Ladies and gentlemen, welcome to the Santhera Pharmaceuticals Half Year 2023 Financial Results and Corporate Update conference call. I am George, the conference call operator. I would like to remind you that all participants will be in listen-only mode, and the conference is being recorded. The presentation will be followed by a Q&A session. You can raise your questions at any time by pressing star one on your telephone. For operator assistance, please press star zero. The conference must not be recorded for publication or broadcast. This conference call may contain certain forward-looking statements based on current assumptions and forecasts made by Santhera Pharmaceuticals. Such statements involve certain risks, uncertainties, and other factors which could cause the actual results, financial position, performance, or achievements of Santhera Pharmaceuticals to be materially different from those expressed or implied by such statements. These factors include those discussed in the comprehensive risk factor disclosure on the company's website at www.santhera.com. Santhera disclaims any obligation to update any forward-looking statements. The conference may be downloaded on Santhera's website during the two weeks following the call. At this time, it's my pleasure to hand over to Mr. Dario Eklund, CEO. Please go ahead. Thank you, operator, and good afternoon and good morning, everyone. Thanks for joining today's call, where we will discuss progress over the first half of 2023 and post-period updates. We're also pleased to discuss the exciting upcoming milestones for the rest of 2023 before taking your questions. Here with me today, as usual, are Andrew Smith, our CFO, and Shabir Hasham, who's our Chief Medical Officer. I'm very happy to reflect on a truly transformational period for Santhera. Strategic decisions actioned during the first half have resulted in the business now being on a solid financial footing. We have cash reach to 2025 and the resource and strategy in place to build a successful European commercial organization to launch vamorolone in DMD, subject to approval, and deliver real and achievable value for shareholders. This has primarily been achieved through the out-licensing agreement with Catalyst Pharmaceuticals. Catalyst has a fantastic track record of success in the rare disease and neuromuscular space. It was our commercial partner of choice for North America, owing to its established infrastructure and both companies' truly aligned commitment to patients. We believe Catalyst is well-placed to maximize the value of vamorolone, and subject to regulatory approval, which is expected by the October twenty-sixth PDUFA date, will ensure patients in North America receive this transformational therapy as quickly as possible. Importantly, in addition to the deal value of $231 million, Santhera will continue to benefit from royalty payments from product sales in North America, while allowing us to fully focus on the commercial rollout of vamorolone to DMD patients in Europe. With regards to the upcoming potential launch of vamorolone in DMD, marketing authorization applications are proceeding as planned, and preparations for marketing, market entry, contingent upon these approvals, are advancing on both sides of the Atlantic. We are in close contact with the regulators, with productive discussions, and timelines are fully on track. From our side, a recommendation by the European regulator, CHMP, is expected in quarter four of this year, and a final decision by the European Commission by the end of this year. Upon approval, we plan to commercialize vamorolone in selected European markets ourselves. These include the DACH region with Germany, Austria, and Switzerland, and also the UK, France, Italy, Spain, and the Benelux countries. At present, preparations are in full swing for potential commercialization at the beginning of next year, initially in Germany and with other key European markets to follow gradually. Activities surrounding market access, stakeholder and KOL, so-called key opinion leader engagement, in these countries are ongoing. In Germany, the buildup of a core sales organization is nearly complete. In Europe, once the marketing authorization is granted, pricing and reimbursement agreements need to be negotiated with healthcare authorities and insurance providers in each individual EU country. This step can be quite complex and time-consuming and will result in staged launches across the region. Country reimbursement requests for the major countries are on track to be submitted shortly after marketing authorization is received. Germany will be the first country to launch in early 2024 and is expected to account for the largest part of our 2024 year revenue. Pending approval, two early access programs will run in parallel to the German launch. The French AAP will generate revenue in addition to Germany. The English EAMS program will initially be free of charge. Both early access programs will also generate important real-world data. Overall, we expect to generate annual sales of around EUR 150 million within five years from launch. In countries not covered by ourselves, we intend to engage with commercialization partners, and in some countries, we are already in the selection process. In parallel, and as I mentioned earlier, we have applied for early access programs in France and the U.K., which could, if granted, allow treatment of the first DMD patients with vamorolone already in Q4 of this year. In addition to the Catalyst deal, post-period end, we completed the divestment of our idebenone business to the Chiesi Group. Again, we retain value in the product while