Profound Medical Corp

TSX:PRN

Earnings Call Transcript 2019-Q4

[Operator]

Greetings, and welcome to the Profound Medical Fourth Quarter and Full Year 2019 Financial Results Conference Call. [Operator Instructions] Please note, this conference is being recorded.I would now turn the conference over to your host, Stephen Kilmer, Investor Relations. Please go ahead.

[Stephen Kilmer, 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 and palliative pain. 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 has 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 or 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 statements, whether as a result of new information, future events or otherwise, other than as required by law.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.

[Aaron Davidson, CFO & Senior VP of Corporate Development]

Good afternoon, everyone, and welcome to our fourth quarter and year-end 2019 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.For the benefit of those who are new to the Profound story, we would like to start off by taking 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 transurethral prostate tissue ablation system that combines real-time MRI with a catheter-based robotically controlled directional thermal ultrasound and closed-loop temperature feedback control software to provide predictable physician-prescribed ablation of whole or partial gland prostate tissue. The TULSA-PRO system is designed to provide customizable and predictable incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men's natural functions. TULSA-PRO is CE marked and received 510(k) clearance from the U.S. Food and Drug Administration in August of 2019 and was approved by Health Canada in November of 2019.Profound is also commercializing Sonalleve, a tissue ablation system that also combines real-time MRI with focused thermal ultrasound that is CE marked for the treatment of uterine fibroids and palliative pain treatment related to bone metastasis and approved by the China National Medical Products Administration for the noninvasive treatment of uterine fibroids.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 and year-end 2019 financial results.To streamline things, all of the numbers I will discuss have been rounded and are therefore approximate. Also, a quick note on share count. We effected a 10:1 share consolidation on October 16, 2019, in order to qualify for listing on the NASDAQ capital market, and our shares commenced trading on the NASDAQ capital market on October 29. This was a significant milestone for Profound as many of our shareholders are based in the U.S., which is also a key target market for TULSA-PRO. As a result of the consolidation, the per-share numbers for the fourth quarter and for the full year 2019 I will cite are based on a recalculated weighted average number of common shares. For the 3-month period ended December 31, 2019, the company recorded revenue of $2.8 million, which was slightly higher than the $2.7 million preliminary unaudited revenue estimate that we announced ahead of the J.P. Morgan Healthcare Conference in January. Fourth quarter 2019 revenue increased approximately 64% from $1.7 million in the fourth quarter of 2018 and was up 310% sequentially from the $682,000 in the third quarter of 2019. This was the result of the ongoing rollout of Sonalleve in China, combined with the traction of TULSA-PRO has been gaining in international markets, since we announced the positive TACT clinical data in Q2 2019. Expenditures for R&D increased $354,000 for the 3 months ended December 31, 2019, compared to the same period in 2018 due to increased spending and testing for R&D projects and options awarded to employees.Increases in materials, consulting fees and share-based compensation, totaling $601,000, were partially offset by $297,000 total decrease in clinical trial costs, rent and salaries and benefits. General and administrative expenses for the fourth quarter of 2019 were higher by $1.2 million compared to the 3 months ended December 31, 2018. The $1.2 million increase was attributed to increases in share-based compensation, consulting fees, bad debt and other expenses, including those associated with our NASDAQ listing, and was partially offset by a decrease in salary, benefits and rent totaling $85,000. Overall, the company recorded a fourth quarter 2019 net loss of $5.2 million or $0.43 per common share compared with a net loss of $4.9 million or $0.45 per common share for the same 3-month period in 2018.Moving to the results for the full year ended December 31, 2019, the company recorded revenue of $5.5 million with $4.9 million from the sale of products and $632,000 from installation, training and support of the multiuse system components. Full year 2019 revenue increased approximately 112% from $2.6 million in 2018. Expenditures for R&D increased $2.2 million for the year ended December 31, 2019, compared to 2018. Increases in materials, consulting fees, travel, share-based compensation, salaries and benefits and other expenditures resulted in a $2.4 million increase in expenses, which was partially offset by a decrease in clinical trial costs and rent totaling $488,000.General and administrative expenses for the full year 2019 were higher by $1 million compared to the year ended December 31, 2018. Increases in share-based compensation, bad debt and other expenses, including those associated with our NASDAQ listing, resulted in a $1.3 million increase in expenses, which was partially offset by a decrease in salaries and benefits, consulting fees, rent and travel, totaling $487,000. Overall, the company recorded a full year 2019 net loss of $20.2 million or $1.82 per common share compared with a net loss of $20.8 million or $2.07 per common share in 2018. As at December 31, 2019, Profound had cash of $19.2 million. Subsequent to year-end, Profound strengthened its balance sheet through 2 transactions. In late January, we closed an underwritten offering of common shares, including the full exercise of the underwriters' over-allotment option, resulting in aggregate gross proceeds of approximately USD 40 million. Net proceeds will be used to fund the commercial launch of TULSA-PRO in the U.S. and the continued commercialization of TULSA-PRO and Sonalleve globally. On the heels of that, we retired our $12.5 million in principal amount loan with CIBC approximately 30 months ahead of its maturity date of July 29, 2022. This extinguished all of Profound's long-term debt and translates to total estimated net interest payment savings of about $900,000. With that, I'll now turn the call over to Arun.

