Profound Medical Corp.

Ladies and gentlemen, thank you for standing by, and welcome to the Profound Medical Fourth Quarter and Full Year 2020 Financial Resource Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To participate in that portion of the call, you will need to press star 1 on your telephone. And please be advised that today's conference is being recorded. Now, I would like to turn the conference over to your speaker today, Stephen Kilmer with Investor Relations.

Thank you. Good afternoon, everyone. Let me start by pointing out that this conference call will include forward-looking statements regarding Profound and its business, which may include, but is not limited to, expectations regarding the efficacy of Profound's technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain, and osteoid osteoma. Often, but not always, forward-looking statements can be identified by the use of words such as plans, is expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes, or variations, including negative variations of such words and phrases, or state that certain actions, events, or results may, could, would, might, or will be taken, occur, or be achieved. Such statements are based on the current expectations of management. The forward-looking events and circumstances discussed in this conference call may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the medical device industry, economic factors, the equity markets generally, and risks associated with growth and competition. Although profound, it's attempted to identify important factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements. There may be other factors that cause actions, events, or results that differ from those anticipated, estimated, or intended. No forward-looking statement can be guaranteed, except as required by applicable securities laws. Forward-looking statements speak only as of the date on which they are made, and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law. For the benefit of those who are new to the Profound story, I would like to take a moment to summarize our business. Profound develops and markets customizable incision-free therapies for the ablation of disease tissue. We are currently commercializing Tulsa Pro, a technology that combines real-time MRI, robotically driven transurethral ultrasound, and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient's natural functional abilities. Tulsa Pro is CE marked, Health Canada approved, and 510K cleared by the FDA. We are also commercializing SaunaLeaf, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastasis. SaunaLeaf is also being approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids. and has recently obtained FDA approval under a humanitarian device exemption for the treatment of osteoid osteoma. While we do not expect this FDA HDE approval to have a material impact on revenues in the near term, it is a significant milestone for our company, and we are making preparations for its U.S. commercial launch later in 2021. On the call today representing the company are Dr. Arun Menawat, Profound's Chief Executive Officer, and Aaron Davidson, the company's Chief Financial Officer and Senior Vice President of Corporate Development. With that said, I'll now turn the call over to Aaron.

Good afternoon, everyone, and welcome to our fourth quarter and full year 2020 conference call. On behalf of the management team and everyone at Profound, I would like to thank you for your ongoing interest in our company. And for those of you who are shareholders, we appreciate your continued support. I will turn the call over to Arun in a moment for an update on our commercial activities. However, before I do, I'd like to provide a brief update on our fourth quarter 2020 financial results. One major change you probably noticed from our press release today is that we have changed our presentation currency from the Canadian dollar to the U.S. dollar. We believe this will result in more relevant and reliable information for those looking at our financial statements and will more accurately reflect the results of our operations, especially given our focus on U.S. commercial activities. To streamline things, all of the numbers I will refer to have been rounded and are therefore approximate. For the three-month period ended December 31st, 2020, the company recorded revenue of $2.9 million, an increase of 36% year-over-year and 29% sequentially over the third quarter. When we announced our preliminary unaudited revenue estimate in early January 2021, ahead of the JP Morgan conference, we hadn't yet made the switch to U.S. dollar reporting. So for clarity, this translates to actual revenue of 3.8 million Canadian dollars versus the 3.7 million Canadian dollar estimate at the time. Total operating expenses, which consist of R&D, G&A and selling and distribution expenses were $6.1 million in the fourth quarter of 2020, an increase of 14% compared with approximately $5.3 million in the fourth quarter of 2019. Breaking that down further, on a year-over-year basis, expenditures for R&D increased 4% to $2.5 million. This was primarily driven by higher spending for the setup and administrative costs of new clinical trials, options awarded to employees, additional headcount, and overall increase to general expenses, partially offset by decreases in material costs, consulting fees, and travel expenses. G&A expenses decreased by 6% to $1.8 million due to lower consulting fees and travel, software, bad debt expense, and depreciation. which were partially offset by increases in salaries and benefits and share-based compensation. Finally, selling and distribution expenses increased by 79 percent to approximately $1.7 million. As noted in our press release, selling and distribution expenses have historically been lower than R&D expenses. However, We expect selling and distribution expenses to exceed R&D expenses in the future as we continue to invest in the commercialization of Tulsa Pro in the United States. Overall, the company recorded a fourth quarter 2020 net loss of $7.5 million, or $0.38 per common share, compared with a net loss of $3.9 million, or $0.33 per common share, for the same three-month period in 2019. As at December 31st, 2020, Profound had cash of $83.9 million. I'd like to close by saying that while our performance in the fourth quarter again speaks to the strength of our technology and our business model, we continue to remain cautious in the near term, mainly due to COVID-19 headwinds, the impact of which are unpredictable. With that, I'll now turn the call over to Arun.

