Xbrane Biopharma AB (publ)

of the Q4 report 2024. My name is Martin, I'm the CEO of Xtrain and I have with me our CFO, Jane Benjamin. And let us go straight into an operational update from the quarter. And after that, Jane will go through the highlights from a financial perspective. And then we will wrap up with the Q&A. Most of you are probably aware of our general business. We are in the space of developing biosimilars. And the slide here shows our biosimilar portfolio. It is addressing originator sales of about 26 billion Euro annually. So sizable market opportunity we are addressing. The first biosimilar we developed was a biosimilar to the iDrag Lucentis. It's called Similusi and it's approved in Europe since late 22 and launched in March 2023 by our commercialization partners Stada. And we are going through a regulatory review process with FDA for an approval in the US. Then we are developing a biosimilar to Cinzia, two billion Euro TNF inhibitory use and treatment of psoriasis and rheumatoid arthritis. Quite unique program. We are the only one or one out of very few developers of biosimilar candidates to Cinzia. And we believe that can be a great opportunity for us and the future partner. Here we're going through an art licensing process. We'll talk more about that. We have the ambition to close an art licensing deal within the close or near term future here. Then Xtivane, it's our biosimilar candidate to Optivo which we recently partnered up with Intas in a global co-development commercialization deal. We're very happy with that. And this program is now going full speed ahead towards clinic in a timeline that goes towards approval and launch up on loss of exclusivity in the US December 28th. We'll talk more about this program and this deal with Intas later. And then we have early stage development of biosimilar candidate to Darcelex in the portfolio. Let's start with the snapshot of Similusi ex-US sales, if you will. The project is now launched across 21 countries, out of which 19 in Europe. You can see the map here on the left hand side, the countries in which the product so far has been launched. We are together with our partners, Stada, seeking approvals also outside of Europe with main focus on Middle East and select countries in Asia. And we hope to be able to get approvals across a few other countries during the course of the year and subsequently be able to launch. We see continued strong growth from a volume perspective of the sales from Stada to end customers. We've seen 20% quarter to quarter growth last quarters. And that's also the growth level Q4 versus Q3 2024. We're very happy to see that the sales trajectory is now following our forecast. There's though still a huge potential for this product across the European market. This is a market of about five billion Euro if you think about anti VGFs for ophthalmic purposes. So that is to say, Lucentes and Lucentes by Similus but also Aelia, Evabismo and other products with same mode of action. And Similus has now only a 3% volume market share if you look at the Rannibismap market. So that is to say Lucentes and Lucentes biosimilars combined. And as those of you who follow us and know we have higher ambitions than this, we've seen other biosimilars collectively take up to 60, 70% of the regenerative product over course of a couple of years. Now sales penetration of biosimilars to Lucentes has been slower than for many of these other biosimilar situations. But we now see that the acceptance of biosimilars in the ophthalmology community in Europe is improving and it is all moving in the right direction. And needless to say, it's a huge potential if we are able to get to it started, take this 3% volume market share up to what we initially were hoping for, 25% volume market share. We're happy to see that Similus is currently the second biosimilar from a market share perspective across Europe, the centers biosimilar. And all in all, during the course of 24, we generated 63 million Swedish crowns in revenue from Similus. In general, we'll talk more about the financials, but the important point to make here is that this comes solely out of profit sharing from sales of the product. We have made no shipments of product started during the course of 24. As you maybe recall, we did substantial shipments during the course of 2023, which constituted a bulk of our revenue generated during the course of 23, but now it's solely profit sharing. So I think it's all moving in the right direction across Europe and we're confident that we're going to continue to see this growth trend during the course of this year and onwards to get towards the levels, which we originally were anticipating. Now moving over to the US, the US still poses a very significant market opportunity for us when it comes to Similus. It is about 10 billion US dollar market again, if you look at anti-BHS for ophthalmic disorders, including Ilea and other products with the same mode of production as Resentes. As you maybe recall, we have a partnership with Valorum Biologics for commercialization of Similus in the US. This agreement is currently being renegotiated and as a consequence of this, and I think maybe Jane will talk a little bit more about that, the upfront payment is going to be reduced on the benefit of higher royalties. So I think it improves our earnings potential or royalty potentials in the long-term perspective when it comes to Similus in the US. Now getting over to the regulatory process, we resubmitted the BLA late last year. We've since had communication with the FDA and FDA is currently requesting some additional documentation from one of our contract manufacturers, which is now being submitted to the FDA on a gradual process and it's all going to be submitted when we come to April and when we get there, FDA are going to decide on a so-called BESUFA date or decision date and also determine whether or not a re-inspection of this production site is going to be required or not. And that will also dictate the review process for FDA. We're still are hoping on a mid-year approval, but we are going to have to get back to all of you in April once all the documentations requested by the FDA are submitted and a BESUFA date is set. But we still believe in the market opportunity or opportunity for Similus, there's one by Similus to Ailea launched so far, but the bulk of Ailea by Similus are held back by the formulation patent, which of course poses a meaningful opportunity for the sense by Similus to nag into the Ailea market. And we do believe due to the reimbursement structures under Medicare part B that interactions of new by Similus in a certain segment, it creates a good opportunity to take additional market share due to the whole mechanism of reimbursement first year being set on the basis of the back as you're not going to have an average sales price at that point in time. So we're excited about the use of opportunity and we're working hard to navigate through towards an approval and of course working closer together with Valorum to make the proper preparations for subsequent successful launch. Now moving over to Ekstivijn, our Optivo Vice-Similia candidate. As we talked about during the course of last year, we were in the process of trying to identify and tie up good commercialization partner for this program. And we're very happy the way this ended up with a license deal with the Intas. Intas is an Indian biosimilar developer. They have been developing a handful of biosimilars which are all launched in the European market via their European sales arm accord. And they have a very strong position, I must say across Europe. A third of all oncology injectables are being sold and distributed by accord in Europe. So they have a very strong position within oncology in Europe. They're now establishing themselves in a very meaningful way in the US in preparation of launch of Ekstivijn. Some of you maybe saw they acquired Coherus, Pegfilter-Stim biosimilar to kind of set the start of that infrastructure within oncology biosimilars in the US. So we're very happy with this collaboration and what it entails is that we're sharing the development responsibilities. Intas are going to be responsible for the clinical regulatory development which then is a substantial investment as most of you know to carry through the required clinical trial. And Ekstivijn is responsible for certain additional CMC related development activities including process characterization and validation. Intas paid it up from 10 million euro. We have upcoming milestones of another 3 million euro and then there's a profit sharing scheme post launch. So we do believe that this program is going to contribute in a very meaningful way to Ekstivijn's income generation from 2029 and onwards. Looking at this from a timeline perspective, we have done all the preparatory work to be able to initiate the clinical trial. We have scaled up to clinical commercial scale. We have confirmed analytical similarity versus the reference product and we have produced the clinical material. So joined together with Intas now, we are gearing up to be able to get this trial initiated. As we've talked about before, we have a streamlined clinical program agreed upon with both EMA and FDA which makes us comfortable that it's gonna be executionable within the timeframe of or leading up to a VLA submission Q4-27 and then leading to an approval Q4-28 so that this by similar candidate can be launched in the US upon loss of exclusivity. Optivo, as some of you know, is expected to reach peak sales of 14 billion US dollar. Significant portion of that is in the US and given the size of this originated product, I think we see rather limited by similar development activity. We believe that X-Tivane is going to be one out of four, five by similars to Optivo, which makes it a very meaningful income generation opportunity for us. And then moving over to XB003, our by similar candidate to Simcia. And as I mentioned in the beginning, Simcia is a TNF inhibitor with 2 billion euro sales roughly. It has a niche position within the TNF inhibitor market. It's a market of about 40 billion euro. And of course we've seen quite a few by similars on the other TNF inhibitors, but despite that, Simcia is holding up its position and that's given its niche within pregnant and breastfeeding women, which is actually sizable niche within these indications. And what's exciting here is that we believe we can be the only by similar to Simcia upon launch. And of course that makes the whole situation more favorable when it comes to discounts versus reference product you need to offer in order to drive a meaningful volume market share. So this is a very exciting opportunity, we believe. And we've done some great progress, I think in the development. It's very difficult to develop and manufacture by similar where high production deal is required in order to get to commercially viable cost picture. We've been able to reach what we believe is required. Thanks to our patented platform technology. And we have had initial advices from both EMA and FDA, which makes us feel comfortable with the analytical profile of our by similar candidate. And as you know, we are working hard now to out license this program and find a suitable commercialization partner as we did with Intas for Xtivain. And we are in promising discussions with, I would say due diligence have come to an end when it comes to the leader in this whole process. And we are on track towards being able to close the deal during the course of this quarter. So that's clearly our ambition and target. So we hope to be able to get back with positive news in that direction within the near term future. With that said, I'm probably gonna hand over to Jane for a financial overview of the quarter.

