Thank you for standing by, and welcome to the ImpediMed Limited half year results call. All participants are in listen-only mode. There will be a presentation followed by a question-and-answer session. If you wish to ask a question, you will need to press the star key, followed by the number one on your telephone keypad. Again, it is star one. I would now like to hand the conference over to Ms. Parmjot Bains, Interim CEO and Managing Director. Please go ahead.
Thank you. Good morning, and thank you for the opportunity for us to present and discuss the first half-year results for ImpediMed with you. As you will have seen, with the release of the financial results for the first half, we also released an investor presentation providing more granular detail about the business and the progress being made. We understand the need for greater transparency regarding key data and believe that this presentation provides this and will be the basis for future presentations. Because this is the first time we have released this presentation in this format, I will take the time to walk through key points on the slides. I will then hand over to McGregor to talk through the financials, and after that, we will open the line for questions.
First, just as an overview, the total revenue for the first half was disappointing and well below our expectations, considering the March twenty twenty-three inclusion on the NCCN survivorship guidelines and increasing payer coverage. However, reimbursement does remain a fundamental driver for provider uptake, and critical mass coverage has gained momentum in the most recent quarter, with 15 states now at critical mass following the recent inclusion of North Dakota and as of this morning, Maryland. Lead time for SaaS revenues is currently six months from lead generation to execution due to the need for customers to synchronize with budget approvals, contracting, and IT security assessments.
The company is actively working through customer opportunities and the sales process to identify areas where we can streamline in order to shorten the time from lead generation to contract execution and revenue, and accelerate revenue generation and breast and other reimbursed lymphedema uses. Reducing cash burn while we increase revenue is a critical focus for management. I commenced as Interim CEO on the eighth of January this year, and McGregor as Interim CFO in March, and we have expressed to the board our desire to move to permanent positions. We are excited to have Christine step into the role of Chair, and McGregor remains on the board as the Executive Director. As previously mentioned, the board is in the process of recruiting for additional directors. Looking at the slides, slide five sets out the investment thesis for ImpediMed.
There is a unique technology platform with extensive clinical trial evidence and definitive clinical guidelines supporting this, which delivers significant clinical benefit to patients. Increasing payer coverage enables acceleration of the breast cancer-related lymphedema device penetration, both within the existing early adopting sites and into new sites of care. The up to AUD 2 billion market opportunity, or TAM, is based on capturing all cancer-related lymphedema. Focus historically has been solely on breast, and we are accelerating the go-to-market model for the reimbursed and FDA-cleared pelvic and melanoma-related cancers. There are multiple future growth opportunities that could be delivered through accelerating partnerships in oncology-related indications. However, right now, our activities are focused on achieving breakeven. These activities include: having a laser-like focus on sales, marketing, medical, and operations teams on high-priority states and IDNs with breast cancer opportunities.
Implementing productivity metrics for our field force to improve lead generation and accelerate sales. Enhancing our customer implementation. We are piloting new pricing models to capture a greater share of that total addressable market and support multiple clinical settings across accounts. We are managing the business with stringent metrics, and we're reducing costs. Slide five sets out our goals and priorities over the next twelve months. These include, one, ensuring every new breast cancer patient in the U.S. accesses early lymphedema prevention through positive sales execution. Number two, delivering a world-class customer experience and rapid implementation. Doing so supports growth in our existing user base and keeps our churn low. Third, we are going to expand and accelerate reach for all cancer patients who are at risk of leg lymphedema.
As I noted, this hasn't been a focus for the last year, but given the uses indeed, a larger market opportunity and existing reimbursement, this is a priority. Underpinning all of this is the need to reach breakeven through acceleration of revenues and management of expenses, and maximizing shareholder value. Finally, we are looking to develop innovative partnerships to accelerate patient impact into existing and new patient populations. This is a lower focus, as my priority of focus is on the four above. However, given time to reimbursement and execution, this needs early and concurrent evaluation. Slide seven just highlights that the foundations of this business are strong and strengthening as payer coverage increases. In many states and accounts, procurement will not proceed without reimbursement, other than in some of our early adopting sites.
There are now fifteen states that have achieved critical mass, which the company has defined as having greater than 80% of the population covered for reimbursement by either Medicare or private payers. We are prioritizing our activities among the eleven top states, which we believe are all likely to achieve critical mass within the next two months, and as well as our IDNs. Our focus is now on execution at the account level. Slide 8, 9, and 10 provide an overview of our unique technology. Our SOZO Digital Health Platform is one device which is effective across multiple indications. There is an increasing wealth of data and publications supporting SOZO. The use of SOZO and lymphedema and heart failure are the two key indications towards reimbursement. Bioimpedance spectroscopy, or BIS. SOZO non-invasively measures, monitors, and manages fluid status and tissue composition.
