Earnings call transcript: Idorsia sees reduced losses, strategic shifts in Q4 2024

Idorsia Ltd (SIX:IDIA), with a market capitalization of $244 million, reported a significant reduction in non-GAAP operating losses for the fourth quarter of 2024, reflecting strategic cost-saving measures and increased revenues. The company’s stock experienced a downturn, with a 7.59% drop to $1.24, following the earnings announcement. According to InvestingPro data, the stock has shown high price volatility, with a beta of 1.29. Despite this, Idorsia remains optimistic about its future, with plans to achieve commercial profitability by 2026, though analysts maintain a Hold recommendation on the stock.

Key Takeaways

• Idorsia’s operating loss halved to CHF 308 million in 2024.
• QVIVIC sales nearly doubled, reaching CHF 61 million.
• The stock fell by 7.59% post-earnings.
• Strategic cost reductions included a significant cut in the U.S. sales force.
• Aprocitantan received approvals in the U.S. and EU.

Company Performance

Idorsia demonstrated robust financial management in 2024, achieving a 50% reduction in non-GAAP operating losses compared to the previous year. The company attributed this improvement to increased revenues and substantial cost reductions in research and development (R&D) and selling, general, and administrative (SG&A) expenses. The launch of QVIVIC in multiple European and Canadian markets contributed significantly to revenue growth, and the company has made strides in its innovative pipeline, securing approvals for Aprocitantan in both the U.S. and EU.

Financial Highlights

• Revenue: Increased, driven by QVIVIC sales growth from CHF 32 million to CHF 61 million.
• Non-GAAP Operating Loss: CHF 308 million, a 50% reduction from 2023.
• Cash Balance: CHF 106 million at the end of 2024.

Outlook & Guidance

Looking ahead, Idorsia anticipates a non-GAAP EBIT loss of CHF 215 million in 2025, with a sales target for QVIVIC set at CHF 110 million. While the company aims to achieve commercial profitability by 2026, InvestingPro analysis reveals several challenges, including rapid cash burn and weak financial health metrics. The company’s overall Financial Health Score stands at 2.02 (Fair), with particular concerns in cash flow management. Discover 12 additional exclusive ProTips and comprehensive financial analysis by subscribing to InvestingPro, including detailed insights into the company’s path to profitability and market position.

Executive Commentary

CEO Andre Muller expressed optimism about the company’s future, stating, "We have a few amount to climb. But I’m confident and I’m sure that the view from the top will be fantastic." Chief Scientific Officer Martin Clozell highlighted Aprocitantan’s significance, noting it as "the first drug able to block the endothelin pathway in systemic hypertension."

Risks and Challenges

• Market constraints due to U.S. scheduling restrictions on QVIVIC.
• Potential competition in the insomnia and hypertension markets.
• Dependence on successful pipeline development and regulatory approvals.
• Economic pressures affecting healthcare spending and drug pricing.

Q&A

During the earnings call, analysts inquired about the timeline for descheduling QVIVIC in the U.S., with management indicating a potential 12-18 month timeframe. Positive discussions with payers for Triveo were also highlighted, underscoring the company’s focus on achieving commercial goals and advancing pipeline assets.

Idorsia’s strategic initiatives and cost-saving measures have set a promising foundation for future growth, despite current challenges and market reactions.

Full transcript - Idorsia Ltd (IDIA) Q4 2024:

Sonia, Conference Operator: Good day and thank you for standing by. Welcome to the iDOLFA Full Year twenty twenty four Financial Results Webcast. At this time, all participants are in a listen only mode. After the speakers’ presentation, there will be a question and answer session. Please be advised that today’s conference is being recorded.

I would now like to hand the conference over to your first speaker today, Andrew Jones, Head of Corporate Communications. Please go ahead.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thank you, Sonia. Good afternoon. Good morning, everyone, and welcome to our webcast to discuss the 2024 financial results. On the call today, we have our CEO, Andre Muller our President of the Yukon region, Benjamin Limal our President of U. S, Michael Moy joining us in this capacity for the first time since the departure of TOSH our Chief Scientific Officer, Martin Clozell and our Chief Financial Officer, Arna Groeneberd.

Then joining us for the Q and A session, we have our Group General Counsel, Julian Gander, in case of questions related to the recently announced agreement. So a lot to get through today. Next (LON:NXT) slide. Before handing over, I need to remind everyone that we will be making forward looking statements. You have therefore been appropriately warned about the risks and opportunities of investing in Hydrosia shares.

