Bactiguard Holding AB (publ)

Thank you, Operator, and welcome to the presentation of Back to Guard's Q4 and full year 2024 report. I will go through the presentation together with my colleague Patrick Buck, Back to Guard's CFO, and we will have a Q&A session towards the end. Thank you all for listening in today. As usual, I will go straight into the overarching theme of the report. We are very pleased to communicate increased revenues and EBITDA profitability, both for the fourth quarter and the full year 2024. We now have three quarters in a row with positive financial development. I wanted to give some brief overall comments on the full year, and as usual, Patrick will review our financial results in more detail later on in the presentation. Looking back at the past year, we have executed on what we set out to deliver. We have discontinued our BIP portfolio and delivered the associated cost savings. We are on plan on the transfer of Back to Guard's Foley Markets to BD. We have strengthened the organization to further enable our licensing business execution, and we are actively working in early stage feasibility testing for potential partner products. We have been through a fundamental shift going from primarily production and sales to becoming a knowledge specialist and license partnership organization. We have also changed our ways of working to enable us to be better partners to our partners and to capture new licensing business opportunities. And even though the journey from early stage testing to full-blown license partnership is long and not always straightforward, we now have laid the ground to be able to move ahead in a focused and disciplined manner. This fundamental shift has also enabled us to deliver 18 million SEC of EBITDA for the full year 2024. This truly demonstrates that our license focused strategy and business model is effective and that the path we embarked on towards the end of 2023 is starting to generate results. It feels great to deliver on our commitments and the entire BactaGard team are entering 2025 on a high note. Let me take a few minutes to recap our unique infection prevention technology. Some of you may have heard this before, but it is worth repeating that we have a truly compelling offering. Our core technology is an ultra thin coating of the noble metals, gold, silver, and palladium. We license the technology to global med tech companies and develop a different coating process for each medical device. The total quantities of the noble metals on any given device are tiny, but when in contact with fluids, the galvanic effect creates something like an electric fence and results in the inhibition of microbe adherence to the surface of the devices. In the pictures in the lower right of the slide taken with an electron microscope, you can see the difference in bacterial colonization between an uncoated surface to the left and a Bactigard coated surface on the right. The Bactigard side shows significantly fewer bacteria colonizing, which reduces biofilm formation over time and thus leads to lowered rates of infection. Over the years, a wealth of data has been amassed that points to the effectiveness of our technology. More than 100,000 patients have been part of over 40 clinical studies covering case reports to randomized controlled trials, and results have been published in renowned peer-reviewed publications. Our studies cover various patient cohorts, continents, and regions, and different therapeutic areas. In short, we know our technology works. As I mentioned in my CEO statement, 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 in delivering healthcare globally. Today, I would like to highlight the issue of healthcare-associated infections, or HAIs. Looking at some data, one in 10 patients worldwide are affected by HII's. 40 to 60% of HII's are caused by medical devices. And the costs associated with HII's related to longer hospitalizations and additional need for treatments 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 cost-effective and offers benefits over treatment. The need for infection prevention across multiple therapeutic areas brings opportunities for back to guard. We believe that the best way to protect against infections is to prevent them. And our vision is to become the standard of care to prevent medical device related infections. This is enabled by the core of our business model to work in partnership with leading med tech companies to enable differentiated and safe medical devices to be brought to a wider market. Our Q4 and full year 2024 results announced today clearly confirm that our licensed focus strategy and business model are effective. Looking ahead, our overarching strategic pillars remain. We will continue to advance current license partnerships, such as the one we have with BD, and develop new applications with leading global medtech players. We will continuously enhance our knowledge and specialist competencies to be the premier partner to our licensed partners. And within wound management, we will continue to focus on profitable growth and expansion into new markets. One important part of our 2024 achievements was how we strengthen the organization across multiple knowledge areas to be able to enhance the collaborations within our partnerships. Strengthening our competencies will be a constant and back to guard as a knowledge driven and learning organization. And today I will focus on two individuals as examples within this strategic pillar. Firstly, I'm happy to announce that Kaisa Bjorklund has joined us as our new head of R&D and part of our executive management team. This is actually her second week or so, but she has had a flying start meeting with the team and getting up to speed with both our opportunities and challenges. Kajsa comes most recently from Seiko, where she had the responsibility for overseeing global strategic projects as director of portfolio management. Before that, she was head of operations and R&D at Orthopedics-focused Ost Design. Kajsa brings a wealth of experience in driving innovation to market and has a PhD in inorganic chemistry. She has also led teams through fundamental