Bactiguard Holding AB (publ)

Thank you, Operator, and welcome to the presentation of Backyard's Q1 2024 report. This is Thomas Van Karch speaking, the former CEO. I want to share a brief reflection before I hand over to our new CEO, Christine Lind, and Patrick Bach, Backyard's CFO. They'll go through the quarterly presentation and will be available for questions on the reports afterwards. Friday, two weeks ago, I formally handed over the CEO role to Christine, concluding an 11-month tenure leading back the guard. It's been a very intense and disruptive period where the strategic shift to focus on the license business was the most central change and going from being a production-based business to specialist and knowledge organization. When I assumed the role last summer, Little did I know what was about to come. We now have set the right strategy and inspiring vision to become the global standard of care in preventing device-related infections. Under the leadership of Christine and her team, I'm confident that Bacterial will become an instrumental company in the fight to protect patients from dangerous, uncoated medical device products that today causes half of all hospital-acquired infections. I would like to express a big and warm thank you to the entire back to guard team. You're all chipped in a very dedicated way, despite tough decisions and actions. You're such a high caliber team once again. Thank you. And on a personal note, being operational responsible for back to guard has been very tough. You're separated from a lot of good and qualified people, which has not been fun whatsoever. With that said, though, it's been necessary when implementing our new vision and focused license strategy. I will do my utmost to support Christine and team in my upcoming capacity as chairman of the board, obviously subject to the upcoming shareholders meeting electing me. I'm humble, but I'm upbeat about our future. With that, I'm handing over the show to Christine.