The L-Dex score, only available from ImpediMed, is designed to detect lymphedema-related fluid changes within the arms. This is trademarked and now within the MASCC guidelines, specifically referenced. Slide eleven is just a reminder of the importance of the PREVENT trial for patient care. As we all know, breast cancer rates in the U.S. population have declined over the last twenty to thirty years due to advancements in early detection and treatment. However, within this increasing population of patients who have been treated for breast cancer, there's an increasing population at risk for treatment-related complications. Breast cancer-related lymphedema is a condition that results from the disruption of the lymphatic system by breast cancer treatment, as one of these complications. While this may initially present as a transient swelling in the ipsilateral arm, breast, or trunk, it can chronically progress to irreversible fibrosis and interstitial hypertrophy.
Breast cancer-related lymphedema further compromises quality of life in breast cancer survivors by associated symptoms of pain, heaviness, disfigurement, and functional impairment, as well as being associated with increased rates of infection and lymphedema-related hospitalizations. I have to emphasize, the PREVENT trial was unique. It provides clinical evidence of significantly lower progression to chronic lymphedema, with early detection using L-Dex and intervention versus the standard of care and tape measure. Slide 12 just highlights the wide guideline support for the SOZO technology. BIS is now included in multiple guidelines. Most recently, as of March last year, the NCCN Survivorship Guidelines, recommending regular screening for lymphedema by symptom assessment, clinical exam, and if available, bioimpedance spectroscopy. Slide 13 just shows how ImpediMed's BIS technology compares with other lymphedema detection methods.
Historically, in clinical practice, many centers continue to use the alternative of objective volumetric assessment, circumferential tape measure, and perimetry. BIS has received favorable assessments within a number of best practice guidelines, including NCCN for survivorship, and is now reimbursed. Slide 14 shows the states that have reached critical mass, which has been achieved since the start of the beginning of this financial year. We had 14 states on here, and as I noted, as of this morning, BCBS, CareFirst in Maryland came on board, so there's now 15 states. It is important to emphasize reimbursement remains critical for uptake. We have potential customers with multi-system requirements who are waiting on reimbursement in their states. As part of our prioritization efforts, we are deeply focused on those top 11 states that are at critical mass and with large patient populations, as well as IDNs.
As announced in November 2023, UnitedHealthcare, the largest private payer in the U.S., updated its policy to state that BIS for lymphedema assessment, CPT code 93702, no longer requires clinical review. The removal of this requirement for clinical review is referred to as silent coverage, and this policy came into effect in January. Medicare in the U.S., along with now forty other payers, currently provide silent coverage for CPT code 93702. In addition, there are fourteen private payers that have published positive medical policy, with North Dakota just publishing and reaching 95% coverage. As mentioned in our second quarter results call, the company estimates approximately 85% of private payers will be providing coverage of CPT code 93702 by the end of the financial year.
On slide fifteen, I've summarized some of my insights since I joined the company seven weeks ago. In that time, I have been to eight states, spent time with our sales, clinical support team, and visited over eighteen customers to gain an understanding of their needs and how this device is being used. You know, my insights are, you know, SOZO is used primarily in the preventative care of breast. However, there is multiple use cases outside of this. There is an opportunity to grow the leg lymphedema indications. Reviewing our data, globally, 14% of our measurements are now on legs, 9% of these in the US. In the US, 80% of customers are measuring legs and plastics, pelvic cancers, melanomas for treatment and prevention. There is a very high customer interest to implement and extend, with strong buy-ins from doctors.
However, as I've noted, reimbursement and matching the clinical flow main critical factors for sites to implement. The lead sites and providers are now extending their device numbers from one to two per site, and then to other specialties as lymphedema prevention programs are established. 21% of our sites have more than three devices, and we need to build on those. There is an opportunity to broaden our product offering through provision of body composition data, which is already available to support broader care and customer retention and growth. As I've noted, our SaaS sales lead times are long, up to six months from lead identification to execution, driven by pricing, budget approval, contracting, and IT assessments. There's also an urgent need for us to build the lead pipeline through marketing and medical education. Slide sixteen reinforces that our immediate focus is on executing BCRL.