Thanks, Aaron. Year-end 2020 marked the 12-month mark of the introduction of TELSA in the United States, and in spite of the delays due to COVID, I'm pleased to report that we successfully executed against our strategic priorities in 2020. The most important of those was to start laying the groundwork to drive significant adoption of TELSA Pro in the U.S. and There were two major pillars of that I would like to focus my remarks on today. First was to start building a high quality US installed base. In that regard, our US market entry strategy for TELSA Pro targets three types of end users. One, early adopters, which includes neurologists specializing in cutting edge alternative prostate disease treatment, two, independent imaging center companies such as RedNet, and three, opinion-leading teaching hospitals. Each of these are unique and play different roles in supporting long-term adoption. The first two early adopter TELSAPRO sites have been treating a growing number and an increasing variety of patients. The experience at these centers mirrors what we observed during our European launch, where surgeons initially used TELSA Pro to treat intermediate risk patients, then started to also treat low and high risk patients, and then those with BPH. The result of that addressable patient population expansion has been higher early utilization than we had expected. At the beginning of 2020, we estimated that after the first six to 12 months of being operational, the average run rate would be 40 procedures per year, eventually growing to 100 procedures or more after that. Today, these centers have exceeded those targets by about 50%, achieving an average run rate of 60 procedures per year. With respect to the second group, the imaging centers, I'm pleased to report that RedNet is now actively treating patients using TELSA after initially experiencing delays related to COVID-19. Midway through the year, we increasingly focused on the third group, establishing TELSA centers at top-tier hospitals. The early results of those efforts has been outstanding, with a list of prestigious institutions offering the TELSA procedure already including the Mayo Clinic, UT Southwestern Medical Center, WellSpan Advanced Prostate Cancer Center, and most recently, Yale Cancer Center. While we have always expected teaching hospitals to be relatively lower volume at first, and we are seeing these institutions being particularly impacted by COVID-19, they remain best positioned to help drive long-term adoption by training the next generation of urologists, presenting at medical conferences, publishing papers in relevant journals, and participating in additional trials designed to support TELSA Pro to potentially qualify for a CXG1 code. This leads me to the second pillar of our TELSA Pro adoption strategy, which is clearly reimbursement. At the beginning of 2020, we announced that we had submitted an application for a healthcare common procedure coding system, C code, from the Centers for Medicare and Medicaid Services, or CMS, for the TELSA Pro procedure. Subsequent to that, we had an opportunity to meet with CMS and a number of hospitals. The feedback from those discussions as well as from our consultants was that an existing code could possibly apply to TELSA For that reason, we asked CMS to set our application aside and allow the hospitals to decide if they would like to use that existing code. While we're not able to provide great amount of detail on the numbers of patients or reimbursement levels, we can say that we're hearing from the hospitals that have submitted for reimbursement using the existing code that they are being paid. While that is clearly a positive, I would like to reiterate, as I have on previous calls, that we view reimbursement and coverage as a three-year plus process, and the usage of the C code is the first step of that process. In the longer term, we expect to conduct additional clinical trials that are mostly designed to expand the body of clinical publications and enable TELSA Pro to qualify for a specific CPT-1 code and ultimately for payment coverage. The first of those is TACT-2, an extension of the TACT pivotal trial by another 35 patients to achieve a total number of patients treated to 150. That study is on track to be fully enrolled in the second half of this year. As we have discussed before, by the end of 2021, we believe that we should have the requisite publications to qualify to apply for a specific CPT-1 code For coverage determination, however, we will need level one studies, which we also expect to start recruiting for before the end of the year. So to summarize, I would like to echo Aaron's comments that there remains significant uncertainty with respect to the TELSA procedures adoption rate in the very near term due mainly to COVID-19. However, We're energized going into 2021 and remain on track to achieve our long-term adoption goals for TELSA Pro. In addition, we're looking forward to launching SonaLeave in the United States later in the year. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator.

