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

Thank you very much. Welcome, everybody, to this call where we are going to present the highlights of the 2020 year-end report of Xbrane Biopharma. So in summary, I think 2020 was an eventful year for us. Despite the COVID-19 pandemic, we've been able to advance our portfolio of biosimilars in a very meaningful way and also to better prepare the company for the future. I wanted to discuss in brief what we've been up to when it comes to, on one hand, Xlucane; then focus a little bit more on our next coming biosimilar, Xcimzane, Cimzia biosimilar; and then talk a little bit about the move into our new facility and what we aim at accomplishing there, the IP portfolio we've been building. And on the team side as well, and then funding and then also what's happening with our subsidiary, Primm Pharma. But let's do it like this, that we start with Xlucane, and we can probably move on to the next page. So here, you can see our overall portfolio, and this is probably familiar to most of you. Xlucane is the lead biosimilar candidate we're developing biosimilar to the eye drug Lucentis. It's in an ongoing Phase III trial. We are targeting to come to market second half of 2022, and throughout will then be commercialized by STADA and Bausch + Lomb. The next coming product is a biosimilar candidate to Cimzia, TNF alpha inhibitor used in treatment of rheumatoid arthritis and psoriasis mainly. Sales of EUR 1.7 billion and goes off patent in Europe 2025. It's an exciting program. As far as we can tell, we're the only biosimilar candidate under development on Cimzia, which is very exciting, of course. And then we're building a portfolio, which can come to market 2028 and onwards led by Xdivane, our Opdivo biosimilar. In our new facility, we're going to be able to initiate one new development program on an annual basis. As some of you may just saw we sent out a press release a couple of days ago where we entered into nonbinding term sheet to divest our subsidiary in Italy, Primm Pharma, and their lead product, Spherotide, to an Italian pharmaceutical company called New Fadem for an acquisition price of EUR 14 million to be paid partly upfront and then over development and sales-related milestones of the lead product, Spherotide. We are targeting to close this transaction with New Fadem during the course of the year after confirmatory due diligence has been conducted and also we've been able to negotiate final agreement. But that is all to be able to focus really all our resources and efforts on building a world-leading biosimilar developer of Xbrane and focus on our biosimilar portfolio. This is a kind of high-level timeline for Xlucane development. As I said, the product is in a pivotal Phase III trial. We had the last patient into the trial in November last year. We're going to do an interim readout when the last patient has reached month 6 in the treatment schedule, which is going to occur in May this year. That is going to take us approximately 2 months for statistical analysis before we will be able to communicate top line data from this interim readout. And also, in accordance to agreement with both EMA and FDA, we're going to submit the marketing authorization application on the basis of this interim readout, and it's going to be done during Q3 this year. And counting on a 12-month regulatory process, we expect to have the approval in place mid-2022, which is time of the European patent expiration of the originated product and will allow for a subsequent launch of the product during the latter part of the year. We are addressing a big market with Xlucane. It's, as most of you know, probably used in treatment of several severe eye diseases, age-related macular degeneration, mainly. And if you look on the left hand of this page here, there is some high unmet medical need when it comes to these eye diseases. We look at the number of affected eyes. We see that in Europe and the U.S., roughly 50% are being treated with adequate medication, which is the VEGF alpha inhibitors. And in the rest of the world, only a fraction of the affected eyes are being treated. And the reason behind this really is due to high prices of these biological drugs and combination with lack or restrictions with reimbursements. And you can see also a fairly significant portion of the treated patients are being treated with the off-label cancer drug, Avastin, which is done because it can be done at a lower cost, but also is attached to several severe safety risks, but it's a sign that the market is in need of more cost-efficient products, something which we will address with Xlucane being a biosimilar to Lucentis. And the market has been growing with some 10% per year. If we only look at the -- sales of the on-label products than Lucentis and the competing drug Eylea, coming up to approximately EUR 10 billion -- EUR 10.4 billion 2019, then we saw a slight decline during 2020, which was COVID-19 related, but we really expect that this long-term growth rate will continue as the COVID-19 pandemic is getting under control. So it's a big market, and we can be looking at how biosimilars have performed generally speaking in Europe and the U.S. lately. And what we can see is that the uptake is going -- is only getting quicker and quicker. We can see in the recent launches of biosimilars, both in Europe and the U.S., that biosimilars took some 40% volume market share over the 12 first months of being at the market versus the respective originated product. So it goes very quick now, and it's a sign of the increasing confidence amongst the physicians and patients to go for biosimilars given the history we have with 15 years or so with biosimilars on the market with no severe adverse events really with usage of these products. And of course, big pressure from ultimate to the payers of using the more cost-efficient product there. Particularly during 2020, we saw a kind of a shift in the U.S., which has been a question mark, to some extent, during the course of the year, say, with regards to adoption of biosimilars. But in 2020, it was a very successful year for biosimilars. We saw that biosimilars to Avastin and Herceptin took 40% volume share over the first 12 months. So probably the best launches of biosimilars seen so far in the U.S. So it really seems like biosimilars, generally speaking, are gaining traction in the U.S., and that is always something we have been rather confident would happen over time. And it's great to see that's actually