Bactiguard Holding AB (publ)

Thank you, Operator, and welcome everyone to Back to Guard's presentation of the first quarter of 2026. Patrick and I will go through the presentation together today. I'll start with an overview of the quarter and our strategic progress, and Patrick will then walk you through our financials in more detail. We will, of course, open up for questions at the end. The title of today's presentation is Building Momentum Through Partnerships, Regulatory Progress, and Organizational Strength, and that reflects how we view this quarter, not driven by a single event, but by continued execution across several areas that are important for Back to Guard's long-term development. I'm actually joining you today from the U.S., where the Heart Rhythm Society meeting starts in Chicago later today. And with that, let me start with a high-level overview of the quarter. Next slide, please. Starting with the key figures and highlights, from a financial perspective, we delivered continued profitability with adjusted EBITDA of 4.9 million SEC. Reported revenues were lower compared with the same quarter last year, and we will come back to the underlying drivers behind that as we move through the presentation. Strategically, however, the quarter has been an important one. We saw increased sales of back-to-guard coded products across our collaborations, and BD has initiated sales of the back-to-guard coated Foley in parts of Europe, marking another step in expanding the reach of our technology. This was also the first reported quarter under the updated business setup with Zimmer Biomet that we announced in late December, and which has been an important transition point for that partnership. During the quarter, we also continue to invest in regulatory-related activities, which are critical for supporting both existing partners and future collaborations. and we delivered a solid performance in our wound management portfolio with Hydrosyn Aqua continuing to be the main driver. Overall, this reflects the steady execution of our strategy, even in a quarter where reported numbers continue to be impacted by external factors such as currency. Next slide, please. Our focus remains on a defined set of strategic therapeutic areas. orthopedics, vascular access, cardiology, neurology, and urology. These are areas where the unmet medical need is clear and where our technology has the potential to deliver both clinical and commercial value. During the quarter, we maintained a high level of engagement across all of these areas. These include early stage discussions with potential partners, work in application development areas, and technical evaluations, again, with potential partners. An important part of this engagement has been our presence at multiple international congresses where we meet with potential partners and with clinicians in the field. These interactions have been critical for building relationships, understanding our potential partners' needs, and validating where our infection prevention technology can create the most value, thus allowing us to initiate meaningful discussions with potential relevant partners. And this is one of the reasons why I am in Chicago. As it takes typically several years from development to commercialization, we should not expect all of these early stage activities to translate into significant short-term revenues, but they are essential for building a pipeline that supports our long-term growth in our licensed business. Next slide, please. Turning now to our partnership with BD. This is a long-standing relationship that continues to evolve and expand the reach of BD back-to-guard coated Foley catheters into new markets. During the quarter, sales of the back-to-guard coated urinary catheters began in parts of Europe, and preparations are ongoing for further expansion into additional markets. A key element of this expansion is our close operational collaboration with our partner BD. During the quarter, back to guard teams have been involved in training and support activities together with BD, particularly for new markets. This includes project education, technical training, and support for both distributors and BD sales organizations to ensure that the clinical value of the coded Foley catheters is clearly understood. These activities are an important part of how we work with partners across the entire value chain. not only licensing our technology, but also actively supporting successful market introductions. While revenues from the BD Partnership were lower in the quarter compared with last year, the underlying momentum remains positive, and we continue to see in-market unit sales growth of back-to-guard coded FOLIs. The partnership is strategically important for both of us, and we continue to see long-term potential as additional markets come online. Moving on to Biomet. As mentioned earlier, this quarter represents the first reported period under the updated business setup for the ZNN back-to-guard trauma nail system. The focus during the quarter has been on two main activities. First, advancing the MDR transition in Europe, which is a necessary step to ensure continued and expanded commercialization under the current regulatory framework. And secondly, continuing post-market clinical studies, These studies are also critical for strengthening the clinical evidence base and supporting future commercial developments. While this existing phase in the Zimmer Biomate Partnership is about building the foundation more than delivering immediate volume growth, it is an important step towards increasing transparency and predictability in our revenues over time. Beyond the operational progress, I want to emphasize that the collaboration with Zimmer Biomed remains constructive and forward-looking with a shared commitment to strengthening the clinical and regulatory position of back-to-card coded trauma implants as a meaningful pillar in the Zimmer Biomed infection prevention category. Next slide, please. Turning to wound management, The portfolio delivered a solid performance in the quarter with Hydrus and Aqua continuing to be the main contributor while Sutra sales are now stabilizing. Revenues were lower compared with the strong first quarter last year due to periodization effects of certain tenders in certain markets, but the underlying development does remain positive. During the quarter, we continued onboarding distributors entering new markets and received encouraging feedback related to both demand and clinical relevance of our products across both our existing and our new markets. We also continued activities related to MDR for this portfolio as well and ensuring that the portfolio is well positioned to support future growth. When management remains an important complementary part of the back to guard portfolio, providing diversification and opportunities to apply our infection prevention expertise in additional areas. And with that, I will hand back to Patrick who will take you through the financials in more detail.