[Arun Swarup Menawat, CEO & Director]

Thank you, Aaron. In many respects, 2019 was a transformative year for Profound, marked by the positive TACT clinical trial results announced last summer, followed by receipt of both FDA and Health Canada approvals for TULSA-PRO in the second half of the year. We were also pleased with the continuing rollout of Sonalleve in China as well as the increasing interest in the adoption of TULSA-PRO in international markets, particularly Japan, since announcing the TACT data. As I have described in the past, the European market has always been important for TULSA-PRO as we learned a lot about the full capability of TULSA which is crucial to our U.S. launch. The first of these is that TULSA-PRO enables urologists, for the first time, to systematically customize treatment based on individual patient needs. The system can be used for whole prostate ablation while allowing the physician to be conservative in the region in which the nerve bundles lie. Second, TULSA-PRO is flexible. It can be used to treat patients who would prefer partial gland ablation of only the diseased areas of prostate or in salvage or palliative patients where the size and the shape of the prostate vary significantly from one patient to the next because TULSA's closed-loop process control capabilities are able to ablate unusual shapes with precision. TULSA-PRO can even be used to shrink large benign prostates that cause highly symptomatic BPH disease. These patients would otherwise require surgical interventions that are associated with significant side effects. This versatility of TULSA-PRO that it can be used to treat a variety of prostate diseases is one of the reasons why urologists have expressed interest in learning to use the technology more frequently. Finally, according to the TACT data, TULSA-PRO-treated prostates shrank by an average of 90% within 12 months, leaving one prominent urologist to describe the system as essentially a nonsurgical prostatectomy that allows the physician to minimize damage to patients' vital functions. This is precisely how we view TULSA-PRO's capabilities. It is a sophisticated and elegant technology that allows the urologist to customize the treatment to fit the exact need of the patient. It is flexible enough to be used in a variety of prostate diseases, and the shrinkage of the prostate posttreatment gives the urologist and the patients comfort in terms of the potential long-term durability of the ablation.I would now like to focus the remainder of the call on our TULSA-PRO U.S. commercialization strategy because, while 2019 was about the TACT trial data and TULSA-PRO's approval, 2020 is really about validating our business model.Our market entry strategy includes 3 primary market segments or delivery channels. The first channel reflects the often opinion-leading teaching hospitals in the U.S. We are pleased to report that TULSA-PRO is garnering a high level of interest from many such hospitals, and we are already in contract discussions with a number of them, including both those that were part of the TACT trial as well as those that were not part of the study. Although these centers will have modest patient volume, especially while procedure is patient pay, the segment is extremely important from a strategic perspective. These are the sites that influence adoption of new technologies through ongoing research to be presented to the urology community, providing education programs for residents and other practicing physicians and providing the necessary support to the societies and payers for reimbursement. We are delighted with this interest, and we'll update you throughout the year as TULSA-PRO becomes operational at these teaching sites.The second channel is imaging centers through which we intend to provide TULSA as a clinical service to urologists across the U.S. As we announced in January, we signed our first-ever U.S. multisite imaging center agreement for TULSA-PRO with RadNet, the largest U.S. owner and operator of outpatient imaging centers. We believe RadNet's early engagement is a sign that they are executing on their strategy to become a leading provider of men's health. TULSA enables RadNet to become a full-service provider of prostate health, ranging from diagnosing the patient using MRI imaging to MRI-guided biopsy to TULSA treatment and follow-up using MR imaging to measure the shrinkage of the prostate. We are currently in the process of installing the first RadNet site in the greater Los Angeles, California area and expect it to be operational by the end of March. Educating RadNet's urologists is an important objective that is already underway. We continue to believe that over the long haul, the placement of TULSA-PRO and enabling an imaging center to become a full-service provider of men's health can be a substantial driver of TULSA-PRO adoption.Along those lines, I'm happy to report that we have also now signed an additional agreement with an imaging center that is not part of RadNet, providing further validation of the strategy. We expect that site will be operational in April. The third channel is that of urologists who specialize in providing only new and emerging technologies for their unique patient