As a result of my time in the field, we have prioritized our activities focused on the 11 key states and IDNs. We have segmented and prioritized the customer lists and aligned on actions to accelerate leads and execute on sales. The team has been working very hard. The following activities are completed or underway. We've realigned our key account managers to prior territories to prioritize states. So notably, we've segmented our customer accounts, updated contact lists, focused marketing, medical, and sales activities towards these targeted accounts. We are trialing and implementing a set volume-based pricing and product strategy to increase customer retention and support new customer acquisition, particularly supporting those larger customers in enabling device placement along the clinical flow. Commencing in April, we'll be organizing our sales team into regional pods with cross-functional customer sales, reimbursement, and clinical implementation teams.
We believe that this will support and accelerate the sales and reimbursement process. We're implementing an all-hands-on-deck approach to increasing lymphedema prevention and SOZO awareness across doctors and healthcare providers through sales, clinical program support lead, marketing, and medical affairs, targeted account education. Finally, we're also adding productivity metrics into our teams to support, to measure productivity and ensuring that we are increasing our customer reach. The marketing team has done a lot of work and has done an incredible job. Two examples of the marketing initiatives that are new are new sponsorships to drive awareness on lymphedema and targeting provider decision makers at reimbursement summits with new partnerships. Slide 18 confirms a significant market opportunity for the business. As we know, the market opportunity for all at-risk cancers for lymphedema is significant and estimated to be up to AUD 2 billion.
Previous estimates of the TAM were based on a range of monthly license fees per SOZO and the number of sites they service. We consider a more accurate estimate of the TAM will take into consideration the actual number of procedures conducted and the company's target share of the economic benefit. We will continue to refine our assessment of the overall TAM, but the indications are that for all TAM for all at-risk cancers is up to AUD 2 billion, dependent on coverage, which is the reimbursement amount obtained, procedures, and the share of the overall economic benefit and payment received. The TAM for BCRL is estimated around 35% of the total. As I mentioned earlier, we are trialing new pricing models to capture a greater share of the TAM and support multiple clinical settings across accounts.
Shifting to a patient-based SaaS pricing model is expected to increase our ability to capture opportunities in breast and other cancers. As I noted, the opportunity for leg lymphedema is greater than BCRL due to the volume of surgeries conducted. They're also covered by most payers. Given the size of the opportunities in leg, current use across sites, reimbursement and clinical guidelines, clinical, marketing, and sales plans are now being accelerated. Finally, the last slide, 20 to 24, just highlight the value of SOZO beyond lymphedema. There is an immediate opportunity to add value to clinicians managing oncology patients with our unique SOZO body composition and segmental data. For starters, we can support broader use beyond surgeons into radiation oncology and medical oncology through provision of this data, pending any reimbursement.
This supports an increasing use case for lymphedema by providing this clinician with the opportunity to more holistically manage patient care, as well as lymphedema. We are now working on analyzing existing data on SOZO to determine the opportunity to expand and gain reimbursement in other oncology-related areas. Slide twenty-five highlights the opportunities in oncology-related indications in the U.S., not only by the number of diagnoses, but also the disproportionate size of oncology drug development pipeline. We will evaluate potential partnerships in this space. Finally, from my side, once BCRL and leg lymphedema execution plans are in place and being executed, we will evaluate opportunities beyond lymphedema. This will likely be in partnerships, given the need for speed and for cash management....
I would like to conclude by saying that we remain confident that the adoption of the world-class technology will accelerate as reimbursement continues to expand across all states in the U.S., supported by effective pricing models, clinical education, awareness, and focused execution. I will now hand over to McGregor.
Thank you, Parmjot. As you will have seen, revenue for the half year was AUD 4.8 million, compared with AUD 5.7 million in half one FY 2023, and AUD 5.7 million in half one FY 2023. The reduction was largely due to the foreshadowing end of the clinical trial program conducted by AstraZeneca, which generated revenue of AUD 0.1 million in the current half period, compared with AUD 0.9 million in the previous half, and AUD 1.2 million in half one of FY 2023. As we mentioned in the investor call earlier this month, for this period and going forward, the company will report all revenue associated with each contract as revenue from contracts with customers, recognizing equal monthly installments over the term of each contract.
We consider this approach reflects the contracts being established with customers, and this change had no material impact on the current period results. During the half year, the company sold a total of fifty-seven SOZO units, of which thirty-two units were sold in the US. This compares with seventy-one units in half two FY 2023, of which forty-six units were sold in the US, and sixty-four units in half one FY 2023, of which thirty-two units were sold in the US. The core business total contracted value signed during the half was AUD 4 million, compared with TCV of AUD 7 million signed in half two FY 2023, and AUD 6.2 million signed in half one FY 2023.
