Thank you, operator, and a warm welcome to Bactiguard's third quarter presentation for 2026. I'm joining you today from Boston following a couple of days at the AdvaMed MedTech trade association conference where MedTech leaders come together.

With me on the call is our CFO, Patrick Bach. I'll take you through the quarter's strategic highlights, then hand over to Patrick for a closer look at the numbers before we open the line for your questions.

Today's title, Accelerating Performance Validates Our Partnership Model, captures exactly where we landed: a very strong third quarter following a solid second, with growth in our license business flowing straight through to earnings and cash flow. Let's dive straight into the quarter.

Let's start with some high-level numbers. We're very pleased to report third quarter net sales growth, excluding currency, of 24%, with total revenue of 58 million SEK, up from 48 million a year ago.

License revenues grew 40%, excluding currency, driven mainly by our BD partnership where we saw the strongest growth in a decade. Adjusted EBITDA came in at 20 million SEK, corresponding to a margin of 34%.

It's a clear demonstration of the operating leverage of the license business with top-line growth flowing through to earnings and cash flow. Strategically, it was a quarter of real progress.

BD is performing strongly across both established and newly launched markets, market-based revenues from Zimmer Biomet are gaining momentum, and we made meaningful headway in our partner dialogues with the strongest engagement in orthopedics. Let me take these one at a time.

Let's turn to the BD partnership, which was a key contributor to the performance this quarter. Revenues from BD grew 30%, excluding currency, and the growth in the partnership is the strongest we have seen in a decade, coming both from concentrate as well as royalties on market sales.

What makes this particularly encouraging is why this is happening. The long-standing markets keep performing well, and the markets launched over the past year, such as the Nordics, Poland, and parts of Middle East, are now generating increasing demand.

That reflects the cumulative impact of our cooperation and development efforts with BD: the regulatory approvals, the technology training across the regions, and the continued commercialization and market development activities in Europe. Increasing volumes in these newer markets validate the work behind those market transitions, and they support our confidence in the long-term expansion of the partnership.

It's also worth remembering the foundation. This is a partnership that goes back to the early 1990s, with more than 245 million Bactiguard-coated Foley catheters to date, and with BD having the exclusive global rights outside of China since only late 2023.

We renewed this agreement for the long term as recently as earlier this year, and there is still plenty of opportunity for us to grow together. Now to Zimmer Biomet.

Under the amended agreement signed late 2025, our royalties are now more closely tied to underlying market performance. This quarter, we saw that start to come through, and in addition to fixed fees, we had double-digit growth in royalties from in-market product sales.

Our partnership with a global leader in orthopedics has clear long-term potential as the use of and demand for Bactiguard-coated implants grows. We also continue to execute on our regulatory programs and on our scientific publication and visibility strategy.

In September, we presented new data at two leading conferences, including a joint publication with Zimmer Biomet comparing silver-containing surface technologies, which shows that silver is not the same as silver, and the differentiation of our noble metal technology, which has no market equivalent. We also presented Bactiguard's data on the durability of the coating.

The relevance of all this data extends beyond the trauma implant and our Zimmer Biomet relationship, and is something we can leverage for the technology across all of our partnerships. Also during the quarter, an independent study from the University of Bari in Italy was published.

These results further confirmed promising infection prevention outcomes with the ZNN Bactiguard nail in high-risk fracture patients. The combination of differentiated mechanism, demonstrated durability, and good clinical outcomes creates trust in the Bactiguard noble metal technology, both from clinicians and hospitals deciding which trauma nail products to purchase, but also for potential new partners.

Now let's turn to business development. This slide is a snapshot across the therapeutic areas and the various categories of our partnerships, including material transfer agreement, application development, exclusivity, and license partnerships.

Given the expected lead times associated with partnership and product development in MedTech, we continue to take a long-term perspective on these opportunities. Having said that, during the quarter, we deepened our engagement and made meaningful headway in various dialogues, which further reinforces our optimism for future product development.

