Impedimed (ASX:IPD) Q1 2027 Earnings Call

0:01 Thank you for joining us to discuss the Q1 fiscal 27 results. I'm pleased to be here with McGregor Grant, our CFO, along with our brand new Chief Clinical Innovation Officer, Nicole Stout. We'll be referring to the 4C quarterly activity report, which you just received, and presentation we launched this morning with the ASX. After our remarks, we'll be answering questions. You can lodge any questions through the presentation using the Investor Hub Q&A function. McGregor, I'll begin with slide three with an overview of the agenda for today's call. I'll start with the business overview, including key highlights and take you through an update on each of the three business segments. I'll then hand over to McGregor to present the financials.

0:46 And then I'll finish up with some closing remarks and cover our outlook for this quarter before handing it over to Nicole as an introduction to her background, her insights into the cancer survivorship space, and why she's here. will then open it up for Q&A. So now turning to slide five. I know many of you will have only had a chance to briefly read the 4C Activities Report and you will see my commentary at the end, which I will refer to throughout the webinar and my recap of Q1. We start from a genuinely strong foundation, an FDA cleared, TGA cleared, CE marked digital health platform with a now complete clinical and commercial leadership team that is building the right field team to drive commercial execution.

1:32 We have seen some exciting developments with new standards and clinical applications in cancer survivorship this past quarter along with expanding the clinical evidence and FDA indications in heart health and the extension of our new clinical applications and partnerships in weight management and body composition to support long-term growth. While these new standards and heightened focus on cancer survivorship is great, It's on the commercial and clinical team to execute on these tailwinds. And lastly, number three, what makes this durable is the platform itself. 662 devices in leading U.S. healthcare systems, 27 IDN partnerships representing over 1,400 hospital opportunities.

2:17 And an infrastructure we can leverage across cancer, heart health, and body composition without rebuilding from scratch for each one. Now as we move to slide six. On the financials, McGregor goes through some of these in detail shortly in the presentation, but clearly there were some positives as well as some areas we need to do better. The sales metrics are encouraging, but definitely below where we'd like to see them. Quarter on quarter revenue increased, and we have seen a reduction in operating cash flow consistent with expectations. Regarding sales, overall unit sales was 47 units, up on the prior quarter with 28 units sold in the US compared with 36 in the prior quarter.

3:02 Again, this is not something we as a team are satisfied with. We continue to see growth in our average price attached to contract renewals. Later in the webinar, I will share more on our commercial leadership in sales and the action plan with our field team. On the reimbursement side, while there's been no change during the quarter in the level of reimbursement, National coverage is over 95% representing 331 million covered lives. This level of coverage is sufficient to support new customer acquisition and re-engagement with existing accounts, giving our clinical teams a concrete reason to help our customers increase utilization. Turning to slide seven to discuss lymphedema and cancer survivorship.

3:48 Although sales in the quarter fell short of the company's expectations, There are converging factors both externally and internally that continue to confirm our confidence with the opportunity across cancer survivorship and our lymphedema plus strategy. Most notably, the National Accreditation Program for Breast Centers, otherwise known as the NAPBC, released its 2027 standards, including a new standard 5.8, which requires their 540 accredited centers to implement a lymphedema surveillance program for all breast cancer patients at risk. Our recent FDA clearance for sarcopenia risk assessment opens the door to providers beyond breast surgeons that are monitoring patients during treatment and in long-term recovery, supporting the clinical pathway to execute our lymphedema plus strategy.

4:42 With new clinical and sales leadership in place, we're addressing performance-driven turnover within the sales team and building the right team to execute on this opportunity. Let's take a closer look at the new NAPVC standard in slide eight. So the new 5.8 lymphedema assessment standard is required. This isn't an optional or nice to have or a recommendation. In addition, existing return to wellness and surveillance standards can also be addressed with the implementation of a lymphedema surveillance program. Even if the ability to support opportunities in addressing three standards with one program using SOZO. Looking forward to Nicole talking more about that at the end of the call. This is referenced directly in this standard and is the only method reference that is objective, fits into existing clinical workflow and is reimbursed.

