Xbrane Biopharma AB (publ) (STO:XBRANE)
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Earnings Call: Q1 2023

May 31, 2023

Martin Åmark
CEO, Xbrane Biopharma

Hello, welcome to Xbrane Biopharma's presentation regarding Q1 report of 2023. Really to start with, this was a transformational quarter for Xbrane. It was the quarter when our first pharmaceutical product, Ximluci, was launched in Europe, and we started to generate revenue from this product. That puts us on the trajectory towards becoming cash flow positive in 12 months' time, and then going towards generating EUR 100 million from this product annually in three years' time. That's our ambition stated since a couple of years back, and an ambition which we stick firmly to. Looking at the quarter, I think we delivered what we set out to do.

We had an approval in U.K.. for Ximluci in January that came in addition to the approval we received from EMA for EU in November 2022. The product, Ximluci, was launched in March, and by our partner, STADA. We'll talk more about that during the presentation. I think the launch went well, and we were able to announce one big frame agreement to which STADA won with NHS England. We also submitted our biological license application to the FDA in April.

We also, in May, arranged a financing of about SEK 350 million in terms of a convertible and a direct share issue, and that is really capital, which now will take us all the way to cash flow positive stage in 12 months' time. Just as a reminder, the portfolio of biosimilar candidates we have under development, of course, first, Ximluci, our Lucentis biosimilar, which now is launched in Europe, and we're seeking approval in the U.S. Here we are partnership with STADA and Boehringer Ingelheim, from a commercialization perspective. Coming to our Cimzia biosimilar candidate, which goes under the name BIIB801. We have a global license agreement with Bayer. Our three oncology biosimilar candidates, Opdivo, Keytruda, and Darzalex.

Just a brief update here, because we're gonna spend majority of the call on Ximluci, but just to mention a couple of points on our Cimzia and Opdivo biosimilar candidates. I think we made good progress here. For the Cimzia biosimilar candidate, we are in the process of scaling up and producing a clinical material, which we're doing during the course of this year. That is then gonna result in, I believe, significant revenue generation during the course of next year in terms of selling the clinical material to Bayer and as per our license agreement with them, and also collect the first milestones.

As you might recall, the deal we have with Bayer consists on Xbrane having the responsibility of the preclinical development, and then Bayer is responsible for the clinical development. We have the hopes of being able to complete the preclinical development during the course of this year, and then turn this program to a positive cash flow generating program during the course of next year. We're quite excited about our Opdivo biosimilar candidate, Xdivane. Here we have now signed up a contract manufacturer for scale-up and the production of clinical material. It's a process which will be going on during the course of this year and next year in order to be able to take this product into clinic in the beginning of 2025.

What we have to do in order to get to approval and launch in December 28, which is when the U.S. patent lapses. We have a stated ambition of signing a license deal with a suitable commercialization partner during the course of this year, and we're confident in being able to deliver on that, as we have a couple of ongoing discussions with interested parties. Something we are looking forward to be able to get back to you all during the course of this year. Back to Ximluci. Here is the development timeline. As I mentioned, launch has taken place in Europe, and we hope that we're going to get an approval in the U.S. in approximately 12 months' time.

Then being able to support the launch by Boehringer Ingelheim over there. In parallel, we're expanding geographically beyond Europe and the U.S. We've submitted a file to the regulatory authority in Saudi Arabia. We're going to submit the file to additional countries in Middle East, and then going beyond that, the process which we do together with STADA. In parallel here, we are also working on scale-up of the production process for Ximluci, which significantly is going to increase our capacity and also further reduce our production costs. This is very important, 'cause we believe that during the course of this year, actually, our production capacity is what's going to put a limit to the sales we're going to be able to generate.

Next year, we expect to be able to go on to tenfold increase our production capacity, working at larger scale on drug substance process. I'm convinced with that scale, we're going to have the best capacity in the industry amongst the Lucentis biosimilar. Very important investment for us. Also in parallel, we're working on them. In addition to the now approved and launched vial, a prefilled syringe, which we hope we're going to be able to launch towards the end of 2024. Now, getting back to progress on the launch of Ximluci in Europe. Europe alone is a very significant market opportunity, EUR 4 billion market, looking at it as VEGF inhibitors for ophthalmic purposes.

