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Intrinsic Value is all-important and is the only logical way to evaluate the relative attractiveness of investments and businesses.
Ladies and gentlemen, Good morning, and welcome to the Bactiguard Audiocast with Teleconference Q3 2021. [Operator Instructions]Today, I am pleased to present CEO, Anders Goransson and CFO, Gabriella Caracciolo. Please go ahead, lead your meeting.
Thank you, operator. If we go to Page 2, please. Every day when I open my computer, I'm reminded of our purpose: Infection prevention, saving lives. You know that if you or your loved ones is unfortunate and get sick and you have to go to the hospital, that 1 out of 10 patients acquires a new infection in the hospital. Bactiguard's vision is to eliminate these hospital-acquired infections, reduce the use of antibiotics and in the end, deliver on our mission to save lives. This is what I'm passionate about and why I decided to join Bactiguard. I am Anders Goransson, and I'm the CEO since October 1. I'm really proud and honored to be given the task to take Bactiguard into our new growth phase. If we go to Page 3. A few key points about myself and my background, as I'm new to most of you, and what I'm bringing into Bactiguard. As a consultant, I worked in health care with hospitals and players across Europe to optimize patient care and improve patient outcomes. I then spent close to 15 years in the industry in the commercial areas: In sales, marketing, strategy, product launch and how to innovate go-to-market models by partnering with the health care systems. Finally, having operated in the last 30 years in the global biotech player, I bring relevant knowledge to our license discussions on how to navigate within large global companies. But I'm not the only one new to the Bactiguard leadership team. If we go to Page 4, please. We have also strengthened our management team by bringing Carl Johan Fredin in the new role of Chief Licensing Officer as of October 1. Carl Johan has many years of commercial experience from leading companies in health care. Most recently, he comes from Molnlycke, but he also has prior experience from health care providers including leading orthopedic clinics as well as other large Medtech and Pharma companies. The interest in Bactiguard's technology is increasing, and our ambition is to accelerate the development of new license agreements and innovative applications for infection prevention together with our partners. We have never had so many discussions ongoing, so Carl Johan is a very timely addition to the team. If you go to Page 5 and our third quarter results, our sales in Q3 are strong compared to last third quarter, up 32% in total. Worth noting when comparing is that the third quarter in 2020 is when the negative effect of the pandemic hit us the strongest. In this year's third quarter, we see strong recurring license revenue where revenues from Becton Dickinson, the BD revenues, have recovered to pre-COVID levels on a 12-month rolling basis. Sales of our own Bactiguard Infection Prevention portfolio, the BIP products, are still hampered by the pandemic and not at the level we would like, but we see positive signals in several markets as they're coming out of the pandemic and the societies are opening and were able to increase our activities. We also see an improvement in our EBITDA compared to last year driven by the increased license revenue, leading to a positive EBITDA in Q3. Our net profit is still negative, while we have an improved operating cash flow in the quarter. What you see at the bottom of the slide is a real highlight as we're moving into a new phase of accelerated expansion. During September, we directed new share issue to the Swedish pension fund, AMF, we received over SEK 220 million in new capital, which gives us the right financial strength to invest to further develop the company and accelerate growth. We turn to Page 6 for some business highlights. If you look at the license business, as mentioned earlier, we see our BD revenue have recovered to pre-COVID levels and that they also increased our stock safety margins, leading to a very strong Q3. However, we expect it to stabilize at pre-COVID levels over the coming quarters. The collaboration with Zimmer Biomet continues to develop very positively. In Italy and South Africa, the first patients have already undergone surgery with the Zimmer Natural Nail, the ZNN Bactiguard-implants. The launch is in progress in Spain, U.K. and Germany, among others. As Europe is now well under the way, the development focus has shifted and the product registration process in the U.S. has intensified over the last few months. The large clinical study that Zimmer Biomet has decided to carry out to further strengthening the evidence of the Bactiguard technology will begin in the autumn. If we focus on our own BIP sales, we are exploring new ways of promoting our BIP infection prevention portfolio together with Zimmer Biomet in some key markets. We can together increase the focus on infection prevention by talking about ZNN Bactiguard Nails as well as Bactiguard Catheters as key tools to reduce hospital-acquired infection. We've also expanded and launched new products in our