The existing contracts in place as at 31 December 2024 are expected to generate core business annual recurring revenue of AUD 10.9 million for the twelve months to December 31 2024. This compares with the ARR at June 30 2023 of AUD 9.3 million, and AUD 8.2 million as at 31 December 2022. Operating expenses for the half year was AUD 17.1 million, compared with AUD 15.6 million in half two FY 2023, and AUD 17.1 million in half one FY 2023. The increase in operating expenses compared with the preceding half was driven by costs associated with the general meeting in December, in September last year, and the departure of the former CEO and CFO.
During the half year, the company had net operating cash flows, cash outflows of AUD 6.8 million, compared with AUD 5.9 million in half two FY 2023, and AUD 12.2 million in half one FY 2023. The increase in operating cash outflows compared with half two FY 2023 was primarily driven by increased costs associated with staff, including recruitment fees and short-term incentives that are paid in the first half. These increases were offset by cash receipts associated with the federal government's R&D credit and the US government's employee retention credit. Cash and cash equivalents at December 31 2023 were AUD 36.9 million, compared with AUD 45.7 million at June 2023, and AUD 26.2 million at December 2022.
As Parmjot mentioned earlier, reducing the cash burn rate while we increase revenue is a key focus for management in the near term. The company has commenced introducing measures to more tightly manage cash flow, establish greater cost discipline in the business, and is targeting a 10- to 15% reduction in annualized operating costs by the end of FY 2024. So with that, I'd now like to open up the call for questions. Thank you.
Thank you. If you wish to ask a question, please press star one on your telephone and wait for your name to be announced. If you wish to cancel your request, please press star two, and if you are on a speakerphone, please pick up your handset to ask your question. We'll pause to organize our roster. Our first question comes from Elyse Shapiro from Canaccord. Elyse, please go ahead.
Thanks for taking the question. Just on your commentary around reaching breakeven, do you have an update on your timing expectations for that?
So the time to reach breakeven, Elyse, is going to be a function of the rate at which we place new units into the market, and of course, the monthly license fees that go with that. Clearly, we are seeking to do that as quickly as possible, as to the precise. And of course, while, and in doing so, seeking to manage our cost base. So, it's hard to put a precise timeframe on it, but you know, we're obviously clearly wanting to drive the top line as quickly as possible.
Got it. And then, just in terms of, you know, how the installed base has been going, I guess, half year to date, you know, have you started to see the benefit of those critical mass dates come through, yet?
... They are that reimbursement from the first financials has just come on really in the last six months. So when the first results were presented at the end of the year, there were no reimbursement data, so they're now coming over. We are starting to see opportunities come through, so just, you know, right now, the lead pipeline or leading opportunities worth around 300. I clearly wanna double that number, so we're aiming, but we are getting pick up in terms of leads. What we're working on now is trying to execute those into recurring sales, given that six-monthly time.
Just around the new kind of PAM updates, looking at a kind of per scan approach, does that imply that you're kind of thinking more of a volume-based approach in the longer run as an option for SOZO versus straight monthly fees?
Yes. We, we'll still be pricing on a monthly fee basis, but looking at setting those contracts up, based on the volume of patients going through our system. So yeah, it's trying to capture the TAM that way.
Got it. Great. Thanks so much.
And our next question is coming from Ruben Bock from Atticus. Ruben, please go ahead.
Yeah, good morning, and thanks for the questions. Just, on the total addressable market, what's the number of cancer diagnoses and the percentage at risk of lymphedema, please?
Just, it's on the slide. For breast cancer, it's 300,000, 311,000 per annum in the U.S. It's actually 90, so technically 300,000. Of those, 86%, on the slide, for breast cancer, are generally at risk of lymphedema, and then of the other types of cancer, about 55%-60% are at risk of lymphedema. It's on slide 18.
And how many diagnoses for the leg?
The non-breast cancer-related, eight hundred and twenty thousand. There'll be surgeries like colorectal, genital, melanomas, or have dissections of the inguinal lymph nodes, urinary cancers.
Okay. Just so I can properly understand, so that's the immediate focus. What does that mean in terms of, you know, market size, I guess, relative to breast and, you know, what we can see or some sales numbers we might be expecting from that leg area?
