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

November 30, 2023

Nasdaq Stockholm SE Health Care Biotechnology earnings 56 min

Earnings Call Speaker Segments

Martin Åmark

executive
#1

Hello, everybody, and welcome to Xbrane's webcast in relation to our quarterly report for the third quarter of 2023. My name is Martin, I'm the CEO of Xbrane, and I have with me today also Anette, our CFO. We have a brief presentation that we are going to go through. And after that, there will be time for Q&A. To start off, we want to go through our key achievements for the first 9 months of 2023. This year has so far been focused very much on supporting our partner STADA in the launch of our lead product, Ximluci, biosimilar to Lucentis in Europe. We have generated revenues so far of SEK 170 million for the first 3 quarters of this year. The product is now launched across 12 countries in Europe, and we are tracking in accordance to the revised sales plan we established together with STADA after summer. Volumes grew 20% in third quarter versus second quarter, that is volumes out to end users from STADA. So we're proud in what we have accomplished as a team in terms of bringing this product to market in Europe. We've also filed the BLA to FDA. We did that in April. It was later accepted for review by the FDA, and we have had the first mid-cycle review meeting with the FDA with no major issues identified and the regulatory process is proceeding according to plan. So we're very happy with that. We also secured financing of SEK 375 million in June. And as I said, we are on track now versus the revised sales [indiscernible] Ximluci in Europe. So these are the key achievements for the first 9 months of the year. Now our current focus is to -- as we've been communicating, in relation to the Q2 report and continuously -- the focus is to get the positive cash flow as soon as possible and in doing that to minimize potential need for additional capital. We have a couple of important deliverables in relation to this. First one, of course, is to continue to support STADA in the sales uptake of Ximluci in Europe. We do that via production, of course, of the product, but also to continuously work towards driving down the production cost and also to prepare for approval and subsequent launch of the pre-fill syringe. Also, it's important for us to get approval for Ximluci in the U.S. targeted for April next year and to secure a commercialization partner for the product in the U.S. This we expect will generate, as the product is launched, revenues from sales of product and royalties. Out-licensing of our Opdivo biosimilar candidate is also of importance, and we're working on that with several parties under active negotiation and that we also expect shall generate license payments in terms of upfronts and several milestone payments. BIB801, our Cimzia biosimilar candidate that we're developing together with Biogen here -- about production of clinical material and in that reaching an important milestone and also sales of clinical material to Biogen. So this, we expect will generate meaningful income during 2024. And then as we communicated last week, we have introduced cost savings program which we, over time, expect should generate savings of SEK 50 million on an annual basis. So all these measures or deliverables are very important with regards to, on the one hand, reducing costs for 2024, but also generate meaningful income. And I believe there's a path forward if we're successful in all this to get to positive cash flow latest by first quarter 2025, as we have previously communicated without need of additional capital. But of course, we cannot out rule delays in any of these deliverables, which would need to -- lead to a need for additional capital, but we're doing all we can to minimize that potential need. So here is an overview of our portfolio. We are developing biosimilar candidates to Lucentis, Cimzia, Opdivo and Darzalex. And as you know, our biosimilar to Lucentis, Ximluci is already on the market in Europe. And let's focus first on that and to shed some more light on how the sales uptake is going in Europe. Ximluci is now launched in 12 European countries. You can see the countries on the map on the left hand side of the slide, most important countries from a market size perspective, obviously, being Germany, U.K. and Spain. Further launches are planned during the course of 2024. And as we talked about in our last webcast, we have seen that the sales uptick is going slower than what we initially anticipated, but we established a new plan to get with STADA after summer. And the important takeaway here, I think, is that we're tracking in accordance to that plan. As we've talked about before, [indiscernible] required for education of physicians as well as payers in a biosimilar naive setting -- ophthalmology setting. But