With that, I hand over to Andre for his introductory remarks. Next slide.

Andre Muller, CEO, Eydorsia: Yes. Thank you, Andrew. Good afternoon or good morning, everyone, and thank you for joining SIA call today. Before going into 24 highlights, let’s deal with the Elephantine CRU, the envisaged out licensing agreement for our PROCITANTAN that we eventually could not close for reason unrelated to SEADrug. As you can imagine, the undisclosed party did not agree to pay an exclusivity fee of US35 million dollars without a thorough assessment of the quality of SEAD data and see a potential of apocitamtad, very frustrating, but we need to move on and now pivot to potential alternative partners.

As a result of this unexpected setback, we need to look for alternative ways to keep the company operational. Due to tight timelines, we had to discuss with partners that had a vested interest in Eydorsia. One partner is Via Tris. The original deal was in March 2024 and secured the future of Selatopel and Senerimod to Phase three year programs, allowing Eydorsia to retain long term upside through potential milestone and royalties. Last week, we announced an update to see agreements that reduce Eydorsia commitment to R and D costs by US100 million dollars which was due in 2025, therefore relieving significant pressure on our cash.

At the same time, we have worked with bondholders for holistic restructuring of the convertible bond debt to remove the debt and cash overhang and to fund the company’s operation with a new money facility of CHF 150,000,000. This is obviously a huge relief, but with so much attention going to see a financial situation of the company during the past months, it’s easy to lose sight of how well the company was performing in other areas. Let’s start with QVVic. I know QOVIC is doing well around the world and particularly in European and Canadian region, we call it UCAN. Benjamin will give you an update today.

We could also slightly grow ESRs in The U. S. Despite some significant lower marketing and selling investments. And Michael will also give you an update. Aprocitrantan, we have secured the approval of Trivio in The U.

S, Jarego in The EU. And we strongly believe that Aprocitrantan has the potential to revolutionize a serious and growing public health problems. Michael will give you an update on launch preparation in The U. S. And Martin will also give you more background on what was called and considered up to recently as resistant hypertension, where the risk of cardiovascular complications such as strokes, heart failure, renal failure is considered almost twice higher than you see usual forms of hypertension.

Martin will also give you some color on our R and D portfolio. And finally, Arnaud will provide the usual financial updates for 2024 and the guidance for 2025. As Andrew said, a lot to get through, so I hand over to Benjamin for the EUCan commercial update. Benjamin, the floor is yours. Next slide.

Benjamin Limal, President of Yukon Region, Eydorsia: Thank you, Andre. Good morning and good afternoon. Cubivik is now available in nine countries across Europe and Canada, our UKAN region. We launched QVVIC in Germany and Italy in 2022 and the most recent launches were France and Sweden respectively in March and September 2024. QVVIC is the first and only dual orexin receptor antagonist in the European market and has been described as the most significant recent development in the pharmacological treatment of insomnia by European Sleep Research Society in its recent guidelines.

This innovative class has also been recognized by local authorities, resulting in full reinvestment in three countries already, Germany, France, The UK, with a rapid and considerable impact on our sales trajectory, allowing the Yukon region to achieve CHF 32,000,000 of net sales in 2024. Sales have shown a steady increase in the first three quarters of twenty twenty four, as you can see, but then you see also the recent acceleration in Q4, particularly driven by a great performance in Germany and an outstanding launch in France. Overall, France and Germany have been the two drivers of our 2024 performance with respectively CHF 12,000,000 and CHF 11,000,000 and I will share more details on these two countries today. Next slide please. This slide represents the actual Qubilik demand across The UK region.

These are the sales from wholesaler to pharmacies And overall, in 2024, we distributed more than 15,000,000 cubic tablets across the region. That’s 15,000,000 restorative night sleep and 15,000,000 revitalized days. There are two main takeaways from this chart. First, as I mentioned, the Q4 acceleration in the cubic demand mainly driven by France and Germany. And second, the importance of reinvestment in The UK region, where 90 of Cubic (NYSE:CUB) demand is coming from markets where we have been able to secure reinvestment and here I include the private reinvestment in Canada.

