Hello everyone, and welcome to DNB Carnegie. My name is Maria, and I'm a Healthcare Analyst here at the bank. Today, I'm very pleased to be joined by Richard Paxman, CEO of Paxman. The topic will be, of course, the second quarter. Thanks for the opportunity to discuss this with you, Richard, and welcome.
Great to be here, and I hope everyone's had a great summer so far.
So, the plan is that I'll hand the word over to you, Richard. Take us through the highlights of the quarter, and then we'll continue on with some Q&A. You also have the live chat, that I encourage you to ask questions if you'd like to ask questions, our viewers. So please take it away, Richard.
Thank you. I want to start, I think, by just talking a little bit about what's gone on. This slide deck is reasonably heavy for a highlight session because it's been a big quarter with commercialization activities, with further investments and work in the reimbursement space with the U.S., as well as, of course, the mergers. There's a lot going on. I think that's probably shown in the report. We'll try and dissect it a little bit, and then we'll have a good Q&A to sort of answer any questions that you might have. The underlying trend for me is very positive, and I'm really pleased with where we're at, both from a scalp cooling and growth perspective of Paxman, but also a Dignitana integration. We're moving closer and closer to our vision.
Let's not forget that what we want is that all patients, no matter where you are in the world, to have access to our scalp cooling treatment, and hopefully soon our peripheral neuropathy treatment as well. That's really important. I think, again, together we can achieve this. Looking at the numbers of people in our organization, of course, adding Dignitana on, and then some headcount into the U.S. business, we're up at about 140 employees now, so substantially more than Q1. A fair amount of those, over 20 of those, are from Dignitana. We'll talk a little bit more about the restructure and what that looks like going forward as we enter into a new era. Overall, functioning very well, senior leadership team strong, and really we're in a good position to take the business forward as we enter into 2026.
Deep dive into the results, or not too deep, I guess we've not got all day, but I think what we've got to look at first of all is trying to understand the sort of split between Dignitana and Paxman, but then also some of the Forex situations as well. We did see 17% growth, including the Dignitana acquisition, and that is our highest level of sales to date. You've got to remember we're only including one month of Dignitana sales, so I'm really excited to see what the consolidated picture looks like in Q3. If you look at that sales growth, only 4.4 million SEK of that comes from organic growth or Paxman's growth alone. Then we've acquired revenues of about 6.9 million SEK from Dignitana. Over 10% of that growth comes from Dignitana. What is important to understand though, as we deep dive into the entities, we've actually seen better growth than that. The Forex translation effect from selling in U.S. dollars or selling in pounds, we go U.S. dollars convert to GBP, British pounds convert to SEK, that's actually been affected. Looking at the UK entity sales, we had some of our, I think our strongest quarters yet with £3.6 million of sales. That's 9% growth on prior year, and an increase of over £180,000 from rest of the world sales from the previous quarter. We had a really strong international sales quarter. In addition to that, we saw 21% growth on the prior quarter for the U.S. alone, and an increase of $300,000 from Q1, or $300,000, should I say. Decent growth.
Our gross profit margins have remained strong and actually very strong for the quarter, and we'll continue to try and work on that. Our operating expenses were absolutely higher than normal. A couple of reasons, we're starting to see now commercialization of CIPN device, so we spent about SEK 1 million in our P&L on those commercialization activities. We did have some higher costs overall in Paxman based on being a very heavy quarter with large exhibitions globally, as well as investments into reimbursement and activity there with our consultants. You've got to look at the addition of Dignitana. We've got a month of extra costs anyway, as expected, plus restructuring costs of over SEK 4 million as well. With all this said, I actually think we perform very strongly, and I'm pleased. Longer term, yes, we will drive up revenues.
Longer term, we will drive up EBITDA margins without question, and therefore profitability. We're confident in achieving that with the restructuring and the investments that we're making. Cash flow, of course, has been affected by the acquisition and restructuring. We've got a small but positive operating cash flow. I always find the cash flow a strange presentation in how it's built up, but I always feel as a good sort of holder of finance and see what's happening is the cash in the bank is always a good signal of how we're doing, the level of creditors, et cetera. Actually, overall, we're in a really strong position. Yes, we've seen some cash outflow, again with the SEK 4.7 million of investments we've made, which were made up of SEK 1.7 million of CIPN, remembering not everything hits the P&L, as well as continued installs into the U.S.