5:33 With a January, 2028 date for compliance, this is the priority target for the commercial opportunities. As we are currently only 25% penetrated Moving to slide 9 and our new sarcopenia risk indication. Our recent FDA clearance for sarcopenia risk assessment adds a clinically relevant output before, during, and after cancer treatment. As low muscle mass is directly linked to worse outcomes in chemotherapy treatment and tolerance, long-term health, and the risk of cancer recurrence. We have already witnessed how this expanded indication is having an impact with opportunities and unlocking access to key stakeholders beyond lymphedema.

6:20 For example, in thinking back to the stakeholder map that I'll discuss a bit later, but showed you all last quarter, our sales team has mentioned that more and more of these NAPB discussions, guideline driven meetings are now including multiple stakeholders across surgery, radiation oncology, medical oncology, nurse navigation, and Cancer Service Line Directors. That is how you advance deals, having all the stakeholders involved in the conversation from the outset versus relying on a single surgeon champion expecting them to drive broad compliance and implementation. Slide 10, McGregor. Now I'll speak to our leadership team, which in my opinion, this slide is as important, if not more important than any slide in this deck. And I've had this tone since the day I took the job and what I focus on.

7:08 We now have a complete commercial leadership team with two key roles added since last quarter. And as you can see, just under half our leadership team has been here less than six months. Gina Kimball in commercial ops is the veteran of that group, having started in June, and Blake Atos started less than four months ago in July. Dr. Nicole Stout joins us as Chief Clinical Innovation Officer, effective November 1st. Nicole is an internationally recognized authority in cancer survivorship and rehabilitation and has built a network of C-suite and program leaders in cancer care and survivorship in her 25 years in this field. Nicole will show more about her background and insights to this segment at the end of the call. Erik Johnson joined the company in August as head of sales, replacing prior sales leadership.

7:59 Erik brings more than 15 years of MedTech sales leadership experience 12 of those years at Hologic where he consistently exceeded sales targets. Erik's first priority has been to assess and rebuild our sales team, and we're excited about the new hires that Erik is working to bring onto the team, as well as some of our more tenured reps that are liking Erik's leadership style and focus. I believe we have the right commercial leadership team in place to capitalize on the cancer survivorship opportunity in front of us. With the convergence of new standards, our clinical offering, and this leadership team, We're well positioned to win. I'll also note that it's been fun for me personally to watch the rest of the leadership team, a group of talented people that I inherited six short months ago, blend extremely well with the newer members as we all share a fierce sense of alignment and accountability to one another.

8:51 We had the full team together in person earlier this month. Nicole Scott was there as well as McGregor and the step change in culture was palpable. That's what wins, and it sets the tone from the top down for how every team and function needs to operate in this organization. Let's go back to slide 11 on the key stakeholder map I just discussed and talked about in last quarter's update. We know this is a complex sale, but this shouldn't scare you. I got news for you. Most sales in US MedTech are complex. The business I most recently was running had numerous customer stakeholders involved in every sale. and the Salesforce members or leaders that couldn't play across those different levels simply didn't last long. For us to be successful, we'll need to effectively move beyond our historical champion, the breast surgeon, to the who and where in the patient is being cared for along their diagnosis, treatment and survivorship journey.

9:49 There can and will be multiple clinical champions driving a system-wide opportunity. The breast surgeon remains an important piece of that map. As I previously mentioned a few pages ago, We have already seen the impact of our new sarcopenial risk assessment indication opening access to medical oncology and survivorship leaders where lymphedema alone doesn't capture the appropriate mind share. With our customer success, sales, and clinical leadership team in place, we're well positioned to quickly understand what these care pathways look like within our customer base and new opportunities. This is what allows us to position SOZO as an enterprise solution and the anchor for longitudinal objective measuring across the patient's treatment and survivorship journey.

10:36 Now to slide 12 to discuss the progress we're making in heart health. While there were no heart failure sales this quarter, our focus remains on building the clinical evidence and customer foundation for scalable adoption. We are working with a prominent large health system with 44 heart failure clinics, actively enrolling patients in two studies. The first using SOZO in heart patients with frailty, and the second using SOZO in comparison with the market-leading implantable pulmonary artery pressure monitoring system. This is coupled with our FDA application to expand our clinical indication across additional cardiovascular conditions. Along with the clinical evidence generation, we're also pursuing collaboration with leading device companies in this space to conduct bench testing alongside active implantable technology. with the goal of broadening our patient population reach for SOZO Pro. We're progressing multiple multi-system opportunities and increasing visibility with participation in two national heart failure conferences in the last four months.

