Xbrane Biopharma AB (publ) (XBRANE) Earnings Call Transcript & Summary

Welcome, everybody, to our call with regards to the Q3 report, which was released this morning. I would like to start with a brief update on where we are from a development perspective. And then our CFO, Margareta, will go through the financial details of the quarter. Okay. So I think the key takeaway here is that we got the last patient into our Phase III trial Xplore with our leading biosimilar candidate, Xlucane. This was a major milestone for us as a company and for the development of that product. The recruitment was delayed due to COVID-19. We're very pleased that we were able to conclude the recruitment, despite challenging times due to COVID-19. So now, and that is in place, the clock is really starting to tick towards us being able to communicate top line data from Xplore expected mid next year and then after that, proceed towards filing marketing authorization application, both in Europe and the U.S. Second big thing is that we, during this week, concluded on a directed share issue, which also provides us the required funding to take us to communication of the top line data and a subsequent filing of Xlucane. And we're very pleased with the support that we've gotten from existing shareholders, but also we are welcoming new shareholders to the company, and -- primarily the Second Swedish Pension Fund and Lancelot Asset Management as 2 new institutional investors in Xbrane. So we're very pleased with that development. And that we now have a clear path ahead towards top line data on the Xplore and also a subsequent filing. Okay. So let's move on to next page. Just to recap a bit on Xplore itself. So this, as many of you know, is an equivalence trial with our biosimilar candidate, Xlucane. And we have recruited 580 patients with age-related macular degeneration globally. And primary endpoint is improvement in visual acuity week 8 after initiation of treatment. And we need to relative the originated product and the comparative product, Lucentis, all within the predefined equivalence margin with regards to improved visual acuity at week 8. Then we're following the patients in a 12-month treatment schedule with monthly injections. And that following up on certain secondary efficacy and safety endpoints throughout the study and at week 52. And to illustrate the story on the right-hand side of this page, you can see clinical data from one of the pivotal trials of Lucentis, where you can see in the blue line placebo group with deteriorated vision throughout the study. And then you can see the 2 Lucentis arms where you can see an improvement in visual acuity throughout the treatment. And you can see here, kind of, illustrated as the black bar on week 8, the equivalence margin, which we -- which Xlucane is to fall within a relative Lucentis that we gate in order to kind of demonstrate equivalence with regards to efficacy compared to Lucentis. And this is a rather wide margin, agreed upon with EMA and FDA, and we are fully confident that we will be able to meet the primary endpoint with Xlucane. This is not uncommon, but it looks like this for Phase III trials to biosimilars. And in a recent study by Medicines for Europe, it was kind of a review of the 38 Phase III trials for biosimilars conducted so far, and none of them actually have failed to demonstrate equivalent efficacy in these trials. And I think that that is a kind of a good picture of the risk level, let's say, with regards to demonstrating equivalent efficacy compared to the originator in biosimilar Phase III trials. And that, in combination with the very strong preclinical data we had coming into this Phase III trial, where we have essentially demonstrated in large set of analytical tests that there is a very high level of similarity of Xlucane compared to Lucentis. So we feel fully comfortable around this trial and that we, mid-2021, shall be able to report positive top line data from the trial and having demonstrated equivalence with regards to improved visual acuity. Okay. So let's move on to next page. Since -- taking a glance back here with regards to the recruitment. So as I said, this was -- and we've been discussing this before in the previous course we've had that the recruitment was delayed due to COVID-19. We saw a setback already in end of Q1 this year. And then coming in after summer in September, we also had some effects from second COVID-19 wave in some countries where we are recruiting patients. But we're very happy now to have been able to conclude the recruitment and that we enrolled the last patient and very thankful to all the clinics that are participating and all the patients participating. So it's a major milestone really for us as a company and for the development of Xlucane. And this really then creates a better clarity with regards to the time line on the continued development of Xlucane. So we are going to do an interim readout when last patient has reached month 6 in the treatment schedule. And then we're going to need another, roughly, 2 months of statistical analysis before we can communicate top line data. So mid-2021, we expect to be able to communicate top line data from Xplore. But the study is going to progress up until Q4 2022 as we're following the patients throughout the 12-month treatment schedule. We are going to file the marketing authorization application to both EMA and FDA on the basis on the interim readout. So that's going to happen after we've been able to communicate top line data, of course. And we still believe that we are on track to get the approval in place in line with the EU patent expiration of the originated product, Lucentis, which is in July 2022. So this is now very good. We have clarity on the time line, and we are on track to get the approval in time and then allow for subsequent launch of the product in prospective regions. Okay. So that was a brief update on Xlucane. And then we can move on to next page. Here's to