Launch took place, as I said, in March, by STADA. The two most important countries right now is the U.K. and Germany. In U.K., STADA's U.K. affiliate won a framework agreement with the NHS England, and this is an agreement with supply of ranibizumab to value up to GBP 70 million. This was awarded together with one other supplier of ranibizumab. It's a very big and important win for STADA, and a very important opportunity for us together with STADA, to be able to generate, of course, significant early sales for the product, but also to be able to contribute in a positive way to patients in the U.K., and realize savings to the healthcare systems.

This runs during the course of 12 months, really, but with an opportunity for prolongation beyond that as well. Beyond the U.K.., Germany, of course, is a very important market. That's really the home turf of STADA, and they're working very actively here in participation at the different conferences, participating in tenders, which are kind of more fragmented, if you will, compared to the U.K.., on hospital or classes of hospital levels, and then working with dedicated field sales force to talk to the different stakeholders and ensure an adoption amongst prescribers to the benefit for biosimilars, generally speaking, for Lucentis, but then specifically for Ximluci.

Apart from U.K.. and Germany, the product has been launched in select smaller countries, and it will be continued to be launched across multiple countries during the course of the year as well. It's really about now, with the volume we have of product, allocate that to the best possible opportunities gradually over time. That's really what we're working towards during the course of this year. Looking at the revenue generation from Ximluci is to clear this so everybody understands then our P&L in a correct way. We're really generating revenue from Ximluci in three different ways, according to the agreement structures we have in place with our two partners, STADA and Bausch + Lomb.

First, we are under these agreements, responsible for supply of finished goods to our partners, and we do that at cost, really, under this supply agreement. That's one revenue stream. We're getting profit sharing from our partners. With STADA, we're getting 50% of the profits generated, calculated as really the STADA's net sales of the product, minus the production cost, minus their sales and marketing expenses. From Bausch + Lomb later, it's a percentage of gross profits generated, which we take part of. The third bucket is really license proceeds, which are relevant under the Bausch + Lomb agreement, where there are milestones to be collected on FDA approval and U.S. launch.

There's really these three sources of revenue. If I look at the Q1 numbers, we had SEK 47 million coming from supply of finished goods to STADA. I think what's important to note here is that we're going to deliver a product to STADA throughout the year, probably delivers with two to three months frequency. We really see that STADA is not going to build up significant safety stock on a finished goods level during the course of the year. We expect that what we deliver will actually be sold during the course of the year. Profit sharing during the course of this quarter was SEK 1 million.

I think what is very important to note here, and actually one of the key takeaways from our reporting here, is that the product is actually profitable already from day one at this rather or relatively small volumes, which we had during the weeks in March, when the product was actually launched. If you think about the sales and marketing expenses, a large portion of that is actually fixed cost in terms of the sales force, which STADA has established, which is a dedicated sales force specifically for this product. With these relatively low volumes, we're already generating profit from the product. I think that's very important to note here. That's, I hope, is explaining the numbers a little bit better here.

If I then turn into coming 12 months, what we are targeting to deliver upon are the following things: Of course, to continue to work with STADA to establish Ximluci as the leading biosimilar to Lucentis in Europe a nd then to navigate the process with the FDA and obtain an approval in the U.S. in 12 months' time or so. That's the second thing, a nd then the overall further geographical expansion of Ximluci together with STADA in the Middle East region and then beyond. That's also a very important component here.

As I said, with in relation to, our other programs, for our Cimzia biosimilar candidate, it's really about producing the clinical material and hand over this development program to Biogen for continued clinical development. Actually, this is going to be very important for us for 2024 from a revenue generation perspective, as we're selling this clinical material and also collecting milestones from Biogen during that year. To sign a deal with a suitable commercialization partner for Xdivane, an Opdivo biosimilar candidate. That's also a very important deliverable for us. All this together shall bring us to cash flow positive stage in first half of 2024, then our clear expectation and ambitions is that this, from that point and onward, shall be a profit-generating company with positive cash flows.

That's probably all from me, and I hand over therefore to Anette, our CFO, to go through the numbers in a little bit more detail.

