Bactiguard Holding AB (publ)

Thank you, Operator, and welcome to the presentation of Back to Guard's Q1 2025 report. Our CFO, Patrick Bach, and I will go through the presentation together, and as usual, we will have a Q&A session towards the end. I will begin by sharing some brief comments on the first quarter results, and Patrick will go through the financials in more detail later in the presentation. Firstly, we are very pleased to again report both continued profitability and revenue growth. We delivered an EBITDA of 9.4 million SEC and revenues of 62.7 million SEC, which is an increase of almost 7% compared to Q1 last year. Increased license revenues stem primarily from our strengthened collaboration with med tech company BD. a prime example of a mutually beneficial relationship that is driving growth for both parties. I will provide a bit more detailed update regarding the BD partnership shortly. Another highlight for Q1 comes from our wound management portfolio. Revenues increased by more than 50% driven by sales of our Hydrosyn Aqua line of products. We now have four quarters in a row with positive financial development demonstrating that we are consistently doing what we said we would do and delivering on our promise of profitability following the financial turnaround and strategic shift from 2024. As a major event during the quarter, in early March, we announced our updated strategic and financial targets to be achieved by year-end 2030, and I will take this opportunity to repeat them. First, more than 10 application areas in exclusivity or license partnerships, Second, revenues of at least 600 million SEC. And third EBITDA of at least 200 million SEC. In connection with the targets, we also revised our focus therapeutic areas for the licensed business. And I will also come back to this in a couple of slides. As I noted in the CEO statement in the report, we have established the solid foundation to achieve the updated strategic and financial targets, while at the same time maintaining a clear focus on growth and profitability. In short, Back to Guard has had a great start to 2025. Before we go into more detail on the quarter itself, I wanted to reflect on the reason we are here to begin with. Infection prevention continues to be a critical global medical need, and the demand for effective solutions is more pressing than ever due to the challenges presented for healthcare providers. Healthcare associated infections are very common, with one in 10 patients worldwide affected by HAIs. 40 to 60% of all HAIs are caused by medical devices. And the costs associated with HII's are significant related to longer hospitalizations and additional need for treatments and the growing problem of antimicrobial resistance also means that treatments may not be able to be effective when used. HII's, however, can be significantly reduced through proactive infection prevention strategies. And it is estimated that up to 50% of all HII's are preventable. According to the World Health Organization, proactive infection prevention is a core pillar to avoiding AMR while also being cost-effective. Back to Guard's infection prevention technology is a real solution to this challenge. With its ultra-thin layer of noble metals, gold, silver, and palladium that has been demonstrated to work on multiple types of materials and devices and in different clinical settings, our technology has amassed a wealth of real-world evidence of its safety and efficacy in reducing medical device-related infections. This technology platform endures beyond today's market volatility. Through partnerships with leading medtech companies, we enable differentiated medical devices to reach a broad global market. With infection prevention as our overarching theme, our focus within the licensed business is to continue to strengthen existing partnerships, such as our excellent collaboration with BD, while simultaneously seeking new business relationships in additional application areas. Another pillar of our strategy is the continuous enhancement of our knowledge and specialist expertise. To further reinforce collaborations within our current partnerships, we will continue investing in critical competency areas such as research and development, medical, and regulatory. These investments are also essential to drive new business and partnership development. Our ambition is to always be the best partner to our partners. By aligning to positive outcomes for them, we similarly achieve positive outcomes for BhaktiGaurd. Within our wound management portfolio, the focus is on continuing profitable growth and expansion into new markets. The need for infection prevention that I highlighted earlier spans our strategic therapeutic areas and prevents significant opportunities for back-to-guard. In the left column, we show the prioritized therapeutic areas for the licensed business, which were revised in connection with the 2030 targets. orthopedics, cardiology, neurology, urology, and vascular access. Each of these include relevant application areas where our infection prevention solutions can play an important role in addressing the unmet need associated with medical device-related infections and where there is commercial and realizable potential for VactiGrim. Orthopedics holds great potential in an addressable market of almost $40 billion with a wide array of relevant application areas covering implants throughout the body. This area also has a significant number of procedures performed and a corresponding high number of device related infections. Rates of infection can also be very significant, especially in fracture and trauma associated procedures where these rates can reach up to 40%. In addition to our existing relationship with Zimmer Biomed in trauma, we are actively seeking new licensed partners for other orthopedic categories. Cardiology and urology are newer therapeutic areas for back to guard, but present significant potential, both in terms of market size of 10 and 9 billion US dollars respectively, as well as meaningful infection rates associated with implantable devices across various application areas. These devices include materials that BactiGuard has coded, and we have expertise in the area, including through our board members, Anna Martling, professor of surgery at Karolinska Institutet, and Dr. Rick Kunz, former chief medical and scientific officer at Medtronic and an expert in cardiology and clinical research. Within urology, we have our well-established partnerships for Foley catheters, but we see continued growth potential in this therapeutic area in other applications beyond the Foleys. Vascular access is an area where Back to Guard has had its own approved CBC product in the BIP portfolio, demonstrating our ability to code and to bring to market relevant products in this category. Across the top of the chart is our partnership journey stages against which we will communicate progress in our business development activities. In the far right column, we have our existing relationships at the license partnership stage with products on market in the relevant therapeutic area. We will continue to communicate both license and exclusivity partnerships to the market with our partner company and the application area included in the collaboration, along with any other material aspects of the collaboration. Our activities at the two earlier phases of application development and material transfer will be disclosed by therapeutic area, and we will not disclose more details around the companies or indeed the number of active collaborations. We will aim to provide transparency on back-to-guards progress in business development while ensuring we protect the confidentiality of product development required during these early stages. The specific timeline from early feasibility under an MTA through to marketed product can vary based on device class, desired product claims, and the associated time to deliver the data demonstrating efficacy and safety. The partnership journey from early stage testing to commercialization can take on average five to seven years as we have communicated previously. Along the journey, partners can enter exclusivity with back to guard for a particular area. And this is the point in which we will announce who the partner is and what we are working on together. By the time of market approval and launch, we will update on the status of our specific partnerships on a regular basis as we do with our existing license partnerships. In addition to these license partnerships shown here, Back to Guard is currently working in early feasibility and performance testing under material transfer agreements within the category of vascular access, as well as in categories that are outside of the highlighted strategic therapeutic areas. While these named therapeutic areas remain the focus of our proactive efforts, we will work on selected opportunities outside of these therapeutic areas where we and our potential partners believe there is a clear need for infection prevention and see potential in our technology. This snapshot will be presented in connection with our quarterly reports or when we announce new exclusivity or license partnerships. Now let's take a closer look at our partnership starting with global med tech company BD. During the first quarter, we continued our active collaboration spanning the entire value chain from technology license to go to market strategies. This is really a model partnership built on newly fully aligned incentives coupled with mutual trust and respect and thus enabling win-win outcomes for both collaboration partners. One example from this past March is when Back to Garden BD attended an important healthcare conference in India, Criticare 2025. Criticare brings together intensivists, anesthesiologists, emergency physicians, and other healthcare professionals dedicated to critical care in India. Addressing such a broad audience together marked an important step in informing local stakeholders and key opinion leaders that BD is taking over the sales and distribution of back-to-guard coated Foley catheters in India following BD's successful market registration late last year. BD is also relaunching the back-to-guard coated Foley catheter BARD-XIC in the US, and a new product website is already available for viewing. In addition, we continue our joint work on the market registrations required to enable BD launches in new markets like the one achieved in India. There is clear demand across markets, and we receive many inquiries from both healthcare professionals and patients about when the coded catheters will be transferred and available in their respective markets. That level of engagement from the healthcare community is the strongest endorsement our technology can receive. Within the trauma partnership collaboration, Zimmer Biomet has focused on the commercialization of the Bactigard-coated orthopedic trauma implant nail, ZNN Bactigard, in existing markets during the first quarter. We also continue to work actively on the processes to retain regulatory approval under MDR in Europe and thus required to enable continued commercialization. The post-market clinical trials in Europe on the ZNN BacterGard also continue and will gather data on infection rates, safety, and clinical outcomes. Both the MDR registration and clinical trial work should be expected to continue for the next couple of years. Our wound management portfolio had a really strong first quarter with a revenue increase of more than 50%. the increase was fueled by a significant rise in sales of the Hydrosyn Aqua branded range of products. In April, we hosted a panel with international wound care experts and specialists to discuss Clean to Heal, a thought leadership concept emphasizing the importance of effective debridement and cleansing to promote healing. The conversation resulted in a consensus report published in Wounds International, a peer-reviewed journal with a longstanding reputation for advancing global wound care through evidence-based insights and expert-led clinical guidance. During the quarter, our Malaysian production site was also formally certified ISO 14001 from the British Standards Institution, manifesting our commitment to high quality and responsible manufacturing and production processes. Reiterating the strategy for wound management, we remain focused on stable profitability and expansion into new markets, primarily in Asia. And now I will hand over to Patrick to review our Q1 financial outcomes in more detail.