Yeah, absolutely. So breast is about 30% of the, what we think is the total TAM, or 35%, and so clearly the rest is in that broader leg-related space. What we're working on, and it hasn't been a focus for the last year, is really working on making sure we've got clear clinical guidelines and then a plan of action to address those. As I noted, within the customer base, around 9% of US measurements is already in that leg space. So we're getting organic growth into that area, but we need some focused sales, medical, clinical sales, marketing activities on it.
Okay, thank you.
Okay.
Our next question comes from Miriam Lee. Miriam is a private investor. Please, go ahead.
Oh, okay. Good morning. Now, the churn, is it definite that the 2-3% is per annum, not per month, not per quarter?
That's correct. Miriam, it's a number of units where the contract has not continued as expressed for the year, expressed as a function of the average installed base for that period.
Right. Okay, good. Now, onto the extras that you're going to try to make the package seem more. I'm not saying that very well. It's going to make the package seem more attractive if you can add in things like the protein, calorie, malnutrition, I think. Now, a couple of those things are FDA cleared, but they don't actually have a CPT code, do they? So you can't charge for them. It's just an idea that the institutions might be more interested in having them as extras. Is that the case? And are they interested? When you've approached and talked to the institute, you know, hospitals about it, are they actually interested in all these extras that you can offer?
Yes. No, absolutely. So, Miriam, you're right. As noted, they're not reimbursed, and so therefore, they're really about offering that holistic management of patient care with those body composition, segmental. And looking at our user base, about 80% have access to that. The companies make a decision not to offer that as a routine last year, and so we're just revisiting the offering of that, given the kind of widespread use of customers into that space and into that area. And while we do that, concurrently looking at how we can get reimbursement for those indications, but we need to analyze the data that exists in order to understand what the opportunities are there.
I didn't catch that very well. Maybe my line isn't very good.
Sorry.
Can you hear me?
Yeah, so the sites are interested. About 80% of sites will use that, have body composition, and we'll be looking and using that data.
Right. Oh, great! Okay, and can I have one more? Sometimes if you know, companies that just sell shoes or something can say how the sales are going up till now for the third quarter, you know, which is really nearly the January and February. Are you able to give any updates on sales, or although it's perhaps not very encouraging yet, but did I hear you say that did you mention a figure for the pipeline and I just didn't catch it?
Yeah, no, I said right now the team is working on around three hundred opportunities and leads. They do take time to execute. So, you know, and it does take time to pick up. And so we remain positive and encouraged, but with the need to focus and accelerate our sales lead time.
Well, that will be very positive if it's starting to show benefit in six months. That would be a huge increase.
Yeah, it'll take time.
Can I ask about what role is Dr. Chen playing in the promotion?
Absolutely. You know, so Dr. Chen is our medical affairs lead. So medical affairs drives medical education, and our clinical support activities. So really around targeted education to doctors, KOLs, to really drive awareness and uptake. Promotion-related activities, though, with the sales and marketing teams.
Right. So does he go to conferences? I mean, what does it-
Yes.
He-
No, absolutely. They go to conferences. We've got plans where we are hosting webinars and dinners with doctors just to drive awareness within our critical priority state. So number of forums in which Dr. Chen and the medical affairs team goes out and drives education. We also use some of our advisors, so Walt Taylor and other doctors, to also help support us on our medical education programs.
Right. And does he retain his private practice as well? Are you allowed to say that?
Yes, I think he does do a minor amount of work on the weekend.
Our next question comes from Bryce Hamilton, from Hamilton Family Trust. Bryce, please go ahead.
Yeah, I've got two questions. So the first one is, there was a tangential reference in the last phone conference about competition. So I guess the question is: Do we see any viable competition starting to weave its way through, or how are we managing that risk?
Yeah, absolutely. So on the slide, we've kind of listed out the competitive platforms that this is slide thirteen. The one that's probably most they're trying to act to compete against us is InBody. So it's a Korean company that's got a BIA, which is a slightly different technology we have, but so they're only one frequency, whereas we're 256 frequencies . They are trying to compete in that space, but don't have the reimbursement on CPT code. So you know, but they are a competitor, and we do kind of actively work to manage them and their messaging into the marketplace.
Okay. And second question was just tying into the interest around sales. So obviously, you're highlighting the six months lead time, which is perfectly understandable. I guess the question is: Are there any significant opportunities coming through from previous works? I note that there was a previous multiple facility deal that was signed, but is there any potential coming through in the shorter term that don't sort of have a six-month lead time starting now?