Anette Lindqvist
CFO, Xbrane Biopharma

Thank you, Martin. As Martin just said, we can today celebrate the first commercial sale in the history of Xbrane, with the revenue stream from Ximluci of SEK 48 million versus then zero last year. We also have some out-licensing money, as also Martin mentioned, that's SEK 14 million, but that's solely an accrued income coming from the Biogen deal for BIIB801. This accrual will remain until Q2 this year. Then the next milestone from Bausch + Lomb will happen at the FDA approval. Looking at our expenses, those of you who listened in a couple of times, you are familiar with this slide.

It shows our total operating expenses, with also the capitalization element, which tend to impact, kind of, and understand the reading of our e-expense development. Comparing a like-for-like, year-on-year, our total operating costs have increased by roughly 3%. That is, you can also see on the red on the red area, the capitalization element has significantly decreased. We started to capitalize Ximluci as of July 2021, when Ximluci met the equivalence criteria. The total revenue, including capitalization, is SEK 76 million, or around about 84% of our total spend. The G&A build is really set up the organization to enable growth of the company for the future.

Last, Ximluci is now worth SEK 1.8 million sitting on the balance sheet, this, of course, is also the Q1 where we started to amortize on that element. What you see in the P&L as reported, you see, of course, a totally different picture. You see a 60% growth of the expenses. That's a very different picture, that is due, as I said, for Ximluci moving into the more commercial phase. The remaining R&D costs are mainly out of outside Ximluci, is really the production of the clinic material for BIIB801, also advancing the development, the preclinical development for our remaining oncology portfolio. Looking at the cash position, we left the quarter with SEK 119 million in cash.

This now, however, combined with our financing solutions of SEK 350 million, we deem enough to take us to cash flow positive position in the first half of 2024. We also see an interesting diagram to the right, we can see kind of the operating cash flow, and we see that we almost leveled out in Q4 2022, as we have just paid significant amounts in prepayments to CMOs. We have prepayment to CMOs for SEK 123 million. Another SEK 55 million in raw material. It's too early to talk about a trend, but clearly, that is what we expect to happen for the next coming quarters. A few details also around the bond.

The first one is around the number is SEK 350 million. It's SEK 225 million, roughly, net proceeds from the convertible, and SEK 125 from the direct to share issue. The counterparty CVI Investments, an affiliate of Susquehanna International. The principal amount is SEK 250. Its maturity is four years from closing. Interest rate is 6% per annum, but noticeable that following the FDA approval, expected in next year, it will be zero. It will be paid in 24 equal installments. It's up to us, Xbrane, to choose if we want to pay in cash or equity. Also the investor has the right to accelerate the amortization.

With this, we would like to really express a big thank you to all our shareholders, new and already existing, and express our trust, and express our thank you for your trust and support of the company. We will do, surely will do our best to spend that money in the best sensible way, in executing on our business plan. Looking at the team, we have grown the team significantly over the last couple of years to set up the company for future growth and also moving into a more commercial phase. Now, we expect this to flatten and to reach almost a steady state at around about 90 to 100 employees.

We feel that's an organization that is that could sustain the growth of the company as we now stands. Last one is also looking at our, the team from a different standpoint, from equity and diversity. It's really a reflection of our values, which are really important to us. The gender distribution of employees is 58% women and 42% men. In the leadership team is 50-50. We have 36% of the team has a PhD, as we are a research-focused organization. Also the last one, in terms of diversity, as described here as a country of birth description so 41% of the team is born somewhere else than Sweden. That is something that we are also very proud about.

With that, I think that was the last slide. Over back to you, Martin.

Martin Åmark
CEO, Xbrane Biopharma

Yeah. That was the formal presentation, and we're therefore open up for potential questions.

Operator

If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Sebastiaan van der Schoot from Van Lanschot Kempen. Please go ahead.

Sebastiaan van der Schoot
VP Equity Research, Van Lanschot Kempen

Hi, good morning, team, and thank you very much for taking my questions. Congrats on the sales, first sales. I'm wondering on the Ximluci sales, can you talk a little bit of what your vision is on how the sales trajectory will be over the remaining of the year, in how many regions Ximluci currently available, and what countries are anticipated to be added over the course of 2023? If I may ask another question on that topic. You just mentioned that the production capacity will be increased by 10-fold. Is that expected to be a single step, or will that be more gradually be done over the course of the year?

Can we then also expect that the deliveries to STADA will be also increased with every single delivery over the course of the year? Thank you.