Thank you. And we will now be conducting the question and answer session. And as a reminder, to ask a question, simply press star 1 on your telephone. And to withdraw your question, press the pound or hash key. One moment while we compile the Q&A roster. Our first question is from Anthony Petrone with Jefferies. Your question, please.

Thank you, and hope everyone's doing well. Arun, maybe to press a little bit on the prepared comments on backlog and not necessarily focusing on procedures, but rather installation cycles. Can you give us a sense of the average installation cycle pre-COVID for a new site and kind of where that sits today just in terms of kind of the hurdles that you have to get past in getting a system fully installed and up and running? And would you classify actually the installation cycle as the bigger headwind related to COVID relative to purely on the procedure side? And then I'll have a couple of follow-ups. Thanks.

Sure, Tony. I'm happy to. So let me describe it by each of the pillars that we talk about, each of the three different types of institutions that we focus on. the biggest impact in terms of the delays was really in the hospitals. And as I mentioned in our prepared remarks, going into the second half, that was a priority for us because we want to get the opinion leaders to get going on this product. So there were a couple of hospitals where we actually had contracts, but the hospital administration simply did not allow even our people to go in to install the system. There were a couple of hospitals where we did install the system, but then in January, for example, they were informed that they could not do new technology procedures, and it sort of got delayed because of that. So I kind of look at this as a one-time thing, and I do think that there is some impact in the early part of this quarter, But the reality is all of these hospitals are now back up and we have installed and they are starting to treat. So to answer your general question, though, from the time we get a contract, a typical startup is somewhere between 75 to 90 days for us at the moment. I think over the long haul, I anticipate it will be somewhere between 45 to 60 days. But at the moment, it's somewhere between 75 to 90 days. Is that answering your question?

Absolutely. That's very helpful. And I guess to hear you correctly, you bucketed the two sort of situations, which is contracts in hand, but the company was not allowed to proceed with the Tulsa install. And then systems that were installed, the procedures were not allowed. I just want to be clear of that. All of those are now installed, or is there a certain portion within the first bucket where you still have to finalize the installation of Tulsa?

No. The agreements we did last year and maybe very early this year, they're now installed and hospitals are now going. As of March, we've anticipated full operation in place. So I think that part is hopefully, you know, there's no third wave, and that part is now behind us.

And then the last one for me, and I'll hop back in, is a little bit more information on the C code. Hospitals that were installed last year are actually being reimbursed with that C code. Can you remind us, Arun, just of the level of reimbursement that's being received under the C code, and whether or not that is sort of universal across the install base of Tulsa's at the moment, or does it vary by region across the country? Thanks.

Sure. So, you know, what we publicly talked about is in general numbers. The APC code associated with that C code generally pays in the overall between $11,000 to $12,500, and that range depends upon what type of institutions is applying. So certain institutions in lower cost areas or smaller institutions will get the lower end of it. Certain other institutions that are teaching institutions will get the higher end of it. And, you know, I think that generally the hospitals are reporting that they are comfortable with the payments that they are receiving. So as I said, I couldn't give you a specific hospital or a specific number. But I think general feedback is that hospitals are getting paid the amount they expected to get paid.

