Bactiguard Holding AB
STO:BACTI B
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Bactiguard Holding AB
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Welcome to the Bactiguard Audiocast Teleconference Q1 2022.
[Operator Instructions] Today, I'm please to present CEO, Anders Goransson; and CFO, Gabriella Bjorknert Caracciolo. Please begin your meeting.
Thank you, operator, and welcome to the call to all our shareholders, investors, analysts and others who have joined today. We will share our Q1 results as well as the detail into our expanding license business with a focus on the 2 new agreements we have signed with Zimmer Biomet as well as Dentsply Sirona, leading companies in their fields within orthopedics and the dental area.
Let's go to Page 2. In our last quarterly call, we presented a new focused growth strategy as well as new financial goals. Core to our strategy is our vision of keeping people safe from infections. We do so by fighting infections to save lives, limit antimicrobial resistance and save cost for the health care system by providing safe and effective technology. We will today share how we're executing on our strategy with a clear focus of getting our technologies to patients.
If we go to me and an overview of our Q1 results. We had a strong sales quarter both in license revenue through our partnerships with leading global medtech companies of SEK 36.4 million compared to SEK 26.4 million in the last year, but also through sales of our own Bactiguard infection prevention, the BIP product portfolio, which increased from SEK 13 million to SEK 15.4 million in Q1 this year. I will share more details on what is driving this performance shortly.
It's worth highlighting that the total sales of SEK 55 million is the highest revenue in a quarter since the start of the pandemic for Bactiguard. It's up 32% compared to the same quarter last year, including impact -- currency effects on the revenue, which means the underlying growth was around 23%. As you see, our EBITDA is impacted by our planned investments into our growth strategy. And we'll come back to later what we're investing in.
If you go to Page 4, and deep dive into our license revenue. In quarter we had a strong income from our key partner, Becton, Dickinson, BD, who is selling urinary catheters coated with our Bactiguard technology in the U.S. and Japan and other markets. In these markets, the Bactiguard coated catheters are market leaders. They had a very strong previous quarter, and our Q1 revenue was SEK 32.2 million, up 27%, including currency effects compared to last year's quarter 1.
Worth highlighting is that the underlying business is relatively stable on an annual basis, and volumes may vary between quarters, and this is in comparison, a relatively high quarter. If you look on the right-hand side, our collaboration with Zimmer Biomet in the orthopedics field is starting to generate significant revenue for us, SEK 4.2 million in Q1. This consists mainly of fees for contract manufacturing of their trauma products, development work for both trauma and orthopedic implants as well as the first initial payment for the new expanded collaboration, which I will talk more about later.
There was also included in first minor royalty income from the sales of trauma implants of ZNN Bactiguard which has launched in Europe and select other markets. So overall, a strong quarter for our license revenue.
If you go to Page 5 and look on the sales of our own product portfolio. We see total sales increasing by 19%, if adjusting for currency, 9% organic growth, driven by strong growth in our focused products. We see our focused strategy and investment behind our own urinary catheter, the BIP foley is paying off. We see close to double sales compared to last year's quarter one driven by strong momentum in key markets like Nordics and India, where we also have invested behind our own sales force.
Our expanding Bactiguard wound care portfolio of wound drains and gel, we are continually rolling out in key markets, and we see having a good momentum, for example, in focused markets within Europe as well in our home market in Malaysia. We also see continued interest and growth in our central venous catheter, a product that we believe strongly in. I also want to highlight that we, in the quarter, published the results of our own study on endotracheal tubes, which is what you use when you incubate a person, for example, patients severely infected by COVID-19. A very common consequence when you're intubated is that you get something called ventilator-associated pneumonia, the VAP, a potentially deadly consequence. In this study, we showed a 53% reduction in VAP, a great result, which was also confirmed in another independent study published recently.