Orthopedics is where partner engagement is strongest. This reflects the well-recognized need for infection prevention in implant surgery, and payers who are increasingly focused on the economic burden of infections.

We are also increasingly a strategic partner beyond the noble metal technology itself. Over the past two years, we have expanded our regulatory expertise and our direct dialogue with authorities, including the US FDA, to help partners through an efficient product approval process, and we continue to strengthen the scientific evidence behind the technology.

That growing involvement shows how the value we bring extends beyond the coating. As always, in a license business, discussions like these take time to mature into signed agreements, and our focus remains firmly on advancing them.

Now to wound management. After a very strong second quarter, wound management had a softer third quarter.

Revenues were 14 million SEK, down just under 9%, excluding currency, mainly reflecting product order phasing and the inherent variability from quarter to quarter. The longer-term picture is therefore more relevant, and wound management grew approximately 14% organically over the first nine months, led by Hydrocyn aqua.

We continue to invest in ensuring product availability, including the MDR process and our operations in Penang, Malaysia. As we've said before, we continue to expect double-digit growth from the wound management portfolio.

With that, over to Patrick for a closer look at the numbers.

Thank you, Christine. I'm very happy to dive into the strong financials.

In short, we delivered strong revenue growth, flat OPEX, accelerated EBITDA margins, and cash flow generation this quarter, driven by our strong development across our license business. For the third quarter, we report a total revenue growth of more than 21% at constant currencies.

Total revenue came in at 58.5 million for the quarter and 166 and a half million year to date. Now, at a rolling 12 months basis, we see revenues at constant exchange rate close to 240 million.

Similarly, net sales grew 24% in the quarter at constant currencies, driven by our license business and delivering solid growth as well on a year-to-date basis. Now, looking closer at our core license business.

Our license revenues accelerated due to strong demand from both partnerships in urology and orthopedics. In particular, we see increasing demand from BD, which came in at almost 38 million SEK for the quarter, up more than 30% at constant currencies.

Also on a year-to-date basis, we report more than 9% growth, and we right now see increasing demand and growth from existing markets and from, in particular, new markets and new market launches across EU and the Middle East. As Christine mentioned, we see the strongest demand and volume shipped to BD in a decade.

We are pleased to see the increase in coated catheters being used worldwide, and we're equally excited about the future to come. Zimmer Biomet contributed with a bit more than 3 million for the quarter, in line with our expectations and reflecting double-digit growth in sales and demand for the ZNN Bactiguard coated trauma nail systems across European markets.

Across both of our partnerships, we do see continued positive in-market volume and sales growth. In particular, we see the accelerated demand from BD new markets, but we also see positive demand within Zimmer trauma and as well across orthopedics in general.

We see a clear demand, an accelerated demand, for our technology and to prevent infections. Now turning to OPEX costs.

For the quarter and for the year-to-date period as well, we continue to manage and keep our total operating costs flat. We do this despite continuing to invest in future growth, such as our efforts in regulatory pathways and even in new clinical data and evidence.

As Christine mentioned, this truly sets our technology apart. This goes for our license business, but also for our wound management business in Malaysia, as we continue to strengthen that platform for continued profitable growth.

Now turning to profitability. Driven by strong growth and demand for our license business, increasing gross margins, and a flat OPEX, we deliver a strong and profitable quarter.

Adjusted EBITDA came in at 20 million SEK for the quarter, up more than 14 million versus Q3 last year, and corresponding to a margin of 34%. This is more than tripling our margin last year.

On a year-to-date basis, we now reached more than 30 million in adjusted EBITDA, and our rolling 12-month now sits above 55 million with a margin of 24%. Now, we're pleased to demonstrate this scalability and leverage in our P&L that we see from the growing demand in our license business, and we are equally excited to continue to demonstrate this in the future.

For the quarter, we also turned a positive net profit of more than 7 million SEK, an improvement of more than 14 million versus Q3 last year. Turning to cash flow.