happening now. Okay. And then in parallel to the ongoing development of Xlucane and the regulatory process, our partners, STADA and Bausch + Lomb, are preparing for being able to launch the product. As many of you know, probably STADA, generic and biosimilar specialists with some EUR 2.6 billion of annual revenue, is going to sell a market Xlucane across Europe, Middle East and selected Asian countries. They have a dedicated biosimilar team in place with sales representatives and a tender team that can manage all the so-important tender processes across the different countries in particularly Europe. And they know how to do this. They've done it before. They have a handful of biosimilars already on the market and have done very successful when it comes to the sales and marketing of these products. And the arrangement with STADA is co-development deal essentially where we split the development expenses and also the profits to come 50-50. And during 2020, we then signed a license deal with the eye specialist, Bausch + Lomb, who's going to sell the market Xlucane across North America. And we're really happy to have that partnership. We believe that Bausch + Lomb is probably the best partner that we could have to commercialize the product in North America. They have a strong presence in the eye segment. They have a sales force in place that have strong relationships and are calling on the roughly 2,500 eye clinics, which today are procuring and administrating Lucentis for patients with age-related macular degeneration and other related eye diseases. So it's easy for them to slot in Xlucane into their existing infrastructure and I believe, it is going to be very successful in sales and marketing of the product. So we're happy to have concluded that partnership during 2020, and we're looking forward to work together with Bausch to make success out of this product. And we have said since a couple of years ago that we shall be able to generate EUR 100 million of net income from Xlucane 3 years after launch. And we still believe very strongly in that, that ambition is adequate and correct and we shall be able to get there. And that's EUR 100 million that is after deduction of production costs, marketing costs and profit splits with our partners. And although the ambition when it comes to market share gain and how pricing will look like is different from counter to counter. If you aggregate it up, the aggregated kind of target is to take 25% volume share of the current Lucentis market at an over time price discount, which could go down to 50% versus the originator, and that will take us to getting to this EUR 100 million, which, of course, is a very significant commercial upside for us as a company. Okay. So that was a brief update on our Xlucane program. All on track, as I said, and we're very much looking forward to take this development further together with our partners and take the product to the market to the so much in-need patients. Then our next coming biosimilar candidate is -- biosimilar candidate Cimzia. And this is TNF alpha inhibitor used in treatment of mainly rheumatoid arthritis and psoriasis. It's actually the only product of the TNF alpha inhibitors, which is clinically approved to be safe for treatment of pregnant women and also breast-feeding women. And that is not an insignificant segment of the market with roughly 70% of rheumatoid arthritis cases being in women and 15% of these in women with an age below 40. And the corresponding number for psoriasis is 50% of the cases in women and 40% below 40. So it's a non-insignificant segment of the market, which I think has been crucial for the growth that this product has been demonstrating over the years with some 12% annual growth now reaching in 2019 EUR 1.7 billion and was even growing in 2020 a bit. So it's a very exciting product for us. And what we feel is really good here is that we are the only biosimilar candidate as far as we can tell, and we believe really it's down to the strength of our platform technology. And we've been working a lot with this development during the course of 2020. And we've now reached the yield, which we have targeted in this development and what we feel is required in order to have a suitable production cost for this product and also to be able to produce it at the available scale of fermenters out there in the world. And we estimate that we have 4 to 5x the yield compared to the originator when it comes to this program. And that is -- we talked about yield and then it's a gram per liter fermentation media. So we estimate that we get 4 to 5x gram per liter fermentation media compared to the process of the originator judged by what is revealed an [ EPAR ] with regards to the setup they're using. And that is very important than to get to this commercially viable production cost and being able to produce it at commercial scale. And that, I think, is the reason for why we are alone when it comes to biosimilar development program. So it's very exciting. And the next steps in this program is that we're going to scale up together with selected contract manufacturer during this year and then take the product into clinic during 2022. We have the ambition to find a commercialization partner for this program before we go into clinic in order to be able to cofinance that journey, okay? Then we are, during the course of the coming weeks, moving into new facilities at Campus Solna in close connection to Karolinska Institute, 2,000 square meters, we're significantly expanding our development capacity over there. And that in combination with the team we currently have in place with 43 employees now. And essentially covering all the capabilities, which are required to take biosimilar all the way to marketing authorization. With this combination, we're going to be able to initiate one new development program on an annual basis. And we're looking into suitable target so to say or biological drugs with patent expiration 2028 and onwards. And we're going to come back to communicate around which developments that we initiate. But we are confident that we are, with the setup, going to be able to build a very exciting portfolio of biosimilars that can come to market 2020 and onwards. So that was a brief update on the business. So with that said, I'm going to hand over to Anette that also maybe can start to introduce herself since it is actually her first call as the CFO of Xbrane. We're very happy to have Anette joined us in January, and I think it's a great asset to the company.

