Hello everybody, thank you for joining the StageZero fourth quarter and year-end 2022 earnings conference call. Joining me today is StageZero Chairman and CEO, James Howard-Tripp. Please note that management's discussion today will contain forward-looking statements about anticipated results and future prospects. Forward-looking statements involve a number of risks and uncertainties. StageZero's results may differ materially from those discussed today. Investors should consult the company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The company disclaims any obligation to update these forward-looking statements except as required by law. With that, I would like to turn the call over to James Howard-Tripp, StageZero's Chief Executive Officer. James, please go ahead. Thank you, Rebecca, and hello everyone, and thank you for joining us for this call. It's at the end of a what has truly been a tumultuous three-year period. If we think about where we were in 2019, when we were getting ready to actually introduce or fully introduce Aristotle to with the advent of COVID, the immediate pivot that we had to do to the PCR testing for COVID, that took us through the better part of two years as we came out of that, and life was just beginning to return to normal. We had Russia invade Ukraine, and we had all of the impact on the global economies. It's been a very interesting process. We go from being a cancer company to being a COVID company, to going back to doing what you set out to do, which is a cancer company. Along the way, we were able to do a number of things. We had built the telehealth system, which we believed was important. It turned out to be absolutely critical to what we did, particularly as we went into COVID, but critical with what we do now as well. In addition to that, the discussion we had had with employers, led us to look for a very strong partner in the clinical area, that led us to the acquisition of the Care Oncology franchise. What we were able to do during the period of COVID was actually begin to prepare for it, to integrate it. As we began to reemerge back into the real-world post-COVID, we were able to reengage with all of the employers we've been talking with, the healthcare systems, the labs, the benefit managers, just all of that group, and began to be able to deploy that full suite of programs. It's that I will actually talk to. If you look at the current cancer crisis, I mean, we invariably talk about it as an absolute tsunami. We all know what happened to cancer screening during COVID. It went down to essentially single digits. As we came back, everyone had to get back into the swing of things. Of course, we'd slowed to get going again. We were also missing all of those intervening years of screening. We've seen a lot of very late-stage cancers coming forward, and everyone is trying to get back to finding it early. I sat with a group on the Toronto side a little while ago, and they told me that, for example, about 80% of their resources are focused on trying to get about a 3% improvement in patients. They're all looking for ways to get this to be better. That really plays in a number of areas. One, find it early. We'll talk about that a good lot in a moment. The next thing is you need to have the right interventions. You need to be able to triage patients. You need to sort them out. You need to be able to have treatment measures for them. That we'll talk about the METRICS study and where we go with that. Then you need to have the whole prevention aspect, notably the risk factor modification. Then you've got to be able to do it all via telehealth. You need oncologist supervision through all of this. You need to do it on both sides of the border here in North America. These things take time, one, to build, two, to cap, three, to fund, and then to make sure that you can deploy them. For us right now, it's very much an issue of deploying what we have and purely execution. We're actually in a very nice place. If you look at, excuse me. I will apologize. I'm just coming off of COVID, and the residual cough won't go. I think the number one catastrophic health claim for self-funded healthcare plans. That is huge. That's over 100 million Americans. It's about 100 million employed Americans. That's seven Americans in total. The overall national economic burden is a staggering $150.8 billion. That's where you need to go. What do we do? As we'll show you in a case study later on, we very significantly reduce cost. That's what it's about. Why is early better? We've shown these slides before. You change your five-year survival rate hugely. You very often turn it on its head. We use the colorectal cancer we often talk to, where you go from about a 90% five-year survival if you find it early to about a 10%-14% survival if you find it late. More than 2/3 of colorectal cancers are found late. Therefore, it illustrates why we have to find it early. This rule is the same for essentially all cancers. The cost savings, too, is just huge. There's essentially a 2x-4x increase in cost for treating late-stage cancer. The only way that you get to do it, never mind the survival aspect, which is critical, the only way that you get to deal with this is you have to find it early. Why can we do this and perhaps some other groups can't? Well, the first is Aristotle, and we'll talk a little more about that in a moment. Aristotle, single