer. Our operating expenses amounted to $609,000,000 of net loss in 2020. I'll go through this in more detail on the next slide. Officer. The additional $24,000,000 in loss came from net financial expenses, mainly related to the increase in net foreign currency exchange losses of DKK 13,000,000 Officer. Danish kroner equivalent to $2,100,000 as well as the increase in interest expenses related to the loan agreement of Prius Capital Officer of DKK6.7 million or equivalent to DKK1.1 million. Overall, the net loss per share was Officer DKK 22.3 in the year end 2020 compared to DKK 16.9 in the previous year, minus Officer. We conclude the year with $727,000,000 in cash, Officer. This is around $190,000,000 Our cash position was significantly boosted Officer. With the prior year as a result of the 2 successful financial increases during 2020, also including U. S. Listing. Officer. So if you look on the next slide, the operating expenses, I would like to spend a bit more time on the operating expenses, Officer, which increased significantly during 2020 compared to prior year, particularly G and A spend. G and A costs were driven by pre launch activities Officer and the build up of our commercial infrastructure and global organization. We strengthened our U. S. And Switzerland based commercial team with 29 employees and we increased the medical affairs activities, particularly for NCC. We further engaged with the scientific community through our communication and education programs. Officer. Yes. Interest expense rose also in 2020 compared to prior year, which mainly due to legal Officer, Investor Relations and other external systems and also a CF based compensation. In addition, we hired Officer, employees in administration, finance, legal and IT to support the growing organization Officer. Our R and D expenses for 2020 also rose compared to prior year Officer. As we advanced our trials in IDM and ALS and also goutiocities and supported our registration activities in NTC, in particular, Officer. The increased cost was driven by the ramp up of the 3 clinical pharmacology registrational trials, increased clinical safety reporting activities in ongoing trials and the Officer of our R and D, like 12 employees. And then next slide please. Officer. That's our financial outlook. As we said before, we expect 2021 to be a transformational year for Officer. With the potential approval of our first part for NCC and the readout of 2 late stage trials in the Q1 of this year. Officer. The outcome and the timing of these events are clearly key factors in driving cruising about 2021 and our outlook. Officer. We expect our operating expense for 2021 to be in the range of DKK800,000,000 to DKK850 1,000,000. Officer. This is driven by continued investment R and D to support the advancement and completion of our multiple clinical trials in IBM and ALS, Officer. In previous data readouts and preparation for Pfizer is successful. Further, we anticipate continuing to invest in commercial infrastructure in the U. S. Officer. And Europe to support product launches if IMOCCO Motors is approved. We cannot speculate on regulatory outcomes, but Officer. We are preparing for success and well positioned to launch IMOCOMO within a narrow window of a potential approval. Officer. Our revenue forecast currently anticipate a gradual increase in sales from IMOXX mode during the second half in the range of DKK 60,000,000 to Officer DKK120 1,000,000 or equivalent to around $10,000,000 to $20,000,000 by year end. Officer. This forecast also includes small amount of potential income from main patient sales in other countries. Importantly, our outlook Officer. 2021 assumes that we award the priority review voucher from the FDA if our model is approved and that doesn't to monetize the priority review voucher. Officer. The value of these charges during 2020 was between $95,000,000 to 110,000,000 Officer. To take all this into account, we expect our operating expenses to total between DKK 800,000,000 and DKK 850,000,000 Officer and to end the year with in excess of DKK 350,000,000 in cash or equivalent to around $57,000,000 Officer. We believe we have a strong financial position and balance sheet to take us through the commercialization in NTC and additional indications, Officer, while also continuing to host a leading rare disease company. Next slide, please. Officer. Before getting to Q and A, let me review what's coming up for Orthozyme in this transformational year ahead of us. Officer. In Phase 2, we are focusing on getting IMOC1 to E MBC patients with early access programs and also preparation for launch. Officer. With commercial rollout both in U. S. And Europe, we will also explore possibilities for partnerships in the rest of the world. We have completed the NDA submission in the U. S. Officer. And our PDUFA date is June 2017. We also submitted the marketing authorization application in EU in November last year and we anticipate the potential approval in Europe in the Q4 of this year. Officer and beyond MDC, we expect top line data from ALS and IBM trials in the first half of this year and the decision to on developing our multimodal efficiencies. Officer. As you've heard today, it is very exciting time for Orthozyme with a lot happening to the company and importantly for the patients with these devastating diseases. Officer. Now I would like to hand back the call to the moderator for Q and A. Bernard? Officer. Thank you. Ladies and