Operator
Good morning, ladies and gentlemen, and welcome to the StageZero Life Sciences' First Quarter Financials Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor to your questions after the presentation.
It is now my pleasure to turn the floor over to your host, Rebecca Greco, Head of Investor Relations. Rebecca, the floor is yours.
Rebecca Greco
Thank you, Tom. Good morning, everyone, and thank you for joining the StageZero Life Sciences' first quarter 2022 earnings conference call.
Joining me today is StageZero Chairman and CEO, James Howard-Tripp; and CFO and COO, Matthew Pietras. Please note the management discussion today will contain forward-looking statements about anticipated results and future prospects.
Forward-looking statements involve a number of risks and uncertainties, and 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.
On today's call, management will refer to non-GAAP adjusted EBITDA. This metric excludes certain items discussed in our press release under the heading, Discussion of Non-GAAP Financial Measures, and any other items that management believes should be excluded when reviewing continuing operations.
The reconciliations of StageZero's non-GAAP measures to the comparable GAAP measure are available in the financial tables of the Q4 2021 financial results press release on StageZero's Web site. With that, I would like to turn the call over to James Howard-Tripp, StageZero's Chairman and Chief Executive Officer.
James, please go ahead.
James Howard-Tripp
Good. Thank you, Rebecca, and good morning, everyone.
Thank you very much for joining us. It's -- I was just going to say it's been a busy quarter.
In fact, it's been a very busy two years. I'm going to start with 2021, and just a recap of, I think, what we were building as we take you through, because I think it spills over very nicely into the quarter, and then sort of where we are now.
So, if you look at what we did in 2021, early time of COVID, we used the COVID testing to dramatically expand our capabilities. I think equally as important with this is we brought in a whole series of very large partners which meant that not only did we get the organization used to working with very large partners, but we got them used to working at a very, very fast pace in terms of all of this.
We, instead of partnering with Care Oncology, and as groups we've talked about that, we actually decided there was much synergy by bolting the two organizations together. And so, we moved to actually acquire Care Oncology, which we did in September of last year.
And, obviously, pull in all of those pieces together has been absolutely critical. We launched Aristotle in the U.S.
and the Greater Toronto Area. And I'm going to come back to that in just a moment.
We launched the AVRT program in the . AVRT, in actual fact, will go even a little earlier than Aristotle would in terms of providing highlights as to where you could look should you be developing cancer.
It ties very importantly to what Aristotle does because, obviously, if you find something on AVRT, begin to then want to have a look in Aristotle. It ties to a series of strategies we're talking to healthcare groups about as well.
We established the onsite clinic in Richmond, Virginia. This was to begin to build out physical presence from a clinic perspective, something that we have now duplicated in a relatively large number of cities across the U.S.
We broadened our strategic relationships, and we talked about this just a little earlier. But if you look at the likes of the people we were able to bring to the , Sobeys, that's just on the Canadian side.
You go to the larger groups, like government, and dealing with it you go to Maricopa County, you go to testing U.S. State Department.
Obviously, there's an interest for us beyond COVID, and this is what we're working with now. We commenced trading on OTCQB.
That was important because it's part of our strategy of trying to get traded properly in the U.S. So, being able to provide that kind of access is important, and it is still in the intention that, some time in the future, when appropriate, to look at a senior board listing in the U.S.
We expanded the management team and the Board, absolutely critical. If you look at who we have around the management table now, particularly building out even to our strategic advisory boards, we've got an absolutely superb group of people, been there before, done it before, know how to do this, all of that really important.
We raised money, absolutely and critical. I think when I go do -- when Matt first joined us, and I've mentioned this before, Matt's comment was, "Good grief, you haven't really done on $25 million in the last five years."
But that's exactly what we had done. And I'd ask you to reflect on that, on literally how much we achieved with literally how little money as we made it through.
But we've built it, and we've grown it. In addition to that, we did reasonable revenue last year, $5 million is -- obviously, we would expect to surpass that this year, but $5 million is a good start.
It was mostly COVID, but towards the latter part of the year we started to transition into the cancer revenue. We've continued that through.
That is really important. And I think the final piece, which is the revenue, $1.5 million in the fourth quarter, I think that's important because it was a mix of COVID and -- sorry, it was a mix of COVID and cancer.
If we move forward to what we've done in the first quarter, we continued that pace. We haven't slowed down in any way.
If anything, we've actually picked up the pace. We fully completed the integration of Care Oncology into StageZero, and we've started scaling the various programs, but all over the world; U.S., Canada, U.K., and Europe.