In the quarter alone, we delivered a strong cash flow from operating activities of 14 million SEK, a substantial improvement of more than 16 million from Q3 last year. Equally, on a year-to-date basis, we see positive cash flow from operating activities of almost 19 million.

Also here, this represents more than 30 million improvement for the 9-month period versus last year. Our total cash flow for the period was also positive at about 10 million SEK for the quarter, and is also positive on the year-to-date period.

Now, given the positive cash flow in Q3, our total cash end of the quarter increased to 55 million. With this quarter's continued positive development in terms of profitability and cash flow, I wanted to highlight the transformation, which is visible when we zoom out and look across periods.

For both profitability and cash flow, we now stand with a solid, profitable, cash-generating platform. We have lifted our adjusted EBITDA with more than 125 million since our reported 2023 number, and our business model today allows us to accelerate and scale that further with increased demand in our license business.

At the same time, we have de-risked the business and lowered our debt and leverage. Again, this is despite investing in future growth and strengthening our organizations as needed, both in Sweden and in Malaysia.

As this chart demonstrates, we have also reduced our net debt to 64 million, excluding leasing, corresponding to a ratio of about 1.2 times our adjusted EBITDA for the rolling 12 months. With the strong results for Q3, we are pleased to demonstrate the accelerated performance, and we're excited about the future ahead.

With that, I hand it back to Christine.

Thank you, Patrick. Looking ahead, we see good reason for optimism.

The progress we've made with BD and Zimmer Biomet strengthens our conviction in the long-term potential of these partnerships. We expect continued acceleration within our license business, supported by growing market traction and increasing demand for Bactiguard-coated products in our existing partnerships.

We will keep supporting our partners through the commercialization journey to accelerate adoption in new markets, while advancing potential partner dialogue to capture the significant long-term opportunities, especially in orthopedics, and deepening our engagement across our prioritized therapeutic areas. Across our ongoing partner dialogues, we see an interest that reinforces our confidence in the opportunities ahead, and our business development efforts remain firmly focused on advancing those discussions towards agreements.

We continue to invest in areas that will drive our ability to capture the opportunity created by the intersection of unmet clinical need to reduce infection risk and the cost burden of these infections, both monetary and in lost quality of life. We do this by delivering new data that increases the appreciation of Bactiguard's noble metal coating as a technology platform enabling future product development, and by advancing regulatory programs facilitating product approvals and market access for partners, including in the US.

We continue to work through MDR transition activities for the trauma implants, as well as in the wound management portfolio to ensure maintained product registrations. Additionally, in wound management, our focus is on growing profitably and expanding into new markets by expanding the reach of Hydrocyn aqua across key markets, disciplined portfolio optimization, and continued investment in our Malaysia operations.

We believe the underlying market dynamics, together with that expansion, provide a solid foundation for future profitable growth. Our strategic direction is unchanged, and we remain committed to our 2030 targets.

To sum up, this was a very strong quarter, and the growing market traction validates the large potential in our partnership model. Net sales were up 24%, excluding currency, driven by license revenues growth of 40%.

Our work with BD delivered this partnership's strongest performance in a decade, with demand from both established and recently launched markets, and market-based revenues from Zimmer Biomet are also gaining momentum. Wound management, despite a softer 3Q, delivered double-digit growth over the 9-month period, and remains on track longer-term.

The leverage generated by scaling our partnerships resulted in an adjusted EBITDA of 20 million SEK in the quarter and an operating cash flow of 14 million. We are advancing the building blocks for future partnerships, with progress in regulatory programs, scientific evidence, and engagement with potential partners.

Taken together, we move into the final quarter of the year with strong momentum, and are optimistic about the future ahead. With that, let's open up for questions.

Hi, Christine and Patrick. Thanks for taking my questions.

First off, congrats on the strong set of numbers. I would still like to start with some detailed questions about BD.

Could you paint us a bit of a more detailed picture here? How much of the growth came from the newly launched markets and versus the ones that you mentioned are long-standing and stable and established?

Forward, do you have any more details to share than just strong demand ahead?

Maria, this is Patrick. Thank you for your question.

