Bactiguard Holding AB (publ) (BACTIB) Earnings Call Transcript & Summary

Welcome to the Bactiguard Q1 2025 Report Presentation. [Operator Instructions] Now, I will hand the conference over to the speakers, CEO, Christine Lind; and CFO, Patrick Bach. Please go ahead.

Thank you, operator, and welcome to the presentation of Bactiguard'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 SEK 9.4 million and revenues of SEK 62.7 million, 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 Hydrocyn aqua line of products. We now have 4 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 licensed partnerships. Second, revenues of at least SEK 600 million; and third, EBITDA of at least SEK 200 million. In connection with the targets, we also revised our focus therapeutic areas for the license 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 a 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, Bactiguard 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 health care providers. Health care associated infections are very common with 1 in 10 patients worldwide affected by HAIs. 40% to 60% of all HAIs are caused by medical devices and the costs associated with HAIs 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. HAIs, however, can be significantly reduced through proactive infection prevention strategies, and it is estimated that up to 50% of all HAIs are preventable. According to the World Health Organization, proactive infection prevention is a core pillar to avoiding AMR while also being cost effective. Bactiguard'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 med tech companies, we enable differentiated medical devices to reach a broad global market. With infection prevention as our overarching theme, our focus within the license 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 achieved positive outcomes for Bactiguard. 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 presents significant opportunities for Bactiguard. In the left column, we show the prioritized therapeutic areas for the license 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 Bactiguard. 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 Biomet in trauma, we are actively seeking new license partners for other orthopedic categories. Cardiology and neurology are newer therapeutic areas for Bactiguard, but present significant potential, both in terms of market size of USD 10 billion and USD 9 billion, respectively, as well as meaningful infection rates associated with implantable devices across various application areas. These devices include materials that Bactiguard has coated, and we have expertise in the area, including through our Board Members, Anna Martling, Professor of Surgery at Karolinska Institutet and Dr. Rick Kuntz, 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 Foley's. Vascular access is an area where Bactiguard has had its own approved CVC product in the BIP portfolio, demonstrating our ability to coat 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 2 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 Bactiguard's 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 products 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 5 years to 7 years, as we have communicated previously. Along the journey, partners can enter exclusivity with Bactiguard 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 licensed partnerships shown here, Bactiguard 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 partnerships, 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 Bactiguard and BD attended an important health care conference in India, CRITICARE 2025. CRITICARE brings together intensivists, anesthesiologists, emergency physicians and other health care 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 Bactiguard-coated Foley catheters in India, following BD's successful market registration late last year. BD is also relaunching the Bactiguard-coated Foley catheter, Bardex IC, in the U.S. 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 received many inquiries from both health care professionals and patients about when the coated catheters will be transferred and available in their respective markets. That level of engagement from the health care community is the strongest endorsement our technology can receive. Within the trauma partnership collaboration, Zimmer Biomet, has focused on the commercialization of the Bactiguard-coated orthopedic trauma implant nail, ZNN Bactiguard, 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 Bactiguard 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 Hydrocyn 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 long-standing 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'm 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 SEK 63 million in Q1, driven by license and Wound Management. Net sales increased to about SEK 59 million or 6% adjusted for currency. In particular, we saw high double-digit growth of 51% from the Wound Management portfolio to a total of SEK 19 million for the quarter, again, driven by Hydrocyn aqua, growing in both existing and new markets. With the positive quarter, we grew our rolling 12 months or RTM to SEK 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 SEK 39 million. As detailed in our report, this was driven by revenue growth of 15% from existing license partners, i.e., with products in market. Notably, revenues from BD was at SEK 32 million, up about SEK 4 million or 8.5% adjusting for positive currency effects. Revenue from Zimmer this Q1 2025 came in just under SEK 1 million at SEK 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 an RTM basis grew to almost SEK 169 million, again, driven by revenue from our in-market license partners growing to SEK 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 SEK 42 million for the quarter, some SEK 7 million in total net savings, and these savings were driven on both personnel costs and operating expenses. Now at a rolling 12-month basis, we see our OpEx coming down close to the SEK 200 million level, with SEK 201 million. In Q1, we continued to improve our profitability, with EBITDA coming in at SEK 9.4 million, an increase of almost SEK 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-month basis, we are reporting EBITDA of SEK 28.9 million. Finally, Q1 operating loss amounted to SEK 2.6 million, yet an improvement of about SEK 10 million versus the first quarter last year. Our net result for the period amounted to a loss of SEK 4.7 million versus SEK 9.9 million loss last year. On cash flow, notably, our cash position decreased in Q1, with the planned and announced repayment of SEK 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 SEK 12 million and cash flow from financing activities at minus SEK 55 million, including the repayments. While negative at SEK 12 million, the cash flow from operating activities improved by SEK 7 million versus last year and were driven mainly by a change in net working capital, mainly accounts receivables of negative SEK 10 million. All in all, our cash position decreased to SEK 46.8 million at the end of Q1, again, mainly driven by the voluntary repayment on loans of SEK 51 million. 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 forward. Wound Management also contributed meaningfully in Q1, where our main brand, Hydrocyn aqua, was the shining star of the quarter with a strong uptick in sales. We are excited about the opportunity represented by our 5 refined strategic therapeutic areas for the license business, concentrating on where Bactiguard'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 SEK 600 million in revenue, at least SEK 200 million in EBITDA by year-end 2030, supported by a goal of securing at least 10 application areas in exclusivity or license 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 Bactiguard 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 U.S. tariff situation is that Bactiguard is not directly impacted. However, we do have substantial U.S. dollar exposure in our license business and a weaker U.S. 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 health care-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.

[Operator Instructions] The next question comes from Kristofer Liljeberg from Carnegie.

Two questions. First one on the partner revenues. It seems although you don't report that separately, but if you do the backward calculation, 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?

Yes. Kristofer, it's Patrick here. Thank you for your question. 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 spill that out directly. We do see a growth quarter-over-quarter, yes. However, it's also important to note that historically, our sales -- our revenues coming from Well Lead in China tends to be a bit lumpy. We do not expect significant revenue growth 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 goods in Q1 versus last year.

But is it an effect of Zimmer Biomet sales becoming smaller?

Not directly, but the change in COGS in this case is mainly related to the sales to China. But obviously, if we do not report any, for example, exclusivity revenues with some milestone fees, then that also changes the margins clearly.

The next question comes from Mattias Vadsten from SEB.

I have 3. 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 Hydrocyn aqua in this quarter that we should think of when we try to model it going forward?

Thanks, Mattias. I'll answer your first question quickly. As stated, we did see higher-than-expected growth in the quarter on Wound 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. 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 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.

Yes. 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 SEK 200 million level. We do see some intra-quarter changes that relates to both the changing -- 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 out cost 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.

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 the 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 months or 24 months? So, answers to all of those questions and other flavors would be helpful. That's my last one.

Mattias, 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 months to 18 months with the transition of our business model from having our own product and production to being primarily focused on license 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 license 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.

[Operator Instructions] There 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 rest of the day.