That's helpful. I'll hop back in. Thank you.

Thank you. Thank you. Our next question comes from Rahul Sargassar with Raymond James. Your question, please.

Good afternoon, Arun and Erin. Thanks so much for taking my question. So my first question really is, I think, Arun, you were referring to all of the existing contracts having been installed. In previous calls, you'd referred to the pipeline being quite strong and that you were continuing to sign contracts. So I just want to clarify, is that the case where all of the existing contracts that have been signed have been installed? Or are there more contracts being signed that would be kind of sort of create this bolus of additional installations that will need to happen as the hospital constraints start to release.

Can I jump in just for a second? Yeah, go ahead. We have contracts signed where there are not, where there are devices not installed and devices not treating patients still.

Okay, great. Go ahead. It's a timing point that what I was referring to is the agreement that we had last year are installed. Not all of them might be public on our website or anything, but are there. But we do have new contracts that we've signed this year which are not installed.

Okay, terrific. Thank you. That's an important clarification. And then so now talking about those additional contracts that are currently being signed, have been signed, and the hospital constraints that you talked about, are you starting to see now that these hospital constraints are starting to be lifted, or do you expect that to be happening sort of into Q2? And, you know, as this bolus of installations, you know, kind of comes to bear, is your team size prepared to kind of handle that large number of installations in sort of the back half of this year?

Sure, Raul. So I think to the extent that we can all predict what's going on with COVID. I think that what we are seeing is, you know, hospitals are starting to come back to normality to some extent. And, you know, I would say the other side in terms of the caution is that we have installed, you know, we have installed the systems but getting up to speed in terms of the volume is still going to take some time because, you know, they have to start getting patients established. Typically patients, it takes about four to six weeks for the patients from the time they schedule the patient to when they actually treat. So, you know, I think there's still some uncertainty, but I think generally things are heading in the right direction in terms of of activity. To your second question, as we've talked about, our pipeline is good. We are adding resources in our company at a pretty aggressive pace, and we have an outstanding team, and they are traveling in spite of all the restrictions. They are quarantining as necessary and so on. So, yeah, I think the short answer to your question is, yeah, I do think we will be prepared as the install base grows and as the utilization grows.

Sure. Thank you. And just one more quick question, you know, about the C code. So, you had mentioned that there are some of the hospitals that are being reimbursed and you followed up with sort of the 11 to 12,000 figure. and recognizing that you want to be judicious in, you know, your projections around it. So maybe if you can just clarify how many different sort of CMS contracted jurisdictions are being currently reimbursed or being submitted to and being reimbursed, and then as a quick sort of follow-up to that, has that started to translate to any sort of any private pay reimbursement, or is that too early to tell?

Raul, I would say, you know, it's too early to – I mean, there are – only a few hospitals, so I would say probably two or three different zones are involved at the moment, so it's kind of early on that. On the private pay, you know, I think, again, the number of patients is relatively small, and so it's hard to predict the future, but I think our general impression is that certain private patients are also being paid. Maybe the amount they're being paid is highly variable, depending upon what type of insurance they have. But the general feedback we have from hospitals is that they are getting payments.

Great. Thank you very much, and I'll hop back in the queue.

Thank you. Our next question comes from Josh Jennings with Cowen. Your question, please.

Great. Thanks. This is actually Neil on for Josh. I guess first off, I just wanted to ask about, you know, the international regions that are in play for Tulsa Pro. So I know Japan is, you know, one country where you've seen subtraction. Could you talk about, you know, the progress that you're seeing there? And then secondly, you know, just with thoughts of pro placements in Europe, you know, if you could talk about the opportunity there and if that's a meaningful opportunity or if investors should continue to just focus mostly on the U.S. opportunity.