11:41 We remain deliberately paced with our investment in heart health until the segment demonstrates the momentum to warrant investment at scale. The small customer facing team focused on this every day remains excited about the future. Let's turn to slide 13 to discuss weight management and body composition. So we continue to see significant opportunity across our four key body composition segments, primary care, sports medicine and research, wellness and longevity, and medically managed weight loss. Although sales fell short of expectations this quarter, the FDA clearance for sarcopenia risk assessment together with the existing indication to assess body composition in unhealthy patient populations extends the clinical relevance of the SOZO platform with GLP therapies as a common thread across these segments.

12:36 We are excited about our partnership with Dr. Jessica Shepherd. Dr. Shepherd is a recognized leader in longevity medicine and OBGYN by background, chief medical officer for HIMSS-HERS and CEO of Sanctum Med and Wellness in Texas. Dr. Shepherd will be instrumental as a SOZO advocate in the longevity, women's health, and concierge medicine space. Dr. Shepherd is delivering an education session in partnership with Impedimed at the upcoming American College of Lifestyle Medicine conference next week in Orlando, Florida. Having personally worked with Dr. Shepherd in the past, her impact is consistently felt and it's an honor to be working with her again. In addition, we have upcoming presence at obesity medicine and wellness and longevity national conferences. As we're learning across these market segments, we have right-sized our direct body composition sales team, and in parallel, are pursuing partnerships with larger strategic players to drive scale more efficiently and control our direct cost basis. We can now go to slide 15, and McGregor will go through the financials. McGregor, I'll kick it to you.

13:46 Thanks very much, Erik. So this is the cash flow slide, and from this you can see that the total operating cash outflow for the quarter came in at $2.5 million, which was in line with our expectations and down $2.4 million versus the last quarter. The main drivers of the lower operating cash outflow were lower product related costs, which were down $800,000 compared with quarter four, and this was mostly driven by the timing of inventory purchases. And staff costs, which are the largest cost component of the business, and were down $1.2 million compared with Q4. The Q1 net cash outflow reflects the actions implemented to reduce the operating cost base by approximately $5 million on a full year basis.

14:31 The company's cash balance at 30 September was $11.6 million, equating to 4.7 quarters of operating cash flow. On to TCV and ARR. TCV for the quarter was $4.4 million compared with $5.5 million in quarter four. The reduction was driven by a lower volume of contracts that were due for renewal in the period. Believe me, on average, there was an 18% price increase for contracts that were renewed during the period. As previously mentioned, we sold 47 SOZO units in the quarter, of which 28 were in the US and 19 in our rest of world markets. Regarding annual recurring revenue, contracts in place at 30 September 26 are expected to generate ARR of $14.9 million for the 12 months to 30 September 27. In constant currency terms, compared with Q1 FY26 a year ago, ARR was $16.1 million, up 12%.

15:42 As Erik has already discussed, unit sales, you can see the installed base is close to 1300 units with 662 units placed in the US. And patient testing continues to trend upward, 8% on the prior quarter, with a three-year compound growth rate of 17%. So before heading back to Erik, I'd like to add my own reflections. The challenges we've faced have forced us to implement changes that strengthen the business for the long term. We now have a sharper focus, a stronger leadership team, and have significantly improved our cost base. I'm very excited that the work we are doing is building on a platform for sustained growth and long-term value creation. So I'll just pass back to you, Erik.

16:29 All right, thank you, McGregor. Appreciate those thoughts. All right, over to slide 19, some additional thoughts here on the Q2 outlook. So every week that I spend with customers, KOLs, our team, The message is consistent. Cancer survivorship needs an objective clinical anchor. Treatment impacts patients in many ways from lymphedema to muscle loss to changes in body composition and the customers we're talking to are aligned that caregivers and patients need a reliable way to measure and manage all of it. That's exactly what SOZO does. With the new standards that will drive lymphedema surveillance programs within NAPBC accredited sites, we have a unique opportunity to drive SOZO as that objective anchor across survivorship programs.

