Biovica International AB (publ) (BIOVICB) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the Biovica International teleconference Q2 2020. [Operator Instructions] Today, I'm pleased to present CEO, Anders Rylande. Speaker, please begin.

Thank you very much, Nas, and welcome, everyone, to the Biovica interim report presentation. So if you move to Slide #2, we have the names of the participant. Besides me here today, I have our Executive Vice President and CFO, Cecilia Driving, Cecilia.

Good morning, everyone.

And also, our Clinical Development Director, Mattias Bergqvist.

Good morning.

And moving to the next slide, the Slide #3 with the agenda. I'm going to make a short introduction to Biovica, what we do, and I'll present the highlights for the report. Matthias is going to take us through the latest study results from clinical trials that we have been performed during this period. And then I'll talk a little bit about what's ahead of us and what we're doing right now. The commercialization plan and activities, where we are and what you can expect next. Cecilia will talk about the financials. And finally, we'll summarize and have the opportunity for a Q&A session for everyone to ask questions. So if we move to Slide #4, the short introduction about Biovica. So Biovica develops and commercialize blood-based biomarker assays to monitor -- to improve monitoring of modern cancer therapies. And the product DiviTum is an assay that can accurately measuring cell proliferation from a simple blood sample of a patient. And as you all know, proliferation and cancer is closely related. The product has in clinical -- several clinical trials, with some of the leading key opinion leaders of breast cancer [indiscernible] projects in the world. Proven its capabilities to early evaluate therapy effectiveness in metastatic breast cancer and other cancer areas. This is also something that Matthias will elaborate a little bit more on as we have the latest results to discuss in this conference. Our initial focus is within the metastatic breast cancer area. Where we are working hard in able -- in order to launch the product on the U.S. market during 2021. And of course, the product itself has great benefits for patients, but also for payers in order to manage the treatments better and with a more individualized treatment schedule. If we move to the next one, slide #5. We were supposed to have a summary of the events during the second quarter and events after at the end of quarter. One major milestone for the company was the submission of the 510(k) application. And leading up to that was the completion of the clinical validation phase, where we met all the criteria that we have defined prior to starting the validation. The clinical validation and the analytical validation that have been formed previously and communicated before summer is what -- the major part of the application and the application itself was submitted by end of September. And we also made a new share issue -- a targeted share issue of a total SEK 148 million. And we got both some new investors and some larger previous investors that took part in the share issue. And we're very grateful for the confidence that the investor shows us and the great interest for taking part in this share issue. And after the period -- sorry, at the end, after submitting the 510(k) application, we got feedback from the FDA that they currently are handling a lot of COVID-19 related applications that has emergency priority. For Biovica, that resulted in a 90-day pause in the handling of the application from the FDA. A month later, we got a confirmation that they now see 60 days. So they are sticking to the original plan of 90 days pause, which is comforting for us. Despite this occasion, we've been able to run our business pretty unaffected in this difficult time of COVID. So we're grateful for that as well. And then after the end of period, we presented or will be presenting at the ongoing San Antonio Breast Cancer Symposium for results from full clinical trials within the metastatic breast cancer area. And that is something that Matthias will elaborate a little bit since its his milestone for us and very important for the activities going forward when commercializing and launching the product. So if we can flip to the next slide summarizing these four. And Matthias, maybe you can take us through the different clinical trials and the results of those.