say a couple of words also on what we've been doing from a development perspective on our preclinical programs. We are progressing, particularly our biosimilars to Cimzia and Opdivo in a preclinical development perspective. And our Cimzia biosimilar, we are finalizing the development of the production process, pilot scale here internally, and we are then doing next year going to scale up the production process to commercial scale together with selected contract manufacturers. And then after that, being able to proceed into clinical trials, most likely during 2022. And we have ongoing discussions with potential commercialization partners for our Cimzia biosimilar particularly looking at, as usual, the largest regions from a market potential perspective, Europe and the U.S. And our ambition is to do -- or to find a commercialization partner in one or both of these 2 territories before we go into clinic with this program. And hopefully, we'll be able to update on this one during 2021 with some kind of a partnership arranged when it comes to commercialization. Opdivo biosimilar program is also progressing very nicely from a preclinical perspective. We have a little bit more time there up on the patent expiration. So with the most efforts, last couple of months has been on the Cimzia biosimilar program as that has a shorter time to patent expiration of the originator and intended launch of the product. Then from -- we kind of categorized here in this picture from a business development perspective, we put our Oncaspar biosimilar in the Spherotide program. Because these are programs, as we currently view now. And as programs, we do not want to invest further into ourselves, but rather seek arrangements with partners that are willing to continue the development of these 2 programs with own financing. So that's what we're looking for here. And I also hope to be able to update on the progress on that and during next year. Okay, good. So that was a brief update on the development during last quarter, Xlucane and the other programs. So maybe then I'm going to hand over to Margareta to go through some of the financial details.

Yes. Thank you. Good morning. Yes, we start with the other operating revenues. So on the left-hand side, we present total income quarter-by-quarter. And here, we have both the license revenue and other operational income. In Q3, we had a total income of SEK 5.2 million, and the license revenue comes primarily from part of the milestone from the Bausch + Lomb agreement, which was signed in Q2 and is recognized over 2 years. And other operational income comes from exchange rate gains on receivables and payables. Looking at administration expenses to the right, we had total expenses of SEK 7.1 million in Q3, which was an increase by only 1% compared to last -- to the same period of last year. It is an increase related to expense growing organization, but it was limited as Q3 2019 included extra expenses due to the Nasdaq listing that took place in September last year. Let's move forward to Page 9. We have the R&D expenses to the left, and they amounted to SEK 52 million in Q3. This was an increase by 66% compared to Q3 last year. Almost all expenses are related to biosimilars and particularly to Xlucane. Of course, the increase is according to plan as we are going into more intensive phase of the Xlucane project. And the expenses so far have mainly been related to the Xplore study, but also to preparing for production and regulatory work. And the expenses for the Xlucane project in the future will gradually be more focused on production and planning for the coming launch. So if we look at the right, we have the net results, and it amounted to minus SEK 57.5 million, which is 55% lower than the net result for the same period last year. Let's move forward to Page 10. So here on the left, you can see the variation in operating cash flow quarter-by-quarter. And for Q3, the amount was minus SEK 103.8 million. This is due to the loss in the quarter, of course, and also changes in current receivables and payables. We usually have quite big variations due to the re-invoicing structure we have with our partner, STADA, and this was also the case this quarter. We did not have any prepayments from STADA during the third quarter, so that is why it was decreasing in deferred revenues. So looking at the cash balance to the right, we ended the quarter with a cash position of SEK 123.8 million. Cash balance has decreased since last quarter, mainly due to the negative operating cash flow. So let's move forward to Page 11. Looking at the summarized figure of the balance sheet, you can see that it has decreased to SEK 316 million compared to SEK 437 million as of the end of the last quarter. Starting with the asset side, we had noncurrent assets of SEK 95 million, which is fairly in line with previous quarter. Current assets amounted to SEK 98 million at the end of Q3, where SEK 90 million is prepayment primarily for the Xplore study. The decrease from last quarter relates mainly from trade receivables from Bausch + Lomb, which have been paid during the quarter. Cash amounted to SEK 123.8 million, a decrease as mentioned before due to the negative operating cash flow. Moving over to the other side of the balance sheet, we have shareholders equity that amounted to SEK 135 million, a decrease compared to last quarter due to the loss in the quarter. Noncurrent liabilities amounted to SEK 14.7 million, fairly in line with previous quarter. And finally, current liabilities amounted to SEK 167 million compared to SEK 232 million last quarter. That includes deferred income and accrued expenses amounting to SEK 147 million, whereof SEK 90 million is deferred income from STADA compared to SEK 130 million last quarter. As mentioned before, we did not receive any payments from STADA during the third quarter, so that is the reason to the decrease in current liability. So that was all on the financials. Back over to you, Martin?