We're performing very well, and we've got a large amount of cash in the bank with still over SEK 149 million. That gives us that confidence in taking the business forward and continuing to make those investments. Just looking here at the Dignitana acquired assets and liabilities, as it was hard to see that in the report. Looking at cash that we've taken on board, looking at some of the tangible assets, the equipment that's out in the field, accounts receivable, overall fairly good. I think what's probably most interesting for everyone is looking at the sort of accounts payable and other liabilities and credit institution liabilities. The good thing is we're not taking on anything that we didn't know. Yes, it's early days, but we actually are fully aware of the full financial situation of Dignitana, which is excellent.
As I mentioned previously, this doesn't include Dignitana, but we had a really strong quarter for overseas sales, especially with our Australian market. We've got 124 systems on order, a little bit weaker than Q1, but we expect that to continue to grow, and sometimes this time of year can be like that. Our investment into our international team feels like it's paying off now. There's a real hive of activity based on having different people in geographic locations and looking after territories across the world. ADTR is great here. Let's ignore Dignitana for the moment, and you will actually see a 20% increase, only a 21% increase on ADTR from the same period last year. It's great because you look at it without Forex movement. If you look at it with Dignitana, and again only one month, 43% increase. Excited for seeing that grow over the period.
As we increase utilization across the board with IBBM, that figure will only get better. To the merger, we really took control on the 8th of June. I think we're only really in reality a couple of months into this, but we're making some really positive strides. Just as a reminder, looking at Dignitana AB, you've got the Swedish entity with some trade and some international activity. Then you've got the main company, and really what we've acquired, which is the Dignitana Inc. business, the U.S. business with over 270 customers in the U.S., driving significant revenues on a monthly basis. Dignitana Italy, we'll call it, with a number of agents. We're reviewing what that looks like going forward and how we utilize that business and understand if it has value for us. The key focus is Dignitana Inc.
and then some of the international activity as we explore and understand their distribution network. Looking at Dignitana alone and looking at their quarterly figures, we saw SEK 21 million of sales achieved for the quarter. That's actually down SEK 1 million from the prior quarter. Looking at translation effects, if you look at the U.S. income, it's actually up $125,000 from Q1. We're starting to see a driving growth there as well. We're pleased actually with the overall performance. As we've delved into the numbers, good margins and a really interesting business. June sales, as I've said before, of Paxman's included SEK 6.9 million of Dignitana's income. In terms of where we're at from a restructuring cost at the moment, we're at about SEK 4.4 million of costs, and that includes some termination costs and other costs that can't be put on the balance sheet.
A cash impact of a little bit less as we've not paid out all restructuring costs as yet. We're making good headway. We've got a very clear plan. Of course, we're now in this post-day one integration period, which will last in reality for us probably just before the end of the year, November time. We're looking to make sure that most things are in place, maybe December, and most changes have now taken effect. Just high level, we've obviously delisted the company. We've removed the Dignitana board. We've unfortunately had to let the CEO go, which was always the plan in reality, and the CFO is currently with us, but the contract has been terminated. We've reviewed the Swedish personnel, and we're bringing a lot of the functions back into the UK.
I have to say, and I've said it in the report, the people at Dignitana, even the ones that we've let go that are continuing to work with us in the transition period, have been amazing, so open, welcoming, supportive, and I can't be, as yeah, incredibly grateful for their commitment. We've just been through a couple of audits as well, and they've performed brilliantly. Hats off to them all. We're going to keep two people in Sweden, so that would be five people leave from that office there as well as the C-suite. We have reviewed the U.S. personnel and functions there, and we have made two redundancies in the sales and business development area.
The rest are in the field and really add value to the business and allow us to start to look at how we operate geographically with both scalp cooling and CIPN in the future. I am out in Lund this week. I am not in Lund now, but tonight I will be in Lund. We are going to do some more work on how to start to close down the operations there and review what we need to do.