That's absolutely critical. You've got to acquire an organization, you've got to bring it inside, and you've got to get everything straightened out so that the systems work.
Everything needs to be regulatory and compliant, all of the boring things that go on the background, but they have to be there before you can actually begin to fully scale. With those in place, we've started to scale.
We're also getting to know where we push. And I think we're seeing some of that.
People are obviously excited by what we've done with COC Plus. That's a result of knowing exactly where to push and how to push, and beginning that process.
We launched AVRT in the U.S., critical. We extended the capability of the COC protocol to Europe; critical.
Europe has 780 million people. Being able to access that, having the infrastructure to do that, knowing where to begin first, second, and third, absolutely critical, but all of that to build out.
It's a market that is twice the size of the U.S. We extended the availability in the U.K.
by launching AVRT into the U.K. as well.
We've started to participate in key summits. If you look at the S.E.E.
Summit, we were one of the key groups, together with Jamie and Simon, as they put that together, to decide that we needed to take the entire concept of liquid biopsy, and the fact that people can access, it's developing, it's true, it's real, it works, there's good solid science behind it. And so, we helped take it out.
If you see who was actually at the table as well, it positions us very nicely as one of the leaders in the field, and that has led to a whole series of additional speaking engagements, particularly with large organizations take it out. You can follow some of this if you look at our own social media.
We expanded the marketing programs for Aristotle into multiple new cities in the U.S. And this is important, because speaking with some of our Canadian shareholders, I think there is a belief that Aristotle has been taken only to the GTA, and that it's essentially not available anywhere else.
It is available in the U.S., it's in multiple cities. Pretty much what we've done in the GTA and what we've done in Richmond is what we're doing, literally, study group by study group as we take it out.
And so literally, month after month, we're actually adding to these and building it all out. I'll talk to the interaction between the various programs in a moment as well, because the COC protocol, Aristotle, AVRT, COC Plus, all tie, and all address the same groups of people.
We closed the additional financing last quarter, and our revenue of $1.3 million, if you look at the fact that we were moving from COVID. COVID revenue, in fact, has come down very markedly.
It's been picked up by the cancer revenue. It's beginning to move in the right direction.
And so, we now intend to continue to build on that. So, where are we going from here?
I think what people want to see is what do we have in line for 2022, what is it that we expect to do this year? And I'll walk through this with a little bit of detail.
The first thing that we have done, as we've talked to, is we've been able to demonstrate that the promotion is dollar-sensitive. So, in other words, having got the various programs in place, if we push on it in the right way we can actually get the incremental growth out of it.
That is absolutely critical. So, as we now begin to push all of those pieces in place, and again I will reference COC Plus, which I think people saw this weekend; that's exactly what you do.
That's the push as we drive on forward. We're expanding access to Aristotle in Canada.
We'll go live in Alberta, the Calgary area in the next little while. And we're also bringing up Quebec as we drive through.
Those are the first -- or I should say the first of the three jurisdictions, GTA being the other that we will drive through. And we will then decide where we go from there.
We're expanding large access across the U.S., as I was talking about, but we're in the process right now of bringing up all of these additional states. In fact, right now, we're live in Texas, we're live in Pennsylvania, we're live in Connecticut.
We're about to go live in New Jersey, we're live in North Carolina, all of these so that the additional states will come on as we move on out. The obvious intent is we want to make sure that we're very widely distributed.
Why not just throw it out to everyone out there? We could do, but if you think about the fact that we are still coming out of COVID, you think about the support systems that have to be in place, you think about how we have to deal with the patients, it's absolutely critical.
And I'll talk to this a little bit more when I actually go into the various programs. It has to be in a very staged way so that we can scale appropriately.
We're back partnering with some innovative clinical groups. This is where we have typically be -- as these groups begin to come back on stream, get back to normal business.
They are obviously open to this again. This includes the employer base.
And there will be more to hear about this as we move out over the next months. We want to launch AVRT in European Union.
I think as I mentioned earlier, 750–780 million people depending upon how you look at it, an extremely large market. AVRT is often the leading edge for a lot of the pieces where people start.
And so, I'll take you to a discussion that we are having with some of the larger healthcare groups at the moment. They may do internal screens that essentially just say cancer/no cancer.
What they're looking for is a way to actually then definitively be able to sort out what kind of cancer those patients might have, and in actual fact to give it much, much greater certainty around probability. That's where they move to us, and so, moving that up in that sense is absolutely critical.
So, those are the kind of things that we are building. And AVRT as I mentioned is critical.
