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Ladies and gentlemen, thank you for standing by, and welcome to the Profound Medical Fourth Quarter and Full Year 2020 Financial Results Conference Call. [Operator Instructions]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, as 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 is 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 to 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 diseased 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 510(k) cleared by the FDA.We are also commercializing Sonalleve, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastasis. Sonalleve has also been approved by the China National Medical Products Administration for the noninvasive treatment of uterine fibroids and has recently obtained FDA approval under our 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'll probably notice 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 3-month period ended December 31, 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 JPMorgan Conference, we hadn't yet made the switch to U.S. dollar reporting. So for clarity, this translates to actual revenue of CAD 3.8 million versus the CAD 3.7 million 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% 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 3-month period in 2019. As at December 31, 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 marks the 12-month mark of the introduction of TULSA 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 TULSA-PRO in the U.S., and there were 2 major pillars of that I would like to focus my remarks on today.First was to start building a high-quality U.S. installed base. In that regard, our U.S. market entry strategy for TULSA-PRO targets 3 types of end users: one, early adopters, which include neurologists specializing in cutting-edge alternative prostate disease treatment; two, independent imaging center companies, such as RadNet; and three, opinion-leading teaching hospitals.Each of these are unique and play different roles in supporting long-term adoption. The first 2 early adopter TULSA-PRO sites have been treating a great number and an increasing variety of patients. The experience at these centers mirrors what we observed during our European launch, where surgeons initially used TULSA-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 6 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 RadNet is now actively treating patients using TULSA after initially experiencing delays related to COVID-19. Midway through the year, we increasingly focused on the third group, establishing TULSA centers at top-tier hospitals. The early results of those efforts has been outstanding with the list of prestigious institutions offering the TULSA 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 TULSA-PRO to potentially qualify for a CPT 1 code. This leads me to the second pillar of our TULSA-PRO adoption strategy, which is, clearly, reimbursement. At the beginning of 2020, we announced that we have submitted an application for a health care common procedure coding system, C-code, from the Centers for Medicare and Medicaid Services, or CMS, for the TULSA-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 TULSA. 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 3-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 TULSA-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 a coverage determination, however, we will need level 1 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 TULSA 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 TULSA-PRO. In addition, we're looking forward to launching Sonalleve 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?
[Operator Instructions] Our first question is from Anthony Petrone with Jefferies.
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.
Sure, Tony, I'm happy to. So let me describe it by each of the pillars that we talk about, each of the 3 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 they -- 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 onetime 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 start-up 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 2 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 but procedures were not allowed. I just want to be clear 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. We -- the agreements we did last year and maybe very early this year, they are now installed and hospitals are now going. As of March, we anticipate full operation in place. So I think that part is -- hopefully, there is 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 the level of reimbursement that's being received under the C-code and whether or not that is sort of universal across the installed base of TULSAs at the moment? Or does it vary by region across the country?
Sure. So the -- what we publicly talked about is in general numbers. The APC code associated with the C-code generally pays in the order of between $11,000 to $12,500, and that range depends upon what type of institution is applying. So certain institutions in lower cost areas or smaller institution will get the lower end of it. Certain other institutions that are teaching institutions will get the higher end of it. And 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.
Our next question comes from Rahul Sarugaser with Raymond James.
So my first question really is, I think, Arun, you're referring to all of the existing contracts having been installed. In previous calls, you had referred to the pipeline being quite strong and that you're 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 will be kind of sort of create this bolus of additional installations that will need to happen as the hospital constraints start to release?
Arun, can I jump in just for a second?
Yes, go ahead, Aaron.
Yes. We have contracts signed where there are not -- where there are devices not installed and devices not treating patients still.
It's a timing point that -- what I was referring to is the agreements 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 have signed this year which are not installed.
Okay. Terrific. 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, how do you -- are you starting to see now that these hospital constraints starting to be lifted? Or do you expect that to be happening sort of into Q2? And as this bolus of installations 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, Rahul. 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 hospitals are starting to come back to normality to some extent. And I would say the other side in terms of the caution is that we have installed the systems, but getting up to speed in terms of the volume is still going to take some time because they have to start getting patients established. Typically, patients -- it takes about 4 to 6 weeks for the patients -- from the time they schedule a patient to when they actually treat. So I think there's still some uncertainty, but I think, generally, things are heading in the right direction in terms of activity.To your second question, we -- 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 yes -- I think the short answer to your question is, yes, I do think we will be prepared as the installed base grows and as the utilization grows.
Sure. And just one more quick question 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 $11,000 to $12,000 figure and recognizing that you want to be judicious in your projections around it. So maybe if you can just clarify how many different sort of CMS contract 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 into any sort of private pay reimbursement or is that too early to tell?