That is ongoing there, but we have been out in Dallas as well and made some changes and really starting to work closely with that ops team to see if we can support them and become more efficient and effective in what they are doing. We have, of course, reviewed the offices, the insurance reviews where we can start to see some synergies. We are doing a full technology review and looking at service provision, seeing what IP is useful to us and not, and then a supplier review. I think the biggest question for everyone is, will we continue with their supply of equipment?
We have signed a new agreement with Thermatec, which looks very different than it does today, with a real focus on single patient use cooling caps and consumables as opposed to equipment itself. We are just deciding how long that contract might look like from an equipment manufacturer perspective, where there is still some demand, so we have to consider that. It has been a very, very positive situation and hopefully drives some better margins in the future as well. We are working with regulatory now to see how we can support that transition as well and having a global partner review. There has been a lot going on in this last probably six weeks, but we are making really positive traction.
We expect these post-merger integration principles, as I have said earlier, to come to fruition by the end of the year, that we start to see those synergies, economies of scale, and rationalization and cost savings. Reimbursement. I think again, you have to think about Forex, but let us deep dive very quickly. We have, if we take a look at our insurance-based billing model, we were a bit concerned at Q1. If you recall, the numbers were lower than Q4. What we have seen now is a bounce back, so achieving $1.16 million compared to $823,000 twelve months ago. It was a modest improvement from the prior quarter, but an improvement. I do really think we will start to see traction at the end of the year. Our sites now are starting to get excited about the ruling and the proposed rules.
Increases in capsole and a positive momentum, but still not fast enough for me, and I'm sure for you too. Positive coverage continues to be great, and we do expect this to improve as we get to higher levels of CPT coding and better levels of coverage. We've talked about this before, working on coding, working on coverage, working on payment. Key for us recently has been working on payment, and we're going to talk about that later. Just remember, as we transition to insurance-based billing model, we see improved utilization overall. We have low levels of utilization today, and what we need to do is get it reimbursed and drive that better utilization, which drives revenue significantly. Two proposed rules came out, the first being for PFS. This relates to the community-based practices, the office-based practices. Overall, we were reasonably happy with this. I think that's important to understand.
This is a really strong breakthrough for both rules and a big step in the right direction. For the first time, we have three codes in the community setting and all three codes being paid for. What we aren't happy with is the levels of payment, albeit okay, we believe that these can be stronger. I'll talk about that later. I was slightly disappointed with the OPPS ruling, and that's partly due to doing with claims data. What they've done is they've looked at the claims data again as where we've previously been. Because we've now gone over 100 claims, what happens is it kicks in a different ruling and it actually chooses the lowest of the three means that they look at. Historically, they've chosen the highest. If they'd have chosen the highest, we'd have been over $2,000.
What they've also done is packaged the other two codes, so they're not paying for them separately, similar to what they did with 0663T. That's not correct. That's not accurate. More work to be done there. Still, what we've got to remember is we've been here before, we've changed it, but what we've also got to remember is that only 15% of our patients are Medicare patients. Typically, commercial insurers will pay 30% to 40% more than Medicare and make their own decisions as well around payment, as they are doing with CPT3 codes. This is a baseline, and we'll continue to work and figure this out. We've held two meetings now with the Division of Outpatient Care and Physician Services to try and move this forward.
What we're trying to do is articulate the patient journey, show the very distinct differences between each of those codes and the work and the supplies or practice expense that's involved with them. We've carried out extensive time in motion studies to really look at the work involved and the minutes involved of each particular process and presented that to CMS in detail. As well as that, we've then been meeting with these groups and really articulating what we need. It's about unpackaging the codes, about putting a better value to the other codes. We've put these requests in formally, so unpackaging, and we're trying to push for that second code, which would be bundled with the third code, about a $450 per treatment situation. How confident am I in achieving this?