Jane. Yes. So we can see that the revenue in the fourth quarter amounted to 66 million Swedish crowns with a gross profit of 61 million corresponding to a gross margin of 93%. On an annual basis, we see that the sales from out licensed products amounted to 132 million Swedish crowns and the 63.4 was generated from product sales. This resulted in a gross profit amounting to 180.5 million Swedish crowns with a gross margin of 91%. Total revenue for the year of 2024 reached 198.7 million Swedish crowns. The administrative expenses amounted to 10.1 million Swedish crowns for the fourth quarter and 40.1 million Swedish crowns for the full year. The main underlying expenses are related to personnel cost and normal activities. R&D expenses amounted to 80.8 million Swedish crowns for the quarter and 391.8 million Swedish crowns for the full year. The main activities are related to the upscale of ex-devain production volumes, the resubmission of the BLA to the FDA and the scale up of production processes for XB003. 78.9 million SEAC has been capitalized on a full year basis. The operating cash amounted to 94 million Swedish positive for the last quarter of 2024, which comprises of 115 million Swedish from an upfront payment from the INTAS Pharmaceutical Partnership for the ex-devain deal, as well as achieved milestones from Biogen. The operating expenses amounted to for the full year operating cash amounted to 133.7 negative million Swedish crowns. Cash from the investment activities counts for negative 17.3 million Swedish crowns for the quarter and negative 52.2 million Swedish crowns for the full year, referring mainly to the capitalization of Ximlusi and ex-devain development costs. From the financing activities, we have a positive 16.8 million Swedish crowns for the last quarter, which mainly corresponds to a bridge loan in the amount of 20 million SEAC that was settled in January of 2025.