Martin Åmark
CEO, Xbrane Biopharma

Okay, I'll try to answer to that question. With regards to specific guidance on revenue generation for Ximluci, we put up the target of EUR 100 million in three years' time. We haven't provided any guidance for the years in between. We feel confident to get there in three years' time. I think probably the best one could do is to assume a linear progression towards that overall goal. Looking at Europe, as I talked about, main countries now are U.K. and Germany, but also, you know, some smaller countries the product already has been launched in.

This is now gonna be broadened to the majority of the European countries during the course of 2023, and we want to get back to specifically launches in, let's say, the remaining three major European countries. Second part of your question, which was related to deliveries to STADA. I think you can expect that this will increase over time as we are delivering ever-increasing volumes of products, I would say, to support the market. As I said, we expect that the deliveries will be taking place every two to three months or so. With that frequency.

Sebastiaan van der Schoot
VP Equity Research, Van Lanschot Kempen

Great. Thank you very much. A single question on Cimzia. Can you give some color on how the scaling up activities are going, whether there's also a milestone associated with creating the first clinical batch for clinical development? Whether there's that such a milestone is anticipated to still fall in 2023?

Martin Åmark
CEO, Xbrane Biopharma

Yes. We're working intensively together with Biogen, of course, but also with our contract manufacturer, AGC Biologics in Seattle, for the scale-up. We're doing the first so-called engineering batch here in just a couple of months, and then post that, GMP batches, which then are going to be used for clinic. So far everything is going well, and we've demonstrated with Ximluci that our platform indeed is scalable. We also gained experience, of course, with scale-ups of this sort from Ximluci. We're confident that this will go well, and we'll be able to deliver a clinical material in time.

Yes, there is a milestone, triggered by successful scale up, if you will, or production of clinical material, where we also can demonstrate similar analytical similarity to the originator, as we demonstrated with a material from our internal pilot scale process.

Sebastiaan van der Schoot
VP Equity Research, Van Lanschot Kempen

Okay, great. Thank you very much.

Operator

The next question comes from Filip Einarsson from Redeye. Please go ahead.

Filip Einarsson
Equity Analyst of Life Science, Redeye

Okay. Hello, everybody, and thank you for taking my questions. I want to start with if you could more elaborately give us a walkthrough of the expected flows between Xbrane and STADA. I mean, you touched upon this earlier, but I mean, even more elaborately, how will this look over the course of the year? I mean, considering this initial deliveries to STADA.

Martin Åmark
CEO, Xbrane Biopharma

I think, as I said before, we're not going to provide more specific guidance at this point in time. I think really one will have to point the eyes towards this EUR 100 million revenue generation in three years' time, and then really, I think the best possible assumption to make is a linear progression towards that level. It's also a question which we are going to get back to during the fall. Whether we're going to be able to provide, you know, count year by year guidance on the sales, but that's something we'll need to get back to. I think that's the best assumption one can make.

What I said also is that it's really now about, using the volume which we're producing with the capacity we have, and direct that to the best possible opportunities in the market, something which we are 100% confident in that, STADA can do and is doing in, the best interest of, well, STADA, but also Xbrane's shareholders.

Filip Einarsson
Equity Analyst of Life Science, Redeye

Okay, got it. Will you report any sort of KPI related to, like, the amount of patients treated or doses sold or anything in the future?

Martin Åmark
CEO, Xbrane Biopharma

Yeah.

Filip Einarsson
Equity Analyst of Life Science, Redeye

The sales price, for example.

Martin Åmark
CEO, Xbrane Biopharma

Exactly. What we hope to be able to to share, we're working on that, is IQVIA data in relation to units sold and, you know, aggregate value sold, where one could follow that and also follow market shares. You know, looking at it as the ranibizumab market or even more broadly, VEGF alpha inhibitor market for retinal purposes. This is something we have the ambition to be able to share with you, starting from next quarter, is data which is lagging a little bit. Also now the product for Q1 was on the market in March.

It's a little bit too early, but that's something which we have the ambition for sure to be able to, you know, report and communicate to all of you, for Q2 report in onward.

Filip Einarsson
Equity Analyst of Life Science, Redeye

I was also wondering if you could provide sort of a broad comment on your view of the launch so far, if everything is going according to expectations or even above or below, or what can you say?

