Q2 2026 OssDsign AB (publ) Earnings Call

August 18, 2026

Speaker #1: My name is Elvin Alder. I work here at DMV Carnegie, and I will be moderating today's presentation. I'm joined here by Mark Vo, the CEO of OssDsign, and Anders Svensson, the CFO.

Elvin Rolder: My name is Elvin Rolder. I work here at DNB Carnegie, and I will be moderating today's presentation. I am joined here by Mark Waugh, the CEO of OssDsign, and Anders Svensson, the CFO. I will now leave the word to the OssDsign team for their presentation.

Speaker #1: I will now hand over to the OssDsign team for their presentation.

Speaker #2: Thank you. Good morning, everyone. This is Mark Wah, and I'm the CEO of OssDsign. If you're new to our quarterly calls, I'll mention again that I joined the company in January of this year.

Mark Waugh: Thank you. Good morning, everyone. This is Mark Waugh, and I am the CEO of OssDsign. If you are new to our quarterly calls, I will mention again that I joined the company January of this year. I also have our CFO, Anders Svensson, with me today, and we are going to walk you through our Q2 2026 results. As always, when we do these presentations, the normal disclaimer. Moving into our Q2 2026 highlights. For the quarter, OssDsign sales of SEK 37.8 million, or approximately USD $4 million, were essentially flat versus Q1 sales performance, and that was in line with my prior guidance. On a year-over-year comparables basis, Q2 translated to a 16% decline in constant currency terms, although that was on a very challenging comparable, driven by some large bulk orders occurring in the last day of that same 2025 period.

Speaker #2: I also have our CFO, Anders Svensson, with me today, and we're going to walk you through our second quarter 2026 results. As always, when we do these presentations, the normal disclaimer: Moving into our Q2 2026 highlights.

Speaker #2: For the quarter, OssDsign sales of SEK 37.8 million, or approximately $4 million, were essentially flat versus Q1 sales performance, and that was in line with my prior guidance.

Speaker #2: On a year-over-year comparables basis, Q2 translated to a 16% decline in constant currency terms, although that was on a very challenging comparable, driven by some large bulk orders occurring in the last days of that same 2025 period.

Speaker #2: Gross margin and EBIT both improved for the quarter versus Q1. I'll let Anders cover the details on those after I finish with these highlights.

Mark Waugh: Gross margin and EBIT both improved for the quarter versus Q1. I will let Anders cover the details on those after I finish with these highlights. The science behind Catalyst and the results we continue to publish remain strong. I have mentioned before that our preclinical and our clinical data were two of the biggest reasons I joined the company. We continue to share that data with our customers during the Southernmost Spine and the International Society for the Advancement of Spine Surgery meetings recently. Additionally, on 3 June, OssDsign shared the publication of a new scientific article in "The Journal of Bone and Mineral Research," or JBMR. This was a preclinical study that evaluated OssDsign Catalyst as a standalone bone graft in trauma versus an earlier generation bone graft.

Speaker #2: And the science behind Catalyst and the results we continue to publish remain strong. I've mentioned before that our preclinical and our clinical data were two of the biggest reasons I joined the company.

Speaker #2: We continue to share that data with our customers during the Southernmost Spine and the International Society for the Advancement of Spine Surgery meetings recently.

Speaker #2: Additionally, on June 3, OssDsign shared the publication of a new scientific article in the Journal of Bone and Mineral Research, or JBMR. This was a preclinical study that evaluated OssDsign Catalyst as a standalone bone graft in trauma versus an earlier-generation bone graft.

Speaker #2: And I'm pleased to tell you that the results showed significantly more bone formation with OssDsign Catalyst at earlier time points, as well as clear evidence that the graft is remodeled over time—in other words, broken down and replaced by bone growth in the body.

Mark Waugh: I am pleased to tell you that the results showed significantly more bone formation with OssDsign Catalyst at earlier time points, as well as clear evidence that the graft is remodeled over time, or in other words, broken down and replaced by bone growth in the body. This study and others continue to support the outstanding performance of fourth-generation nanosynthetic bone grafts like Catalyst. Next, some additional significant organization updates. On 25 June, we announced Adam McAnerney as OssDsign's new VP of sales. Adam is an experienced medical devices sales leader with a great track record of leading teams to achieve above-market performance in his previous roles. He is quickly getting up to speed, working closely with our regional sales teams. Regarding those teams, our new area sales director for the East also started on 10 August.

Speaker #2: This study and others continue to support the outstanding performance of fourth-generation nanosynthetic bone grafts like Catalyst. Next, some additional significant organization updates. On June 25, we announced Adam McAllister as OssDsign's new VP of Sales.