transformations at both large and startup companies. Leveling up our R&D knowledge, which is the core of Back2Guard, enables our future success. And with Kaisa leading the R&D team, we will ensure that we drive innovation, work cross-functionally, and strive to be the very best partners to our partners. I am also happy to announce that Nathanael Bachrach, who has been our interim head of R&D, will remain with us in a new role as chief scientific officer, also in our executive management team. Tani is based in the US and will now focus his efforts on new partnership development. During the year, Tani has been instrumental in discussions with potential partners to enable our R&D team to deliver feasibility testing. His vast experience in successful product development and launch in combination with his mechanical engineering and biomechanics background and impressive record of publications and innovative patents continue to bring back to guard important leadership. Outside of these two individuals, we have also strengthened our regulatory and clinical competencies and are currently defining Back2Guard's US regulatory strategy to ensure that we can work more effectively together with our current and new licensed partners in the very important US healthcare market. In addition, we have added capabilities in business intelligence, data analysis, and AI, allowing us to synthesize knowledge and enable informed commercial outcomes for Back2Guard. Put together, our combined intelligence, knowledge, and experience underlie the ongoing review of our financial targets. And we will comment briefly on this later in the presentation. I would like to revisit our business model, which we introduced in Q3, 2023. It reflects the partnership journey and gives us a good overview of the different stages from new business development discussions on the left and the transition to application development through to licensed partnerships with commercialized products to the right. The green section is the most important from a revenue generation perspective where revenues from exclusivity fees and licensed partnerships are the two most meaningful contributors. Today, our existing partnerships have commercialized products and generate royalties. And we are also engaged in early stage testing with potential partners for various application areas. This early stage testing and even full application development projects are best executed in a confidential manner. And we are committed to safeguarding competitive advantages for Back2Guard and our partners, especially at this early stage of the partnership journey. In addition, we know that the nature of development work means that not everything will succeed. But as we do, the business model generates significant leverage that enables the next development as well. Now let's turn to an update on our license partnerships. Our collaboration with BD has been enhanced throughout 2024 with a global approach, as well as a close dialogue and joint effort across the value chain between our companies. This partnership was a main contributor to our increased revenues and positive EBITDA. We are extremely pleased with how the partnership with BD has evolved, and we have come a long way from being competitors in certain markets to becoming true partners with aligned interests and mutual benefit. We continue to work closely on the expansion of back-to-guard coded Foley catheters into both existing and new markets, including collaborating on market registrations, which are required to enable BD's launches in former BIP Foley markets. In short, our BD collaboration is a model for what our focus on licensing business can deliver. Now over to Zimmer Biomet. They are also strong believers in the importance of infection prevention. Within the trauma setting where our collaboration with Zimmer remains, infection rates are high, and consequently, the need for infection prevention is clear. Commercialization of the BactiGard-coated orthopedic trauma nail implant branded ZNN BactiGard is progressing, especially in Europe. Importantly, Zimmer Biomet is conducting four clinical trials on the ZNN back-to-guard nails. The main study compares the ZNN back-to-guard to uncoated implants, and all studies include important objectives such as fracture-related infections, as well as safety and other clinical benefits. We are also focused on the regulatory processes enabling continued commercialization in Europe, as well as the approval path in the US. As communicated earlier, the agreement covering orthopedic products outside of the trauma segment was terminated in early October, 2024, due to a more complex and lengthier path with the US FDA than Zimmer Biomed had initially anticipated. The termination was clearly a disappointment, but the work in the partnership gave us a deeper understanding of the US approval requirements. And we now have important learnings relevant both to our continued trauma collaboration with Zimmer, but also for the back to guard technology overall. Notably, back to guard owns the commercial rights to all coded orthopedic medical devices outside of trauma. And we are now seeking licensed partners in this therapeutic area. We have focused a lot today on what we have delivered in terms of the license focus strategy, but I would also like to provide an update on our wound management portfolio, which contributed to profitable growth in Q4 and for the full year. The strategy for wound management remains focused on stable profitability and expansion into new markets, primarily in Asia. Highlights from 2024 include the regulatory approval of Hydrosyn Aqua in India and the publication of a randomized study with Hydrosyn Aqua in the Open Access British Journal of Surgery. The study showed that using Hydrosyn Aqua solution in peritoneal and wound lavage reduced overall surgical site infections by 58% and superficial surgical site infections by 72%. These significant results further enforce the efficacy of Hydrosyn Aqua in infection prevention. And after that tour of the most important areas of our company, I now hand over to Patrick to go through our financials for Q4 and 2024 in detail.