So since public reinvestment is so critical in The UK and region, let’s take a look at the current status country by country. Next slide please. Starting from the top in Germany, as already reported, Cubivik is the only Insomnia treatment that does not have the

Speaker 4: four weeks prescription limitation. I’m very glad

Benjamin Limal, President of Yukon Region, Eydorsia: to share that with prescription limitation. I’m very glad to share that we’ve been able to finalize the pricing negotiations with TKV AZ. The positive final outcomes of these two steps two years process with Amnog will be made public in early March. In The UK, Cubivic is recommended as a first line pharmacological treatment for patients with chronic insomnia after or as an alternative to CBT I. Priority in The UK in 2024 was to secure regional access and the team has achieved reimbursement throughout eighty five percent of The UK population already.

In France, ASM F4 and rapid negotiation pricing negotiation allowed us to have Cubivik launched at the March ’24 and I’ll share more details on the French performance. In Canada, Cubic is available to private market patients since November 2023. Private market represents almost 55% of the Canadian insomnia market and so far 85% of the private Canadian lines are covered. In parallel, we now have submitted QBVIC to both Ines and CDA and we expect final public reinvestment decisions by the end of twenty twenty five. Now moving to the countries where we have launched out of pocket or self pay.

Let’s start with Italy. Qubic was launched in Italy in the self pay market in November 2022 with prescribers restricted to only psychiatrists and neurologists who account for approximately 20% of the insomnia market. IFA recently agreed to expand the prescription rights to all specialties, including GPs, allowing us to now cover 80% of the market potential we’ve been excluded from in the last two years. In Spain, Cubivica was launched in the self play market in September 2023. Public reimbursement dossier was submitted last year.

We expect final decision around mid-twenty five. Spain is the biggest in Sogne market in UConn and Spanish health authorities are very well aware of the problem of addictive treatment use they are facing since years. We are also in discussion with Swiss and O3N authorities to make Cubic publicly reimbursed. Next slide please. As agreed, I now would like to focus on the two countries which generated 70% of our 24 sales, starting with France, where we launched in March ’2 specialists only first and where we expanded promotion to GPs in October of last year.

Just two numbers I like you sorry to recall. 450,000 tablets were sold in September 24. Three months later in December 24, we sold 1,400,000 tabs in France. We’ve tripled the Cubic demand in three months, thanks to our co promotion partnership to GPs with Medarini, who deployed one hundred and sixty thirty five reps to promote Cubivik to the French primary care prescribers with, as you see, immediate impact on our performance in France. Next slide please.

Next country focus, Germany, where we have launched in November 2022 and we’ve been managing a two years long access and pricing process now coming to its end. Germany quarterly growth kept increasing steadily, especially to represent 40% of the market potential, clearly have now adopted Cubivik, thanks to our marketing and medical activities. We are today very excited to announce that we’ve agreed a commercial partnership with Berlinchemie, a Menarini owned company, to reach the GP prescribers who represent 60% of the market in Germany. Two Sixteen Reps, Sixteen cans will visit GPs from April 25. And we strongly believe this co promotion will strengthen and accelerate our uptake in Germany.

Next slide please. So to conclude with UKAN region, I want to remind you about the massive opportunities Insomnia market represents with almost 4,000,000,000 tablets sold every year in a large majority coming from outdated products having many known issues. We’ve made great progress in 2024 through our targeted marketing activities, our very precise commercial execution to increase Q3 vehicle awareness, first to specialists and then to GPs. These efforts are paying off with more and more prescribers who have adopted QVic to treat their chronic insomnia patients. Best illustration of this progress reflected by our new patient share clearly demonstrating that our commercial efforts with QVVic in The UK region are beginning to translate into promising success.

I’m very confident especially with the commercial partnership such as MENARINI in France, Berlinkemi in Germany that Qelvic adoption will keep accelerating in 2025. Thank you. Now, we’re handing over to Michael for The U. S. Focus.

Next slide please.

Michael Moy, President of U.S., Eydorsia: Thank you, Benjamin. By the end of twenty twenty four, more than one hundred and seventy five thousand U. S. Patients have been treated with QVIVX since launch. More than 550,000 prescriptions have been dispensed and the product has been prescribed by more than 50,000 healthcare professionals.

Throughout 2024, we optimized our resources and promotional effort and adjusted our commercial approach to get more towards a payer paid model. And we made a lot of great progress on that. I’m very pleased that we’ve been able to see steady U. S. Sales growth for Qbibic the last year and we’ve been able to increase the sales to over CHF 28,000,000 despite drastically reducing our marketing and selling investments, notably by reducing our field force in April 24 from two fifty reps to 100 reps.