Rahul, I would say it's too early to -- I mean, there are only a few hospitals. So I would say maybe probably 2 or 3 different zones are involved at the moment. So it's kind of early on that. On the private pay, 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.
Our next question comes from Josh Jennings with Cowen.
This is actually Neil on for Josh. I guess, first off, I just wanted to ask about the international regions that are in place for TULSA-PRO. So I know Japan is one country where you've seen some traction. Could you talk about the progress that you're seeing there? And then secondly, just with TULSA-PRO placements in Europe, if you could talk about the opportunity there and if that's a meaningful opportunity or if investors should continue to just focus on -- mostly on the U.S. opportunity?
Neil, those are 2 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 the -- 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 technology by -- 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 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 what generally happens is what's happening with us is we got our CE mark early, 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 is some traction at the leading hospitals in the United States, the Europe is starting to pay attention to us, also to say, hey, this technology is something we want to evaluate as well.So 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 #1 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 then if I could just add in one follow-up question here. There was a recent study published in JAMA just on prostate cancer screening with MRI. The results of that study seemed to indicate there's potential to increase the use of MRI for prostate cancer diagnosis. So could that prove to potentially become or provide a tailwind for TULSA-PRO adoption, I guess, particularly with the imaging centers?
Yes. So Neil, that's also a really good question. So there is 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, that 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.Now 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 the MR 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 the trend.
Our next question comes from Frank Takkinen with Late Street Capital.
Two for you today. Starting with sites, just asking a little bit more directly. I think you guys ended around -- or at around 8 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. Yes, I mean, I think, Frank, you're right in that we're 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 -- certainly, during the months of January, February, there have been some delays in the start-ups. So we [ started embedding ] 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 are more about the long term. So I think we're generally likely to see these installed 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 their -- 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 -- obviously, we want to be very cautious and so on, but I do think that 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 sources of confidence that we have going forward.
That's helpful. And then just a 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 6 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 outperformance 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've 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.
[Operator Instructions] Our next question is from Ben Haynor with Alliance Global.
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 a potential decline in R&D, just recognizing that you're going to start the level 1 studies by the end of the year?
That's an Aaron question, Ben.
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, there's 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 is not a repeating cost, for instance, in Q1. We accrue at some lower rate throughout the year. But -- so there's some -- also some sort of onetime costs in there in Q4 that made it higher.
Okay. That's fair. And then you mentioned managing the funnel. Who are kind of the accounts or the account types that the newly added personnel are going to be calling upon most frequently? I mean is it some hospitals, is it imaging centers? Who is really getting the focus? Is it all of the above?
It's all of the above.
Yes.
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 headcount 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 Sonalleve, you got the humanitarian exemption. Have you already started having conversation with the folks that could be kind of the initial installs in the U.S.? And what do those sites look like? And what's sort of splash are you planning to make when you do launch? And I imagine with just the Humanitarian Device Exemption, it's probably not a big one, but I figured I better asked the question.
Yes. No, Ben, I think it's a good question. With respect to that, I think we have so far spent most of our time on what is the right strategy and what are the target hospitals. 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, don't expect any sales news on that in the first half. But yes, we do -- we have a target set of hospitals. These will be mostly pediatric hospitals. And hopefully, there -- they have funds available through their charity organizations and so on, which might be a little bit different. So we are starting to engage with these few specialized hospitals. 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.
And our last question comes from Michael Bunyaner with TLF Capital.
Arun, congratulations to you and the team for the success during an impossible year.
Thank you, Michael.
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?
Yes, absolutely. Michael, let me start by that concept that Neil had talked about is that 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, we're obviously delighted that all 3 of the big MR companies are working with us. Obviously, that's an important point for us.Second is that at the high level, the MR companies have their own specializations. And 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 cater to the needs of the -- of our customers rather than forcing them to use an MR 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 a high level, GE is the largest MR company in the United States. And so having access to that installed base is really important to us.So now given that we're at that early stage, is it -- was it something that we urgently needed to have an installed base today? Not really because generally, even the large hospitals will have 2 of the 3 suppliers, and we have been able to manage so far. But I think that as we go forward, particularly long term, it will be an important -- a very important agreement for us.
And 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-win-based agreements. And so we -- the things that we need to do in terms of developing our software. We are doing things that they need to do in terms of their development they are doing. So 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. 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 start-up, and we are certainly energized with what we accomplished last year. And we're really looking forward to 2021 and updating you on Q1 2021 with U.S. dollars. I guess I would 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 the -- and TULSA is, in fact, on the cover of the journal. So if you have not seen it, please...
American Urological Association.
Yes, AUA Journal. Thank you so much.
And ladies and gentlemen, this concludes today's conference call. Thank you for participating, and you may now disconnect.