Speaker #2: Adam is an experienced medical devices sales leader with a great track record of leading teams to achieve above-market performance in his previous roles. He’s quickly getting up to speed, working closely with our regional sales teams. Regarding those teams, our new Area Sales Director for the East also started on August 10.

Speaker #2: That role had been vacant since May, and we screened and interviewed a number of candidates. I'm very pleased with who we were able to hire for this important position, and I know she's going to be a great asset for our sales team.

Mark Waugh: That role had been vacant since May, and we screened and interviewed a number of candidates. I am very pleased with who we were able to hire for this important position, and I know she is going to be a great asset for our sales team. Overall, since January, when I joined the company, we have replaced more than 50% of OssDsign's commercial team. I mentioned before that our path to doubling the size of our team, which was a goal set forth by my predecessor, would not be a linear progression, and we would see some turnover alongside the additions we are making. The changes we have made have better positioned us for commercial execution going forward. We will continue to add members to this team, and I do not see an immediate ceiling on that as long as our hiring both supports and delivers on our commitments to growth.

Speaker #2: Overall, since January, when I joined the company, we've replaced more than 50% of OssDsign's commercial team. I've mentioned before that our path to doubling the size of our team—which was a goal set forth by my predecessor—would not be a linear progression, and we'd see some turnover alongside the additions we're making.

Speaker #2: The changes we've made have better positioned us for commercial execution going forward. We'll continue to add members to this team, and I don't see an immediate ceiling on that as long as our hiring both supports and delivers on our commitments to growth.

Speaker #2: I also want to let you know that I'm personally involved in our hiring process for the commercial team members, because it's important to me that we're hiring the right people, both professionally and from a cultural fit perspective.

Mark Waugh: I also want to let you know that I am personally involved in our hiring process for the commercial team members because it is important to me that we are hiring the right people, both professionally and from a cultural fit perspective. Finally, regarding organization, I mentioned in our release that since February, our entire team's incentive structures are aligned to growth. That is another important dynamic that ensures our reward structure is tied to our shareholders' expectations. Before I hand things over to Anders, I will reiterate that I still believe we can achieve the goals put forth last year as part of OssDsign's ScaleToProfit strategy. The market is highly competitive, but OssDsign Catalyst is as well. As you can see, we are making aggressive changes to return our sales trajectory to strong growth. I am also pleased with the progress we have made on our next product release, MIS Catalyst.

Speaker #2: Finally, regarding organization, I mentioned in our release that since February, our entire team's incentive structures are aligned to growth. That’s another important dynamic that ensures our reward structure is tied to our shareholders’ expectations.

Speaker #2: And before I hand things over to Anders, I'll reiterate that I still believe we can achieve the goals put forth last year as part of OssDsign's scaled-to-profit strategy.

Speaker #2: The market is highly competitive, but OssDsign Catalyst is as well. As you can see, we're making aggressive changes to return our sales trajectory to strong growth.

Speaker #2: I'm also pleased with the progress we've made on our next product release, MIS Catalyst. I'll have more to communicate next quarter on this launch, but things are moving forward quite nicely since our last release call.

Mark Waugh: I will have more to communicate next quarter on this launch, but things are moving forward quite nicely since our last release call. I will now hand you over to Anders, who is going to walk you through the financial results this quarter in more detail. Anders?

Speaker #2: I'll now hand you over to Anders, who's going to walk you through the financial results this quarter in more detail. Anders?

Speaker #1: Thank you, Mark. Now, as Mark mentioned, in Q2 we saw a decrease in sales compared to the second quarter of '25. In SEK, we reported 37.8 million in sales; that's compared to 46.5 million last year, which translates to an 18.7% decrease.

Anders Svensson: Thank you, Mark. As Mark mentioned, in Q2, we saw a decrease in sales compared to the second quarter of 2025. In SEK, we reported SEK 37.8 million in sales. That is compared to SEK 46.5 million last year, which translates to an 18.7% decrease. As you can see here in the growth chart, we still experience some USD headwind on sales, but considerably less than we did in previous quarters. So the actual underlying decrease, as Mark mentioned, is 16% for the quarter. You may also remember that our Q2 2025 sales were inflated by some last-day orders, which would explain roughly half of that organic decrease. Still, we acknowledge that there is room for improvement, and we are working hard to achieve that. When we presented our Q1 results, we guided our Q2 sales were expected to come in around the same level as Q1.

Speaker #1: As you can see here in the growth chart, we're still experiencing some USD headwind on sales, but considerably less than we did in previous quarters.

Speaker #1: So the actual underlying decrease, as Mark mentioned, is 16% for the quarter. You may also remember that our last-day orders would explain roughly half of that organic decrease.