17:14 Our pipeline remains strong and continues to grow, and it's clearer and cleaner than ever. But we need highly engaged and talented sales reps in every seat to go execute. With the new sales leader, several newer experienced reps now in place, and more in the hiring process, there is a ramp to meaningful countrywide productivity and to the larger system-wide deals this opportunity demands. We're solidifying strategic and KOL partnerships in the weight management and body comp market segments and have validated that we're in the right segments with the right solution. And we're building the clinical evidence, industry collaboration, and regulatory clearance in the heart health segment to support commercial reach and broaden the patient populations the technology addresses.

18:01 Our sales performance this past quarter was not acceptable. Leanne Ralph AAICD and a relentless focus on results. Make no mistake, the urgency inside this company has never been higher and neither has my conviction in this opportunity.

18:48 So thank you to our investors for your continued support and to our employees around the world for their commitment in achieving our shared goals. Before I open the webinar for questions, I'd like to invite Nicole Stout to introduce herself and share her thoughts as to why SOSA should become the standard of care in cancer survivorship. Nicole Stout joining us as Chief Clinical Innovation Officer says a lot about where this company is headed. Nicole is one of the most respected voices in cancer survivorship and rehabilitation in the world, and she brings a unique combination of clinical and business strategy. That matters for our customers, for our team, and for the credibility of what we're building. Over to you, Nicole, and welcome.

19:29 Thanks so much, Erik. Thanks, McGregor. Good day, everyone. I am obviously thrilled to be here. As the new Chief Clinical Innovation Officer, I have almost a 30-year history in this field of breast cancer survivorship, cancer survivorship, and lymphedema. And I've known the Impediment Company and the device since its inception. I've done research. and I've seen the evolution of that technology through the research I've done, the work that I've conducted and I have no doubt that this is the best the technology has ever looked in my mind and that's the reason that I'm here. I see unprecedented opportunity for this technology going far beyond lymphedema, far beyond breast cancer related lymphedema.

20:18 Now I know our intent is expansion in lymphedema Leanne Ralph AAICD Leanne Ralph AAICD Leanne Ralph AAICD Leanne Ralph Now, you can look at all the papers that I've published and, you know, that's fantastic. But at the end of the day, what matters is implementation in our clinical sites. What matters is getting patients measured with this device in an ongoing interval fashion so that we can detect meaningful change early and we can intervene.

21:09 Now, that's been important in the lymphedema world, but it becomes more important now with expanded indications in heart failure, body composition, especially in sarcopenia. McGregor, if you could go to the next slide, please. So what I think about is the patient journey. And Erik showed you that very complex stakeholder map. I don't think of that so much as a complex map. I think of it as an interconnected continuum of care. And along that care continuum, we have multiple points and multiple stakeholders that we now have the capability to engage in a way that we never had opportunity in the past. lymphedema was centralized in the breast surgical clinic necessarily so that was the individual the provider most concerned with the follow-on after axillary dissection and sentinel lymph node biopsies to monitor for lymphedema happened in the breast surgical clinic and now that we've expanded indications in sarcopenia and body composition it makes us relevant more relevant throughout that entire continuum of care Medical oncologists care about what happens to their patient's body composition so that they don't have to dose reduce their chemotherapy.

22:26 Medical oncologists care about what happens to patients on anti-hormonal therapies because over time those individuals lose lean mass. When they lose lean mass, their performance status suffers, their cancer outcomes are poorer. That's the case that we make in breast cancer. We now have the right to be in that space. Longitudinally, SOGO becomes the clinical anchor for a survivorship program. I've been in the survivorship space for decades. And survivorship as a program service line has languished in our capability in implementing service lines. It's been tough to do. The reason, as I reflect on 25 plus years, I think one of the reasons is we have not had a clinical, objective, point of care measure that can help to guide clinical decision-making with the sensitivity and specificity that we have in Zozo now. And that isn't just about lymphedema.

23:26 So when we talk about body composition and we talk about heart health, we're not just talking about the longitudinal pathways that a breast cancer patient follows through medical oncology, radiation oncology, and beyond, as you see here. We're talking about every cancer patient. We're talking about every prostate patient. We're talking about every lung that every colorectal and GI cancer and many many others. So the longitudinal nature of ongoing interval surveillance becomes the anchor for how we conduct survivorship care. It's the first time we've had a clinical objective measure in this space and that is just the beginning because as Eric alluded to heart health sarcopenia assessment in our GLP-1 patient population We have tremendous opportunities to put our device, to put our sales teams, to put our prowess into different rooms, in different clinics, and to have those conversations on a much larger scale within our health systems to get these devices to wherever the patient happens to be moving to within the system. So breast cancer remains our core.

