Thank you very much. Welcome everybody to this call, where we're going to present the quarterly report for 2021. Myself, I am the CEO of Xbrane, and I have with me Anette, our CFO as well on our end. First of all, let's go through the highlights for the quarter. This has been a quarter where a lot of the activities within Xbrane has centered around preparation for filing for Xlucane. This is, as many of you know, massive undertaking, where we need to put together all the preclinical documentation, everything centered around the supply chain for the product, as well as the clinical study report eventually. It's a massive undertaking to prepare such a file to apply for marketing authorization to EMA and FDA respectively. That's consuming a lot of the effort within the organization today. Of course, also related to Xlucane, the continuous support on the phase III trial XPLORE, which is coming towards an end during this year. We've also spending a lot of time on our development program for Xcimzane, our Cimzia biosimilar, where we are finalizing now the process pilot scale. We are also spending a lot of time to discuss with partners both on the contract manufacturing side, but also CROs for the upcoming clinical trials and also potential commercialization partners. We hope that we shall be able to scale up this process with the selected contract manufacturing during the course of the year, and then during next year being able to take the product into clinic and hopefully also together with a commercialization partner. Of course, we have, as many of you know, moved into new facilities at Campus Solna. It's a new biotech lab, where we really have expanded our development capacity significantly. We have a Capital Markets Day planned for 17th of May where we're going to provide a virtual tour of the facility and explain more in detail our capabilities in this new facility. I hope that as many of you as possible are able to join that Capital Markets Day. Really the plan and what we can do here with the team also we built up is to initiate one new development program on an annual basis. We really now can gear up and develop a broader portfolio of biosimilars. Thinking about next 12 months, what can be expected with regards to milestones? Of course, Capital Markets Day on 17th of May is important. Top-line data, we're going to talk more about the ongoing phase III trial and what can be expected with regards to top-line data. That we can submit marketing authorization application to EMA and FDA during Q3 and Q4 this year. We hope that we're going to be able to complete additional licensing deals for Xlucane in some territories where that is required. We're thinking particularly about China, Latin America and Japan. As I spoke about with regards to Xcimzane, taking that development program further into commercial scale manufacturing and also establishing a partnership with the commercialization partner. This is the timeline for Xlucane. As you know, XPLORE is the ongoing pivotal phase III trial. We had the last patient in this trial in November last year. We have recruited 583 patients into this trial. We are going to do an interim readout when the last patient has reached the sixth month in the treatment schedule, and that is essentially happening next week. The last patient in is having its month six visit next week. We're going to do a cutoff, and we are going to work on cleaning the database and also doing the required statistical analysis to get to an interim study report which is going to then support the marketing authorization application to both EMA and FDA and in agreement with both authorities. We expect to be able to file in Q3 to EMA and Q4 to FDA. The study is continuing up until November this year, since it's a 12-month treatment schedule. Last patient will have reached the month 12 by November this year, we are complementing the regulatory file with the final study report throughout the process. All in all, counting on 12-month regulatory process, we expect to be able to have approval in place from EMA and FDA during the second half of 2022, subsequently allow for our partners to be launching the product. Just to repeat a little bit here, maybe for those of you who have listened to us before, what this pivotal phase III trial is about. This is an equivalence trial with the objective of demonstrating equivalent efficacy and safety compared to the originator product, Lucentis. We have then recruited 583 patients with age-related macular degeneration. We're splitting them up in two groups, one group being treated with our biosimilar candidate, Xlucane, and one group being treated with the originator product, Lucentis. The primary endpoint occurs at week eight, so when the patients have reached week eight in the treatment schedule. It's related to relative improvement of visual acuity, Xlucane versus Lucentis. That's the primary endpoint. With that said, when we now are doing the interim analysis, all the patients will, of course, have concluded week eight, and we will have the full data set for the primary endpoint. When we come out with the top-line data mid this year, it's going to include the final analysis on the primary endpoint. Of course, there are a couple of secondary endpoints. We are, from a safety perspective, monitoring adverse events. We are