Bactiguard Holding AB (publ)

Thank you, operator, and welcome to the presentation of Backdoors Q4 and for the 2023 report. On my side, I have Patrick Bach, our CFO since November last year. Welcome to the team and to the financial markets, Patrick. Together, we will go through the presentation and as usual, be available for questions afterwards. But firstly, as I'm sure as you have seen, we announced some really exciting news yesterday evening. Back to God has appointed Christine Lind as its new CEO. With her international background, extensive experience from our industry combined with her modern collaborative and executional leadership style, Christine perfectly fits the bill for Back to God and our strategy ahead. In addition, being an American, having lived in Sweden since 2015, she can easily maneuver in both cultures. I cannot overestimate the value the US will have for BackGuard's future.

Christine will assume the role as CEO on May 14th in connection with the Annual General Meeting.

The headline of the report summarizes Q4 and the year in an excellent manner, a stable fourth quarter marking the end of a challenging year. 2023 was also characterized by fundamental change. Entering 2024, we have full focus on the licensed business, where the biggest potential for Back to Guard lies, both from a profitability and impact perspective. We will enable leading global medtech companies to bring their medical devices with backwards unique infection prevention coping technology to the market. It's our new strategy in a nutshell. And I'm confident that we are now putting the challenges of non profitability behind us. So what's happened since we announced the Sharpen strategy in October last year? The transformational transformation is well underway and I want to revisit this slide which I showed in connection with the Q3 report and give you an update. On licensing, as stated, we are doubling down and are working closer than ever with our current partners. The most important development during the fourth quarter was the strengthened relationship with Beck & Dickinson, our longest and strongest partnership. In fact, This both deepens our partner collaboration and we deliver the first of the three deliverables we promised to you, the market, to find partners for the three products within the bacterial infection prevention portfolio. I will revert to the latest agreement with BD in a minute. Look at the rest of the BIP medical devices, the yellow box. We are gradually terminating production and have discontinued our sales force. We're also in dialogue with both current and potential partners to license out back to us technology for the central venous catheters, the CVCs, and the endotracheal tubes, the ETTs. The conversations are positive and the interest is underpinned by the strong clinical data we have across the BIT portfolio gained over the last 10 years. As mentioned in my CEO statement, Back2Go has invested hundreds of millions of kroner in our coated medical devices over the past decade. This has not been in vain. It's the bedrock that we build upon when forming the future partnerships. And finally, the box in the middle, the backbone of our business, namely our infection prevention technology. most important asset. In the course of 2023, we have increased the focus on R&D, strengthened the Coating Development Organization, and institutionalized processes further. Following the strategic review, we decided to perform all coating and development activities in Sweden, and consequently, we have started building a new lab facility in Markary. Marker will be a complementary site for R&D and host training and technology certification activities. It will also be used to set up demo production lines for licensed partners.

With all this comes change in terms of our corporate culture and ways of working.

We are evolving into a knowledge and specialist organization. a profound change for backyard and an absolute necessity to achieve profitability and reach our bold financial targets. BD, or Beck & Dickinson, is one of the largest metric companies in the world, and we have been in partnership since the early 1990s. During our partnership, more than 230 million coated folic catheters have been sold And this has generated more than 1 billion US dollars in additional sales for BD. That's a rather hefty amount. And dear listeners, this is one product. And I'll say again, one product that has generated additional sales of $1 billion for our partners. There are many, many medical products out there that should be coated. In December, We strengthen our ties with BD by signing an agreement granting them an exclusive global license, except China, for back-to-guard coated folic catheters. The handover process is ongoing and has been well received among both distributors and end users. And even more importantly, our collaboration with BD is working extremely smooth. It's fair to say that we hit the ground running, and the interest for back-to-guard coated catheters post-New Year has accelerated across the globe, it seems like the world is noticing the issue with multiresistant bacteria to a larger extent. And sadly, it's triggered by the situation in Ukraine, where antibiotic resistance are in excess of 90%. And again, the estimated market value of folies sold around the world annually is in excess of $1.5 billion.

and it has an underlying 5% growth.

We can't think of a better organization than BD to partner up with in urology. We know each other well and share common values with a commitment to help patients in need and not least make the world a healthier place. We're working closely together to make a relaunch or a combined offering, meaning in the US and Japan markets, where BD is dominating today. Furthermore, we are having initial discussions on other products in the urology field. This truly confirms that the strategy of doubling down on existing partnership is a crucial one for our future success. We expect the extended BD agreement to have a small but positive effect on the 2024 income statement, however, contribute substantially more over time. With this agreement, we will turn a stable business with BD into a growing one. We are bending the trend. Patrick will elaborate further on the BD figures later in this presentation. Our partnership with Zimmer Biomed continues to make progress, and we have a great collaboration. The transition from soft to full launch of ZNM Backdigard is ongoing, and we see increased sales in both existing and new European markets, albeit from low levels. In addition, we expect a launch in Japan in July 2024. After that, Zimmer Biomet will offer back-to-guard coated products in markets representing around 50% of their trauma sales. Please note that today we coat a smaller part of Zimmer's trauma portfolio and we are currently working on coating additional products within the trauma offering. As already stated in Q3, our best guess is that Zimmer Biomed obtains trauma FDA approval early 2026. Worth noting though, is that 50% of Zimmer Biomed's trauma offering is actually outside the US, where their products are already approved. To put some flavor to our collaboration, Check out the smart and impressive marketing materials on CNN Back to the Garden. A unique combination of two prime technologies making stronger health care and patient impact together. And on this one, you don't want these nasty bugs to stick on this implant that you have on the left side of the picture. You really want them not to adhere to the surface.