Thanks.

So to summarize the fourth quarter, revenue generated of 66 million Swedish crowns during the quarter, key highlights, the license agreement around ex-devain with INTAS, progress of Ximlusi sales across Europe, big launch in 21 countries and continuing to see a growth trend of 20% quarter by quarter. And overall, if you compare towards viewport 2023, it's a little bit more than 200% volume growth. And then resubmission of the VLA of Ximlusi to the FDA. And looking ahead during the course of this year, what we are really focused on now, as I said, to conclude an out-license deal with XP 003, to navigate through an FDA approval for Ximlusi, which is gonna be branded LUCAMSI in the US and to together with INTAS, initiate a clinical trial for ex-devain. And then of course, to work closely together with Stada to continue the strong growth trend of Ximlusi across Europe and additional territories. So with that said, we can move over to the Q&A and start to see if there are any questions on the ones who called in.

If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Qian Hun Li from Pareto Securities. Please go ahead.

Hi, good afternoon and thanks for the update. Just have some quick questions regarding the account payables for 242 million SEC. Can you elaborate a bit on your payment schedules? Thank you.

Yes, we have agreed payment plans to three of our main suppliers, which constitutes the bulk of these accounts payables where we made a certain payment just after year end, so in January, and we're now making gradual payments to these three main suppliers.

Okay, thank you. And maybe another question regarding the upfront payment from Intel, so the remaining part is expected to be recognizing by Q2, is that correct?

Yes, it's gonna be recognized up until May this year.

Okay, all right, thank you very much.

The next question comes from Philip Enersen from Redeye. Please go ahead.

Hello everybody, thank you for taking my questions. So I wanted to start on the Valorum topic. And can you explain why you haven't received the upfront from Valorum yet and what topics are the current negotiations on? Thank you.

Yes, so it has been related to ongoing refinancing or financing of Valorum, which has made an inability for them to pay the upfront as agreed in the license agreement. And then as a consequence of that renegotiation of the license agreement has been initiated, is yet not concluded, but I do believe it's gonna be concluded in the near term future, which essentially is meant to create more financial room if you will for Valorum to carry through the preparatory commercial activities for an upcoming launch of this program, given the financial resources they have at hand. And as a consequence of that, significantly increasing the royalty rate for X-Brain and Stada.

Okay, so we have a few more. Could you also tell us what is your view on the US running this amount of opportunity in light of the sample reasons taken?

Yeah, no, I think we still view it as a very significant market opportunity. The volume is there definitely. I think what the Sandos News shows is probably that the discounting or has been a little bit higher than anticipated or pricing has been going down a little bit quicker than anticipated. And although I think they've said that they're gonna get back on the topic, I think our read on it is that they are withdrawing the product from the market to reintroduce it with kind of a resetted ASP, if you will, which then determines a new reimbursement level. That's my read on the situation. And as far as I can tell, it's not impacting our overall view of the market opportunity. We still believe that it run a business in itself and then going beyond from that, the whole Aelia market and the current off-label Avastin market poses combined very good market opportunity for our product, Ximenozir Lucamse was gonna be branded in the US.

Okay. When do you expect the pre-filled syringe to be launched, really?

We're still working on the syringe and we are targeting to get towards an approval during the course of the year in Europe initially, and then we need to take that further on into other territories such as the US subsequently.

