Inventiva S.A. (IVA) Q4 2024 Earnings Report, Transcript and Summary

Good day and thank you for standing by. Welcome to the Inventiva Full Year 2024 Financial Results Webcast and Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today Frédéric Cren, CEO and Co-Founder. Please go ahead sir. Frédéric Cren: Thank you Operator and good morning and good afternoon. Welcome everyone. Thank you for joining us to discuss our 2024 full year financial results. We issued a full year press release this morning and the webcast will be available in the investor section of our website. I want to remind everyone that various statements that we may make today during this conference call and during the Q&A session will include forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995. Joining me on this call is Jean Volatier our Chief Financial Officer and Pierre Broqua, our CSO and Co-Founder. I will first go over some of the key highlights for 2024 and the recent updates of our activities before I leave the floor to Jean who will go over the full year financial results and of course we will have some time at the end of the call for Q&A. So on the highlights for 2024. So, 2024 ended on a very positive note and we started 2025 strong , ready, and enthusiastic for what is ahead of us. In 2024 we have made significant strides in the clinical development of lanifibranor with a tremendous support and commitment of our clinical trial site where we have been able to close screening of our Phase 3 NATiV3 in early January 2025. We can therefore confirm that we target the completion of recruitment in H1 2025 as previously guided. This will start the countdown to our topline result expected in the second half of 2026 making of lanifibranor, the second oral drug that could be approved in the United States in March. In addition to be very close from reaching completion of enrollment in 2024 and in the first quarter of 2025, we had three data monitoring committee meetings with positive recommendations to continue NATiV3 without modification to protocol. The most recent one took place in February 2025 during which the safety data of more than 1,200 patients randomized in NATiV3 were reviewed. With this progress in our Phase 3, we are truly at an inflection point in our company's journey and we have already begun strengthening our team to ensure we're fully prepared for successful regulatory suit missions and the commercialization of lanifibranor. In 2024, we also reinforced our clinical data set for lanifibranor with the publication of the positive results of LEGEND our combination proof of concept trials with lanifibranor and in fact disclosing inpatient with MASH and Type 2 diabetes. The primary point was met with a statistically significant reduction in HBA1C with lanifibranor alone and in combination. Insulin sensitivity was improved, consistent with other study and additional improvement where it was observed in combination with empagliflozin. Markers of liver injury were significantly improved and this improvement was solely driven by lanifibranor. The second goal of this trial was to look at the potential mitigation of the weight gain when adding an SGLT-2 inhibitor to lanifibranor. We are very pleased to show that the combination of lani with empagliflozin completely mitigates the weight gain. Furthermore, lanifibranor alone and in combination leads to a shift towards metabolically healthy tissue. Finally, meta-analysis data suggests that GLP1 has a similar effect when combined with PPAR. This study is particularly significant given the high prevalence of Type 2 diabetes among patients affected by MASH. We are convinced that the profile of lani is ideal to treat patients with advanced fibrosis and diabetes, a patient population which is hard to treat and high risk to progress to cirrhosis. We are looking forward to looking more in depth at our lani effect when combined towards a drug, particularly GLP1 and we have randomized approximately 15% of patients on GLP1 in the Phase 3 study. This year we also announced that our partner Hepalys has launched the clinical development of lanifibranor in Japan with the initiation of a Phase 1 study. We believe that with the licensing agreement that we have in place in Japan, South Korea with Hepalys, and in China with CTTQ, lanifibranor will be ideally positioned to potentially become the leading oral drug in MASH in these two important geographic areas. Looking now at the organization and at the governance, we are committed to make lani a success story for patients and this is definitely a priority for Inventiva. We are focusing on changing and challenging all our resources and efforts into achieving this goal. As part of this process, we are reinforcing our development team to ensure that we are fully prepared for regulatory filing and the potential commercial launch. In February, following a strategic review, we announced the decision to focus all of our resources to the development of Lani. Unfortunately, this decision comes with a stop of all pre-clinical activities not related to Lani and would lead to a reduction of approximately 50% of our workforce. I want to emphasize that this was not an easy decision and whether our research team has been core to Inventiva for the past 12 years and has been instrumental in the development of Lani. We are currently negotiating with the Worker Council and while I'm unable to comment further at this stage, we are committed to working together through this transition. Regarding the governance of Inventiva, we also reinforced it and we reinforced our Board of Directors with the appointment of three new board members. The first one is Andre Turenne, he's the President and CEO of the Boston-based biotech Matchpoint Therapeutics and former Global Head of Business Development at Sanofi. In December, Srini, the Founder and Partner of Samsara Capital joined us and we also nominated Mark Pruzanski as Chairman of the Board. You all know, you all are familiar with Mark. He's been the CEO and Founder of Intercept and has shaped the MASH market over the last years. Mark brings of course, a wealth of experience in both MASH field in the U.S. along with deep expertise in financial strategy. We are excited to have him on Board as we work together to achieve our mission of bringing Lani to patient and driving meaningful progress in the treatment of MASH. Now finally, before I hand over to Jean for the financial situation, in 2024 we successfully closed on several dilutive and undilutive financing operations, raising approximately a total of $184 million in gross proceeds. Most of these amounts come from our three trans-financing of $125 million each. This financing came from existing and trusting investors and especially new investors. We received the first tranche in 2024, and will be eligible to receive the second tranche following the announcement of [indiscernible] we should have then met all operational conditions necessary for the second tranche. Let me now turn to Jean who will provide you with more details on our 2024 financial report.