So beware. A recap of our new strategy.

This is the business model which we introduced in connection with a Q3 report last year. Well, the green section is clearly the most important from a revenue generation perspective. The customer acquisition process follows a well-defined roadmap. And once an application development agreement is signed, it transforms into revenue generating partnership. We focus on the green boxes. This is how we will report revenues ahead, and we believe this will give a better understanding, be more relevant and transparent when it comes to when the actual revenues kick in. Our revenues are generated across three stages, application development partners, accessibility partners, and license partners. An application development partner is a development project where we test different medical devices, services, and materials on behalf of our customer. Our teams work in close collaboration, and the outcome is uncertain until satisfying results are achieved. Some application development projects will not materialize, and this is a natural part of our business. And as I mentioned in my CEO statement, Dance by Sirona was an application development project which we agreed not to pursue further due to change priorities on their side. Importantly, and I would like to emphasize this, we have already entered into a development project with another leading dental organization. We will not disclose the parties' names. In development projects, some will materialize, some will not. By disclosing names too early, we will only mislead you.

We will announce once an exclusivity agreement is struck.

An exclusivity partner gets an exclusive right to apply our coating technology to a certain medical device. For this right, they will pay a handsome amount every year, and they will have the right, once regulatory approval has been attained, to become a full-blown licensed partner. Examples of licensed partners are ZMN Backyard Trauma Analysis in the market, and BD's Back to Guard Coated Foley, Bardex IC. With that, I'm handing over to Patrick to take us through the financials.

Thank you, Thomas. I am very happy to present our Q4 and full year financials, which we can say represent a stable fourth quarter, marking the end of a very challenging year indeed. Turning to the Q4 figures. It shows the high level results of a stable quarter in alignment with our expectations. We delivered total revenues of 61 million SEK, EBITDA of minus 4.2 million, a net loss of 27 million and operating cash flow of positive 4.1 million for the quarter. The total revenues of 61 million We're down 11 million, or 15%, versus Q4 last year, but in line with our expectations given the record Q4 in 2022, which included VD's stock building. Our revenues in Q4 were driven by recurrent license revenues of 29.5 million SEK, primarily from VD, which we are happy to see are back on pre-COVID levels. In addition, we saw BPP sales in Q4 of 24.1 million SEC, up 9 million versus Q4 last year, driven by strong growth within wound management, as well as strong BIP growth due to the portfolio's end-of-life sales. Regarding Q4 key events, as Thomas mentioned, we are excited to have strengthened our relationship with BD as we announced in December. This is very much in line with our announcements of the Sharpen strategy with full focus on the license business and the phasing out of the portfolio. And to recap, in Q4, we announced our updated financial targets for twenty twenty eight with net sales exceeding one billion SEK and EBITDA of five hundred million. looking at the period january to december 2023 evidently shows a challenging financial year indeed the result however is in line with our expectations while affected by the 42 million sec adjustment from the profit warning in q2 for the full year we delivered total revenues of 223 million sec EBITDA of minus 76.1 million, a net loss of minus 138.4 million and operating cash flow of minus 60.9 million per year. Total revenues that amounted to 223 for the full year were down by 30 million or 12%. As expected for the full year period, our license business was severely affected by the decreased BD volumes. Recurring license revenues were 104 million SEK down from 139 million. For BD, we saw 93 million point one versus one hundred and thirty three point nine million last year. Revenues from recurring royalties and contract manufacturing amounted to 11.2 million versus 5.6 million last year. Non-recurrent license revenues for the full year was 12.9 million versus 22 million last year. The decrease compared to last year is primarily related to the regulatory revenue that was received in 2022 from CIMA. Looking at the BPP revenues, we delivered 84 million for the full year versus 62 million last year, an increase of 22 million. This increase is related to both growth in wound management and the end of life sales within BIP. Total cost for the quarter was 85 million SEK, while for the period January to December, was 355 million including the 42 million one-off. Post our transformation the operating cost will evidently decrease. As mentioned before we anticipate yearly savings of above 25 million SEK on a full year basis when the BIP portfolio is fully phased out. Looking at the rolling 12 months We evidently still see declining revenues as well as EBITDA indicating the challenging year. With significantly lower license revenues from BD as a result of their stock reductions in the middle of the year, as well as our 42 million one-off adjustment. Going forward for 2024, as stated, we will report revenues by the different partnership types with development revenues, exclusivity revenues and license revenues. give a clearer and more transparent picture of the revenues and how they evolve over time so in q4 we kicked off our new strategy and focused our efforts on the license business which as already stated is the greatest potential for practicality The strengthened relationship with BD announced in December is a great example of our focus on the license partnerships. And together, we believe we can increase the sales of the BactiGuard-coded polycatheters in existing and new markets. Looking at the figures, Q4 was driven by the recurring license revenues of 29.5 million, primarily from BD, which we're happy to see back on pre-COVID levels. Worth noting is that The Q4 2022 was a record quarter for BD who was building up their stock. Non-recurring license revenues for the fourth quarter amounted to 2.6 million, which are primarily related to the exclusivity rights attributable to the collaboration with Semo Biomed signed in 2022. For the full year, the BPP revenues were 84 million SEK, an increase of of 36% compared to 2022. Again, partly attributable to the end of life sales for the BIP. For Q4 in isolation, total BPP was 24.1 million SEK, 61% higher than the quarter last year. As previously stated, with the BIP portfolio of medical devices fully phased out, we expect a negative effect on the BIP revenues. of 25 million SEK on a full year basis, while the yearly savings are anticipated to be over 25 million SEK also on a full year basis. And as Thomas mentioned in the beginning of the presentation, we are gradually terminating production and have discontinued Salesforce for the rest of the BIP medical devices, which together will drive the anticipated savings. On wound management, we now see a standalone business oriented for growth and profitability. This stands for 54 million SEK of the BPP full year 2023 revenues and represent an increase of 24% compared to last year, in line with our expectations. Another positive development is that HydroSyn Aqua have obtained approval in India. So to conclude, With our change of strategy, we will go from a medical device production company to a knowledge and specialist organization. And a profitable high margin business. In this slide, I want to recap our financial targets, which we announced in the connection with the Q3 report. The targets relate to profitability and growth with the time horizon of year-end 2028. For profitability, we have an EBITDA target of 500 million SEC, And for growth, our target is net sales in excess of one billion SEK. To deliver this, we have a strategic target of 10 application areas in license partnership, which means having products in the markets by end 2028. Measuring this will give a better understanding of how we make progress in terms of expanding our technology. We are well underway on our transformation from being a medical device production company to becoming a knowledge and specialist organization and have a high margin business. Thank you. And back to you, Thomas.

