Thank you very much, and hello, everyone. I can start directly to move to the first or the second slide. My name is Anders Rylander. And together with me, I have Cecilia, our CFO.
Hello, everyone.
Ann. So let's move to the agenda slide, Slide number 3. So today, we will talk about, first, a short introduction what by Rick Jaiss and what we do, then we'll go through the Q4 highlights, then Cecilia will talk about the financials, Elena Akya and we'll have time for a question and answer session. So next slide. So just a few words about BioVica, what we do.
So BioVica develops and commercializes blood based biomarker assays to include monitoring on modern cancer therapies. And the way we do that is through our product, Divitum, which is a biomarker assay that measures Enel Slang, which is closely related to cell proliferation. And the product has been part of several clinical trials where we have demonstrated the capabilities and the value of the products. And the focus for us is to use it within metastatic breast cancer in order to monitor the treatment during yes, the monitor the outcome of the treatment during metastatic Kasz, who has cancer face, sorry. And the addition is to contribute to more informed decisions for physicians that would lead to best possible treatment outcome for cancer patients.
So both patients and the health care providers benefits from more effective use of resources and more effective cancer monitoring. And if we move to the next slide, I'll talk just a little bit about technology and how it works. And as I said, we're measuring an endpoint called Thymine kinase, which is present in the bloodstream. So we can, with our Sansepil, biomarker assay, PIGELAVE and VASUREIT. And it's been shown in several clinical trials that this enzyme correlates very closely to the cell proliferation rate and also the aggressiveness of the cancer disease.
And this is myself as cancer, of course, is defined as an unprofitable cell proliferation. So with Vivitum, we measure proliferation that will eventually result in increased tumor volume. And currently cancer treatment are being monitored with imaging as a standard procedure. And with imaging, you measure the change in tumor volume, and that requires a couple of months to be able to follow-up Erika with the result. And with dividend, we've shown that already after 2 weeks into treatment, we can see significant changes patients that responds to therapy.
So we can maybe return of quicker and more efficient follow-up assets, very simple to Jacob Blad's sample from the patient. So that's the high level about what the product does. And the product is also implemented on a stellar platform, which makes it easy to adopt for the different clinical labs around the world. So if we move to the next slide, we have a summary of the most important events during the Q4. It's a 3rd, but it's, of course, the 4th quarter that ended in end of April for Bailet.
First of all, when it comes to clinical results within breast cancer, we did in a collaboration with Karolinska Universita Harsco, a clinical trial that was performed several years ago within Logi Advanced Breast Cancer that now was published in the Asthma Open Journal. This is important for us in several for several reasons. We would like to expand into locally advanced breast cancer from the metastatic area where we have the most of our documentation. And it's also important for us to show that we correlate well to the well established Ki67 biomarker, which is based On Silhu, tissue based and require biopsy. And of course, we can do provide similar information from a blood based assay.
It's a great advantage for patients and the treatment physician, of course. So that's important outcome of that clinical trial. Another important thing is health economics and being able to get into the U. S. Reimbursement system.
And in order to provide take the first step in that process, we've developed a budget impact model, which was presented at a conference in May this year, Health Economic Conference. And the conclusion from that model is that for every dollar spent on dividend, you'll get $3 back in savings. And that's basically within the cost of treatments. And the model is based on our clinical results so far and also other assumptions regarding costs for treatments and diagnostics being used currently. So this is important for our reimbursement process and our discussions with payers that we have initiated, and this will also result in a publication going forward.
Another important thing is to have a strong team in order to execute our business plan. And this Porter. We have strengthened the team both within the commercial area with Hellefisker and the Redilakoy area with the Joaquin Arbit On. And after the end of quarter, we presented results outside the breast cancer area also in collaboration with Karolinsja. And this was within the metastatic melanoma area where patients were being treated with immunotherapies.
And we will start also very in Genting and Pharmacy. We were both prognostic and predictive before start of the Reitman. And I also saw an opportunity which will pursue further to widen the use outside of breast cancer and both within mastocytialanoma and we'll further look into used to monitor feeders within immunotherapies. So Davos. A short summary of the highlights.
So if we move on to the next slide, which is a summary of the FDA process that we are currently in. And this is important for us since the U. S. Market is our key market, which is first of all, we're looking to launch the product. And to be able to do so, it requires regulatory clearance.
And in this case, it's called 510 by the FDA and that clearance would allow us to market the product on the U. S. Market. And we made our submission already in September last year, and we Kast. We the first two milestones during autumn of 2020.