Speaker #1: Still, we acknowledge that there's room for improvement, and we're working hard to achieve that. Now, when we presented our Q1 results, we guided that Q2 sales were expected to come in around the same level as Q1.

Speaker #1: And as you can see in the growth chart here, we actually grew by 2.4% quarter over quarter. But as you can also see, the growth was entirely exchange-rate driven.

Anders Svensson: As you can see in the growth chart here, we actually grew by 2.4% quarter-over-quarter. As you can also see, the growth was entirely exchange rate driven. In fact, Q2 sales did come in at the same level as Q1, as per our guidance. Moving to the LTM chart. You have heard us say so many times now that growth is not going to be linear over time, more likely take the form of a staircase. I guess the current LTM slide is case in point, with the decreasing last 12 months run rate presenting as our current sales plateau. The latest 12-month period sales are 7% higher than the 12-month period leading up to Q2 2025. Which of course is an increase, but much less of an increase than we have seen in previous observations.

Speaker #1: So in fact, Q2 sales did come in at the same level as Q1, as per our guidance. Moving to the LTM chart, you've heard us say so many times now that growth is not going to be linear over time.

Speaker #1: More likely, it takes the form of a staircase. And I guess the current LTM slide is a case in point, with the decreasing last twelve months run rate presenting as our current sales plateau.

Speaker #1: The latest 12-month period sales are 7% higher than the 12-month period leading up to Q2 2025, which, of course, is an increase, but much less of an increase than we've seen in previous observations.

Speaker #1: As stated earlier, our sales reorganization, which is still ongoing, has been quite extensive. We expect those efforts to start delivering improved commercial momentum later in the year.

Anders Svensson: As stated earlier, our sales reorganization, which is still ongoing, has been quite extensive. We expect those efforts to start delivering improved commercial momentum later in the year. On the gross margin, 92.1% was an improvement over the 91.6% in the first quarter, but clearly below the 96.8% very high margin reported in Q2 last year. There are so many factors that impact gross margin. I cannot go into detail on all of those, but suffice to say that the main drivers behind our current gross margin development is product and customer mix, as was the case in Q1, but with very different mix effects. There are still some exchange rate-related production cost effects from when the dollar peaked in early 2025, but the main current driver is mix. With that, I will hand you back to Mark.

Anders Svensson: As stated earlier, our sales reorganization, which is still ongoing, has been quite extensive. We expect those efforts to start delivering improved commercial momentum later in the year. On the gross margin, 92.1% was an improvement over the 91.6% in the Q1, but clearly below the 96.8% very high margin reported in Q2 last year. There are so many factors that impact gross margin. I cannot go into detail on all of those, but suffice to say that the main drivers behind our current gross margin development is product and customer mix, as was the case in Q1, but with very different mix effects. There are still some exchange rate-related production cost effects from when the dollar peaked in early 2025, but the main current driver is mix. With that, I will hand you back to Mark.

Speaker #1: On the gross margin, 92.1% was an improvement over the 91.6% in the first quarter, but clearly below the 96.8%—a very high margin—reported in Q2 last year.

Speaker #1: Now, there are so many factors that impact gross margin—I can't go into detail on all of those—but suffice it to say that the main drivers behind our current gross margin development are product and customer mix.

Speaker #1: As was the case in Q1, but with very different mix effects. There are still some exchange rate-related production cost effects from when the dollar peaked in early '25, but the main current driver is mix.

Speaker #1: And with that, I'll hand you back to Mark.

Speaker #2: Thanks, Anders. Although Catalyst has only been in this space for about four years, we've built a strong body of evidence. I'm pleased to tell you that we now have 19 preclinical and clinical publications and white papers, and a world-class registry that contains an always-growing number of patients.

Mark Waugh: Thanks, Anders. Although Catalyst has only been in this space for about four years, we have built a strong body of evidence. I am pleased to tell you that we now have 19 preclinical and clinical publications and white papers and a world-class registry that contains an always growing number of patients. OssDsign has consistently been reporting both high fusion rates and fast bone formation with Catalyst. This demonstrates rapid progression to fusion. The Boden model, a highly regarded preclinical model, showed 100% fusion for Catalyst, and our top fusion study also showed 100% fusion again at two years. Speaking of the world-class registry I mentioned, our PROPEL registry showed Catalyst with an 88.4% fusion in a highly complex real-world patient population. When we see other products marketing their products' fusion rates, those rates are often among patients with multiple exclusion criteria.

Speaker #2: OssDsign has consistently been reporting both high fusion rates and fast bone formation with Catalyst. This demonstrates rapid progression to fusion. The Bowden model, a highly regarded preclinical model, showed 100% fusion for Catalyst, and our top fusion study also showed 100% fusion again at two years.