Thank you, Christine. I am pleased to present the financial results for our first quarter of what is indeed a new year. In short, we deliver continued profitability and growth. positive EBITDA, now for the fourth quarter in a row, and good growth across our core business, driven by both our license business as well as our wound management portfolio. Total revenue grew about 7% to 663 million in Q1, driven by license and wound management. Net sales increased to about 59 million or 6% adjusted for currency. In particular, we saw high double-digit growth of 51% from the moon management portfolio to a total of 19 million for the quarter, again driven by Hydros and Aqua growing in both existing and new markets. With the positive quarter, we grew our rolling 12 months, or RTM, to 266 million in total revenue, again driven by growth from both our license and wound management portfolio. The BIP portfolio is, as planned and announced, phased out and will not contribute with any significant revenue in 2025. Now turning to our core license business, We saw first quarter revenue growth of 12% to a total of 39 million. As detailed in our report, this was driven by revenue growth of 15% from existing licensed partners, i.e. with products in market. Notably, revenues from BD was at 32 million, up about 4 million, or 8.5% adjusting for positive currency effects. Revenue from CIMR this Q1 2025 came in just under a million at 0.9 million and pertains mainly to royalties from in-market trauma products. We report no significant exclusivity revenues nor application development revenues in Q1. Now with the Q1 growth, our license revenue on a RTM basis grew to almost 169 million, again driven by revenue from our in-market license partners growing to 162 million in RTM. On OPEX, we continue to operate diligently and with cost control. In Q1, our total operating costs decreased by 13% to 42 million for the quarter, some 7 million in total net savings. And these savings were driven on both personal costs and operating expenses. Now, at a rolling 12 months basis, we see our OPEX coming down close to the 200 level with 201 million. In Q1, we continued to improve our profitability with EBITDA coming in at 9.4 million SEC, an increase of almost 11 million versus the negative result of Q1 last year. The improved Q1 result was mainly driven by the increase in total license revenues as well as the high wound management growth while continuing to keeping our costs under control. Now, on a rolling 12 months basis, we are reporting EBITDA of 28.9 million. Finally, Q1 operating loss amounted to 2.6 million, yet an improvement of about 10 million versus the first quarter last year. Our net result for the period amounted to a loss of 4.7 million versus 9.9 million loss last year. On cash flow, notably our cash position decreased in Q1 with the planned and announced repayment of 51 million on loans as we have completed a refinancing with SEB until 2028. For the first quarter period, we report cash flow from operating activities at minus 12 million. and cash flow from financing activities at minus 55 million, including the repayments. While negative at 12 million, the cash flow from operating activities improved by 7 million versus last year, and were driven mainly by a change in networking capital, mainly accounts receivables of negative 10 million. All in all, our cash position decreased to 46.8 million at the end of Q1. Again, mainly driven by the voluntary repayment on loans of 51 million SEK. With that, back to you, Christine.