Thank you, Christine. I am very happy to present our financial results for the fourth quarter and for the full year period. In short, we see our license focus strategy delivering increased revenues, in particular license revenues and EBITDA profitability. Now turning to our total revenue split for Q4, we see total license revenue amount to 44 million SEC, an increase of 12 million adjusted for currency corresponding to a growth of 38%. We see revenues from BD amounting to 35.8 million, an increase of almost 7 million adjusted for currency effects. This was about 24% growth. We see revenues from Sema Biomed amounting to 3.6 million, a small increase of 0.5 million. These revenues pertain mainly to exclusivity revenues from the multiple orthopedics agreement, as well as license revenues from the trauma agreement. Revenues from licensed partners in total amounted to 41.2 million, an increase of almost 12 million. Adjusted for currency effects, this was an increase of about 40%. Revenues from exclusivity partners amounted to 2.5 million, a small decrease of 0.2 million. Revenues from application development partners amounted to 0.6 million, an increase of that same amount. Revenues from our wound management portfolio amounted to 15.6 million for the quarter, an increase of 1.7 million, corresponding to about 12% growth. Revenues from our BIP portfolio was 3.2 million for the quarter, so a decrease of about 7 million. And we do not expect any additional BIP revenues for the coming fiscal year. Other revenues amounted to 5.2 million and currency effects amounted to 2.2 million for the quarter. So in the fourth quarter total, revenues amounted to 68.3 million, an increase of almost 7 million adjusted for currency effects corresponding to about 8% growth. Revenues for the full year period, January to December, amounted to 261.9 million, an increase of 38.7 million, adjusted for currency effects that is corresponding to close to 13% growth. Now looking closer at the net sales development, we saw Q4 net sales of 63.1 million, an increase of almost 7 million and adjusted for currency effects. We saw about 12% increase. On a full year basis, we saw net sales totaling to 241.7 million, an increase of about 40 million. And adjusted for currency effects, the net sales increased more than 20%. As mentioned, we see strong growth in our license revenues. We see stable, profitable growth in wound management portfolio. And we saw the phase out of the BIP portfolio. Now turning to our EBITDA development, as Christine mentioned, we are very pleased to announce profitability on an EBITDA level, both for the fourth quarter, as we did for the third quarter, and on the full year basis now. EBITDA for the fourth quarter amounted to 8.4 million SEK, an increase of almost 13 million versus last year, and our EBITDA margin was around 12% for the quarter. EBITDA for the full-year period, January to December, amounted to 18.0 million, so a large increase of 94 million versus our EBITDA last year, and the EBITDA margin for the full-year period was about 7%. The improved results mainly pertain to the large 42 million provision made in the second quarter of 2023, pertains to the increase in total license revenues, decrease in cost in raw materials and consumables, as well as a decrease in our total operating expenses. Now, turning to our operating expenses and looking closer at the cash flow, for the quarter, cost for raw materials and consumables was about 6 million, a decrease of almost 10 million. Other external costs was about 22 million, a small decrease of 0.3 million. Personal costs amounted to 30 million, an increase of almost 5 million. And in total, our total operating expenses, OPEX, amounted to 54.4 million, an increase of just over 4 million. For the full year, we see our total OPEX amounting to 207.9 million. That is a decrease of 27.3 million, which corresponds to about 12%. And all in all, we are pleased to conclude that we delivered the cost saving exceeding 25 million on a yearly basis, following the strategic transformation that we announced last year. Now turning to our cash flow for Q4, we see cash flow from our operating activities amounting to 18.9 million. Cash flows from investing activities was minus 1.7. Cash flows from financing activities amounted to minus 7.6 million. In total for the quarter, we see cash flows amounting to plus 9.5 million. On the full year basis, our total cash flows was minus 11 million and for the full period, cash and cash equivalents at the end of December amounted to 116.7 million. As Christine stated earlier in our presentation, we are currently conducting a thorough review of our financial targets. This work encompasses analysis of our market potential, and the partnership opportunities for our technology. The process involves in-depth evaluation of the key strategic therapeutic areas, including targeted application areas within these. It includes the associated infection rates, regulatory approval timelines, and commercial scale-up through licensed partners. All aspects must be balanced with the operational leverage of our business model. And as promised, we will revert with the outcome of the review no later than end of Q1 2025. And with that, I'm happy to hand over to you, Christine.