Thank you, Thomas. It is great to be here and thank you all for dialing in to what is my very first Back to Guard quarterly report delivered on my second Thursday as the CEO. As I stated in the CEO comments, I am looking forward to working with our sophisticated board of directors, including with Thomas as the incoming chairman, as well as Christian Kink in his new role as senior advisor. It is so valuable to have this full support. For those of you to whom I am new, my quick background. I have spent more than 25 years in and around the life sciences sector, including in CEO and business development and strategy positions, as well as in investment banking at Merrill Lynch in New York, advising biotech and pharma companies. I am an American, hence my very American accent. I have lived in Sweden since 2015, and yes, I do speak Swedish. Turning more importantly to the Q1 2024 report, The key message that we want to relay is that the strategic transformation has been concluded, and I would like to provide more details on that. If you have followed back to guard for a while, you will recognize this slide. We first showed it in connection with the announcement of the sharpened license focus strategy in Q3, and I would like to go through it one last time to showcase what we have achieved in terms of the transformation and restructuring of the company. Let us review these achievements by the articulated focus area starting with licensing. First, we have strengthened the organization both in terms of capabilities and ways of working. We are now working in a project-based manner with a partner relationship in focus with the aim to continue to strengthen long-term collaborations through teamwork and accountability for results so that Back to Guard is recognized as a true partner rather than being seen solely as a solution provider or a contract manufacturer. Second, we have already enhanced the relationships with our current partners, in particular with BD, but also with Zimmer Biomet. I will come back to this a little bit later in the presentation. Third, we are intensely engaged in dialogue with new potential partners. However, given the new way we will report revenues, we will not provide more information on these new partners until we enter exclusivity partnerships. In other words, we will announce once we are closer to starting to generate revenues, which we believe is more relevant from a financial perspective. Later in the presentation, Patrick will elaborate further on the framework for the reporting of our various partnership stages. The next focus area is R&D and our coding technology. We have further institutionalized the entire R&D organization, processes, and structure. We have kicked off the Billy Cerval Academy, although this is still in very early days, so I will not formally tick that off yet. Lastly, work is well underway on the production and laboratory facility in Markerid, and we hope to have it up and running sometime during Q2. Going forward, all coding materials production and development activities will take place in Sweden, in one of our two facilities in Tullinge or Markerid. Turning to the BIP portfolio, Importantly, we licensed out the folies to BD, and the handover process of these additional markets is making great progress. We're in the final stages of winding down sales of own medical devices. For the CBCs and ETTs, we are in conversations with potential partners, but it is still too early to report on, and it is important to note that we expect these activities to have very limited impact in 2024. To summarize the financial impact of the strategic transformation, we are on track to deliver cost savings of more than $25 million sec on a yearly basis. Separate from the licensing strategy, I would also like to emphasize our focus on growing the wound management business, consisting of both the wound healing offering of Hydrosyn Aqua and a wide range of surgical sutures, including specialist sutures for cardiovascular and ocular operations. In its totality, this Sharpen strategy is how we will be able to deliver on our vision to be the premier partner to leading med tech companies, joining forces to redefine infection prevention and improve health worldwide. This is the last time we will address this slide. Q1 will be the last quarter characterized by the transformation, but we expect continued activities stemming from the transformation during the remainder of 2024 as we fully transition to the new strategy. So let's dig into our business. Becton Dickinson, or BD, is one of the global market leaders within the urology therapeutic area. BD is our longest, strongest, and closest partnership. In fact, we have been partners with BD since 1995, and over the years, more than 230 million back-to-guard coated Foley catheters have been sold. No adverse events associated with the coating technology have been reported. and the product has generated more than three and a half billion US dollars in additional sales for BD. With BD, we share common values and a commitment to always put patients first and have the ambition to make the world a healthier place. As mentioned already in the Q4 presentation, the estimated market value of fully sold around the world is in excess of 1.5 billion US dollars annually and is estimated to grow by around 5% every year. In the category of strengthening existing partnerships, BD is a perfect example. Late December last year, we signed an interim agreement granting BD an exclusive global license, excluding China, for back-to-guard coded Foley catheters, and an expanded long-term license agreement is expected to be signed during the first half of 2024. So what have we accomplished in Q1? Back to Guard obtained MDR regulatory approval in Europe for the coated silicone Foley catheters. This marks an important milestone as it will support and accelerate BD's go-to-market strategy in Europe. It is also a good example of Back to Guard's capabilities as a specialist and knowledge organization where our ability to navigate the rather complex European regulatory landscape has provided great value to our partnerships. We also attended BD's Global Sales and Marketing Summit in the US where our BD project leader held a presentation on how our coding technology is differentiated and benefits their urology and critical care portfolios. This is really important to repeat as the strength of our offering to our licensed partners is that the coding technology differentiates their medical devices in the market. So please keep that in mind. Some 50 BD sales and marketing leaders from various markets listened in and engaged in a lively Q&A. A little fun fact, in the photo to the right is Micah Brinkley. This is BD's star salesman of back-to-guard coated catheters in the US. Clearly, we have a lot of ambassadors within BD, and they are also a crucial part of the future potential for back-to-guard. In connection with the license agreement announced in December 2024 for additional markets for back-to-guard coated Foley's, The transition is ongoing and making great progress. The transfer will continue throughout 2024, and during this period, either we or BD will ensure that the market demand is met. With the new agreement with BD, we believe our historically stable partnership is now strengthened and is a growing one. I'll start with a short recap of our partnership with Zimmer Biomass. Zimmer is a global leader in the orthopedic therapeutic area, and our partnership involves two categories. The first, signed in 2019, relates to Zimmer Biomet's orthopedic trauma implants, for which BactiGuard received CE marking for the coded version in 2021. Today, this trauma nail system is called ZNN BactiGuard. In 2022, the partnership with Zimmer Biomet was expanded to cover multiple product segments, such as implants for various types of reconstructive surgeries. I would also like to mention that in 2023, Zimmer Biomet had an overarching strategic theme called Let's Talk About Infections, used at conferences and in various conversations. And Back to Guard attended many of these, highlighting how our technology could prevent infections, a critical topic within orthopedic procedures. Looking at how the trauma collaboration specifically has developed in Q1, The demand for ZNN BactiGuard continues to increase following the launch across European markets in 2023. The uptake is, however, at a slower pace than we originally anticipated, but the interest and recognition among clinicians is strong, and the need for safe and effective infection prevention strategies is getting more and more attention. The next important event is the launch of ZNN BactiGuard in Japan, which is still planned at the end of Q2. Here again, we understand it will take some time before sales should be expected to ramp up. It is important to bear in mind that successful launch and sales of new technologies and products within our industry takes time and persistence. Together with Zimmer Biomet, we are continuously moving forward. Interestingly, once the ZNN back-to-guard is launched in Japan, Zimmer will offer back-to-guard coated products in markets representing around 50% of their trauma sales. We are confident that infection prevention is a very important issue to healthcare systems. Back-to-guard coded products have strong clinical evidence, and thus we know that our technology adds value. Now over to you, Patrick, to dig deeper into the financial results.