We're expanding access to Aristotle to greet AVRT countries outside of North America, U.K., EU, and via partnerships. We've got considerable interest in that.
We will bring those up in ways. And in fact, that may expand even into Aristotle as well.
So, it could be very very interesting. We're adding additional cancers to Aristotle.
I think as we have talked before, we're not looking to in actually fact try and do 50 cancers. We think that's an inappropriate strategy.
We are going much more with a limited number of cancers. But, notably those that have standard of care behind them.
And what we want to do is we want to go deep with them. And so, it's by deepening the offering we want to be able to stage over time select cancers.
We are starting with colorectal. We're moving to breast and then lung so that we can be able to differentiate not only the stage of cancer but obviously follow them over time.
So, that is what we've set for ourselves for 2022, and obviously together this, of course incremental revenue that we expect to follow very clearly from this. Matt, hand over to you.
Matthew Pietras
Thank you, Jim, and good morning, everyone. While we move on to the financials, Q1 was a really good quarter for us.
It demonstrates quite clearly our stability and our growth as we evolve from primarily COVID testing to a healthier mix of cancer-based lab testing and clinical consultation. So, in the first quarter we had about $1.3 million in revenues, of which about a third of that roughly $400,000 was attributed the lab.
And then, the remaining two-thirds or $900,000 was attributed to the clinic. This resulted in a total comprehensive loss of roughly $600,000 or $0.001 per share on a fully diluted and basic basis.
As we have always done, we continue to evaluate our investments in research and development, and marketing, advertising, and we calibrate it associated with the resources that we have. And when you think about research and development, Jim talked a little bit about what we are planning on doing.
And, we've obviously continued to invest in the next-generation of Aristotle where we don't just want to look at additional tumor type. We also want to look at staging and phasing of the tumors.
And so, we put a $127,000 in the first quarter in research and development. We would love to put a lot more to accelerate that growth and movement to the next generation of Aristotle.
But, we do that as we can. Same is true for sales and marketing.
We spent roughly $500,000 -- $487 to be exact on marketing and advertising. Again, that's a place where we love to put more money so that we can accelerate the sales funnel.
But, resources dictate our ability to do that. And that's where the investment in the future will come into support both our research and development, and our sales and marketing involvement.
But on a total general and administrative basis, we're also looking at our resources on a continued basis. Now that we are about six months out from the acquisition and we are looking at where we best optimize the resources we have and bring in new resources and reduce others, we're continuing to look at the general and administrative expense as part of our business.
We spent roughly $2 million in the first quarter. And, we'll continue to keep our eye on that as we go forward.
For an adjusted EBITDA basis, we had a $2.6 million loss for the three months ended March 31. The difference is primarily driven by the revaluation of gains on warrants and contingent considerations inputs.
Moving to the next slide, we'll talk a little bit about the revenue streams and the revenue model for the organization because I really want to drive home the fact that it so closely correspond to our mission. And as you are all aware, our mission is to improve cancer and chronic disease outcomes through early detection and intervention.
Well, when you think about how we generate revenue for the business, Aristotle clearly represents that early detection. And the clinical programs we have are the interventions.
Let's talk for a couple of minutes about how those come together. You can access any one of these pieces of our product portfolio individually.
But, obviously we encourage the conjunction of both because that's how you get the best solution for patient. And so, a typical patient will come in interested in understanding the risk for cancer and gain access to the Aristotle test that's $1495 per test.
A patient may do that once a year -- once every other year. Depends on their circumstance, right?
But when you think about the first year of access to our program, the Aristotle at $1495 is the first piece. Very often patients will then enter into the AVRT protocol.
Pricing for that in U.S. is roughly $330 per visit, ACTUALLY, $1,320 per year.
So, a patient in their first year with us will likely spend $2,815 for our programs. And as I mentioned, there is a hybrid here of transactional revenue.
And then, there is transformational revenue that results in a longstanding sustained relationship where we gain basically ongoing access to the patient over time. The TREAT protocol is priced at $925 for the initial visit and follow-ups are $330, so that's essentially $1915 per year in the first year, and then, $1,320 thereafter.
As you've all seen, over the weekend we launched the Care Oncology Plus platform globally. That's also similarly priced to AVRT given its synergy is -- synonymous platform that operates to AVTR.
When you think about the revenue to this organization, it's driven in part by obviously laboratory testing and then the ongoing clinical consultation programs that provide for the interventions in sustaining health and wellness. As we move forward to the next slide and talk a little bit about our synergistic value proposition for patients, gaining access on a telehealth platform.