Next slide. We’re limiting our commercial efforts in the short term while we wait for the anticipated descheduling of the dual orexin receptor antagonist class of sleep therapies. The Citizens’ petition that we submitted outlines scientific and medical evidence demonstrating that the DORA class has a negligible abuse profile and lacks physical and psychological dependence and therefore should not be a scheduled class under the Controlled Substances Act. Adorsia continues to be very confident there is a solid and very compelling case here. In fact, yesterday, I was in Washington, D.

C. On Capitol Hill meeting in offices on both the Senate and the House side as we continue to find legislative advocates for our citizens petition. Descheduling the class would remove many, many access barriers for patients and the prescribers, which add complications for physicians and consequently, we hope it would unlock the true value of QVIVIC in The U. S. Next slide.

So until the potential descheduling comes through, for 2025, the company has implemented a change to the commercialization approach for QBIVIC with the objective to continue to reduce operating costs while maintaining the sales. We have expanded our multi year relationship with Syneos. This was primarily around our sales organization. Syneos Health (NASDAQ:SYNH) will now be more of our commercialization partner. We’ve switched from around 100 field sales reps to 20 virtual sales reps operating remotely.

And we’re using very advanced analytics and digital strategies to be highly focused and targeted. Adorsia and Syneos will coordinate our marketing efforts, digital search and media, data analytics, our market access activities, all to support the virtual representatives and maintain sales. Next slide. And as you heard Andre mentioned earlier, in parallel, we’ve been preparing for the launch of africitention or Triveo in The U. S.

We made Triveo available to doctors and patients in October of twenty twenty four. There are millions of patients in The U. S. Whose high blood pressure is not adequately controlled by other drugs. Again, you will hear this is a massive opportunity and unmet need within our healthcare system.

Our team has fully developed the launch plan. We have a fully developed product campaign. Everything is properly planned out, including field sales force deployment and promotional activities. But the decision of the underclosed party not to close the Afrasitenin deal urged the reduced U. S.

Team to execute a much more limited and focused launch of Triveo in The U. S. In order to maintain and increase the value of a potential out licensing deal for afrostatantin. So we’ve been very encouraged by the initial and ongoing conversations with our KOLs, with our payers, who understand that Triveo is addressing a significant patient need and that treating these patients who remain uncontrolled at a very high risk, they are at a very high risk for serious cardiovascular events. So now to hear more about that, I’ll pass along to Martine.

Next slide.

Martin Clozell, Chief Scientific Officer, Eydorsia: Thank you, Michael, and good morning, good afternoon. Picking up on Afrocentan, I would like to highlight a few points. Resistant hypertension, when subjects are still hypertensive despite three drugs or more at optimal dose, remains one of the biggest medical need in the field of hypertension. This form of especially difficult to treat hypertension is particularly seen in some population. Patients with renal failure, African Americans, high body weight or older age.

When hypertension resist despite such combination of several antihypertensive drugs, this speaks for a key role of Endotelen, which we know since more than thirty years as an important player in hypertension, but which was not blocked by classical antihypertensive drugs. Aprocitrantan is the first drug able to block the endothelin pathway in systemic hypertension. Next slide. A PROCITANTAN is a once daily tablet. It’s one dose for all.

It’s easy to use for patients, easy to prescribe for physicians. It can be combined with other drugs and importantly, it can be used in patients with renal failure. Afrocetentan even on top of three drugs or more, adopting all dosage and even after controlling for good compliance, decreased blood pressure by more than 15 millimeters of mercury from baseline. It was well tolerated long term with an extremely low number of discontinuations and also had an impressive effect of decreasing proteinuria. These properties taken together make aprositenant a highly differentiated drug and ideal for the millions of patients who are unable to bring their hypertension under control with existing medications before aprositentan, particularly for difficult to treat patients with chronic kidney disease and hypertension.

We are prioritizing the partnering of aprositentan to make sure we can get this outstanding discovery to patients as quickly as possible. Next slide. I would like also to spend a few minutes talking about our other assets at late and at earlier stages of clinical development. As you know, we have put our portfolio of research and developments to a rigorous prioritization and we have limited our activities in R and D in order to make the money that we have last. Each portfolio compound has been assessed in the context of the competitive landscape for the feasibility of Ei Dacia to be able to develop a loan or to be generating the appropriate clinical preclinical and clinical proof of concept data enabling us to recognize the value of the assay.