Wound Care portfolio in Sweden and Malaysia during the quarter. And we are preparing the upcoming launches, for example, in Spain and Germany, which have been slightly delayed due to the pandemic. And we continue to expand our product portfolio required to the vigilance acquisition last year. During Q3, we continued the rollout of Aniocyn in the Nordics, which is for the attractive veterinary segment with very positive customer feedback so far. Finally, we do see an increase of Catheter sales across some markets as they are opening up more and more. If we go to Page 7 and deep dive in our great collaboration with Zimmer Biomet a little bit. As highlighted, the launch of ZNN Bactiguard is ongoing, and new markets are opened up one after one. We're working together with our partner to address opportunities and challenges to expedite the [ uptick ] of the product across the globe. The joint focus we have on infection prevention is something we together are leveraging on the impactful marketing campaign, Why Take Risk with Infection Control. The Bactiguard coating is effective and safe insurance against infections. I have an opportunity to talk to a surgeon that had multiple years of experience with Bactiguard-coated trauma implant. We shared his and the patient's experience. I can say based on this that I'm confident that Bactiguard-coated trauma implants will be a game changer for patients in the future. As ZNN Bactiguard gradually reaches out to more patients, our license revenues will increase. I therefore see our collaboration with Zimmer Biomet, one of the world's leading Medtech companies, will create new opportunities for Bactiguard and expand our licensing business considerably going forward. It is great that our partner has branded the product line ZNN Bactiguard, spreading our brand even more across the globe. If we continue to Page 8, please. Regarding our own portfolio of Bactiguard Infection Prevention, the BIP products, we're now going into a new phase where the aim is to accelerate our revenues significantly over time, and the key focus will be to strengthen our commercial approach. We have built up good learnings over the recent years that we can leverage as we strengthen our go-to-market models and how we commercialize our products. We will have a tailored approach depending on different market characteristics. Some key learnings. First, in those markets where we have our own sales force, like the Nordics, Malaysia, India and the Middle East, we do see we get good traction, and we also create a better feedback loop directly from the customers into our own organization. This enables us to continuously improve our customer value proposition and adapt our approach. Secondly, based on these learnings, we're also able to better support and cooperate with our distributors to drive our sales. We're looking to expand and strengthen our geographic reach with a focus on key global markets. Thirdly, we will further leverage our Bactiguard Academy program and assets. It's a clinical implementation program with great tools to support clinical sales. For example, we have digital assets, for example, videos with over 10 million downloads on YouTube, that we can really leverage further across the globe. Last, we now have a broader product portfolio that enables us to get more leverage across our resources and be more relevant to new partners and health care providers in key segments. Based on this, I feel we're very well positioned as we move into our next phase, and we will start to selectively invest to drive accelerated growth, and we will adapt our go-to-market model depending on the market attractiveness and needs. We go to Page 9, please. We have talked a lot about COVID, and unfortunately, it still has an impact on us and others, and we will have to live with COVID as we go forward. Across the globe, vaccination rates are rapidly reaching sufficient levels to reduce the spread of the virus, and we see that health care in most regions is gradually returning to more normal activity levels. We also see our own activity as well as our license partners' activity have increased significantly. Our assessment is that the demand for our products will increase as we see an improvement in the pandemic situation. But there is still uncertainty about possible new outbreaks of the coronavirus and measures to control the pandemic. For example, as you can see on the graph, for Europe, we are currently seeing an increase of infections, which also means there is large uncertainty in the coming quarters for all of us. Though it is important to note the huge impact that pandemic have had globally, and all of us have been impacted by the disease and the measures against it, close to 5 million people have lost their lives to the disease. It is terrifying in huge numbers. However, it is important to put in perspective of the AMR threat. By 2015, anti-microbial resistance threatens to kill as many as 10 million yearly. If we turn to Page 10. This is even more important as we look at the effect COVID has had on hospital-acquired infections. A recent study by the U.S. Center for Disease Control and Prevention shows that all major types of health care associated infections increased significantly in 