populations. Along these lines, our first commercial site, Vituro Health, located in Sarasota, Florida, is now operational under the supervision of Medical Director, Dr. Stephen Scionti. Vituro Health is a leading urology practice cooperative that focuses on emerging technologies, and Dr. Scionti is one of the nation's leading authorities in noninvasive ablated therapies for prostate cancer. Since then, Dr. Scionti has used the technology in a variety of cases, ranging from focal or partial gland treatment to full gland ablation of patients with intermediate risk disease. In that regard, he has already confirmed the flexible capabilities of the TULSA-PRO system.In summary, we consider each of these 3 TULSA-PRO delivery channels are unique and key parts of our strategy to drive adoption. We plan to tailor our value proposition to each of these channels' needs. For example, we're working with RadNet to help educate their urology community and with the teaching hospitals on the next generation of clinical publications. We will work with all to provide the appropriate content for their social media presence. We continue to believe that 5% or more of the prostate disease market is patient paid which gives us sufficient room to grow during the introduction of the technology. And that, altogether, our market entry strategy will create sufficient presence to enable us to capture a good part of this segment. The second key part of our long-term TULSA-PRO adoption strategy is clearly reimbursement. We 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 in November. Typically, most companies do not apply for a C-code until a year after 510(k) clearance. But since we met the criteria, we decided to move forward quickly. A C-code is a unique temporary procedure code established by CMS for the Hospital Outpatient Prospective Payment System, or OPPS, to promote the adoption of new medical technology that otherwise had no codes to facilitate payment. C-codes are used on Medicare OPPS claims but may also be recognized on claims from other providers or by other payment systems. Should Profound receive a C-code for TULSA-PRO, it would provide for a 3-year period of coding and billing methodology for facility costs where patients may ultimately only be required to personally cover the related physician fees. Getting a C-code does not guarantee that it will actually be paid by insurance or CMS. We will still have to work with payers towards positive coverage decisions. Since filing the C-code, we did meet with CMS in February to help them better understand our technology, and now it is with their Evaluation Committee to make a final decision. We expect communication from CMS by midyear, and it could range from anywhere to asking us to wait for 1 more year until a few commercial sites are operational to agreeing to a new code or allowing us to use an existing code. I'd like to reiterate that we view reimbursement and coverage as a 3-plus year process, and this application is the first step. As for 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 code. We expect patient recruitment to begin by midyear 2020 for planned additional trials.Let me conclude our opening remarks by laying out some early U.S. commercialization metrics against which we will be measuring our success internally. We expect to have 20 sites under contract by end of 2020 with 15 of those operational. By operational, we mean performing procedures. Typically, we'll take approximately 120 days from purchase order to first procedure, including system inflation and physician training. This start-up time will reduce to 75 to 90 days as we gain experience. In terms of mix, we estimate more than half of these sites will be run by independent imaging and commercial centers and with physicians who focus on emerging technologies with the remainder at teaching hospitals. We estimate that after the first 6 to 12 months of being operational, the average run rate will be 40 procedures per year, eventually growing to 100 procedures or more after that. Of course, these numbers will change if and when the TULSA-PRO procedure becomes eligible for reimbursement.Finally, I'd like to add that continued demonstration and advancement of TULSA's clinical value is a key part of our adoption strategy. We anticipate that TULSA will be a subject of presentations at multiple conferences in 2020. For example, Finland's Turku Hospital will present data on the use of TULSA in patients with radiorecurrent prostate cancer as well as patients with BPH at the upcoming meeting of the European Association of Urology in Amsterdam in the third week of March 2020. We expect publications like these will continue to solidify the utility of TULSA across various types of prostate diseases. In many ways, 2020 marks the beginning of a new chapter for Profound. And to summarize what we're looking forward to in the near term: additional TULSA-PRO site agreements and U.S. operating sites, beginning patient recruitment for additional U.S. clinical trials focused on obtaining longer-term reimbursement and progressing TULSA-PRO's reimbursement strategy. This ends our prepared remarks for today. With that, we're happy to take any questions you might have. Operator?

