Thank you very much. Hello, everybody. Thanks for calling in. We are here to present the Q2 report of Xbrane Biopharma. We go to page three. Just going through some of the highlights of the second quarter of 2021. We can start with our Xlucane program, our biosimilar candidate to Lucentis. We were pleased to receive positive top-line data from the interim readout, which we did in the ongoing pivotal phase III trial. That then triggered a confirmation of our plan to submit the Marketing Authorization Application to EMA, the European regulatory authority, and that will be done next month. It is practically finalized. We worked a lot with that document throughout the year, but intensively during the summer, and it will be submitted during the course of September. When it comes to the Biologics License Application to FDA in the U.S., it's now planned for the fourth quarter of this year. We are going to have a meeting with the FDA in August where that exact plan and the final date will be confirmed, the final date will be set. It's all proceeding according to plan when it comes to filing of the product to the authorities. Of course, an important element for Xlucane is planning for the launch of the product, provided that the product is approved, of course. We are now finalizing the negotiation of supply agreements with our respective contract manufacturers to secure the capacity for production of the product during the first couple of years on the market. We are looking forward to getting back on this topic during the course of this quarter. We plan to sign those firm agreements in this quarter. That's very important, of course. I think these are the highlights on Xlucane side. On Xcimzane, our Cimzia biosimilar candidate under development, I think it's progressing well as well. We are finalizing the process pilot scale now internally. Also here we are in finalization of negotiation with the contract manufacturer for the scale-up of the production and also producing clinical material. I think we'll close that agreement during the course of this quarter and then proceed with the scale-up together with the selected contract manufacturer to be able to take the next step in the development and also take the product into clinic. We are also, as we've been discussing before, in discussions with potential commercialization partners. We have the ambition to partner this program up at the preclinical stage, and we hope to be able to achieve that during the course of the coming 12 months. That's an exciting element here as well, of course. I think our Xcimzane program is also moving along nicely here. Looking at the broader pipeline, Xdivane, our Opdivo biosimilar candidate, we have an ongoing process development internally. We are also, as we discussed in the Capital Markets Day held in May this year, we have the intention to select one new biosimilar candidate this year, and we are going through a selection process currently. That, as discussed, are going to be targeting products with patent expiry 2028 and onwards. We conducted a directed share issue end of June, beginning of July. We raised approximately SEK 380 million, we're very thankful for the support from existing shareholders, and also we welcome new shareholders to the company in connection with that share issue. We are very happy to be certified as a Great Place to Work by the Great Place to Work Institute. I think this is a testament that we have a good working atmosphere and a strong culture here at the company, and that we've come together nicely as a team here. We're very pleased about that. Looking ahead in the coming 12-month period with regards to milestones, of course, then submission of Marketing Authorization Applications to EMA and FDA as discussed for Xlucane. Very important. There's also ongoing work to find some additional partners for some remaining territories, let's say, for sales and marketing of Xlucane, thinking about Latin America, China, and Japan. That's still ongoing, and I hope that we're going to be able to get back with something on this front during the course of the coming 12 months. On the Xcimzane program, as I said, starting the scale-up of this product together with a select contract manufacturer. Also our mission is to tie up a commercialization partner for the program during the course of the next 12 months. I think it's an exciting time ahead for us here. Okay, if we move to next slide. This is a little bit more in detail the timeline for Xlucane. The interim readout, which we presented the top line data of in end of June, that was based on six months data from all patients. We are then continuing the Xplore trial. Last patient will have concluded 12 months of treatment in November, and we will then have the full 12-month data in first quarter of next year. We are submitting the Marketing Authorization Application now to EMA on the basis of the interim readout, and then we're complementing the file with the full study data in first quarter of next year. It's a regulatory process of some 12 months or so. We hope that we shall have the product approved during the second half of 2022. Shortly after the patent expiry in Europe of the originator product, which is in July 2022. Provided that the product is approved, we can look forward to launch of the product sometime late 2022. By, of course, our two partners, STADA and Bausch + Lomb, respectively. That's the high-level timeline. If we move on to next page. I was not intending to go this through in detail. We had a call when we announced the top-line data from the interim readout in Xplore. Just from a high level, it was a positive readout. We met the primary endpoint, which is defined as the difference in the change in visual acuity at week eight between Xlucane and the reference product, Lucentis. The 95% confidence interval around the difference needs to be confined within a defined equivalence margin of ±3.5 letter, which was the case. We met the primary endpoint. That's very good. When it comes to