And I think it's important to rationalize where healthcare is moving today and into the future, access is now much more easily obtained through online platforms and in online interventions, and telehealth platforms like we provide. The Aristotle test, it provides the output to the patient via single sample of blood.
The specimen can be collected at your home, at your office, or even in one of our laboratories throughout the United States as Jim described earlier. Furthermore, the clinical consultations, our gynecologists and our specialists have the ability to intervene with you on an ongoing basis.
We have a general health platform through the products that we have both the AVRT and the Care Oncology protocol called TREAT. I'll pass it off to Jim to tell you a little more about those products now.
Jim?
James Howard-Tripp
Great. Thanks, Matt.
I'll the stay with the theme that Matt just go through which really is the interconnected support it is. And, I will tie them all together at the end.
But just to go through again what the products are. Remember Aristotle, Aristotle the first ever mRNA gene expression test for the detection of multiple cancers, high sensitivity, high specificity which gives a good accuracy; all of that extremely important.
We'll be publishing additional data on this as we go out through the year. So, I think people can become as familiar with it as they need to.
But, Aristotle I am getting very very good acceptance as it goes through. And I think particularly as we talk about deepening the effort, right now as we look at the colorectal cancer site, we are doing polyps versus stage I, stage II, stage III, stage IV.
I think as we have talked about why is that important, it's important because if you give the gastroenterologist that information pre-colonoscopy, they have a much better idea of what they are looking for. And as a result of that, our data shows that the likelihood of finding the cancer is much greater, which is exactly what you want.
It also is a very usefully screening tool. And don't forget in a lot of markets stool test is still the way that colorectal cancer screen for.
Remember the stool test have a very poor compliance rate. So, clearly you need something better than that.
So, as we drive down this providing greater information, providing the ease of being able to get to it, absolutely key, and it's beginning to get picked up really, really nicely. I'll tie that to the next program which is -- it's actually the COC protocol.
We call it TREAT filed internally as a way of differentiating it. But the TREAT study was initially developed by one of the founders within the group whose wife had breast cancer.
Looked at it, didn't like the way the treatment was going. Thought he could do better at that.
He was in the teaching hospitals in London, U.K. He had a lot of resources and they developed that.
The salient paper the one that was published in glioblastoma which actually showed a very marked improvement in survival benefit across 80 months with being on this, and there are follow-up papers to come from this. This is then being extended into multiple cancers.
We do, for example, large numbers of women with breast cancer, men with prostate cancer. But literally treat patients with virtually every cancer on them.
So, it actually has proven to be extremely beneficial. If we move to the next slide which is in fact AVRT, what we did was we pulled AVRT forward.
So, one, think about it, you have Aristotle where you can do the definitive screening type of cancer, not type of cancer. You go to COC protocol where you can treat patients that currently have cancer in terms of looking for a better outcome, notably with dealing with metabolic pathways that either lead to the growth of cancer or lead to the death of cancer.
You move to AVRT which pulls much forward from that. And so, if you look at the metabolic pathways, you would in actual fact get all kinds of indication of metabolic pathway disturbance.
These typically lead to chronic disease. Chronic disease very typically is a precursor to developing cancer, a lot of very established pathways.
By finding them early and actually dealing with them, it actually works extremely well and you put all of that together. I'll go now to COC Plus which is what we launched over the weekend.
So, COC Plus in actual fact is a response by us to a whole series of issues that were being presented into us by patients. And so, COC Plus deals notably with those metabolic pathways but in a way that is outside of the normal COC protocol program.
It deals a lot with nutrition. It deals a lot with supplemental guidance.
It deals with stress with sleep pattern. It deals with insulin resistance.
It deals with a whole series of other issues. All of which we know contribute to the well being and better outcomes for the patient.
The response to it has been remarkable. And so, this is where it actually all ties together.
So, we're literally just out of the door. And we're fully booked at this point.
And we've been building up to try and make sure that we can actually deal with incremental patients as it comes through. But in addition to that, it's not just the COC Plus that patients are coming for.
We're getting incremental numbers of patients now coming for the COC protocol. We're also getting incremental numbers of patients actually asking for the Aristotle test.
So, it's built through. So, you can see the interconnectedness of this what Matt was talking to.
As we go moving out quite obviously, we've talked for long time about working with large organizations. We are in discussion with these.
As I mentioned, we will announcement over the next few months as we go forward. But together with this, the first question that we get is these groups all begin to return to normal or a degree of normal after COVID is how do we manage these employees?
How do we manage the patients? How do we deal with this?
And we're one of the very rare groups that actually have this infrastructure. We have our own oncologists, our own nurses.