I'm unsure at the moment, but this is a starting point, and we're going to work closely with CMS and all our customers to provide comment and make sure that we can move to a better and more fair calculation for those cancer centers. The same with MPFS. We're concerned that there was not the right education from the rook to CMS in articulating what practice expense involved, what was the typical patient look like. We've educated CMS on this, and we'll be providing further comment letters to support this. This is a very busy slide, but what we're trying to do is slowly creep up that pricing point to fairly reflect the amount of work that's involved by the nurses and the hospitals offering this or the cancer centers offering this. We continue to push the coverage strategy with MAC.
I'm not going to go into this, but we're still making progress with First Coast, Novitas, and NGS. We hope by the end of the year, we'll have better news to share with you. Now it's about commercial payer outreach. First, we're working on a payer dossier along with other engagement strategies to start improving commercial payer coverage. A key focus is our simple switch. It's about pushing those customers to switch to this new business model. We've just launched our new branding and our new messaging to support that switch, which really encourages hospitals to start to look at this now or at least prepare for the CPT1 coding.
Looking at our directed issue, we all know why we raised the money, and we've now started to spend that, not in huge amounts, but about SEK 1 million on commercialization that's hitting our P&L, and then a cash impact of just under SEK 3 million, where we've capitalized certain development costs and research costs. New product timeline, we're on track. We've not moved away from this as yet. There are slight delays with some of our completion of testing documentation, but we're still expecting FDA clearance early in the new year, potentially second quarter if things get delayed. Unfortunately, we've had some setbacks with the Breakthrough Devices Program. The issue was that our device is not considered life-saving, so now we're looking at what we call a STEP program, a Safer Technologies Program.
Although this is not quite as exciting as the Breakthrough Devices Program because reimbursement focuses more on approvals and speed of approvals, it still is a positive step forward. I'm not going to go into all the clinical data because I'm talking longer than I planned, but there's so much to talk about. CIPN, again, huge unmet need. We know that affects a large number of people. It's sort of 30% with grade 2 CIPN. We've got two ongoing studies. Just recently, we've presented our phase two study at MASC. Really strong results. I think if you look at the number of patients who have had grade 2 alopecia, I mean grade 2 CIPN, we're seeing about 4% compared to that 30% and more that we see in other trials. Really, really promising results and excited to see more data being presented later this year. The study in the U.S.
continues to progress well, and we've got, I think, well over 350, probably close to 400 patients recruited now. We're just about to kick off our clinical trial in the U.S. with Dana-Farber. Again, looking very positive. I'm sure Maria is saying, "Why is he taking so long to get through that?" Apologies, but as I said, lots to get through and hopefully some clarity around the NPFS and OPPS.
No worries. Thank you, Richard. This was great and indeed a lot happened the quarter, so it was good if it took your time. I have, of course, the first question is on the one-offs related to Dignitana. The question is, if you could elaborate more on this, was it mainly just related to personnel or was it something else in there? You've mentioned it briefly in your presentation, but could you just wrap it up? What were the one-offs?
Yeah, there was a large chunk of that from a personnel perspective. We, I hate the word terminated, but it's the reality. There are costs in the U.S. for severance packages, costs for severance packages for the CEO, and then some additional costs that can't be considered as the acquisition, but one-off costs. Merely severance in reality and some transactional costs, but overall, those will be the big chunks.
Yeah, of course, this is a people's business, difficult decisions and everything. When do you think, when do you expect these changes to? You're expecting the integration work to end by end of year, but when can we expect more positive notes in the numbers?
I think you probably start to see that coming through in December. Although you won't see December sit alone, we'll be running with more headcount until roughly November, potentially partly December. You'll start to see the reducing of OpEx.
Good to know for us analysts, always.
Yeah.
If we zoom in back to the U.S. market, which is obviously very important, and now with Dignitana and so on, I was wondering about how many clinics do you now have that are connected to the program. Do you disclose that number?
We don't, but I was looking at possibly disclosing it this time. What we're doing, I'm going to try and report some different numbers next time. We'll look at where we are utilization-wise, so number of systems versus number of patients versus number of locations, and trying to start to share some different indicators. I'll be honest, it was a tough quarter for further and asked us the numbers, so we left it and thought, let's not complicate it more. Dignitana had about 270 locations. We've got about 640 locations, I think. We're not far off a thousand, sort of thousand locations across the U.S., which is brilliant, really. Strong foothold.