Finally, worth mentioning is China, medical devices needs to be reapproved on a regular basis, and we received a reapproval for the coming 5 years on our BIP Foley during the quarter. This will support our partner Well Lead in their development and approval process of their own locally produced coated catheters. As we all know, China is currently heavily impacted by COVID, which makes timelines uncertain.
If you go to Page 8. As you saw, our EBITDA is impacted in this quarter by our investments into our new strategy, mainly as we invest in our commercial capabilities. I just want to iterate why we believe this is the right time to invest and fuel our growth. First, we have strong clinical evidence which have been strengthened in the last year, including the ETT study I mentioned just recently, showing that Bactiguard coating works and reduces infections in multiple application areas. Secondly, we now have the capital to invest to fuel the future growth. And I think our 2 new development and license agreements are real-life proof of concept that this is the right time to invest and further fuel growth.
If we go to next page, we will now deep dive into our 2 new license agreements. First, in the orthopedics area with Zimmer Biomet, and then in the one in the dental field with Dentsply Sirona. Looking at Page 8, please. As you might remember from our focused growth strategy that we're prioritizing 6 therapeutic areas. And we have, in the last 3 months, expanded our partnership with Zimmer Biomet in the orthopedics field, but we're also entering a new therapeutic area for us, the dental area, with the recent announcement of the agreement with Dentsply Sirona. Both are high potential markets, and we see -- in which we see our Bactiguard technology can make a real difference for patients.
Let's go to Page 9 and deep dive into our expanded partnership with Zimmer Biomet. Let's start by taking a step back and look on our history with Zimmer Biomet. In September 2019, Zimmer Biomet and Bactiguard entered into a first license agreement for trauma applications based on the CE-approved Bactiguard implant. In less than 2 years, Zimmer Biomet launched their trauma nail, the ZNN Bactiguard in Europe, the regulatory working process for the Zimmer Biomet trauma implants in other regions is still ongoing. Then 2.5 years after the original agreement, a very close collaboration and work together with Zimmer Biomet, they have chosen to expand the partnership to the majority of their portfolio. This shows a true belief and confidence in the Bactiguard technology, which, of course, is important for us in discussions with also other potential license partners.
If we go to Page 10 and just recap the financials of this new agreement. So this agreement would generate license and development fees of $1.5 million during 2022 and a part of that is already in the Q1 results. An additional $7.5 million in milestone payments contingent on U.S. regulatory clearance for different product categories. Most importantly, once products in the future, achieve regulatory clearance and reach patients, we will start to generate royalties. The royalty level on net sales, very slightly by product category, but are similar to our earlier agreement with single-digit royalty rate.
Worth noting, this is an exclusive global license covering the majority of Zimmer Biomet's current portfolio, which includes joint replacements like new hips, knees and shoulders, which is a very common product used in the Western world. It is fair to say it would take multiple years before these products will be regulatory approved and start generating royalty income. Though if Zimmer would decide to [ quote ] a significant part of the product portfolio, the potential royalty income could be significantly higher than the current BD revenue, up to 10x higher. So this has significant long-term potential.
To summarize, right, our expanded partnership with Zimmer Biomet is a huge milestone for us at Bactiguard. Not only does it give us a significant license development and milestone payments as the collaboration proceeds, it also -- once the product in the future receive regulatory clearance and start to reach the patient, it has the potential to significantly increase our license revenues.
Let's go to Page 11, and look at the current progress of the collaboration within the trauma field, which we started 2.5 years ago. As mentioned, ZNN -- Zimmer Biomet launched the Zimmer Natural Nail, the ZNN Bactiguard in Europe the last summer, right? And just to be clear, what is a nail. It's something you use when you have an accident like a motorbike accident and you break your tibia bone, for example. You put in the nail with some screws to stabilize the bone during the healing which will be then taken out. This product is now launched across Europe and select other markets, and there is a high priority from both Zimmer Biomet and us to register this product and get approval in other key markets. The feedback from customers so far is very good and enabling Zimmer Biomet to have a differentiated product in the market, which is what our coating enables our license partners.