In short, we have a global agreement with BD, we supply BD on a global basis. We're not able to exactly split out the growth from existing and new markets, and we're not allowed to report that either.

What we can see, however, underlying is that we do see positive growth in both existing markets, but as we report today, significantly also from new markets. Obviously, the new markets are growing from a very low base, but we definitely see part of the growth that we see in this quarter coming from the new markets as well.

Then

looking forward, Maria, to your question about if we can give any more color around the future ahead as well, we do see BD continuing to launch in new markets, and we do support them with various sales training in various places. I think we have mentioned also trainings that will help them launch in further markets in Asia, as well as continuing to drive demand across Europe.

There are still multiple countries available in Europe for BD to continue to launch into, and we expect them to do this.

All right. On wound management, then.

The slightly softer Q3 now because of order phasing, as you've mentioned, should we expect a stronger contribution in the coming quarter? Also, I noticed that we haven't talked about the continued investment in Malaysia.

What does that specifically entail?

Thank you, Maria. Good question.

This quarter, obviously, we saw a softer performance on the wound management business, which, as we described, is primarily due to order phasing. We continued to see very, very strong demand for Hydrocyn aqua portfolio in the wound management business, and we continue to expect and see double-digit growth for the full year and for the years ahead.

When we talk about investments in Malaysia, we talk about investments within the organization. We're also talking about operational investments in machinery, and we're also talking about MDR investments.

All these are within our costs today, and are held within our OPEX lines, being flat for the quarter and also for the year-to-date period.

Thank you. Since you are on costs, a last one, a super short one on costs.

For the quarter, it's flattish or a bit down year-over-year. How should we think on the cost base going forward?

Thank you. Good question.

We have obviously communicated over the past quarters and years that we deliberately have taken cost out of a business to have the platform, a scalable platform, that we have today. We don't expect to reduce in terms of salary costs.

On the opposite, we have said that we are investing in our organization, and we will continue to do so as needed. At the same times, we are pulling out savings from other operating costs, for this quarter and for the year-to-date period, it's flat.

We don't expect to keep it necessarily flat or certainly not decreasing going forward, but we will continue to see a very scalable platform also in terms of OPEX going forward.

All right. Thank you very much.

I'll go get back into the queue.

Thank you, Maria.

Hi. Thanks for taking my questions, and also from me, congratulations on a strong here today.

I was having a follow-up on the BD side, I just want to make sure that we cover this discussion around stocking effect. It's been there in the past.

You have been managing that, and it typically evens out in a few quarters' time. Does this Q3 support thinking of it being some positive stocking effect, and that we should be careful on Q4 specifically, or yeah?

I just wanted to make sure that we cover that aspect of it. That's my first one.

Good question, Mattias. To be honest, we have obviously considered that ourselves, and we have dived into that, and we have in-depth discussions with BD.

We see a very positive quarter in Q3, lifted by growth, in-market growth in both existing and new markets. When you do launch in new markets, obviously, this will jump in the books for the first time, as we see it significantly for the quarter.

We have confirmed with BD that we do not see, and they do not see, any significant stocking effects, we do not expect a changed momentum, any changed downward momentum due to this in the future periods. As Christine mentioned, we know some of the markets that are launching, but we'd also do expect further markets to launch, we are excited about the future developments with BD.

In short, no, we do not see any stocking effects in Q3.

Perfect. Is it possible to comment on how many new markets they have launched in today?

Hi, Mattias. Unfortunately, we can't comment on either number or specific new markets and effects there.

Again, we are happy to note that there is still significant opportunity in terms of launches. The markets where BD is now beginning to roll out are far from the total number of places where they have market rights to.

We do see good opportunity here, and we also have a partner who is exceptionally good at market launches and then also maintaining that traction over a very long period of time. We do expect BD to continue to deliver not just in terms of new market launches, but also growth for the markets that they have already launched over the coming quarters and over the longer term.

Thank you. I appreciate that.