Yes, of course, Anders, thank you. It's my pleasure to walk you through our trials that will be presented at this meeting. And it actually kicks off today, the San Antonio Breast Cancer Symposium. This is sort of the world's cutting-edge scientific program in breast cancer. So it's a great theme for us to be at. And we are, as Anders already alluded on, on stage with 4 different clinical trials. And this is, of course, a clinical trial program and outcome that is highly valued by us than any biomarker company. And the results are strong, but they are also the outcome of our many years of dedicated work with a laser focused aim to provide unique clinical value in a specific patient group. And that patient group is what you see on this slide, metastatic breast cancer patients, specifically the application to monitor these patients and to early evaluate the efficacy of their therapy. So the trials that I will be highlighting today is a SWOG study, which is also our FDA application trial under clinical validation study. It is the PYTHIA study, which is our first planned prospective trial that kicked off in 2015 already. It is a study from University of Nebraska and Washington University, looking at a new dosing of a CDK4/6 inhibitor, which is part of the standard therapy today. And it is a study from the Mayo clinic, which is a genomic study, sort of a future study where DiviTum is included as a benchmark to measure again. So if we then go to the next slide. This slide actually summarized our trial program up to date. And the early trials that we did here in order to establish our DiviTum application to monitor metastatic breast cancer, we did already back in 2013, together with the Karolinska. So ever since then, we have been very committed to provide unique value for DiviTum in this area. And as the first proof-of-concept study made it possible for us, then initiate new collaborations on the other side of the pond in the U.S. and those 3 trials will be part of the trials that are presented at San Antonio Breast Cancer Symposia. So up until now, we have published 6 trials in metastatic breast cancer in full. And these 4 trials now at San Antonio will be published as abstracts. So all in all, we now have 14 clinical trials within breast cancer from early-stage to late stages, and that includes more than 2,300 patients. And DiviTum has also been in focus for 3 editorials, summarizing the results and value of our assay. And the applications addressed are the prognostic application, looking at recurrence in early breast cancer, but also progression and survival in the metastatic setting. And for monitoring, the key thing is to get quick feedback on treatment efficacy. We can then move to the next slide. So the first study, I want to highlight that we would present in San Antonio, it's the SWOG study. This is a very large trial, and it shows that DiviTum is a strong prognostic biomarker for progression-free survival and overall survival. Samples are taken at baseline and then at cycles 2, 3, 4 and 7. And that is, of course, transferable approximately to months, 2, 3, 4 and 7. So all in all, 1,726 samples were analyzed in this trial with 100% evaluation rate. And that is important because not all liquid biomarkers have this valuation rates. For example, CA 15-3, it's only possible to evaluate approximately 80% of patients. But in this case, we were able to analyze 100% of all samples in the study. So the highlights of the results are that values at baseline at a subsequent time point, it's associated with worse prognosis in these newly diagnosed patients. And it is also important that you have a biomarker that is independent from baseline. So if these patients come into the clinic, they are diagnosed, but then you might not -- you might -- the physician might forget to get the sample, and then it's also important that the biomarker can provide information also at cycle 2, 3, 4 and 7, and that is exactly what we have provided evidence for this trial. So findings also demonstrated the patients with low DiviTum value at baseline and relatively well on single agent therapy, and they may not need combination therapy. And that was a new finding here that DiviTum also can predict -- can be a tool for selecting therapy already when patients are diagnosed here. So this has been a very pleasant finding in this trial, which is also predictive capacity of DiviTum. Okay, but we will see more of this trial because this is the study that also FDA will take into consideration for our application. If we then move to the next slide, which is the PYTHIA trial, this is the first prospective DiviTum study, where we planned together with IBCSG/BIG or The International Breast Cancer Study Group and the Breast International Group. This study has also been funded by the European Commission to our Horizon 2020 grant, it is the bio valid project that we were awarded in 2015. So in this study, 122 patients have been enrolled. And they were enrolled at 19 centers in Belgium, Italy and U.K. And the study addresses this Fulvestrant therapy of an endocrine therapy in combination with the CDK4/6 inhibitors. And what is exciting here is that samples are taken at baseline and then at 2 and 4 weeks. And the results demonstrate that patients who get a suppression demonstrated by DiviTum at 2 weeks. They have a significantly better progression-free survival. They have a significantly better outcome at 6 months. And those patients have an 85% progression-free survival at 6 months compared to 17% of those who don't get suppression. So that means that DiviTum can quickly identify patients with poor prognosis and resistance of therapy. And the authors although conclude that DiviTum may be used as a novel biomarker to select patients for alternative treatment modalities. Okay. So then we go to the next study. There are a lot of study and a lot of science here for you, but this is also an important trial because 1 of the challenges of providing drugs today for this patient group is, of course, also tolerability here. And at the University of Nebraska and Washington University, they decided to embark on a journey to look at the new dosing of a drug called Palbociclib, CDK4/6 inhibitor, which is part of the standard therapy today. But they were not happy with the tolerability of this drug, so they decided to do a new dosing schedule, giving the drug for 5 days on and 2 days off instead of 3 weeks on and 1 week off. And they were successful in this because this dosing schedule showed the better tolerability. But it was also important for them to have a biomarker that could provide evidence that this dosing schedule also provided strong efficacy data, and also had a biomarker that can identify which patient who responded to this new therapy. And what's interesting with this trial, too, is that there is a lot of samples in this trial, and they are taking a baseline 2 and 4 weeks and then every 3 months for more than 2 years. So this -- these patients were followed for a long time with many samples. And the results demonstrate that patients with a response or no disease progression, they had significantly lower DiviTum values at baseline then patients with progressive disease. But during the serial monitoring of these patients a rise in DiviTum levels predicted disease progression, more than 3 months prior to imaging progression, also highlighting the capacity of DiviTum to sort of conclude on what is coming, many, many months ahead of what is able to -- what you're able to detect with imaging today. So the DiviTum levels at the baseline and on-therapy dynamics demonstrate promising results for response prediction and monitoring of this new standard therapy in metastatic breast cancer and palbociclib cycle. Okay. So we then move on to this final trial that will be presented, which is a genomic trial, which is, of course, part of the future because if you want to learn about this disease and improve both regarding therapies, but also our knowledge about how to monitor and how to to get early signals on resistance development of tumors. Then it's important that we increase our knowledge on the genomic side of things. And in this trial at the Mayo clinic, the first 32 patients in this study have been analyzed, and samples are taken then at baseline and after 2 months. And the aim of the study is to look at the predictive capacity of DiviTum and provide a comprehensive genomic assessment in order to identify new genomic variants pathways that are associated with an early decline in PK and then, of course, correlate that to patient outcome. So the results that will be presented at -- if the congress demonstrates the patients with high or low DiviTum values. They have different genomic expressions, which is, of course, interesting here. And the pattern between DiviTum levels of the patients' genomic expression profiles may be important for future monitoring of metastatic breast cancer to test new treatments to overcome the resistance that eventually occur for this chronic disease. So the study is ongoing, and it will report updated data from additional time points in greater number of patients in future. Okay. And then we can go to the next slide because all of this data, the solid clinical trial program that Biovica have developed together with our key opinion leaders across the world, have generated a lot of interest in DiviTum. And these 5 trials are some of the ones I want to highlight on the work that's ongoing at the moment. And you might have followed Johns Hopkins because they are also a leading university regarding statistics around COVID, but they're also a very, very successful university on oncology, and we are very happy to collaborate with them on a trial looking at the early identification of progression in this area. And also, a recent study that we have initiated collaboration on just 2 weeks ago that we highlighted in the press release, it's a collaboration with the Christie Hospital in U.K. and also 4 Swedish centers will be part of it. And that study will also look at the early identification of progression added with the optimal time point to sample for DiviTum evaluation in the course of therapy. And then we have a study with the Karolinska Institutet called PREDIX, which is a preoperative trial, looking at the Neoadjuvant response marker, DiviTum as a Neoadjuvant response marker during preoperative treatment. And then there is an independent trial from us called BIOITALee that is performed by Novartis, quite large trial, almost 300 patients, and that trial will have a name to early identify disease progression. And then we're doing a proof-of-concept study, which is interesting in a way that it's looking at different combination of drugs. It is palbociclib in combination with chemotherapy. So we're also addressed it in patients that are not hormonal responsive in this therapy. So the data from this ongoing trial program will, of course, support our submission to the FDA and what we are aiming at being a approval next year. So the data from this program will start to produce results from next year, some -- hopefully in good timing with the U.S. approval. But it will, of course, also be important for the reimbursement and for later on the clinical uptake. Okay. Anders, I think I'll put a stop there, and I'll hand the word back to you.