Speaker #2: Speaking of the world-class registry I mentioned, our Propel registry showed Catalyst with an 88.4% fusion rate in a highly complex, real-world patient population. When we see other products marketing their product fusion rates, those rates are often among patients with multiple exclusion criteria.

Speaker #2: And in this industry, this is basically filtering out the risky, less likely to fuse patients for a clinical study—comorbidities such as high BMI, smoking, osteoporosis, or other issues such as failed prior surgeries, and more.

Mark Waugh: In this industry, this is basically filtering out the risky, less likely to fuse patients for a clinical study. Comorbidities such as high BMI, smoking, osteoporosis or other issues such as failed prior surgeries and more. This means that some of the competing data out there is not showing what the real-world performance of a product is. We include all kinds of challenging patients in OssDsign's Catalyst registry and our reported results. This is why you and our customers will continue to hear us say, "Real world data, real world results." These ongoing investments in clinical data are a key part of our strategy. Before we wrap things up and take questions, I will quickly reiterate our ScaleToProfit strategy, which OssDsign shared in Q3 of 2025. Again, there is four pillars in this strategy. First, accelerating access and coverage within the US market.

Speaker #2: This means that some of the competing data out there is not showing what the real-world performance of a product is. We include all kinds of challenging patients in OssDsign's Catalyst registry and report results.

Speaker #2: This is why you and our customers will continue to hear us say, "Real-world data, real-world results." These ongoing investments in clinical data are a key part of our strategy.

Speaker #2: And before we wrap things up and take questions, I will quickly reiterate our scale-to-profit strategy, which OssDsign shared in Q3 of 2025. Again, there are four pillars in this strategy.

Speaker #2: First, accelerating access and coverage within the U.S. market. We are still working to double our U.S. sales force—we are very close. But as I discussed, we've made some changes in our organization.

Mark Waugh: We are still working to double our US sales force. We are very close, but as I discussed, we've made some changes in our organization. We are absolutely stepping up on our marketing efforts, especially from an awareness perspective, and I look forward to seeing some of the things we have planned continue to roll out this year. As I've mentioned previously, we are starting to see uptake in the foot and ankle segment of the market as well. Second, expanding our product portfolio and indications. I mentioned the MIS solution for Catalyst and our hydrophilic strip product is also progressing. We said this before, but we will be seeking another indication for Catalyst this year. Third, to continue investing in and building a leading repository of clinical evidence. I already covered our PROPEL registry.

Speaker #2: We are absolutely stepping up our marketing efforts, especially from an awareness perspective, and I look forward to seeing some of the things we have planned continue to roll out this year.

Speaker #2: As I've mentioned previously, we are starting to see uptake in the foot-and-ankle segment of the market as well. Second, we are expanding our product portfolio and indications.

Speaker #2: I mentioned the MIS solution for Catalyst, and our hydrophilic strip product is also progressing. We have said this before, but we will be seeking another indication for Catalyst this year.

Speaker #2: Third, we will continue investing in and building a leading repository of clinical evidence. I already covered our PROPEL registry. Our Level 1 randomized controlled trial is moving forward according to plan, and we will continue to strengthen OssDsign's reputation as a differentiated, top-tier biologics company, with very compelling clinical evidence to support Catalyst.

Mark Waugh: Our level 1 randomized controlled trial is moving forward according to plan, and we will continue to strengthen OssDsign's reputation as a differentiated top-tier biologics company with very compelling clinical evidence to support Catalyst. Finally, the fourth pillar is to scale production and to add a US production footprint. We are working to implement a more scalable, more cost-efficient production process and to bolster our existing production. The good news is we believe we've identified a way to do this in a very cost-efficient manner. I want to close our call today by reiterating what I said during our Q1 release regarding transparency. I've committed to transparency with this team and to our shareholders, and I'm not in any way communicating to you today with some sort of a mission accomplished attitude or victory lap kind of messaging. However, I am pleased so far with the transformation we're undergoing.

Speaker #2: And finally, the fourth pillar is to scale production and add a US production footprint. We are working to implement a more scalable, more cost-efficient production process, and to bolster our existing productions.

Speaker #2: The good news is we believe we've identified a way to do this in a very cost-efficient manner. I want to close our call today by reiterating what I said during our Q1 release regarding transparency.

Speaker #2: I've committed to transparency with this team and to our shareholders, and I'm not in any way communicating to you today with a "mission accomplished" attitude or a victory lap kind of messaging.

Speaker #2: However, I am pleased so far with the transformation we're undergoing. We delivered a Q2 sales result that was in line with our guidance, slightly improved our gross margin, and completed a large amount of fundamental commercial restructuring while delivering improvements to our adjusted EBIT.