We have access to the dieticians, we have all of this. We can deal with this.
We can actually triage the -- either the patients or employees, we can begin to put programs around them; we can interact with their own physicians in terms of taking it out. And it's turning out to be as critical as we believed it would be, because without this infrastructure you actually can't do these programs with the groups.
So, we're obviously looking to a lot of very good things as we move forward with that. It all ties together strategically.
We are uniquely positioned. We -- and instead of just partnering, as I mentioned earlier, we actually decided to bolt these two organizations together.
We believe it's going to be absolutely strategic differentiation as we move forward. We have vertical integration, which allows us to manage all of the pieces I just talked about.
But as a result of that, we also have integration of the revenue streams. Patients don't just come for an Aristotle, but they come for the interpretation of the Aristotle, a large number of them look for guidance afterwards.
Clearly, if they test positive and they go through to show that they have cancer and it gets treated, they are candidates for TREAT. If they have raised issues as it comes through this, they are candidates for AVRT.
In the middle with all of this is COC Plus. These are programs we can offer not only to them, but all of the large healthcare groups and the employers that deal with them, so absolutely important.
The other thing too is we've got an amazing group of people around the table working with us, very, very experienced, marvelous physician group. And we get to be able to benefit from all of that.
If you look at I think what is so key in this period now, it's quite obviously our ability to be positioned on this stage as a credible player, as a group that has stature, as a group who signs, is recognized as being good. And that is actually developing really, really nicely for us.
I think if we go back a little while, people were saying, "Where on earth have you been?" We're not getting that anymore.
People actually see us, know us, they're coming to us. We're not always having to go to them; they're actually coming to us.
That's a very significant advantage. We're getting to speak with larger and larger groups as it moves on out.
Why? Not only because of what I've just gone through, but also because we have the infrastructure.
In fact, we're one of the very few groups that has the infrastructure that actually can do what we're setting out to do. We've sorted out a lot of the issues on the digital marketing and online advertising piece, and this is absolutely critical.
I think there's often a belief that you have a product and you throw it out at the marketplace and see what sticks to the wall, and you go from there; doesn't work with Cancer. Those will work -- well, while in healthcare, doesn't work with cancer.
You've got to be part and parcel of the cancer community. You've got to be within the groups, you've got to be recognized, you've got to be understood, you've got to be trusted.
Building all of that is absolutely critical. And that's part of infrastructure we have been building.
And I think we can see that start to pay off as we look at what's beginning to occur, out from COC Plus, which is the first sort of immediate high-profile launch that we've done right now. Now, we're , of course, all the other pieces and pulling it up together with it, so it really works.
And then just going back to where Matt was, clearly we want to continue to invest in research and development as we bring it forward; there are additional programs, additional opportunities, additional depth to Aristotle that we want as well. And I'll finish just with a recap of, I think, what we've laid out 2022 KPIs.
And this is how you can look at where we intend to go this year. You can look at us coming back and being able to tick the boxes to say, yes, we've done that.
In the way that 2021 was an amazing year, and we pretty much did everything we said we would, our first quarter of 2022 has been pretty much the same way. Now, we look for the revenue ramps, now we look forward to being able to continue to tick these boxes for you as we move out across the year.
And I think, with that, Rebecca, do we have questions?
Rebecca Greco
Yes, James, we have one question on the call, and then we have some questions in the webcast. Do want to start with the question on the call, operator?
I see someone's queued.
Operator
Certainly. I will bring in the first question.
And the question today is coming from . Jim, your line is live.
Please go ahead.
Unidentified Analyst
Yes, James, and thanks for the conference call. I'm just concerned with COVID; it put a damper on cancer screening, cancer treatments quite a bit.
There was a rise -- there is a rise in cancer because of it. I'm just wondering the effects of the present worldwide events, inflation, cost of living, it's getting harder for the average Joe, it's going to be harder the next few years to afford basic necessities and put food on the table.
Where I live, it's over $2.00 a liter for gas, loaves of bread are $5.99 a loaf, and flying, if you fly for work, coach is getting to be as expensive as first class was last year. Do you think that will affect us further in screening and treatments of cancer?
James Howard-Tripp
So, thanks, Jim. That's actually a super question.
We're obviously monitoring exactly all of that. And so to answer it in a series of pieces, starting with the return to screening, and you're absolutely right on that.
We saw a massive reduction in cancer screening while COVID was around 2020 and 2021. I mean, in some instances cancer screening was done kind of 86%, so just huge.
