Good day, welcome to the GENFIT full year 2022 financial results and corporate update. At this time, I would like to turn the conference over to Stephanie Magner. Please go ahead. Hello, everyone. Thank you for joining us on this conference call organized to follow up on the press release we published yesterday with our 2022 annual results and an update on our R&D pipeline. It can be accessed via our website at ir.genfit.com. Joining me on the call today are Pascal Prigent, CEO, Thomas Baetz, CFO, Dean Hum, CSO, Carol Addy, CMO, Mariam Kabaj, CTO, and Pascal Caisey, COO, who will also join for the Q&A session. Before we begin, I'd like to remind everyone that statements made during this conference call, including the Q&A session relating to the group's expected future performance, market potential, business prospects, events or plans including clinical plans, regulatory approvals, anticipated timelines for clinical development and study enrollment, whether developed alone or in partnership and expected cash used in our operational activities are forward-looking statements as defined under the U.S. Private Securities Litigation Reform Act of 1995. They're based on management's current assumptions and estimates, which although believed to be reasonable, are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in or implied or projected by the forward-looking statements. For a further discussion of material risks and other important factors that could affect our business operations and financial results, please refer to those statements contained in our most recent filings with the SEC and AMF. These forward-looking statements speak only as of the date of this webcast and other than is required by applicable law, we don't undertake any obligation to update or revise forward-looking information or statements, whether as a result of new information, future events or otherwise. Following the prepared remarks, we'll open up the call for questions that will be addressed by GENFIT management. Please limit yourself to one initial question to allow time for others. I now turn the call over to our CEO, Pascal Prigent. Thank you, Stephanie. In this call, I will highlight the progress we've made across GENFIT in 2022. I will discuss our perspectives for 2023 as we are now nearing an inflection point with the upcoming release of ELATIVE top-line results. 2022 was an important year insofar as we continued to execute the strategy we outlined for you at the end of 2020 and reaffirmed in 2021. The 3 components of our strategy remain the same. 1, maintain good financial visibility. 2, accelerate our late stage PBC program. 3, build a richer and more diversified pipeline. We obviously have been working on those 3 components over the past 3 years. One could see 2020 as a year where we focused on improving our financial situation. In 2021, it was the acceleration and strengthening of our PBC program with the Ipsen deal. In 2022, it was the reinforcement of our pipeline. As outlined last year, our R&D strategy is to develop assets in rare and severe liver diseases for which there is a high unmet medical need. We have chosen to focus more specifically on ACLF because we believe that the lack of available therapies, the number of affected patients and existing public health trends make it a medical priority. The acquisition of a clinical-stage biopharmaceutical company, Versantis, in 2022, consolidated GENFIT's position as a leader in acute and chronic liver failure and other severe liver diseases. Our pipeline now includes six programs, four clinical stage and two pre-clinical stage programs. We believe that this rich pipeline, combined with an important near-term catalyst and robust cash position, provides us with a unique opportunity to drive significant value creation in 2023 and beyond. Let's first talk about financial visibility, and I will let Thomas give you more details about our financials in a few minutes. We are in a good place with a robust cash position at the end of 2022. In fact, the EUR 140 million of cash and cash equivalents that we had at the end of 2021, 2022, can fund all of our existing programs and take us to Q3 2024. In addition, if the results from our phase III PBC trials are positive, we should receive several regulatory milestone payments in this period, as part of the agreement with Ipsen, obviously those will significantly further expand our cash runway. About the PBC program, though. In 2022, we made good progress. We announced the enrollment of our last patient in ELATIVE around mid-year. We confirm that we expect to report top-line data from a pivotal phase III study in PBC towards the end of this quarter. We continue to believe that elafibranor could offer another treatment option for patients who suffer from this devastating disease. Based on its phase II result, its profile could be very attractive for patients with PBC who do not respond well to UDCA. Beyond ELATIVE, GENFIT and Ipsen also stepped up their collaboration throughout 2022 in order to maximize the potential of a program. In particular, there