Thank you, Patrick. Time to conclude 2024. We have strengthened the organization to embrace the opportunities within the licensed business. We have discontinued our own sales of the BIP portfolio and reap the benefits of the associated cost savings. we continue to deepen and advance our current partnerships where BD is an excellent example with growth and mutual benefit. We have a pipeline of early stage projects for potential partners with feasibility studies ongoing across multiple therapeutic areas. And our wound management product portfolio has delivered stable growth. As mentioned many times today already, we have increased revenues and delivered on our commitment to EBITDA profitability. We are on a journey that takes time and requires stamina and commitment, but the potential for our technology across our strategic therapeutic areas is high, and we are poised to take back the guard to the next level. With a steadfast focus on profitability, we remain fully dedicated to preventing medical device related infections with the vision to make back to guard technology the global standard of care. And with that, we 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.

Thank you. A few questions. First on the high EBITDA sales. Would it be possible to Give a little more color on what's driving that, whether it's related to higher volumes in, if I phrase it, old markets, so U.S., Japan, anything from new markets, what's happening with price, and also what potential you see for continued growth in 2025 and forward in this revenue line.

Hi Christoffer, this is Patrick Bak. Thank you for your question. We do see strong growth from BD this quarter and we see it on the full year basis. We are pleased with that and we are confident about the development of our partnership. This is also what we believe we see in the results. Q4, we saw an increase of almost 7 million, corresponding to 23%. That is obviously significant. As well as for the full year period, we saw revenues from BD increasing more than 30 million and more than 33%, which is also significant. We have some comparisons last year that obviously affect this as we have discussed throughout this year. But I will say we are pleased with the run rate that we have seen during 2024. We remain confident that we continue to strengthen and grow the partnership with BD and that we will see that in our business as well.

Hi, Christopher. This is Christine. I'll add a little bit to that as well as the market specificity. We do see drivers of revenue from both new and existing markets. So it's a little bit difficult for us to say we have a specific breakout on that. And as regards the newer markets, we should comment that all regulatory processes do take time. And we are continuing to be in the process of supporting the filings that lead to our ability to shift the market registrations to BD. It is well underway and to plan. But of course, we need to continue those activities to enable new market launches as well.