secondary endpoints, we saw similar patterns of our biosimilar candidate, Xlucane, versus the originator product, and no signals from a safety front or anything like that. I think it was a positive readout, and we are moving forward towards submitting the Marketing Authorization Application on the back of this interim readout and looking forward to the full data in Q1 next year. That's probably the highlights of the quarter. With that said, I am leaving over to Anette for the more financially related update. Thank you, Martin, and good morning, everyone. Let me just take a few moments to take you through the financials of the second quarter 2021. Starting with the total income amounting to SEK 3.6 million versus SEK 5.3 million in last year. And those of you familiar now with Xbrane, you would recognize that we accrue the first milestone payment from our licensing partner, Bausch + Lomb, that we received in Q2 2020, so a year ago. On the rise, our expenses amounted to SEK 61 million, somewhat higher than last year. And this increase of SEK 6.3 million is totally explained by the increased R&D cost, now close to 85% of the total spend in Q2. Of course, as Martin mentioned, the major Xplore study is running full speed, but the spend is also a result of the increased activities related to the broader pipeline, e.g., Ximluci and Xdivane. The next slide, please. The net result, meaning the summary of the two earlier diagrams, amounted to a net loss of close to SEK 60 million from SEK 59.2 million versus SEK 53 million last year. Of course, this is then a result of the increased R&D expenditure that I just mentioned. Also, I would like to remind you that as good accounting practice, our R&D costs are up until now fully expensed, and nothing is capitalized on the balance sheet as of Q2 2021. This practice, though, may be subject to review during 2021 as we receive the positive data from the Xplore study. We'll come on to that in future calls. The shareholder equity amounted to SEK 149.7 million, versus SEK 191.3 in Q2 2020. This might look odd, but this is after the successful direct share issue that we made in June, in which we raised SEK 380 million, will be accounted for in the third quarter as the shares were registered and also the payment was received in early July. That will have an impact, as you will see, on the cash position as well on the next slide. For operating cash flow, we ended negative for one of the reasons I just mentioned, but also normal variations due to our reinvoicing mechanism that we have with our commercial partner, STADA. As you can see, we ended the quarter with a cash position of SEK 129.3 million, not then accounted for the direct share issue of SEK 380 million before transaction costs that we received early July. The impact of that will be seen in the third quarter and the next interim report. That is all for the financials. Thank you very much for listening. Back to you, Martin. Thank you. We're also happy to note we are growing the team. We are now 60 employees, and I think we have had an easy time to recruit talented people, and we're growing to be able to meet our commitments and undertakings on the Xlucane program, but then also to be able to drive our further portfolio of biosimilar candidates. I think we are growing the team in a good way. We are maintaining a very diverse team from a gender, ethnicity, and experience perspective. We are measuring the satisfaction with the team. I think we have a very satisfied team, generally speaking. We're using a measure here internally, which is called Employee Net Promoter Score, where we now have a score of 42, which I think can be related to within the global average of some 6% or so. I think it's very good. We're very happy about that. I think that's also reflected in the outcome of this Great Place to Work survey and the certification. This Great Place to Work certification. We're very happy about being certified. I think they mentioned this Trust Index, and I think we came very high on that one. Of course, there are also some elements that we can take from that work and survey to continue to work on with the aspiration of really being the best workplace worldwide when it comes to pharmaceutical development. Capital markets events. We are going to present at the Pareto Conference coming up here in the beginning of September. We are going to be at the Kempen Conference in London in November. We're also going to participate in the virtual LSX Investival Showcase Conference in November. Probably we're going to add a couple of other events to this list as well, but this is what we for sure have in the planning. We hope to be able to meet some of you at some of these events or on other instances throughout the rest of the year. With that said, that I guess is the end of the formal presentation here, and we can move towards Q&A, and we'll go through the questions that we have here from the chat, and then we're going to move over to potential questions coming from people who have called in. Okay. Okay, first question, "Do you have any updates on Xoncane development and partner?" is the first question. Yeah, for everybody who on the call, Xoncane is our Oncaspar biosimilar candidate. I do not have a particular update right now, but hope that we'll be able to come back during the course of this year with an update. As we've said previously, this is a program where our intention has been to find a partner for this program who is willing to take it onwards with limited remaining requirements from us from an investment perspective. We hope we shall be able to accomplish that and be able to communicate something around that during the course of the year. Next question: "Could you leave a comment regarding your view on the FDA's first approval of an interchangeable insulin biosimilar? I understand this could be relevant for Xcimzane, but what difference is there from a development perspective?" Yeah. Indeed, FDA has a guidance on interchangeability of biosimilars. Essentially