Thank you, Matthias, very much. And you'll, of course, be around also for taking questions around these clinical collaborations and results from them. So if we move on to the next slide, we have a high level slide describing our path -- the key activities in order to commercialize and launch the product. And I'll give you an update where we stand on these different activities. And first of all, it's the development of the product. And you can see that, that has been completed since quite some time now. And the product has, as I earlier mentioned, also been validated, and that was an important basis for the FDA submission. Moving on to the clinical development, which Matthias has covered. It's In a way, you can say it's complete because we have most of the data that we think we -- it require in order to launch the product. We have, as you've seen as now several trials that add significant number of patients, also increases the data on U.S. patients we have had prospective data, and we had a strong result on the CDK4/6 inhibitors and on -- in comparison with the current best practice, which is imaging. So that adds a lot of strength to our evidence of the value of the product. But we will, of course, continue with, as Mattias showed, ongoing trials to strengthen the evidence further. When it comes to the regulatory pathway, yes, that's the 510(k), and you can see that, that's also completed from our part at least. We've made a submission, and we're eager to see the feedback from the FDA, which we expect that they will start assessing our application beginning next year. In parallel, we will also submit for CE marking using the IVDD process in Europe. Key activities that we are working with right now is commercial partnering with a lab partner that can offer this bid to masses service. And also have an efficient, strong sales force that can be complementary to our offering. And also be a partner when it comes to the next area, reimbursement and to get paid for the product. And reimbursement and guidelines goes very closely hand-in-hand. So we're working also with that, and I will give a specific update on where we stand within that. And in order to launch a product, we tie everything together, and we have a communication planned together with our key opinion leaders, when it's time for launching the product, which we expect to do mid next year. If we move to the next one. I have a breakdown over the reimbursement area. That's been an area with high intensity of a lot of progress this period. And of course, with the data that Mattias just presented, it's complements us and is a strong foundation also for this area. And 1 important milestone for us will be inclusion in the guidelines. And the most important ones are the NCCN and ASCO guidelines. And we are now initiating those discussions and starting to plan for that to happen. In parallel with that, we have initiated a project in order to develop a budget impact model and the deliverable. There will be a value dossier to be used in the discussions with the different payers to be able to prove the value for the product, for the payers. And of course, that will also be -- we can use a lot of the data and results from our clinical development program, which Mattias presented. Going forward, with that, we also need a strategy for coding and coverage, which we also developed, how we will work initially with a nonspecific code, and then over time, we'll get a specific code, and we have planned for that. And that also goes for the different types of payers that we would like to interact with and define process for payment and price levels. And we will, of course, start with the early adopters. Some have a lowest threshold for required evidence and those will be our early adopters, which we will interact with initially, and then we will expand the coverage over time. And that goes also hand-in-hand with our distribution model. Initially, we'll have a pre-centralized model so we can ethically manage this payment process and getting into the reimbursement system, and we work together with our lab partner to do this. And over time, when we've established ourselves in the reimbursement system, we can widen the distribution and have a more distributed model. And a very good thing here for us is that the enzyme that we are measuring is stable, and we're able to transport it, allowing for this kind of a centralized model. That's the update then on guidelines and reimbursement. I'll move on to the next one. So here's a slide how we intend to launch on different geographical markets, and an estimation of the market potential for the product. And as you can see, our ambition is to introduce the test on the U.S. market being the biggest and most advanced and trend setting markets which also has a reimbursement system one, although complex, but one reimbursement system that we'll introduce the product on. We've also estimated the market potential per market, and we've done that based on market research, where we have interviewed payers and key opinion leader oncologists to get input from for use of products and price levels. Where we have received the feedback on the U.S. market, around $300 to $500 per test. And on the Nordic and European markets, we estimate about half the price levels. That combined with the number of patients living with the disease is what's made up the figures you see on this slide. We estimate that on each market that we will enter, that we will be able to gain 15% of this market potential 3 years after launch of product. And so we start with U.S. and it's planned for midyear next year. And the second market we will enter, and we will -- we believe we'll be able to reuse a lot of the assets being developed on -- for the U.S. launch is the biggest, top 5 biggest European market and the Nordic markets. And for that, we will also work with partners on the different countries on the European market. So this is the first application in metastatic breast cancer area. And then 1 should bear in mind that this is just a small portion of the total potential, also this is the first geographies. There's a great potential to expand, as you saw on Mattias slides, we already have data from. And ongoing trials within the locally advanced area, which we expect the current treatments being used within metastatic breast cancer where we have strong data to enter. And we are also interested to expand outside of the breast cancer area, where we already have data in the large cancer areas like lung cancer and gastrointestinal cancers for instance, and you see the same unmet need for DiviTum as we see within the metastatic breast cancer area. So if we move to the next slide, we are into the financials, and I'll ask Cecilia, if you could walk us through that?