2020. For some, close to 50% increase. This is serious because these infections lead to extended care times, increased costs, but also increase mortality. As you see at the bottom of the table, MRSA, the super bug, also increased with 33%. The pandemic has really highlighted the importance of infection prevention going forward. I just want to iterate that these hospital-acquired infections are most commonly caused by bacterial growth in medical devices, which is exactly what our Catheters for urinary tract, the bloodstream and the respirator tract prevent, leading to lower infection rates. We have an example of this on the next slide. Slide #11, which is our own VITAL study. This was presented at a recent congress and was recognized as one of the award-winning presentations at that congress. It's a new study that shows that Bactiguard's endotracheal tubes reduce the risk that seriously ill intensive care patients acquire pneumonia by more than 50%. Ventilator-associated pneumonia, VAP, is a serious complication that can affect intubated patients who are supported by a ventilator. During the pandemic, data on several countries have shown that the risk of VAP has increased, which is serious, because VAP leads to extended care time, increased cost, but also potentially increase mortality. So this is great data for patients at risk of intubation. For us, as Bactiguard, it also adds to the extensive body of clinical evidence that when you coat a medical device with the Bactiguard technology, it does lead to large reduction of hospital-acquired infections. This strengthens our clinical evidence in yet another application area and will also support us in future license discussions with new -- for new applications. If we go to Page 12. Finally, as the pandemic currently is slowing down, I was able to travel and personally meet our staff in Malaysia and see our great operations there. What you see here is a contract manufacturing for Zimmer Biomet, our Catheter production site as well as the bottling of our wound care solution. I was very impressed by our team and operations in Malaysia, and I see we have a great manufacturing footprint to build from as we scale up our ambitions, both for our own products but also potential contract manufacturing for future license partners. Now I would like to hand over to Gabriella for a deep dive into our financials.
Thank you, Anders. Good morning, everyone. My name is Gabriella Bjorknert Caracciolo, and I'm the CFO of Bactiguard, and I will take you through the financials for Q3 2021. Next page, please, Page 14. On this slide, we look at the sales development and profitability in a rolling 12-month perspective. And looking back, the last 12 months, there is a clear negative impact from the pandemic on our operations due to the reduced regular health care and postponed interventions. And, as Anders has mentioned, we still see the pandemic impacting our revenues, but we also see continued signs of recovery mainly in the licensing business, but also a stabilization regarding the sales of the big portfolio in certain markets even though the uncertainty continue to be high. Starting with the licensing business, the blue bar in the chart. We have a solid platform in the recurring license revenue from BD. The revenues from BD vary slightly between quarters but are essentially stable on a yearly basis, roughly SEK 100 million a year. This quarter, the revenue from BD is increasing where the BD volume increased with 32% and the royalty fee increased approximately with 20% compared to third quarter 2020. The royalty is based on previous quarter end user sales, and this indicates that the recovery in the U.S. markets has continued. One of the highlights this quarter, as Anders also mentioned, is Zimmer Biomet has initiated the launch of practical coated Zimmer implants. Given the one quarter delay of royalties, we have not received any royalties this quarter given the recent launch. Sales of our own portfolio is growing in importance in terms of the broader product portfolio also contributing to the more stable revenue streams, and here shown in the green bars. To mention a few highlights, we continue to see sales growth in Europe and the Middle East. The growth was primarily driven by wound care products, and we also saw a positive development in the demand for our Catheters in certain markets. During Q3, the sales of the products accounted for approximately 30% of the total revenue. The yellow bars show new license revenue, which is lumpy in nature and connected to the deal-making process. During last year, we did not close any major new license deals, mainly due to lower investment appetite impacted by the pandemic. In addition to the milestone payment from Zimmer Biomet in June, we have a new license revenue related to product development activities in this quarter. The revenue mix with higher level of licensing revenue is impacting EBITDA positively in the quarter. Next page, please. Looking at the financial overview quarter-on-quarter, the revenues totaled SEK 45.2 million, a revenue increase compared to the same quarter last year totaled SEK 34.1 million, an increase of 32% and currency adjusted 36%. The comparison with the third quarter 2020 is heavily impacted