Martin Åmark
CEO, Xbrane Biopharma

No, I think it's as per our expectations, we were very happy, of course, with the framework agreement with NHS. That, you know, couldn't have been in our plan, but of course, you have these different tenders with a certain probability, right, in the plan, and some materialize, some don't. I think so far it's working according to our plan, and we're very happy to be able to support these very significant volumes to patients in the U.K. under this agreement.

Filip Einarsson
Equity Analyst of Life Science, Redeye

Okay, one more, if I may.

Martin Åmark
CEO, Xbrane Biopharma

Yeah.

Filip Einarsson
Equity Analyst of Life Science, Redeye

I'm curious about the recent capital injection. Can you comment on was there any particular reason you did this ahead of the anticipated acceptance of your BLA submission to the FDA in June, or something on that could be helpful?

Martin Åmark
CEO, Xbrane Biopharma

Yeah, well, the BLA was submitted when we did the capital raise. We're now expecting to get it validated and have a filing decision mid-June from FDA. Something which we are absolutely confident in will happen. We've had an intimate dialogue with the FDA throughout this year since we had to withdraw the previously submitted BLA. We're sure that we have been able to address all the concerns and, let's say, information gaps which if they had in relation to the application. When it comes to the timing of the financing, as you typically do, we've been exploring different ways of financing the business up until cash flow positive stage.

As soon as we had come to a conclusion, what we believe would be the best financing for the company, we decided to go ahead and execute. I think that's the most prudent choice to do, since you never know, well, ever, and specifically in these market circumstances, how the sentiment can change in capital markets. I think it's just best that when you have come to conclusion of what you want to do and find a traction for such a transaction structure, it's just best to go ahead and do it.

Sebastiaan van der Schoot
VP Equity Research, Van Lanschot Kempen

Okay, perfect. Thanks.

Operator

There are no more questions at this time on the teleconference, so I hand the conference back to the speakers for any written questions from the webcast.

Martin Åmark
CEO, Xbrane Biopharma

Yes, let's go ahead with the first question in the chat here. What will be the timing of a profit split when it is accounted for? We are going to account for our part of the profits generated within the specific quarter when it was generated. Are we getting a report from our partner, STADA, of course, after the quarter has ended, we then invoice upon that report and get paid but the revenue recognition is within the quarter when the profits actually were generated. How indicative is this for the future? Would you be able to indicate how you expect the sales to develop during 2023? I think this is a question we've covered so far in the call. You mentioned capacity increases in 2024. Will this result in any payments to the producer?

Will this change your average production cost? Yes, this is an investment, we're essentially producing three batches, validation batches at the larger scale with our contract manufacturer. It's triggering, of course, a payment, and that was also one of the use of proceeds of the recent capital raise we did. These validation batches, which we do at larger scale, we can later commercialize once we've had the regulatory approval for that larger production scale. The regulatory approval is just a variation to the existing approval, which you get on the basis of an analytical comparison of the larger scale versus the currently approved scale. We expect to be able to commercialize these validation batches during the course of 2024.

Yes, indeed, this scaler will significantly further decrease our production costs, which is going to be very important, of course, since this money is trickling down to bottom line for us and STADA. Okay, next question here. When you target cash flow positive Q2 2024, does this also take into account the amortization of the principle for the convertible, assuming all settled in cash? Do you plan to pay it all back in cash rather than equity, if everything goes according to plan with Ximluci in the U.S.? Yes, we expect to be cash flow positive, even considering payback of the amortizations in cash. We are going to evaluate upon each amortization, whether we're going to pay back in cash or shares.

I think it's going to be dependent on how we're progressing towards our plan and also, I think the strength of the share price. The default in the agreement is to pay back in cash. Okay, next question: What is your volume capacity at the moment for Ximluci in Q2 to Q4 2023 relative to Q1, given your mostly sold product in March before you scale up in 2024? We have, at the current scale, the capacity definitely to track towards this EUR 100 million in sales in three years. At the current capacity, we can track towards that in 2023 and 2024, but we need a larger capacities and then to be able to really take the last step in 2025 towards that towards that level.

