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

Welcome to the Bactiguard Updated Strategic and Financial Targets Conference. [Operator Instructions] Now I will hand the conference over to the CEO, Christine Lind; and CFO, Patrick Bach. Please go ahead.

Thank you, operator, and welcome to the presentation of Bactiguard's updated strategic and financial targets. As released last evening, we are announcing 3 strategic and financial targets to be achieved by year-end 2030, more than 10 application areas in exclusivity are licensed partnerships, revenues of at least SEK 600 million and EBITDA of at least SEK 200 million. Today, we will provide an update on our license-focused strategy and share more details on the comprehensive review we have performed of the market potential and partnership opportunities for Bactiguard's advanced infection prevention technology, resulting in these targets. Bactiguard's CFO, Patrick Bach and I will go through the presentation, and we look forward to your questions at the end. I would like to take a few minutes on the new Bactiguard, now just over 1 year into executing on our license-focused strategy. Following our transformation, we have become a different company, shifting from production and sales to business development and partnership focus. We have a truly differentiated technology. It works on multiple types of materials and devices. It is clinically proven to be safe, biocompatible and highly effective in reducing medical device-related infections and has decades of real-world inpatient experience. The core business focus of the new Bactiguard is our partnerships. We have a couple of well-established license partnerships with global MedTech giants, which continue to be the backbone for our business going forward. In addition, we see significant potential in future partnerships in our target therapeutic areas, which we will also take the opportunity to update you on today. Our vision remains unchanged. We strive to become the global standard of care for preventing medical device-related infections and our updated strategic and financial targets serve as our road map for moving towards this inspiring vision. Our call to action that creates the urgency for us to deliver to these targets is the pressing need for infection prevention solutions. We see growing recognition of infection prevention as a critical global medical need and the demand for effective solutions is increasing due to the challenges presented for health care providers. Health care associated infections are very common with 1 in 10 patients worldwide being affected by HAIs. 40% to 60% of all HAIs are caused by medical devices. And the costs associated with HAIs related to longer hospitalization and additional need for treatments can be significantly reduced through proactive infection prevention strategies. It is estimated that up to 50% of all HAIs are preventable. In addition, the problems of antimicrobial resistance mean that treatments may not be effective when used. According to the World Health Organization, proactive infection prevention is a core pillar to avoiding AMR, while also being cost effective. The Bactiguard technology presents a real solution to this very real issue. And by working in partnership with leading MedTech companies, we enable differentiated and safe medical devices to be brought to a broader market than Bactiguard could achieve alone. During 2024, we laid the foundation that will enable us to deliver to our 2030 targets. We delivered on the strategic shift required to work together with our current and future partners in our licensing business, and we have delivered financial outcomes that put us in a position to grow in the future, including EBITDA profit in the second half of 2024 and for the full year and positive cash flow from operations. This positive cash flow also enabled us to refinance our bank loan of SEK 171 million at the year-end 2024 with a smaller loan financing of SEK 120 million, in turn, allowing us to have savings on interest expenses in the coming years. During the year, we have invested in strengthening the organization across multiple knowledge and specialist areas to be able to enhance the collaborations within our existing partnerships and source new potential partners. Alongside this license-focused business, we also have a wound management product portfolio generating stable growth and profitability. We also take with us the learnings gained from working in closer collaboration with our partners as well as those from the Zimmer termination of the broader orthopedic agreement in the fourth quarter, a key trigger for us to review our financial targets. We are a much different company today compared to the end of 2023 when the previous targets were set. The Bactiguard that has entered 2025 is a truly new Bactiguard and the foundation that we have built is what provides us the confidence to now launch revised strategic and financial targets that we believe are achievable and that will allow us to deliver on the potential inherent in our business model and strategy. So now to the key part of this presentation, the outcome of the comprehensive review. And I would like to hand over to Patrick to give some more flavor to both the process and the updated targets. Patrick, over to you.