Thank you Frédéric. Good morning, good afternoon everyone and thank you for joining us on this call. So, yesterday I said we have issued our press release covering the full financial results for the fiscal year 2024, and of course I will provide you with key highlights, a P2 answer more detailed questions during the Q&A time. So, I will start with the cash position and cash flows. So, we have reached at the end of 2024, 96.6 million of cash position versus 36 million at the end of December 2023, therefore a net positive variance of close to €61 million. As a matter of fact, this represents half a year, roughly of annual office. The key factors as said by Frédéric is of course the $184 million, €170 million of raising under different operations, dilutive and non-dilutive. The fourth principle are of course the raising of the second tranche of 25 million drawn in January 2024 from the European Investment Bank. The second in July 2024 was the raising of 20.1 million with the issuance of YLTDs. The biggest one of course related to the -- up to 348 million finance structure transaction in October 14, 2024, represents €116 million net proceeds received during the fourth quarter. And eventually we received also the milestone, the first milestone of CTTQ, or Sino Biopharm, our Chinese partner as part of the financing in October. And you remember that there are three tranches, three milestones related to this transaction also we can come back on that. So therefore we have confirmed, we do confirm the cash runway guidance disclosed previously, meaning we can operate until September 2025 without the contemplated second tranche of the financing. And after the contemplated second tranche of the financing, we should reach September 2026. Let's talk now about the key figures of the profit and loss account. So we have recorded revenues in 2024 of 9.2 million and it refers to the milestone that I talked about earlier with CTTQ Sino Biopharm, compared to 17.5 million on the same period in 2023. The other income line is stable at 5.5 million, compared to 5.7 million, it represents as usual essentially the R&D French tax credits. Of course the most important line is the R&D expenses which still represents more than 80% of our global operation expense. So amounting to 19.9 million in 2024, compared to 110 million in 2023, showing a decrease of 17%, which was due to the delays we have to face in 2024, to be noted that as the announced during the second half of 2024, this R&D expenses are started to increase again, following the restart of the patient recruitment in NATiV3. The marketing and business development line is still not significant at 2 million, stable compared to 2023. But with the approaching of the end of the Phase 3, expected to increase in the near future, because we start preparing the NDA filing and the commercialization capabilities. In terms of G&As reaching 15.8 million for 2024, compared to 13.8 in 2023, so a slight increase of 14%. We have had a complex year in terms of transactions, but also we have reinforced our IP position and therefore, we have a slight increase in particular in other legal and compliance fees. There is a rather unusual amount you can notice in the net financial loss, 86 million compared to 5 million in 2023. Two items, one of items of 33.4 million, which is related to a specific IFS retreatment, non-cash, related to the fair value of the second tranche to be realized we expect very soon, and has to be treated as a very significant instrument since considered as a corruption instrument. And we have also this year 12.2 million of non-cash interest and related to the loans and related to the royalty certificate amortization. Bottom line, the company's net loss for the full year is established at 184.2 million compared to 110.4 million in 2023. I will now turn it over to Frédéric for the conclusion and Q&A. Thank you for your attention. Frédéric Cren: Thank you, Jean. So we've made important improvement, significant stride, and I'm confident that we have a tremendous opportunity ahead of us with lanifibranor. If you look at 2025 we anticipate announcing the completion of randomization and the release of the second tranche of $127 million from a structuring financing. Today, we are the only Phase 3 that is recruiting currently and evaluating the normal liver targeted drug candidate. We have a robust data set, including our Phase 2 in which we observe an improvement of one stage fibrosis in just six months of treatment. The demand for MASH treatment is clear, and the available treatment options are still limited today to a single mechanism of action. We believe that given the heterogeneity of the patient population and the broad prevalence of MASH, having multiple oral treatment options will be again change for patients. Thank you, and we are now open -- we now open the floor for questions.