Next question. With BIIB801, what milestones and costs are you expecting in the rest of 2023 once shifts to Biogen? As I said, after the preclinical development production of clinical material, we hand over the responsibility to Biogen for continued clinical development. At that point in time, we expect no further costs for xpend in relation to that development. We expect rather significant revenue generation from actually sales of the clinical material to Biogen as per the agreement we have in place, but also collection of milestone from Biogen triggered by successful scale-up. Okay, next question here. You mentioned hope to sign Xdivane agreement in 2023, what are the likely timings for Keytruda and Darzalex biosimilars? Now, yes, we target now an out-licensing of Xdivane, our Opdivo biosimilar candidate during this year.

Keytruda and Darzalex biosimilars are probably three to nine months behind the Xdivane biosimilar candidate. We've realized that although we had before the ambition to do more of a portfolio deal with all these three products to suitable commercialization partner, we realized that that is even for companies we like to partner up with a rather big engagement, and we believe it's then better to split this up. Even though we're partnering for Xdivane with a partner who's also interested in the other two products, it could be structured with options on the other two products or similar like that. The focus really now is to get the partner for Xdivane, since also, as I mentioned, we're now starting a scale-up and production of clinical material, which is a more capital-consuming part of the development.

Next question here. You mentioned the production capacity of Ximluci is capped in 23. Can you say how much revenue is that capacity limited corresponds? I think this question we answered to previously. Regarding Ximluci, can you comment on gross margins initially and going forward in 23 and 24, once you gain scale effects? That's a question we are not giving guidance on specifically. I think one can refer back to our Capital Markets Day presentation, when we talked a little bit more broadly about our strategy and long-term ambitions of the company. What we said then was that we have the ambition to add one new product annually to our portfolio, we plan to continue with our current business model of out-licensing at the preclinical stage.

If one assumes that we do similar deals like what we've done in the past, and modeling out the 50/50 arrangement we have with STADA, we believe when we get to this level of EUR 100 million of income generation from Ximluci, we will have an R&D expenditure of about EUR 50 million. At that level, generating very healthy margins still. We believe that this is a capital efficient and lean business model for us. Okay, next question here. Regarding Xdivane, which sequentially seems to be the third biosimilar line, is the intention now to sign a separate deal for this biosimilar, or is the intention still to make a deal for the entire oncology portfolio? Okay, this we answered to earlier.

Next question. Can you communicate more on Xcimzane development timeline, e.g., duration of clinical process and regulatory? As I said, we expect that Biogen will be able to initiate clinical trials during the course of next year, and we expect that the clinical development will take approximately two years and regulatory development, approximately one year. We hope that towards the end of 2026, the product could be approved and launched. Next question. Xbrane generated revenue in Q1 from Ximluci, but communicated launch in April. Could you clarify launch process a bit? Can we expect revenue to grow constantly or fluctuation during the next 12 months? One could expect constant growth of revenue generation during the coming 12 months. As I explained earlier, different sources of revenue.

Of course, now what we delivered from supply of product to STADA, one should interpret probably as products to be sold during the course of the coming two to three months, since I said that that's, roughly speaking, the frequency with which we're going to deliver product to STADA. That volume will or the deliveries will increase in volume, if you will. Also, of course, the product was only sold to the market during a couple of weeks, in March, and therefore, the part which is profit-sharing, one should expect will increase constantly during the course of the coming 12 months. Okay, next question. Could you clarify how revenue from Ximluci is treated in accounting? This deal is communicated to be profit-sharing, but Xbrane has, pro cost of goods sold.

How is this done in practice? Okay, yeah, we explained the revenue, sources of revenue, and we also talked about revenue recognition. It's really from supply of goods to STADA. When we ship to STADA, we also recognize the revenue in that stream, and then we recognize revenues in the quarter when profits were generated in terms of sales of the product by STADA. Cost of goods is really the production costs of the products that we shipped to STADA during the quarter. OK, next question. In the biosimilar industry, there is a move towards continuous production as opposed to batch, as illustrated by Sandoz Evotec partnership. Can you comment on your strategy with regards to that subject, please? Very good question.

Our key differentiator as a biosimilar developer is to have the lowest production cost on whatever biosimilar we choose to do. That's our differentiation. Currently, we have a platform technology which centers around how we genetically engineer the host cell for maximum productivity or yield, if you will. We're also, as part of, or as an outcome from our strategy process last year, executing on other aspects, such as different process technologies, which could lead to lower production cost. One of those is continuous production, where we've started an internal initiative and recruited talented professionals within this field. We're starting to develop a platform around continuous production to be leveraged for the product where we believe it makes sense.