Oh, no, absolutely. Look, the team has been working very, very hard, so, you know, they have worked, and the sales force team has worked very hard, the marketing team. So everybody's been working very, very hard on driving opportunities. So we, you know, and we do track them on an almost daily basis, and trying to help support the team to execute those. I think the ramp-up will take a little bit of time, just as we really try to focus and help execute on those. But there are opportunities in the pipeline, they'll come up.
Okay. All right. Thank you. That's all I've got.
Now we have a question from Peter Gregory, who is a private investor. Peter, please go ahead.
Good morning, and thanks for taking my questions. First of all, Tamra, I'd like to congratulate you on the content of the presentation you've just shared with us. The very clear understanding that you appear to have very quickly got of the business, and also the fact that you are taking absolute direct control over the whole go-to-market process. I think that's a very positive step forward. I'd like to comment on the utilization question, and I note that you've not mentioned in terms of establishing utilization the actual nurse-to-patient relationship contact. Because I would believe that this is a fairly critical decision point where the nurse makes a decision as to whether to actually test or not.
I'd further comment that if the people at that coalface position are not absolutely committed and passionate about SOZO, and that they see it can give the people they care about a wonderful post-surgery life, they're likely to perhaps negatively impact on the expansion of use within a facility. And I would expect that these people are part of a community of that come from like facilities around the area and perhaps even nationally. And as a consequence, if they are not very positively engaged, will not be proactive in helping the success of SOZO broadly. I'd like to just get your sense on that.
I'd also like to make a comment on your statement, opportunities to broaden product offering through provision of composition data to support broader care and customer relationship. I'd suggest that those capabilities would give those nurses at the point of patient contact a lot more confidence and a lot more ability to give a much broader care provision to those patients, and that that's an extremely valuable part of the offering in terms of getting these people on board.
Oh, absolutely. And you're 100% right. And to be honest, a lot of the people I met when I visited the customers were not just the doctors, but the nurse practitioners, the lymphedema therapists, the administrators that were doing the measurements. So you're 100% correct. They are absolutely critical on both implementing those once the sale has been made, but also on managing and driving utilization. So we have a CPS team that works very closely there with that group of healthcare providers just to help drive utilization. We check low utilization sites on a weekly basis just to make sure what uptake looks like.
We are extending sessions that have worked successfully for large accounts to across to broader groups, which is just coffee groups or virtual webinar opportunities where they can dial in and talk about the data that they're seeing and help manage their care. You're absolutely right. Utilization is absolutely key because we've got to create a positive experience for them to pick up the additional sites. I kind of referenced earlier. We've got around 21% of sites. We've got three devices or more, which means there's a large number of sites with one device that could actually go up. That's the low-hanging fruit for us as a business, and we've got to make sure they get the best possible experience.
So that's by driving utilization and L-Dex, but you're right, and that's why the body comp data is really important, because they can look more holistically at that patient's care, and have a broader conversation.
Yeah. That's fantastic, Parmjot. I'm really happy to hear that. I have two more quick questions. One is, can you tell me how many of the sales through regional are associated with the Jane McGrath Foundation?
Oh, no, I don't actually know that, but I'm meeting regional this afternoon, so I can find that out.
Okay.
I talked to them yesterday, but I'm gonna go do it in person.
Okay. That's great. My follow-on question to that would, how can that be leveraged?
Yeah.
Um.
Yeah. I'll ask them that. Good question.
Okay. I'd also like to ask about, I think you've recently lost two salespeople.
Yes.
Can you talk me through the lead time in getting a rep up to being 100% effective and productive?
Yeah. So what we... It does take time, so it's probably a good three-month process. But what we've done is where we're losing teams, we're actually bringing the opportunity to bring the CPS across. So we've actually got existing staff that can rapidly get up to speed. And then, as we realign our territories, focusing on those top eleven states means that we've got, you know, experienced reps really managing those priorities and those opportunities. But you're right, we've got to keep our reps, and top focus and really support them to help them execute on the sale.
Okay, that's it from me, Parmjot. Thanks very much.
Thank you.
Let me remind you, if you would still like to ask a question, to enter the queue, press star one. And our next question is coming from Grant Percy, from Yallingup Equities. Grant, please proceed.
Thank you. Thank you for the excellent presentation. Would you be able to just talk us through, if McGregor will still be involved with the organization going forward? I understand that, I suppose we're paying them quite a bit in consulting fees to help us with the pre-NCC guidelines, but now we've got post, will they still be involved with ImpediMed going forward?
Sorry, so Grant, I just... I missed the start of that question. Who are you referencing?
McGregor. So that would be, Chelsea's team that helps with all the,
Oh, the reimbursement team?
Yeah, correct.