simplifying operations and strengthening our balance sheet, freeing up resources to be deployed for our European vamorolone launch. I'm incredibly grateful for the team's determination. Everyone here is driven by the same goal, delivering this potential life-changing therapy to DMD patients as quickly as possible. No one would argue that it hasn't been a bumpy ride, and we have had to make many difficult decisions along the way. But I'm extremely pleased and proud of where we are today, and incredibly excited about what the remainder of 2023 will bring. With this, I'm handing over to Andrew for a review of our financial performance and financing. Andrew, please. Thanks, Dario, and hello, everyone. I'll start with some comments on the financial performance, followed by a status update on our overall financial position. Let me first turn to the interim 2023 results, covering the first six months to June 30, where I reference amounts in Swiss francs, unless otherwise stated. Revenue from contract with customers amounted to CHF 3.9 million, including net product sales of CHF 1 million. This compares with a negative CHF 6.3 million in the same period last year, which included accruals of CHF 6 million associated with the French Raxone reimbursement case. We recognized revenue from out licensing progress milestones of CHF 1.9 million related to the license granted for vamorolone in China. While in the same period last year, we recognized upfront milestone of CHF 11 million. Operating expenses of CHF 22.5 million were 25% lower year-on-year, primarily due to lower development expenses. These development expenses reduced to CHF 9.7 million from CHF 16.9 million, as we progressed from the clinical stage into regulatory stage for vamorolone in DMD to U.S., EU, and U.K. authorities. Marketing and sales expenses were CHF 4.3 million, compared to CHF 5.9 million on a comparable basis, and i.e., excluding the non-recurring accrual of CHF 2.1 million in relation to the French Raxone case in the prior year. This represents a slight increase due to higher pre-commercialization activities for vamorolone. G&A expenses amounted to CHF 8.4 million against CHF 7.1 million, for which the increase year-on-year reflects the addition of personnel in key functions in view of the market readiness, preparations for vamorolone in the U.S., and corporate activities. Financial income amounted to CHF 5.7 million versus CHF 5.3 million, and like last year, this was mainly related to the net positive change in fair value of financial instruments. While financial expenses remained relatively constant year-over-year and amounted to CHF 8.8 versus CHF 8.9 million, mainly due to interest and make-whole expenses. In summary, this resulted in net financial expense of CHF 3.1 million compared to CHF 3.6 million in the same period last year. For the first half year, 2023, there was a loss of CHF 23.3 million, compared to a net loss of CHF 29.7 million in the same period last year. As of June 30, 2023, and notably before the licensing transaction with Catalyst, the company had cash and cash equivalents of CHF 1.7 million, compared to CHF 1.4 million as of December 31, 2022. Since June 30, we've closed two major transactions, which have provided significant funding and markedly reduced near-term liabilities, thereby extending the company's cash reach into 2025. In July, we closed the collaboration and licensing agreement with Catalyst, and upon close, we received the upfront milestone and equity investment, which together net of costs, amounted to CHF 78.6 million. We used around CHF 29 million of these funds to repay all exchangeable notes outstanding with Highbridge, and this relieves the company from the significant portion of debt, removes covenant obligations, and limits potential future dilution with a markedly strengthened balance sheet. Importantly, the pro forma remaining cash and cash equivalents of CHF 49.6 million enabled the company to advance its commercialization strategy in Europe and provide funding for post-marketing commitments. We will keep under review the need for further financing to support market growth and pipeline development, and retain treasury shares, conditional and authorized capitals to facilitate any future placement or issues subject to market conditions. Also, in July, we completed the transfer of Raxone to the Chiesi Group, and as you know, Chiesi already held worldwide rights to idebenone in LHON, except for France and North America. As part of the transaction, Chiesi Group will assume a settlement liability in the amount of EUR 25.3 million related to the French reimbursement. This full disposal of business allows Santhera to streamline other operations, reduce operating costs, and redirect resources to vamorolone, as well as by reducing our liabilities, helps further strengthen our balance sheet, while also retaining a further potential upside with contingent value for LHON in the U.S. and other indications worldwide. In summary, the U.S. licensing transaction, the completion of the Raxone transfer, and the repayment of the Highbridge exchangeable notes provide, together with expected income from operations, cash runway into 2025. We keep the need for additional financing to fund development and vamorolone launches under constant review. Further detailed financial information can be seen in the published press announcement released earlier today, and the financial report available on our website. I thank you for your attention and continued support. I now hand back to Dario. Dario? Thanks, Andrew. And with this, I close our summary remarks and hand over to the operator to run the Q&A