Hello everyone, and welcome to Biovica Capital Markets Day for 2022. It's great to have people back here physically, so welcome to you and to everyone also that is watching virtually. Today, this is the agenda for today. I will start with the introduction of the company, and then I'll hand it over to Warren and his team in The U.S., who will be present virtually and present the US go-to-market plan, the sales strategy, our CLIA lab, how we'll build that up, and Amy will also give scientific update on the latest results. Then we'll go back here to Stockholm, and Henrik Winther will be presenting the progress we have made this year when it comes to pharma collaborations. Finally, Charlotte Kjærgaard will facilitate a Q&A session.
You're able to also ask questions which will be discussed and answered here. During my presentation, I'll do a short company introduction and a product introduction and overview. I'll talk through the clinical evidence and the collaborations that is a foundation for our go-to-market plan. I'll talk about the market size, the potential and the overall strategy on how to go to market and the team currently working for Biovica executing the plan. Before I move into that, I'll just say a few words about myself. My name is Anders Rylander and I have a background within management consulting, many years at Accenture and within IT and strategy, the combination, before moving into ICA AB as the CTO.
After that, I co-founded Axholmen Management Consulting firm and developed that for several years. More than 10 years ago, I came in contact with the innovator and founder behind Biovica, and as an investor, and was attracted very much by the great potential of the company, being able to improve lives for cancer patients and, but also, of course, the health economic benefits for healthcare providers and payers and the commercial potential. I made an investment, and a few years later, I also was asked to become the CEO of the company, which I did. I'm also main shareholder, actually the largest shareholder, as well as the CEO of the company. To move into talk a little bit more about Biovica and the company.
Biovica in its current form is founded in 2009, but the innovation and is based on research that has been performed at Uppsala University many decades spanning many decades back. The company was IPO'd in 2017, so we're currently being traded publicly on the Nasdaq First North Premier. To date, we have more than 4,000 shareholders and also some large institutions that has invested in Biovica. Our headquarters are in Uppsala, but we have established ourselves with an office and a lab in San Diego, a life science hub in the US, which we'll talk more about when Warren, Kendon, and Dan is presenting.
In this business, of course, complying with regulatory standards is very important, and we have been certified with the ISO 13485 certification. That's also the basis for coming regulatory approvals such as CE label, which we already have, and the ongoing 510(k) clearance process, which allows us to market the product for clinical use on the largest market in the world, the US market. The product is called DiviTum. It stands for Dividing Tumor, and that's what we do. We are measuring cell proliferation. As you all know, cell proliferation is essential in our body, but it's also what defines cancer, at least uncontrolled cell proliferation.
Hence, we're able to provide essential information, very important information to the treating physician about the aggressiveness of the disease, but also during treatment to give quick feedback if the treatment is effective or not. That is our key application, which we are working hard in order to commercialize. Our initial focus area is the metastatic breast cancer, where there is an unmet need for these kind of biomarkers to give quick feedback on treatment efficacy, if the treatment is effective or not. Currently, the standard method being used is imaging diagnostics, where you take a snapshot of the tumors before and during treatment, and that requires a couple of months, three to four months to be able to follow up if the treatment is effective or not.
Biovica has shown in clinical trials that we already, after two weeks into treatment, can provide feedback 83 days ahead of imaging if the patient is in risk of progression or not. We will provide some advantages in comparison to the current best standard being used. Both when it comes to quicker feedback, but also more convenient process of following up on treatment efficiency. A key strategic element in our go-to-market strategy is to provide data that as proof of the performance of the product. This is an area where we have been very successful in collaboration with some of the leading academic institutions in the world.
So far, we have in collaboration with the leading key opinion leaders within these institutions been able to complete 24 clinical trials that has been peer-reviewed and published in scientific journals, proving the value of the product. The majority of the data is within breast cancer, our focus area, but we also have important evidence, proof of concept outside breast cancer in some major cancer areas like gastrointestinal and lung cancer, but also malignant melanoma with immunotherapies, which is a key focus area for us. If you should summarize the results, you could say that it's been shown to be prognostic, being able to look into the future, you could say, and tell how aggressive the disease is and assess the risk for recurrence in the early phases of cancer, local cancer.
In later, so-called metastatic cancer, we've been able to show when the patient is in risk of progression, but also for overall survival data. When we have had access to serial sample, being able to follow the patient over time and to monitor the treatment, we've been able to, as I mentioned previously, show that we can provide quick feedback on treatment efficacy, as I said, in 83 days in median, ahead of imaging, which was the result in a trial together with Washington University in St. Louis. Talking about our collaboration partners, Washington University in St. Louis is one of them, which we have performed several clinical trials with great success.
We have also Mayo Clinic, where we are in our third clinical trial and with Dana-Farber, Johns Hopkins and the SWOG Network, which is a cancer network that reaches out to many oncologists. That was the trial that we then later used for our FDA application. That means that we have established ourselves on the US market with some of the leading institutes on the US market. In Europe, we have collaborations with Karolinska Sweden and the IBCSG breast cancer group, creating a great coverage in the European countries as well. This is also key to have collaborations, collaborating partners that are objective and can get the word out and talk about this data in an unbiased way. It's a strategic success factor for us.
These are the activities that we have been working on for several years, and we're very close to launch the product after clearance in U.S. to get clinical usage and uptake of the product. The product has been developed and validated to meet the requirements of FDA. Based on that, we have documented in clinical trials that I just talked about the regulatory pathway, the 510(k) being the most important. Also the data that we have generated will be important for guidelines, for reimbursement, and also for partnering and in as the last step to be able to market and launch the product to oncologists and patients and payers. When it comes to commercial partnering, we will use different models on different markets.
In The U.S., on the US market, we will establish our own CLIA lab, and offer the product from that, which Warren will talk a little bit more about. On other markets, we'll use partners to offer the product. This is the high-level launch plan. The first market we intend to launch is on the US market, where we also have developed a lot of data and assets that we are able to reuse to a great extent on this next market we're looking at, and that's the European market, where we will look at selected countries in Europe, and the third one is the Japanese market.
The market potential figures is based on market research that we performed, based on interviews with key opinion leaders, oncologists, to assess the unmet need for this type of biomarker assay product and the testing frequency. We also made several health economics projects and interviewed payers based on the results. We received feedback about the value of the product and the price sensitivity. That, combined with the number of patients living with this disease, makes up for the potential of this in this slide. When we enter a market, our ambition is to realize 15% of this market potential after three years after launch. When it comes to the 510(k) process with the FDA, it's something that we have been working with the FDA already.
Several years ago, we had the first meeting, got them some good guidance on which process to use, which data to generate. We were able to complete our submission by September 2020. We quickly passed the first two milestones before the pandemic situation hit the FDA, and they had to reallocate their resources and focus on COVID tests. All other tests that was non-COVID tests were put on hold. When during 2021, this process was restarted, and we have had a very positive and good discussion sorting out all the open questions and also complemented with the data that they requested us to complement with.
Now we have submitted our updated application that contains all the answers that the FDA have requested, and we expect to see a clearance now within a couple of months. We have really exciting times ahead here when it comes to finally being able to end this product with a clearance. It's also important, of course, to have health economics supporting the value of the product, and we have done that, as well together with the researchers at Fred Hutchinson Cancer Research Center. This is the outcome of their work where they have modeled based on the data that we have generated, how this will impact payers' budget, so the budget impact model. This has been presented on several health economic conferences, but also been published in a peer-reviewed scientific journal.
The results show that with DiviTum you can make major savings both when it comes to monitoring costs but also when it comes to treatment costs. To a factor of for every dollar that you invest in DiviTum, you get three dollars in saving. That's based on a price level of $400 per test. You can also say that this validates the price assumptions used on the previous slides when we talk about the market potential. The metastatic breast cancer launch in the US is the first of many that we plan. We plan to expand outside of the US area into Europe and into Japan.
A key area that is closely related is of course locally advanced, which is the phase, earlier phase of metastatic breast cancer, where the same type of treatment is now being approved and used, and we also have ongoing trials and positive data. That's a natural next step for us to expand into, which also adds to the market potential. We also done an analysis on which other cancer areas would be interesting, where there is an unmet need, and where there are treatments that we could complement and provide important information for patients and treating physicians. We've concluded that the metastatic malignant melanoma, where patients are being treated with immunotherapies, is one area where we also have positive data from a trial together with Karolinska that recently were published.
Other areas are non-small cell lung cancer and metastatic prostate cancer. That also adds greatly to the market potential and doubles it in comparison to the breast cancer area. The last area that we are active in already is the collaboration we have with pharma companies, where we are supporting their development of new therapies and are serving them with kits and fees for fee-for-service work. We have an ambition to develop that into co-development projects that will result in new products for Biovica. This is an area that Henrik Winther will dive into and explain a little bit on where we are and how we are looking to advance. In order to do all this, to drive all these different activities, of course you need a team.