[Operator]

[Operator Instructions] Our first question comes from Rahul Sarugaser with Raymond James.

[Rahul Sarugaser]

Congratulations on an excellent 2019. I think everyone is quite pleased with the performance so far. So I guess my first question is around the first installation. Maybe you can shed a little more light in terms of how long it took from potentially the date of sale to the first patient treatment -- treated? And if you're also able to then further elaborate on what is the current rate or number of treatments -- sorry, number of patients being treated per week at that site?

[Arun Swarup Menawat, CEO & Director]

Sure, Rahul. Good afternoon, and thank you for the comments. So the first site was in Sarasota, Florida, and it took about 4 months to get it started. And it was a little bit unusually higher than what we originally expected because it was the first time that we engaged with the imaging center in Florida, and it was the first time the imaging center did an interventional procedure, where they needed to get permission from the Florida health system to be able to do the procedure and then install the anesthesia equipment and so on. So I think it was actually a good exercise, and I think future ones should get better. And as I said in the prepared remarks, I think, ultimately, we'll bring it down to about 75 days from the time we signed the agreement.With respect to the rate with which they're treating, they are off to a pretty good start. Our expectation has been that the first year, a typical site will be between 30 to 40 procedures. I think they will certainly exceed that expectation based upon the number of patients they have already done. As you know, we have put together a program that we call the Genius program, where we help them with conducting a variety of patients. And so the first few patients that they have performed include whole-gland therapies with intermediate-risk disease. It includes partial gland or what they call focal. It also includes patients who have both prostate cancer and BPH. So the idea was -- of the start-up is always going to be let's get you going with the full range of the capability, and now we're working with them on increasing the productivity, so they will start from where they started, which was about 2 patients, to now they'll start on 3 patients and then ultimately get to 4 per day. So I think in summary, good start. There've done the variety of cases. They are now next up on their learning curves on productivity, and I do think that they will exceed that 40 for the first 12 months.

[Rahul Sarugaser]

Great. That's really helpful. And then just to drill down a little bit where you talked about the 2 per day and then soon to be 3 per day. Is that in a given week? Or how many days per week would that -- would those numbers be functioning?

[Arun Swarup Menawat, CEO & Director]

Right. So at the moment, the -- it's a pretty rigorous start-up program that we have. So because of the rigor, we actually not only perform -- we're doing 2 cases, at the moment, every 2 weeks or 4 per month basically. And we -- after -- during the middle week or after 1 week, we actually do a full review with them, and we are making sure the patient satisfaction is doing very well. We're making sure we're looking at the various aspects of the treatment, and we're monitoring where it's taking them longer so that we're developing the optimization of the workflow with them of their low on site. So I think that the idea is that we start in a very controlled manner. And then the next step, as I said, will be 3 per week every other week, and then we'll increase from there as time goes on.

[Rahul Sarugaser]

Great. And then one sort of final sort of question around pricing more generally as you are pricing these -- now subsequent sale with RadNet and then -- and so on and so forth. You had, in the last call, shared that the sort of pay per click, is it around $2,500 and of course the consumables at around $4,000. Are you seeing durability in that pricing? Or are you seeing variance?

[Arun Swarup Menawat, CEO & Director]

Yes. No. I think that the pricing is in place, and we are seeing durability in those numbers. I think that over the long haul, I would say, model at $6,000 per patient in terms of total. But certainly, every agreement that we have at this point is much higher than that number.

[Operator]

Our next question comes from Ben Haynor with Alliance Global.

[Benjamin Charles Haynor, Analyst]

Excellent. So first off for me, you mentioned that you signed an agreement with another imaging center and that they should be up and running in April, if I heard you correctly. Maybe could you characterize that imaging center's profile? Is it a stand-alone center? Is it part of a kind of multiunit chain, part of the country? Were you in touch with them prior to signing the RadNet agreement? Any color that you can provide there would be helpful.

[Arun Swarup Menawat, CEO & Director]

Sure. Ben, we -- I will do my best to provide what I can. We did not announce the name of the center just yet, only because we're very close to getting them up and running, in fact, within the next few weeks. And they have a lineup of patients already, and they will have their own media campaign. And we have sort of decided that until they announce it and we're going to try to do things that way. Until they announce it, we won't necessarily announce the name. But this is in terms of providing a little bit more color, it is in the middle of the country, a large city and again a center that has effectively a 5-star facility with similar mindset of being able to diagnose the patient with a state-of-the-art MR device and biopsy of the patient and exactly the same idea that they want to add treatment to the system. They have been looking at a number of technologies, and they picked ours to provide the full service for them. So I apologize for not providing the name. We just want to be respectful of our customers, but I think it's only a matter of week when they have treated their first couple of patients. And I think at that point, it will be public, and you'll hear about it.