Before the process was halted and that was due Sue. The pandemic situation as the FDA reallocated their resources to Krogi, Test Processes. The pause was prolonged, but we were last week to be one of the few applications that was restarted and this happened already in January late January this year. And since then, we've been in what they call substantive review phase and been interacting with FDA. Anne.
The process has been a lot slower than normal. And for several months, we've waited for a response from the FDA, but it has been restarted, and we are now in good dialogue with the FDA, which is very promising. And so the milestone that we have set out to get clearance during the Q3 Detir. That's what we still are working towards. So that's Sjor Samui about the FDA process.
And if you move on to the next slide, it's another area, which is really important to us and that's the laboratory partnerships. And as we're looking to launch both in U. S. And Europe, we are in discussions with potential partners on both these markets. And the reason for this is that we offer a kit to pest, but of course, we need partners Dattan Form, the analysis as a service to the customers.
And we also are looking to Tim, make agreements with lab partners that has sales force, so it can be complementary to the sales force that we're working to set up in order to target the customers. And we're working here in 2 steps. We are before we get the regulatory clearance discussing and will soon agree a company agreement that makes the test available for testing within research use only, which we are allowed to do already before clearance. Evan. As soon as possible after hearing, we will move to a commercial agreement that offers the product as a service for clinical use on these markets.
This way, by doing so, we can cut the time because there's a lot of activities that can be performed already before clearance, for instance, the validation process and so on. So that's a short update about the lab situation. So if we move on to the next slide. We have a slide about our commercial road map and the market potential within these different areas. So if we start at the top, the focus area now is to launch the product in on the U.
S. Market, which we expect to do later this autumn after clearance as the FDA. And my first phase is to read the first milestone we set out that we should be able to realize 15% of the market potential 3 years after launch of products. That all requires require hard work in order to get into the reimbursement system, expand coverage on reimbursement and the way of doing that is through guidelines, which we're also working to get inclusion into Wyden, our commercial partnerships and building our sales force in order to reach out to the customers. In this setting, we have a great foundation to build on with a strong key opinion leader network that we have established from many clinical collaborations we've done with this area.
And long term, we believe that We can realize 50% of the market potential. And as you see to the right for the metastatic breast cancer area in on the market U. S, selected markets in Europe, that is the 5 largest countries plus Nordics Han Japan. We believe the market potential is around US400 $1,000,000,000 to US700 $1,000,000,000 Perje, and that's based from extensive market research we've done, where we have interviewed payers for feedback about the value and the pricing of oncologists and also combining with a number of patients living with the disease. The next area to expand into is the locally advanced breast cancer area, where we can reuse a lot of the channels that we established within the best Verdi Kiep, being a leader in network and so forth.
But we just need to require regular for expansion in order to widen the use of within the locally advanced area and of course, clinical data to support the value of the credit product. Babionery, are active within that area, and we have some ongoing trials in the area to build the evidence needed. And the locally advanced area will extend the market potential further within the Bascan Cebu area with 30% to 40%. And we already are looking to expand outside of the breast cancer area where we have done some initial clinical trials, proof of concept, as we call it. The metastatic melanoma is a very good example.
We also have proof of concept data with the lung cancer area. And the 3rd area we are looking into target is metastatic prostate cancer. And those three together will further add the market potential with $1,000,000,000 to $1,500,000,000 and the last area we're looking into and we are in an early phase where we have collaborations with Karma. They are buying our product currently and using it in the development of new products. And the next natural step is to try to move into benefit, Bilbo Matt, collaborations and new co development projects, so called companion diagnostics, in order to complement new cancer therapies with complementary diagnostics.
So this is the commercial roadmap long term, and the initial focus now is to launch the product within the U. S. Market. So if we move into the next slide, we will move into the financials, and Cecilia will guide us through that.
Yes, hi, Ulrich. Thank you, Anders. We start with the sales numbers. The 4th quarter sales Hasbine 318 pounds from Swedish tons, and they are derived from 2 new customers. It is both encouraging and satisfying that we are adding new pharmaceutical companies as customers, and they are using the dividend for developing new promising transfer products, and we look forward to work with them going forward as well.
During the Q3, we received 2 major orders and May 1, we have already been reported on those and on the last time. And we haven't delivered anything more on these orders yet. So they still remain having delivered when the customers need more kits for their trial because this is Research Use Only Orders. And as you know, we focus our efforts on taking dividends in the clinical market and expect Sisi Moore, continue sales after launch. And now we're going over to the cash balance on the right hand side of the slide.