Over the years, we've put together a really, really strong and experienced team where all people, key people here on this slide have experience from doing this successfully in the past. The latest addition is of course the US team that during the last 12-18 months has been established and is of course a really important addition to the overall strength of the team. You will introduce yourself going forward. The same goal goes for our board of directors that also has been now around for several years and supported the company for several years. We have experience within both diagnostics, taking diagnostics to the market, developing diagnostic companies within pharma, within oncology.
can mention, for instance, Chairman Lars Holmqvist, that in the role of CEO of Dako, developed that company into a successful sale to Agilent. A lot of experience have gone through this process in the past that they bring to our board of directors. As you can see also, all the board of directors and most of the key employees also have equity in the company, have invested in the company. That was my short introduction, and I will now leave it to Warren to go through the U.S. go-to-market plan together with his colleagues over there in the U.S. See if this works. Warren, are you with us?
Hey, thank you very much, Anders. I really appreciate it. My agenda and what I'm gonna talk about for the next 20 minutes or so is the go-to-market strategy and really the rationale behind that, clinical or critical success factors and why they're important to us, and our immediate focus and really what those priorities are. A little bit about myself. I'm Warren Cresswell. I'm the president of the Americas for Biovica. I come with about 25 years of experience in both diagnostic products and pharmaceutical side of things. On the diagnostic side, I have IVD, PMA, specifically companion diagnostic experience, device experience.
I was at Dako for almost 17 years, so I've had the opportunity to have a number of different positions there from running business in the U.S. to Latin America to Asia-Pacific markets. I went on to be chief commercial officer and eventually CEO of a company called Prometheus Laboratories, which was a Nestlé-owned company, and there, that was a CLIA laboratory where we manufactured, we actually developed and launched, high-value multi-analyte algorithm-based products, for the GI market specifically. Throughout my career, I've had a number of different positions, but really my expertise lies in, you know, executive leadership, the commercial side of things, business development and operations.
When we take a look at the U.S. market, obviously it's very large, and it's complex, and it's convoluted, and one question is how are we gonna be successful in this particular market? There's a number of different points I wanna touch on. One of the things that was so intriguing to me when I joined Biovica was DiviTum itself and really understanding the clinical utility of DiviTum, understanding the unmet clinical need in the marketplace, understanding the size of the market, and the other piece that was really intriguing was that the opportunity for follow-on indication, so really the life cycle management of the product, it's significant. There's many, many opportunities that I know others will be talking about as well. Our go-to-market strategy, we've put a lot of effort into. We think it's very well thought out.
It's executable, and it aligns, or it actually overlaps completely with other very successful high-value diagnostic companies, and I'll be talking about that in future slides. Our US team that we're putting together is very experienced. They have experience in launching high-value products that do change the standard of care. We're also committed to the clinical side of things with building clinical data. That was one very impressive thing when I joined the organization was how much clinical data was already created and our commitment moving forward to build clinical utility data. Lastly, our KOL relationships.
You know, we have, I think the organization has done an incredibly good job at being able to build this network of key opinion leaders, and I know Henrik will be talking about all of our work with our pharmaceutical partners, and this is really a significant part of our business moving forward as well. When we talk about go-to-market strategy options, there are really three separate options we can look at. One is the standard distributor model where products are sold directly into that distributor, then gets an order, they fulfill that order, and they move on. The second is really direct sales into clinical labs, and what that means is organizations like ourselves selling directly into community hospitals, IDNs, university settings. That's the second option.
The third option is the CLIA lab model, and to make sure everybody understands, a CLIA laboratory in the US means that a laboratory can receive tests and report out human samples. Whether it's a hospital, whether it's a dentist's office, or whether it's an urgent care facility, these are all CLIA labs. These are really the three models that we have to choose from, and you don't have to choose one. In many cases, you use multiple models. The first two, the distributor model and the direct sales to clinical lab model, you do have to have either FDA cleared or approved tests that you would sell, and we would fit into that bucket. The other is you really have to have an existing demand for the product, and you have to have reimbursement already established for the product.
From a direct sales into clinical lab perspective as well, it has to be really the standard of care. You know, when you sell the product, from a distributor perspective, you know, are they gonna go out and generate demand? Probably not. The same goes for in the clinical lab as well. An order comes in through the clinical lab, and they fulfill it. When we take a look at the CLIA lab side of things, this is where you have a sales force. You go out, you drive demand with specialty physicians, so in this case it's breast oncologists. We also will work closely with insurance companies to drive the reimbursement process as well. At launch, our best strategy is pursue the CLIA lab model.
However, you know, we've hedged, and we reserve the right to then expand our business potentially and maybe pursue as well direct sales in the clinical lab at a later date. Initially, our strategy will be the CLIA lab model. Successful high value diagnostic companies follow the CLIA lab go-to-market strategy as well. Whether you're looking at organizations like Exact Sciences or Genomic Health or Guardant Health, they all have followed these particular critical success factors that I will get into in my following slides. Those five critical success factors are managing relationships, managing the reimbursement process, ensuring that your product has full access across The U.S., developing a sample biobank and the importance of that, and also the data mining and the data development that goes along when launching your product.
Managing stakeholder relationships are incredibly important, and with the CLIA model, it affords us a number of different things to do here. We're able to really understand who the patient is that's using DiviTum. In the first two models that I described, the distributor model and selling into clinical labs, we're blinded by the fact of who the patient is, who the physician is, and even what the reimbursement is on the payers. In the CLIA lab, we can understand these three points. From a patient perspective, we wanna know which patient is having is using DiviTum. We want to know what their test results are. We wanna know how often they're using DiviTum, their response to therapy. This is valuable data to collect and understand.
It gives us the opportunity to engage with the patient as well because when the blood sample comes into our lab, we'll have the patient information, we'll have the physician information, we'll understand what therapy they're on. It's incredibly important information for us. From a physician perspective, we'll know which physicians are ordering DiviTum and how often they're ordering DiviTum, how many patients they have on DiviTum. Very important. Also, what their clinical decisions are based on the results of DiviTum. Finally, on the payer side, we'll be able to closely manage those relationships with payer to make sure what Anders was just saying is, you know, our target is somewhere in the neighborhood of that $400 amount.
We'll be able to engage payers and make sure that we're able to achieve that type of reimbursement. That really gets into my next slide, which is, you know, there are four separate reimbursement channels in The U.S. On the top left side, we have public insurance. This is typically Medicare, Medicaid. Many of you may know Medicare. Medicare is for people in The U.S. that are over 65 years of age qualify for Medicare. This falls under CMS. We have private insurance. This is what most people in The U.S. have under the age of 65. This is what a typical employer would offer, and I've given some examples there. On the right-hand side, we have hospitals and general reference labs.
Just to make a distinction here, on the left side with the insurance companies, part of our organization is managed markets or managed care, and we have the expertise to go in and negotiate with these institutions to ensure that we will get paid when DiviTum is used by a patient that has one of those insurance programs. On the hospital or general reference side, it's more of a contracting business, so that's typically called market access. We have the expertise there as well to be able to go in and contract with institutions, and this could be to get a blood draw from a patient. In some cases, the hospital will wanna do the billing on their own versus us doing the billing.
There's some legal reasons behind that as well, why in some cases, hospitals for some patients need to do that, and same with reference labs. Some of the largest customers out there are these very large reference labs that collect blood samples and will send those blood samples through because your patients have orders for DiviTum. Finally, the fourth channel are the patients. We're not running a cash model here, unlike, you know, some of the products on the market like Ancestry.com, where you're looking for the lineage or your heritage. That's not our business model. In the US, there is something called co-payment or co-insurance, and patients do have a financial obligation to pay a portion of their bill.
If they get tested, there is a commitment there that the laboratory has an obligation to collect, and that's really the fourth area that we'll focus on as well. One common misconception is access when you think about a CLIA lab, because CLIA, a CLIA lab is really kind of a centralized lab in The U.S., and oftentimes people think if you launch your product through a CLIA lab, you're really restricting yourself from an access perspective, but it's actually the exact opposite. With a CLIA lab, we're able to receive samples from anywhere in the country. Whether you're at Fred Hutchinson Cancer Center in Washington or Moffitt Cancer Center in Florida or University of Pittsburgh in Pennsylvania, we can move blood samples across the country in a 24-hour period.
When we receive those samples in, we can actually test and result out as quick as 24 hours as well. The movement of samples around and the turnaround time really doesn't get impacted much by having a centralized laboratory. Now one of the big benefits of having a CLIA lab is the ability to create a sample biobank, and when we collect blood samples from patients, the one thing that we will really focus on is collecting the sample with consent. What that means is we will wanna receive that blood sample into our lab, we will aliquot that sample out, and we will have the opportunity to do further analysis beyond DiviTum testing.
As you can imagine, when you're collecting those samples, you can build a biobank incredibly quick, and we will have, not only will we have the sample, we'll have the patient information, and we will have, certainly some clinical information to go along with that. That will help us a number of different ways. It'll help us help us develop, or further accelerate our, product pipeline and test hypotheses of different products that we've thought of. Lastly is the data development and data mining. With all of those samples that we're collecting, into the laboratory and putting into our biobank, there's many different opportunities we can use this data for. In some cases, it can be product positioning.