Mark Waugh: We delivered a Q2 sales result that was in line with our guidance, slightly improved our gross margin, and did a large amount of fundamental commercial restructuring while delivering improvements to our adjusted EBIT. We have not usually provided specific guidance, but did so last quarter. As we communicated within our release for this quarter, we do expect some headwinds in Q3 solely based on what we historically experience given US vacations or holiday seasonality during both July and August. However, I still have confidence that the changes we've made and the foundation we've laid will translate into tangible results later this year, and I still look forward to reporting on that. I want to thank you for joining our call today, and I will now hand it back to the operator who will handle questions.

Speaker #2: We have not usually provided specific guidance, but did so last quarter. As we communicated within our release, for this quarter, we do expect some headwinds in Q3 solely based on what we have historically experienced given U.S. vacations or holiday seasonality during both July and August.

Speaker #2: However, I still have confidence that the changes we've made, and the foundation we've laid, will translate into tangible results later this year. I still look forward to reporting on that.

Speaker #2: I want to thank you for joining our call today, and I will now hand it back to the operator, who will handle questions.

Speaker #1: Perfect. Thank you, Mark and Anders, for the presentation. Remember, if you want to ask a question, you're able to submit it in the box below the stream.

Elvin Rolder: Perfect. Thank you, Mark and Anders, for the presentation. Remember, if you want to ask a question, you're able to submit it in the box below the stream. We will read it out loud here. Maybe we can begin a little bit on these contract renegotiations. You mentioned in the report that you're seeing progress there on that matter. Can you give us some more kind of indications on how one should think and how far you've resolved these matters, and if they will continue to affect your business there in H2?

Speaker #1: We will read it out loud here, but maybe we can begin a little bit on these contract renegotiations. You mentioned in the report that you're seeing progress there on that matter.

Speaker #1: Can you give us some more kind of indications on how one should think, and how far you've resolved these matters, and if they will continue to affect your business here in H2?

Speaker #2: Sure. I think the takeaways on that are, given the size and scale of our company, there were a couple of larger IDN sort of customers that we were in renegotiations with, and I'm pleased to say that one of those has resolved, and we're now on a three-year contract with them going forward.

Mark Waugh: Sure. I think the takeaways on that are, given the size and scale of our company, there were a couple of larger IDN sort of customers that we were in renegotiations with. I am pleased to say that one of those has resolved, and we are now on a three-year contract with them going forward. The other one, unfortunately, has not yet resolved. We are still working through the details on that. We continue to do cases in many of their facilities, but these things often take quite amount of time, and so hopefully I will have an update on that on a future call.

Speaker #2: And the other one, unfortunately, has not yet resolved. We're still working through the details on that. We continue to do cases in many of their facilities, but these things often take quite an amount of time, and so hopefully I'll have an update on that on a future call.

Speaker #1: Great. You mentioned the MIS option for Catalyst, and you will give an update here in the next quarters. But can you also comment a little bit on the hydrophilic strip?

Elvin Rolder: Great. You mentioned the MIS option for Catalyst, and you will give an update here in the next quarters, but can you also comment a little bit on the hydrophilic strip? How has the development been going for that release, and what are your internal kind of expectations on what that will be able to unlock versus what you are currently able to offer?

Speaker #1: How has the development been going for that release? And what are your internal kind of expectations on what that will be able to unlock versus what you're currently able to offer?

Speaker #2: Yeah, thanks. So we view Catalyst's underlying technology as sort of a platform, and so anything we do is within the frame of reference of that being a line extension, and sort of taking that technology and putting it into other uses.

Mark Waugh: Yeah, thanks. We view Catalyst's underlying technology as sort of a platform, and so anything we do is within the frame of reference of that being a line extension and sort of taking that technology and putting it into other uses, and that is really what that strip is all about. That project is also progressing quite nicely. We have completed some initial preclinical animal studies. We are in the process right now of basically investigating that data with great rigor and looking at the pros and cons and the outcomes in each of those animal studies. That will move forward much more quickly once we get past the preclinical phase, but I cannot really commit to timing on that until I see what the results of all that is.

Speaker #2: And that's really what that strip is all about. That project is also progressing quite nicely. We have completed some initial preclinical animal studies.

Speaker #2: We are in the process right now of basically investigating that data with great rigor, and looking at the pros and cons, and the outcomes in each of those animal studies.

Speaker #2: That will move forward much more quickly once we get past the preclinical phase, but I can't really commit to timing on that until I see what the results of all that are.