Thank you, Margareta. Then with regards to upcoming events, we're participating -- we have been participating in this week and the LSX Inv€$tival Showcase; next week, the Jefferies conference, which is around digital where we're going to participate. And then we have a presentation at the Redeye Life Science Day, 26th of November, so that we will present the company, where we're standing. And then next upcoming event is the Swiss Nordic Bio event arranged by Vator Securities. So these are the upcoming events. So to have the opportunity to listen to us, particularly on the Redeye event, that's a great opportunity to get further update on the company. Okay. So I think that concludes today's formal presentation, and we can proceed to trying to answering the questions that are coming in.

And I'm going to start to read out the questions and then provide a short answer. Do you see significant changes in the ranibizumab biosimilar race? Do you think Xbrane can get marked approval before patent expiring in EU? So yes, we are on track to get the approval in line with the patent expiration of Lucentis, which is July 2022. And so this -- we're clearly on track of doing that. With regards to changes in the biosimilar race, as many of you know, we have 2 main competitors from ranibizumab biosimilar perspective, Samsung-Biogen program and Formycon-Coherus program. And I do expect a situation where these 3 products are being launched more or less simultaneously in Europe after the patent expiration of the originated product. In U.S., as many of you know, patent expired over this summer. And we'll have to see. I think now, it more can look like a simultaneous -- more or less simultaneous launch by Bausch + Lomb, Coherus and Biogen as there was news recently from Formycon that filing to FDA was postponed to first half next year. Second question, does the blinded information from the study support that there is not any safety or efficacy issues so far? So we can refer back to this question that's been asked before. And as you know, we are conducting -- we'll be monitoring the study from a blinded perspective for ethical reasons on the one hand to ensure, of course, that there are no unexpected adverse events emerging, which in that case would trigger a more detailed investigation. And if there were to be such serious concerns or potential halt in the study. That has not been the case. And we have not been able, from a blinded perspective, of course, to observe anything that is deviating from normal usage of Lucentis from an adverse event perspective. From an efficacy perspective, it's really -- from an ethical perspective, observing kind of the lower end of change in visual acuity, if I put it like that. So the potential part of the study population, which has a significant deterioration of visual acuity. And looking at it from that perspective, we cannot see anything which deviates, on a blinded perspective, of course, from normal usage of Lucentis. Okay. So third question, is there any significant changes in the wet AMD market? And is there still room for ranibizumab? Cynthia, we are following the market very closely, of course. And we saw a decline overall in the market during the first half of this year due to COVID-19. Now looking at the Q3 figures from Novartis and Roche, considering Lucentis sales, it seems like they're back to pre-COVID-19 levels in Q3. And it seems like Eylea has returned to growth or is growing in Q3. And the ranibizumab, as many of you know, have been facing some issues due to unexpected adverse events. And it still seems to be so that sales are not really -- not picking up really as far as we can read from the quarterly report of Novartis. So yes, definitely, we do believe that Lucentis has a strong position in this market, and that there definitely is going to be place for ranibizumab biosimilars really playing in this whole anti-VEGF market for ophthalmic use of EUR 10 billion. We do believe that there is a significant need for cost-efficient products, emerging actually from the extent usage of off-label Avastin, which, of course, is down due to cost reasons despite an inferior safety profile compared to the on-label drugs and also looking at the currently untreated population. So there's a big need for cost-efficient products in this market and definitely, therefore, a need for Lucentis biosimilars. Okay. Fourth question. Could you comment what the time line is with regards to potential license agreements for Japan and South America? I guess referring to Xlucane. So this work is ongoing together with our partner, STADA, with regard to Japan and South America and also on our own end with regard to China. So the work is ongoing. And hopefully, we shall be able to, during next year, and update you with some positive news on that plan. But our ambition is really to, together with STADA, take this product as globally as possible and trying to find the best possible commercialization partners in territories where STADA decides not to commercialize themselves, Japan and South America, such territories. Okay, question 5. Could you tell about Xcimzane time line? When is the clinical test -- when is the clinical trial going to be started? And so next year is really going to be about scale-up of the production process together with the selected contract manufacturer. And then the clinical trial, we