blood test, multiple cancer. Very particularly, it can find early cancers as well as it can find late-stage cancer. Secondly, we have built out the program of work in perhaps ways that we weren't initially looking at. We built it out into the employer program, we built it out into the treat program, which we use elements of that. I'll explain that as we go along. Without having these three pieces together, it's actually difficult to deliver the kind of programs that employers actually want. Aristotle, the work off of, essentially almost 20 years' worth of work on our side started with Eli Lilly and Pfizer, moved out into development of ColonSentry from there into the first mRNA gene expression test that actually will indicate your likelihood of having that particular cancer, your probability of having that particular cancer. We have high sensitivity and specificity. We'll typically go for 99% specificity, so that it's about as accurate as it possibly can be. The sensitivities are very high as well. I think it's fair comment to say that in general, we're better than the standard tests that are out there, like significantly better than the standard tests that are out there. We do all of this off of a single sample of blood. Aristotle, cancer today, yes or no. The next piece with this is, well, what about the probability of developing cancer tomorrow? It ties together in two ways. One is a series of attendant risk factors, but in actual fact, we've been able to move that across into the treat program as well, because it gives us a series of biomarkers against which we can measure the protocol or the utility of the protocol that we're administering, and we can begin to affect risk factor modification. This is the other piece that employers have asked us for. As you bring the program forward, it's a matter of how you implement it, but can you do it all the way through? What they're not after is simply a yes/no answer on the fact that you may have cancer. They're looking for much more than that. This is what a work does. The way we do it is that the biomarker testing will essentially flag across a whole series of areas, one of which is cancer. Bearing in mind that metabolic syndrome is a risk factor into all of this. It ties into insulin resistance. There's some very interesting new data on how various cells, both immune cells as well as cancer cells, take up energy and how they use it. In actual fact, very often when you start treatment, you get an increase in insulin resistance. Increase in insulin resistance makes it more difficult for the cells to actually take up the energy that they need. If the immune cells are the more critical piece in that, in fact, normalizing insulin resistance could increase the efficacy of the immune system, and so you actually get a very positive response. Again, I'll take you back to some of the results that we've got out of the METRICS study. All of these tie together. When you're an employer, and we're sitting with you and the employees, we will look across this whole series of factors and look at each factor, and we can give you strategies by which you could work with our docs in order to ameliorate the risk. That is critical. This is something that is of great interest for the insurance companies as well, reinsurance as well, we're in discussion with them. Final piece in all of this is that our process is really our difference. It really is an ability to come forward and to say, "Right, we can work with you all the way through this." We'll talk in a moment about the Ontario Fire Fighters. This has been absolutely critical. At the same time that we've been working with the OHSA to with the Health and Safety Committee to begin to get the testing underway, we've had to build the entire system behind this to ensure that the firefighters can not only get tested, but the fact that if they get positive findings, they can actually get triaged and then get the right kind of handle into the healthcare system. This is critical, as is telehealth. All of the time, our process is truly a big part of our difference. If we look at the market opportunities and the value proposition, you know, people would say, "Why should I be interested in this company? Why should I buy the stock?" We would tell you it's for the reasons that we're going to go through in the next series of slides. One, look at the size of the self-funded employer market. We've long said that this is an absolute key area for us, 64% of the employed workers in, excuse me, the U.S. are covered under self-insured or self-funded arrangements. That equates to what I was talking about earlier. That's approximately 100 million Americans. If we talk about the U.S. alone, remember the US is our primary market. It's about 157 million people in total. If you look at the companies and the way they group from a self-insured, in 2020, nearly 75% of the self-insured companies had 500 employees or more. The opportunity is really large. The case study that we've shown, and we use breast cancer, but of course, it applies to all of the cancers which we've run it through, shows as we ran all the way down the model, that the cost avoidance is approximately 58%. This holds by and large for the great majority of the cancers that we would look at. I think a question that we've been asked before is, does this include the cost of the testing into it? Well, when you take