Thank you very much, Christine. So obviously, we are happy to present today here some of the things we have worked on over the last few months. We have conducted a comprehensive review of our strategic and financial targets. This work has included in-depth evaluation of our key strategic therapeutic areas, targeted application areas, what we see as the associated infection rates, very importantly, regulatory approval time lines, partnership time lines and commercial scale-up potential, all of which Christine and I will go through in detail today. With reference to the slide, I want to highlight 3 categories of our work. So first of all, as mentioned, we've done a comprehensive market review. So we've reviewed external data sources across therapeutic areas, clinical studies and product classifications. We have leveraged all the internal data we have from decades of doing our own research and testing to identify, you can say, high-potential adjacencies and opportunities. Based on that, we have prioritized according to medical needs, market size, technology fit and so forth. Next, we have also done a thorough review of the process from going from a market opportunity to actual commercialization. So we've looked into analysis of approval time lines across these therapeutic areas and the medical classes. We have reviewed and assessed, you can say, our internal data knowledge on this, how does the regulatory time lines and pathways look like. And then we have scoped milestones and phases from early-stage testing to commercial launch. Finally, we've built all this together in a model that represents our opportunities, but also the realities. We have a dynamic and granular model of our potential application areas. It includes our detailed assessment of our underlying and expected growth from the existing businesses as well as from the new businesses. And we also have a thorough assessment and scenario building of key input variables, such as how do we scale up, what kind of maturity rates do we see and things like churn like that. So all in all, we believe we have a much clear understanding and much more reliable data on our market potential, our partnership opportunities and where we expect our current business to take us in the coming strategic and financial period. Our strategic targets and financial targets, along with the updated therapeutic areas, is what Christine and I will explain in more detail. And as I said, these are built on a solid foundation of facts and data. Before diving into our revised targets, I want to emphasize that while we've set goals for the 2030 period, we do see a longer-term potential of our technology platform that is significant. Our business model is scalable through operating leverage. We will evolve and see margin expansion increase over time. And we expect the financial profile to continue to increase in terms of profitability and cash flow in the target period and beyond. Also importantly, the partnerships that we work on and plans to announce over the next years will be the key drivers of our long-term growth potential as well. So this brings me to the first part of our updated targets, which is our expectation for partnership development. Our goal is to establish 10 application areas in either exclusivity or license partnership by the end of 2030. This target is based on our data and assessments of not only sort of the opportunities, but also the partner time lines and how we work with them over the next years. Christine will in the next slides as well go through some of the details on these go-to-market time lines. Next, we have an updated target on profitability as well. By year-end 2030, we expect to deliver at least SEK 200 million in EBITDA. Although this target is lower than the previous of SEK 500 million, we maintain our focus on profitability over the target period, and we will continue to have a disciplined approach to cost throughout the period. Turning to revenues. We have an updated target to deliver revenues of at least SEK 600 million in -- by year-end 2030. Equally, this is lower than the previous target of SEK 1 billion. But here, we want to emphasize that this is carried 2/3 by our existing business. So as mentioned before, we have done a rigorous analysis of both new potential from the new business as well as where we see our existing business take us to 2030. So time to shed some more light on the time lines for the go-to-market. And back to you, Christine.

Thank you, Patrick. One of the keys to our targets is the potential we see in highly relevant therapeutic areas for our technology. We have defined a revised 5 strategic therapeutic areas. These are orthopedics, vascular access, cardiology, neurology and urology. We see relevant applications within these therapeutic areas where our infection prevention solutions can play an important role in addressing the unmet need associated with medical device-related infection and addressing the growing demand for safer and more effective health care solutions. After a thorough review, we believe these updated therapeutic areas of focus for the license business represent the fields where our technology holds the greatest realizable potential for future license partnerships. Orthopedics holds a 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%. Zimmer Biomet remains our partner within the trauma category. With the learnings from the terminated broader orthopedic collaboration, Bactiguard has also gained a much deeper understanding of U.S. approval requirements in these segments. Furthermore, Bactiguard owns all commercial rights to our technology outside of the trauma segment, and we are actively seeking licensing partners in this therapeutic area. Vascular access, cardiology and neurology all present significant potential, both in terms of addressable market size and infection rates across the various therapeutic areas. In this context, I would also like to highlight the unique experience we have access to 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. Their valuable insights have also been instrumental in helping us define a realistic potential across our selected therapeutic areas and will be invaluable in new business development activities. Finally, urology is a category where we already have well-established partnerships for foley catheters. And while catheter-associated infections are still meaningful, the Bactiguard-coated Foley has already had a positive impact. We see potential in this category beyond the Foley catheter and urology remains a key therapeutic area with continued growth potential. Separately, we will address wound management as a therapeutic area within our wound management product portfolio, and Patrick will provide more insights in a couple of slides on the potential we see in our products. Now that I have reviewed where we see the greatest opportunity, I want to spend a few minutes on go-to-market time lines. The partnership journey from early-stage testing to commercialization takes several years. With our partnership journey funnel and regulatory categories for medical devices as the framework, on average, it takes 5 years for a Class II medical device and 7 years for a Class III device to take the journey from initial testing in a partnership through to start of commercialization. During our evaluation process and through learnings gathered in our existing and previous partnerships, with the experience and knowledge we have accessed by building on competencies, we have a significantly enhanced understanding of the requirements and time lines. Now we continuously build on this knowledge and enhance capabilities within our organization to fully focus on being a true partner to our partners. By aligning to positive outcomes for our partners, we similarly achieve positive outcomes for Bactiguard. On the left, under material transfer agreements with potential partners, Bactiguard and the potential partner are able to conduct agreed-upon feasibility and performance testing to give both parties the confidence that we believe a coated product with the desired outcomes is developable. As we move through to application development partnerships, the real work of developing a specific coated device truly begins. Several key activities impact the time line throughout this journey, including the development of the product and coating processes, delivery of nonclinical or clinical studies to determine the desired outcomes and which we can use to seek regulatory approvals, setup of supply chains and launch preparations through to full-blown commercial activities. The specific time line for any particular product can vary based on device class, desired product claims and the associated time required to deliver data demonstrating efficacy and safety. Along the journey, partners can enter exclusivity with Bactiguard for a particular area. And this is the point at which we will announce who the partner is and what we are working on together. And certainly, by the time of market approval and launch, we will update on the status of our specific partnerships on a regular basis. Before this stage, the competitive advantages offered by working in confidentiality are important and valuable. Now I will turn it over to Patrick for an overview of our wound management portfolio contribution to our targets and further review the details.