we are confident that, overtime, we will work through this process and we'll get to the potential of the product long-term, which remains the same as we've talked about before. And looking specifically at the main countries here in the U.K., as you know, STADA affiliate in the U.K. was awarded a frame agreement for sales of [indiscernible] in Ximluci to NHS England. And what is happening now is that the sales force is working through to convert the so-called trust. So conglomerates of hospitals, which need to make active purchase decisions on the specific product. So it's a process of converting trust after trust to realize the volumes which are dictated in the frame agreement. In Germany, there are multiple ongoing commercial activities on different segments in the market really to try to drive further volumes. And in Spain, there was a launch taking place at end of May, and we are getting initial positive feedback from clinics across Spain, but it's also a process which is under a buildup. So I think we have good and positive feedback from the clinics that are using Ximluci, but the process across these main countries and the other countries as well is about converting or adding more and more clinics using Ximluci. Beyond Europe, there is a registration process ongoing across multiple countries in the Middle East, and we are also working actively to try to bring Ximluci to as many countries and regions in the world outside of Europe as possible. And from a market size perspective, if we're looking at anti-VEGFs for ophthalmic purposes outside of U.S., it's a market of about EUR 5 billion annually. Ximluci is launched in the countries we saw on the previous slide, and that represents some 35% to 40% of this market. Ximluci captured a market share of 0.5 percentage point in the ranibizumab market in this region in Q3. So that was a market of EUR 350 million. So you can -- with these two numbers estimate, the net sales of Ximluci in this region during third quarter. It was the second biosimilar in terms of net sales during the quarter, which, of course, is a sign of strength. And volumes are growing on a quarterly basis. We saw 20% volume growth in Q3 versus Q2, 25,000 units has been shipped from STADA to end customers so far or up until the end of third quarter, actually. So I think we're seeing, again, positive signs in the right direction and that we are following the revised sales plan established after summer. Important here is that our belief in the long-term potential of Ximluci remains. We do believe that eventually, ranibizumab biosimilars will take a corresponding share of the originator product sales for ranibizumab market overall of 70% or so, which is corresponding to what we've seen in other settings in oncology and in immunology when biosimilars have been introduced to the market. It is, again, biosimilar naive market setting, which makes taking a little bit longer time. But we strongly believe that the end game will be corresponding to what we've seen in other settings. And we do believe, and this is our and STADA's ambition that Ximluci will be the preferred choice amongst the ranibizumab biosimilars on the market. So the long-term belief in the product remains both for Xbrane and for STADA. Then from a development perspective here, we are going through the regulatory process in the U.S. We'll talk a little bit more about that. We're also working with development on the pre-filled syringe. As you know, we have launched so far the vial as have the other ranibizumab biosimilars in Europe. We are expecting to be able to launch a pre-filled syringe first quarter of 2025, which we believe also will be important in terms of driving additional conversion of the market to biosimilars and specifically Ximluci. Then looking specifically at the U.S. So this is market of approximately USD 8 billion. It's a big market opportunity. And we really see good traction of ranibizumab biosimilars in the U.S. In Q3, ranibizumab biosimilars sold for approximately USD 50 million. So that really shows that the market is perceptive to the more cost-efficient alternatives and using biosimilars. We are now going through the regulatory process. As I mentioned in the beginning, that is proceeding according to plan. We've had the mid-cycle review meeting with the FDA. There has been no material issues identified so far, which could jeopardize the approval of Ximluci by FDA but important in this process is that we have upcoming pre-proven inspections of both the drug substance and the drug product sites in the first quarter of next year. The so-called [indiscernible] date is in April 2024. In relation to this, we are also proceeding according to plan with negotiations with future commercialization partner for Ximluci in North America. And we are very optimistic that we will have a commercialization partner in place, if