Thank you very much, Christine. For Q1, we report lower revenues while continued EBITDA profitability and positive momentum across our businesses despite timing effects. In short, we deliver an adjusted EBITDA of 4.9 million and a margin of approximately 11 million versus 15, sorry, of approximately 11% versus 15% last year, explained by a lower revenue quarter, notably on BD due to timing effects. Total revenue decreased 16%, excluding currency effects, while the full reported revenue amounted to 46.9 million for the quarter. Our net sales were down 17%, excluding currency, and reported at 42.4 million for the quarter. For both license and wound management, we report lower revenues versus our first quarter last year, partly due to timing effects, while we do see positive momentum across our businesses and customer relations. For our license business, we report a decrease of 20% excluding currency in a total reported revenue of $25.1 million. again driven by lower BD revenues, while we reported higher revenues on Zimmer. Looking closer at the management portfolio, we saw a decrease in revenues of about 8% for the first quarter, excluding currency effects against a very high base of last year. In this quarter, we continue to see strong underlying growth for HydroSyn. In addition, we also see a positive stabilization within sutures. We continue to see great demand for our portfolio and onboarding of new partners and distributors in attractive markets. And our expectation is still that the wound management portfolio will deliver double-digit growth going forward. Now, looking closer at our core business, we saw licensed partner revenues decrease by 22%, excluding the currency effects, and reported at 24.2 million. Obviously, notably down for this quarter, driven by BD, while the similar revenues were reported higher than last quarter. Looking at BD, we saw revenues coming in 16% lower than last quarter when we exclude the currency effects and reported at 21.1 million. While we see positive momentum at BD across all markets, as Christine mentioned, we did see notably lower shipments of our concentrate to BD in this quarter alone. As this constitutes the majority of our revenues in the isolated quarter, this obviously affected our results. We see, however, positive continued growth on the actual royalties on sellout volumes of back-to-guard coated catheters across BD markets. And in fact, we observed the second highest royalty amount from BD over the last three years. with the highest amount, in fact, being our most recent Q4. So this supports our continued view on a positive and growing partnership with BD. And we are excited and busy about collaborating on future launches in 2026. On CIMR, we reported Q1 revenues of 4.1 million, which represents our new mutual agreement on the CNN back to glad nail system announced in December and our continued partnership. Overall, across our partnerships, we see continued positive in-market volume growth for both BD and CIMR, and we see additional future demand for customers and clinicians for our technology. On our operating expenses, we continue to demonstrate diligent cost control. In Q1, our total OPEX was 39 million, approximately 8% decrease versus our Q1 last year. While reducing cost and complexity, which we have been doing over the last year in particular, We have at the same time continued to invest in our business, including strengthening of the organization, which Christine also has mentioned. While we do continue to exercise cost control, we do not expect continued reductions on people costs. However, we do expect small reductions on other external expenses going forward. As mentioned, despite a decline in revenues, we continue to deliver positive EBITDA profitability with 4.1 million for the quarter in EBITDA and 4.9 million in adjusted EBITDA. The reduction in profitability is driven by the lower revenues, as mentioned, while our continued cost control and scaling our licensed business enables us to continue to deliver positive results. Our adjusted EBITDA reflects non-recurring external NBR costs, which we have expected for this quarter and continue to expect in the coming quarters. Our operating result for Q1 amounted to minus 7.2 million versus the 2.6 last Q1. And our net result was minus 5.6 versus the 4.7 million last year. Looking at cash flow, we see total cash flow for the period of approximately 10 million and operating cash flow of about minus 7.4 million. This was driven by change in working capital. And while being negative, it was an improvement versus our first quarter last year. And all in all, total cash at the end of Q1 amounts to 35 million Swedish kroner. With that, back to you, Christine.

Thank you, Patrick. I want to communicate that factors impacting our financial results this quarter do not change our strategic direction or the underlying fundamentals of the business, and our targets for 2030 are unchanged. We remain focused on strengthening our partnerships, advancing our regulatory pathways, and building long-term value through disciplined execution across our portfolios. And with that, I would like to open up for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad. To enter the queue, if you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Christopher Liljeberg from DNB Carnegie. Please go ahead.