were significant investments and efforts to be ready to file as quickly as possible, as well as prepare for potential commercial launch next year. I believe it's worth remembering a few facts. First of all, by 2024, if approved, elafibranor could potentially become a new therapeutic option for patients with PBC not responding to UDCA and become the first alternative to currently approved second-line treatment. Second, in this market, elafibranor has a differentiated profile. phase II results with elafibranor in PBC showed in just 12 weeks of treatment a statistically significant improvement on both the primary endpoint as well as on the composite evaluation criteria, which is the same as the primary endpoint of a pivotal phase III trial to support accelerated approval. We believe that a larger trial and longer treatment duration should confirm those findings. In addition, the results show a positive trend on the improvement of pruritus while preserving a favorable safety and tolerability profile. All of those positive conclusion have been published in the Journal of Hepatology in 2021. Also obviously we expect the ELATIVE trial to confirm the favorable safety and tolerability profile of elafibranor and add to the safety data for more than 1,000 patients in our biopsy-based RESOLVE-IT trial in NASH. Third, this is a market that's estimated to be at $1.5 billion in the coming years and up to $3 billion in the US and EU5 by 2030. We think that by combining a desirable profile, first-in-class status with Ipsen's proven capabilities and footprint in both the US and Europe could lead to commercial success. That in a fairly sizable and fast-growing market with relatively low competitive intensity, with only 1 approved product and 1 additional phase III program underway. If the trial is positive, the commercial perspective is therefore promising. Under the agreement with Ipsen, GENFIT is eligible for double-digit royalties of up to 20% of total elafibranor sales. In addition, GENFIT is also eligible for regulatory, commercial, and sales-based milestones up to EUR 360 million with a potential first significant milestone payment as early as 2023 and additional potential milestone payments next year. Therefore, we really look forward to providing top-line efficacy and safety data in the next couple of months as this will hopefully make this potential more tangible. Let's talk now about the pipeline. While these near-term results of our PBC trial will obviously be transformative for GENFIT, we also see beyond this outcome, and indeed, we have people working to expand and diversify our pipeline beyond PBC. GENFIT is determined to capitalize on its strength and knowledge in rare liver diseases to bring innovation into several therapeutic areas where patients have critical needs. I will now provide a brief update on the rest of our pipeline. The areas we have chosen to concentrate our efforts on share a few characteristics. They are rare liver diseases, they are serious conditions for which no or few therapeutic options are available. Given the magnitude of the unmet needs related to this disease, it is expected that most of these programs will qualify for some of the expedited regulatory pathways provided by health authorities. Finally, let me point out that although rare, these different conditions taken together represent a total market potential of $11 billion in the US and the largest European countries by 2030. Let's start with the 3 clinical stage programs that we have. That is in addition to PBC, of course. The first one is VS-01 in ACLF. ACLF is an underserved medical condition that's associated with high short-term mortality. 23%-74% mortality at 28 days, depending on severity grades. Currently, no drugs have been approved in ACLF. In the US only, there are over 600,000 hospitalizations per year for decompensated cirrhosis, with 10%-30% of ACLF prevalence in this population. The number of patients is expected to grow due to the aging population, the increasing prevalence of non-alcoholic fatty liver disease, NAFLD/NASH, diabetes, obesity, as well as alcohol consumption and drug-induced liver injuries. 10 years ago, the total inpatient cost for cirrhosis, with and without ACLF, was already estimated to be more than $10 billion, with a cost per hospitalization that was 3 times higher when patients had ACLF versus just cirrhosis. Very high burden on the healthcare system. VS-01 is an innovative first-in-class therapeutic drug candidate based on a proprietary scavenging liposomes technology. It's administered directly into the abdominal cavity following drainage of ascites, one of the most common complications in patients with ACLF. The phase 1 trial highlighted the favorable safety and tolerability profile of VS-01 and provided encouraging preliminary efficacy results with about 80% of treated patients improving or stabilizing their disease. The phase II will be an international open label randomized controlled multi-center proof of concept study that will assess the efficacy, safety, and tolerability of VS-01 in