Elvin Rolder: Hmm. But in terms of kind of positioning the company against IDNs and hospitals and surgeons alike, what are your kind of internal expectations on how much more of a market can you kind of unlock with this product? Will it be like a third of a market, or what should one's expectations be on what it enables you to do?

Speaker #1: But in terms of kind of positioning the company against IDNs and hospitals and surgeons alike, what are your internal expectations on how much more of the market you can unlock with this product?

Speaker #1: Will it be like a third of a market, or what should one's expectations be on what it enables you to do?

Speaker #2: Yeah, I think I would temper that just a bit. Not because it's not a great product or project, in both cases—for both the strip and the MIS—but Catalyst itself has such a huge opportunity ahead of it in the market in the US.

Mark Waugh: Yeah, I think I would temper that just a bit, not because it is not a great product or project in both cases for both the strip and the MIS, but Catalyst itself has such a huge opportunity ahead of it in the market in the US. I will say this, when it comes to these kinds of line extensions that are not fundamental brand-new products, but again, leveraging that Catalyst core technology and people having the expectation that it will deliver on the clinical performance. What it does is allows us to use a US saying to kind of keep the fox out of the henhouse.

Speaker #2: But I will say this: when it comes to these kinds of line extensions, that are not fundamentally brand-new products but, again, leverage that Catalyst core technology—and people have the expectation that it will deliver on the clinical performance—what it does is allow us to use a US saying: to kind of keep the fox out of the henhouse.

Speaker #2: I don't know if that translates well to things in Sweden, but it's always good to have those kinds of ancillary, line-extension type products so that if a surgeon does prefer to use a strip in those kinds of cases, they don't have to call on one of our competitors. We're giving them an opportunity to speak to one of our customers.

Mark Waugh: I do not know if that translates well to things in Sweden, but it is always good to have those kinds of ancillary line extension type products so that if a surgeon does prefer to use a strip in those kinds of cases, they do not have to call on one of our competitors, and we are giving them an opportunity to speak to one of our customers. On the other side of that coin, it does allow us to penetrate accounts where maybe somebody prefers to use a strip for many of their cases, but we do not have that technology yet. So, we have the putty right now, but we could go in and say, "Hey, we have this strip now. Can we have that conversation again?" So that is what it really means for us.

Speaker #2: But on the other side of that coin, it does allow us to penetrate accounts where maybe somebody prefers to use a strip for many other cases.

Speaker #2: But we don't have that technology yet, so we have the putty right now. But we could go in and say, "Hey, we have the strip now."

Speaker #2: "Can we have that conversation again?" So that's what it really means for us.

Elvin Rolder: Hmm. Great. In terms of kind of sales hiring activity for the sales force, how far along have you gone now? Do you feel that you have kind of hit a plateau that you are satisfied with for the coming foreseeable future, or are you continuously kind of adding more, and how much more should we kind of think that you would like to add to the organization?

Speaker #1: Great. And in terms of kind of sales hiring activity, for the Salesforce, how far along have you gone now? Do you feel that you've kind of hit a plateau that you're satisfied with for the coming foreseeable future, or are you continuously kind of adding more?

Speaker #1: And how much more should we, kind of, think that you would like to add to the organization?

Speaker #2: Yeah, I'm not satisfied just yet. We've done a great job transforming the sales team, and as I mentioned in our comments in our release, we've now changed or turned over more than 50% of the commercial team as it existed on an org chart as of January 1.

Mark Waugh: Yeah. I am not satisfied just yet. We have done a great job transforming the sales team, and as I mentioned in our comments in our release, we have now changed or turned over over 50% of the commercial team as it existed on an org chart as of 1 January. We have multiple open positions still open right now that we are recruiting for and hiring for. I do think we will see some more stability in that team now that we have made the changes, in terms of what that org chart looks like right now, and I am very pleased with how the team has responded to some of the changes we have made. But there is no real ceiling on the hiring.

Speaker #2: We have multiple positions still open right now that we're recruiting for and hiring for. But I do think we'll see some more stability in that team now that we've made the changes, in terms of what that org chart looks like right now.

Speaker #2: And I'm very pleased with how the team's responded to some of the changes we've made. But there's no real ceiling on the hiring. So yes, we've had this stated goal to sort of double where we were from January 1, 2025, which is still our goal, but I wouldn't be surprised to see us exceed that goal in rapid fashion too.

Mark Waugh: Yes, we've had this stated goal to sort of double where we were from 1 January 2025, which is still our goal, but I wouldn't be surprised to see us exceed that goal in rapid fashion, too. As long as we can support the business case for a hire in a new geographic area that helps us to accelerate growth, we're going to explore that.

Speaker #2: I mean, as long as we can support the business case for a hire and a new geographic area that helps us to accelerate growth, we're going to explore that.