session, please. We will now begin the question- and- answer session. Anyone who wishes to ask a question may press star and one on their touchtone telephone. You will hear a tone to confirm that you have entered the queue. If you wish to remove yourself from the question queue, you may press star and two. Participants are requested to use only handsets while asking a question. Anyone who has a question may press star and one at this time. Our first question comes from the line of Bob Pooler from ValuationLAB. Please go ahead. Good afternoon, gentlemen. First of all, congratulations on a strong quarter start of actually the second half with the Catalyst and Chiesi agreements. My question is first starting on vamorolone. How are your discussions progressing with the U.S., E.U., and U.K. regulators? And can you provide any feedback on their views regarding the approval in DMD? Yeah. Hi, Bob. Thanks for the accolades. And thanks for the question. I think that question is probably best answered by Shabir. Shabir? Thanks, Dario. Thanks, Bob. Regulatory interactions, Bob, are going well. In the U.S., we completed our late-cycle meeting August 10, where the FDA stated no substantive review issues have been identified to date. They also stated again that no AdC om is currently scheduled, and they also said that they're on track for a PDUFA date of October 26. Just as a note, we're just waiting for the final minutes of that meeting. In the EU, we remain on track with the Day 180 responses. We've had very collaborative interactions with the rapporteur, co-rapporteur, and the EMA, just to align on how we proceed with the last few questions. Again, we remain on track for a quarter four CHMP decision with EC adoption towards the end of the year. Very much in the same guise in the UK, where we're continuing to have very open and collaborative discussions, dialogue with the MHRA, and we anticipate approval timelines in parallel with the EMA process. Okay. Thank you. Then just on Catalyst, how is the cooperation progressing? Have you had team meetings? How important do they see vamorolone in their portfolio, and how much effort will they put behind the North American launch? Yeah, I think I'll take that one. Obviously, I think, I think the, the upfront, and the deal structure, signifies the, the importance to Catalyst of, of this deal. I, I, I think it was, one of the top 10 licensing deals worldwide in terms of quantum in the first half of the year, and certainly, I think the largest licensing deal for any European company so far this year. The, the, the, the, collaboration is progressing really, really well. There's good chemistry between the two organizations. We, we are completely calibrated and aligned. In fact, we had our first joint steering committee meeting physically in, in, in the U.S. just, within 48 hours of the deal closing. We established six work streams, where we have pretty much the key players on both sides of the Atlantic involved in these work streams. They typically meet once a week, and then, the program team slash steering team meets about once a month to review progress there. And the joint effort really is to make sure we transfer all our knowledge and know-how and resources to Catalyst to make sure that they are in a very strong position to provide a strong or a competent and powerful launch in early Q1 of next year. So there, everything is on track and we're also starting now to explore additional indications that we would like to jointly develop. There's a long list of potential indications that where you today have prednisone as a standard of care for longer- longer periods of time in pediatric and adolescent patients, where they suffer from, these side effects that, vamorolone doesn't produce or produces significantly less. And so we have to align and calibrate with, Catalyst on which ones of those, of that long list do we want to pursue and, in what priority, and then, jointly start developing those. So we have a joint steering committee meeting coming up again in November, where we'll cover that. So really, the short answer is, going really well. Okay. And I believe you'll get also results for Becker's muscular dystrophy also soon, on one of the trials, I think. I think the Becker's trial... Shabir, can you speak to the readout timings? I think that's next year only. Is it next year? Yeah, it's next year. It is next year, Bob. Yeah. Okay. Sorry for that. Then just going back, or going to the EU, how is the specialist sales force going there? How do you see the build-up? I think it's a country-by-country launch. And, any indication of the cost that you, that's required to build up a specialist sales force? Yeah, I'll defer the cost to Andrew, but I'll speak to the build-up. Obviously, as I mentioned in my prepared remarks, it's a staged rollout, so we're not- we don't want to build a sales force and an organization in every country too early and burn cash. So the priority now is on Germany, which is the first country to launch, where we pretty much have the team complete. In the U.K., we have medical staff on the ground to make sure that the EAMS program is on track and is properly enrolled. And we'll start building the commercial organization as we get closer to a NICE decision on pricing, which we expect to be somewhere mid-next year. In France, we already have also a medical person on the ground, and we're reviewing the need for additional people there. Then we're starting to hire at headquarters what we call the virtual hub staff, which are the support functions for these markets. In terms of number of FTEs, we expect of about 35 additional FTEs for the commercial organization