Thank you, Christine. I am very happy to present our Q1 financial results, which indeed highlight the end of our strategic transformation. and are in line with our expectations. Turning to the Q1 figures, we delivered total revenues of 58.8 million, EBITDA of minus 1.5 million, a net loss of minus 9.9, and cash flow from operating activities of minus 19.1 million SEK per quarter. Total revenue for the first quarter amounted to 58.8 million, as mentioned, a decrease of 2.4 million, corresponding to 4%. Adjusted for currency effects of 3 million, revenue decreased by 9%. EBITDA for the first quarter amounted to 1.5 million, an increase of 5 million, and the EBITDA margin was minus 2.6%. Net loss for the first quarter was 9.9 million plus versus 22 million last year cash flow from operations for the quarter amounted to minus 19.1 million and note that this is mainly due to change in accounts receivables of minus 16 million which are driven by outstanding amounts and not yet due in the quarter with our long-standing partners as for key events in the quarter first as we announced In our year-end report, we have agreed with Dentsu Placerona not to pursue the application development project further. Secondly, Hydrosyn Aqua received approval to start commercialization in India. And thirdly, Bexigard obtained MDR approval for our coated silicone Foley catheters, which will support BD's go-to-market strategy in Europe. As we are happy to report revenues this quarter in a new detail split, I would like to recap our business model, which we introduced in connection with our Q3 report and detailed in our year end and annual report. Our pre-partnership phase on the left hand side and the partnership phase on the right hand side follows a well-defined roadmap and shows in a more relevant and transparent way how we evolve our revenue revenue generating partnerships our revenues are generated across these three stages application development partners exclusivity partners and license partners an application development partner participates in a development project where we test the coding technology to different medical devices services and materials ActiGuard's coding development team works in close collaboration with the partner here some application development projects will not materialize, and this is a natural part of our business. An exclusivity partner gets an exclusive right to apply our coding technology to a certain medical device, but has no products in the market yet, for instance, due to pending regulatory approvals. Simo Biomed and their broader orthopedics portfolio is an example of an exclusivity. A licensed partner has the right to market and sell medical devices with the BactiGuard's coding technology in a certain region or globally. Most of our revenues are generated through partnerships at this stage. BD and Simul Biomed and their trauma implant CNN BactiGuard are examples of these licensed partner revenue streams. Please note, all partnerships will not follow all these three stages. and an agreement with a partner can generate revenues from the different phases and streams simultaneously. Now, turning to our new actual revenue split for Q1. Total license revenue amounted to 35.1 million, decrease of 4 million corresponding to 11% adjusted for currency debates. Revenues from BD amounted to 28 million, A decrease of 8 million, corresponding to 23 percent adjusted for currency. Worth noting is that Q1 2023 was another record year for BD, who was building up stock, which was subsequently downward adjusted during Q2 2023. Revenues from CIMA Biomed amounted to 3.2 million, an increase of 1.4 million. Revenues from the management portfolio amounted to twelve point seven million an increase of one point six million. Revenues from our portfolio amounted to six million. This is an increase of one million and the growth is primarily due to the portfolios end of life sales in connection with the discontinuation that we have announced in connection with the transformation. Other revenues amounted to 4.9 million, a decrease of 0.6 million. Currency effects in this quarter amounted to 2.8 million Swedish kroner. So total revenue for the first quarter amounted to 58.8 million, a decrease of 2.4 million. Adjusted for total currency effects of 3 million, our revenues decreased by 8.8%. Now turning to our operating costs and cash flows for Q1. Since Q3, we have focused on our strategic transformation and as communicated, we are on track to deliver cost savings exceeding 25 million on a yearly basis following the transformation. The costs for raw materials and consumables for the first quarter amounted to 11.5 million a decrease of 2.7 million, corresponding to 19%. Other external costs amounted to 18.8 million, a decrease of 4 million, corresponding to 19%. Personal costs amounted to 29 million, an increase of 2.9, corresponding to 9%. Other operating expenses related to currency exchange losses amounted to negative 0.7 million. In total, our operating expenses, or OPEX, amounted to 48.8 million, which is a decrease of 4.8 million, corresponding to 9%. Cash flow from our operating activities for the quarter amounted to minus 19.1 million. This is mainly due to changes in our accounts receivables of 16 million which is driven by outstanding amounts not yet due in the quarter with our long-standing projects. Cash flow from investing activities amounted to 6.2 million, and this is mainly attributable to investments in our new sites and in digital systems. Cash flow from financing activities for the quarter amounted to minus 6.3 million, which is mainly due to amortization of loans of 3.8 million. In total, cash flow for the quarter amounted to negative 31.6 million, and total cash and cash equivalents at the end of the period amounted to 95.8 million. With that, I'm happy to hand over to you, Christine.