You know, we're gonna understand how physicians are using DiviTum, the results that patients are getting, and how clinically the physicians are managing those patients. That's very helpful to us in regards to product positioning. I just mentioned product development, also life cycle management of the product. It'll help us develop a clinical dossier, which is used specifically with payers to get reimbursement. It drives utility of the product, and also from a publication perspective, this really drives opportunities to publish data as well. When we take a look at the CLIA lab itself, just to be clear, we manage everything from end to end.
We will have a sales force that specialize in calling on oncologists, and Kendon will talk a bit about that and targeting and how we do that specifically. We will derive that utilization with the oncologists. We will have patients use a Biovica blood collection kit, and those samples will come directly into a Biovica-owned CLIA lab. We will receive tests and report out those results. We have a revenue cycle team as well that works directly with those insurance companies, private and public, with hospitals, and also with patients to ensure payment for the services rendered. Lastly, our focus. It really boils down to three things today.
One is putting the organization in a place for demand generation for DiviTum, one is the clinical data and reimbursement side, and the other is the operational side of the business that Dan will speak with. When I pass it over to Warren here in a minute or two, he's gonna really talk about the sales function strategy, what we're doing there. Also in that demand generation, we have a very qualified marketing team with expertise there to be able to drive these high-value diagnostic products in The U.S. From a market access perspective, we've actually already identified almost all positions that we will need moving forward with highly skilled individuals that have expertise in this.
Medical affairs, so we need that expertise to be able to have discussions with physicians, whether it be scientific or clinical or medical perspective, and Amy Williams is responsible for that area. Dan Kaiser will be talking about the CLIA lab itself. He'll be talking about both kind of the certification process and accreditation process, and certainly the lab is getting in place to be able to receive, test, and report out those results. Dan will talk a bit about that. Amy is gonna talk about, as Anders indicated, some exciting data, and, you know, her responsibilities, and her work with managed care or managed market and market access really drives that reimbursement side of our business, so that's kind of the third focus as well.
With that being said, I'm going to pass it over to Kendon Richards to talk about The U.S. sales plan.
Great. Thank you, Warren. Good afternoon, everybody. It's a pleasure to be able to spend some time with you here today. I think we have a little bit of a delay here. All right. Our agenda for today is, I'll walk through the specialty diagnostic selling process, how we establish specimen channels, reimbursement pathways. We'll talk a little bit about our sales organization that we're working on putting together right now, as well as, how we will focus on physician targeting. Just a little bit of background about myself. My name is Kendon Richards . I'm the executive director of sales for the United States. I have over 25 years of combined pharmaceutical and diagnostic marketing and sales experience.
I spent the last 10 years of my career in the diagnostic specialty space as a sales leader, and the majority of that time has been spent as the national sales director for the leading US GI specialty lab. Now, over my career, I've had the opportunity to launch 15 new products, and over half of these products have been in the specialty diagnostic space. My experience in launching these specialty diagnostic products is very similar to DiviTum. The majority of these diagnostic tests that I've helped to launch have been new, innovative, high-value tests that have changed the standard of care.
Now, the challenges and the opportunities we're going to talk about a little bit today that we will face for DiviTum are the exact same challenges that I and my team have successfully addressed and excelled at in delivering against in my past role. I'm super excited about this opportunity with DiviTum and very, very confident that, given my experience and the team we're assembling, that we'll be very successful in driving the success of DiviTum. Now, what I've learned from my experience is that there's a very basic recipe for success in launching new innovative specialty diagnostic tests that change the standard of care.
First, you really need to create awareness and interest with your key opinion leaders and your key users, and you do this by presenting compelling data, and that's the exciting thing about the opportunity at Biovica. As Warren mentioned, the clinical data that has been amassed already is very impressive and is very compelling for physicians. We then work to obtain advocacy. Specifically, we start with the key opinion leaders and the key users, and with that advocacy, we use that advocacy to drive trial with them personally so they get clinical use and experience and begin using our tests.
We also use that advocacy to help them become champions, to share their experiences using the product with their colleagues, so we can begin to create a snowball effect where more and more people gain experience with the product. Another very important aspect with gaining that advocacy is to get that advocacy from these key opinion leaders and key users for them to start to speak to their affiliated hospitals and their affiliated labs to go out and seek and ask to gain access for the tests within their own systems. Now, as we do this, then we work to establish ordering channels, and we need to.
Because we are a relatively small specialty lab and do not have physical facilities where the patients can go get their blood drawn, we work with laboratories to make arrangements so the blood can be drawn and sent directly to the Biovica CLIA lab. Now, we do this a couple of ways. One, we set up specimen handling agreements with labs where we pay a nominal fee to the lab to cover the cost of drawing and sending the blood to our lab and second, we also have the option to contract directly with labs to provide DiviTum testing as a covered in-network benefit. Under the CLIA model, as Warren had mentioned, we make those contracts with the labs. They draw the blood. They send the blood directly to us.
We still perform the tests, and then we send the results back to the CLIA lab, and they have the opportunity to do the billing for that testing. Once we establish the blood sample pathways, we work to overcome any logistical challenges, and we closely monitor and manage those channels. Once these pathways are set, we work to drive demand. We build on the momentum we gain with advocacy. We build on the momentum we gain with access, and as that demand grows, we're able to expand in-network coverage and health insurance coverage. Now, within the Dx specialty space, there are really two key differences between diagnostic specialty sales and pharmaceutical sales. The first one, as we talked a little bit about, is you must secure the blood sample and have it sent to your laboratory.
Now, HCPs or healthcare practitioners use a variety of routes to have their blood drawn, and the preferred route they may use for their standard labs may not be available when ordering their specialty diagnostic products. These specimen routes are also often unique to the individual physician, and many times we find that practitioners in the same office may prefer or have access to different channels. The second difference between diagnostic and prescription sales has to do with the way the test is paid for by the patient's insurance. Reimbursement for specialty diagnostic products is often a little less straightforward, and the patient is often less familiar with the process. Insurance coverage and in-network privileges at local hospitals and IDNs will also influence what tests a prescriber has access to using as well.
Due to these differences from pharmaceutical sales to diagnostic sales, representatives must have a very strong understanding of the differences and be skilled in addressing the logistical issues. Now, although launching a specialty diagnostic product is a little different from the pharma model, we will be building a team that is highly experienced and that will have a very sound and extensive track record of success in the diagnostic selling space.
To speak a little bit more about specimen access channels, the Biovica team that we are assembling has been very successful in the past in establishing multiple ways in which blood can be routed, which will ensure that we will be able to get the samples sent to the Biovica CLIA lab in San Diego. We will follow a formula that we've successfully used in the past to establish multiple specimen channels from which blood can be drawn and sent to the Biovica lab. We will partner with in-office phlebotomists. We'll contract with hospitals and IDNs. We'll do this in two ways. As I mentioned before, we'll set up specimen handling agreements where we pay the nominal fee to have the blood sample sent directly to us, and we will also contract through lab pricing agreements.
We will also route samples through the general reference labs, which have broad coverage throughout the country. We'll set up specimen handling agreements with local and regional labs as well. Lastly, we will also use mobile phlebotomy, where we contract with a third-party company to go to patients' homes or places of business to draw the sample and send it to our lab in San Diego. What we're gonna do is we're gonna work to ensure that our offices have viable specimen channels, that every office will have at least one method, in many cases, multiple methods in which they'll be able to get blood drawn and sent to San Diego to our laboratory, so they can get results.
Now, not only does this give those offices and physicians multiple options, but what we've also found as we customize and work directly with these offices to find solutions that meet their needs, it really has a great effect in establishing relationships with those offices. Also, the result is strong customer loyalty with our practitioners that we work with. Now, there's really three ways or pathways for DiviTum reimbursement to take place, and Warren's talked a little bit about this. At the end of the day, patients and practitioners are most concerned about what the patient's out-of-pocket costs are gonna be. Now, we'll receive payment via three ways, and all three of these payment avenues will be utilized right away and will evolve over time. The first and perhaps simplest is patient self-pay.
Now, patients can be billed directly, and with a reasonable patient out-of-pocket cost for DiviTum, this will be a viable avenue for some patients. If the patient has insurance, in most cases, patients do have insurance, Biovica can work with the patient to also assist in submitting claims. We will also look for solutions where we'll have the opportunity to provide safety nets for patients through patients' assistance program. The second form of payment can be received directly from the hospital system or the IDN through in-network contracting. I've talked a little bit about that. In the past, our team has been very successful in contracting directly with hospital systems and IDNs to have the testing added to their in-network benefit. Now, doing this really creates a win-win-win situation. The first win is for patients and healthcare practitioners.
They gain immediate access to new innovative testing within their normal systems. It's great for physicians because they can order the test just like they order their normal, regular labs, and the patient's testing will either be covered or they'll receive a bill in a way that is normal to them. They receive a bill from their hospital system just like they would be accustomed to receiving for their normal labs. The win for the hospital system and IDNs is they have the opportunity to provide new and cutting-edge testing, and this drives institutional prestige along with physician and patient satisfaction scores. It's great for the institution as well. It's also a win for Biovica because we receive direct payment and prompt payment from the contract, the contract agreements with the hospitals and the IDNs.