The closing amount was SEK 145,000,000 at the end of the year, and we are well capitalized ahead of commercialization in U. S. And Europe. Our round right now is about SEK 3,000,000 for the last 12 month period. And going forward, this will increase when we invest in the launch activities.
Emilio Permaal.
Yes, Permaal. Cash assets are sufficient for more than 2 years of operations without factoring in expected Increasing sales. And as you know, the higher level of expense Kopette last year. It's a bit attributable to the dividend projects associated with the preparations for commercialization. And also the organization has been growing, and we are now 20 employees compared to 17 last year.
And this would We will continue growing a little bit. The increase is in line what we have planned for. And I'm turning over to Anders.
Thank you very much. So just to sum it up before moving on to the Q and A. So the next slide, the summary slide. So we have a built in our product that addresses an omni within this area for more personalized strictness within metastatic cancer and specifically within the monitoring area. And the product has been part of several scientific collaborations with some of the world leading Nikhil Kiena Nieder.
So we have a strong foundation for our commercialization process. And that's what we are in the middle of. So the upcoming milestones are much related to that. So it's 510 clearance and launch within the Q3, which, of course, launch of product means that we need to have a signed agreement with a Sander Gunen, with the last partner that can offer the product as a service. By end of the year, we are aiming to get our 1st reimbursement on the U.
S. Markets. And also and before I have a new year, we are looking to launch within the first country of the Europe Nordic Arias and I will go out to meet a commercial contract and a partner that can offer it as a service plus regulatory approval on the Nordic and C marking basically in Europe. So with that, we have a very exciting 2021 in follow ups. Anne Riddhav.
I'm opening up for questions.
Thank you.
We have a question from the line of Richard Anders Katz from ABG Sundar Collier. Please go ahead.
Good morning and thank you for taking my questions. Could you please outline in a little more Deteil. You know that the steps that are left from achieving a 510 clearance to The first order being placed and shipped, so to speak, by treating physician in the U. S.
Yes. So what we need to do, of course, first, Parklane Clears and that's not enough because we need to have a service agreement with a map market, which we together can offer to the oncologist, which is making the decision to order the test in Discussions as a payment with the patient, but we also need Ingo. That comes with a logistics solution to get to the samples sent to the lab because we will start initially with a pretty centralized model, and we have the advantage here that the time in China's TK Alaus for shipping of samples. Initially, we expect out of pocket sales Antti. We get into the reimbursement system.
And in order to get into the reimbursement system, we will, together with our lab partners, set up a capability to claim reimbursement that has been negotiated with Abili to claim reimbursement and has been negotiated with the payers to do so. We also need to treat awareness of the product. So we're working with that as well, both with our key opinion leaders to be present on upcoming conferences, and we also have initiated discussions with patient organizations. We just recently, this week, had our 1st patient advisory board in order to creative awareness of the product and also, of course, get the patient's feedback In, so we can tailor our messaging going forward.
Right. Perfect. Thank you very much, Anders. And on the partnership side, you seem to indicate that you could have more than one agreement in discussion and Sabral for region. How should we think in terms of the number of potential agreements in place in the U.
S. And EU in the next The 12 to 18 months, what's possible then?
No, I think initially, we'll see with getting one agreement is important and because we can serve centrally because you can ship samples. And then over time, we will add partners. So initially, you can expect during 'twenty one Juan agreement initially on the U. S. Market and same thing on the European market and then we will widen from that.
We won't be we won't have exclusive agreement initially. Yves, and that's not our plan.
Perfect. Perfect. Yes, sure, sure. And How short after potential clearance could you have a partner in place, I mean, hypothetically?
I don't know. We want to, of course, minimize the time. That's why we're doing we're already now initiating all in the discussions with partners to be able to initiate validation before clearance, so we can cut time. Sohrab, and it's more a commercial discussion after that. So I can give you a number because Rudi Pennen on an external party, but we are working to minimize that so we can do it as soon as possible after clearance.
Sure. And just a quick one on the PRO MIX study. How should we think about the findings in that study given that Now measuring timing kinase is typically not compatible with the use of chemotherapy, just as we understand the results there.
No, that's good that you point that out. And that's a trial that we initiated actually a couple of years Agao. And since then, we are more focused towards Andrew Klein Therapies and CD346 inhibitors, which is our focus area. So I think it's Mor the value is more towards the prognostica. We can have a prognostic value also in the locally advanced setting.