Elvin Rolder: Hmm. Perhaps staying a bit on your last comment there, have these hires been mostly kind of filling in these kind of geographical white spots that you've had previously, or has it also been doubling down on existing geographies to kind of help penetrate the markets that are perhaps too big for one or two people to kind of target?

Speaker #1: Perhaps staying a bit on your last comment there, has these hires been mostly kind of filling in these kind of geographical white spots that you've had previously, or has it also been doubling down on existing geographies to kind of help penetrate markets that are perhaps too big for one or two people to kind of target?

Speaker #2: I'll answer the second half of that first. I would say that, given our scale and presence in the US markets, we don't have an issue yet where we need to sort of double up in specific markets to enable us to tap additional opportunities.

Mark Waugh: I'll answer the second half of that first. I would say that our scale and presence in the US markets, we don't have an issue yet where we need to sort of double up in specific markets to enable us to tap additional opportunities. So most of the hires have been in that white space or to replace people who are no longer with the organization.

Speaker #2: So most of the hires have been in that white space or to replace people who are no longer with the organization.

Elvin Rolder: Hmm. Perfect. We'll move on to perhaps the US manufacturing footprint. I think it has not been discussed as much recently in favor of other topics, but can you perhaps give a more detailed kind of explanation on what you're able to do there? I think it will be interesting on how one should think on when you're perhaps able to move more of the footprint towards the US, both timeline-wise and what that maybe can unlock in terms of gross margins and inventory levels as well.

Speaker #1: Perfect. We'll move on to perhaps the US manufacturing footprint. I think it has kind of not been discussed as much recently in favor of other topics, but can you perhaps give a more detailed explanation on what you're able to do there?

Speaker #1: I think it will be interesting to see how one should think about when you might be able to move more of the footprint towards the US, both timeline-wise and what that could unlock in terms of gross margins and inventory levels as well.

Speaker #2: Yeah, I think it'll make us more efficient. I don't see it moving the gross margin side of the equation. As far as that second source, what it's going to do for us, though, is take out a lot of geopolitical risk.

Mark Waugh: Yeah, I think it will make us more efficient. I do not see it moving the gross margin side of the equation as far as that second source. What it is going to do for us, though, is take out a lot of geopolitical risk. I think I commented on this after the Q4 call. There is always some level of risk when you are a sole site, especially when you are a sole site with a production facility elsewhere. We are in great shape from an inventory perspective at all times, so it is a pretty low risk for us, but it will be good to have that second site. I do not know if the US will enter any new tariff programs or other things like that could actually impact gross margins at some point if we do not have that second site. But I mentioned the cost-effective way we have identified to do this.

Speaker #2: I mean, I think I commented on this after the Q4 call. There's always some level of risk when you're a sole site—especially when you're a sole site with a production facility elsewhere.

Speaker #2: I mean, we're in great shape from an inventory perspective at all times, so it's pretty low risk for us. But it will be good to have that second site.

Speaker #2: I mean, I don't know if the U.S. will enter any new tariff programs, or other things like that, that could actually impact gross margins at some point if we don't have that second site.

Speaker #2: But I mentioned the cost-effective way we've identified to do this. I mean, fortunately for us, from a partner perspective, we believe we've identified a way to add that second production facility without having to spin up our own higher level of CapEx to accomplish it.

Mark Waugh: Fortunately for us, from a partner perspective, we believe we have identified a way to add that second production facility without spinning up our own higher level of CapEx to accomplish it. So I am very pleased with the progress that our team is making on that right now. I cannot give you specific timing on it just yet because it is still too early, but the solution that presented itself only happened within the last quarter or so, and we think not only will we be able to do that faster than anticipated, but at a much lower cost to organizational resources as well.

Speaker #2: So, I'm very pleased with the progress that our team's making on that right now. I can't give you specific timing on it just yet because it's still too early, but the solution that presented itself only happened within the last quarter or so. And we're very—we think not only will we be able to do that faster than anticipated, but at a much lower sort of cost to organizational resources as well.

Speaker #1: Great. And then perhaps finally, on the randomized controlled trial—you’re mentioning that enrollment can begin perhaps quite soon, at least. Is it possible to give some comments more on the study design? How many centers are included in the study, how big is it, and any further kind of additional details on what the kind of readout will be able to tell the market and tell surgeons, and so on?

Elvin Rolder: Great. Then perhaps finally, on the randomized control trial, you are mentioning that enrollment can begin perhaps quite soon at least. Is it possible to give some comments more on the study design, how many centers are included in the study? How big is it? Are there any further kind of additional details on what the kind of readouts we will be able to tell the market and tell surgeons and so on?