Thirdly, patient payment may also be received directly through health insurance plans. On day one, we'll begin to submit claims and expect to receive payment from insurance through claims and appeals. Over time, as we produce utility data and gain inclusion into the treatment protocols, and we demonstrate increased demand, we expect added coverage for DiviTum through the health plans as well. Now, a little bit about our sales structure. Our first wave, we will construct well-balanced regions to optimize efficiencies and drive overall sales. We will strategically target customers and allocate our call capacity against the highest potential customers. We'll develop very concrete call plans to make sure that we're focusing our efforts on the right customers.
We'll provide them with the right messages and at the right frequency based on these call plans. Now, in regards to building the sales team, as these new regions are staffed, we will build a world-class diagnostic sales team. Now, over my last 25 years of experience, I've had the opportunity to build multiple sales teams and have built an extensive network of extremely successful and talented salespeople with proven track records specifically in the diagnostic space. We expect to hire experienced DX sales professionals, salespeople who have had experience establishing specimen channels, professionals who have existing relationships with key hospitals and IDN systems, people with proven track records and histories of successfully negotiating in-network contracts, and folks who have expertise in working directly with offices and laboratories on DX logistics.
Now, in addition to having a strong network, Biovica and DiviTum also present a very exciting opportunity. DiviTum is an innovative new product that has the opportunity to change the standard of care, and I got to tell you, people want to be part of this company and be associated with this product. Folks want their efforts to be meaningful, and oncology especially provides salespeople with an opportunity to truly make a difference in patients' lives. I have a long list of very successful salespeople who have been proactively reaching out to me because they want to be part of the Biovica team. They're excited about the opportunity, and they want to be part of helping to establish a new standard of care in the oncology space.
Now lastly, in regards to targeting, our targeting will use a proven targeting model that has been successfully used in the past to gain adoption with the new diagnostic tests. We'll focus on HCPs with the highest potential in order to order DiviTum in areas where the business is accessible, and we will use multiple data points in our targeting model. The overlay data that we will use will include making sure we're focused on influential KOLs, key NCI and NCCN cancer centers, oncologists who have the highest propensity to treat metastatic breast cancer, areas where sample access can be achieved cost-effectively, and also overlaying that data on top of hospital systems, IDNs, where we have had a history and we know that we can have success in terms of contracting to achieve the highest returns.
With that is the summary of our overall sales strategy and our go-to-market plans for DiviTum. I'll now turn the presentation over to Dan Kaiser, who's our Head of Regulatory and Quality and Lab Operations.
Good afternoon, everyone. I hope everyone's doing well. I'm Dan Kaiser, responsible for establishing the commercial lab here in San Diego, and I'm not sure I'm able to advance the slide here, but I wanted to go to the agenda slide. I'll be explaining a little bit about the logistics and regulatory considerations for establishing the commercial lab. Next slide. I have over 25 years of experience in regulatory and operations, most of that in IVDs and CLIA laboratories. I've worked at Boston Scientific, Johnson & Johnson, Merck KGaA, Nestlé Health Science, and I'm now happy to be at Biovica, establishing the lab here in San Diego. Next slide. I'm joined by Dr. Curtis McGuire, who has come on board as our laboratory director. I've worked with Dr. McGuire since 2014.
We have a really good relationship, so I'm very happy he's gonna be on board. His background is in clinical pathology, but also importantly is a CAP regional commissioner. The accrediting agency, one of the few here in the United States who accredits commercial labs, College of American Pathologists, is very close to his heart, and he's worked with them for a number of years, which should really help us gain our accreditation. Next slide. What we're focused on is complying with the Clinical Laboratory Improvement Amendments. That's a section of the regulations here in The U.S. that governs commercial labs. We'll be overseen most directly by the California Department of Public Health, since we're located in San Diego, and what we're doing is submitting for our CLIA certificate of registration.
Once we have the registration, there's about a 30-day period for the state of California to issue those post-application. We're able to accept patient samples and actually provide patient test results out. They want us to be able to do this so that we can start our proficiency testing and move towards accreditation or certification through the state of California. In our case, we've opted to go with the College of American Pathologists and gain accreditation. We'll have a very good period of time to actually work towards full accreditation and getting what's called a certificate of accreditation. The first one, certificate of registration, allows us to get into the market. The certificate of accreditation allows us to maintain our place in the market as we move forward.
There's some other small jurisdictions here in the United States that we'll have to apply to separately. New York State has their own, CLIA regulations at the Wadsworth Center, and we'll be complying with that. Washington State as well. Combined, these represent about 7% of the U.S. marketplace. We're also gonna be working to comply and model all of our procedures to the ISO 15189 standard. This is a standard for commercial labs and is very well developed, very well understood by both, California Department of Public Health and the College of American Pathologists. Because we do want to ensure samples get to our lab, we've developed our own, collection kit.
Because we're making what's called a Class I device here in the United States, serum collection kit, we'll also register the facility with the U.S. FDA and California Department of Public Health as a manufacturer and be able to distribute this kit throughout the United States. Next slide. The quality system we're putting together based on the ISO standard, we've already developed our quality manual and are putting together our safety manual, HIPAA compliance requirements, all of the equipment material controls. Of course, all of our processes here fortunately are modeled after the processes that have already been well established at Biovica in Sweden. We are replicating and validating those processes. We're also setting up our retained sample and biobank processes and minus 80-degree cold storage capabilities.
All that'll be put in place essentially by the end of June. On the operational excellence side, essentially, as Warren had mentioned, we can get samples to the lab within 24 hours, provide results very quickly, and we're gonna be kind of moderating how quickly we provide results when we first start up based on very low volume so that we're efficient at using our plates. As we scale up, capacity at the lab will easily exceed market capability. We could basically get to over 1,500 tests a day without changing any of our methods or equipment. That's quite a bit of volume. Of course, beyond that, if we get to that point, we can continue to scale up and support anything that we're able to bring to the San Diego laboratory.
We will be working to put a lot of infrastructure in place in the coming weeks, including laboratory information systems, quality management systems, and working to make sure that we put all kinds of recycling methods and things in place to be sensitive to the environment and the impact we have in the environment. Next slide. The laboratory is already set in San Diego. There's an image of it there, and we're going through now and doing the product flow from samples coming in to full test and providing test results out. We're populating the lab now with all of the equipment, lab furnishings, and things that we'll need to start testing and then, of course, to scale up as we continue growing the business. Okay, after that, I wanted to turn it over now to Dr. Amy Williams, who'll be talking a little about the clinical considerations for DiviTum.
Thank you, Dan. All right, I think I'm maybe having the same issues you were having. All right, yeah, someone else may have to move the slides. There we go. Yeah, next slide. Good day, everyone. My name is Amy Williams. I'm the Head of Clinical Development and Medical Affairs at Biovica, and I have the pleasure of sharing with you today some new and exciting data from the past year. This data has led to an expansion of our thinking about the possible clinical utilities for DiviTum and the ways that it may help oncologists manage their patients' care. I will also tell you about an advisory board that was held in the U.S. last year, and I will end with some very exciting news about an upcoming presentation at the annual ASCO meeting next month in The U.S.
I joined Biovica in February of last year. I have a Ph.D. in pathology, and for over 20 years, I've worked in oncology drug development at all stages, from early drug discovery to clinical trial development to product launch and then ensuring uptake in the market after approval. I've worked for several large pharma companies. The most recent was with Novartis on their breast cancer team, where I supported many of the company's FDA-approved drugs, including Kisqali, one of three approved CDK4/6 inhibitors on the market.
Novartis and other CDK4/6 drug manufacturers have tried for years to find a biomarker that could predict response to this class of drugs, and so far, no good biomarker has been identified. One of the reasons I was so excited to join Biovica is that I believe thymidine kinase has the potential to finally fulfill this unmet need for a predictive CDK4/6 inhibitor biomarker, and that's some of the data I will be sharing with you. Also on the Biovica clinical development team, we have Mattias Bergqvist. Mattias has been with Biovica for over 10 years. He has extensive experience in brand management from previous roles, and he's currently doing a great job directing all of the DiviTum clinical trials outside of The U.S.. Next slide. It's been a very busy 12 months for Biovica.
Many of the clinical trials which were initiated years ago have completed enrollment. The TKA data from those trials has been analyzed, and the results were either published or presented at major congresses in 2021 and early 2022. More important than the publications themselves are the insights and new information about DiviTum that we gained from these trials. Next slide. I will share with you data from just one of these studies. It was a Novartis trial called BioItaLEE that was presented at the ESMO meeting last fall. Next slide. The trial was a breast cancer study that treated patients with Novartis' CDK4/6 inhibitor drug ribociclib. CDK4/6 inhibitors in general have become the worldwide standard of care for patients with hormone receptor-positive metastatic breast cancer. Almost every HR-positive metastatic breast cancer patient will be prescribed a CDK4/6 inhibitor at some point during their course of therapy.