Thank you, Christine. While our primary focus and greatest potential lie in our license business, our wound management portfolio has contributed with profitable growth in 2024 and as well, we see that continuing in our strategic and financial target period towards 2030. Just to recap, so Bactiguard's main wound management brand, it's called Hydrocyn aqua. It's a product line that is designed to promote wound healing and prevent infections. We see and expect continued growth coming from existing markets, primarily in Southeast Asia as well as expansion into new markets, primarily via distributors. We expect continued profitable double-digit growth in the coming period. And we are comfortable and satisfied with these expectations. We have it integrated in our total financial targets. And as mentioned, the strategy remains focused on maintaining profitable double-digit growth. Turning to our complete financial targets for the 2030 period. One of the strengths that we would like to highlight is that we do see that the current business drives about 2/3 of our total financial targets. We maintain our focus on EBITDA profitability in the period. We will continue a disciplined approach to cost, and we will grow our existing businesses as well as we are poised to pursue new partnerships, which also would contribute to our business by 2030. In relation to our existing businesses and in relation to the Zimmer Biomet partnership on Trauma, we want to, again, reemphasize here that due to the uncertainty on those time lines, we do assume that the current partnership does not have a large impact on these financial targets towards 2030. We will grow by focusing on the select application areas within our strategic therapeutic areas, which Christine has highlighted. And again, here, we expect revenues coming from these new application areas, the majority will likely come from exclusivity revenues and milestone fees in this period towards 2030. As mentioned before, while we disclose our strategic and financial targets for the 2030 period, we want to highlight that we do see significant operating leverage and scale beyond 2030 from the business model. So as we see the application areas that we intend to deliver before 2030, as we see them mature beyond 2030, we do expect significant scale and leverage and substantial EBITDA expansion in the business. We obviously, for that reason, also project that we will see a much larger contribution to the total top line coming from new partnerships versus today than the existing partnerships. Again, this is -- we don't have targets beyond 2030, but we want to highlight that we do see significant scale and operating leverage from our business beyond the period. With that, we are very confident about the future. And with that, I would like to give it back to you, Christine.