by the end of 2024. If, if- Okay. I'll take, I'll take the cost, Bob. So again, you know, timing depending on early stage progress with the reimbursement authorities. So Dario said we'd stagger it, but I'd see towards the end of 2024, a run rate of around CHF 10 million-CHF 15 million of additional cost to support the marketing organization in Europe. And what we will do is, as we get closer and post-approval, give a more detailed guidance towards next year. Okay, that's, that's good. And then just finishing on vamorolone, Sperogenix, we should forget that they're also working on a launch in Greater China. When do you expect this to happen, and will this also trigger a milestone? Yeah, I mean, we're making good progress with Sperogenix in China. The current assumption is that we don't need to do an efficacy study in China to get it approved, which means that we could submit in mid-2024 timeframe, mid next year. So approval would then typically be about a year later than that. Somewhere mid-2025, we're expecting approval in China. Both submission in China would trigger a milestone, as well as an approval in China will trigger a milestone. And also a U.S. regulatory approval would trigger a milestone. The nearest milestone from China would be around the PDUFA date or shortly thereafter. Okay, that's interesting. Then if I may switch to financials, just what is your estimated cash position, as of what? First of September or end of August. Is that the CHF 49.6 million? No, that, that was a pro forma. as at June thirtieth, based on the transaction. Yeah, we'll give out further numbers later in the year, as we're going through settling... We have settled the exchangeable note with interest. some taxes and vendors. So we'll give specific guidance later in the year, but we've again sufficient cash runway through to into 2025. Okay. Then on the Chiesi agreement, what is the impact of this full divestment of Raxone for the second half and, and the coming years? So immediately there's no cash change related to the Chiesi other than the- redirection of internal resources. However, what it does do is take away the roughly CHF 25 million cash liability that was payable in 2024 and 2025. And also, we currently have a CHF 6 million intangible asset that would be released. So there'll be a net impact on the balance sheet of around CHF 18 million, strengthening the balance sheet. In the longer term, as I mentioned earlier, we still have potential upside if there's a US approval for Raxone, with a single-digit royalty or milestone up to around CHF 10 million, as we announced at the time. Okay. And just the final on that, do you expect also additional license agreements for vamorolone in 2023 and 2024, pending then, approval? The answer- Yeah. The answer is yes. I mean, the focus right now is on Europe. I mean, we have a- potential approval just around the corner, so getting the smaller European markets that we don't intend to commercialize ourselves and partnered is of highest priority right now. And we're already in- in a number of markets, we're already in the selection process, so we're quite, quite far advanced there. I'm hoping to be able to announce some partnerships in Europe by the end of the year. With regards to Japan, we're currently discussing with Catalyst what their intent is regarding Japan, while we're keeping the other parties that we have had discussions with warm. Japan has been admittedly slower than we had hoped. this, I think this is very cultural. I don't think it's that different in other companies. Partnering in Japan does take time. They're very thorough. And then we obviously have, now as we get closer to approvals, now we're also having unprompted interest from parties in other markets such as Brazil, Israel, the Middle East, GCC and Saudi specifically, where we're trying to entertain those discussions to the extent our bandwidth allows. But we're still a relatively small company, and we need to make sure that we- prioritize the large markets before we start engaging in extensive discussions in smaller markets. These discussions and the due diligence that goes with them are quite time-consuming for both parties, but when you're a small team, it's particularly stressing. So I've given guidance to my team that, you know, getting European partners set up now is of highest priority. Okay. Well, thank you for answering my questions, and I hope you end the year just as strong as you start the second half. Thanks very much, Bob. Thanks for your questions and interest. As a reminder, if you wish to register for a question, you may press star and one. Gentlemen, we have no more questions over the phone. Thanks very much. In that case, I'll just make a final comment here, and want to thank you all for joining today and for your interest in Santhera. The remainder of this year, 2023, will truly be exciting as we look forward to potential regulatory approvals for vamorolone in both U.S. and Europe in the last quarter. And if approved, vamorolone will be the first and only product in Duchenne that would have been approved across both territories, U.S. and Europe. So it's really a not only a milestone for us, but it's also a milestone for the Duchenne community to finally get a drug that is available for all patients, irrespective of genetic mutations, with a full approval in both U.S. and Europe, and we're very proud of that. Thanks again for joining today, and I look forward to updating you soon on other progress. Ladies and gentlemen, the conference is now over. Thank you for choosing Chorus Call, and thank you for participating in the conference. You may now disconnect your lines. Goodbye.