Thank you. [Operator Instructions]. And your first question comes from the line of Ritu Baral from TD Cowen. Please go ahead.

Hi, everyone this is Nicole online for Ritu. Just a quick question, are the background doses -- sorry, the patients on background doses of GLP1, are they low-dose diabetic doses or are they also composed of high-dose for weight loss? And just a quick follow-up, how many patients do you guys estimate that you have enrolled that are on background as SGLT2 inhibitors? Thank you. Frédéric Cren: So, on the first one, I'll answer and then let Pierre address SGLT2 if you like. Oh, go ahead.

GLP1 is mostly anti-diabetic dosing. It's not only semaglutide it's other, well, semaglutide is included, but you have also other case, other GLP1 agonists. Frédéric Cren: And by the top of my head, you had between 6% to 8% of patients on SGLT-2 inhibitor, a baseline.

Great, thank you.

Thank you. We will now go to the next question. And your next question comes the line of Sam Harma [ph] from Jefferies. Please go ahead.

Hi, thank you for taking my questions. So, I know you expect to complete enrollment within the first half of this year. But what's your level of confidence in randomizing that last patient and main cohort by -- to secure that €116 million capital increase? And then secondly, given it's likely you have cash including this second tranche to just the readout in 2H 2026, what are the plans for any additional financing and I know you previously communicated that it would make sense post the data to have a partner. What's the level of interest here from pharmas to be able to close a deal as quickly as possible? Thank you. Frédéric Cren: So many questions. So the first one on the confidence of recruiting before the end of April, I would say, high confidence given we have communicated to all sides to stop screening at the beginning of the month of January. And we took that decision because we had sufficient patients already run the math and sufficient patients in screening to reach the target of 969 patients, which are the patients that we need to enroll in the main cohort to achieve a 90% of hiring [ph] with the assumption of the SAP. The average screening period is between 10 to 12 weeks. And so we feel very optimistic that we will meet at the end of April objective. On your question about partnering, there is a lot of interest in the MASH market. I would say finally, given that we've been going through a series of failures in the field, and luckily some companies that have reported positive data, and more importantly, Madrigal Rezdiffra [ph] has been approved. There is no need of biopsy to prescribe it, and the commercial launch has been very solid, and they're definitely in the direction of the blood-baster potential. So, of course, that drives a lot of interest. We believe we have a very strong package. We are the only oral drug currently in Phase 3 development. Most likely, once we will announce the end of enrollment we can reassert that we'll be the next oral drug to be potentially approved. And given the results we have had in the Phase 2B, we feel extremely strong on the commercial success of lanifibranor. On how we manage our resources, of course, we're actively managing our financial resources, and we're confident that the step we're taking will allow us to execute on the clinical trial. We work and we're committed to advance the clinical program and ensure the long-term value of Lani. And of course, while we do that, we continue evaluating all options to secure the funding needed to achieve our objective, which is to execute the clinical trial, file for NDA, and commercialize Lani first in the U.S., and then in the European community.

Thank you.

Thank you. Your next question comes from the line of Annabel Samimy from Stifel. Please go ahead.