the cost of testing and you divide it by the number of cancers we look at run through, the cost is negligible. It comes down to less than $100 per per particular cancer through driving through. The cost is negligible in that sense. Again, key cost savings, if you find it early, cost savings, if you screen, you find it early and you treat it early. The second case study, as we looked at with the firefighters, and this for us has been particularly important. It's not only the very large, 86% of all claims for firefighter work-related deaths is from cancer. I say that again, 86%. Just think about that. It has to be dealt with. You look at the large number of firefighters, and this is Ontario alone. There's 30,000 in total, 11,000 are full-time, 19,000 are volunteers. This is a program that they want to apply to all of them. Part of what we were asked to do was not only help them establish a program and bear in mind that they were working this through all the ranks at all different levels, but to help them identify and answer a whole series of questions. Who's most at risk? Is it age? Is it duration of service? Is it a combination of both? Is it exposure to certain kinds of fires? Is it one area of Toronto versus another? Is it Toronto versus rural areas? Where do you get your greatest risk? Can we measure this? Can we track it? We've taken time to work with them to actually present in front of the various municipalities to make sure that we get it into the budget process. Why? Because we didn't want it to be simply a one-off deal that's done once a year. We wanted this to be ongoing multi-year, year after year. It needs to be part and parcel of the process. That's the key thing. We can tell you that in actual fact, we begin the formal testing process next month being April. We're off and we're moving. How are we going to deploy it? It'll be Aristotle, the cancer today. It'll be your AVRT metabolic pathway panel. Are you developing cancer tomorrow? Depending upon the results that we get out of that, will dictate how you go through the triage. Bear in mind, the triage on our side is supervised by oncologists. We've also built out the full support system. For example, if someone in the GTA is diagnosed, with a positive result, can we hand off it to the right groups, all the way through to the hospital system to ensure that they get worked up completely, to ensure that if they're positive, they get treatment completely, that they get followed through. We've built that system. That is now in place. Together with this, we'll be doing a health economics analysis. Obviously, you know, people are interested in how it contrasts. It's the data that is almost as critical as we build it through. As we said, it's city funding, its multi-year, and we're starting now. Worth looking at, the KPIs, that we established for 2022 as we were coming out of COVID. We'll talk about 2023 and where we're going. The key thing with 2022 is the integration of Care Oncology, both in the U.K. and the U.S., and then the redesign of a lot of the programs so that they're fully integrated with what StageZero brings forward. As we move through 2022, what we did was we saw COVID essentially come down to pretty close to zero in the first quarter. We then moved directly into cancer testing again as we built it out. Bear in mind that it isn't an immediate turn-on. There isn't an immediate switch, and everyone goes, "Right, we're ready to go." The first thing is that organizations had to get back to being normal. They had to decide that they were in actual fact surviving, and they could begin to focus back on employees. As they started with all of that, we needed to make presentations to them. We needed to bring it into their budget process as it goes. You're not doing just individual tests or for one employee. You're doing many tests with many employees. It has to fall into the formal budget process. To a large extent, a lot of that has now been going forward, and there's been good progress. We engaged very strongly with the Ontario Fire Fighters, as we talked about. We presented at their conferences. We developed the proposals to take to management in cities. We've sat with the management groups in front of the cities as we've taken it through. We are, as we mentioned, the approvals are starting to come through, and we're getting ready to move right now. We begin with those groups, as I mentioned, this April. We integrated the full AVRT process into it. Of course, into the latter part of last year, we initiated testing in the U.S. first responders in general. That process continues. At the end of, you know, part of all of this is we had to move very quickly. We had to make sure that our house was as lean and mean as it could be, that we were at all times prepared to drive it through. In the latter part of 2022, we had to look at how the Care Oncology groups were operating. We had acquired groups that had more staffing, had larger infrastructure that was necessary. In addition to that, some of the IT, for example, had to be rebuilt. We undertook all of those aspects as we rolled it forward. By the end of 2022 in the U.K., we essentially had the unit at breakeven. In the first quarter of this year, we actually have the unit above breakeven, and we anticipate full profitability by the second half of 2023. I think it's worth talking to the revenue as we drive it, and particularly