what has to be done is a switching study where you compare the pharmacokinetic pattern of your biosimilar candidate versus the reference product during the course of, I think it is four switches between the products. I think this becomes relevant from a commercialization perspective on products who are mainly sold via the retail channel. That makes sense, I guess, for an insulin biosimilar, as has been done now. This is something we are looking into when it comes to our Xcimzane program. It's possible to design the phase III trial in such a way that you conduct this switching study as a part of the phase III trial, then also go for interchangeability designation by the FDA. That will be the most natural way to do it. We have made no decisions of that yet, and as I described earlier, our intention is to tie up a commercialization partner to this program pre-clinically. We also expect that such a commercialization partner will provide meaningful insights into the desirability of going for interchangeability designation or not. It's good to see, of course, that this first interchangeable biosimilar has been approved by the FDA and pave the way for further interchangeable biosimilars in the U.S. Okay, next question. Can you update on Xlucane's registration readiness, i.e., mock inspections and also your supply chain CMOs you work with? What has and what has not been cleared already by EMA and FDA? Yeah. We have three main contract manufacturers, you can say, in the supply chain of Xlucane. It's our drug substance manufacturer, Biotechpharma, located in Lithuania. It's Swissfillon, filling the substance into vials and pre-filled syringes, located in Switzerland, and then PCI doing the final packaging. Biotechpharma is previously approved by Lithuanian authorities and thereby by EMA but not yet by FDA. Swissfillon is previously approved by both Swissmedic which has a mutual recognition agreement with EMA and then also by FDA. PCI is previously approved by both MHRA, and this is a U.K. site, and FDA. I think when it comes to this question, the main element which we are working on is ensuring that our drug substance manufactured by Biotechpharma is prepared and ready for the pre-approval inspection by the FDA, which is likely to be triggered by our submission of the Biologics License Application to the FDA. I think that work, well, it has been ongoing for quite some time, and I think it progresses well. We will probably be able to report back on that as it's getting closer with the potential pre-approval inspection by the FDA. Okay. Next question. What are your takes on the many changes in the U.S. for biosimilars? Last month, the FDA approved the first interchangeable insulin biosimilar. Also in terms of your competitor's U.S. partner, Coherus BioSciences, which embarked on a new journey as a drug developer within immuno-oncology. We are very happy to see that the recently launched biosimilars in the U.S. has fared very well from a sales perspective. I think Amgen's Avastin biosimilar is targeting $1 billion of sales to actually being a blockbuster. That's quite phenomenal to have a biosimilar as a blockbuster. I think the situation now in the recent launches, both of Avastin and Herceptin biosimilars, more resembles the European experience. I think they had 40% volume market share by month 12, which is similar to what we've seen with launches recently in Europe. We're very happy to see this development in the U.S. For us, this had always been a question of time more than anything else, when biosimilars really would get traction in the U.S., and we're happy to see that happening now. When it comes to Coherus, we're noting that they are moving into novel drug development. We shouldn't comment so much on other companies in that sense. We're interested, of course, also in the immuno-oncology space since we're working on an Opdivo biosimilar. I've said that before. Actually, I'm more comfortable in developing a biosimilar to Opdivo than going into development of a novel PD-1 inhibitor. I think these products, in particular, the clinical journey is quite significant if you're going to get approval for all the different indications. That's a real benefit with doing a biosimilar in this space because with one phase III trial in one well-selected indication, you can get indication extrapolation in all the indications approved of the originator product. I'm pretty happy actually with going on the biosimilar track when it comes to the immuno-oncology space. We're very much looking forward to the continued development of our own Opdivo biosimilar. Next question here. In what regions have licensing deal negotiations for Xlucane progressed the most? I guess that refers to regions where we have communicated we want to complement with additional partners, Latin America, Japan, and China. I would be saying that currently where we together with STADA are most advanced is in the Latin American territory. I hope that we shall be able to get back with something on that, but also in the other territories during the course of the coming 12 months. Okay, moving on to the next question. With the recent directed share issue of SEK 380 million, combined with the sale of Primm Pharma for approximately SEK 140 million, do you expect this cash position to be sufficient until Xlucane can bring in enough revenue? I am not at all going to promise that. The Primm is SEK 14 million, it's not SEK 140 million. Yeah. Okay, the first one, the Primm Pharma. We have, as you have noted, a non-binding term sheet with a company called New.Fa.Dem. to divest Primm Pharma. Although the total proceed is EUR 40 million, roughly SEK 140 million, it is not non-binding agreed upon as an immediate payment in that transaction. A part is an immediate payment, but a part of that complete transaction sum is milestone-based. We can only focus on the SEK 380 million. I think the main thing here, if this will take us all the way to Xlucane bringing in enough cash that we become cash flow positive