Okay. Okay, and the last one, if I may. And that is from a liquidity point of view, how far will your current cash take you?

Well, I think what we now need to do is that we need to get a deal done with XP-003 during the course of this quarter as we've communicated in order to be an expected upfront payment from such an arrangement, secure the company's need for its further working capital requirements.

Okay, thank you for taking my question. I'll stop with updates.

Thank you.

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. There are no more phone questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

Oh, from the written questions, I see we have questions regarding the upfront payment which you have addressed, and also a question with regards to the syringe which has also been addressed.

Yeah, and I can comment also, there's a mention about buy again. There was a milestone expected to come in of five million US dollar from buy in subsequently. We had a discussion with them and agreed upon an immediate payment by half of that milestone. So that's why we took a credit loss also on 2.5 million US dollar in relation to that milestone.

And can you present some big differences and similarities between X-Brain and just EvoTech in which situation does X-Brain have a stronger position?

I think what we really have focused on from X-Brain's perspective, and where I really do believe we have a competitive advantage is related to our platform technology, which I feel confident in that it provides us with a higher proactivity if you will, or yield in the expression of the targeted antibodies and leading to a low production cost. And I think we can see at X-B003 or SimCyobio simulacanidate as a testament of that. We are the only one or one of the very few developers of a simulacanidate to SimCyobio where you really have a challenge in getting to high productivity or high production yields on a fairly difficult to produce antibody fragment in this case. So I think this demonstrates the potential of our platform technology and our focus. And I do believe that the production cost is in this market going to be more and more important. And therefore I do believe that X-Brain and our platform technology is going to become more and more relevant within the space.

So we have received another question with regards to Biogen. I think that was addressed.

any other questions or JonovianRG Yabajian

we addressed. Okay, will you publish a summary of Q&A after the meeting? Yes, we think we have done that in the past, but maybe not in the most reasonable or recent courtly calls, but that we can certainly do.

Okay, let's see here. Another question.

How will the outlicensing of products affect the profit and loss this year? Well, too early to tell. We have certain revenues, as we talked about from the upfront payment from INTAS, which is going to be partly recognized during the course of this year. We are hoping and expecting on an outlicensing of XP-003, which we also do believe shall lead to revenues being recognized during the course of this year. We also have milestone payments expected from INTAS, so we believe that outlicensing or license fees, generally speaking, are going to contribute in a meaningful way to revenues during the course of this year. They come in that sense at 100% gross margin, if you will. So I think we'll have a quite good contribution from license fees during the course of the year. It's hard to say at this point in time, though, exactly what the amount it will be.

Okay,

let's see. I think there's another question on buy-in. Did we address that? Why the buy-in payment was halved? I think we came into a certain dispute with buy-in with regards to to which extent the milestone had been completed or not. And I think in the light of that, we were also in need of rather quick payment and resolution. So that, I think, was the background to the agreement on taking an immediate payment of half of the milestone payment. The pre-fits arranged, we have addressed that. Okay, are you planning to reduce your company costs? If so, how? We did a cost reduction program in end of 23. We introduced that one and we've seen the results of that during the course of last year. And we are continuously after that looking very carefully at our costs. But we need to balance that versus making progress on the respective different programs in order to be able to generate revenues and income that goes across all the programs essentially. So it needs to be balanced, but we work very consciously looking at the cost picture.

Good. Okay.

I think that probably concludes the Q&A. There's a question about cash flow, timeline of cash being cash flow positive. And actually, as you probably can see now, also fluctuates from quarter to quarter based on a slide which Jane showed where actually there was a positive cash flow during the course of Q1, but that was driven by by and large by upfront payments from Intas coming in. So it's going to be fluctuating, I guess, actually based on certain such events. But we're also seeing that the cash being generated from sales in Europe from Stada is progressing. So that will contribute more and more in a meaningful way. And also we have the expected upcoming approval of Kimlis in the US, which also then is expected to contribute from a cash perspective in a meaningful way via milestone payment from a part of a loan, but also prepayments of goods to be shipped. So it's a little bit hard to predict at this point in time, so we're going to have to get back to this question. But it's also going to be fluctuating a bit during the course of the year due to this kind of event such as out licensing.

Would you say that the Stada sales activities in the European Union for Ximena are progressing as planned?

Not as they were initially forecasted upon launch. But when we reset the whole sales plan, Q3, 2023, then that plan is now followed and we see volume growth, which are in line with the expectations which were set back then.

I think that was the last question.

Good. OK, then we thank all of you who listened in to this call and those of you who put forward questions. We are, as there was a question here, going to provide transcripts to the Q&A and put them on our web page. So with that said, thank you very much. And we're here. Should there be any further questions? Thank you.

Thank you.