Thank you, Patrick. Great to have you on board. You will hear me as a broken record. No quality report under my leadership will be without a section on the challenges and the danger of biofilm. This is my way of putting the global health care issues into perspective and explain why I'm such a strong believer in what our technology can provide. And that actually starts with biofilm, which is formed when bacteria and other microbes sticks to the surface of medical devices, making the bacteria more resistant to both the immune system and antibiotics. When biofilm is established, the resulting infections are very hard to treat. and sometimes not treatable at all, which means sepsis and death. To repeat what I've said many times before, to mitigate the risks associated with biofilms, medical devices intended to stay in the body for more than two days should be coated. Obviously, with our infection prevention technology. A coated surfer is crucial to avoid biofilm formation and to prevent healthcare associated infections, saving healthcare systems billions, and to be a force in the battle fighting multiresistant bacteria causing the death of millions of people globally.

You've seen this slide many times before, but it's worth revisiting.

I'm confident with our ability to grasp the vast opportunities in meeting these unmet medical needs. The global societal challenges, including healthcare associated infections and antimicrobial resistance are as pressing as ever. And unfortunately, Ukraine is evidence of that, where you have stocks and stocks of antibiotics, which are useless. And for us, the market opportunity is huge. but also the potential to really do good, save and enhance quality of life. Back to God is an excellent example of sustainability and impact truly integrated to the business model.

Our common goal is profitability and impact. Time to conclude with some reflecting remarks

In June, Bactigar has been listed on Nasdaq Stockholm Exchange for 10 years. It's fair to say that we have had both opportunities and challenges, as well as chairs and setbacks. But the one thing has been constant, a strong determination to make a positive impact on health care and for the well-being of patients. Bactigar has a safe and biocompatible coating technology in making it simple to avoid medical device related infections. By joining forces with leading medtech partners, I'm convinced that our infection prevention technology will become the global standard of care as stated in our vision. And importantly, that we will reach our financial targets. With the books for 2023 closed, we are on the right path and we will achieve profitability in 2024. I would like to conclude 2023 by extending my deepest appreciation to you investors, to our partners, and evidently to our employees, for your trust and dedication. Looking forward to unleashing the true potential of our unique technology.

Thanks all for dialing in and for listening. We're now ready for any questions you may have.

If you wish to ask a question, please dial £5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial £6 on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any written questions and closing comments.

Thank you, operator.

As I said, we are halfway through in the transformation of what we intend to become. I must say, if I've been a little bit gloomy the past quarters, I must say we do see a very clear path all the way forward. And I can only reiterate my optimism with that said. I'm humbled to say it needs to be delivered. It needs to be executed. And I'm very, very pleased to have Christine on board, we're going to be a tag team going forward. And it's really up to us to safeguard to you that we can deliver upon our promises. So thank you for listening.