Thank you, Martin, and good morning, everybody. My name is Anette Lindqvist. And as the newly appointed CFO of Xbrane as of a month and a bit. I have been in the life science industry more than 25 years. I'm passionate about patients and very, very happy to join Xbrane. Hence, today, I'm going to share a few slides and to give you an update on the Q4 financials. On the left, you can see the total income. We define it as total revenues and other operating income. In Q4, you can see a total income of SEK 5.3 million. This is primarily generated from a milestone payment based on the agreement with Bausch + Lomb. The contract was signed during Q2, but the first time payment is recognized during the 2-year period. The rather tiny other operational income represents natural exchange rate gains on receivables and payables. Of the administrative expenses to the right, they were SEK 7.3 million in total in Q4. By the looks of it, an actual decrease by 12% compared to 2019. However, the fourth quarter last year included expenses related to the NASDAQ listing that took place last year in Q4. Hence, isolated the organization and the administrative expenses have both grown a bit as the organization has also strengthened with 3 FTEs in Q4 versus last year. So not surprisingly, the R&D expenses, as visualized to the left, have increased with more than 61% versus last year and amounted to SEK 58.6 million in Q4. Almost 100% of those expenses related biosimilars in general and Xlucane in particular. This step-up in spend is fully in line with the Xlucane project plan as the project has moved into a more cost intense phase, including patient recruitment and other clinical work. Up until now, the R&D expenses have mainly been driven by the explore study, but will now gradually become more focused on validation of the manufacturing process, regulatory work and other activities planned for the upcoming launch. The net results for Xbrane on the right amounted to a net loss of SEK 63.1 million, which is 5% less than the net results for the same period last year. So despite this increased R&D spending, the result is somewhat better compared with fourth quarter last year. As then we have an inventory write-down of our subsidiary, Primm Pharma, of SEK 18.3 million as well as the cost for the NASDAQ listing, as I mentioned before. So to the left, you can see the variation in operating cash flow quarter-by-quarter. In Q4, the amount was minus SEK 67.6 million. This is almost entirely due to the operating loss and changes in account receivables and payables. Also bearing in mind the reinvoicing structure we have in place with our partner, STADA, the working capital for Xbrane can at times be very, very volatile. Looking at the cash balance to the right, we ended the quarter with a fairly strong cash position of SEK 243.1 million. And that cash is obviously then improved since last quarter due to the direct share issue of SEK 200 million, and that is before the transaction costs that we made in November. And by that, that was all on the financials. So back to you, Martin.

Thank you. So last page is really an update on the capital markets events that we're going to hold and participate in during the first half of this year. We intend to do an own arranged Capital Markets Day during April. So we'll get back with an invitation to that. It's to present a better, the new facility and our capabilities there. But we'll get back with an invitation. Then we're going to participate at Kempen Specialty Pharma & Diagnostics Day in May and ABG Sundal Collier Life Sciences Summit then the Redeye growth day. So although probably all of these events will be virtual, we hope to meet as many as possible of you on these virtual events. With that said, I think we can conclude the presentation, and we can see what questions we have and try to answer them as good as possible.

So first question here. How does the divestment of Primm Pharma facility affect the development of your preclinical assets like Xlucane? Are there any updates specific to Xlucane development? It is not affected at all since the Xlucane program has been development run by our team up here in Sweden. So biosimilar to product called Oncaspar. So it's unrelated. And updates on that program specifically, no specific updates that we can be giving right now. I think it is a program that we also will be able to get back to during the course of the year to communicate potential developments, but nothing to report right now. That seems to be the only question that we received for this call. So with that said then, we thank you all for calling in and listening in and wish you all a pleasant rest of the day. Thank you.