expect to be able to start in 2022, and we still believe that we shall be able to bring this product to market at the time of patent expiration. Question 6. Could you comment on the situation of Spherotide further? What is the strategy with the asset currently? Well, as I mentioned in the presentation, we have decided -- and we did this half year ago, so -- to really focus our resources on the development of our biosimilar pipeline. And we are seeking a partner for Spherotide in the shape or form, which allows the product to be developed further, but without further investments from Xbrane. And that could be a complete divestment of our Italian subsidiary, Primm Pharma, or it could be a licensing arrangement where, as I said, a potential partner that would undertake all the coming required investments to take the development further. Okay. Next question. As the manufacturing process for Xlucane being finalized, can you speak on scalability? Is a different pegylation technology being used for Xlucane? And is there anything regarding the manufacturing technology use in Xlucane that may give an advantage compared to Oncaspar? If yes, will we see this in future messaging, okay? So quite specific questions on our Oncaspar biosimilar program. So we are in the process of finalizing the manufacturing process. It has not been scaled up to commercial scale, so I cannot comment on that. And it is a pegylated product, Oncaspar. All we're trying to do with regards to our biosimilar development is to develop a biosimilar with a similar pegylation as possible as the originator and thereby, also no clinical advantage compared to the originator, but really striving to get as a similar product as possible from both an analytical perspective but then also from a clinical perspective, of course. Next question. Several patients have, at this stage, been treated for more than 52 weeks in the Xplore study. Have you done any readout data on these patients? And if you have, what is your results? Is the result in line with equivalent margin to Lucentis agreed with EMA and FDA? So the answer is no. We haven't done any readout on these patients. First readout is going to take place when last patient have reached month 6 in the treatment schedule. Next question. Regarding Xdivane and Xcimzane, there is a partnership established in May, June 2019. Quoting the press release, "During this period of evaluation, Xbrane has granted to STADA the right of first refusal for a license of Xcimzane and Xdivane for Europe." How long is this evaluation period? And what is the current status of this? So this is correct. STADA has been granted the right of first refusal for a potential European license of these 2 programs and -- I'm being caught a little bit off-guard here, since evaluation period was up until initiation of clinical trial. So that is the way I remember the prolongation of that right of first refusal. I might have to come back on that one. The next question, how is the burn rate of capital expected in the coming year? Current burn rate, SEK 50 million to SEK 60 million per quarter is for a full-on Phase III study. Can we expect this to drop as people reach the end of treatment in 52 months? Yes. So the burn rate related to the clinical trial, Xplore, will go down during next year. But there will be other expenses related to Xlucane, primarily related to preparing for securing capacity for the launch volume of the product. And I do expect that the current burn rate is the reasonable expectation also going forward. But the kind of type what we're going to invest into is going to shift where decline in the spend on the Phase III trial, but then it's going to be spent on other required items to prepare for a successful launch. Okay, next question. Is the cash position presenting, excluding recent directed share issue, once the directed share issue has been received, what is the runway with current cash? Okay. Yes. So the cash position, which was presented in the Q3 report was as of last September, and this was a SEK 123.8 million. And the directed share issue was conducted this week essentially and provided an additional SEK 200 million before transaction costs. And that gives us a cash runway up until the end of Q3 next year executing on our business plan potentially, investing in, as we want to do, Xlucane as well as our 2 preclinical programs, Xcimzane and Xdivane. Next question. The start-up participate in the directed share issue. This one is -- no, STADA did not participate with regards to existing shareholders on the kind of, let's call it, tough tenders probably. We have Swedbank Robur Fonder and TIN Fonder participating. Then there were smaller existing shareholders participating, but then also, as I said in the beginning, a couple of new investors coming in, particularly on the institutional side, Lancelot and the Second Pension Fund. Okay. Good. I think that concluded all the questions that we have received. So I, with that said, want to thank everybody for calling in and listening and providing good questions. I did the best I could to answer them. Should there be any further questions, do not hesitate to reach out to me or to Margareta, and we will do our best to answer. A transcript from this call will be published on our website in the near-term future. So with that said, thank you very much for calling in and listening.