following efficacy with regards to improvement in visual acuity throughout 12 months, and we're also following a couple of other secondary endpoints throughout these 12 months. On the right-hand side here, just to give you a little bit more flavor on how this works statistically with regards to the primary endpoint. You can see this is data from one of the pivotal trials of the originator product, Lucentis, where the red and the yellow lines are improvement in visual acuity for two different dosage strengths of the originator product, and the blue line is placebo. Essentially what it means now is that at week eight, we compare the improvement in visual acuity of Xlucane to Lucentis, and the confidence interval around the difference, correctly said, needs to fall within the predefined equivalence margin by the authorities. That's illustrated on this graph. We feel pretty confident around this upcoming top-line data. You can look at it from a statistical perspective. We started the trial at 90% power initially. During the course of the study, we got an agreement with the authorities to actually expand this equivalence margin. We decided not to reduce the size of the trial also due to the emergent COVID-19 pandemic and a certain fear about the increased dropouts in relation to what we initially expected. Now, that did not really materialize to the extent that we expected, and now we clearly have a power which is well north of 95%. We feel confident around the power with regards to the primary endpoint and the statistics in the trial. Also, during the course of this trial now, probably some 6,000 injections have been performed. The blinded Data Safety Monitoring Board is looking into levels of adverse events on a blinded level, of course. So far we haven't observed any abnormalities with regard to adverse events compared to normal usage of the originator product. We feel confident around that this top-line data is going to come out positive. We can go to next slide. Also, of course, based on the extensive comparative analytical work we have been doing, which, of course, is a requirement for regulatory approval and also was a requirement for initiating the trial. As you know, the mode of action here is that the product binds into a growth factor called VEGF-A in the human eye. We have, as a part of this comparative analytical package, been able to test the binding into this growth factor in a laboratory setting. We have demonstrated that Xlucane binds the same place, same strength, same duration to the growth factor VEGF-A as Lucentis. That, in combination with another 20 or so analytical methods, we feel that we have a very robust comparative analytical package. Of course, we've been discussing this with the regulatory authorities and also got their agreement on that this actually looks like we have demonstrated analytically a very high level of similarity. That, of course, brings additional comfort to the upcoming top-line data from XPLORE. That is, of course, exciting and of course, the next very important milestone in the development of the company. Okay. With that said, I will leave it over to Anette to go through some of the financial highlights for the quarter. Thank you very much, Martin, and good morning, everybody. As the CFO of Xbrane, I would like to take a few moments to take you through the financial analysis of the Q1 results. Starting with the total income. On the left-hand side, that amounted to SEK 4.1 million versus SEK 4.9 million in Q1 2020. Those of you who have listened in on our previous presentations, you'll remember that we accrued the first milestone payment from the licensing agreement with our commercial partner, Bausch + Lomb, and this over a two-year period. This contract was signed in Q2 2020. The other components refer to income from non-core operations and some exchange rate gains. A bit more interesting, on the right-hand side, our expenses, they amounted to SEK 54.8 million, which is really on par with last year's first quarter of SEK 54.5 million. The R&D costs, 84% of the total costs. They were slightly lower than Q1 2020. This is phasing only. Notable is the lower spend in Q1 versus the Q4. That is then explained by the XPLORE study, as Martin said earlier, that was fully recruited and peaked cost-wise in November last year. For the G&A or the admin expenses, they were a bit higher in Q1 this year versus last year. This is mainly then one-off costs related to the move to our new premises at Campus Solna. The net results for Xbrane is really the net of what's shown on the previous slide, amounted to a loss of SEK 51.3 million. This is SEK 0.5 million less than the net results for the same period last year. As a reminder, please also note that all R&D costs are fully expensed in the P&L. Nothing is then capitalized on the balance sheet. For shareholders' equity, we leave the quarter with SEK 208.4 million versus SEK 139 million in Q1 2020. That's, of course, a result of the two successful share issues we made in 2020. Those amounted to a total SEK 325 million net. For the operating cash flow, we had a positive cash flow in Q1 of net SEK 7.3 million. This is just due to our re-invoicing mechanisms with our commercial partner, STADA, who in this instance, paid a fairly large invoice to us in January 2021. On the left-hand side, you will