Thank you, Patrick. So, time to wrap up. You have seen this slide many times before, but it is truly crucial when putting our infection prevention technology into perspective. both from a financial and societal impact perspective. On the left-hand side, the demand for more effective and safe healthcare solutions is clear, driven by economic and demographic developments, as well as the unfortunate increase in political unrest, conflicts, wars, and natural disasters. There are clear unmet medical needs with the global societal challenges, including healthcare associated infections and antimicrobial resistance being as pressing as ever. Notably, prevention strategies are, according to the World Health Organization, one of the most important factors to solving these issues. Turning to the right-hand side, while I am fully aware of the challenges Back to Guard has had in the past, our top priority ahead is to truly seize the $80 billion U.S. opportunity presented within the strategic therapeutic areas that are key for our infection prevention technology and in wound management. With the licensing focus strategy, both revenues and margins are expected to increase for back to guard as we expand the use of our infection technology globally through partnerships. We are set to scale up in a cost effective manner and create profitable and sustainable growth for the future. And with that, we are now ready for any questions you may have either on the line or in the chat. Operator?

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, and good morning. I have two questions. First, if you could give any update on the new extended collaboration with BD on the global scale. Secondly, if I look at what you report now as licensed partner revenue, 32.4, if I'm adding up BD sales and The seamer sales that you wrote about in the text, that's 31.2 million. So I just wonder what the rest is on that line. Thank you.

Thank you, Christoffer. I'll take your first question on the BD collaboration and we'll ask Patrick to respond to the license revenue question if that is okay. On the BD collaboration, it is a good relationship, of course, even closer today than it was in the past. I think it is beneficial that we are moving from having been a competitor to them in other markets to being a partner, which is good for the relationship, even in the already existing markets in the US and Japan. In Europe and our other new markets, we do need to remember that the approvals are back to guards. The product is back to guards. The sales material and the sales force was back to guards. And we are in a transition period where it is ongoing, but it does take time. We are also very happy to have had the MDR approval in Europe, as we do believe that this will help BD ramp up. So all in all, the collaboration, I think, is going very well to date. And of course, the partnership feels stronger than ever. And on the license revenues?

Could I just follow up? So the BIP sales you had in the quarter, if I remember, six million or so, that will go to zero more or less. And instead, you will get a higher royalty from BD coming quarters.

Hi Kristoffer, this is Patrick Bach. Just to answer your question regarding the BIP sales. The total BIP sales is what we have announced earlier that we are discontinuing. We have announced that this will impact our revenues with up to 25 million, whereas we said we at the same time were reducing costs exceeding 25 million. During this year, we will see BIP sales until we have fully transitioned all the Foley markets to BD. So depending on that transition, we will see in the coming quarters as well, perhaps some BIP portfolio sales. But our expectation is that this will obviously continue to decrease.

Okay, but when do you expect some meaningful impact on on the BD line from royalties in EU markets, so outside Japan and US?

As we have communicated, the outlicensing of our BIP portfolio, including the folies to BD, but also the other products, will have a limited effect in 2024.

Okay. And the other question on the license partner revenue line.

Yeah, yeah. So your question was in addition to BD and CIMR, which drove the revenue in the license partner revenue stream?

Exactly. If I add those two, that's lower than the 32.4 million reported on that line.

Yeah, yeah. In that bucket, we have a license revenue from all our license partners. And as we have previously communicated, we do also have a license partnership with Wellead for our Foley catheters in China.

Okay, thank you. But could I just ask you, is all the Simr revenue booked in that line?

Our total Simr revenues for the quarter were 3.2 million. In general, and also for this quarter, the SIMR revenues do split into both license partner revenue stream, the exclusivity partner revenue stream, and also, to some extent, the application development partner revenue stream.

Okay, so we have no idea how much of SIMR is through underlying royalties and how much is just non-recurring then?

We have reported the total amount for Zimmer. Yes, we have not specified in the report the detail split on those three categories for Zimmer.

Could you give some color on that? Because I guess, you know, ramping up those Zimmer revenues will be extremely important for you to have any chance of reaching the financial guidance or the medium-term guidance. I think it's a very important metric.