Christopher, to your last point about price... Have there been any changes to the price?

Yeah, thanks Christopher. To your last question about price, there has been no changes in pricing. So that is not a factor here.

And do you see potential for continued solid growth also in the old markets?

I think we see. Yeah, I think. Thank you, Christopher. I think we see a continued strengthening of the partnership across all markets within the partnership. And that should include also the existing markets.

okay yeah um then my second question relates to uh to the simmer by math agreement um is it possible for you to comment on whether they are close to or if sales is close to to increase about the minimum levels you have in in the contract And also now for 2025, as part of the revenues will go away, do you think total semi-biomed revenues will be higher or lower in 2025 versus 2024?

Thank you, Christoffer. Relating to semi-biomed, We report in the fourth quarter revenues from CIMR relating to both the now discontinued orthopedics agreement as well as the trauma agreement. As for 2025, I don't think we can foresee the sales levels of the Zimmer trauma products. However, I think it is clear that with the Q4 result, we saw the last revenues in connection with the discontinued orthopedics agreement. What we have seen in 24 in relating to the trauma agreement, is that the total revenues coming from that agreement is driven both by minimum royalties as well as royalties in market. And that we believe will be a continued picture into 2025.

After the termination of the agreement, how much of the, let's say if you haven't had the broader orthopedic agreement in 2024, how much of Zimmer sales should we remove them?

What I think I can... So to understand your question, right, you're asking to the CIMR revenue share of the orthopedics agreement.

I think what we... Or how much of CIMR Biomet is... Sorry, how much of CIMR Biomet revenue you have reported for 2024 is trauma that will remain?

We don't have that number in detail disclosed. However, for Q4, we report that the revenues reported in Q4 mainly pertains to that discontinued agreement. Okay.

And did I interpret correctly as you think similar revenues will be lower in 2025 than 2024?

We do not have a prediction for 2025 but what I think we can say is that in 2024 As reported in Q4, we recognized the last revenues from the multiple orthopedics agreement. So that will not be recognized next year. So there will be a portion of the total revenues that will not be in 2025. But we cannot predict what will be the revenues coming from the other agreement.

Okay, that's a fair point. And do you have any news on timing for, you know, future filing of the trauma nail in the US?

We can't give a timing point on that because we don't have a timing from Zimmer Biomed either. However, I guess we can say that we do continue to understand the US regulatory pathway. which is important there and that the we should also be aware that the work ongoing in Europe with the clinical studies is of course a very important timeline both for Europe but also for data generally for our product in global markets.

Okay. Final question. The reason you didn't upgrade or updated on the long medium term financial outlook now in in in connection with the report what's the reason for that are you planning to have a separate session on this or what's the thinking thank you

We are currently and still conducting a thorough review of the targets. So we do plan to come back as we had stated at the end of the quarter. So we are still in the process of conducting the thorough review.

Okay. Thank you.

Thank you, Gustav.

Thank you. The next question comes from Mattias Vadsten from SEB. Please go ahead.

Hi. Just to get back to the last question there. Will the financial targets be announced then in the press release, you know, mid, let's say between the export quarter and the first quarter? Is that correct?

I'm Mattias, this is Christine. We will certainly revert back publicly with the results of the outcome of our review and we will do that before the end of the first quarter. So before the end of March most certainly.

Okay, good. And then I have a couple of questions here. So first one I We'll try to tweak the question on the BD question you got before, so about the fully catheters here. If you could maybe provide us with a bit more of a timeline for market registration, as well as maybe to provide an update on, you know, in which market will the fully catheters be sold by BD here in 2025? To get a better understanding there would be great.