about 60 adult patients with ACLF grades 1 to 2 and ascites. It is anticipated that the first patient will be screened in the trial this quarter. The second clinical stage program we have is evaluating NTZ in the same indication, ACLF. Two phase 1 studies were completed in the fourth quarter of 2022 and the first quarter of 2023. They provide preliminary insight into NTZ pharmacokinetics and safety in the setting of hepatic impairment or renal impairment. The studies support moving into the next phase of a program, which will be a phase IIa proof of concept study in patients with ACLF grade 1 and 2, that will be further discussed with FDA. The study initiation is targeted for the second half of 2023. Our last clinical program is evaluating GNS561, a novel clinical-stage autophagy/PPT1 inhibitor for the treatment of cholangiocarcinoma. CCA is the second most common primary liver malignancy diagnosed globally and represent about 15% of all primary liver tumors. The incidence is increasing. There are limited therapeutic options for this aggressive disease. The five-year survival rates are 5%-15% in the advanced and unresectable cases. Even after curative-intent surgery, the clinical outcomes are disappointing, with five-year survival rate of 7%-20%. As a reminder, in December 2021, we licensed the rights from Genoscience Pharma to develop and commercialize it in CCA in the US, Canada, and Europe, including the UK and Switzerland. GNS561 mechanism of action showed promising results, and preclinical and clinical evidence provided the scientific rationale to develop this asset. The phase I-B/II--A trial will evaluate GNS561 in patients with advanced KRAS-mutated CCA. In the phase I-B, we'll evaluate the safety and tolerability of GNS561 in combination with a MEK inhibitor. We'll also identify the recommended doses for the phase II-A, in which the safety and efficacy of the combination will be assessed in patients who have otherwise failed standard of care for first-line therapy and who do not have an actionable mutation. GENFIT targets to screen the first patient towards the end of the second quarter of 2023. A word about our two preclinical program. The first one, VS01-HAC, is a potential first-line life-saving treatment for acute hyperammonemic crisis associated with inborn errors of metabolism in urea cycle disorder, or UCD, and organic acidemia, or OA. IND-enabling non-clinical studies are targeted to be completed in 2024. The second program, VS02-HE, is developed in hepatic encephalopathy, which is one of the major complication of advanced liver disease and portal hypertension, and is closely linked with ACLF. As many as 45% of patients with cirrhosis will experience at least one episode of HE. VS02 is a urease inhibitor and a hydroxamic acid derivative that is designed to inhibit ureases in the gut. IND-enabling non-clinical studies are targeted to be completed by 2025. Although these are early stage programs, they represent a significant potential, with a market size for severe hepatic encephalopathy alone estimated to be around $3 billion in the US and the largest European countries by 2030. For UCD and OA, estimation for 2030 is about $1 billion for the US and the EU5. Before handing it over to Thomas, let me conclude with a word about NIS2+, the next generation of our NIS4 technology for identifying at-risk NASH patients. Several presentations were made during the last AASLD, highlighting the potential of NIS2+ to be an effective screening tool for the enrollment of patients with at-risk NASH in clinical trials and as a potentially valuable prognostic tool for early detection of fibrosis progression in at-risk NASH patients. The future of NIS2+ is through an in vitro diagnostic test, or IVD, as a standalone diagnostic. We continue to explore the possibility of obtaining regulatory approvals alone or with a development and commercial partner. The recent development in the NASH field means that this market could soon see the launch of one or more therapeutic options. When that occurs, it will be essential for physicians to identify appropriate patients, and it will be essential for payers to ensure good use of the approved drugs. I think we all know that biopsies are not scalable and cannot be the solution, and that the non-invasive test is a much-needed alternative. We believe we have the best solution to identify those at-risk patients. I'm now handing over to Thomas, who will highlight key financial elements from today's press release. Thank you, Pascal. Hi, everyone. Thank you for joining us. Firstly, I would like to refer to the press release issued yesterday evening for a summary of our financial results for 2022. Our revenue and other operating income for 2022 amounted to EUR 26.6 million compared to EUR 85.6 million for 2021. Our operating expenses amounted to EUR 53.9 million in 2022 compared to EUR 53.8 million in 2021. As a result, in 2022, GENFIT generated a consolidated operating loss of EUR 27.3 million compared to an operating gain of EUR 31.8 million for the previous year. Our financial result