If these drugs are given in the first-line metastatic setting, most patients will remain on a CDK4/6 inhibitor for two to three years. Other than hormone receptor positivity, there's currently no biomarker that can predict benefit for a CDK4/6 inhibitor. It remains an unmet need in oncology. We have very strong data suggesting that DiviTum may be able to function as a biomarker of CDK4/6 inhibitor response. Next slide. This is the DiviTum TKa data from the BioItaLEE trial. Patients were treated with a combination of two drugs, ribociclib plus an endocrine therapy, letrozole in this case. Blood samples for thymidine kinase activity analysis were taken at three different time points, pretreatment, two weeks after starting treatment at day 15, and then again two weeks later at what is referred to here as cycle 2, day 1.
It's important to understand how these drugs are taken by the patient in order to interpret the TK activity data. The endocrine therapy drug, the letrozole in this study, is taken once a day, every day for each full drug cycle. One drug cycle is 28 days. However, the ribociclib is taken once a day only for three weeks, and then the patients stop taking the drug for a week. This diagram on the lower left illustrates why this is important, for the TK activity sampling time points. At baseline, the patient has not yet taken any drugs. At day 15, they've been taking both drugs for 15 days. At the third time point, day 28, the patient has stopped taking the ribociclib for a week but is still taking the letrozole.
If we use TK activity data from just the on-treatment time points, there are three distinct patterns that can be observed. On the right side of the slide are spaghetti plots that illustrate these three patterns. For each plot, the three different sample time points are on the bottom axis, and the TK activity level is the vertical axis. Each line on the plot represents an individual patient. You can see how each patient's TK activity levels change across the three different time points within each plot. Pattern one, which is the one on the far left, represents patients whose TK activity levels were fully suppressed to below the level of detection of the assay on day 15. TK activity levels remained below the level of detection on cycle 2, day 1, which is one week after stopping the CDK4/6 inhibitors.
Patients with that exhibit pattern 2, that's the one in the middle in blue, also have TK activity levels that drop to below the level of detection on day 15. On cycle 2, day 1, after having stopped the ribociclib for a week, TK activity levels rise or rebound. Pattern 3, which is the one on the far right in yellow, represents patients whose thymidine kinase activity levels never fall to below the level of detection at any time point. All right, next slide. Where this data becomes very interesting is when you align those three TKA patterns with patient outcome. In this figure, you're looking at progression-free survival curves for each TK activity pattern.
Progression-free survival is the amount of time that a patient's disease is being well controlled by the drugs they are on, and the tumors do not grow or progress. Along the horizontal axis is the progression-free survival time in months. The vertical axis is the percentage of patients at each time point who are progression-free. Look at pattern one. That's the black line. This is the group that had complete TKA suppression at both time points, and you can see that almost no one progressed on the combination of ribociclib plus letrozole for a year. The median progression-free survival time has not even been reached yet in this group after over two years of follow-up. Pattern 2 , that's the blue line, that the median progression-free survival for that group is 22 months, which is very good, but these patients clearly do significantly less well than the pattern one patients.
Pattern three is the yellow line. These are patients whose tumors never stop proliferating, at least according to their TK activity levels. Not surprisingly, they have the worst median PFS time of the three groups, with just 10 months. Next slide, please. I just showed you some data from one trial, but we've seen this pattern consistently across multiple trials with different CDK4/6 inhibitors in combination with different endocrine therapies and in different disease settings, both metastatic and early breast cancer. We see this same V pattern and a very similar mixture of patients that have a complete TKA response and do very well on CDK4/6 inhibitors along with those who do not exhibit a complete TKA response and subsequently do less well and progress faster on a CDK4/6 inhibitor. Next slide.
Based on this data, as well as what we know about the function of thymidine kinase and cyclin-dependent kinases and how they are connected, we believe that we have a strong biomarker that can predict a patient's response to a CDK 4/6 inhibitor from the measurement of thymidine kinase activity at just three time points during their first cycle of therapy. This is an illustration of the three different TK activity patterns along with what we believe each pattern indicates is happening within the tumor and then subsequently what that predicts for outcome for the patient. Pattern three, this red line at the top, seems to indicate that the tumor has not completely stopped proliferating or growing.
The presence of detectable thymidine kinase activity suggests that complete cell cycle arrest was not achieved, and not surprisingly, the length of time on therapy will be short, and the patient's outcome will be poor. In pattern two patients, that's represented by the yellow line, a complete cell cycle arrest does occur while the patient is taking their CDK4/6 inhibitor. There's a rebound in TK activity levels on day 28, which we believe represents the tumor dividing again during that one-week drug holiday, suggesting that these tumors were only transiently or temporarily arrested while on therapy and that this arrest is reversible. These patients do fairly well and will have a good outcome on therapy, but because their tumors are growing and dividing for one week out of every four, they will eventually progress.
Pattern one patients, that's the blue line on this chart, also undergo a complete cell cycle arrest while on a CDK4/6 inhibitor, but this arrest appears to be more durable and does not seem to be reversible during the drug holiday. The data suggests that these patients will remain on therapy for a very long time and will have an excellent outcome. Next slide. We think that these TK activity patterns will have utility in clinical practice beyond just predicting patient outcomes. On this slide are several potential ways that an oncologist could use DiviTum TKa data to manage their patient's care.
For the pattern 3 patients in red, if a physician sees that their patient is having an incomplete response to the CDK4/6 inhibitor that they've prescribed, this is an opportunity for the physician to explore why that patient's tumor is not responding and possibly take some action. One explanation is that the patient is maybe not taking their medication properly, or they could be on a second medication, which happens very frequently, that is interfering with the absorption or metabolism of the CDK4/6 inhibitor. There are a list of drugs that are known to do this. Seeing this pattern could trigger the physician to ensure that their patient is taking their medication according to manufacturer's instructions.
The other possible explanation for a tumor that's not responding to a CDK 4/6 inhibitor is that it may have a mutation which makes it resistant to this class of drugs. This profile may trigger a physician to order a tumor mutation profiling test to look for a mutation. For the pattern 2 patients in the yellow, they will likely do very well on therapy, which is good news, but they do have this rebound in thymidine kinase activity during that one-week break from their CDK 4/6 inhibitor drug. It is possible that these patients could benefit from either an endocrine partner switch or a CDK 4/6 inhibitor switch. For the pattern 1 patients, those are the ones in the blue, their TK activity profile suggests that they will do really well and will stay on therapy for a very long time.
Perhaps these patients could be scanned less frequently. A physician could choose to reduce the number of imaging scans from every three months, which is standard, to possibly once or twice a year instead. Next slide. We're collaborating with Washington University in St. Louis on a prospective clinical trial called TK IMPACT. This is the first study where oncologists will receive real-time DiviTum TK activity data from their patients' blood samples, and they can act on this information if they so choose. The study population is metastatic hormone receptor-positive breast cancer patients who have been prescribed any FDA-approved CDK4/6 inhibitor along with any approved endocrine therapy. The diagram on this slide illustrates when blood will be collected for TK activity testing every two weeks for the first two cycles and then monthly for the next five cycles.
This might sound like a lot of blood draws and blood samples, but it actually aligns exactly with the monitoring recommendations for all three approved CDK4/6 inhibitor drugs. No additional blood draws would be required in order to use DiviTum in these patients. Next slide. Late last year, we held a scientific advisory board with 13 different breast cancer medical experts from 12 of the leading NCI cancer centers in The U.S.. We ensured that every section of the country was represented at the ad board. We also had a good mix of experience among the participants, some who had a lot of prior experience with DiviTum and also some who had no experience or even no awareness of DiviTum.
We shared our new clinical data with these experts, and we had very productive discussions about how best to use DiviTum in the clinic to manage their patients' care. Next slide. The reaction to the data was very positive. You can see some of the comments here on this slide. Additionally, the advisors also had some new ideas and suggestions for us for how DiviTum could be used in clinical practice. Discussions have continued with many of the advisors to initiate new research collaborations. Next slide. Separate from the advisory board, we've also had some new unpublished data which suggests a novel utility for DiviTum. We have filed a patent application for this new utility, so unfortunately, I can't disclose what it is today.
I can only share that it is still within the oncology space and that it would help address an unmet need within a very large market. Once the patent application is approved, we can communicate more details. Next slide. I will end on another bit of exciting news. At the annual ASCO meeting in Chicago next month, DiviTum will be featured in an oral abstract where it will be compared directly to ctDNA data from the same patients who participated in the BioItaLEE trial. We already know from past presentations at ESMO and the San Antonio Breast Cancer Symposium last year that TKA data and ctDNA data highly correlate with each other. We also know that there are some important key differences, and those will be highlighted and discussed during this ASCO presentation.
If anyone is registered for ASCO and would like to view the presentation live, it will be held on Monday, June 6th at 6:18 P.M. Eastern time. It will also be recorded and available on demand for viewing later on the ASCO website. Thank you all for your attention. The next presenter will be Henrik Winther, Biovica's head of business development and pharma collaborations.