Thank you, Patrick. Bringing it all together, I would like to provide an update on where we stand today and the frameworks we plan to use to continue to communicate our progress along the journey to achieving our targets. We continue to see increasing interest in infection prevention strategies, both within our existing partnerships and in potential new ones. The more we educate the market about our technology, its ability to mitigate infection risk and how it differentiates partner Medical Devices, the more confident we are about the joint commercial opportunity and our ability to reach our set targets. If we look at where we stand today, this is a snapshot of where we are currently working across our partnership journey funnel. At the far right, we have our existing relationships with Zimmer, BD and Wellead with products on market in our licensed partnerships. Moving backwards in the funnel, we will continue to announce exclusivity and license partnerships to the market, including the name of our partner company and the area included in collaboration. The 2 earlier phases will be disclosed at a therapeutic area level to provide transparency on our development progress, but to protect confidentiality at this stage. Today, Bactiguard is working in early feasibility under material transfer agreements within the categories of vascular access as well as in categories that are outside of the named strategic therapeutic areas. While these named therapeutic areas remain the focus of our proactive efforts, Bactiguard will also work on selected opportunities outside of these therapeutic areas where partners see potential in our technology. This overview will be presented on a regular basis in connection with our quarterly reports going forward. Looking ahead, the overarching pillars and priorities remain unchanged. With our license-focused strategy, we aim to be the premier partner for leading MedTech companies fully aligning with our mission. We will continue to strengthen existing license partnerships such as our excellent and growing collaboration with BD. A key 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 R&D, medical and regulatory. As Patrick stated, our existing business is the primary driver of our 2030 targets. Simultaneously, new business development remains a key priority, expanding into new application areas with current or additional partners. As I just highlighted, our pipeline includes early-stage projects for potential partners with feasibility studies already underway. Our investments in enhancing our core competencies will also be essential to drive new business and partnership development. As an example, regulatory is an area we have underestimated the need for direct involvement rather than relying on our partners to deliver the critical aspects related to the coating on market approvals. We are currently defining Bactiguard's U.S. regulatory approach to fully capitalize on the opportunities of our infection prevention technology. Simultaneously, regulatory authority demands on MedTech companies is increasing, impacting not only Bactiguard, but others in our sector, and we recognize the need to continue to build our expertise in this area to enable stronger collaboration with partners. As Patrick emphasized, our business model enables significant operational leverage and scalability and the efforts we are making to support new business development over the coming years should be expected to deliver significant upside beyond 2030. Last but not least, within Wound Management, we will continue to focus on profitable growth and expansion into new markets. As we conclude today's presentation, it's important to highlight the rigorous approach we took in defining our long-range plan and future targets. We took the time required to ensure we built these targets on solid data, insights and collective knowledge to ensure well-founded decisions under our new business model. Our financial targets, delivering an EBITDA of over SEK 200 million and revenues of over SEK 600 million by year-end 2030, are significantly lower than those set in late 2023. However, they are realistic, achievable and grounded in a deeper understanding of our business. We are confident we can meet these goals with our existing business as the primary driver. Thanks to the experience and learnings gained over the years and the thorough analysis we have done, we now also have a clearer understanding of go-to-market time lines. While we cannot pinpoint exact dates for new or existing partnerships and applications, we now know for a fact that commercialization takes several years, starting from early-stage testing. We are excited about the opportunity represented by our strategic therapeutic areas: orthopedics, vascular access, cardiology, neurology and urology. Interest in our unique infection prevention technology continues, both among existing partners and new potential collaborators. Our updated therapeutic areas alongside our strategic partnerships represent the areas where our technology holds the greatest potential. Over the next few years, our business development efforts will result in at least 10 application areas under exclusivity or licensing agreements by year-end 2030. As Patrick explained, Bactiguard's financial profile will strengthen over time. Beyond 2030, operational leverage and scalability truly kicks in, enabled by the partnerships signed over the coming years. Our new strategic and financial targets will be accompanied by a steadfast focus on EBITDA profitability, including a disciplined approach to costs. As we broaden our perspective, we remain fully dedicated to preventing medical device-related infections with the vision of making Bactiguard's infection prevention technology the global standard of care. And with that, we would like to hand over to the operator to open up for questions.

[Operator Instructions] The next question comes from Arvid Necander from Carnegie.

Diving in for Kristofer here. So a couple, if I may. First off, how should we think about costs going forward? Will you have to add to the team in Stockholm and able to succeed with the new deals that you aim for? And secondly, with roughly 2/3 of the SEK 600 million in 2030 coming from existing products and contracts, is the majority going to be from BD or will Zimmer make a meaningful contribution to this? I'll start there.

Thank you, Arvid. This is Patrick here. Thank you for your 2 questions. If I may split them in 2. First on costs, so we will continue to strengthen and invest in our organization where we see the need and where we see that it has a future value and impact on our growth. So that may be within our team in Stockholm or elsewhere. We will maintain a disciplined approach to costs, and we will maintain our expectation to deliver increased profitability year-over-year and also positive cash flows. So we will do that in a balanced and sensible way. But we will, of course, make sure that we invest and we strengthen where needed within the organization over time. To your question regarding the 2030 top line and the part comes from existing business versus new business, we do see that approximately 2/3 of our total financial target for 2030 top line is driven by our existing businesses today. So that is, as you know, primarily the urology business that sits with BD in most markets and it's also our Wound Management business. We do expect double-digit growth across these businesses. And as mentioned, due to the uncertainty and sort of these time lines that Christine also explained in detail, we do not assume a significant part of the financial targets to be driven by the Zimmer partnership by 2030. So I hope that answered your question, Arvid.

Yes, absolutely. Just the last one, if I may, and then I'll jump back into the queue. What is your current assumption for the timing of Zimmer's approval for trauma in the U.S.?

Arvid, it's Christine. Thank you for that question as well. As Patrick mentioned, we do know that those timings are uncertain right now. It is a little bit difficult for us to project exactly when a U.S. approval may come. We do understand that these time lines are longer than originally anticipated. And so at least within our financial targets for today as well, we are taking a conservative approach to our view on the Zimmer collaboration, especially in the U.S.

[Operator Instructions] 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.

Thank you for your questions today as well as your engagement and for tuning in. We appreciate your interest and look forward to your continued support as we pursue Bactiguard's long-term potential and look forward to continuing to updating you on our journey to becoming the global standard of care to prevent medical device-related infections. Thank you again, and have a great rest of the day.