for 2022 was a financial income of EUR 3.5 million compared to a financial income of EUR 37.7 million for 2021. As a result, GENFIT generated a net loss of EUR 23.7 million in 2022 after adding a copyright income gain benefit, tax benefit of EUR 0.1 million. Compared with a net gain of EUR 67.3 million in 2021 after deducting corporate income tax expense of EUR 2.2 million. As of December 31, 2022, our total financial debt amounted to EUR 75.3 million compared to EUR 74.2 million at the end of 2021. As of December 31, 2022, GENFIT had EUR 140.2 million in cash and cash equivalent and current financial assets compared to EUR 258.8 million at the end of 2021. Now that you have the numbers in mind, let me give you some color and explain where these figures come from. Briefly touching upon revenue and other operating income. Our revenue essentially came from three streams related to Ipsen. For context, in December 2021, we received a EUR 120 million non-refundable upfront payment from Ipsen as part of our licensing and collaboration agreement. EUR 80 million was recognized as revenue in 2021, and EUR 40 million was booked as deferred revenue and is gradually recognized as revenue in subsequent periods following the completion of the ELATIVE double-blind study. As such, of that initial EUR 40 million in the deferred revenue balance, EUR 15.9 million was recognized as revenue in 2022. EUR 3.3 million was recognized as revenue in 2022, in accordance with the inventory purchase agreement signed with Ipsen, pursuant to which Ipsen purchased inventory of elafibranor active pharmaceutical ingredient and drug product during the second half of 2022, with the prospect of transferring the conduct of the ELATIVE study to Ipsen. EUR 1 million in revenue was generated from the services rendered by GENFIT to Ipsen in accordance with the transition services agreement signed in 2022, which essentially outlines the scope of services to facilitate the transition of some activities related to the phase III clinical trial evaluating elafibranor in PBC. Other operating income included mainly the research tax credit granted by the French tax authorities, which amounted to EUR 6 million for 2022. A word on our acquisition of Versantis. On September 29, 2022, we closed the acquisition of Versantis, a private Swiss-based clinical-stage biotechnology company focused on addressing the growing unmet medical needs in liver disease. This acquisition aims at consolidating GENFIT's position as a leader in ACLF, significantly expanding GENFIT's pipeline, and combining Versantis' expertise with GENFIT's know-how in conducting complex development programs in liver disease to strengthen and accelerate research and development. The total purchase price includes an initial payment of CHF 40 million, or EUR 41.9 million paid at closing. A net cash adjustment of CHF 2.8 million, or EUR 2.9 million, paid in December 2022. Acquisition costs totaling EUR 1.8 million paid in 2022, and additional milestone payments of up to CHF 65 million, contingent on certain outcomes in the future. The impact of this acquisition, net of the cash acquired, totals EUR 41.5 million. A word on our debt balances. For context, at the beginning of 2021, we were able to renegotiate the partial buyback of our convertible bonds. In the latter half of 2021, we were also able to secure three non-dilutive loans totaling EUR 15.3 million granted in the context of the COVID pandemic. The nominal amount of our convertible loans as of December 31, 2022, stands at EUR 56.9 million, the same balance as at the end of 2021. There have been no conversions of this debt in 2022. The outstanding amount of our non-dilutive loans as of December 31, 2022, stands at EUR 15.2 million compared to EUR 15.3 million as of December 31, 2021. There was no new issuance of debt in 2022. As a reminder, during the first half of 2022, as we were already planning to do in late 2021, GENFIT requested an extension of The bank PGE and the Bpifrance PGE. Both extensions were granted by the respective counterparties. About our cash position as of the end of 2022, GENFIT had EUR 140.2 million in cash equivalent and current financial assets. Net of cash in transit earmarked for payment in early January of EUR 0.3 million, that is compared to EUR 258.8 million as at the end of 2021. The decrease in cash equivalent and current financial instruments between the end of 2021 and the end of 2022 includes the payment of EUR 24 million in January 2022, representing the VAT collected on the initial upfront payment received from Ipsen in December 2021. The disbursement of employee participation in the profit of GENFIT S.A. in May 2022 for a total of EUR 0.6 million for the fiscal year 2021, and the acquisition of Versantis AG totaling EUR 41.5 million net of the cash acquired. In our projections, as we continue to advance our current product candidates from the preclinical studies and conduct clinical trials, we expect that our cash used in operational activities will amount to EUR 60 million in 2023. This amount does not include potential expenses we may incur in future business development activities such as in-licensing. I now turn the call over to Pascal. Thank you, Thomas. Before moving to Q&A, I would like to thank all the patients and the physicians who are collaborating with us to advance treatment options in all the diseases we target. And now I'd like to open the call for questions. Operator, if you can begin the Q&A session, please. Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you're using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, please press star one to ask a question. We'll pause for just a moment. We'll go first to Thomas Smith with SVB Securities. Hey, guys. Good morning. Thanks for taking the questions. First on the ELATIVE study, can you just remind us of your latest expectations and what you expect to show on the primary composite endpoint as well as the secondary endpoints of alk phos normalization and pruritus improvement? Yeah. Hi, Tom. Thank you for your question. I guess, our expectations will obviously be to replicate what we've seen in the phase II. I don't know, Carol, do you wanna comment on this? That's exactly right, Pascal. Tom, thank you for your question, and good morning to you as well. Yes, indeed. We anticipate with ELATIVE, which as you know, this will be a 52-week data readout as opposed to the 12-week data readout for the phase II study. We do anticipate seeing a similar improvement in biochemical indices of cholestasis and similarly, the same favorable trend that we observed in improvement in pruritus. Of course, this will be a more robust data readout given the increased duration of exposure to elafibranor and as well the increase in sample size in the ELATIVE trial relative to the phase II trial. Understood. That's helpful. Just to, follow up, on that, we saw on ClinicalTrials.gov that you made some changes to the secondary endpoints and the way that you're measuring changes in pruritus. Can you just, walk us through the changes that you made, the rationale there, and, how you expect that to impact the signal for elafibranor on pruritus? Sure. Just to refresh memories, as we understand, pruritus is one of the major symptoms that are impacting patients with pruritus. If I'm a patient with PBC, this is really impacting my overall quality of life, and I want relief as quickly as possible. Certainly when we think about how we translate that to clinical trial conduct, as we saw in our phase II trial after 12 weeks of exposure where we saw favorable trends and improvement, this is suggestive that elafibranor has the potential to provide short-term relief of symptoms. With that in mind, we did include some near-term time points in the ELATIVE trial to better understand elafibranor's potential to provide near-term relief of symptoms of pruritus, but as well, sustained relief, which is also important for patients experiencing this symptom. Okay. Understood. Just maybe lastly on VS-01, it sounds like you're on track to dose the first patient in the phase II ACLF study this quarter. Is it still your expectation that you'll be able to report interim data from the study in the first half of 2024? Just remind us what we can expect to see from that interim analysis. Sure. You're right. We are imminently on track to get our first patient enrolled. We have regulatory approvals in four countries in the EU, an IND submitted in the US, and so patient screening is imminent. We are on track based upon what we understand to have interim analysis read out in first half of 2024, but also with the understanding this is the first time we've enrolled a study with in patients with ACLF, and we understand this is a rare condition, and so we will be learning a lot as we get the study underway. In terms of interim analysis, this will really be aimed to understand whether we will, after 40 patients having been enrolled, be on target in terms of the effect size that we are anticipating, and this will be helping to guide our further enrollment of the study and whether or not we would need to adjust the sample size accordingly. Really, aimed for internal decision-making. Okay. Got it. Aimed for internal decision-making. Should, I guess how are you anticipating, I guess, communicating the results from that interim analysis? It sounds like we shouldn't expect to see data, but maybe more qualitative, color around what you're seeing and I guess any changes to the study design. Is that fair? Yes. I think that would be a fair assessment, Tom. Thank you. Okay. Got it. Thanks for taking the questions and looking forward to the ELATIVE data later this quarter. Thanks, Tom. We are too. We'll go next to Sushila Hernandez with Kempen. Hi there. This is Suzanne. I'm on for Sushila. just a few questions, if I may. We were wondering on ACLF for the NTZ and VS-01. Are you planning to target the same patients in the NTZ phase II as in the ongoing phase II with VS-01? Could you once again elaborate for us how both products fit in the treatment paradigm? Then I have a follow-up. Suzanne, thank you. Sorry. You cut up a little