Super. Thank you very much, Amy. Yes. I'll be speaking about our pharma collaborations. More precisely, I'll be speaking about the strategy we have with the pharma collaborators or our collaborations in general, our current status with these pharma collaborations, and then also the financial impact those collaborations have on our business. A little bit about myself. Currently, the head of our business development and pharma collaborations. I have +20 years experience within the diagnostic field, very much around bringing biomarker assays into the routine clinic. I've had, you know, some managing roles both in R&D and business development in that respect. I have a special passion around companion diagnostics and collaborating with pharma. I was actually design responsible for the first global market companion diagnostic HER2 test from Dako.
I was also responsible for both the development, registration, and the commercialization of a couple of key companion diagnostics on the market. It was for the two blockbuster drugs, Keytruda and Opdivo. I was, I guess, building the companion diagnostic unit at Dako and also Agilent Technologies. If we look at Biovica's thinking about pharma collaborations, I should start by saying why do we actually want to collaborate with pharma? There's both, you know, a patient perspective and a business perspective. I guess, the patient's perspective is that we really want to improve personalized treatment by adding our biomarker to that solution. We do that actually by adding our biomarker to that solution. By adding a biomarker in a better way, we can select those patients that will benefit from a specific treatment at a specific time.
That's the patient benefit of really improving personalized treatment. Business perspective is that these kinds of products are high-value products. Secondly, these products are typically the development and registration, commercialization of these products, we can have them funded by pharma. That's why we wanna collaborate with pharma, why we want to build companion diagnostics. Our strategy is two-staged. Initially it's about building trust with pharma. Very important to build this trust both in our biomarker, but certainly also in our company. Strategy-wise, we approach oncology companies, it is within cancer we focus on companion diagnostics. We reach out to companies both in U.S. and EU. Initially, it's offering a fee for service where we do TKA testing.
This testing is typically performed in preclinical and early clinical studies with pharma. That's, I should also say these pharma companies' highest success rate is really aiming at, large and mid-sized pharma, so that is also what we do. At stage two, going from, you know, the building trust in the biomarker and our company, we move into true collaborations where we, you know, together with pharma, develop these companion diagnostics and monitoring diagnostics that we have the opportunity to do. What kind of services are we then providing to pharma today and going forward?
Right now, as I said, it's primarily within research, which means that, because we have a lot of experience in the TKA biomarker, obviously, we actually participate and our pharma, they consult us to bring in the biomarker to their clinical trials. We advise them, you know, how many samples or at what time points to acquire these samples or, you know, collect these samples, I should say. That's part of our service. We also naturally undertake the TKA testing, and that TKA testing, we either do in-house currently in our Uppsala facilities, but also of course we'll do that in our CLIA facilities in US, going forward. We also have a couple of key collaborating laboratories that we can use for these activities.
We have UCR in Uppsala, and then we have the Mayo Clinic research facilities also in The U.S., where our assay has been established. When we have undertaking the testing, you know, we'll have some results and then again, pharma ask us, you know, please help, you know, interpret the results, you know, and help us where to set cutoffs. This is also part of the service we currently provide and you know, where we spend hours together with pharma. It's all fee for service as I said. Next step and a natural continuation of this research collaboration is obviously to move into IVD development of these companion and monitoring diagnostic devices. Where are we currently with our pharma collaborations?
Actually, I think it's a great opportunity to present today because we had a great year, fiscal year, last year with our pharma collaborations. It's partly due to I think a very professional organization, you know, ready to execute on these projects together with pharma. Certainly also due to the great clinical data we have out there now that was presented by Amy. Some really great data that has attracted pharma. It's mainly the predictive and monitoring capabilities of the TKA biomarker that has attracted pharma. Amy did a fantastic presentation, so I'm not you know, gonna repeat but perhaps a little bit, you know, summarize what it is that is attracting pharma.
Number one and the first line on the cartoon here is really the ability of our TKA assay to in a population of breast cancer patients to identify and select those patients that will benefit from a single treatment versus a combo treatment. This was shown in the SWOG study. I have a slide here that Amy actually developed a slide elegantly presenting, you know, what I mean by this ability to identify and select those patients. If you look to the left, you see a population of patients here that is if you look at the overall survival as Amy presented before. Two curves, you know, two different parts of the population.
One part of it, you know, receiving the combo treatment, the blue line, and then part of the population only receiving monotherapy, the red line. If you don't use a TKA biomarker as is shown here to the left, I mean, there's barely any difference between the two populations. The blue line is, you know, a little bit higher than the red line, but it's not significant. If you then look to the right, and this is, you know, a case where you then introduce TKA as a biomarker to select, identify patients. You can see that if you are expressing TKA highly, then suddenly the two lines differentiate. It's very clear that the blue line significantly benefit from you know the combo treatment.
The blue line is the combo treatment and it significantly benefit from this combo treatment. This is what TKA can actually do. It can differentiate between benefiting and not benefiting from combo treatment. You can see on the lower one you have a low TKA and there's really no difference between the two populations getting combo versus monotherapy. This is a great example of actually using TKA to predict and select patients. The benefit here is of course if you are a low TKA expresser why then have the second drug? You're just gonna have, you know, more side effects and it's gonna be very costly, but it has no effect. This was an eye-opener obviously to some of the pharma companies.
Going back to the cartoon here, Amy already mentioned the BioItaLEE and the PYTHIA studies, where by help of three TKA measurements can actually identify again in a population those patients that will benefit from a CDK4/6 inhibitor treatment, those that will not, and those that will have to, you know, have an adjustment of their CDK4/6 treatment. Also an eye-opener to pharma obviously. Then the palbo dosing study also here using our biomarker as a monitoring biomarker. Again, keep an eye on the patients and identify those that still benefit from the treatment and those who don't and have to switch.
These studies, the SWOG, the BioItaLEE, the PYTHIA, and the palbo dosing studies, all the results coming out last year was really convincing to pharma that, whoa, the TKA biomarker can be used as a stratifying tool to our patients. That really attracted them. It was both large companies and also mid-size companies that reached out to Biovica to ask for the TKA biomarker assay. As you can see from here, indications that they were looking at these different pharma companies, typically solid tumors including breast cancer. You can also see from the table here that we have different types of agreements with these pharma companies. It's still service agreements. It's however moving towards, you know, close to the collaboration agreements.
We often start off with what we call a TISA, so that's an evaluation service agreement. They want to test our assay, our biomarker, and see what it really can do. They wanna test, you know, our company, you know, can we execute? They wanna test the data. Are they robust and reliable? If they're happy, they move into broader collaborations. So far, we actually haven't had anyone not moving into the next step, moving into broader collaborations, that being master service agreements or research agreements. We also have a couple of pharma companies and a bigger pharma company that has actually entered into supply agreements with us, receiving our research use only kits and then running their own trials in their own CRO laboratories.
Actually, the onboarding of pharma last fiscal year, the one that just, you know, ended, exceeded our expectations. What I tried to show here on this slide is that on the upper part of the arrow here you can see the plans or expectations we had for fiscal year 2021/2022. We had planned to sign three of these TSAs, the evaluation agreements. We had hoped to be in a master service agreement discussion and have that initiated. We planned on having three mid-sized pharma companies into our portfolio, and we also planned on having three pro-projects initiated.
When we ended the year three weeks ago, we looked at our progressions with the pharma collaborations, and we actually had two TSAs. We had three master service agreements signed, one large-sized pharma company and six mid-sized pharma companies in our portfolio, and we have six projects initiated. It was actually far above our expectations. If you compare the results from 2021, 2022 to our goals for next fiscal year, we come to the conclusion that we are, you know, ahead, one year ahead of time with our pharma strategy and goals. Moving into the financial impact and expectations. Again, here I try to show the two stages we operate in.
In the stage one, where we build trust, we do research collaborations with pharma. The revenue really comes from these services that we provide and the research use only kits we provide. You can see that there's typically a price tag on each agreement which we have with pharma, and that'll then generate a certain amount of Swedish krona. You can also see that we then move into a stage two at a certain point of time. It's a natural continuation. What we have in our plan for stage one, I should say, is that we really want to run approximately 10 projects with pharma. That's based on my experience from the Dako Agilent days that if you have 10 projects running, typically one project will go all the way through to a CDx product.
Having 10 projects running will naturally kickstart stage two, you can say, which is a collaboration with pharma and developing a true companion diagnostic or monitoring diagnostic product. In stage two, the way you should read this slide here is really that in stage two of our strategy, what you see on the left side on this slide here will continue. We'll still have the research collaborations, the sale of research kit. In stage two, we add on the CDx development activities and the fee for service revenue we generate from there. You also see in the table here, the sizes of fee for service revenue. You see the sizes of the product sales revenue from for these CDx products.
This is again really based on the experiences from my Dako and Agilent days, how much, you know, such a product and fee for service can generate. A yearly revenue potential of a typical companion diagnostic product lies between, you know, $50 million-$100 million. If we dive a little bit more into stage two, because this is really where you can realize the potential of this business. If you look at the components you have in the revenue here, we have tried to put it into two buckets. You have a bucket which consists of the research use only activities, that is, the services and the kit sales, plus the companion diagnostic development projects.