Yeah, hi. A couple of questions. First on this... lower BD revenues in the quarter. You talked a little bit about it, but is it possible to split how much of BD sales typically is royalty versus product sales? And then the low product sales you highlighted in the quarter, would you say that you ship below trend in this first quarter, or was it so that you were above trend in... in the second half of last year? That's the first question.

Thank you for that. In general, we have two main drivers of our revenues with BD. The far majority comes from the concentrate sales that we ship to BD. We ship that every single month. before we are of course subject to changes in their ordering pattern of basically our technology which is a raw material into their supply chain process what we see in the royalties is that we see positive growth on bds sell out in all markets and as i mentioned we do in fact see the second largest royalty over the last three years, with the largest royalties being actually our last Q4. So this means what we see from BD is actually that the sellout of the Bactigard coated catheters in BD markets continues to be positive. In this quarter alone, as we've stated, we see a total revenue from BD being significantly lower. This is due to the lower amount of concentrate that we have shipped. So this obviously affects our reported revenues for this quarter loan. As we have seen historically, their ordering patterns changes and we're not in full control of this obviously. And we saw high ordering patterns, obviously, during 2024. And in the recent quarters, we've seen a bit lowered ordering patterns. This doesn't change our view and our visibility to the positive growth in the BDE sales of Bechtelgaard Coated Catheters in the markets.

Based on the royalty trend, would you say that the current run rate for total BD sales is more fair level than what you saw in maybe third and fourth quarter last year?

Yeah, so I think we have mentioned that the sellout volume for BD, which are royalties, is based upon. The visibility we have here, Christoffer, is the same positive mid-single growth numbers that we have mentioned before. So technically there is no big shift in that. So that remains positive. I think we spoke about in the recent quarters as well that while we saw very high double-digit growth on BD sales in 2024 and in the beginning of 2025, where we had Q1 2025 as probably the last very high quarter for BD, this is obviously not translated into market growth in the same inherent quarter.

Hi, Christoph. This is Christine. Sorry, if I can just compliment on what we see going forward, which I hope is a good compliment to Patrick's answer on what we see looking back. I think as we had indicated before as well, since there was a delay in the regulatory approvals, especially for the European markets with the CE mark, which was a delay versus what both BD and we had expected together. It does mean that they had ordered concentrate or a little bit of stock up in anticipation of launches. So now, of course, we are seeing the benefit of the information we provided in Q4 that they now have the approvals in place to be able to have sales and initiate sales in Europe. And we do see that now going forward with BD having started sales of the back-to-guard coded folies in parts of Europe.

Okay, thanks. And my question, second question. So looking at the total revenues from BD and CIMA that you report, that's higher than total license partner sales. Is it possible to say The development revenue you had in the quarter, I think it was $1 million or so, is that related to BD or CIMR?

I think we can say that that is related to CIMR. And as historically, we do have revenues with CIMR that have been split across basically the three revenue buckets we have, Christopher. In this quarter, you're absolutely correct. We do report CIMR revenues split on two of the buckets, both the licensed partner revenues and the application development revenues.

Okay, thank you. Yeah.

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. The next question comes from Mattia Vadsden from Seb. Please go ahead.

Sorry, since this misses, can you hear me?

Yes, we hear you, Mattias.

Oh, that's great. Hi, thanks for taking my questions. First one is, you highlight the changes in the leadership team in the CEO letter. I don't know if you could elaborate maybe a little bit further on the workforce of BaxiGuard and focus perhaps on the license sales. So how many are sort of dedicated to ensure new deals, that new deals can flow here in the coming years? And yeah, how does the team engage to make this happen? And has this sort of changed in line with the new research strategy, just to get some further understanding? That's the first one.

Thanks, Mattias. Yes, indeed, as we indicated, we have decided to actually strengthen at the executive management level to be able to complement the capabilities that we already put in place to help support the license organization. But also, I would say the wound management team. So as we think about our portfolios, we've tried to strengthen in the leadership team across all of those. We started last year by primarily strengthening around our existing R&D capabilities. So having onboarded our chief scientific officer and the head of regulatory, sorry, head of R&D, who we announced last year. And this year, we're now adding the complementary capabilities into the management team that also help us deliver value across the whole value chain to our partners. So that includes as well regulatory capabilities and our commercial teams, both in the form of business development and alliance management. So that's directly where we work there. But that also includes our commercialization activities in support of marketing and the sales training, for example, that we've mentioned we're doing with BD during this quarter and going forward. So this also represents our ability to help support our partners across the entire value chain, all the way from technology through regulatory approvals and through commercialization. So that has been an important compliment. We've, of course, had these capabilities within our organization, but want to make that transparent and our senior leadership team levels. In addition, we've also brought on board during last year, a leader for our wound management business who is located in Malaysia together with our headquarters there for the wound management business. And that person is also now a part of our leadership organization so that we can also ensure that we have continued focus on growing and developing the wound management portfolio, especially from a commercial standpoint. So this organizational strength has been really focused on ensuring that we can drive growth in both parts of our portfolio, both for license and for wood management.