bit at the end of your question. I got the first part, and I'm going to let Carol answer about the different population. The second part of your question, we didn't get it here. Unless, Carol, you got it. No, I was going to say the same. Suzanne, you did break up at the end. Right. It was if you could elaborate once again how both products fit in the treatment paradigm? Got it. Okay, great. Let me address your first question. If I'm understanding, how are we distinguishing the patient populations that we will be enrolling in our VS-01 trial relative to the NTZ trial, if I understood your question correctly? Yes. Certainly, both studies will be enrolling patients with ACLF 1 or 2, 1 or 2 being indicative of the number of organ failures experienced by these patients. The distinction here is that our VS-01 trial will be inclusive of patients with ACLF grade 1 or 2 and who also have ascites. Ascites is the fluid that accumulates in the abdominal cavity, and patients having ascites typically undergo a procedure called paracentesis, where this fluid is removed by a catheter that's inserted into the abdominal wall. VS-01, of course, is administered through the same catheter. In contrast, the NTZ study will not require that patients have ascites, although many patients will. We do anticipate some overlap, but we're also being mindful of how this will impact our site selection so that we're not going to be in a competitive enrollment situation. In terms of treatment paradigm, there are a number of guidelines, clinical guidelines that are available in the EU and in the US that provide recommendations for standard of care for these patients. For example, treatment of ascites, treatment of infections of the acidic fluid that we refer to as spontaneous bacterial peritonitis, as an example. What we anticipate is the use of VS-01 and NTZ on top of a background of standard of care for short-term treatment of ACLF. We know that these patients progress very rapidly in their clinical course. Our anticipation, based upon what we've observed to date, both in preclinical and clinical studies, as is the case with VS-01, that we would expect to see short-term impact that could help in further progression to additional organ failures. What we're hoping to see, of course, is regression and improvement in those organs that have failed. The one thing that I would add, Sushila, is, I mean, obviously, we are a little bit breaking new ground in ACLF. The expectation is that because this is such a serious disease, multifactorial, very complex with high mortality, it's very unlikely that one drug is going to be a silver bullet. It's probable that you could use multiple drugs to manage this patient. One thing that for us is important is the fact that NTZ and VS-01 would at least theoretically act on this disease for very different mechanism of action. Therefore, they are not competing. They are more like complementary therapeutic options. Got it. Thank you. That's very helpful. Lastly, if I may, if I understand correctly regarding your cash runway into Q4 next year, that this includes the potential milestones from Ipsen. Can you provide more color on the size and what events those milestones from Ipsen are related to? Just wondering if there's a more significant chunk residing in one trigger or if it's more fairly spread. Thank you. Yes. It does not include the milestone from Ipsen. Our guidance is Q3 2024 with the current cash or cash equivalent, and that does not include the milestone. If we do include the milestone, our cash runway goes significantly further. We have not guided on the size of the different milestones. The only numbers we've provided, and that's part of the agreement with Ipsen, is the total amount of milestone, which is EUR 360 million, but we're not guiding on the respective milestones. Got it. We will go next to Martial Descoutures with ODDO. Good morning and good afternoon. Thank you for taking my question. Another quick question on your guidance. You highlighted that you have a financial visibility until Q3 2024. I would be really interested to know what do you include in this guidance in term of developments, not in term of milestone from Ipsen, but specifically in term of your development. In your business plan, where will you be in your pipeline calendar specifically for VS and NTZ at this horizon? Thank you. Hi, Martial. Yes, we do include everything. The finalization of the program in PBC with Eli Lilly, all 3 phase II studies. As we've said, we have 2 that are starting or starting to screen patients right now, and 1 that's forecasted to do it in the second half of the year. Mainly, mostly those are VS-01 in ACLF, NTZ in ACLF, as well as GNS561 in cholangiocarcinoma. All the preclinical work that's currently ongoing with VS-02 and VS-01 in UCD. All of that is included in the guidance. We've of course, all the additional work that's being done by R&D in terms of the different activities that we have. When we say, we're funded until Q3 2024, it's like everything we've discussed is in scope. Thank you. We'll go next to