Yeah, to not complicate things further, the simple switch, how does it actually work? Like practically, when the clinics decide to go on to that model, what happens? How do you support them? What do you do?
Yeah, so we call it the simple switch to entice people. I'm not sure how it is. It's quite a multidisciplinary approach. First of all, we're trying to engage with the different stakeholders involved in making a decision like that. Actually, it varies from cancer center to cancer center. We'll then present, share the benefits and the pitfalls of the new model and the sort of challenges that we see under a CPT3 code versus a CPT1 code. We share the data. In reality, they do it every single day of their lives. They buy products from the suppliers, from the manufacturers. They give them the patient and they bill insurance. That is why we call it the simple switch, because in reality, it's simple. They need to build in some new workflows. They need to get procurement involved, legal involved, revenue cycle management.
They need to set up the relevant coding in their systems, the appropriate notations, and supporting documentation to prove that they've done those codes. When they're up and running, it works. Procurement sometimes can be a bit funny depending on contracts and where they're buying them from, if they've got a contract with McKesson, et cetera. It's not rocket science.
Yeah, a very enticing name indeed. I have a question here about a bit of a different topic on gross margins. With higher volumes increasing going forward, what are your expectations of the gross margin dynamics going forward?
Okay, as I'm not really allowed to talk about forward-looking statements too much, we do want to drive improved gross margins, of course. I think I've talked about this before, but as we switch from self-pay to insurance-based billing, we should see improved gross margins because we're getting a better price per patient in reality. We've also got some other projects that are looking at purchasing of our cooling caps and single patient use cooling caps and reducing some of the costs there. We've done some work with Dignitana on reducing some of the supply costs there as well. Longer term, we think we'll continue to drive improved gross margins.
Service for us in terms of Paxman is a big cost, but as we grow that, as we grow more systems in the field and we review our service offering in terms of services and medicines, we think we can drive some cost out of that too.
A short follow-up on that. What's included in the COGS? Very short question.
What's included in the COGS? Okay, so all the costs of manufacturer, of course, so excluding the caps on deployed, so where it's our own asset, it isn't, but you've got the cost of sale of selling equipment. You've got the cooling caps themselves on a single patient use basis. You've got the transactional costs, and I call them transactional costs, meaning shipping of the devices, shipping of the cooling caps, storage of the cooling caps, 3PL services. You've got then, if you're an insurance-based billing model, you've got the cost of an enrollment, cost of a BI, so our hub costs in reality, and then service and maintenance.
Thank you. I'm sorry for jumping to another topic again, but on utilization rate, how would you want to see change going forward in the coming quarters? Are you planning to introduce maybe some new KPIs for reporting next quarter or the following year or so, so that we could keep track of that maybe?
I think I alluded to that a couple of moments ago, and I would have liked to have tried to do it this quarter, but I think too much going on. I think by the end of the year, or it might be at the end of the year where we look at Q4 and do a full summary of the year, but start to compare even utilization between self-pay versus IBBM and then track that as a KPI and see if it improves then over time with CPT1 codes. It can be complex to look at, and it can give strange messaging, but we are going to start providing more information, especially as we get closer to building momentum with reimbursement or building more momentum with reimbursement.
Thank you. Let's see, now there are more questions incoming here. When do you expect the ice compress study to complete recruitment?
The ice compress study will be a little bit longer. I'd expect probably a 12-month period, if not potentially longer. The recruitment will finish, but then there's a longer-term follow-up as well.
You say that the sites are excited about the new CPT codes, and do you expect to see an impact on them at the end of the year? What will the preparations on the sites look like with the introduction of new CPT codes, I imagine?
Okay, so those sites that are already using our insurance-based billing model, what they need to do is work with their payers on contracting to start saying, "Look, the CPT1 codes are coming. We need to start having a discussion about making sure these are covered and paid for." What they'll need to do from a sort of IT perspective is build those codes into their systems. I'd love to say on day one, January 1, everything will be, "Tada! There we go. They're up and running." There is a bit of a lag by all accounts, so it doesn't happen immediately.