gentlemen, we'll now begin the question and answer session. Officer. Officer. Your first question comes from the line of Thomas Powers from Danske Bank. Please ask your question. Officer. Yes. Thank you very much. A couple of questions from me. So just if we just dive into the Officer. Full year guidance 2021 guidance. So I'm just wondering how much impact should we expect from the, you would say, the commercial preparations Officer in both the ALS and IBM trials if they, of course, readout positive. And then in sort of in addition to that, Officer. I'm just wondering if you actually have the capacity internally to submit 2 NDA filings Officer in parallel. And could you maybe give us some guidance on the expected filing time lines Officer. To submit the NTAs after we have the top line readout here in the Q2. And then I have a couple of pipeline questions. So maybe we Officer. Yes. Thank you, Thomas. It's Officer. Good question. So the cost so what we have included in the outlook is, as I said, the filing cost Officer for ADAS and IBM, if they are positive. And then also as you address, Officer. Turning capacity and so on. So it's something that we're working on, finding a solution on, but I'll let Thomas Zettler Officer. Go through the filing process. But on the cost side, it's very much depending on data what extra cost we can see Officer coming in, in 2021. Because it is very strong data in ALS, that's one situation. And then if it's strong data in IBM, Officer. It's another one because of the difference between the indications. And if both combined is positive, then of course, you will have Officer. To engage with patient open stations on the medical affairs side and so on. So we will have the ramp up in cost on certain areas. Officer. But put a number now before we have the data that I'm not comfortable with Thomas. But, Bleddler, would you answer the Officer. Our ability to file 2 products simultaneously and maybe also if you have any, let's say, Officer. Sorry to talk about timing. So, Gretel. Yes. Thank you, Anders. Well, Thomas, obviously, Officer. Filing an NDA or an MAA does take a lot of resources, so you rightfully asked that question. We have 2 Officer. 1 working on ALS and 1 on IBM. So we are looking to take into account Officer. Obviously, in a scenario where both trials lend themselves for submission of the trial, Officer. We will have to look at the data, look which of the indications would have to take priority. Officer. That will be based on both an assessment of the likelihood of success, but also on the unmet need. And we Officer. We will include additional resources to advance the findings as quick as possible. You should anticipate Officer. It's not an exactly parallel filing. There will be a certain sequence in the filing with the first filing intended Officer, is still in this year. Okay. Thank you. And then if I could just ask on the ALIS Officer. Just in regards to the open label trial, you managed to recruit 100 Officer of 20 patients or you can say about half of what you had in the Phase III and combined with the historical data with Officer. So I'm just wondering if now we have some it's been a few months here. So anything that Officer. That makes you maybe a little bit more upbeat or downbeat on based on the number of patients based on other factors like dropout rates Officer. Whatever you see among these patients that could sort of reflect the number of patients who are able Officer. And then I have a last question also just on the EAP. Officer. I think Marty said you had now have 812 centers in your prepared remarks. So I'm just wondering how many NCC patients Officer. It's actually by now on the early access program. And do you have any sort of projections on the expected number Officer. That you aim for here now with in connection with, let's say, midyear launch maybe, now that we at least have the Officer. We have the 2 seventy program from Mallinckrodt now being terminated. So I'm just wondering whether you're seeing a big uptake of patients coming to Officer with that program being shut down. Thank you. Okay. Yes, Wettler, Officer. I'd like you to talk about the dropout on ALS. And then, Mauritan, if you could comment on where we are on the EAP in the U. S. And the expectation for Officer. So first, as a reminder, we are still blinded Officer. So I will refrain from speculating on the outcome of this trial. Officer. Having 120 patients rolling over from the randomized trial into the open label Officer. It's absolutely within the frame that I expected. Bear in mind, we have had Officer. A number of patients, a good fraction of the patients who have met their survival endpoints, Officer. So have died. And we have a number of patients who, as expected, have discontinued from the trial. All Officer. The numbers we have to date on a blinded level are well within our expectations. Officer. Thank you. And then on the EIP? Yes. On the EIP, I'll take that question, Officer. It's okay. We have, I believe now, to your point, we've had increased interest, Officer. Obviously with some of the market events taking place, but just around 35 patients enrolled Officer, with a split towards children and adults, skewing to the side Officer of more adult patients, but a fair amount of children have enrolled as of late. Officer. We anticipate that to continue to grow as there's a significant need for these folks. Officer. All right. Great. Thank you very much. Thanks, Thomas. Officer. Your