Thank you, Anders. We start with the sales numbers. Sales during the period are to customers in the research market and as such, they vary considerably from 1 period to the next year. And since our customers is the pharma companies, and they stayed relatively large orders with the purpose of analyzing an entire clinical study at a time, it differs a lot. This sentiment then can clearly be seen when comparing with last year's sales. And our focus now is to take DiviTum to the clinical market, and that will probably generate revenue with more regular state, but not until after regulatory approvals. Now we leave the page chart and look at the cash balance. As you can see, the cash balance has increased significantly. We ended the first quarter with a share issue of SEK 148 million as Anders said at the beginning, and the issue cost was about 5% of that. And after issue costs, the cash balance increased by SEK 141 million. And at the end of the second quarter, we had SEK 162 million in cash, and that will cover our operations for more than 24 months. The run rate is now about SEK 3.3 million for the first 6 months. And going forward, this will increase when we invest in the launch activities. The higher level of spend compared to last year is a bit contributable to the DiviTum (TK) projects associated with the submission of the 510(k) application to FDA and the preparation for commercialization. The organization is growing and the average number of tests is now 21 compared to last year's 17 and we will continue to grow the organization, preparing for the commercialization of DiviTum. And the increase has been in line with what we have done and it has been, in fact, slightly lower. And that's about it. Handing over to you, Anders.