Thank you, Patrick. Time to sum up today's call with some key takeaways. We have had a great start to 2025 and delivered both continued EBITDA profitability and revenue growth, and this for the fourth quarter in a row now. Our BD collaboration is the solid backbone driving license revenue growth this quarter, as well as the greatest example of a mutually beneficial partnership to continue to build on going forwards. Wound management also contributed meaningfully in Q1, where our main brand, Hydresyn Aqua, was the shining star of the quarter with a strong uptick in sales. We are excited about the opportunity represented by our five refined strategic therapeutic areas for the licensed business, concentrating on where Back to Guard's technology offers the greatest and most realizable potential. In essence, areas where our infection prevention solutions can play an important role in addressing the unmet need associated with medical device related infections. This was also reflected in our updated targets, delivering at least 600 million second revenue, at least 200 million second EBITDA by year end 2030, supported by a goal of securing at least 10 application areas in exclusivity or licensed partnerships. Our scalable business model combined with strong operational leverage is expected to deliver significant value even beyond 2030 through partnerships established in the years ahead. While we have delivered a solid first quarter, I want to acknowledge that global market conditions are more volatile and unpredictable than ever. Although back to guard is not immune, We believe that companies with a clear long-term strategy and strong fundamentals are better positioned to navigate turbulent times. Our current assessment of the US tariff situation is that back to guard is not directly impacted. However, we do have substantial US dollar exposure in our licensed business and a weaker US dollar will negatively affect our results. We will continue to monitor developments closely in this evolving landscape. Amid this uncertainty, the relevance of our technology remains crystal clear. It offers a real solution to a challenge that extends far beyond short-term market volatility, the issue of healthcare associated infections. The interest in our unique infection prevention technology continues to grow, both among existing partners and potential new collaborators. We have now established a solid foundation to achieve the updated strategic and financial targets while at the same time maintaining a clear focus on growth and profitability. Most importantly, we are doing what we set out to do. We're delivering on our promise following the financial turnaround and strategic shift in 2024. And with Q1, we continue to deliver consistent results. And with that, I would like to hand over to the operator 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 Carnegie. Please go ahead.