Neil, those are two very good questions. So first of all, in Japan, We do anticipate that it is outside of the U.S. It is going to be an important market for us, and we do continue to see traction, but we do need to get regulatory clearance in Japan, and we anticipate applying for it in 2021. It's hard to predict exactly when we get it, But in the meantime, we are getting new orders from Japan that are based upon their policy of importing technologies through direct import policy. So we are an innovative technology, as they recognize, and they're using the direct import concept to do so. So we're not able to advertise in Japan at all at the moment. but it is word of mouth that is working. And it's also giving us some, you know, confidence that, hey, once we get the regulatory approval, that it's a market that we do want to pay attention to. And as we go through it in Japan, we'll keep you certainly informed on that. With respect to Europe, that's also a very good question, actually, because, you know, what generally happens is what's happening with us is you know, we got our CE marker, we started to learn about our technology, we started treating patients. And that education helped us when we came to the United States in 2020. And now, again, it happens typically, is now that there's some traction at the leading hospitals in the United States, you know, Europe is starting to pay attention to us also to say, hey, this technology is something we want to you know, evaluate as well. So, you know, we are starting to see more interest, whether it translates into higher numbers, it's hard to say at the moment, but it is certainly translating into additional clinical trials that are funded by Europeans for us. And so I think from that perspective, I do think long-term Europe will become interesting also. And for certainly in 2021, you will see additional clinical publications coming out of Europe that will help us globally. So I kind of think U.S. is by far our number one priority. Japan is going to continue to become important to us as we go forward, and I think Europe will be next as well.

Great. And if I could just add in one follow-up question here. You know, there was a recent study published in JAMA just on prostate cancer screening with MRI. You know, the results of that study seem to indicate there's potential to increase the use of MRI for prostate cancer diagnosis. You know, so could that prove to potentially become or provide a tailwind for Tulsa Pro adoption, I guess, particularly with the imaging centers?

Yes. So, I mean, that's also a really good question. So there's quite a bit of activity. And one of the reasons why people used to ask us this question early on, is having an MRI a problem for you? Will you be able to find time on MRI? And what we're really finding is that there is a sort of a workflow that the MR companies are looking at, that leading hospitals are looking at, to see if they can use the MRI for diagnostics as I've kind of talked about it a little bit before also, but the clinical workflow from MR-based diagnosis to MR-based biopsy to Tulsa as MR-based treatment and then post-follow-up being MR-based also because nobody really wants to do biopsies unless they really have to do it. Chances of us replacing biopsy in the very near term is probably low. But I completely agree with the concept that there is a lot of work going on at DMR companies on continuing to improve the imaging technology for diagnostics. You might be familiar with the concept of PI-RADS, which has been more of an academic concept where academicians have been using that to stage the patients. I think you will see the PI-RADS concept get more and more adopted in the diagnostic world, and I think that will lead to a much more uniform workflow. So I haven't said anything, actually, what you've said, but I'm just putting more color into this, that having multiple companies, diagnostic companies, and with our technology providing treatment with MR, I think it's in sync with what we see as a trend.

Great. Thank you.

Thank you. Our next question comes from Fran Tackinen with Lake Street Capital. Your question, please.

Hey, everyone. Aaron, thanks for taking my questions for you today. Starting with sites, just asking a little bit more directly. I think you guys are at around eight active sites in the United States. Previously, you guys have helped us out a little bit, just providing some broader goalposts to think about installs on a go-forward basis. So hoping you guys could help us out as much as you can, understanding there's a lot of uncertainty with the environment, just trying to get a little better understanding for your expectations on installs in this year. And then even if you could kind of think on a longer-term basis, that would probably be helpful as well.