Pat Sinterstein. We already have other plants within that area, so that further confirms that. But also that we could be a liquid alternative to TI67. That's also valuable to us when it's in other settings. When it comes to the treatment regime, you're right, that's not our focus here with chemotherapy.
And we see the opportunity in local advance more about when as we expect the CDK4six inhibitors to move into that area for hormone positive patients. Perfect.
Thank you. And just a final one. Do you have any examples of launches of ELISA based Biomarkers in Oncology in recent years. I just thought that it could perhaps guide our thinking in terms of launch trajectory, etcetera? Or should we just stick with nonco type DX type trajectory?
Yes. I think you should because we're not exposing sort of the platform to anyone else in the lab in that sense. So we will offer it as an analysis service to the customer. And then with a lab that can perform essentially when you ship the samples. You're able to get after volumes and have an efficient process and possibly automate the Eliza, which kind of takes away the biggest disadvantaged with the LIFO, which is the manual process.
So there is the laboratories that you're speaking, They have been and they are currently integrating automation solutions for ELISA, New ELISA test kits that are coming in essentially and it's a sort of standardized procedure for them.
Yes. So we've been discussing that as well. And then they have a different infrastructure per lab. So some like in Fresco in Europe, it could be that they have an instrument that's possible to automate, which is on the CE Mark, but not Hakone K. Clear.
In U. S, it could be a different situation. So that's a discussion you have to take per partner.
Sure. Perfect. That's all for me. Thank you very much for taking my questions. Have a good day.
Thank you.
Our next question comes from the line of Johan Ooneros from Redeye. Please go ahead.
Thank you, Johan Erik. Thijs for taking my questions. A few remaining, on the FDA process, could you is it possible to be more specific where you are. Are you in the interactive review stage? Or our we are in the substantive review, and we I don't know if they are already following there because the interactive review is when your discussions in discussion with where you don't stop the clock.
In this case, the F3 themselves has stopped Carlos for a couple of months before coming back and so on. So it's a special process. We at least Iqtente. I have to tell you that much that we have received in several rounds actually questions. We responded, and now we get the questions that we are now working to respond to.
So and we have a good dialogue. We think the questions that we get Ari Isenabell. We understand the rationale. And we've been working with the understand we're coming back with an answer Toedam. So yes, that's why I can say we're not definitely is not following the normal processes with interactive review and additional information.
Thanks, Erna. And we have to do the normal process. Thank you. That's helpful. And that's a step towards my next question.
These questions and the final a clearance. Will that involve some indication as to position? And could this also have a bearing on how you calibrate the test and what sort of position that could be described. Yes, I hello, Sean, but yes, those discussions are ongoing. It's the FDA has both high and low, both very detailed, Varadso.
Some more on the intended use, for instance, is not changing the use, but it's just wordings, but that could actually that will affect how you calculate the performance Alkam and so on. So that's why we will communicate data like that after we have a Okrusion or agreements with the FDA at Tieranis. But I think the main message here is that we're really happy that the process is restarted, and we're in discussion with the FDA. We know what to come back with, and we feel confident that we can respond to questions. Excellent.
And just clarification as to the other presentation and questions regarding non exclusive partner in the Nad Market from the U. S. Side. So as we should we understand it like that the most likely is that you will have this agreement with one partner in the lab market and that will move on to the clinical in the next step with the same partner. And then Sarkli.
Yes, that's correct. That's our ambition now. And that's because then we can start the validation Aureli. And yes, so get the collaboration going and I'll tap the time to commercial agreement where we offer this to customers for clinical use. Soren already offered to customers for research use initially.
This is an area where we'll be struggling a bit due to the pandemic situation, the labs have shifted focus to a great deal due to the high demand of COVID testing. So even labs that has their focus within oncology normally has been occupied doing COVID testing, and their business development work has been reduced. The good thing here is that we see an improvement as the pandemic situations Arnd Gettingbetter, and that opens up the opportunity to move forward for us within this area. Excellent. Thank you.
And a reminder, please, regarding how many prospective studies that are sort of ongoing and either better when we can expect from First Results. Yes. That's a good question. So the first the trial that has been completed. It's the PIFIA trial.
It's with the IBC C. F. G. And Big Against Breast Cancer Network, a very strong keeping a leader network in Europe. That was presented at the San Antonio Breast Cancer Conference and Doctor.
Luka Maloney, presented at our Capital Market Day as well. So that is, as Luka at the Capital Market Saptan Murtejesad. It's about to be submitted to a journal scientific journal to be published, yes, hopefully later this year. So that's the first one. Then we have ongoing trials.