First, LicerafStar in Phase III. With LicerafStar being in a rare disease and also with so much experience with the compound and the treating community, we believe we cannot answer alone. We have already conducted the largest study for patients with Fabry disease. And that’s why we did not treat significance on the primary endpoint of neuropathic pain. LUCERASTA showed a marked reduction in the decline of kidney function.

This is a major medical need in Fabry disease. We are currently investigating in a small kidney biopsy study. If this effect on EGFR slope is accompanied by an histological change and we will see the results from this in the coming months. And at that stage, we will further discuss the regulatory pathway with EFT. So next inflection point therefore is quite near term.

Next slide please. We then have exciting and very unique early stage clinical pipeline that has come from our discovery group. Funding permitting, we intend to develop this to the next inflection point before finding a partner unless someone is happy to join forces already today. For example, we have our ACK3 antagonist, former called CXCR7 antagonist for progressive multiple sclerosis. This first in class compound showed in every one of the preclinical tests we did including human oligodendrocyte precursor cells, a unique combination of remiallinating effect and anti inflammatory effect with decreased inflammatory cell infiltration.

Second, we have a six year three antagonist, which we plan to develop in GT LIGO another first in class targeting systemic therapy for Vitiligo, targeting very specifically a system which is deemed to be very important in Vitiligo pathophysiology. There is a huge medical need in VTLIGO with very, very few drugs and no drug systemically approved. These two compounds, XCR7 or a CCR3 and XCR3 are ready for Phase II proof of concept studies. Our CCR6 antagonist for immune additive disorders offers unique potential as a first in class oral targeted systemic therapy for effective treatment of T helper seventeen driven diseases, which can be immunodermatology and in osteoimmune disorders. An earlier stage portfolio is composed again of potential first or best in class compounds and this portfolio is again truly innovative.

TAM does not allow me today to go into detail for all earlier preclinical assets, which we discovered. But again, we have really discovered very special compounds such as, for example, our LPA1 receptor antagonist for immune mediated and fibrotic related disorders, where I am convinced we have a best in class compound due to its insurmountable binding mode on the LPA1 receptor. It has proven inhibitory activity and efficacy as anti inflammatory and anti fibrotic in several preclinical models of inflammation and fibrosis. Or our CFTR Type IV corrector for cystic fibrosis, a unique corrector targeting a totally new binding site on the CFTR protein, which has been identified again by our team, to name just two. I’m happy to spend more time during the Q and A to give you more color of any compound in our portfolio.

But for now, I’ll hand over to Arnaud to take you through the financial update. Next slide, please.

Arnaud Groeneberd, Chief Financial Officer, Eydorsia: Thank you, Martin. Good afternoon and good morning to everyone following the call. Let’s start by looking at the non GAAP operating results. As you know, Hydorsha sold its APAC business to NxThera in July 2023. Therefore, we show you the 2023 pro form a, excluding the APAC business for a better comparison with 2024.

More details are provided in the next slide, but here you can clearly see that we were able to increase our revenues, but at a significantly lower cost. The lower cost R and D cost is primarily due to the cost saving initiative that we implemented at the end of twenty twenty three and the Vitrext deal relating to the Phase III programs of Solatogrel and Senerimov. EY DORSIA continues to assume clinical services and clinical costs for both programs, but these costs are netted against the deferred revenue, having no impact on our P and L. The SG and A cost reduction is primarily due to a reduction in sales and marketing costs in The U. S.

And HQ, while we continue to invest in the EU Chem growth. This results in a non GAAP operating loss of NOK308 million, a reduction of almost 50% compared to 2023. Next slide please. Looking now at The U. S.

GAAP and non GAAP operating results in more detail. The Hydorshare led business reports significant growth in QVIVIC sales from 32,000,000 to 61,000,000, which is largely driven by the EUKen region. In 2024, the partnered business mainly includes the sale of intermediate products to partners on a cost plus basis. This also explains the relatively high cost of goods. Used GAAP operating result of SEK $232,000,000 includes SEK 125,000,000 gain resulting from the Vytus deal and restructuring charges.

Next slide please. Let’s now look at the cash development in 2024. We started the year with SEK145 million in cash. During the year, we had cash inflows from product sales of $107,000,000 and cash outflows of $263,000,000 for SG and A OpEx and $128,000,000 for R and D OpEx, excluding the Phase III trials for zlotogrel and senerimod. Other cash inflows of $10,000,000 include working capital movements below EBITDA items and the $30,000,000 royalty monetization with Arbridge regarding Agambri, the D and D drug of Sonterra.