not by the end of the year, Q1 next year, at least before the approval so that we, together, can make the appropriate preparations and plannings for a subsequent launch of the product. And we believe in the dialogues we've had so far with potential partners that are good prospects for a third ranibizumab biosimilar entering the market and good reasons to believe that the third entrant can gain a significant share of the market, looking both at the existing ranibizumab market, including the biosimilars, but also the market opportunity in off-label Avastin and also Eylea and [indiscernible]. I think there are good signs with this. We saw the other day that CVS, for example, took out Eylea in their formulary for benefit of ranibizumab biosimilars. So I think that is a sign that also Eylea part of the market is addressable for ranibizumab biosimilar. And as you know and as you see here, is a very sizable market opportunity. Then coming to our broader portfolio. We have an increased commercial focus, generally speaking, around our portfolio. We want to focus on what can generate revenue in the short-term. And that has led us to terminating the development of Xtrudane, our KEYTRUDA biosimilar. We have choose to prioritize Xtrudane, our Opdivo biosimilar candidate as our immuno-oncology biosimilar to proceed with. We believe this is the right thing to do. Its the first PD-1 inhibitor to go off patent, and it's a very sizable market, EUR 13 billion of originated product sales estimated in 2026. This is more limited competition as far as we can tell now when it comes to other biosimilar candidates under development for Opdivo compared to KEYTRUDA. It seems to me that most other biosimilar developers have gone for KEYTRUDA and done that neglecting Opdivo as a biosimilar opportunity. So we believe we are in a good position there. We have also had good progresses in our development of our Opdivo biosimilar candidate. We have established the process internally. We've demonstrated good analytical similarity across a panel of close to 50 quality attributes. And we have scaled up the production process to our 200 liter ferment scale, which we have in-house. For those of you who have visited us, you have been able to see that. And this is the first program we are scaling up to that pilot scale. So I think that demonstrates scalability. We went from 5 liter fermentation scale up to 200 liter fermentation scale and the process was robust in that scale up, which gives us comfort ahead of the upcoming further scale-up and production of clinical material to take place during the course of next year with our selected contract manufacturer. Then if we look at our Cimzia biosimilar candidate, BIB801, which we are developing together with Biogen. It's a very important year next year where we are going to produce clinical material, and we expect that this program shall generate meaningful revenues for us during 2024 in terms of milestone payments and income from sales of clinical material to buy. And so it's a very important program for us, again, from a short-term revenue perspective. Then we are continuing with the development of Xtrudane, our DARZALEX biosimilar candidate as previously planned. And this more commercial focus of our portfolio, as I discussed, has also led us to introduce cost savings program, termination of Xtrudane led to freeing up some resources in the organization. And this is a program which we expect or plan should generate SEK 50 million in annual savings once fully implemented. And to be very specific here, what we're talking about is the reduction of some 38 positions, 20 of them are consultants, which we have had a process of phasing out gradually already from the end of second quarter and onwards. There were 4 vacancies, employees that had resigned, which were not filling up again. And then we've had to reduce 14 positions, which are occupied by permanent employees, unfortunately. This, of course, has been a very tough decision for us to make, and it's a very tough process to go through, but it is necessary for us to be able to get a positive cash flow as soon as possible and minimizing potential need of additional capital. We are retaining a core team of 75 employees. And that is an organization which is sized and equipped to be able to develop on our current development portfolio, as described and also with an R&D organization sized to be able to develop one new biosimilar candidate annually. However, introducing new programs into the portfolio, we are going to wait with until we feel that we have the financial means to make such investments. This program will be realized gradually from this quarter onwards, but the full savings effect we'll see in third quarter of next year. So with that said, I'm going to leave over to Anette to go through more details around the financials for the third quarter.