notice that our cash position is significantly strengthened by the two share issues performed in last year. Hence we leave the quarter in a fairly strong position with a cash of around about SEK 240 million. That completes really the financials, and then back to you, Martin. Thank you, Anette. We've also been growing the company from a team perspective. We are now 51 employees, and I think we've been able to attract and recruit many excellent individuals with experiences from some of the well-known pharmaceutical companies here in Sweden and abroad. I think that now when we are growing, we can also look a little bit statistically on the team from a diversity perspective. We have a high or good level of gender equality with 50% men versus women, both in the staff as well as in the management team. We have a diverse team from an international perspective with 53% of international origin within the staff. This is a very science-driven activity. We have a high degree of people with PhDs, 33%, which we're happy with, and it's really required because we really have the ambition to be at the forefront when it comes to the development of biological drugs. We're starting to also track the motivation in the team. Of course, key for us as in any knowledge-based activity is to keep the team motivated and to ensure that all the good people that we are attracting to the company are staying with us. We are tracking the satisfaction, if you will, with Xbrane with a measure we call Employee Net Promoter Score which is 42%. I won't go into the details of how it's measured. We can only say that average globally amongst companies using this metric is 6%, so 42% is very good, actually. We're happy with that, and this we're tracking on a quarterly basis and, of course, taking action on anything which is perceived as negative and making sure that we have a motivated and happy team in place. We'll also have spent some time to establish core values within the team, which really is an articulation of what we believe has made us successful in the past and also what we want to articulate going forward to continue to be successful. You see this on the upper right-hand side on this page. This is really about, in a way, keeping the entrepreneurial spirit, what we had in the beginning with impossible is nothing and make it happen and have an innovative edge, beat yesterday and really recognizing that this is, at the end of the day, a team effort where everybody's needed, and we win as one. We're happy with that, and we're happy to have such a great team in place. Upcoming capital markets events. As I said in the beginning, we are organizing an event on 17th of May, where we are going to go into more depth on Xlucane, of course, also on our platform technology. Our CTO and Head of R&D, David Vikström, will present the platform technology and go into more depth around that. Siavash Bashiri, our Deputy CEO, will be present and will do a virtual tour of the facility and also present more details around our team. Anders Tullgren, our Chairman of the Board, will also join that event and present his view on the future of the company. I really hope that as many of you as possible are going to be able to join that event. We are participating in a few capital market days arranged by some banks here, Kempen on 12th of May, ABG on 25th of May, and Redeye on 2nd of June. If there is the possibility to see us there, you're very welcome to do so as well. Okay. With that said, I think we have come to the end of the formal presentation and can shift to Q&A. We are going to look here on the questions that have been posted and do our best to answer to them. First question. Is the six-month plus two-month estimate how exact for publication of phase III top-line data? Okay, let's see if I understand the question correct. The six months, that's fixed. As I said, last patient who reached month six in the treatment schedule is happening next week. That last visit is next week, and then we're going to do data cut-off. Two months for database cleaning and statistical analysis, of course, somewhat approximative. Therefore, we have said that mid of this year, so during the summer, we're going to be able to communicate top-line data. Next question. Which steps there are remaining before Xlucane could be taken into clinical trials? Will there be, for example, a PK study in animals or similar to Xlucane? Okay. Next step is really about scaling up the production process to commercial scale together with the contract manufacturer. There is not a requirement to do an in vivo trial in animals. We are not going to do that. We're going to go straight into phase I trial in humans and healthy volunteers, which we expect should happen during 2022. Next question. Could you tell more about financing strategy and if Xlucane will generate enough cash flow? Do you estimate two financing rounds before that? As we've stated before in our annual report, for example, the cash we currently have will take us at least to Q3 this year. On the back of Xlucane, net income generated from Xlucane, we hope that we shall be able to reach a cash flow positive state sometime during 2023. Of course, it's a gap in between, which needs to be closed from a financing perspective. We are currently evaluating how we shall do that. We are discussing with our