I also want to point out that the first patient has been included in the Tibia Post-Market Clinical Follow-up Study, which is key to strengthen the clinical evidence for orthopedic applications of our technology. So that's what I plan to share about the Zimmer Biomet collaboration.
If we go to Page 12, a and look at the new agreed development agreement with Dentsply Sirona. This agreement was signed on 8th of April, and it's key agreement as it's our first inroad into our prioritized therapeutic area, the dental. This deal within the initial development phase, which is approximately 1 year, generate development and milestone fees up to $0.9 million. If we then enter into a license agreement, it can generate another $1.1 million in milestone payments. Continues on regulatory approvals, and of course, as in our other license agreements, it could generate royalties on net sales once commercialized. The royalties are aligned with other agreements and are in the single-digits range, but depends on the level of claims, we can support the launch products with.
I also want to highlight, right, this is another exclusive global agreement addressing a segment within the dental area, with a market value of $1.2 billion. So a big potential we're going after.
If you go to Page 13 and look at why did we take Dentsply Sirona for being our partner in the dental field. So they are the largest global infrastructure dentistry and have a full range of products supporting dentists and dental practices across the globe. There are key players in the segment. And if you look on the right-hand side, you see that, for example, in the dental implant market, they are the third largest player with 30% global market share. We really see Dentsply Sirona as the right partner as we're now entering the dental field.
To summarize, right, in the last 3 months, we have significantly strengthened our license collaborations, and we're confident for the continued execution of our focused strategy.
Now over to Gabriella to look in more details into our Q1 financials.
Thank you, Anders. Next page, please. So good morning, everyone. My name is Gabriella Bjorknert Caracciolo, and I will take you through the financials for Q1 2022.
Next page please, Page 16. On this slide, we look at the revenue development and profitability in a rolling 12-month perspective. We now start to see the financial impact from our focused growth strategy. We see a positive development of rolling 12 months revenues due to strengthened core business aligned with our priorities and EBITDA being negatively impacted by investments mainly in the marketing and sales area.
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 between quarters, but are essentially stable on a yearly basis, roughly SEK 100 million a year. This quarter, the revenue from BD was SEK 32.2 million compared to first quarter last year, the increase was 27% and adjusted for currency, 13%. Included are also the royalty fees that are also higher compared to the same quarter last year. In license revenue, we also have license income from Zimmer Biomet related to contract manufacturing.
Sales of our own portfolio is growing in importance, and the broader product portfolio is contributing to more stable revenue streams here shown in the green bars. The interest in the BIP portfolio is increasing after a slowdown during the pandemic. The growth is mainly driven by BIP Foley's and Wound Care. The yellow bars show new license revenue, which is historically lumpy nature and connected to the deal-making process. And as Anders already have mentioned, we are very happy about the expanded agreement with Zimmer Biomet that generated SEK 2.8 million during this quarter.
Looking at the results, we have a negative development of EBITDA in the quarter due to the investments in the growth strategy. And to summarize, we now start to see the impact of the strategy being implemented.
Next page, please. Looking at the financial overview quarter-on-quarter, the revenues totaled SEK 55.2 million, a revenue increase compared to same quarter last year totaled SEK 41.8 million, an increase of 32% and currency adjusted 23%. The comparison of the quarterly revenue was mainly driven by the increase in BD revenues and also the new license from Zimmer Biomet. And as Anders also mentioned, this quarter, we actually had the highest revenue since the pandemic started.
EBITDA for the first quarter 2022 landed on negative SEK 4.0 million and an EBITDA margin of negative 7% and is lower compared to previous year due to the increased investment in our growth strategy. And this was mainly driven by other external expenses that increased by SEK 10.3 million in the first quarter due to the increase in consultants and temporary staff focusing on activities related to accelerating the expansion.