We received a USD $350,000,000 cash inflow from the Vitrus deal, which converted into CHF308 million, of which US200 million dollars were committed to fund the ongoing Phase III trial of zlotigrel and sopenerimod. This commitment was reduced by CHF100 million in February 2025, which will result in no cash outflow for these trials in 2025. In 2024, we paid CAD 73,000,000 as R and D contribution for the Phase III trials, leaving a CAD 27,000,000 R and D commitment for 2026. This results in a cash balance of CHF 106,000,000 at the end of twenty twenty four. Next slide please.

As mentioned by Andre, in the last weeks, we were able to secure the future operations of Eydorsia through three key measures. As just mentioned, the amendment of the Vitrus deal relieves Eydorsia from USD 100,000,000 R and D funding commitment for 2025. A holistic restructuring of the 2025 and 2028 convertible bonds, which removes the large debt and cash overhang was a very important pillar of the future going forward. And finally, some of the bondholders backstopped CHF 150,000,000 new money facility, which will fund the Hydorsia business well into 2026. Next slide please.

This slide shows the result of the holistic restructuring that we announced last week. Both convertible bonds will be extended by ten years from the original maturity date. So the 200,000,000 convertible bonds originally due in 2024 will be pushed out to 2,034 and the 600,000,000 convertible bonds due in 2028 will be pushed out to 02/1938 with a put option in 02/1936. The agreement with certain bondholders means that we already know that around 75 percent of the existing Eydorsia convertible bond debt will be exchanged for notes in the SPV that we are establishing. All remaining bondholders can voluntarily exchange their restructured Eydorsia bonds for SPV notes.

And I believe that the final amount left with Eydorsia Limited will be lower than the CHF205 million that you see on the slide. In addition, once it is clear that the final debt to be carried over will be, we will adjust our share count. 190,000,000 shares issued by year end 2024 will increase to approximately $220,000,000 to $222,000,000 shares depending on the percentage of convertible bonds exchanged. The $288,000,000 diluted shares by year end 2024 will see a limited increase to approximately $294,000,000 to $3.00 4,000,000 shares depending on the removal of the potential conversion from the existing bonds. As you can see, the issuance of shares and warrants associated with the holistic bond restructuring, together with the new money funding, will bring the dilution to 14% to 15% on the shares issued and down to 2% to 5% on a diluted basis.

Next slide please. This slide shows the financial outlook for 2025 compared to 2023 and 2024 operating results of the Eydore CLED business. As already explained by Benjamin, we expect that the momentum in the EU Kenyan region will continue through 2025 and beyond, which drives the growth of Cubivik sales to 110,000,000. At the same time, we have and will further reduce our cost base to ensure that the money will last longer. This results in a further improvement of the non GAAP EBIT loss to $215,000,000 Next slide please.

And then finally, the guidance for 2025. As mentioned on the previous slide, an expected non GAAP EBIT loss of $215,000,000 which together with contract revenues of $15,000,000 results in a total non GAAP EBIT loss of $200,000,000 A U. S. GAAP result of SEK 155,000,000 includes the SEK 100,000,000 R and D cost sharing waiver by ViaTRIS and the restructuring charges. Next slide please.

And I hand over to Andre.

Andre Muller, CEO, Eydorsia: Yes. Thank you, Arno.

Speaker 4: To

Andre Muller, CEO, Eydorsia: conclude, I want to remind you of the priorities that we have set for 2025 and our immediate future. It’s up to us to make the money at last and make the right decision on how it is spent. We have already some clear priorities. Firstly, we continue to prioritize finding a partner for our proceeds in turn. I believe we can secure a great deal for our proceeds in turn and see us sooner, see us better, because we will be able to repurpose the money needed for The U.

S. Launch activities. Secondly, the best way to solidify our future is to accelerate the success of QEIC in the Yukana region. Our current forecast have us reaching commercial profitability with QEIC in 2026. The faster we can become commercially profitable, the greater we believe will be in Hydrosia’s future success.

And we also continue our efforts to get Theodora class rescheduled in The U. S. And there’s a good chance, as Michael explained, that we can finally unlock the true value of QErik in The U. S. As we are seeing in CU Can region, if we are able to remove this barrier, big barrier to prescription.