as we bring the new program. If patients stay with us within the Care Oncology side, typically for 12+ months. The average revenue per patient in pounds is essentially about 1,100 GBP. What we're doing with the new enhanced protocol, and the new enhanced protocol includes biomarkers, it includes tailoring that is on an ongoing basis. Perhaps I can explain that this way. We initiated treatment with one particular patient with the protocol as it was. As he became aware of the new protocols we were bringing forward, he asked to upgrade to the new program, went into the biomarker testing, we, for example, found that a series of these biomarkers were significantly out of line. It is not something we would have seen before, but he said it again, he would have seen before. What we did was immediately bring him back in. We adjusted the protocol as we worked with him. In actual fact, he was delighted because he took better results out of all of this. It becomes a very fact-driven and very goal-driven, results-driven program as we take it through. Of course, it allows us to produce the type of results that we believe we saw out of the METRICS study. That's where we go. As we move with this, obviously it's incremental pricing. The incremental pricing, we believe, will have a fairly marked effect. It markedly moves our gross margins up. We're also planning for an E.U. launch in 2023. We will look for expansion there. We will start with individual countries and then expand out. Turning to Care Oncology in the U.S., we did fairly similar. We reorganized into the back end of 2022 to where we actually have a much more efficient organization. The same IT issues remain, the same programming issues as we work through them. Right now, having reorganized, we're approaching breakeven, and we expect full anticipation... Sorry, full profitability in the second half of 2023. Key is we have launched the expanded Care Oncology Protocol. Again, patients stay with us for an average of about 12+ months, and revenue under the existing program has been essentially just under $2,000. With the enhanced program, particularly as it builds out with the lab tests that everything goes with that pricing essentially doubles. It's critical. It gets more physician time. It gets more nursing time. It will now give mental health support. It will give better pharmacy support. In addition to that, we have the ability, as we talked about, to set very specific goals for the biomarker and then to track the patients against it. It's been accepted very well by patients, and it's exactly what people are after. It makes a very significant difference to what we do from a revenue perspective. Canada, too, is a very significant market. Canada typically has fewer options for patients. We're actually just beginning on the Canadian side as we're expanding out, working with groups that are putting in place on the Canadian side. That literally is kicking off as we speak. Very positive across all of this. If you look at it, you know, let's say for every 1,000 patients that we would have within our system, and we have several thousand patients in, if we converted all of them or for the current pricing as we've looked at it, every 1,000 patients is essentially worth about $3 million in revenue to us. If we have 1,000, it's $3. If we have 2,000, it's six. If we have 3,000, it's nine. You can build the models from there. It's worth talking about the METRICS studies. It's one of those events that I think you really stop and look at. You know, glioblastoma, the work was initially done in glioblastoma stage four patients. Why? Because outcomes are typically very poor and treatment options are very limited. Therefore, the course of the disease is relatively short. What the group did was add the COC Protocol as adjunctive to standard of care treatment. Remember, standard of care is generally surgery first, radiation second, and then chemo third. What they saw within an 18-month period was a doubling of overall survival. It went from about 14.8 months to 27.1 months. We looked at your two-year survival in percentages, and it was 64% versus 28%. It's a relatively small study that's gonna be followed up with METRICS II, but we're very hopeful that we will continue to show the same results as we build it out. We will be doing it in the UK as well as in North America. We're already talking to the Toronto groups that will be involved. We're actually very excited about this. Bear in mind that we deal with all cancers. This may be an example of gastro only, but we deal with all cancers. This too is very important not only to cancer patients, but obviously as you talk to employers as well. They're after what we can do, and particularly as you pull it forward, so it continues to build it up. The employer cancer screening program we've talked to is front and center for us. Absolutely critical piece of how we have built our organization and where we expect to go. Short recap, we're talking about 64% of U.S. employees. U.S., our major market. That's about 100 million employed individuals. It's about 157 million Americans in total. Cancer is the number one driver of cost in claims for catastrophic health care, bearing in mind the companies carry that, but they actually share it with the reinsurance groups. Munich Re, SCOR, the groups like that as they work with, so it has equal relevance to them. The economic