Thank you, Cecilia. And also here, we're able to question about -- starting the Q&A session. To summarize this, I think we have a very interesting and product with high potential that can address an important unmet need currently within metastatic breast cancer to improve monitoring of treatments. And it's also an unmet need outside the metastatic breast cancer area. And -- but our initial focus is within metastatic breast cancer. We also have a strong collaborations with some of the leading key opinion leaders and academic research centers in the world within the field. And together with them, we have completed several clinical trial with great outcome, which will be the basis for the entire commercialization process. And the market potential, we estimate to about $400 million to $700 million for these initial markets within metastatic breast cancers. And that's U.S. and the big European countries and the Nordics initially. And the upcoming milestones to look out for is the 510(k) process which we're in, where we expect that the FDA will start their assessment in quarter 1, and so we can see an approval in second quarter next year. And in parallel with that, we're working to get an agreement with a commercial partner, a lab, a mid-tier lab in the U.S., which will be our partner for the U.S. launch, which will be done in parallel with or right after an FDA approval. And soon after that, we expect to receive the first U.S. reimbursement on the U.S. market, and we'll work to build a wider and wider coverage, reimbursement coverage within the U.S. market. And we're looking through collaborations with partner within Europe to enter the first European market by end of 2021. So we have very exciting times ahead of us during next year and onwards, when we are about to bring DiviTum to the benefit of the breast cancer patients in -- on these markets, which we look forward to very much. Thank you very much. That was our presentation, and we are now open for questions.

[Operator Instructions] Our first question comes from the line of Rickard Anderkrans from ABG.

Congrats to the recent developments here. So first of all, if I've understood things correctly, looking at the commercialization side here, you've indicated that that you, in the longer term, could enter an agreement with a larger commercial partner or perhaps several lab partners in the U.s., is this correct? And what do you expect you need to get in place before expanding your commercial footprint in the U.S., would it be broader guideline inclusions or reimbursement coverage? Or what steps should we expect for you to expand that commercial presence in the U.S., if you will?

Yes. I think all of those will help. So the reason for a more centralized model initially is to be able to control and handle the interface with the payers for reimbursement which is a key success factor. When you have established processes with more and more payers, we can widen the distribution model. And that goes also hand-in-hand with expectation of an increased sales. And for the development of the reimbursement and sales also the factors you mentioned, inclusions in guidelines, for instance, is a factor that drives sales uptake and reimbursement coverage. And in the end, also commercial collaborations. I'm not sure if you're happy with that answer, Rickard?

Yes, of course. And just as a clarification there. In terms of these lab partners, are they usually keen on getting exclusivity? Or is it a trade-off between sort of a revenue split, if you will, that they are willing to leave exclusivity open? Do you understand a bit what I'm looking for in terms of their terms in the agreement, yes?

Yes. Yes. So we are not looking to enter exclusive agreements initially. No that is not our strategy. So we're looking to work with non-exclusion agreements, and we believe from the discussion we've had so far, that that's a way forward that will work well.

Great. And just looking at the case load of COVID-19 cases in the U.S. and the continued rush here for testing applications. Are you seeing any worries that your 90-days FDA delay could be extended? Or how should we think about that potential risk on the timeline?

Yes. I think it's comforting that we have received feedback. The FDA promised monthly feedback, and we received that about a month after the first communication. And they said -- initially they said 90 days, and in the second feedback, they said, you can expect us to start this in 60 days. They're not giving any guarantees, but it's a positive sign, at least.

Great. Great. Sounds promising. And just a final question here on the prognostic use case and particularly looking at the abstracts here from the San Antonio Breast Cancer Symposium. Isn't it usually the case that patient response is poorer in a faster-growing tumor versus a slower growing tumor, i.e., that TK1 sort of at baseline answers and already clear question in terms of a prediction of outcome in the patients so that, i.e., a higher TK 1 activity sort of per definition leads to a poorer response? So how should we think about the prognostic use case data?