next question comes from the line of Anders from Redeye. Please ask your question. Officer. Good afternoon. Can you guys hear me? Yes. So Anders, I'm I'm trying to get my head around the outlook as well. Am I correct that there is Officer. There's a discrepancy there between what you guide for an operating loss and the cash position. And is there, for instance, something that lies behind that you Officer. Could you see a buildup of CapEx and or net working capital for the current year? Officer. It's a very insightful question here. So yes, so when the product is potentially approved, Officer. Then whatever you produce as product, you put on the balance sheet. So there might be some cash flow investments or some investments in products Officer. That is not on the P and L. So I would say that's the most direct. That's the biggest change Officer. That would take place when we get the approval potentially. Okay. So build up on working capital basically? Officer. Yes, right. Yes. Okay. And then in terms of Officer. In the early pipeline, can we expect any anticipated milestones for the current year in terms of Officer. Preclinical and or research activities. If there will be anything, they'll be in the second half. Officer. It's an early stage program. So we haven't defined any milestones for the second half yet, but Officer. It's a possibility on this. Okay. Thank you. Officer. Your next question is from the line of Devine Ahmed from Bank of America. Alka. Please ask your question. Hey, good morning. Can you hear me? Yes. Officer. Okay, perfect. Can I ask a question on your upcoming data for ALS? Specifically, what type of information should we expect to Officer at the top line. It also is it your belief that you would be able to apply for approval based on this Officer. Specific study if it is in fact positive. And then the second question is on the competitive landscape in ALS. Officer. There are quite a few companies that are trying to explore this indication. One that I specifically like your thoughts on is from a company Officer, which, last year, I believe, or recently produced statistically significant of positive data to their study. I wanted to know how you think about how your program could differentiate potentially from this one. Officer. And just noting that the potential for ALS is quite large. There could be room for many players. Just wanted to get your thoughts in general Officer, about where you think your program in ALS could be differentiated further? Thank you. Officer. Thank you. Bledel, will you start trying to answer what you can cover here? I think it's a very good list of questions. Officer. Yes. I tried to chalk it down, so I hope I remember everything. Otherwise, you may have Officer. Well, first, what is the information we expect from the top line results? Officer. We will have 18 months, which is the primary the time point of the primary assessment. We'll have 18 months data on the of Primary Endpoint, the CAAS, which is the combined assessment of function and survival, on both components, which are also secondary endpoints, Officer ALSFRS, R and survival. We will also have information on the pulmonary function Officer and additional secondary endpoints. And we do anticipate to have information on biomarkers here. Officer. The greatest interest is, of course, with the neurofilament light chain, both in CSF and Officer in plasma. Also, of course, we will have the safety probability information. You Officer. You asked about Amelix and the Amelix Phase 2 trial that was Could you just maybe just answer the probability Officer. Our assumption and that is also based on the Type C meeting and the scientific with FDA and scientific advice with EMA is that this Officer. Our scientific advice with EMA is that this trial supports an approval if positive both in the U. S. Officer and EU. And of course, we would also then have ambitions to go beyond those regions. Okay. Officer. The trial was specifically designed also to address both needs from FDA and EMA Officer. With this regard. And this actually does take me to the comparison to the Amelix program, which was a Officer of 6 month randomized placebo controlled trial followed by an open label extension. Officer. The primary endpoint in the AMALYX trial was the ALSFRS R at 6 months. Officer. They have since reported also an advantage Officer of longer survival with patients who were initially randomized to the active drug Officer versus placebo. If you now want to compare our Officer Phase 3 trial, that's an 18 months trial. We, this positive, will demonstrate an effect both on survival and functioning. Officer. And we will have 18 months of randomized blinded data, which of course gives you a longer time span to understand the Officer. The effect of the drug growth, both efficacy wise and also from a safety and tolerability perspective. Officer. In addition to that, we also have an open label extension as you also heard just earlier. So we will Officer, who start treatment late and will even further understand the long term benefit of treatment with amokimol. Officer. Arimockel is amplifying the heat shock response and natural stress response. Officer. And with that, arimocimol would lend itself to combination with a range of other treatments. Officer. So we do not conceive other treatments in development or approved Officer being approved as being in competition with imocamole. In our view, the future treatment of