Just on wound management, I'm so sorry if I missed this during the call, but on the order phasing, did you quantify that in any way?

Hi, Mattias. No, we did not quantify the order phasing as such.

We obviously reported a record high Q2, and for the Q3, we see a softer quarter with close to 10% decline. The underlying demand that we see in our business is just as strong as of Q3 as it was in Q2, and as we forecast it at the end of the year.

As Christine mentioned, we're very comfortable with that business, and we expect double-digit growth for the full period and for the periods to come. It's a sort of technical order phasing that has to do both with some of the customers we have, but also due to some regulatory order phasing that we experience in Q3.

Thanks. To be clear in the comment, that double-digit for the full management business, not only for Hydrocyn?

Correct?

Perfect.

Correct. That's absolutely our expectation.

As of the year-to-date period now, Mattias, we stand at approximately 14% organic growth for the business, and we do expect to continue that for the full year. As we talked a little bit about early in the call, we do expect wound management to come back with a strong quarter in going forward.

Perfect. That's very clear, I think, thanks for that.

The final question, I just wanted to follow up on the earlier question here on costs for a bit. OPEX is stepping down quite a bit, I would say, quarter-over-quarter in the OPEX side, selling and other external expenses and operating expenses.

First question is, are those costs somewhat tied to the wound management sales in any way so that when that is lower, they go down? Or is this just usual seasonal patterns in your view?

Good question. Obviously, to some degree, but not significantly.

You can see we manage our OPEX overall strategically. We talked about we have no plans to take out further costs in terms of salary.

Quite the opposite, we have invested and strengthened organizations both in Sweden and in Malaysia. We continue to find savings and to operate more efficient in terms of other external costs, and that's why you see a netting effect that in this quarter is flat or even better than that, and for the year-to-date period also flat.

Yeah. Then yes, the final one, to be fully clear, there is no sort of non-recurring effect that is causing the lower costs that you want to single out, really?

Correct. Correct.

I think in the past, we have sort of flagged if we have any significant sort of on the top line fees or recognition of certain milestone payments. This quarter is without any material one-offs or non-recurring effects, Mattias, both on the top line, but also on the bottom line.

I think what we've spoken about, the P&L that we see now in the Q3 really demonstrates sort of the leverage and the scale that we see in our business when we meet increasing demand in our license business.

That's perfect to hear, and thanks so much again for taking my questions.

Thank you, Mattias.

Thank you. As we reported in the quarter, we see double-digit growth from the in-market sales and royalties with Zimmer.

This comes from the ZNN Bactiguard nail system across Europe, and we're very pleased to see that. Obviously, as we have discussed, that is still from a low base relatively, at least to the other partnerships we do have.

We are, of course, looking for that to increase, and to expand that across more therapeutic areas within orthopedics. As we have also disclosed over the last periods, we have changed our partnership together with Zimmer Biomet.

We today have a non-exclusive agreement for the trauma nail system, which covers that. We do have fixed fees, as well as royalties, coming from that agreement.

Still, within the total reported Zimmer numbers, we do have a majority of fixed fees in there, but we do see a growing amount coming from the in-market royalties, coming from positive demand in sales growth of the ZNN Bactiguard nail system.

As I think Mattias also asked about, we do not have any sort of particular non-recurring things or any significant capitalization of R&D work or anything. What we do have reported in our results is that part of the OPEX costs that we report, we take out of the adjusted EBITDA.

This relates to what we see as non-recurring adjustments for MDR costs. We have that approximately around 6 million for the full year, sorry, 6 million for the year-to-date period for the nine months.

As previously, we have flagged this for 2026 and 2027, and while this can vary from quarter to quarter, I would say the 6 million for the year-to-date period is a good run rate that we can apply and expect for 2026 and for 2027. Again, this is included in the total OPEX costs, but we exclude it in the adjusted EBITDA figure.

Okay. Then we will say thank you for all of your questions and for your continued interest in Bactiguard, and reiterate our optimism for the future ahead.

We look forward to seeing you for the next quarter. With that, back to you, operator.