is related to, one, that we are progressing on Xlucane according to plan with the regulatory approvals and launch. That is one critical thing, of course. The other thing is that we are successful in doing a deal with the commercialization partner for our Xcimzane program, and that deal is of such a structure that we get the meaningful payment and also meaningful financial support for the continued development, thinking mainly about the start of the clinical trials. If both those events come through, it could be so that this can bring us all the way to cash flow positive stage. Nothing that we can at all promise now, because it hinges upon these two events, which we are going to report back on during the course of, let's say, the coming 18 months when it comes to getting the approval in place for Xlucane and also getting the product to market. Can you talk a bit about the Xoncane? Do you see any interest from potential partners who want to finance the project? Yeah, we talked about this earlier. There's nothing so much more to say. We hope that we shall be able to come back during the course of the year with an update on that program. It's a smaller product, as many of you are aware, but still, there is some interest in such a program for specific companies engaged in that space. Okay. Opdivo is an approved drug in many cancer indications. What is the biosimilar regulatory pathway in this case? Does every indication need a separate clinical phase III biosimilar equivalent? I think I answered this question earlier. Although we have not discussed this with the regulatory authorities yet, the general way that authorities look at this is that you do one phase III trial in one indication, then get indication extrapolation to the other indications. There's nothing that makes us believe that that would not be the case for our Opdivo biosimilar. That's clearly what we plan and believe shall be the case. Last question. Will Xoncane enter into clinical trials this year? A clear answer to that question is no, it's not going to happen this year. Again, we'll have to come back and update on this program a little bit later during the course of the year. Okay, excellent. Those were all the questions that we received over the chat here. Thank you all very much for those. I think we are going to hand over and see if there are any questions coming from people who have called in. Yes. We have one question from the line of Mattias. Please go ahead. Your line is open. Yeah, good morning, Mattias Häggblom, Handelsbanken. Two questions, please. Maybe if you could elaborate a bit about the upcoming meeting with FDA here in August that you alluded to. What in particular in terms of guidance or clarity are you looking for from that meeting that you can share with us on future updates? Secondly, on the biosimilar for Cimzia discussions, is the current thinking to have a similar structure like Xlucane with cost and profit sharing, or are you contemplating other deal structures as well? Thank you for the question. I think the first one was related to the upcoming meeting we have with the FDA. The main question here is really what is the timing that the FDA can accept between submission of the Biologics License Application and complementing that file with the full study data? Since we know when the full study data will be in place, that's Q1 this year, let's say the response to that question from the FDA will dictate when we're going to be able to submit the file. There are some other questions, but that's the main thing which will dictate the timeline. The next question related to Xcimzane. One potential structure which is on the table is of course, a cost-sharing arrangement which similar to what we have for Xlucane with STADA. I think a more natural way, which most potential partners are more used to working with are more strict license deals. I would probably be saying that it's more likely to end up in such a way, but for sure, our ambition is to at least get half of the investment of such a program financed by a potential partner. Hopefully more, of course, but that goes without saying. At least half, so we'll get a meaningful support from a financial perspective in the development phase from a partner. Then again, probably the most important thing when it comes to such a selection is finding a partner which we believe really can bring the product to market in a successful way. Thank you so much. Thank you. Thank you for your question. As a reminder, if you wish to ask a question, please press star one on your telephone. There are no question. I will hand back the conference to Martin. Please go ahead, sir. Yeah. One more question coming in from the chat there. What is your cash runway following the capital increase? As I discussed a little bit earlier, it is very much dependent on what we do from a deal structure on Xcimzane and when we do it. I think the best one could do to come to a base case on that one is to look at our negative cash flow the last couple of quarters, which has been around, let's say SEK 50 million-SEK 60 million and let's say extrapolate that into the future. I think that is the best that anyone can do to forecast the cash runway because then again, it is very much going to be dependent upon these two events, what I discussed earlier, that we are following the timeline for Xlucane and also the nature of the deal we do around Xcimzane. Okay. That was probably the last question, and I thank all of you who called in. I thank you for all the great questions that you asked, and I hope that we were able to provide somewhat helpful answers. I encourage you to otherwise reach out to me or Anette via phone or email for further discussions, and I hope that we can meet and discuss further during the rest course of the year. With that, I think we can end the call. Thank you very much. Thank you very much. That conclude the conference for today. Thank you for participating. You may all disconnect.
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