Also personnel costs increased since we continuously have strengthened the commercial capabilities. The net result for the first quarter 2022 was negative SEK 16.5 million and is related to depreciation including also depreciation of our coating technology by negative SEK 6.4 million, which is the same every quarter and according to plan. 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 Q1 2022, we had a negative operating cash flow of negative SEK 11.9 million compared to negative SEK 0.9 million for the same quarter 2021, mainly driven by the investments in our growth strategy. The increase in license revenue during the first quarter will result in a positive contribution to the operating cash flow in the coming quarter. The overdraft facility was not utilized and compared to March 31, 2021, where it was negative SEK 14.4 million. Available liquidity, including overdraft facility at the end of the quarter was SEK 232.3 million compared to last year, SEK 54.4 million. The new shares issued in September 2021 enables us to continue to invest in our focused growth strategy.
Next page, please. We have currently a turbulent situation in the world with COVID-19 and the war in Ukraine. Even though WHO in April reported the lowest number of deaths in COVID-19 in 2 years, the pandemic is still impacting part of the world like China and the future development is still difficult to assess. There is a terrible situation in Ukraine with huge humanitarian impact. We do not have any operations or suppliers in Russia or Ukraine. However, Bactiguard is supporting the health care system in Ukraine with intensive care products. And to summarize, the uncertainty in the global economy is high and supply and logistic chains are disrupted, and we see an increase in risk for potentially higher cost related to transportation and raw materials.
And with that, back to you, Anders.
Thank you, Gabriella. If we go to Page 20 and just to summarize, right? I hope we've shown you that we're on our path to execute on our strategy. and that our vision of keeping people safe from infections really contributes to United Nation's global sustainable development goal. We've an effective and safe technology, we have the clinical evidence that shows that it works. We have major market potential we're going after with a focused growth strategy. We come from a unique market position, and we already have a broad product portfolio, and most importantly, we have a very scalable license business as a foundation. With that, we aim to deliver on our financial targets, which we communicated last quarter, which was, to iterate, right, revenue of over SEK 1 billion in 2026 and an EBITDA of over SEK 400 million in the same year.
So with that, I hope you have enjoyed the call. And operator, over to you for any potential questions.
[Operator Instructions] We just have the first question come through from the line Mattias Vadsten of SEB.
Based on the uptake here we see year-on-year in the BIP sales segment, do you expect sort of a sequential quarter-on-quarter uptake there to continue? Or what's the current outlook given the situation in your various end markets right now?
It's a very good question, right, and as Gabriella highlighted, it is hard to predict in these uncertain times. But we do feel we have a strong underlying momentum on our focused products, and therefore, we do expect continued growth in those products. However, right, in countries like China, situations are quite there and does impact us. So uncertain, but we see strong underlying growth, and we believe we will have momentum going forward.
Understandable. And in terms of BD revenues, it looked very strong in Q1, of course, here. What do you comment on what sort of quarterly variations we should expect going forward? Or should we expect or see BD revenues to be on normalized level now? And on a yearly basis going forward to expect what it was before the pandemic, how would you comment on that?
As we said, right, we do see the business being very stable on an annual level, and there is quite significant quarterly fluctuations. But of course, also the BD business have been impacted by the currency effects we highlighted, which, of course, create an uncertainty going forward depending on how the currencies evolve.
Perfect. And then just on the -- we were all waiting for the approval for trauma implants in the U.S. with Zimmer Biomet, any update there in terms of expected timing, any insights that you have that you can share?
Well, as you know, this is a top priority of us and of Zimmer Biomet, and we're working closely together in pushing this forward, right? But I don't -- I can't share any more detail around the expected timing around that. But as you know, it's also uncertain and long-time processes to get the products approved.
Yes. And then previous -- just to remind, that has been the [indiscernible] towards the second half of this year, basically.
Yes. So it is hard to estimate exactly when the approval will come. But it is in work and high priority.
[Operator Instructions] Okay. There seems to be no further questions coming through from the phone line. So I hand the floor back to our speakers.
Then thank you, everybody, for joining and look forward to keeping you updated as we progress on the implementation of our strategy going forward.