Hi. Thank you for taking my question. On the screening again, is there any specific rate in the meeting step on that screening that could derail that last person who is enrolled into becoming an actual randomized patient in the primary arm? And then secondly, I guess now that the -- as you've alluded to, that the MASH market appears to be forming with the first approved treatment, the profile of the FGF21s [ph] are emerging, and there's additional data emerging on encryptions being able to drive MASH resolution. Has the way you thought -- you think about the market and the population that lani would be most appropriate for exchange at all and how do you see this market fragmenting with the potential introduction of lani? Frédéric Cren: So thank you Annabelle for this question, so very interesting. So to your first question, what can derail the randomization of the last patient? Once the patient is in the screening pool, we have a certain amount of period of time to complete all the examination that are on the protocol. So during that period, we need to do all the lab tests, we need to do the biopsy, the biopsy are digitized and they are read centrally. And it's all that process that takes between 8-12 months, not months, weeks. And then once the patient is randomized, there is an appointment in each to show at the hospital, and then he is randomized in the study. So that's why this period takes a certain period of time. There is a total amount of time for that period, so at a certain moment, if we see that the patient doesn't present himself to an appointment or the site is not reactive enough, and so this period of time to screen a randomized patient is overdue. We can screen-fail the patient automatically. So that's why gives us confidence that we will randomize the last patient as guided before the first half of H1 2025. On your second question on where we see lani play a role in the market shape. As I said before, Madrigal launch really showed that there is a huge market, and even more so, because we believe Madrigal is not a tremendously efficacious drug, so we believe the market will further develop when we will arrive with a more efficacious drug. And also semaglutide with a commercial marketing of NOVO will help enlarge the market. Where we see Lani work, clearly, and this is something we get the treatment positive feedback as we have a drug that is really ideal for patients that have advanced fibrosis, F2S3, and on top of that Type 2 diabetes. This is a large population. We estimate that more than 50% of patients with MASH have Type 2 diabetes, especially in the F2S3 population. This is a population which has a fibrosis progression that is faster than the overall population. They are more difficult to treat, and the profile of Lani where we can see fibrosis reduction in six months, we can see a resolution of NASH, and especially a strong insulin sensitivity activity with a drug that helps you control your diabetes is a profile that resonates very well. And then lastly and that’s something really important to highlight is that it is a well-known mechanism with endocrinologists and diabetologists. In the U.S. alone you have close to 6 million prescriptions of Pio. Pio is, as you know, all the PPAR gamma, let’s call it a first generation PPAR gamma with a profile that is really less attractive than ours, but still even if it's generic, even if it's not prescribed promoted, you have 6 million scripts every year written in the U.S., which really demonstrates that these diabetologists and endocrinologists are very familiar, very used to prescribe PPAR's mechanism, and so there will be, we think, attracted by the profile of lanifibranor.

Fantastic, thank you very much.

Thank you. Your next question comes from the line of Ed Arce, HC Wainwright & Company. Please go ahead.

Hi, good morning everyone. Thanks for taking my questions. Just a couple from me. So, I just wanted to get your thoughts on R&D expenses throughout the year considering both the impacts of the recent reduction in workforce and the -- of the early programs but also as well the fore moment of NATiV3 in a few months and the carrying expenses of that? And then also relatedly, just wondering if you could help us to understand any potential milestone payment receipts for this year that you would expect? Thanks so much. Frédéric Cren: Jean, do you want to take this question.

Sure, so for the profile, let me say, of the R&D expenses this year, as I said they are decreased by 17% because we know we have to face some operational problems, but we have restored the recruitment in Q2, so the decrease versus last year and versus budget, also, which present basically something like 20 million represents this momentum for 2024. If we talk about 125, we come back -- I would say we come back to the normal way. We expect, compared to this year, a slight increase in the expenses as I mentioned, because we will start, and for excel also, we start to prepare the commercial capabilities. We will focus on the NDA filing also, so it should increase, let's say, by 10% to 20% compared to this year. And with regards to the expected milestones, as of today, what we know about the milestones related and connection with the transaction, as you know because there are three milestones expected from our Chinese partners CTTQ. One has been raised, has been collected in 2024, and there is one milestone per tranche. So we are contemplating the second tranche of the financing in 2025. So together with the second tranche, we may receive, we will receive the second $10 million milestones and practically anticipate 30 days after the last randomization disclosure.

Great, thank you so much.

Welcome.

Thank you. Your next question comes from the line of Jacob Mekhael from KBC Securities. Please go ahead.

Hi there, and thanks for taking my question. Looking ahead to the top line data in the second half of next year, I was just wondering if you can share with us how soon after the last patient completes their treatment you will be able to share the results and perhaps how does that tie in with your cash runway being till the end of Q3 2026? Frédéric Cren: So, yeah, we for once the last patient, where the last patient last visit, I guess we'll need to wait for a couple of months to publish the top line data. And then as we said, once we will have the last patient randomized, we'll have of course more clarity on when that date will be. And in terms of financing, once we raise the second tranche, which we expect to raise pretty soon, we'll be in a clear position to show that we have the means to deliver on our clinical objectives.