24:37 Proceeding and following the patient along that journey, though, now becomes our challenge and one that I'm sure that we're going to meet through this integral surveillance anchor through a SOGO device. So I'm thrilled to be a part of this because I see unprecedented opportunity for us to grow and to scale. And I'm thrilled to hand it back to Erik, my new boss. And I'm thrilled to be here and to see the questions that you all have. Thank you for your time.

25:06 Absolutely, let's open it up for questions, McGregor.

25:11 Thanks, Erik, and thanks, Nicole. We do have a couple of questions that are in a similar vein here. One is, well, they're both asking around sales for quarter two. How are they looking for the start of the quarter and how is the remainder of this quarter tracking?

25:28 Yeah, I think we got a couple in today. I think it's similar. Now I'm in my third time doing this. First time I was a week in. on the job, and I've kind of seen this pattern of we forecast a bunch, a bunch fall out at the end of the quarter, we miss the number, and then a few of those trickle in early on in the quarter, so kind of similar story. What I haven't liked is kind of an eerie kind of lag or pause or quiet period throughout the middle of the quarter, and that's just, it's not sustainable, and it's not, it shows the lack of The lack of account control and sales process and discipline there and advancing these deals versus, you know, begging for a signature at the end of the quarter to get it through.

26:14 So I would say, going back to my comments, I like the pipeline. I like with the NAPBC how clean things are looking and our messaging and what we're doing. But we're also down, you know, we finished this quarter down four sales reps and through healthy turnover, I would say. and we're in the process of hiring those sales reps and getting them ramped up. So that's where we sit for the start of the quarter.

26:43 Thanks Eric. Another question regarding technology. Is there any other equipment on the market doing similar diagnostics but much cheaper?

26:53 I would only answer that for like pure body comp and again that's why we've learned a lot and kind of figured out where do we play and when versus going to a gym, for example, where they're looking at their capital budgets and they can get something like they don't care as much about FDA clearance and our clinical data and the extreme more accuracy fluid that this shows versus bioimpedance analysis. So companies like InBody and CICA, they're the cheaper alternatives. And there's some of those areas where we just, that's not where I want the team spending time. I call them doing knife fights. against a lesser technology that sells on price and is in more of that segment where it's cash pay. They care more about the bottom line than anything.

27:39 And so that's where we're at. But as far as in cancer, absolutely not.

27:47 Thanks, Erik. A question that I can answer is regarding the number of shares on our register and what is the company and the board considering in relation to that. We're aware of the significant number of shares that the company has issued and while we're not dealing with it right now, we are aware of issues, as I said, and we'll address that at the right time. And then there was a question around, you know, what do we think about the share price and what actions are we taking in relation to that?

28:23 Yeah, I mean, again, we go, I control execution, not the share price. Our job is to deliver results the market can see quarter after quarter. And obviously the share price follows that. And I think the other things we've been talking about on our team, what are things we can do to drive that unmistakable momentum where people that have been sitting on the fence or maybe have been burned in the past by investing in Petamed, whether it's 10 years ago, five years ago, two years ago, whatever it is, What are things that we can show? What are some partnerships we can start building actively? Nicole and I were on a call today just discussing this with some major oncology players. You know, stuff like that is going to drive. We need to drive results, but we need to show that unmistakable momentum that this is the playbook we know how to run. We know how we're going to execute it.

29:09 And some of these deals take a little more time to get done, but that's what we have to control. And the share price follows.

29:18 Great. Well, Erik and Nicole and all, I think that we don't have any other questions that have come in. So, I think I'll hand it back to you, Erik.

29:29 Okay. Thanks for the questions and continued support. As I hope you've seen, I'm very optimistic about the outlook for Impedimed. And as always, look forward to providing an update next quarter and talking to many of you over the next several weeks. I'll be in Australia for the AGM in a few weeks as well. So, Thank you again for running it McGregor. Thanks everyone. Have a great day.