Anette Lindqvist

executive
#2

Yes, thank you, Martin, and hello, everybody. My name is Anette Lindqvist. I'm the CFO of Xbrane since some years back now. The first slide I want to share with you to spend some time on is really on our revenues. We understand we are the first to acknowledge that our revenues is a bit difficult to understand. So hence, let me take you through the -- the net revenues created in the quarter, SEK 59 million and SEK 171 million year-to-date, reflects the fact that we have managed to put single chip on the market late March. It's now been in the market for 6.5 months up until September. It has been generated net positive profit each quarter from day 1. So as Martin said, that is something that we feel is a key achievement for us. Looking at the quarter and looking at the diagram, I want to first highlight that the gray area in the bottom for the previous quarters represent out-licensing accrued income from Biogen. That was a deal we made last year, and that was based on accrued up until June this year. So from this quarter, we don't have any out-licensing deals before we secure one of the agreements that we spoke about. So this is -- the total sales reflects supplies to startup at standard cost and profit split. And those combined amounts to SEK 59 million. Our aim is to share more and more market data in these calls, meaning what STADA sells in the marketplace to patients and end users. This is totally different from our revenues presented here because these are shipments and to STADA that we reflecting in the revenues and also then, obviously, the profit share. I also want to highlight the deliveries as we spoke about in earlier calls, happen is regularly. So we could have one delivery in the quarter. We could have two. We could even have 0. That means that will be irregular presentation in terms of the revenues. So the traditional growth is very, very difficult to read anything out of these numbers. We also -- what we also can say is we sell a standard cost tends our gross margin is impacted by production and currency variances for the [ SEK 4 million ] delivered in the quarter we had a share of currency variances due to our cost of mainly in euros. Looking at the company expenses quarter Q3 last year, those have increased by SEK 32 million. But for those of you who remember, we actually had -- we capitalized some of the R&D expenses last year. And compared to second quarter of this year, we have actually had a reduction in costs. For Ximluci, I would say that cost mainly is regulatory activities and also development of the PFS. Those are, obviously, not capitalized. For BIB801, we have costs for production of clinical material mainly related to drug substance, tech transfers to CMOs and also raw materials used in those activities. And then also for Xtrudane costs related to progressing preclinical development activities. We expect that the total company costs, OpEx mainly, will start to -- we will see some already from the savings scheme delivered in Q1 with full implementation than in Q3. So those you would gradually see on this graph. Cash flow. We leave the quarter with SEK 167 million at hand, which is basically what we had last year, almost the same amount at this time of the year. Our operating cash flow amounted to SEK 125 million in the quarter. Out of this, Ximluci represent about 70%. That's mainly related to -- again, to the PFS development, regulatory, commercial activities and inventory buildup. We also spent in terms of cash flow, a significant amount in prepayments to our suppliers that obviously that we will benefit from next year. We also wanted to take the opportunity to do a bit of a recap on our outstanding convertible bond. We secured a bond this is part of SEK 250 million in June at a conversion price of [ SEK 93 ]. The deals we made are quite favorable looking at the marketplace or market environment now. We have a favorable interest rate of 6% up until estimation of FDA approval, so hence, April next year. And thereafter, it's 0. We have a remaining duration of 44 months when we leave September. And generally, amortization are in equal installments every second month, but they can be deferred and they can be accelerated. And next amortization is now due in December. And whether we -- as a company, it's our decision whether we should progress that in cash or in shares, and we want to do that as the best for the company. So far, the first one we did in July, we did in cash and the next one we did in shares in September. I also -- we also at [indiscernible] shared our financial calendar. This year, we have been very, very late. We acknowledge that and is for good reasons, as we have discussed on previous occasions. It is due to the fact that we have sales reports, revenue reports that come from STADA, and they have in the contract as 45 business days before they need to issue that report to us. However, we have jointly work with STADA. We have now a very, very good process in place. So we are happy to say that we are back to where we were last year. So as you can see that we have moved forward our report dates quite significantly in the first, second and -- second quarter next year. And by this, I think that was my last section. So then back to you, Martin.

Martin Åmark

executive
#3

Yes. So the key takeaways from this webcast and for the quarter, we're proud to have supported the launch of Ximluci across Europe. We are happy to see that we are tracking in accordance to the revised sales plan we established with STADA after the summer. We see growth Q3 versus Q2 of units shipped really from STADA end customer 20%. And we are in 12 countries, but launches in more countries are going to take place during the course of next year. And priorities going forward, as we've talked about, is to get to positive cash flow as fast as possible and preferably without need of additional capital and if so, to minimize that potential need. And what is important in that process is the uptick of Ximluci in Europe goes now according to the revised plan, and we shall do all to support our partner STADA in that with regards to continuous production cost reductions and introduction of the previous syringe, particularly. The regulatory process in the U.S. is of very high importance, of course, to get the FDA approval in time, to establish a U.S. partner and then support that partner in subsequent U.S. launch of Ximluci. The out-licensing of Xtrudane, our Opdivo biosimilar candidate is also very important from an income generation perspective, in the short-term as well as delivering on milestones on BIB801 versus Biogen and established contract with them from a short-term revenue generation perspective. So these are the key takeaways. And probably in relation to that, we are opening up for questions. So I think we start with questions.