Two questions. First one on the partner revenues. It seems... Although you don't report that separately, but if you do the backward calculation, it seems that sales from well-lead has increased quite significantly. Is this only related to China and could you describe how volatile that revenue line is? And then a question on the raw material cost that is up significantly here as a percentage of

sales versus what you saw in the third and fourth quarter if you could explain the reason for that thank you yes hi christopher patrick here uh thank you for your question uh in brief yes you are correct we do have sales to our license partner in china well lead it is part of our existing license partner revenues however we don't spell that out directly And we do see a growth quarter over quarter. Yes. However, it's also important to note that historically our sales are revenues coming from well in China tends to be a bit lumpy. We do not expect significant revenue growth from from China in this year versus last year. And to your question regarding the raw materials. It depends depending on the different partners we sell to. So yes, we did have a slightly higher cost of boost in Q1 versus last year.

Yeah, is it but is it an effect of in the biomass sales becoming smaller?

Not directly, but the change in Cox in this case is mainly related to the sales to China. But obviously, if we do not report any, for example, exclusivity revenues, which are milestone fees, then that also changes the margins, clearly. Yeah, makes sense. Okay, good. Thank you. Thank you.

The next question comes from Matthias Vadsten from SEB. Please go ahead.

Hello. Thanks for taking my questions today. I have three. So starting off, if you could elaborate a little bit more on the high wound management sales. I guess, should we view this as a new sort of level, or did you have any favorable sort of large orders for hydrogen aqua in this quarter that we should think of when we try to model it going forward.

Thanks Mathias. I'll answer your first question quickly. As stated, we did see higher than expected growth in the quarter on wool management coming from both existing and some selected new markets where we have not seen growth before. We see overall strong continued double digit profitability from the wound management portfolio. I would say when we say double digit growth, we certainly don't mean that we will deliver plus 50% every single quarter. And as you will find, the comparable in Q1 24, as it was in 23, is also usually a low month for our wound management sales.

Okay thank you and then on OPEX I think it was good OPEX cost control in this quarter disregarding then the cost of raw materials already discussed so would you say this is this level is reflective of the level to be anticipated this year or are you expecting a certain volatility in let's say personnel expenses and other external expenses that's the second one?

Yeah, good question. We do report low OPEX this quarter versus last year, but also versus our run rate the last 12 months. I would say our rolling 12 months is now at a 200 million level. We do see some intra quarter changes that relates to both the changes coming out of the transformation we did last year. But of course also is that we will continue to invest and strengthen the organization where we see the need. But overall we feel that we have taken out a significant part of our OPEX in the business. We will continue to have cost control. But obviously we will not continue to take our costs at the same level as we have done in the last 12 months. We will continue to invest in our organization, but we will continue our focus on growing the profitability as well.

Thank you very much. And then the last one, so how we should look upon the work to find new partners in related therapeutic areas. I think you said interest is increasing, which is good to hear, but sort of any flavor as to how you work with it, how many ongoing dialogues there are, if that has changed anything recent 12 or 24 months. So answers to all of those questions and other favors would be helpful. That's my last one. Thank you very much.

Hi, Mathias. This is Christine. Thank you for the question. Great questions as always. In terms of our new business development activities, yes, you're certainly right that the level of activity has increased significantly over the past, I guess I'll call it 12 to 18 months with the transition of our business model from having our own product and production to being primarily focused on licensed partnership. So the level of activity has certainly increased significantly. In line with that, we also see increasing interest and more activity in our early feasibility work and our discussions with partners around what early feasibility work could look like. So hopefully we're giving a little bit of flavor there that we definitely are enthusiastic about the work that we see ongoing. I of course want to make sure that I continue to exercise caution that getting from our early feasibility work to actually having an announced exclusivity or licensed partner will of course be expected to take some time. But we hope to be able to continue to show increased activities across our therapeutic areas on the pipeline snapshot that we presented earlier today as well as we go forward.

Thank you very much for that.

Thank you, Mathias.

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad.

are no more questions at this time so i hand the conference back to the speakers for any closing comments thank you for your great questions as always and for everyone's engagement and for listening in today we look forward to our next opportunity to be able to update you on the progress in our business and please do not hesitate to reach out to us in the meantime thank you for today and have a great