Okay, thank you. And just maybe one more question, if you can perhaps just remind us on the deal with Hepalys in Japan, what SH3 [ph] program would look like there and would that be entirely funded by your partner or do you have to contribute to that? Frédéric Cren: Yeah, so that's a very good, very good question. All our licensing in Japan, South Korea, and China, all the clinical development that are done locally are financed by our partner. So the, in Japan, the current Phase 1 and the Phase 3 will be financed by Hepalys. We will have no impact on our finances. And similarly, the ongoing Phase 3 in China is totally financed by CTTQ, Sino BioPharm.

Okay, thank you very much.

Thank you. Your next question comes from the line of Rami Katkhuda from LifeSci Capital. Please go ahead.

Hey guys, thanks for taking my questions. I guess first, how are you guys thinking about the design and timing of an outcome study, where does the FDA require you to be with it prior to the filing of an NDA for Lani? Frédéric Cren: So yeah, the outcome study. So there's been a couple of months ago, got a new guideline from the FDA. It's very clear, the study, the outcome study needs to be underway at the time of NDA filing. So this is exactly the plan we have internally and that we have discussed with FDA, which is to run an outcome study inpatient with compensated cirrhosis. And this trial will be underway when we file for NDA. And currently, we plan to file for NDA in the first half of 2027.

Got it. And I guess with enrollment nearly complete here, can you remind us of the powering assumptions for NATiV3 for the combined endpoints? Frédéric Cren: Yes. So the study is powered at 90%. And we used the data from the Phase 2B, which as you know, is a six month trial. And we have used what we believe is a cautious approach. So we looked at the placebo effect, we have increased it by some percentages. And similarly, the effect size was reduced by a couple of percentages for both doses. And that's what we used for the powering at 90%. Why do we believe this is a prudent approach is because the Phase 2B was a very successful trial. We met the primary endpoint and also the key sensory endpoint. But it was a six month trial and given the mechanism of action, and also the data that has been published by our competitors, and you if you look at data 12 or 18 months, you clearly see that with longer period of treatment, we believe the effect size of Lani will actually be greater than what we saw in the Phase 2B. To answer your question, that's how we powered the study.

Got it. Thank you very much.

Thank you. [Operator Instructions]. And your next question comes from the line of Ellie Merle from UBS. Please go ahead.

Hi, everyone. This is Jasmine on for Ellie. Thank you for taking our question. So a question on the combination of Lani and SGLT-2 inhibitors. So going forward, what are your plans to study this, do you think you'll need to generate more data here to support this combination used by physicians? And then secondly, how important do you think the mitigation of the weight gain with this combination is going to be to physicians and patients, particularly in the segment of MASH patients that are also obese? Thank you. Frédéric Cren: So, thank you, Ellie. So on your first question, we have no plans to develop a fixed dose combination Lani that has SGLT2 inhibitors. Why we did the study? Because I think it's important to have data that show that the metabolically healthy weight gain that you see in patient with -- that in some patients treated with Lani it's approximately one third to half of the patients that gain weight. We have demonstrated that this weight gain is metabolically healthy. We have demonstrated that there is a plateau effect so it's actually a weight gain that stabilizes after six to nine months of treatment. Nevertheless, some patients probably will be looking for an approach besides the lifestyle or besides a diet to control this weight gain. And so we wanted to show that if you combine Lani with an SGLT2 inhibitor, you manage to retain the benefit of both drugs and at the same time mitigate the weight gain. That was shown with that study. We also believe that the data that we are generating right now in the Phase 3 with patients with GLP-1 will help show that that's actually a very good combination, adding GLP-1 to Lani to retain the advantages of both drugs, but also mitigate the weight gain. We will also be a nice combination to address the weight gain.

Thank you. There are currently no further questions. I will hand the call back to Frédéric. Frédéric Cren: Thank you, operator, and thank you everybody for attending. Great set of questions. You have understood that our next milestone is the end of randomization. It's going to be, of course, for us a strong event, but also I think for the MASH community, because it starts the clock for an important Phase 3 that we'll read out. And when I say important, because if you look at the profile of Lani, we really have a drug that can be a game changer for patients that are suffering from MASH. With that, I really thank for your strong support over 2024. And as I said, we have ahead of us, I think, a very exciting 2025. And I'm sure we will have several opportunities to discuss throughout this year. Thank you very much.

Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.