Operator

operator
#4

[Operator Instructions] The next question comes from [ Sean Hammer ] from Jefferies.

Unknown Analyst

analyst
#5

I have a few. So just on your Cimzia biosimilar, what's your confidence in entering the clinics perhaps towards the end of 2024? And secondly, what's your confidence in your partnership with Biogen and carrying forward the biosimilar to commercialization? And finally, how long would it take to run a combined Phase I, Phase III trial? Because from my understanding, you can integrate the aspects of the Phase I into the Phase III. So how long would it take to run all of that together?

Martin Åmark

executive
#6

Thank you for the questions. First of all, we have high confidence in being able to support Biogen with clinical material during the course of next year for them to enter clinic if it's late 2024 or beginning of 2025. So we have high confidence and we'll be able to achieve that. I think what you're referring to in your second question is the publicly communicated externalization plans of Biogen biosimilar business. And we have no further knowledge or information around that than what it's publicly communicated from Biogen, but we feel high confidence in that whoever is potentially eventually acquiring that business will see the value in our Cimzia biosimilar candidate and continue to invest behind it and bring it to market. We shall remember here that this program is the only biosimilar candidate under development targeting Cimzia and this is still EUR 2 billion product. So it's a sizable opportunity. And we have also, over time, had significant incoming interest from other parties, which I think helps a sign of the general commercial interest in this asset Sorry, what was the last question?

Anette Lindqvist

executive
#7

Combined Phase I, Phase III.

Martin Åmark

executive
#8

Good. The exact clinical program for this product will have to wait and see, and it's going to be subject for discussions with the regulatory authorities. As you probably know, there is an ongoing discussion even within the regulatory authorities with regards to waiving Phase III trials altogether for biosimilars. And this product specifically is a TNF inhibitor, and we have quite a lot of experience on biosimilars to other TNF inhibitors. And we, for this product have very strong analytical data, we believe. So I think that is a possibility of having Phase III waived. And otherwise, I think it's perfectly feasible to be running actually two separate trials 1 phase and 1 Phase III in parallel. You can do that since you can go straight into Phase III trials with biosimilar candidates like we did, for example, with our Lucentis biosimilar. So I hope that answers your questions.

Unknown Analyst

analyst
#9

Just on Ximluci, are you expecting to gain interchangeable designation from FDA?

Martin Åmark

executive
#10

We haven't so -- We haven't now in the current BLA submitted -- submitted an application for interchangeability designation. However, we are considering to do that immediately after approval.

Operator

operator
#11

The next question comes from Felicia Rittemar from VL Kempen.

Felicia Rittemar

analyst
#12

So I have a couple of follow-up questions on how you record the sales for Ximluci and how that is reflected in the income statement. So first question, is it correct that the profit sharing for the third quarter is about SEK 4 million?

Martin Åmark

executive
#13

Anette, do you want to take this question?

Anette Lindqvist

executive
#14

Yes, I would be happy to. No, that's not correct because as I said, we sell a standard cost in our cost of goods sold, not actual cost. So that means that we have first thing, we have production variances and also more significantly this quarter, we also have currency variances impacting the combined sales from a cost and profit share.

Martin Åmark

executive
#15

I can probably add to this that we are no longer going forward going to separately disclose what we generate from sales of product and from the profit sharing from STADA. And that goes in line with our ambition to become more and more transparent with regards to the end sales from STADA to end customers. And if we're going to be more transparent on that, we cannot provide full transparency into the actual profit sharing we are receiving from STADA. So I hope that also gives a little bit of background.

Felicia Rittemar

analyst
#16

Okay. Yes. And then my final question is, can you provide a bit more guidance on when we can expect the first milestone payments on the Cimzia biosimilar? And do you think that will be enough to provide runway into the first quarter in 2025?

Martin Åmark

executive
#17

We expect that during 2024 and -- it is not solely going to be enough. We need to be generating revenues across more of this income generating deliverables or aspects, which I presented on the previous slide, including that sales uptake of Ximluci in Europe is tracking according to plan, license proceeds expected from a U.S. partner and also from a future partner for Xdivane.