Juan is the John Hopkins in the U. S. Where we Niyi. The patient has been involved, and the trial is ongoing. And it's and you won't see the result this year, but later next year, you can expect the results from that to come.
Alain. There is a third one that has been mentioned that Luca Maloni, for instance, mentioned at the Hector Markite and at the Bio Itali trial, where we also have been involved. You haven't seen in our official communication since we are not involved in actual work. We just sold the kits basically. But Luka communicated that is also about to be completed and will be presented on an upcoming conference pretty soon.
Those are the 3 ones that have been mentioned. Then of course, we are looking to strengthen our there's actually a 4th on the left. It is CDK4six as well Eda Pluca also mentioning this presentation. So that one is also being started up. And then we are looking to initiate smaller and more targeted trials for Rheembourg's processes, but we haven't specified exactly which ones.
Hekes. This was presented by Emil Williams at our Capital Market Day also, what how we're thinking within that area. Yes. Thanks. And just to remind me again, is that 4th trial, is that the Novartis trial?
Eilat, the Biureka. So that was mentioned by me. I forgot the Piraeus trial, which we have in our own communication Kossir, a collaborator in that as well. Excellent. I think just Pernod.
Yes. Finally, advanced breast cancer, you've been clear lately that, that's probably request modified label later on. Could you give some indication on Taim. Let's say that we will have that, let's say, 510 decision in Q3. Can you get the advanced breast cancer within a year or is that too early?
I think I need to be careful to commit the time lines here. I can talk about the process though. The big effort now is to get the product cleared, Hartein came cleared, including both analytical and clinical validation. And the clinical validation is specifically for the metastatic breast cancer area. In order to widen the use for a locally advanced Eiria.
We can do a supplementary process, so it's an easier process, but it requires clinical data supporting the value within local advanced breast cancer and that's how we haven't specified. So I think we can build on the fact that we have cleared the products in that case and we don't have to do we only do have to do a supplementary process. Excellent. Can you would you expect to be in a position where you can specify the time line by end of this year. Yes, we will need to come back with a time line.
I realize that around that as well. Ekstrand. Thank you very much. That's all for me.
We have a question from the line of Dan Achiuti from Pareto Securities. Please go ahead.
Thank you for taking my questions. Just a brief follow-up on the FDA discussion. So you mentioned that there are open Sebastian that you're now preparing answers to. Can you shed some more light on what the exact questions those are and if there are some concerns from the FDA?
No, I don't want to get into details more than I've done, but I can say that it is around different parts of the Entail de Abbatejian. It's around the performance part and the clinical validation. And it's more of a discussion, the feedback from the FDA there, it's reasonable. Etc. About how you interpret different standards, how you interpret the clinical trial setting and so on, and it's always based in science and facts from the FDA.
So we think the feedback is reasonable. And also, we believe that we will be able to sort come to an agreement with the FDA. Sometimes it has been that the FDA understands more that we have explained better, so they understand and accept. Sometimes it's been that as Nick Pointer that we need to add some documentation in our application. So it's a good discussion, and we feel that we can respond well to the FDA, Jorg, the feedback.
Okay. Thank you. Maybe just regarding Thailand. When do you think will you respond to these open questions?
Nao. We will be working we're working right now and we have been doing so for, yes, about a month. So that the real worrying thing for us was during that period when the FDA kind of pause the process. So we're actually very happy to get these questions and get back into the discussions because then the process is progressing. So we've been working with this for a month, and we will be working continuing to work a couple of weeks into the summer.
And yes, basically, in order to make that deadline in by end of Q3 that we've set out.
Okay. Thank you. And just one more question on the partnerships. Can we expect Handel that the FDA approval will ignite the cascade of payer reimbursement agreement and on top of that and The partnerships or can we even expect some signings prior FDA approval?
We have had the ambition to do it prior, but I think it's realistic to do like you said, that this the FDA milestone is important in the commercial discussions and could ignite us as well. That's so I agree both within lab discussions, but also it's an important milestone also in the discussions with Pharma Partners and payers. So yes, it's an important milestone in many ways for us.
Okay. Thank you very much and good luck with everything.
Bye. Thank you.
There are no further questions Sreedes Sturdes. I hand back to the speakers for any closing remarks.
Well, thank you very much for your attention and the questions, and we will get back to you on the next quarter report in the Salinas as well. Thank you very much.