It takes time for the codes to filter and get used, but what's important for the work that we're doing is start working with those cancer centers, make sure that they're having those conversations with their payers and understanding the payer mix to say, "Look, you know these CPT1 codes are coming. You're covering the CPT3 codes. We need to be prepared for day one because the CPT3 codes eventually disappear and these kick in.
The next question is, I think it's one of your favorites. I know that there are two topics you really like to talk about, and it's always Forex and Trump and tariffs. This question is on tariffs. How are the new tariffs affecting the company? If you just say it briefly, because I think you talked a lot about it in the previous quarter.
Yeah, so we've got the 10% tariffs, limited effect on the capital deployed. We capitalize that, depreciate over the five years. It is a cash cost, of course. On the consumables, it's about $30 per cooling cap that impacts us. What we haven't done yet, we're seeing the impacts of the cost. We're not quite there with our inflated pricing, the cost of that cost yet. You'll see some inflated pricing in the quarter, but it's not really taken effect, only because contracting to change pricing is not as simple as one would like. We hope to see mitigation of tariffs back you through.
All right, enough with the tariffs then. Maybe, how are your dialogues going with private insurance providers? Or is it something out of your scope?
Not out of our scope, definitely not. What we wanted to do is be quite fierce in our approach, and it's been very much coding to start with, and then coverage from Medicare, so MAC. What we wanted to do is get these proposed rules out, so we had a bit more clarity around what things looked like when we started to speak with the commercial payers. There was a slide which I went through relatively quickly where we've developed what we call a commercial payer dossier. In essence, it's like a scalp cooling brochure which highlights all the benefits and the clinical data about scalp cooling, where it's being used, how it's being used, and then it'll talk about the existing landscape of CPT3 codes and then the new landscape of CPT1 codes. What we'll do then is have some commercial payer engagement.
We'll say, "What do you think about this? How shall we present this to people?" Once we've done that, got that feedback, we'll start to make a more aggressive, I mean the least aggressive person you've ever met, but a more intense process of reaching out to payers, understanding coverage, and looking at our key payer mix as well. It'll be important. Where do we go first?
Yes, thank you. Okay, next one. Your organic growth in the second quarter was below the levels we've seen in previous years. How do you view the slowdown, and what is your take on why the core business might not be growing at the same pace organically as it used to?
I think that's a good question. Please take a look below the set numbers to the actual UK and U.S. currency numbers. The growth was okay, not as strong as, let's say, 2023, 2024. I think it's also important our end is getting bigger. Yes, we might not be growing at 40%, but when you're turning over £5 million as opposed to £20 million, it's a different scenario. We also have been less aggressive in installations of our scalp cooling equipment and tried to focus on utilization. I'm not concerned. I think this year we're seeing a year of building on where we've been and building on what the future looks like. I'm very confident that we've got a long runway of growth ahead of us without question.
Time flies when you're having fun. Maybe if we can wrap this session up and if you could tell us what you're looking forward to in the coming 12 months, what is going to happen to Paxman? What do you want to happen?
Okay, so we'll have a full integration by the end of the year, and that will make us look a very different business with both companies. We'll that start , to have that scale, which will be exciting. Coming into the new year, not January 1, I might add, but coming to the new year, seeing the benefit of those CPT codes and seeing our customers becoming more readily switched than they have been over this last, probably I'd say 12 months. It's been a bit sluggish. When that starts to happen, I think we'll really start to see that improve utilization. I think the number one exciting piece in the next 12 months is the launch of the CIPN device. That will transform the business again, so that real step up. I think we can be aggressive with that approach based on the money we raised earlier this year.
A lot going on, but a really exciting 12 months ahead.
Yes, indeed. We look very much forward to following your progress on all of the above-mentioned projects and plans. Thanks a lot, Richard, for joining us, and thanks for walking us through the report.
My pleasure. Great to see you.
Thank you all for watching.