Operator

operator
#18

[Operator Instructions] There are no more questions at this time. So I hand the conference back to the speakers for any written questions and closing comments.

Martin Åmark

executive
#19

Thank you. So Anette, do we have any questions over the chat?

Anette Lindqvist

executive
#20

Yes, we do. The first question, I believe that we -- you just responded to, but is how much was profit sharing fraction in Q3 of Ximluci and that was exactly what you just spoke about a minute or so ago. The second one is, is there updated time line regarding [indiscernible] upscaling?

Martin Åmark

executive
#21

It's going to take place during the course of 2024, including production clinical material, which then entails running off several GMP batches.

Anette Lindqvist

executive
#22

And those are going to be sold to Biogen, right, for significant amounts?

Martin Åmark

executive
#23

Yes.

Anette Lindqvist

executive
#24

Next question. Is cash flow effect from terminating KEYTRUDA biosimilar front-loaded, linear or backloaded towards end Q3 2024?

Martin Åmark

executive
#25

So we have not made a substantial investment into that program. It is below SEK 10 million, what has been invested so far into that program, but there will be no future cash flow effects on that going forward.

Anette Lindqvist

executive
#26

Next question, on the amortization, I believe. The cash situation looks very worrying at the moment. What is the plan for repaying the maturing bond at this time. We will see another issue of shares made at a big discount or temporary funding available through other sources?

Martin Åmark

executive
#27

As we have described in the presentation, our focus is to get to positive cash flow as soon as possible and we do all we can to get there without need of additional capital, but it is contingent upon us delivering on the different income generating aspects, which I talked about, including Ximluci sales uptick in Europe, Ximluci FDA approval and U.S. partner and license proceeds from our Cimzia and Opdivo biosimilars, respectively. However, we are, of course, also having active dialogues with the current and potential future investors, both on equity and debt side and to see if we have to refinance the company somehow try to do that in the best possible way.

Anette Lindqvist

executive
#28

Next question. What is your take on Ongavia relative success in the U.K. during Q3 by 50%. It seems to be more of a pricing issue than hesitant of ophthalmologists.

Martin Åmark

executive
#29

Well, I think what one needs to remember here that this product came to the U.K. market first in summer last year and had some time to convert several important trusts or conglomerates of hospitals and under an agreement with NHS. So there was a timing advantage there. Now we see that Ximluci is tracking well with regards to market share gains in the U.K. market in relation to Ongavia.

Anette Lindqvist

executive
#30

Next question is a figure of 25,000 doses for SEK 170 million during 2023. So far, correct. It equates to more than SEK 6,000 per dose and seems very high. Is the high gross margin solely rely on the scale up?

Martin Åmark

executive
#31

That is not the correct math to be doing. Our sales of SEK 170 million the first 3 quarters of this year relates to sales of units to STADA and profit sharing from STADA. The 25,000 units refers to STADA sale to end customer. And of course, there is an inventory buildup that can take place in between. So it is not the right math to try to do.

Anette Lindqvist

executive
#32

The SEK 170 million, if I may add, is also from out-licensing accruals maybe the first and second quarter. So is the high gross margin solely reliant on the scale up?

Martin Åmark

executive
#33

No, I think that here, it's more related to some variances on the production side and the currency effects, as Anette mentioned, and also a gradual increase in profit share coming in from STADA. Effects from the scale-up and lower production cost thereof, we expect to kick in earliest by the latter part of next year.

Anette Lindqvist

executive
#34

25,000 units are said to be shipped from STADA after launch in March. Can you please clarify if it is a unit equivalent with the vial?

Martin Åmark

executive
#35

Yes.

Anette Lindqvist

executive
#36

Next question. Have you underestimated the entry barriers considering the weak sales of [indiscernible]?

Martin Åmark

executive
#37

Yes, I think in the beginning, when the product was launched, we underestimated the time it would take in a biosimilar naive market to educate the different stakeholders, physicians and payers to drive conversion. We underestimated the time that would take. However, as we have described in this call, we are convinced that eventually we will get to a similar penetration or conversion rate, what we've seen in, for example, oncology or immunology settings that biosimilars stake beyond 70% of the volumes of the originator product. So we're confident we will eventually get there. But this is more of a slow build than what we anticipated by the time of the launch of the product.