Finally, we must leverage our innovative portfolio through targeted development of some of our assets and partnering others. This could be a great source of income to keep our R and D engine fueled. And with this, I hand back to Andrew to open the Alliance for the Q and A.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thanks, everyone. And now we have time to take your questions. As I mentioned at the beginning, we are also joined by our Group General Counsel, Julian Gander for the Q and A. With that operator, please open the lines for questions.

Sonia, Conference Operator: Thank And the first question comes from Henrietta Berg from Deutsche Bank (ETR:DBKGn). Please go ahead. Your line is now open.

Henrietta Berg, Analyst, Deutsche Bank: Hi there. Thanks for taking my questions. Just a couple please. Firstly, could you give us some timelines for the reschedule for Kivovik in The U. S.

Or any tangible next steps that you could share? Secondly, for Trivio, could you talk us through payer discussions and access levels and any conversations you’ve had so far? And then a last quick one please, what do you consider to be the most important data point looking into the next twelve months? Thank you very much.

Andrew Jones, Head of Corporate Communications, Eydorsia: Okay. I think we’ll start with you, Michael, for the discussion of the descheduling timeline and Trivial reimbursement, and then we’ll come to Andre for the what he considers the most important item coming up.

Michael Moy, President of U.S., Eydorsia: Yes, absolutely. On the scheduling, we have benchmarked a handful of other products that have gone through this process and that leaves us we would project there’s a lot of unknowns of course in Washington, but within the next year or so would be consistent with a few other products on the benchmark. So while we watch that, we’re cautiously optimistic. It is a somewhat unpredictable process, but we have made a lot of great progress recently. And I think those benchmarks would put us in that next year to eighteen month period, hopefully sooner.

On the Triveo side, we are very continue to be very optimistic. The discussions with payers, I think this coming in as a later line product has allowed us to kind of naturally be in the approval process. In other words, the nature, as you heard Martine describe of these patients is that they have failed multiple lines of therapies. And that has been that has given us a very good path with most of the payers. I think they see the real value of the product and they see that these patients are truly struggling.

Many of these patients for years, sometimes decades, have been struggling with their hypertension. And this being the first new mechanism and first option in more than forty years, we’ve been having a great recognition of the payers of that fact and that this is something that these patients desperately need. Andre?

Andre Muller, CEO, Eydorsia: Yes, Michael. Thank you. So Henrietta, to your questions on the CEA priorities, actually we as Jocelyn mentioned, all priorities are important to Adolcea. But first one is the commercial goals, which is 110,000,000 sales with almost tripled in sales for Europe and Canada and hopefully doing a little better and maintaining sales in The U. S.

Although it’s very important for us because here we are in control of our destiny and this will bring us to a sustainable overall profitability. The second one is relating to Aprosit and Tan. We are actively working as you know on the deal. And Michael and the U. S.

Team is also working in close collaboration with our partner, Seniors Health on how we can go for limited targeted loads. And lastly, as Martin explained, we have really unique innovative portfolio pipeline assets. And here, we definitely need to see how we can bring these assets to see a next inflection points. So if we believe that we need a partner, we’ll try to find a partner. We have some discussions for these mid or early stage assets.

One which was not mentioned by Martin because of lack of time was also Phase one for Clostridium difficile, where we expect results by the end of the first half of twenty twenty five. So we have a few inflection points here demonstrating the potential value of the assets, proof of concept, including of course, and I mentioned Martin mentioned it with Lucerastat because that’s the next drug, which has the potential to get market authorization across the globe. So we should be very happy with the recent developments because we extended significantly the cash runway. But we have a lot to do and of the reusing what I said that JP Morgan, I would say, we have a few amount to climb. But I’m confident and I’m sure that the view from the top will be fantastic.

Henrietta Berg, Analyst, Deutsche Bank: Great. Thank you very much.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thank you, Anurag.

Sonia, Conference Operator: We will now take our next question. Please stand by. And the next question comes from the line of Youssef Zimmermann from Octavian. Please go ahead. Your line is now open.

Youssef Zimmermann, Analyst, Octavian: Yes. Thank you. Thank you, team for taking my question. Maybe two, one on the financing and the restructuring of the situation there. With the creation of the special purpose vehicle, can you help me understand a bit better where the obligation related to the proceedings on reacquisition fits?