Now, BD, of course, now has global rights outside of China. So those markets are the areas where BD will be focused. We do expect that the US, which is the core market for BD generally, and certainly within the urology segment, which our product is a part, is the most important market for BD and where they will focus, we are sure, a continued amount of energy. So the US, of course, remains an important market for them. They do not share, so we cannot share on their behalf where all of their markets are specific for our Foley catheter. However, we can comment that, of course, they are also looking towards launches in some of the markets that were previously BitFoley markets, but which are now transitioning to them. Again, we do appreciate that the registrations do take time. It is a little dependent on the timelines for the actual processes with the regulatory authorities. So while we are continuously making the filings together with BD that will enable those launches, we do need to await the appropriate regulatory timelines to be able to get those back. So that will be rolling. A little bit difficult to say exactly what the timelines will be for completion of all of them. But it is well underway and certainly as we have new countries, we will inform appropriately.

Okay, good. But today, are there any or how many new markets or let's say old bit markets then are there today? Or is the oil sales coming from like Japan, the US and those markets that they had before? Thank you, Mattias.

We actually can't comment on the very specific market information. Again, this is information that BD does not share. We are therefore not entitled to share it either. But I can comment that certainly we would expect to see a combination of both new and existing markets.

I think, Matthias, just to add to that, I think we see it as a global partnership, excluding China. We believe that PDC sees it the same way. This is the first year of the extended partnership. As Christine mentioned, there is a lot of work in the regulatory filings in each country. But we are pleased with the strengthening of the partnership, which is also what we believe we see in the results.

Good. Then I had a question on, you talked about some clinical studies and so on going on. What key milestones do you think we should look out for, let's say, in the next 12 to 18 months that we know of?

Very, very great question. The clinical trials have, I guess I'll say, relatively long endpoints. For example, 12 month follow up after surgical to review infections associated with fractures. So while this is a very important metric, certainly we can appreciate that with a 12-month follow-up timeline, that means that a study will take years and not a couple of months. So these studies are ongoing. They are on clinicaltrials.gov if you would like to be able to find out more information on them as well. And when the full results of the study are available, we will then be in a position to be able to share the outcomes of them. But they are ongoing. We, of course, continue to receive updates from Zimmer on that. But until a study is complete, we would not be able to announce additional results.

That's a good answer. Then in terms of total cost in the P&L. So my question is, if you are anticipating a continued cost reduction, for 2025 versus 2024. And yeah, any comments that you could share with us about what you do with the cost base from here on is of course helpful. That's my last question.

Yeah, appreciate that Matthias. I think this year has been an important year for us to make sure we have costs under control and also that we reduced our costs. We have done that in connection with our transformation, which means that we saw reduced costs in terms of COGS as well as OPEX. We see going forward in line with the business mix, we see that we will have a continued strong growth margins, meaning that we will have less COGS than what we have had historically. I think on the OPEC side, we will definitely continue to focus on our costs and have costs under control. I cannot say that we will continue to reduce costs. We will strengthen and we will make the necessary adjustments to our business in order to achieve the growth that we want to pursue. But we will do that with having cost under control. And as we mentioned earlier, being committed to EBITDA profitability.

Okay, thank you for the presentation and the answers.

Thank you, Mattias.

Thank you, Mattias. The next question comes from Christopher Liljeberg from Carnegie. Please go ahead.

Thanks. One more follow-up here on what you said about time for the follow-up on the European trials. Is it true that those need to be done before before filing in the US. Is this trial that's going to be used in the US filing, you think?

The European trials form a couple of purposes. They're, of course, to collect data in general across the ZNN back-to-guard NAIL portfolio of products to be able to enable A couple of things. One of them, of course, is data in general, which helps all registrations in all countries. And the other aspect, which is equally important, is also to be able to drive commercialization. So this data does support, of course, potential for claims. and other marketing materials and information, which is important in their discussions with surgeons and physicians. So this is a data that is meant to serve more than one purpose.

Okay. All right.

Thank you, Christopher.

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

Okay. It seems we have no written questions in the queue. So then I will be very happy to conclude. Thank you for great questions today and the engagement and for listening in. And we look very much forward to our next engagement opportunity. And please do not hesitate to reach out to us in the meantime. Thank you.