That is really the blue line to the right, and how it evolves. The gross margins for that piece of the business is typically between 46% and 50%. The big win is obviously on the actual product sales that will kick in later in stage two because it will take some time before we have developed the companion diagnostic product. But here the potential is obvious. In these projections, we have built in some key assumptions. Again, these assumptions really come from my experience back in the Dako and Agilent days. As I mentioned before, typically, you know, 10% of research use only projects will continue into a full development project, IVD project, product.
20%-30% of CDx projects turn into CDXs. A typical timeline for developing such a companion diagnostic is four years, and if it's an add-on where you just add another indication to an existing companion diagnostic, that'll typically take, you know, 1.5 years. These projections made us set some goals for our business, some milestones for our business. Our expectations are really that within the next six to eight years we'll have
At least SEK 50 million in research use only revenues. We'll have our first CDx product launch within the next four to six years, not at least based on the very promising clinical data we have now. Then there's a potential for the CDx business revenue to become or to come near to SEK 500 million Within the next eight to 10 years. So with that I'll hand it back to, Anders.
Okay. We can stay here.
Yeah. 2.
All right. I'll just summarize before we let the questions in and discuss those. I'd like to say that we have, as we've hopefully shown today, a very interesting and important biomarker, and an assay to measure that. That can be really valuable for patients, but also for treating physician, for healthcare providers and for payers. Together with our collaborating partners, the academic institution and key opinion leaders, we've been able to prove that with data, and that is now the foundation for all the activities that we're doing now. The regulatory process, but also we built a team, a really strong team on our planning for the launch, as soon as we have the regulatory approval in The U.S..
We have some exciting times ahead. The first one, which we expect to happen now in a couple of months, is the 510(k) clearance and the clearance of our CLIA lab. We'll need a couple of months to plan and launch the product in U.S. We expect that to happen before end of this year. The next step is to launch it in Europe on the first market in Europe. In eight to 10 years, Henrik, we have the CE companion diagnostics as well.
Mm-hmm.
Thank you a lot for everyone who has listened in to this. Now Charlotte is ready with some questions that I think have been submitted to us. We're looking forward to that.
Thank you, Anders. That's true, I have a couple of questions, and we've had some from the web as well. If you want to pose questions, please continue to do that because they will come up here on the screen. I'll start a bit where you ended on the FDA, because you've had a couple of questions on that from the web.
Yep.
Is there any possibility that the FDA won't approve your application? Can we just settle that for-
Yeah. Of course there's nothing like a risk-free business. We have had a very good discussion with the FDA. The only problem really is the long turnaround times. The dialogue in itself has been really good. We've been able to sort out all the open question. The last remaining bit was the additional data that the FDA wanted to see. We agreed beforehand, before performing the trial, now from January to April about the study design, and then we performed the trial that complied with the goals we set up, and the FDA has also approved that before sending it in. We've gone through a number of steps, sorting out all the open issues.
That, of course, will, in our mind, increase the probability for success a lot going through this process.
I guess the worst case scenario is not a "This is not approved." It's continued questions, so to speak.
Yes. There will be further discussions and that will of course. When I say in the coming months, I assume that we will have a smooth process going forward. I've taken some contingency for. Like, a normal process would take one to two months, but we're not back to 100% normal according to the FDA. They still have resource constraints due to the pandemic situation. But it's a lot better because they have increased resources and the backlog that they have is a lot less. Things are moving in the right direction also at the FDA office according to their public-
That is another question. I guess you've
Yeah
Answered it already. What would be a standard reply time for FDA in this situation?
Yeah.
I guess there is no standard.
one to two months according to the process that was on one of my previous slides.
Yeah.
Yeah.
Yeah. That was that. Now, going over to some of the other, leaving FDA, it is important that you get reimbursement. We've talked about that. Do you have a timeline on the plan for reimbursement? Any milestones that we should look out for?
Yeah. I think what we can do is to give some guidance roughly, and I think, Warren, if you could elaborate a little bit on that.
Yeah, absolutely. Thank you for the question. From a reimbursement timeline perspective, this is something that we work on immediately upon FDA clearance of the product. As you can imagine, there are many different insurance companies in The U.S. So the timeline for Blue Cross Blue Shield versus Aetna, you know, versus UnitedHealthcare, they're all different. The one thing I wanna make absolutely clear about is that there is a differentiation between reimbursement and payment. So from the beginning, we will get paid for DiviTum. We'll get paid through this direct bill channel or the hospital networks in general reference labs and patients. But we will also get paid through insurance companies as well. Typically, when you get reimbursement coverage, you know, you're within their policy.
When a bill is submitted, you get paid very quickly, very easily at a predetermined amount for the test. Prior to having that coverage, there's just a process that you have to go through. You submit a claim, and then you typically have to go through an appeals process where you show medical necessity, and that's what we will be doing from day one. There's a bit of a difference. We will get paid for the assay. It's a little bit more work, but as we work towards coverage, then it'll be a bit easier. From a timing perspective, that's really driven by product utilization and clinical utility, and we're working on clinical utility today.
As soon as we launch the product, we'll have a better understanding of the uptake of the product which will really help dictate how quickly insurance will cover the product, moving forward. I hope that answers the question. The one other piece I do wanna mention with this is when Kendon was speaking about the targeting of physicians and the high-value physicians that will use DiviTum, we do actually overlay insurance companies and their location. Insurance companies, you know, you don't find it the same insurance company in every state or even every part of the state. This is one of our targeting strategies as we actually look at not only the physician but the provider, and what we do is we take a look at the providers that are typically early adopters in paying for novel tests.
Hopefully that answers that question.
Thank you very much. Now we have a question from the audience here. Johan Nierås, please.
Yes. Thank you for taking my question. First, I can follow up on the FDA process regarding this last clarification. I believe it was some related interpretation of data. Is that something that could have an impact on how the precision and how you interpret the data?
Henrik, do you wanna elaborate, help me elaborate on that?
Yeah. I mean, the discussions we've had is primarily related to the analytical performance and the way we undertook, you know, some of the studies, the data we provided. They wanted to have some additional data on the so-called robustness of the assay. They wanted to have it in a little bit of a different way than we had understood and also, you know, there is a lot of guidelines and new guidelines and what have you. We designed the new study, and we sent it to FDA. They approved it, and then, you know, we submitted the new data. They looked at the new data just briefly and accepted them but then have to discuss them internally in a broad way.
Thank you.
Mm-hmm.
I guess it's difficult to have a clear-cut answer if it affects the read out of the precision. It's more methodological.
No. It's. I think you're thinking about the clinical performance. This was technical data, and it was the study overlapped the previous study that we done to a great extent that Henrik said. We just had to add some additional samples to reconfirm what we already confirmed in the previous round. Yeah, it's a technical performance part that was clarified.
Yeah.
In the format that the FDA wanted, basically.
Correct. I mean, we should emphasize, I mean, there's two parts. I mean, there's always the analytical performance of an assay, which is the technical. This is, you know, how the assay is performing technically. Then there's the clinical piece, which is, you know, the clinical data you have shown using your assay, which I guess is, I mean, it's not more important, but, of course, very important, you know, when you show sensitivity, specificity, and what have you, from a clinical perspective. I think the confusing part is you always talk about sensitivity and specificity, you know, from two different angles. Technically, how does the assay, you know, come out technically, you know, from a sensitivity and specificity way? Clinically, how does the assay come out sensitivity and specificity-wise, on the clinical side? You have those two aspects.
In this case, it was the technical piece of the assay. How does it work in every laboratory? How does it work in your own lab when we transfer it, you know, to the operations and all that stuff? It's very technical. It was just, I say just because we had undertaken the stability testing, you can say, or performance testing, analytical performance testing in one way according to a certain guideline. FDA was really asking, you know, for some additional testing according to a different guideline.
Mm.
You know, we provided those additional data.
That part of the application, we believe we worked through it so many times now and presented, convincing data. I would say that's a low risk.
Yeah
In this part of the application. Yeah. In general, we covered, I would say, more or less every area in deep discussions with the FDA. That's why we feel confident with the process.
Yeah.
Thank you. It's good to have the clarification anyway.
Yeah. Yeah.
The next stage is, of course, what you alluded to, this typically one to two month waiting time, put it that way, which could, of course, perhaps be longer given the circumstances. You have the status of an interactive process. Is that something you benefit from during this process as well?
We had a status of an interactive process leading up to the submission, and I think we have benefited from that because we've had a very open discussion being able to sort out the questions that was open with the FDA. Before resubmitting, we clarified everything, so there should be nothing that we haven't discussed that should arise from that discussion, is our understanding. I would say that's the benefit. The FDA are suggesting an interactive process when there are only minor questions to discuss and resolve. Basically, our biggest challenge is that this interactive process has still meant long lead times in the
We have turned around the answer in maybe 24 or 48 hours, and then waited weeks to get the response from the FDA due to their resource situation.
Thank you. This, your strategy to approach the US market, by the clear pathway, put it that way, it may not be familiar to all investors or the audience. What is the main advantage, would you say?