financial advisors and as usually presenting the company to existing and new investors to gauge their potential interest. There is a financing gap to be closed, and how exactly that will be done, we'll have to get back to. Next question. Thanks for your time this morning. Are there any updates on Xoncane development? Will Xoncane enter into clinical trials this year? Thank you. Okay. Xoncane is our biosimilar candidate to Oncaspar, and this is actually a program which has been down-prioritized internally. We're focusing on Xlucane, Xcimzane, our Cimzia biosimilar, and Xdivane, our Opdivo biosimilar. There is not any clarity on if or when we would do such potential clinical trials. Rather, our intention here and our strategy here is to be able to find a partner that can continue to invest behind this program and take it forward. We have such ongoing dialogues, and we hope to be able to conclude that, but that will be under the premises that Xbrane would not invest in a meaningful way going forward into this program. I hope that we'll be able to provide an update on that then during the course of the year. Okay, next question. You said that you're confident in the phase III study result. Is it correct to say that by now you have at least 90% of six months of phase III data available to you? Thanks. Okay. Next week, 100% of the patients will have passed month six. Actually, well above 50% of the patients have concluded the full study. We do not have that data at hand. Now it's a data cutoff, and it's a process of database cleaning and then a statistical analysis before we, as a sponsor, can take part of analysis of unblinded data. We do not have any unblinded data at hand as of now. Okay, next question. In the Q1 report, it is mentioned that positive cash flow from sales of Xlucane is expected during 2023. Until then, additional financing is needed to run the company. Okay. How much capital do you expect the company will burn until positive cash flow from Xlucane? With the financing strategy we discussed, there is a gap, yes, between Q3 this year and 2023. Exactly how big that financing gap is depends on so many variables, particularly what we select to do and how when it comes to our current preclinical programs. As I said, our ambition is that we shall do licensing deal with the commercialization partner for our Xlucane program, and our intention there is to get some financing support for the upcoming clinical trials. The exact terms of such a deal are, of course, as of now, unclear and are very important in terms of estimating exactly what the gap would be. We cannot give any further details on that right now. Okay, next question. Can the market expect any further information regarding commercialization deals for Xlucane in new geographic areas with new current partners ahead of top line data? Can the market expect any research analysis being published during the upcoming six months? As I said in the presentation, we are by ourselves and together with our partner, STADA Arzneimittel, discussing with potential commercialization partners or distributors in three particular territories, being China, Japan, and Latin America. We hope that we shall be able to conclude such partnering deals during the course of this year. When exactly during the course of the coming 12 months that would happen is hard to say. We cannot say anything with regards to if that would be expected to happen before top-line data. We're working on it, and I'm confident that we'll be able to strike such deals. Exact timing, we cannot comment on. Okay, next question. Is there any upfront payment from STADA if top-line phase III is positive that is to pay to Xbrane? Answer is no. The arrangement with STADA is that they paid an upfront payment when we entered a deal, and then there is a 50/50 cost-sharing of the investments that we're doing into the program. There are no milestone-related payments. That is different when it comes to Bausch + Lomb. Their milestone payments are on regulatory approval and launch. Okay, next question. When might we get an update on Xlucane partnering dialogues? Okay, this I discussed a little bit earlier. I hope during the course of this year we shall be able to come back with some news on that. Okay, next question. What is the target commercialization date for Xlucane? Okay. No exact date is set. It's up to our commercialization partner, STADA and Bausch + Lomb, on the exact timing of launch. As I discussed, we hope that we shall have the regulatory approval in place during second half of 2022, which then would allow for a launch thereafter. It's different from country to country. In some countries, a launch could be happening more or less immediately, taking into consideration processes for pricing and reimbursement, but in other countries, it's anything from a zero to six-month process if you look at Europe. It's a little bit different from country to country, but ultimately, the exact timing in each specific country is a decision by our two respective partners. Okay. That concludes the list of questions here. I and Anette, we thank you very much for participating in this call. Should you have any further questions, don't hesitate to reach out to any of us over email or phone, and we shall happily discuss. For now, thank you very much. Thank you.
Loading workspace