So where does where is this obligation now to be considered? And what’s the priority of repayment? And then the second question on your pipeline, what do you think is a realistic timeline for us to hope for

Speaker 4: additional updates and understand a bit where you go with the assets that you

Youssef Zimmermann, Analyst, Octavian: just drove in the showed in the presentation? Thanks.

Andrew Jones, Head of Corporate Communications, Eydorsia: Okay. Thanks for that, Joris. I’ll hand over to Arnold for the first question.

Arnaud Groeneberd, Chief Financial Officer, Eydorsia: Hi, Joris. Yes, so the SPV will acquire the Ivory, the Vitrus contract for Solarti Brill (AS:BRIL) and Senerimat plus aprocitrantan. And any income that will come from these assets, 30% of our Procytenantan will go to J and J and 10% of Solatograft and Nerimod income will go to J and J. That remains unchanged. So that will come to Adorsia.

Adorsia will pay to J and J.

Andrew Jones, Head of Corporate Communications, Eydorsia: And then, Andre, what are you thinking on the timelines?

Andre Muller, CEO, Eydorsia: Yes. Maybe just to add on CSPV, Joyce. Meaning that the remaining 70% or 90% respectively for Apositetentan and Viatrice, Selatogrel and Cenaiimod will go to see SPV, I. E. Repaying SPV notes.

So that’s also very important and because as you have seen, almost 75 of the bondholders have agreed to exchange the existing convertible bonds or SPV. So it’s at approximately EUR 600,000,000 that will be will move from Idolsea Limited to CSPV. Regarding CSPV pipeline, we have some inflection points as mentioned with Dicelstat and Clostridium difficile. So that’s mid of this year. So stay tuned.

And for all the other assets, it’s like out licensing or M and A process where you cannot predict what the outcome could be, but we are actively discussing with potential partners to maximize the value of all compounds in our pipeline portfolio.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thank you for the question, Joris. Operator, do you have another question?

Sonia, Conference Operator: We have no further questions on the telephone lines. I would now like to hand back to we have one more question on the telephone. Would you like to take it?

Andrew Jones, Head of Corporate Communications, Eydorsia: Yes, please go ahead.

Sonia, Conference Operator: We will now take a follow-up question. And the follow-up question comes from Youssef Zimmermann from Octavian. Please go ahead. Your line is now open.

Youssef Zimmermann, Analyst, Octavian: Yes. Sorry for bothering you. Maybe just one additional question on the on going forward funding your operations. Is it correct for me to assume the funding will come from the QVIL sales from this new backstop money facility? And then any potential R and D pipeline deals that you will realize?

Or is there any potential additional income streams that I have missed now? Thank you.

Andrew Jones, Head of Corporate Communications, Eydorsia: Andre, do you want to take that on? Where we’re going to get our future funding from?

Andre Muller, CEO, Eydorsia: We are still investing, Joris, to be clear, in Qurate reducing the loss, which we incur. So sooner we drive sales, see a better and the faster we’ll reach breakeven and profitability. So that’s for QUEVIC. For our Procittentan, as you understand, there’s nothing to be expected in Hydrosia Limited because any proceeds will go to CSPV to repay CSPV and notes and to J and J to repay the contingent liability in connection with the return of the Aprositeneten right. So you’re right, the new money facility, USD 150,000,000 plus I would say the removal of USD 100,000,000 R and D commitment in connection with the deal with ViaTRIS will bring us to well into a twenty twenty, twenty six.

And of course, we no longer have to repay in 2025 the CV convertible bond 2025. And we would we will no longer have to pay down the road and with investors put in August 2026, the 600,000,000 convertible bonds. That’s what Arno explained as being removing a significant debt and cash overhang. And now on top and above, if we manage to secure some upfront payments in connection with some deals from our portfolio. This will definitely help to extend even more the cash runway of Fidorsia.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thank you, Andre.

Sonia, Conference Operator: As there are no further questions on the phone lines, I would now like to hand back to Andre Jones for any closing remarks.

Andrew Jones, Head of Corporate Communications, Eydorsia: Thank you, Sonia. So this concludes the call for today. Thank you everyone for your time. Keep an eye out for the publication of the annual report 2024 on 03/27/2025. This consists of the business report, the governance report, compensation report, sustainability report and the financial report, which was already published today.

We have our first quarter results on April 30, our AGM on May 28, and we look forward to speaking with you again at latest at our next scheduled webcast with a half year financial reporting on July 30. And with that operator, please call down the lines.

Sonia, Conference Operator: Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect.

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