You're right; we're seeing what's being described as sort of a tsunami of late-stage cancers coming forward. So, what it is is it's propelling everyone to move back to the screening stage.
But it coming back step by step, it's not as if everyone just turned the tap on immediately and went. It is coming back in different ways, at different rates.
The good thing is we're nicely positioned for that. And I think because, going back to my comments about being right in the middle of the cancer community, you have to part of that.
If you're part of that it works, it you aren't part of that it's actually difficult. So, we're very pleased with that.
And I think we're starting to see those fruits. With respect to, yes, the war in Ukraine, general disruption around the world, inflation, what we're doing, so one, we're actually keeping our prices as low as we possibly can so that we can make it attractive that way.
But you'll also find that we've introduced payment plans, so that's the other way we did. We find most of the people coming in to work with us are sufficiently concerned.
Again, if you go back to the audience, if it's someone that, "Gosh, I think I'll get tested for cancer today," they would probably be very concerned about price. We tend to not go anywhere near those.
However, if it is someone whose brother has just been tested positive for cancer, is within the cancer community, they're concerned about themselves, they know the survivor benefits. They also know the cost differential; the cost of treating early-stage cancer is magnitudes different to treating late-stage cancer.
So, it is not just survival of finding it earlier, it's actually the cost of finding it earlier. So, all of that actually is playing fairly well for us.
And certainly I think, at least at this point, we're not seeing a drop-off in utilization. If anything, we're actually continuing to see increases.
So, hopefully it stays that way. But yes, we are monitoring it very carefully.
Unidentified Analyst
Okay. And I'd -- you had mentioned partner labs for Aristotle.
I see Quest Diagnostics popping up whenever you apply for testing and stuff. Are they strictly a phlebotomy service or is this a partnership that you're in with Aristotle?
Or how does that work? Do they draw blood, and everything is tested in Richmond?
James Howard-Tripp
Yes, so two different sets. So, Aristotle, Aristotle is tested in Richmond.
So, we have in actual fact a fairly large number of partner agreements with labs across all of the various cities. So, the key with that, so, for example, if I talk with GTA, I think I'm not speaking out of turn to say we're actually partnered with Sinai Health.
So, Aristotle samples in GTA actually go to Sinai Health for us. What they do is they do what we call stabilize them.
So, in other words, they can cross the border, they can get delayed over time; mRNA is very sensitive, you need to make sure you don't lose or corrupt the sample in any way. So, for example, we do that.
And so we, we're bringing those up all over the U.S. as we do this.
It'll also allow us, for example, to do testing in a whole series of other countries. It's actually a rather neat strategy.
So, on the one hand, we have all of those things going on. The other is we have a series of lab tests, so for example, COC Plus as well as AVRT have a very specific set of metabolic tests that we want done.
Quest is our U.S. partner for that.
Beyond that, we have a series of health groups, phlebotomy groups, healthcare organizations. Some of it we do ourselves.
You can come to our own clinic in Richmond, Virginia, for example, you can walk-in into the lab, into the clinic, we'll draw your blood there and then, and so we're setting those up. So, we have very large numbers of everything from labs through phlebotomists that can draw the blood for us; all of that to make it as convenient as possible.
Some people like a physical site to walk into, a whole series of others like us to go to them. And, of course, don't forget it, if you're working with, let's say, a healthcare group or an employer, then we need to go to them, so the same kind of infrastructure that we used, for example with Maricopa County, is the kind of infrastructure that we would utilize there as well.
So, we have all of that on tap.
Unidentified Analyst
Okay, and one last quick question, if you may -- if I may. As an investor, there's a lot coming around the corner with your company.
It's going to cost. Can we as investors expect another round of financing or another reverse split on the stock?
James Howard-Tripp
Yes, so to answer those directly, yes, we are going to need to finance going forward. We can't tell you exactly when, we'll sort it out.
I would go to the comment I made in the beginning, Matt, your -- "Good grief, have you guys really done this on $25 million." You know, we've taken about $25 million in five years.
If you think what we've done in that, we've developed all of these products, launched all of these products, acquired a company, integrated it, and generated revenue through this. I think you'd be hard-pressed to find another group that's done anything similar to that.
So, we know that, moving forward, and Matt showed the sort of $500,000 that we spent on promotion. We'd like to be able to put $1 million, $2 million, $3 million, $5 million against that as we move forward.
Some of that will come from organic revenue growth. But obviously, if we can spend more aggressively against it, from a promotional side, it really helps.
So, I think the fair answer is, yes, as fast-growing companies do, you finance when needed. On the reverse split, I know there was a lot of buzz in the marketplace.