Okay, so if you look at the organization, how many are working solely with finding new partnerships, I don't know, engaging in fairs and conferences and so on today?

Yeah, the way that we, I guess I would say from a license perspective, the way that we go to market here is actually by using complementary strength in our organization. So it's both a commercial focus team, which is a handful of us. Of course, even those of us in executive positions, me especially, I guess I would say, represent the commercial aspect of the organization. We're a handful of people that are solely dedicated to doing that. We also complement with, I would call it our technical sale because of course, from our partners, since we are co-developing their products and getting the regulatory approval, those portions of our business development activities are very important. And so our key leaders in our R&D organization, our technical organization are also a very strong part of that along with our regulatory team. So it's really an important delivery and a sale that we make across all of our different capabilities and competence areas, because it is actually the whole that helps us deliver new partners.

Okay, thanks. And also, if you could elaborate a little bit year-to-date here, how dialogues have proceeded with potential new partners or further discussions with the partners you already have today. if something has happened and also do you see any apparent triggers sort of coming 12 to 24 months that can improve the potential to to secure a deal like any data on on the coding technology or or something thanks great question yes we do

see a lot of momentum, I guess I would say, especially in the key therapeutic areas where we have been focusing over the period of time. So if I just pick, for example, the orthopedics category is a very important one for us. Some of the work that we have done to I guess I would say to reorganize how we work with Simmer Biomet has also been an important enabler for our business development discussions and with other potential partners. This is a very good category for us, both from a market potential standpoint in terms of sure size of market, but also in terms of where the unmet need is in infection prevention. And we see certainly a lot of interest for that. Uh, and we're indeed at the, uh, the largest orthopedics conference as well, um, earlier in the quarter. So this has been an important area for us to develop. And we do see a lot of interest in momentum in this category. Uh, we're also working actively across, uh, I guess I would call it both the cardiology and the neurology categories where we do see, um, interest in, in potential developments there, uh, and indeed are, uh, the, the work that we have started doing, which has been apparent on our pipeline page. in the cardiology area is on track. Some of this work does take a little bit longer to be able to deliver because they are some feasibility studies that in certain cases can extend several months to be able to deliver the initial results that will allow us to then move forward in potential partnerships So it does take a little bit of time for us to actually be able to deliver the, I guess I'll call it the deals on the other side that are apparent here, but we are very confident in the momentum sort of across our therapeutic areas and with interest across the categories.

Okay, good. One final question should be fast. Costs again low in this quarter. So I understand that you cannot make future projections maybe on a quarterly basis, but can you talk about costs more generally? How do you look at it coming one to two years? Should we still anticipate costs to come up as you grow the organization, or is this more sort of flexible against the momentum on top line and dialogues and so on? Can you give some color there, how you think about it?

Yes, thanks Mathias for the question. As we said over the last two years, and last year in particular, we have obviously taken out a lot of costs relating both to people costs, but also external costs. We have done so while still strengthening the organization. And creating a team, which you're also speaking to, that focuses a lot more and is enabled to grow the licensed business. As we look forward, we do not see or plan any significant reductions in cost on the people side. We have a strong team today. And as Christine has said, We will continue to strengthen where needed, but we have established the team that we are today. On the external side, we will continue to demonstrate cost control and to take out costs where we can. But as we've said previously as well, we will continue to invest in the business and do what we think is right for the long term. And we will keep our, you can say, focus on EBITDA profitability. So that remains. So I guess what we say is that we do not see further reductions on people cost. We expect slight reductions on external expenses. But we do keep our focus on our EBITDA profitability.

Okay. That was all for me. Thank you.

Thank you.

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. 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.

Okay. Thank you everyone for joining us today. I can see that there are no further questions. Thank you for the thoughtful questions that we've received today and for your continued interest in Back to Guard. We appreciate our dialogue and we look forward to continuing to update you on our progress in the coming quarters. Thank you for today.