Yes, as Christine mentioned, Simr are rolling out in Europe as we speak and also expected to launch in Japan in late Q2. So the revenues that we recognize for Simr includes both the in-market sale royalty. It includes also minimum royalties and it includes exclusivity fees in terms of annual exclusivity fees and milestone fees. The nature of these revenue streams do differ over the year, and they differ also with respect to the timing of when we recognize these, and that's why you will see

And Christopher, from a qualitative standpoint, we can repeat, as Patrick said, that the European launch is ongoing. Interest from clinicians is very high. And what we're hearing is that once a clinician is converted to VactiGuard, they don't go back. Conversion of the rest of the market, of course, does take time. But we are quite confident in the enthusiasm around the VactiGuard products in the market.

But have they still only launched one of the many trauma products with the coating in Europe?

Yes, it is the ZNN back to garden that is the launch product.

Okay, thank you.

Thank you, Christopher.

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

Hi, thank you. Can you hear me?

Yes, we hear you.

Good. Thanks for taking my questions. First one on Dents by Serona, not to pursue the application development project further. It was announced in Q4, of course, but happened in Q1. My question is if you remain as update in this segment for the infection prevention technology, and if you have already today sort of negotiations with further players ongoing. That's my first one.

Thank you, Matthias. It's a great question. And yes, we are as confident in the coding technology in the dental arena as we were before. We do have multiple discussions ongoing. And I guess I liken it a little bit to synchronized swimming. Which is to say that there'll be lots of effort here, but the market will only get to see the part above the water. So when we actually announce the collaboration and the exclusivity agreements with our partners, whereas all of the vigorous swimming under the surface will not be announced, but rest assured it is ongoing and we do believe quite a lot in our technology in this area.

Thanks for that. And then I think wound management product developed well in 2023 and some growth here in Q1. I mean, in this segment, what's in your view is a sort of reasonable growth rate ahead in, let's say coming years. And then if there are, if you see any trigger points with sort of a new market launch or, you know, let's say a further, some further products coming online or anything, to support a boost in sales growth for that sort of segment coming years. That's my next one.

Thank you Mathias. Patrick here. I appreciate the question into the wound management portfolio. Wound management includes both our HydroSyn products and also our sutures business. Wound management is a business that we expect to grow and to grow profitably. So we do expect growth rates from the room management going forward as well. In Q1, we saw almost 12.7 million in sales and 14% growth. And as mentioned, we do expect continued growth and profitability from the room management business going forward. As we stated as an event in the quarter, in India, early february we did receive approval to start commercialization um so obviously we do expect sales uh from india in this year uh all and from from a from a base of nothing so uh so we do expect some growth there uh but overall for the wood management business uh yes this is growing now and we do expect continued growth and profitability from that business

good and then in terms of vd royals revenues um here in q1 and also q4 is that representing normalized figures for this agreement in your view and then it has of course been volatile recent year and also during covid for understandable reasons you know if if it's fair to assume let's say a more stable development ahead or will we always have those kind of stocking effects when it comes to that agreement that's my last one

Yeah, thank you. I appreciate the question. Uh, indeed we have seen, uh, fluctuations in the past year, uh, which, uh, hit us, um. Uh, indeed in Q2 and Q3 of last year, um, as we communicated in Q4 of last year. we saw BD levels being back on track. And the volumes and the activity we have with BD in Q4, but also continued in Q1, shows us that we expect that this will continue to be on a stable and solid level. We don't expect any major fluctuations. But of course, we are subject to to BD sales and to their production. But overall, we are very confident about the potential and the collaboration with BD going forward.

Good. Maybe one more question from me as well to follow up on the earlier question about BIP sales, how that will be phased out. Would you say, you know, is it fair to assume it's about zero when you exit here?

know searing q4 or how should we choose um as as we have communicated our um our strategic uh intent uh was to uh our license the the police uh 2bd which we have done for for europe and and globally excluding china um at the same time uh we have been the producer and we have stock levels and we have customers that are demanding the product. As Christine touched upon, we are in the transition phase and while we are handing over the license to BD, we also want to make sure that our existing demand is being met and of course that our inventories run down. So this is a process that we carefully handle and you can expect that we will sell obviously less bib products but depending on this handover we will see bib sales in quarters to come we cannot say exactly when we will see the last bib sale but this is the development that we expect okay good but let's say you are not producing anything more in this so it's only the inventories that will be sold um we we have as part of the transformation um discontinued the portfolio which includes also shutting down our manufacturing in malaysia in tonight that is planned uh for this year um so we will discontinue production we will not produce more so to say um after 2024 Hence, we will deplete inventories and end debt productivity.

Okay, thanks for the answers. Thank you, Mathias.

As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.

Thank you, operator, and thank you everyone for listening in today to our Q1 2024 call. We look forward to seeing you again in the near future.