Yeah. The main advantage is that we will directly interact with both our customers, the different hospitals and oncologists, and the payers, and removing that one layer. We will have control over the process of achieving reimbursement, like Warren said, with the different payers. We'll be in the driver's seat. I think to me, that has to be the one decisive factor which has convinced me that that's the right strategy. I don't know if you wanna add something to that, Warren.
No, I think you said it perfectly.
Given the additional opportunities and the ambitions that you presented today and partly earlier, I presume that the ability to control and secure patient consent and to actually be in control of the data and the opportunities that may give is also part of it.
Yeah, that's an additional benefit. It's not the main driver, but it's an additional benefit of the strategy. It works very well because it's a win-win. With an informed consent, we can present to the patient not only the test result, but also how it works in a trend with previous test results. As Amy, when she presented your results, you could see the pattern in itself provide some very, very important value. Being able to present that to the patient, of course, is beneficial for the patient and for the treating physician, but also for us to be able to use that data to further explore opportunities to combine with other biomarkers and to develop, to shorten time to market for new products. It's a-
Mm-hmm.
It's a nice model. We create a lot of knowledge. The information in itself is valuable because, yeah, we can draw conclusions from that.
In real life, there's always the flip side. What's the main disadvantages then?
Well, there's a disadvantage that we need to staff a lab, so we need to have additional competence to do this. I think that trade-off is worth it, especially with Dan Kaiser with the expertise and experience doing this successfully in the past. Look at the big picture, it's worth that extra effort.
Are you comfortable in giving any indication of the cost of this operation and the time when it will be, not fully operational, but ready to perform tests?
The good thing is that initially it will only be a couple of full-time equivalents in the lab. Of course, when the volume scales, we need to scale as well, but then we will have increased revenues. It scales well also. We can make really efficient processes to scale as well. It won't be a significant cost in the total in our financial statements.
The lab presentation part was very full with details, but some takeaways was that you will be able to service more or less the whole country from the central lab.
Yeah. Yeah.
It seemed like there might be some additional requirements in some regions. Was it New York and Washington?
Yeah. First of all, there's a technical aspect here, which we didn't mention that much. We have developed, or in the process of developing the blood collection kit to simplify this process, and it will go through FDA approval as well. We're making progress there. That's also based on assumption that the blood samples can handle this transportation. We've done the trials doing that confirm that as well. Of course, the biomarker and the blood samples must be able to handle that logistics. That assumption has been checked and verified as well. That's also part of the equation. When it comes to the different territories, different states have different rules for this. New York is one that normally takes some time to get approval.
I don't know if some of the US people, if it's Warren or Dan who wanna elaborate a little bit how this set of rules work with approvals for the CLIA lab in different states. Warren?
Maybe Dan could comment.
Maybe Dan, yeah.
Yeah. Certainly, Anders, and thank you for the question. We're very happy to be setting up the commercial lab in San Diego. In addition to all of the benefits on the revenue side, it certainly helps us control the test and its introduction in The U.S. marketplace, very well. We'll make sure the test results go out, and DiviTum gets a good reputation in the marketplace. For the first patient test samples, of course, that's the CLIA registration. There are different jurisdictions like New York, as you mentioned, and Washington State that have their own regulatory schemes, but fortunately, none of the requirements are different. It's just the filings and approvals that are handled separately. You don't need different processes or different procedures or anything like that. We'll set up our initial processes. We'll get the registration.
We'll go forward with the accreditation pathway, and those states will accept that method. We just have to file separately in those jurisdictions to get approvals. Those take anywhere from, you know, three to six months, sometimes not as quickly as California, but we'll file them as early as we can and get on market in those jurisdictions as quickly as we can.
Excellent. If everything goes to plan, you will secure a 510(k) approval. Is that something that will be important also in the CLIA strategy, the status of 510(k)?
Not necessarily. There's no dependencies like that, but there's this dependency in the way that we intend to offer our 510(k) cleared test through our CLIA-certified lab. We need, of course, to have the clearance to be able to offer it as a 510(k) cleared test, although it's through our own lab. That's why we need both the clearance and accreditation.
Yes. I was also thinking about the next layer, securing reimbursements and traction.
I mean, there are uncleared tests like laboratory LDTs that are reimbursed, so it's no requirement, but a cleared test of course facilitates reimbursement as well as pharma collaborations, et cetera, also as well.
Excellent. Finally, if I may, congratulations, you already secured and proved that you attract pharma interests, which was an interesting part of the presentation. Also in the CLIA part, it's also a requirement and secure demand from, well, from the clinical segment of the market. How will you go about securing that?
You mean for clinical use or for pharma use, or for both maybe?
No, for clinical test monitoring therapies from specialist centers.
All right.
and the like.
Yeah. Warren, you had that in your presentation. You wanna elaborate on the plan on how to generate demand?
Well, I'm sorry. What was the?
I think-
Specific question? I didn't quite understand.
The question was, after a cleared test is available, you need to work on how to generate demand. If you could elaborate a little bit on how we're gonna generate the demand on the US market.
Yes.
Is that something we need to do?
With a different strategy, perhaps a partner or so, they would have done that, a commercial partner. Now with the CLIA strategy, I guess you will need to secure that or support that more directly in-house.
Yes. That's correct. Having the CLIA laboratory, we will have a specialty sales force that calls on oncologists directly. Those specialty sales reps not only will they talk about the clinical utility of DiviTum specifically, but these particular sales reps are also experts in regards to the logistics behind getting that patient sample sent to the laboratory. This does give us our best opportunity to be able to drive utilization of DiviTum. If we simply sold this into clinical labs directly into a hospital lab, then there's no driver out there discussing the product and working through the logistics to be able to get those samples into those hospitals. It's really this joint effort between sales and our clinical group discussing the clinical utility of the product to drive demand.
I hope that answered your question.
Thank you. Thank you.
Great. You've had many questions here. I hope most.
That's good.
of them have been answered in this discussion actually. There is one question here, and it's about the competitiveness of the product. Is there something already now in the short term which could reduce the market potential for DiviTum?
In the short term, we believe we have a very strong position, especially if you look at the metastatic breast cancer monitoring area. Our data, a little bit like Amy touched upon, we believe is unique. Over time, of course, someone could develop something similar without infringing our patents. That's of course a possibility, but we still will, in that case, have a first mover advantage with all the clinical data that we have generated. I believe we will have a very strong competitive position.
Tests like ctDNA and
ctDNA is some really, really interesting technology and also a hot topic. However, within this area, I think Amy touched upon that as well. We believe we have a very convincing data, performs very well against ctDNA, something that's been shown in the BioItaLEE trial and will be on that oral on ASCO in about a month or less than a month from now. However, I want to be fair to say also that the key focus for ctDNA has not been in this space, but in earlier phases of the cancer in different applications. We're not a head-to-head competitor against ctDNA.
This touches another question, about how you will position the product. Will it be towards cost savings, such as reducing futile treatments, or will it be differentiating, as Henrik was talking about high-risk patients, to aid the design of a treatment or changing treatments? Would you-
Yeah.
Do you need to make a focus on either of them?
We will position what we can prove with data, and we have the luxury of having both. In a health economic model, the lowest threshold initially when launching it is to do cost comparison, cost avoidance, which we can prove. We will start with that, and over time, we will generate data on more ambitious claims.
And then-
Yeah.
I'm gonna try and understand this question, actually, but it's because I know too little. For how long can you operate with a CLIA certificate of registration before you get the certificate of accreditation?
Maybe, Dan, you can elaborate a little about how that work with accreditation and a certificate.
Thank you, Anders. There's different pathways, but since we're going the accreditation model, we actually will file for the certificate of registration from State of California, and they give you up to two years to gain accreditation, because we're working with College of American Pathologists. That's quite a lengthy period of time. During that time, we'll be establishing proficiency, sending data to the CAP organization, who will actually be doing an on-site inspection. State of California will recognize all this and allow us to continue operate while we're working through that process. We have quite a bit of time to gain accreditation.
Great. I'm gonna ask this question just because I want everyone to hear their questions being asked.
Okay.
How important is shareholder value to you?
Well, I think we all are driven about, yeah, a couple of different drivers. I think we discussed this internally, so I think we share this as a team. I think one very strong driver is to make a positive impact and change for patients and for society, healthcare providers and payers. Of course, we understand, and we are all in the management team and the board of directors, somehow shareholders and have that incentive as well. We also have a lot of people has put their trust and invested capital in our company.
We realize that the shareholder value and return is also important, and we have great potential with the product to generate that is my and others' belief. Yeah. I think what's attracted me is the unique opportunity to do both makes a really positive product that has a great value, you say, socially, and at the same time generate shareholder value.
I think this has been a really good run through. The questions, I hope that you all have had answers to your questions. If you haven't had them, please email ir@biovica.com. We have one from you, one last one. No?
No.
No? Okay. There was one about putting the presentations on the web, and they will, of course.
Yeah
be there. I'm handing over to you, Anders, to summarize.
Yeah, I will just like to thank everyone, you that were here and to my team here who presented, and to you, Charlotte, who facilitated the session. Thank you very much.