Anette Lindqvist

executive
#38

You mentioned expected revenues from BIIB801 clinical material, how will these be structured the revenues?

Martin Åmark

executive
#39

Structured. It essentially sales of material as per agreement to buy. So it will be logged as revenue and related production cost in connection to that.

Anette Lindqvist

executive
#40

Any estimate when Phase I can we begin?

Martin Åmark

executive
#41

As it was a previous question, I mean, earliest late '24, otherwise beginning of '25, that's the best estimate we can give now.

Anette Lindqvist

executive
#42

With starting point in Q3 cash burn, how will that burn be impacted Q4 and onwards following the cost saving program. The clarification would be helpful.

Martin Åmark

executive
#43

How the cost savings program will impact?

Anette Lindqvist

executive
#44

Yes, the cash burn.

Martin Åmark

executive
#45

So these savings of SEK 50 million are going to be materialized gradually from the fourth quarter until full effect third quarter next year. But important to note, when you look at our cash flow, there are other very important fluctuations and a lot of our cash flow has been related to activities we do with contract manufacturers, frankly speaking, for all of our programs. And that's something which we also are to optimize. And of course, in the cash flow, there is also an income component, which we've talked quite a lot about in the call, which we're trying to optimize as well. And I guess our expectation is that cash flow for this quarter will be negative, but not of the same magnitude as the cash flow in the third quarter and then the cash flow will be significantly improved again, provided we're successful in delivering on these different aspects we talked about in this call that are important from a short-term revenue generation perspective.

Anette Lindqvist

executive
#46

Any comments on number of patients adherence or patients prescribed Ximluci continuing the treatments with your grant?

Martin Åmark

executive
#47

I think this is too early to say something which we wish to be able to track going forward when the product has been on the market for some longer time.

Anette Lindqvist

executive
#48

What is the present view on the Ximluci cash flow from the STADA deal that originally thought to be SEK 1 billion, 3 years after launch of the global launch?

Martin Åmark

executive
#49

Yes. That also entails the U.S. market, just to be clear, so 3 years also post U.S. launch. And it was always contingent upon the view that ranibizumab biosimilars would take beyond 70% of the originated product sales and that Ximluci would take its fair share of fair third, if you will, of that market. So I think that fundamental view still holds through. And we hope we get there within the time frame of 3 years post U.S. launch. So we're going to be talking about coming into 2027.

Anette Lindqvist

executive
#50

Yes. On the slide with markets where Ximluci is launched, France is missing. Any comments on activities there?

Martin Åmark

executive
#51

Correct. France is, of course, a very important market in Europe, and it's a market where we hope a launch can take place during the course of next year. It is a market which we're aware the prefilled syringe is of high importance, potentially of higher importance than in some of the other markets. So we are hoping on being able to see a penetration of that market once we have the prefilled syringe approved and launched.

Anette Lindqvist

executive
#52

Can you share anymore details on why you think the sales in Europe will pick up in 2024?

Martin Åmark

executive
#53

Because it is a process which takes some time related to education of the different stakeholders involved and we see traction, we see that sales are growing. We had a 20% volume growth Q3 versus Q2. And we just need to continue this trend to get to the numbers in 2024 as per our revised sales plan from after summer together with STADA.

Anette Lindqvist

executive
#54

This inventory buildup and the subsequent cash flow effect is now completed. What can we expect for the next coming quarters?

Martin Åmark

executive
#55

Yes. I think that our inventory on the balance sheet should be expected to remain rather stable at the current levels.

Anette Lindqvist

executive
#56

Yes. No, I would agree because with the -- also the loss of the PFS that will build up as well. That was the last question on the chat moderation slide.

Martin Åmark

executive
#57

Excellent. So then we thank all of you who listened in and asked and post excellent questions to us. We remain available for any further questions over e-mail or phone. And we look forward to talk again in relation to year-end report coming up in February. Thank you.

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