burden overall is a staggering $150.8 billion. Therefore, you want to intervene as early as possible. The other piece, as we talked to, is that approximately 75% of these self-funded plans have 500 or more employees, and this is as of 2020. We've started with the first responders. We talked about that. We're well down the budget process, some of it kicking in now, some of it will kick in during the year. I think it's really important that we come to the fact that you don't turn these programs on, and everyone lines up at the door on day one. What you do is you turn the programs on, and then people feed in across the year as it goes. So, we're looking for incremental utilization as we build on out, but we're also looking for a group to start today and then probably not finish for two-three months. It will feed in all the way through this. It takes time to get it going, but once it moves, it moves pretty quickly. Just to recap again, the Ontario Fire Fighters, 30,000 in total, 11,000 full-time, 19,000 part-time, and we go to the cities for multi-year funding so that we can continue to build it all the way through. We also build the data for them, all of this drives too. We will be at some of the conferences this year. The first one, in fact, is in May, and they've asked us to have a booth and to actually draw blood at the booth. We will begin to do those things as we move through. It's a really nice way to think about doing it. Benefit providers are key for us. Benefit providers work with the employers. They take innovative plans to them. They are focused on giving them plans that reduce or maintain their costs. They're obviously interested in giving the best benefits that they possibly can for employers and employees, but they need to maintain cost. If it is at all possible, reduce cost. Remember that if you can show a 2% cost reduction to an employer, you typically get their interest. When you're delivering the kind of cost reductions we talk about, you absolutely get their interest. Benefit advice is a huge part of what we do. In addition to that, in just in terms of straight Aristotle tests, we built a network of labs across across the U.S. We're in discussion with much larger lab groups as well, looking at how they can independently offer Aristotle. From there, we're talking to healthcare groups as well. We're looking for that to come on stream as we move out during the year, whereby we incrementally expand our reach. I think it's worth talking to what the revenue is. If we do a single Aristotle test, we have it priced at $949. If we do just a single Aristotle test, that's essentially what you get from it. If you work with an employer, we're also gonna do the metabolic panel with the consultation that drives through that. That's an additional $795. Just, even just beginning to move in with that, we're at a much, much higher level. What we will do out of that is don't forget that a significant number of the employees are going to test positive for one of the aspects that drive through the Metabolic Pathway Panel. They are likely to take care in the risk mitigation program. Again, something that employers are demanding. As a result of that, they will stay with us. We've said, "Well, what if, what if one quarter of these people do it?" You see what it does is it takes the revenue from a straight Aristotle of $949 to more likely $1,600-$2,400. There is a very sound economic rationale from our perspective for doing this other than just giving employers. In summary, I think as we've talked about, cancer is the number one catastrophic cost for self-funded healthcare plans. Early cancer detection is critical, absolutely critical. It markedly reduces costs. It markedly improves employee five-year survival rate. 40% of cancers are avoidable. You've got to have the risk modification program. That means you've got to be looking for them in the first place. It comes back again to the screening, but the right kind of screening, and you have to flag that. Telehealth, critical. Oncologist or let's say physician oversight, but in our case, metabolic oncologist oversight, which is even better, absolutely critical. Employers need to know that you are going to take care of their employees that test positive. They don't just want a lab result. You're how many workers are employed in the self-care plans. That's over $100 million. We talked about how many employees are in the 500+ group. That's 75% of the, of the self-funded employers, which on the case study, if you look at where we're at, just how significant you can change the costing. We're well above the 2% threshold, which groups typically look for. From there it is really Aristotle's key proverb that the risk factors both can stand on their own, but they're much more powerful when they're used together. We actually look forward to what we believe will be a very good 2023 growth. We're very aware of the fact that we have to execute. We're in a strong position at this point, and as long as we execute and as to ensure that we've got an adequate supply of cash to fund what we're doing, we believe that we can achieve our objective. Rebecca, back to you. Thank you, James. Thank you everyone for joining us on this call. If you have any questions that we have not addressed, please submit them via the form that you have accessed this call. Thank you.
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