Yeah. Yep, yep, yep. No, no, reimbursement remains critical. So we've only got, you know, fifteen states. We've got to get all our major providers across the board, and across the line. So that remains critical. What we will do is look at shifting out-of-pocket assistance program support, where we don't need that anymore from a local reimbursement support to having that reimbursement team work on the critical accounts at the account level. So we've got some states where, you know, even 85%, you still need a reimbursement support to go in at the account level and look at this very specific payer mix, and help them understand their return on investment for the device as they put this into place.
So we're going to refocus the way that that team looks in the next couple of months as we, you know, get our reinvestment up.
Okay, great. And I suppose following along with Peter's question, is there anyone actually writing up testing programs for, I suppose, each patient, or is it really that random? And are any, I suppose, existing user bases running either the IPD LPV plan, or are they running their own plans?
There is a number of protocols and guidelines that are out there for clinicians to use. We have the PREVENT trial, which has the recommendation of 11 tests to be done over three years. The American Society of Breast Cancer Surgeons has their guidelines, which actually has 13 tests to be done, and then the L-Dex clinical practice guidelines, which are written by Shah, has got 17 tests over five years. They really vary by the account, but we give them the guidelines around the L-Dex clinical practice guidelines. There are very, very clear guidelines that we help support the teams to go out, and the clinicians to go out and implement. And that is provided as part of the implementation program.
Okay, thank you. So are they actually running full programs at the moment?
Yes, there's a number of systems that have been on for over a year now with very, very successful lymphedema programs. And we're really looking to emphasize those as we bring new payers on, because in effect, it's you know, successful implementation of LPP. There's also a very successful implementation of a new service line for these providers in the U.S., which also generates revenue. So absolutely. We're absolutely-
Okay, that's excellent. Okay, that's all my questions. Thank you very much.
Okay.
We now have a question from Ian Hyde, who is a private investor. Ian, please go ahead.
Good morning, Parmjot. And you're gonna have to excuse me, I've got COVID at the moment, so I sound-
Oh, yeah.
Fuzzy, that's assumed. Just quickly, SOZO Pro, update on that, please.
Yep. So hi, Ian. Hope you're getting well. SOZO Pro is still in the process of development, so we are just working on the development and launch plan for that one. Right now, you know, it's important to come out, but right now the focus is just rolling out the current SOZO within the U.S. opportunity.
So, okay. So, more news later this year?
Yeah. Yeah. Yep. We'll update on that.
Yep. There's a little, I guess, debate out in the world with the MASCC guidelines that came out. Can you provide some clarity around what impact that will have in what areas for the company?
Absolutely. So the MASCC guidelines are interesting because it's, A, it's in a world-leading journal, you know, The Lancet, which, you know, it's probably a little bit more ex-US, with BMJ probably being a key one, but it still is one of the world's leading journals. It's interesting because it specifically references this, and it specifically references L-Dex and its guidelines. We know there's dialogue and it is set for an international audience, with less access to resources in the US. So the kind of minimum testing is a lot less, five to seven, versus what we are recommending and what the American Society of Breast Cancer Surgeons recommend in the US, which is 13 tests. It's something that is useful for us as we try to expand on this international market and see what the opportunities are.
But it is a piece of work that we are leveraging in the U.S. just because the strength of The Lancet.
Sure. If I remember, part of the MASCC guidelines stating that what they said was then subject to further investigation, so their guidelines could be updated potentially at any time or after further studies or something?
Yeah. Yes. yeah, and I don't think there's a timeline on that guidance, but I think all guidelines do continue to develop and evolve as they go forward. But we haven't heard of a timeline or an update on that.
Cool. Okay, well, thank you. NCCN, we've got twenty-two of thirty-three bodies using it. Have you been able to identify what's the holding point for the other remaining hospitals?
No, we are working through those as a priority, so the NCCN, the large IDNs, and across the accounts and just line by line. And that's where Medical Affairs, Steven, has been important, just to reach out and start to make sure we've got those relationships with the centers that aren't using it, to really try to understand what the barriers are and how we convince them to come on board. So absolutely focusing on really building the relationships into those centers and understanding what they're not bringing it on.
Okay.
It may be reimbursement. I mean, reimbursement has, as I go out and have this narrative, I would decide does remain key, but, not on an account-by-account basis yet.
Okay. So it's more watch this space. Okay, so have you been able to identify, as yet, with the six-month timeline to get a contract over, the finish line, standard issues which could help to reduce that at all, or it's really a case-by-case situation, or?