We did a reverse split some time back. And we don't have a consolidation on the table, there's no logic to that.
We would only do that if at we -- let's say, we were in striking distance of being able to go do something like a big board U.S. exchange, otherwise, no logic to us doing that at all.
So, that's definitely not on the table.
Unidentified Analyst
Okay, thank you.
James Howard-Tripp
Unidentified Analyst
Yes, thanks.
James Howard-Tripp
No, you're very welcome. Good questions.
Operator
Thank you. And the next question is coming from .
Bradford, your line is live. Please go ahead.
Unidentified Analyst
Yes, hi, James. I'm wondering like with being that everybody knows early cancer detection is critical and life-saving, what is being done to promote this to both the Canadian government, getting it on to healthcare system and also insurance companies in the U.S.
to have them offset some of the costs to the patients?
James Howard-Tripp
Yes, well, let me just figure out how to sort of work through those pieces. Let me start with Canada first -- or I'll maybe deal with the FDA and Canada at the same time.
We know at some point it is going to be appropriate to take some of what we do -- I'm sorry if the answer is going to be a little complicated, but some of what we do to the formal authorities like that. And by that I mean Health Canada as well as FDA.
The issue, and you'll see the same -- we're all talking the same line, ourselves, GRAIL, Exact Sciences, all of us, we're all talking the same line, which is that if we take the U.S. pathway, for example, it's five years, maybe seven years before you can accomplish what it is that you were just talking through.
So, you've got the develop all of the data that they would want to see in the way they see it. It's not that you don't have the data, but it's generally not automatically in the way they would want to see it.
You then go through the approval process. All of this is probably going to take you two to three years.
And then from the U.S. side, you're going to drop into what's called USPSTF review, they typically only issue rulings about once every seven years.
You need to be within the cycle for that. So, at best, you're five years out, you may be a lot more than that.
Now the question is what do you submit? Everything that we're doing is so rapid.
So, if we submitted Aristotle today, it would have a colorectal cancer test that essentially says, yes, you have colorectal cancer, no, you don't. If we submit in a little while we would have an Aristotle that has a colorectal cancer test that says polyps stage I, stage II, stage III, stage IV.
It's a significant advancement. If we go a little further down the road, we would likely have something similar for breast, we'd likely have something similar for lung.
So, these are developing real-time, which is why the U.S. runs what's called LDT, laboratory developed tests.
98% of the lab testing in the U.S. is not FDA approved because it keeps moving like this does.
And you go through. So, we're all figuring out how to work with those groups to take it through.
But it's -- we all know that at some point we're going to have to figure out the exact strategy. But it's difficult.
It's difficult to sort out right now because we are just moving too quickly. Now, going to insurance; insurance important.
And so on the Canadian side, we did two things because we get questions on this. One, we called a series of the private insurers and we said, "Right, we know you do cover tests outside of Canada, lab tests out of cancer for this.
Would you cover our tests?" And the answer came back that said, probably.
And we said, "Okay, explain." And they said, well, if you, the patient, have the right plan with us and you have it prescribed for you by a physician that is licensed to prescribe it, and you submit the invoice with the information, they said, yes.
Then, yes, it should get covered. We went further than that, we actually called OHIP.
And we said, "OHIP, would -- how would you deal with this?" And they said, "Well, you can run through preauthorization."
And they said we do this, and yes, if there's preauthorization we would run. So, similar things on the U.S.
side, we provide all of the patients that do the testing, we provide them with invoices, they can submit the invoice as to their own insurers. The insurers, again based upon everything I just went through, type of plan, type of deductible, et cetera, et cetera, may or may not reimburse you.
And it runs that way. Will we talk to some of the insurers as we go down the road?
Yes. Is there an effort to do some of this?
Yes. In the U.S.
there's actually a congressional -- there's actually an effort by kind of the lobby in funds of Congress right now actually pushing for the types of tests to get covered without having to go through the formal FDA USPSTF route just because it takes so long. And as I said, what do you submit?
So, it's getting there, but that's the best answer we have at the moment. Sorry, that was long and very complicated, but I told you --
Unidentified Analyst
Yes, okay. So, if I understand correctly, then there is a possibility in Canada that certain insurance companies will cover part of the cost of the testing?
James Howard-Tripp
That's correct. That's correct.
Unidentified Analyst
Okay. So, each individual would have to verify with their insurance company.
James Howard-Tripp
That's correct.