Matthias, is there something you can help us sort out?

Yes. I mean, that's a good question, Rickard. But the thing is that you, of course, need to establish that. I think we have established that DiviTum is greatest technology patient data to conclude that. And also, if you're going to bring that knowledge into the application of monitoring these patients going forward, it is great to have a baseline value and to conclude that. And we have also demonstrated that DiviTum is an independent biomarker here, irrespective of what you find with other markers, what you find with other risk and prognostic factors. So I think we are on a very solid ground, and we have a very strong evidence that DiviTum can provide unique data on its own. And of course, the prognostic outcome is very, very important, specifically looking at progression, but also looking at overall survival, of course. But then you can also add to that, the predictive authorization now seem to get from this first evidence from the SWOG trial, but it might also be important that you establish these values with a specific cut off. And here, DiviTum is completely unique towards everything else you compare against because we've established our own cut offs in our own solid trial. You must use DiviTum in order gain that knowledge. So if you are above or below a specific cut off, that is very, very important to you because that means that you have the opportunity to get the patient to answer to a specific drug, of course. So that is also important, not only the prognostic perspective.

Sure. Great. And just final there on the prognostic. Do you think that the prognostic use case will require larger prospective and mortality based outcome studies to reach guideline inclusion and uptake? Or do you think that other endpoints such as progression and these types of endpoints are enough, if you will, to gain traction and uptake in that sort of use case?

Those a few questions in one, Rickard. The first 1 was regulatory wise, if we believe that the prognostic claim requires prospective trials and more patients, is that correct?

No, basically, just in terms of getting guideline inclusion and broader uptake, if you believe that larger prospective trials, which look at mortality will be needed to reach guideline inclusion and commercial uptake and they are covered from the insurance companies and so forth?

Okay. I understand. Okay. That's a good question. And I think if we can in prospective trials, and we will have that data over time. If we can prove that by managing treatments using DiviTum, you can have a better survival outcome, that's, of course, fantastic. And it's not unrealistic but it's -- we don't have those data yet. We will have those -- that data. And you can, of course, speculate then what the results will be, but I rather not to. But our go-to-market strategy -- and yes, the commercialization process and launch project everything is not taking that. It's not a requirement for that. It's -- it could be an -- that comes on top of on the data that we have. Do you understand what I mean?

Yes, sure.

We by making that claim, we could, over time, add that when we have that data, but we haven't based our go-to-market process on that because that would add a couple of years on the timeline.

Sure, sure. Right. So that might be a few years from right now?

But we will continue -- yes -- but we'll continue doing clinical trials that will add data and add possibility to add claims when it comes to intended use.

[Operator Instructions] Next question comes from the line of Niklas Elmhammer from Redeye.

I actually have a bit of a follow-up question to the last one. Maybe you answered that already, I didn't understand it. When do you think it's realistic to expect to be included in any guidelines? The current clinical evidence if it's sufficient, so to speak.

Yes. We haven't given, by the way, that precise because we are just initiating those discussions now. And we don't see it as a requirement for the first -- the early adopters when it comes to payers because we have -- we believe we have significant data and together with the 510(k) clearance for start initiating those discussions. Especially if we have the health economics that we're also working with and expect to have done before we get guideline inclusion. But we don't -- yes. But we think also we can use a lot of the data that we have to get included in the guidelines, and we expect the NCCN to be the first one. But we haven't set a date for that, but we'll come back to that when we have had these initial discussions. But it's in -- within the time period, when we say we will get this 15% market share, we -- within a 3- year period, we have assumed that within that period, we would have guideline inclusion. So that's roughy. If you want more detail that we'll come back to you.

Okay. Just regarding sort of the launch activities and the U.S. commercial organization. Are you planning a ramp-up right now? Are you hiring now? Or are you as such contingent on the FDA process, so to speak?

Yes, that's a good question. We are actually ramping up now. And soon we'll present some key hires that will be important to drive the work in the U.S. So yes, we are strengthening our U.S. organization according to the plans that we have communicated previously that we will have a small, but strong and specialized U.S. organization that can work effectively with our partners and with the reimbursement.

And as there are no further questions, I'll hand it back to the speakers for closing remarks.

Well, thank you very much for the interest and the great question, and we look forward to come back as we progress and move into a very exciting 2021 for Biovica. Thank you.

This now concludes our conference call. Thank you all for attending. You may now disconnect your line.