No, there's sort of standard ones. One is, which is why we're having a look at the pricing model. Right now, going through an OpEx and a CapEx approval process, you know, device sale plus monthly fee, takes you through two different budgeting approval processes. So part of the new pricing work is we're piloting not just a volume-based, you know, kind of tier pricing model, also on a monthly basis, but to try to standardize the offering. So we're just going for, rolling the, you know, trying to streamline, so just going through an OpEx approval. IT assessments take us a while, and so what we've just done is, you know, put a single point of contact within ImpediMed that really is kind of owning and managing across the whole IT, privacy, security, screening, process.
So those are probably the two biggest bottlenecks that we're seeing at the moment, across this, just to try to accelerate the approval.
... so is there a, I guess, from a layman's point of view, common sense with some of these issues? Have you found that there's any difference between the size of the hospital or clinic, as in a smaller hospital or clinic potentially could be more nimble around some of these areas, or that's, you haven't seen that at all?
Yeah, they both probably take. They both need the budgeting and the IT privacy and the contracting. Maybe in some cases, that's, you know, the low-hanging fruit, you know, probably the smaller sites where we can. The opportunity is there, given the time and investment needed, is to try to get the existing sites to go up because they've already got the IT assessments done, and they've already got a standard contract. So they're the kind of low-hanging fruit that we really need to see if we can drive utilization or more devices around. And then for the new sites, definitely try and go after a bit of scale, larger sites, but just because the time and the work needed is very similar across size.
Sure. Thank you, folks. With the LPP, with everything that you've been finding out, have there been tweaks around your structure or what's provided with that at all to users and/or new customers?
There is not, probably not structure, but just more content, so a lot more support, and in fact, this morning on the sales call, you know, we've just teams created to a better and clearer implementation deck, that you know, sales team will use at the outset. Just really trying to tweak that sales process and the understanding of the customer and what they need to have in place as they roll this out, but you know, we are getting a number of sites. When you look at the installed base in the U.S., there are a number of sites now putting either LPP programs in place or even treatment programs, so hopefully that critical mass will grow, and that word of mouth will grow and that use will grow.
Sure. Okay. I had a question, and then I've just gone into a cave of the fog. So what was it? Oh, I can't think. Oh, anyway, so just back to leg lymphedema, is there some sort of a timeline around when that may have some progress and you can actually start executing on that?
We're trying to accelerate it. Right now, we're just looking, trying to build on the users that we've got. So we've got an existing base that's using it. What we're just doing is just developing and tightening up the clinical plan, just understanding if there's an additional data or what information is needed to do that. So we'll come back to you with a timeline because that hasn't been a focus of the business. So it's something that is relatively new, that we have now put into place, the last six weeks to really drive forward.
Sure. Okay. So putting it, thinking about all the things that you've put into place, so with all these new, processes, procedures, customer contact, lead generation, et cetera, et cetera, this has all been done without any new staff. It's just been refocusing and redeploying existing, personnel, i.e., no more costs?
Yes. No, absolutely, and you know, some of it, a lot of it was done. Like, there were things that are already underway and, you know, there's teams already there working very, very hard. We're just trying to refocus a little bit, so there's the existing base that's there, which is focused.
Sure. Okay. And lastly, with... I know it's not a focus right now, but we already have CPT codes for our heart.
Mm-hmm.
The inference is you're looking at doing some pre-get it off the ground studies or understanding. Is that correct?
Yeah. Understanding really at the start, right? What is the clinical data that's needed? Because the company has developed an algorithm, HF-Dex, which was, you know, has got the 51% cut off. You know, what we've got to do is just understand from doctors what the base of the data that's there, and then what else is needed, and what is the best way of addressing that. So we really need a proper business plan before we progress on that. But there is, it would appear, it is, given it is reinvestment, and an algorithm, it's an opportunity that we really do need to understand better fast.
All right. So, more. Watch this space.
Absolutely. Thanks, Dan.
Yeah. All right. Thank you. That's it for me. Bye.
There are no further questions at this time. I'll now hand back to Ms. Bains for closing remarks.
Absolutely. I just wanna thank the investors, you know, for your ongoing support, and just to reassure that we're absolutely driving towards revenues, you know, and breakeven of costs, and really trying to ensure that, you know, patients that need access to this incredible technology have access to it. And so looking forward to connecting on the road show. I think Miguel and I will be on the road for the next couple of weeks, and please reach out anytime you've got questions. Take care.
Thank you.
This concludes the conference today. Thank you for participating. You may now disconnect. Have a good day.