by COVID-19, and that capital sales decreased in particular. EBITDA for the third quarter 2021 landed on SEK 1.2 million and an EBITDA margin of 3%, mainly explained by the revenue mix with increasing license revenues but counteracted by inventory write-offs and increase in bad debt reserves and continued investments in sales staff and marketing activities. EBITDA year-to-date, however, is lower than previous year due to the extraordinary orders of this infection in 2020. The EBITDA margin year-to-date 2021 is 4% compared to the same period 2020, where it was 17%. The net result for the third quarter 2021 was negative SEK 10.8 million, and is related to depreciation of our coating technology by negative SEK 6.4 million, which is the same every quarter and according to plan. Furthermore, this provides a tax shield as the value of our coating technology increases when we signed new license agreements or when the sales of our own product portfolio increase. The cash flow is not impacted by the depreciation. Now turning to the next page, please. On this slide, we have the overview of our cash flow and liquidity. In September, we received SEK 228 million before transaction costs in new capital through directed new shares issued to the Swedish pension fund AMS. For the third quarter 2021, we had a positive operating cash flow of SEK 14.3 million mainly driven by licensing revenues. And at the end of the period, our overdraft facility was unutilized and the available liquidity, including the overdraft facility, was [indiscernible]. Looking forward, we see that the core strength of Bactiguard, our coating technology, will play an important role in driving infection prevention. And with that, back to you, Anders.
Thank you, Gabriella. Let me turn to Page 17. During my first month, I've had the privilege of meeting and listening to our licensing partners, doctors, nurses and patients on how they perceive our products. Also had the opportunity to personally meet all the teams in both Sweden and Malaysia and to discuss infection prevention and our passion to save lives. Can therefore rightly say that Bactiguard is very well positioned and that the need for infection prevention has never been bigger. Bactiguard and our unique technology have an important role to play. In our license business, we're already partnered with 2 of the leading global medtech company. We have a wound care portfolio that can continue leveraging, we have a strong, experienced leadership team, and now, we have the financial muscles to capitalize on our assets and strengthen our commercial approach. I'm very proud and energized to lead Bactiguard as we now accelerate growth and take Bactiguard to the next level. Thank you, everybody, for taking the time to listen. And operator, we're ready to take any questions.
[Operator Instructions] I already have a question from Mattias Vadsten. Please go ahead.
Yes. Mattias Vadsten from SEB here, and [indiscernible] it's nice to see the recovery here year-on-year. A few questions, I will take them one by one, I guess. Could you provide an update on the launches for trauma implants with Zimmer Biomet ahead when the current pace with Spain, U.K., Germany and so forth, is done, in terms of timing and what geographical areas that are prioritized?
Yes. So if I start by answering that, right? So thank you, Matthias. It is a great question. As highlighted, right, the launch is ongoing in those 3 markets and others. We don't yet have a kind of -- sorry, we're working together with Zimmer Biomet on the launches, right? But they're not yet in patients in those markets, but we're working to overcome that and, as quickly as possible, get into patients. But as you know, a launch takes time. And what we have done is also shifted the regulatory focus towards the U.S. to make sure we can also enter the U.S. market as soon as possible.
And on the large study there, let's say, initially in the autumn, that's also good to hear. When will that be done and published? I guess that would be an important marketing tool in the U.S. and also in other markets in Europe.
Yes, it is. So it's starting during the autumn, just pending final ethical committee approval. And such a large study, which is multi-[ central ], double-blind, randomized, right, takes time. So it's many years before we will have the results. More excited that I actually don't know yet, considering it's my first month in the role.
Okay. Perfect. And just some flavor. And then I guess it's minor, but is it possible to disclose the sales number for some implants with Zimmer in the quarter? And to that also, perhaps, can you provide some flavor as to how to think about the development for the remainder of the year? It would be helpful with just some flavors, no exact numbers.
So Matthias, it is a great question, and I can't disclose that at this time. But also the royalty will come in the quarter after the sales, so that's what I can say currently.
Perfect. So moving on then, given that I at least assume sales were limited with -- similar this quarter, BD was obviously really, really strong. Do you expect this to hamper Q4? Any material effect, or is it reasonable to expect sort of pre-pandemic level in Q4 and the quarters ahead after that?