Alex Cogut with Bryan, Garnier & Co. Hi. Good afternoon. Thanks for taking my question. Just on Elative, I was just wondering if the trial is powered specifically to show statistical significance on pruritus. How would you expect the impact on liver enzymes to materialize considering the results in phase II? I have a few other questions. Carol, do you want to take that? Alex? Yes, sure, Pascal. Alex, thank you for the questions. Indeed, in ELATIVE, we have framed our pruritus endpoints as key secondary endpoints. As such, the study is in fact designed to ensure that we are able to demonstrate statistical significance in terms of change from baseline in pruritus as we are assessing by means of daily assessment of NRS scores. The other question that you had was pertaining to changes in transaminases. Could you maybe help me to better understand, are you referring to change in transaminases from an efficacy perspective or from a safety perspective? Because we can consider both. I guess from an efficacy perspective first, right? If you, I think in a phase II, it was a bit of an less clear trend. I mean, granted it was a smaller trial. I was just wondering how would you expect that to pan out in the phase III. Again, in keeping with the earlier response, we do anticipate that we will be replicating the results of our phase II trial. In that study, as you're aware, we saw demonstrated significant improvement in cholestatic indices, whereas stability was demonstrated in transaminases. Stability, which we interpret in a favorable sense, in terms of not having any adverse effect in terms of safety profile. Got it. Once you have the phase III top-line results, how long does Ipsen have contractually time-wise to decide on the next step? Yeah. We can't really speak on behalf of Ipsen. Suffice it to say we're working very closely now with Ipsen in close partnership so that we may, enable the data readout by the end of this quarter. Certainly we'll be working to support them in terms of next steps in terms of ultimately NDA submission. That will really be their responsibility. We're playing a very supportive role here. I would say, I mean, you know, it's not contractual. If the results are supportive of a filing, obviously it's in both companies' best interest to go as quickly as possible. Yeah, I was just wondering there, are there any other considerations they would have on the results to be supportive of filing? I mean, apart obviously from the, let's say, the primary and the key secondary endpoint. No. I mean, if the efficacy is what we hope it will be, then, and if we have a saleable product, then we'll go ahead. Got it. Okay. Just a last question on NTZ. Could you elaborate on the significance of the, sort of the upcoming data in May in light of the, sort of the phase two you're planning? Sure. Alex, the data that we have acquired thus far with NTZ is the basis of, from 2 phase I studies that were conducted. These studies are enabling and supportive of our proceeding with a proof of concept study in patients with ACLF. Remember that patients with ACLF have varying degrees of liver and, many times, renal impairment or failure. It was very important for us to do some initial studies, these phase I studies, 1 in individuals with hepatic impairment, the other in individuals with renal impairment, so that we would better understand the pharmacokinetic profile of NTZ in these conditions and more importantly, safety. Safety, of course is top priority because our ultimate patient population, patients having ACLF, are acutely ill. We really wanted to have a very good understanding of safety prior to going into the evaluation of NTZ in a proof of concept study in patients. Got it. Okay. Thank you very much. Look forward to the future results. Thank you, Alex. Great. Thank you for all of these question. I think that that concludes our call. I would just say as in closing that 2022 was a very important and transformative year for GENFIT. It was marked by both the progression of our lead program and the expansion of our pipeline in rare and severe liver disease, notably with the acquisition of Versantis. We are now approaching an inflection point. This quarter, we expect to report data from our pivotal phase III study in PBC. There is still an important unmet medical need in this market, and we are very encouraged by the previous phase II data reported as part of this program. We believe elafibranor has significant potential, and we hope it will be demonstrated soon. Beyond this exciting milestone, we have built a rich pipeline that now includes three additional phase II stage programs and two preclinical stage programs. This pipeline, combined with a robust cash position and potential near-term commercial perspective for elafibranor, provide us with a unique opportunity to drive significant value creation in 2023. So we look forward to providing future updates soon and throughout the year. Thank you very much for your attention. This does conclude today's conference call. Thank you for your participation. You may now disconnect.