Unidentified Analyst
The other thing, also, I mean Biden has made it very abundantly clear that he wants to go full force on cancer detection and treatment, and he wants to -- I mean he's got some coined phrase for it. But it sounds like the U.S.
is -- under Biden is very keen on accelerating the processes that were bogged up before, and trying to make things move a lot faster. So, that's why I'm saying perhaps now is the time to get in front of the decision-makers, whoever they be, in the U.S.
and say, you know -- because, if I understand correctly, Exact Science, with their poop in a box, they get a lot of their -- their testing is covered by insurance in the U.S., isn't it?
James Howard-Tripp
They do. But two things with that, one, it took them that protracted period of time.
And I think it took them nearly six years to actually get there from the point at which they began, all the submissions to FDA and then all the way through. So, it took a significant amount of time.
The other thing is their test, Cologuard, in actual fact is the kind of test that it makes perfect sense to take forward because it doesn't move, this is the test, end of story, it doesn't move, it doesn't change, you take it in. Ours, as I was talking to, and in fact GRAIL is talking about the same thing, and Exact Sciences, they're talking about what they're going to try and do with their Thrive platform.
We're all saying the same thing, and the first question is, okay, what do we submit? What do we submit?
And how do we deal with the changes that goes forward, because by the time we get through approval, in three years time -- even basic approval in three years' time, this test is markedly different, and it needs to be markedly different. So, that's the piece we're all trying to answer.
So, that's why going to the insurers in the meantime is the way around this. And yes, there's a significant amount of effort not just by us, but our whole series of groups.
Biden's group, it's called, the Cancer Moonshot. Canada actually has a similar initiative in terms of that.
So, are we aware of these? Yes.
Are we with them? Yes.
Are we talking with the various insurance groups? Yes.
We'll do whatever we can to help.
Unidentified Analyst
Okay. One more question like to address.
I don't know, you must be aware, but there are certain individuals on social media that had been really into crossing the line in defamation.
James Howard-Tripp
Yes.
Unidentified Analyst
-- in regards to you and the company.
James Howard-Tripp
Yes.
Unidentified Analyst
And I'm just wondering, I mean as an investor, don't you think something like that should be addressed?
James Howard-Tripp
We do. Thank you for raising it.
We do. I will tell you we take this very seriously.
So, everything, from being in the hands of our lawyers, through taking it up, through all of the authorities, including to the OSC. So, I think what I can tell you is that yes, it is very visible, and everyone is watching it.
And yes, we are definitely trying to do something about it.
Unidentified Analyst
Okay, good. Thank you.
James Howard-Tripp
Well, you're welcome. Thanks for the questions.
Rebecca, in terms of time, how are we doing?
Operator
And there are no further questions.
James Howard-Tripp
Yes, okay.
Operator
There are no further questions from the balance…
Rebecca Greco
I think we have no further questions on the call. Thanks, Tom.
Maybe we would just have one last question off of the webcast. We have asking about what we foresee in terms of uptake from employers this year based on COVID moving to the background?
And whether we have any special initiatives for getting employers up and running? So, maybe James, you want to just answer that one?
And then we're just about out of time.
James Howard-Tripp
Yes. Matt, shall I do that?
Matthew Pietras
Sure, go right ahead.
James Howard-Tripp
So, Patrick, one, nice to hear from you, thanks. The employers, but also larger healthcare groups, have long been a target of ours.
The good thing is that as we all come out of COVID people are starting to come back and look at what they do. I think I've explained on a different call, at one point, that said if you look at a large airline, just as an example.
The large airlines, until recently, have been hanging on for dear life just to make sure that they can survive. They definitely weren't about to now trying to introduce cancer tests in programs.
But as this starts to come back to normal, as people start to get a degree of normality back, it's exactly that. I think what we can tell you, we're definitely in discussion with groups.
We're walking down this platform. Timing is always difficult.
I wouldn't give you that, but other than to say, watch the space. We've got a mix of small and large groups as we move on out through this.
And so, it'll be a matter of bringing it in. What is key for us is the infrastructure that we've built with a lot of this.
We wouldn't be able to do it if we weren't constituted the way we are. And I think as Matt sort of very elegantly was going through laying out the interrelationship between the programs, that part all very important.
So, yes, remains an absolute focus. Yes, it's coming back to life.
Yes, we are moving down that path. Okay, I think with that we're essentially out of time.
So, thank you. Thank you for joining.
Thank you for the questions. They were actually very insightful and very helpful.
And we look forward to continuing to report progress as we move on out through this quarter. Take care.
Operator
Thank you. Ladies and gentlemen, this does conclude today's conference call.
You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.