Gabriella, can you address that?
Yes. So Matthias, we do see that the revenue from BD stabilizes. So this quarter was a high one, and it's very difficult to say anything about the next quarter, but we have our view that it will kind of be the same volumes year-on-year.
Okay. Perfect. Then one more from me, then I -- on -- just on when -- a long time ago, the company ordered products now, I think Q4 '19 was the last time. And we all know, the collaboration will transform into a license deal as fast as locally-produced catheters in China are approved for. [ Well ] -- but do you expect sort of more orders from [ well lead ] of products? And also, can you provide enough of the timing on when locally produced Catheters may be approved? And well, we'll only purchase coating and pay royalty to sell.
So as you highlight, we are working with the approval process with our license partner, [ Velib ], to get locally-produced catheters approved in China. And as you know, regulatory processes are usually very difficult to predict in terms of timing. We have a strong focus and are fully committed, and we do everything we can to get it done as quickly as possible, but it is uncertain. And also, in light of COVID, the uncertainty of the timing becomes even more from that perspective. So I wish I could give you a more exact answer, Matthias, but that's what I can offer.
I understand. Some uncertainty.
We have another question from Hans Bostrom.
This is Hans Bostrom, Trinity Delta. I had 2 questions, please. If I look at the Slide 14 in your slide deck and also comparing that with your profit development. And looking at this over the last 4 years, [indiscernible], I just want to understand, you're talking about the COVID effect being the key driver for your deterioration of profitability. But if I look at your 12 months rolling revenues, 2021, when compared to the period 2017 to first half '19, they're up something like SEK 30 million, SEK 40 million, but your EBITDA is down SEK 20 million. And I just want to square the circle here, what are the particular [indiscernible] associated with this? Obviously, you make market investments, but you also mentioned some additional depreciation of coating technology, maybe that's been an additional factor. If you wouldn't mind giving a bit of a breakdown of what actually explains the significant difference between your revenue development being significantly up, but your profits being down over these, and then stripping out the 2020 period? And secondly, I'd also like to gain a better understanding of what the potential revenue opportunity is for your license revenues and royalties from Zimmer. Does this -- the Bactiguard product actually cover the entire nailing range, both the kind frames and the [indiscernible] nailing? And what type of revenue opportunity on the [indiscernible]. And if you wouldn't possibly be able to give a kind of percentage of that end customer revenue, you might be able to fetch from license revenues and royalties.
So let me try to answer those questions, and then I'll ask Gabriella to compliment a little bit. If I start with the second question. So the current agreement with Zimmer Biomet is for the trauma implants, and what we announced when that was signed is that if all implants in their trauma line was coated, it would equal a license revenue about 3x the size of the current BD license revenue on a yearly basis. So that's a little bit about the magnitude of that deal. If you look at the historic numbers, right, first, I want to caveat with it's my first month in the role, so I don't have the full history here and everything. But I think a key driver you should look at is the license revenue, which we had pre-COVID, which is the yellow bar, which, of course, has a higher EBITDA impact which then, during the COVID times, have disappeared a little bit. So that is, I think, as companies stopped some activities because of the uncertainty, led to an impact on our EBITDA line. But maybe, Gabriella, if you want to elaborate a little bit around the profit line?
Yes. I think we will come back to our strategy. We have a clear growth strategy, and in order to grow, you need to invest. So we have been preparing the company for the future growth journey, making investments mainly in staff, driving the personnel costs up, but also in the commercialization perspective, where we cover a broad span. Everything between branding, digital marketing. And also, we have started to invest in our commercialization capabilities. So if I should try to kind of keep it a bit high level and short.
And what about the depreciation of coating technology that you mentioned? Is that something that has started -- kicked in recently?
Not at all. That has been -- we have been having the depreciations from the start, and it's the same amount each and every quarter, so it's very predictable.
[Operator Instructions] Well, it seems that we have no further questions.
Then I want to thank everybody for taking the time to dial into the call and listen to us, and we look forward to staying in contact as we continue the Bactiguard journey. Thank you, everybody.
Ladies and gentlemen, this concludes today's conference. Thank you all for your participation. You may now disconnect.