Sure. Yeah, I mean, I think, Frank, you're right in that 8 to 10 range of installs. I think we're a little bit cautious in the sense that, as I mentioned before, there has been, you know, certainly during the months of January, February, there have been some delays in the startup. So we're sort of bidding what's really functional and what's not functional versus installed versus not installed. But Having said that, I think these are very, very short-term things, and we're more about the long-term. So I think we're generally likely to see these installs becoming functional sites pretty quickly. With respect to the pipeline, I think that we continue to see that we have a very good pipeline of imaging centers that are interested in adding Tulsa to their portfolio. We're continuing to see that the imaging centers that signed up with us last year want to increase the number of sites that they want to go with. We're seeing additional early adopters. We have a pipeline of additional early adopters in our list. And we certainly see a number of leading hospitals continuing to be very interested, and we are in dialogue with more so in certainly the rest of this year. You will see, again, opinion-leading sites adopting this technology, and I think that I won't give you specific numbers, but I just feel, you know, obviously we want to be very cautious and so on, but I do think that, you know, when I look at adoption of game-changing technologies, the fact that leading hospitals are also leading adoption of a game-changing technology, which is a little bit unusual, is certainly one of the source of confidence that we have going forward.

That's helpful. And then this is the second one on the utilization front. I appreciate your comments on the outperformance versus original expectations by about 50%. on the utilization in the first six to 12 months. Maybe talk about the second number a little bit of getting to that over 100 procedures on a longer term basis. Do you feel that that's still a realistic expectation or do you think given the confidence in the utilization in the early days you could see out performance to that second number?

Frank, I would say that 100 is still a very good target for us. I do want to sort of provide a little more color in the sense that the reason why we saw this increase is that generally as the clinicians began to learn about the technology more, they felt that they could use it in a broader set of patient population. So in terms of the fact that this speaks to the fact that we could be applicable to a larger population and thereby the opportunity is bigger than what we started out with, I think that certainly we feel pretty good about. And I think you will see case studies and publications that will begin to show that broader potential of this technology in this year, later this year. But I would say at the moment, we still think using 100 as a target is pretty good. I think in Europe, certainly we are seeing that the top commercial sites are getting to be beyond 100. In the long haul, it's possible. But I also think that, to be honest, I think 100 is more of an average. I think we will probably have some sites that don't get there, and we'll probably have a few sites that will be a little bit higher than that.

Great. Thanks for taking the questions.

Thank you, Frank.

Thank you. And as a reminder, ladies and gentlemen, to ask a question, just press star 1 on your telephone keypad. Our next question is from Ben Hainer with Alliance Global. Your question, please.

Good afternoon, gentlemen. Thanks for taking the questions. First off for me, just on the commentary about sales and marketing expense exceeding R&D, is that kind of more of a function of, well, I know it's a function of selling expense going up, but how much of a function of that is, you know, a potential decline in R&D, just recognizing that you're going to start the level one studies by the end of the year?

That's an errant question, man. There's definitely some ebbing and flowing here, Ben, but sales and marketing, we've definitely been working on growing the team fairly aggressively to be able to manage the funnel. From an R&D standpoint, definitely that's where I'm getting at the ebbing and flowing. There's also things like we had a very good year, so we accrued for bonuses in the fourth quarter, which spreads across all areas that, you know, is not a repeating cost, for instance, in Q1. You know, we accrue at some lower rate throughout the year. So there's also some sort of one-time costs in there in the Q4 that made it higher.

Okay. All right. That's fair. And then, you know, you mentioned managing the funnel. You know, who are kind of the accounts or the account types that – You know, the newly added personnel are going to be, you know, calling upon most frequently. I mean, is it hospitals? Is it imaging centers? You know, who is really getting the focus? So it's all of the above.

It's all of the above. So it's imaging centers, it's hospital executives, it's physicians, urologists, interventional radiologists, radiologists. It's all of the above.

Okay. And do you have a head count that you expect to get to or anything you can share on that front?

We haven't disclosed that yet at this point.