patients with ALS Officer will be a combination treatment that combines the different treatments and hopefully Officer, tailors the treatments to the active patients along the lines of personalized medicine. And here again, the broad mechanism of Officer of Arimocmo lends itself to be used as a component, as a pillar of such combination treatment. Officer. Thank you so much. Thank you, Tazeen. Thank you. Officer. Your next question comes from the line of Yatin Samajah from Guggenheim Partners. Please ask your question. Officer. Hey guys, can you hear me? Yes. Perfect. So just a couple of questions for me. First one is Officer. On the revenue guidance that you provided for $10,000,000 to $20,000,000 Can you maybe talk about some of the push and pulls? How should we think about the price? Officer. And what about the range of patients that you assume for this level of guidance? Officer. Yes. So it's a very good question, Yasin. I won't dare to talk about price before we get the approval Officer. So what we have built the assumptions on is, as Valentin described, the number of EAP patients that are in, but also could come in until we get the approval. And then of course, the naive patients in the U. S. That are not currently on treatment. Officer. So it's a combination, but it's yes, but the pricing is too specific for me to go into detail. Officer. Okay. And then just one more question on the EAP. With regard to the Mellencroff drug, which has a recent failure, can you remind us Officer. How big was their EAP and what your expectations are for transitioning those patients Officer. Maybe into your program and what was the split between U. S. And Europe for their program, if you have that information? Thank you. Officer. Yes, we don't have the specific information. We know that the trial was done globally and then also in Europe and the U. S. Officer. But else we don't have any insight. Of course, VICOM patients are asking us that program will Officer. Stop having the patient being treated in October of this year. So there's still some Officer. I don't know the specifics. Okay. Thank you so much. Officer. Thank you. Thank you, guys. Your next question comes from the line of Ritu Baral from Cowen. Officer. Good morning, guys. Thanks for taking the question. I wanted to ask about any anticipated Officer, safety monitoring requirements that you guys might have in the label and how that might impact Officer. Either how your patient hub will run and what it will need to keep track of and ultimately of the launch. And I have a follow-up. Okay. Thank you, Ritu. Pletla, would you start if you're there? Officer. I must say we have not had any concrete indication yet from the regulators Officer on obligations for safety monitoring following an approval. Officer. And I would actually like to refrain from speculating here. Fair enough. Officer. And then a question for Molly. Can you remind us again how the Patient Hub is set up? Is that are those contract services or are those Officer. In house people and in the event of a potential early approval, are they ready to go right now? Officer. Yes, they're ready to go right now. So, we are working with an outside source Officer, to set up our what some would deem in this business, call it a hub or a patient services model Officer, for each prescription to come through and be handled on a patient by patient basis. Officer. Great. And then last question, Anders, as you think about Officer. The ALS data and the IBM data coming in and the differences in market size, Officer. I guess, how are you thinking about potentially changing the price? I know in Officer. Answer to Yatin's question, you don't want to give specific price for MPC, but what are the tools that Officer. You might be able to use to, I guess, Officer. Officer. Yes. It's a good question also because we might get the data before we get the approval. So of course, that might also influence the positioning also on the price because Officer. If we have clear strong data, that's one scenario. So there's a lot of aspects here. But specifically on the pricing, Officer. So we have made some assumptions on, of course, MVC alone. And then we are also doing some Officer. Discussions on what to do if storm data comes in ALS because you know as the market is so much bigger, a number of patients and also Officer. New patients coming into the disease every year in the U. S. Might be 5,000. So it's a very big market potentially. So Officer. Molly, I think this is more into your area. So you've been doing a lot of thinking in this. Maybe you can provide a bit of color. Officer. Yes. I think you said most of it. We're scenario planning for various different permutations Officer and doing it based off of analogs and where the market is today. So we can do so Officer, responsibly and do it the right way. So we're thinking through every different scenario. Officer. Officer. Officer. There are no further questions at this time. Please continue. Thank you very much. So I would just close off by saying that I appreciate very much Yefasti's pace in today's call. Officer. And we look forward to continue to provide you updates on our progress, especially the first half of this year. You can see all the Officer. The activities that's going on, so we will continue to provide information on those activities and also a potential improvement in the second half in the EU. So Officer. You'll hear a lot from us this year. Thank you very much.