Speaker #2: Yeah, I'm going to paint in broad brushstrokes here because we are, I would categorize it as, sort of 99% baked on the protocol design.

Mark Waugh: Yeah, I am going to paint in broad brush strokes here because I would categorize it as sort of 99% baked on the protocol design. We had a great meeting with our clinical advisory board approximately 4 weeks ago, if I recall correctly. Ongoing discussions with our chief clinical lead on this to get the protocol completely signed off, moved forward. My clinical management team member is in the US right now, traveling around, meeting with a bunch of the sites that we have been vetting for this. That is going exceptionally well. So I think what we are going to see as we move into the latter part of Q3 and into Q4 is more of a deliberate tactical contracting with these sites that we have identified.

Speaker #2: We had a great meeting with our clinical advisory board approximately four weeks ago, if I recall correctly. Ongoing discussions with our chief clinical lead on this to get the protocol completely signed off and moved forward.

Speaker #2: My clinical management team member is in the U.S. right now, traveling around and meeting with a bunch of the sites that we've been vetting for this.

Speaker #2: That's going exceptionally well. And so I think what we're going to see as we move into the latter part of Q3 and into Q4 is more of a deliberate, tactical contracting with these sites that we've identified.

Speaker #2: I think, timing-wise, it's difficult on these kinds of things in terms of how much time it's going to take. I'll probably be in a better position in the next quarterly call to actually share specific end numbers based on where we are with the statistical analysis on that, as well as a little bit more on the timing. The timing itself is always sort of TBD depending on how fast each site enrolls.

Mark Waugh: I think timing-wise, it is difficult on these kinds of things in terms of how much time it is going to take, and I will probably be in a better position in the next quarterly call to actually share specific end numbers based on where we are with the statistical analysis on that, as well as a little bit more of a timing. The timing itself is always sort of TBD, depending on how fast each site enrolls. But I think the key takeaway on this is, I am very pleased that this was something that was started to sort of be moved into place before I joined, and we have been able to accelerate it and move it to fruition.

Speaker #2: But I think the key takeaway on this is I'm very pleased that this was something that was started to sort of be moved into place before I joined, and we've been able to accelerate it and move it to fruition.

Speaker #2: Because if you really look at the U.S. landscape on products in this space, there are only a handful that have actually taken the strategic tack and actually made the investment to go after getting level one data.

Mark Waugh: Because if you really look at the US landscape on products in this space, there is only a handful that have actually taken the strategic tact and actually made the investment to go after getting level 1 data. I think it is also important to note that although that is a sort of checkbox or a watermark that some systems want to see on level 1 data, I will continue to be bullish on the data that we are mining from PROPEL and the registry. And I frequently, even on my own, and certainly our team members do even more frequently than I do, have discussions with both clinicians and with value analysis committees and others that show the strength of that PROPEL registry.

Speaker #2: I think it's also important to note that, although that is a sort of checkbox or a watermark that some systems want to see on level one data, I'll continue to be bullish on the data that we are mining from Propel and the registry.

Speaker #2: And I frequently—even on my own, and certainly our team members do even more frequently than I do—have discussions with both clinicians and with value analysis committees and others that show the strength of that Propel registry, because we're not filtering out all those patients that have comorbidities and other things.

Mark Waugh: Because we are not filtering out all those patients that have comorbidities and other things, we are not excluding them, you can actually see how this product performs in a real-world US population that is frequently full of high BMI, other comorbidities. So, as great as I think it is that we are doing a level 1 study, I equally think it is fantastic that we have PROPEL, and we are one of the few companies that has an ongoing registry like this in the space. And soon we will be joining a very, very small list of companies that actually have either a level 1 study in progress or the ability to report out on that.

Speaker #2: We're not excluding them. You can actually see how this product performs in a real-world U.S. population, which frequently has a high BMI and other comorbidities.

Speaker #2: So, as great as I think it is that we're doing a Level 1 study, I equally think it's fantastic that we have Propel, and we are one of the few companies that has an ongoing registry like this in the space.

Speaker #2: And soon we will be joining a very, very small list of companies that actually have either a Level One study in progress or the ability to report out on that.

Speaker #1: Great, thank you. There are no more questions at this time, so I think we'll conclude the presentation here. Thank you so much to both Mark and Anders for the presentation and Q&A session, and thank you to everyone for listening in.

Elvin Rolder: Great. Thank you. There are no more questions at this time, so I think we will conclude the presentation there. Thank you so much to both Mark and Anders for presentation and Q&A session, and thank you for everyone for listening in. Have a good day.

Speaker #1: Have a good day.

Speaker #2: Thank you.

Anders Svensson: Thank you.

Mark Waugh: Thank you.

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