Okay. So stay tuned. Got it. And then just thinking about, you know, you've got the humanitarian exemption. You know, have you already started having conversation with the folks that could be kind of the initial installs in the U.S.? And, you know, what are those – what do those sites look like, you know, and what sort of splash are you planning to make when you do launch it? I imagine with just the humanitarian device exemption, probably not a big one, but I figured I better ask the question.

Yeah, no, Ben, I think it's a good question. You know, with respect to that, I think we have so far spent most of our on, you know, what is the right strategy and what are the target hospitals, you know, knowing that at the moment it is a capital strategy and knowing that that's a bit of a difficult thing during the COVID era, I would say, you know, don't expect any sales news on that in the first half. But, yes, we do have a target set of hospitals. These will be mostly pediatrics. hospitals, um, and, um, you know, hopefully they're, um, you know, they have, um, um, um, you know, funds available to their, their charity organizations and so on, which might be a little bit different. So we are, you know, we are in, you know, starting to engage with, uh, with, uh, these, you know, few specialized hospitals, um, You may have seen on our website there is an interview from National Children regarding this that was just put in just a few days ago. So you're right, we're starting to get there. I think it's a compelling application. Let's see how it goes. Okay. Well, good. Thanks to the color guys, and I'll leave it at that. Thank you, Ben.

Thank you. And our last question comes from Michael with TLF Capital. Your question, please.

Good afternoon, gentlemen, and our own congratulations to you and the team for success during an impossible year. You received, well, you've announced an agreement with GE Healthcare in December of last year. Yes. Could you just share the importance of this, especially in light of the studies that you hope to see published later this year as it relates to the installed base, as it relates to market share, and as it relates to the adoption.

Yeah, absolutely. Michael, let me start by that concept that you had talked about. I do think that MR is going to continue to be an important aspect of prostate management from diagnostics to treatment to post treatment. So there is a lot of attention that the MR companies are putting at it. I think the fact that we can fill this one big gap that existed in this workflow, I think puts us in a very interesting position. So from that perspective, you know, we're obviously delighted that all three of the big MR companies are working with us. Obviously, that's an important point for us. Second is that at the high level, you know, the MR companies have their own specializations, and, you know, the GEs, for example, tend to have specialization more in the imaging centers, whereas Siemens tend to have more specialization in some of the teaching hospitals, and so on. So I think having that flexibility allows us to, you know, cater to the needs of our customers rather than forcing them to use, you know, an MR that, you know, that we're compatible with only. So it makes a much easier story for us or a conversation for us to talk about. And again, at the high level, GE is the largest MR company in the United States. And so having access to that install base is really important to us. So now, given that we're at that early stage, was it something that we urgently needed to have an install base today? Not really, because Generally, even the large hospitals will have two of the three suppliers, and we have been able to manage so far. But I think that as we go forward, particularly long-term, it will be a very important agreement for us.

Did I understand correctly that they're essentially sharing for the costs for the development and the software development and all of the testing?

I mean, our agreements are sort of win-based agreements. And so, you know, the things that we need to do in terms of developing our software, we're doing the things that they need to do in terms of their development they are doing. So, you know, I think that is pretty consistent with the agreements we have in general.

Well, congratulations. It speaks for itself. The largest installed base and a very difficult company to work with is your partner now. So thank you so much. Best of luck for this year.

Thank you so much, Michael.

Thank you. And with that, ladies and gentlemen, we conclude our Q&A session for today. I would like to turn the call back to Arun Menawat for his final remarks.

Thank you so much. Thank you for being so supportive. I think Michael's point is right. It was a difficult year of our startup. And we, you know, we are certainly energized with what we accomplished last year. And, you know, we're really looking forward to 2021 and updating you on Q1 2021 with US dollars. I guess I would I'd like to add one more quick point that in case you may or may not have noticed it, the TACT clinical trial, in fact, in the month of March is now fully published in the journal, in the print journal, and Tulsa is, in fact, on the cover of the journal. American Neurology Association. American Neurology, yeah, AUA, AUA's lead journal. Thank you so much.

And ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.