We're also discussing with companies out there, which have different platforms and technologies for continuous manufacturing and seeing whether we could be having partnerships around this element, which for some products, particularly products of high volume, could be valuable from a production cost perspective. Okay, next question. Can you walk us through the fact that you had SEK 47 million in sales and almost the same in COGS? What kind of gross margin do you expect in a stable situation, for example, within three years? Exactly. That was a little bit what we went through in the presentation, that a big part of the revenues from Ximluci was delivered to store our finished goods, for which we compensated at cost, essentially.

SEK 1 million of the revenue generated was profit sharing. I think that's worth to note and a big takeaway here, that we're actually generating profits even at this relatively low volumes, which actually were sold by STADA during the few weeks where the product was on market in Q1. Of course, the margin will significantly increase over time. I mean, as you can imagine, as I said, sales and marketing expenses on STADA side is to a large portion fixed, and therefore for Q1 are rather high as a percentage of their net sales. Of course, that percentage will decline significantly over time when we get the scale effects. Okay, next question. Your reporting of Q1 is two months after end of quarter.

Any reason for this late reporting, and do you have any plans for reporting earlier? Indeed, and we during last year, were reporting earlier, we've decided to have a financial calendar during this year in a reporting two months after the end of the quarter. This is just because we are coming into this new phase for the company, with revenues generated from sales of Ximluci and to make sure we're going to be able to have a date for release of the quarterly report, which we can stick to and deliver upon.

I definitely believe that we're going to be able to shorten this time, maybe even during the course of this year, but definitely for next year, as we have all the processes in place to get the report in place in a shorter timeframe. Next question. Congrats to the first phase of Xlucane. Do you have any forecast for full 2023, 2024? This we've covered. Next question. I'm translating to English here. Congratulations to strong report, sales of SEK 48 million from Ximluci. How is it accounted for? Is this money from STADA's sales? I think this we've covered during the course of the call. Next question. Can you describe the sales process at larger markets?

Are the sales going through big orders to pharmacies or regions? How does it work? Does it differ between markets in Europe? First, it differs a lot from different markets in Europe, and maybe it's best here to comment a little bit further on U.K. and Germany, since these are the two most important markets here and now, and also are different in a way. In the U.K., it's really a payer-driven market, where NHS issues tenders, which was the case for NHS England, which STADA U.K. affiliate was part of winning. That kind of puts the frame. It's still a multi-winner tender process, and I think most countries have decided to go for multi-winner tenders because it promotes more of a sustainable industry with multiple suppliers.

Of key concern, of course, for the buyers is to be able to secure supply to the respective markets. This was a multi-winner tender, which STADA U.K. affiliate won together with one other supplier. Now, after that, there's still a sales process where the sales force needs to speak to the different so-called trusts under NHS. These are organizational entities consisting of one or multiple hospitals. There is still a sales process that needs to take place, and then the hospitals call on volume from one of these two suppliers, STADA and the competitor, according to the framework agreement, where, of course, pricing and deliveries and stuff like that are dictated. That's kind of U.K..

In Germany, it's also tender processes, but more fragmented, as I think I mentioned, more in hospital or cluster of hospital level. I would say that it's more of a market where the payer puts the framework in a way, but the decision is more strongly with the physician. Here it's a work after you winning a tender, with a certain hospital, to work with the prescribers and making them comfortable, of course, in using a biosimilar. Speaking about the clinical data, where we've demonstrated equivalent efficacy and safety and also to make them comfortable in using that more cost-efficient alternative.

That's an ongoing process, but I would say a country where actually the physician has a stronger decision power in comparison to the U.K.. That's kind of two alternatives. There's everything in between across Europe, but this is why it's key really for us to have an experienced commercialization partner, such as STADA, who have boots on the ground in all the countries and know how they work and are able, with the established, dedicated sales force, to work efficiently in each specific market despite their differences. That concludes also the questions that we had coming in over the chat. Let's just check in if there are any further questions coming in from people calling in. Otherwise, we're going to be closing the call.

Operator

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

Martin Åmark
CEO, Xbrane Biopharma

Okay. We thank all of you who listened in and for asking great questions, and we are hoping to able to speak to you again, if not before, when we release Q2 report in August. Thank you very much.

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