[Benjamin Charles Haynor, Analyst]

Okay. That's definitely helpful. And then I think it was on the Q3 call that you guys mentioned that you had visited something like 75 U.S. institutions and about half of them had come to you. I guess do you have any update on where that stands now? I mean are you still seeing a lot of incoming interest? And what's the status of you guys going out there and pounding the pavement, being that it doesn't seem like you necessarily need to?

[Arun Swarup Menawat, CEO & Director]

Yes. So Ben, I think that I want to kind of start with a bit of a caveat. I think that we are at an early stage, and I think you know me well enough that we're very, very data focused. So I want to be careful as we proceed. Having said that, I agree with your statement that we really are not having to pound the pavement or do prospecting. We continue to have incoming calls. We have multiple contracts in the works with multiple sites. A number of them are teaching sites. And as you know, as -- I guess, first of all, as I kind of already described a little bit, working with imaging centers or the emerging specialists or about emerging markets or technologies, I think you can see we are getting agreements done at a pretty rapid pace. For an early new treatment, we're getting them done in like 3 to 4 months. With the teaching hospitals, there are multiple ones out in the works. There are no pricing issues or anything like that. They are moving actually at a fast pace based upon their standards. So a typical teaching hospital is 12 to 18 months. I think we'll get them done in 6 to 9 months, which, for them, is much faster. But obviously, for us, we -- our strategy, as I described in our prepared remarks, is to really get a few of these community sites, a few of the imaging centers and a few of the emerging sites, and I think we have additional contracts in every one of these channels.

[Benjamin Charles Haynor, Analyst]

Okay, great. And then just lastly for me. You mentioned in the prepared remarks RadNet men's health. If I'm not mistaken, they have a number of women's health-focused centers and the advertising campaigns out there. Do you think -- or get the sense that they're trying to do something similar with men's health kind of perhaps with TULSA-PRO as the "anchor procedure'? Or is that reading too much into it?

[Arun Swarup Menawat, CEO & Director]

No. Ben, you have it exactly right, to be honest. I think that, that is exactly what they told us during our discussion that they felt that when they did the women's health program, it was a very successful program for them. And in fact, this one could be even bigger because treatment is included. It's a bigger solution for them. And they also see the fact that, quite frankly, men get more sick when they get in this age group, and they see this as a way to capture a percentage of the patient population. And they do have a pretty good campaign plan that you will see also becoming public within the next few weeks, which we'll cater, yes.

[Operator]

Our next question comes from Andre Uddin with Mackie.

[Unknown]

This is Toby for Andre. So I have 2 questions. First, should we expect any interim results of the TACT 2 trial this year?

[Arun Swarup Menawat, CEO & Director]

So TACT 2 recruitment will begin by summer. I would guess that you probably will not see significant new data from TACT 2, but you will see 2-year data this summer from TACT 2. And you will see additional publications of different subsets of patients being done, smaller subset, but it will validate the flexibility of the technology. But I think the additional TACT 2 itself probably is -- once we start by summer probably would be too early to see anything significant.

[Unknown]

Okay. So secondly, I want to switch the gear a little bit to the story in the U.S. So based on your corporate presentation, a new -- Profound filed a regulatory application for this device in the U.S. last year. So when do you expect to hear back from the FDA? And do you have any initial commercial plan for this device in the States?

[Arun Swarup Menawat, CEO & Director]

Sure. That's a good question. So the file is now complete. We did go through a full FDA audit, and we have completed all of the data that FDA was looking for. So I don't have a prediction in terms of when we would get it, but I do think that we will get it. We should be able to get there. Obviously, it's up to the FDA. But from our perspective, the file is now complete. And so it's in the FDA for their evaluation. The -- with respect to your second part of that question, it is for a very rare disease, and we do have interest in that area. So I am not in a position to provide significant update in terms of commercial -- the quality of our commercial strategy yet. But I think that you might think of it more as a strategic move that we were able to get our first indication. Once we do get it, that we can get our first indication from the FDA. And then our strategy is to continue to then expand that indication, which we think will be a lot easier to do than if we started with some bigger indication. So do I expect some activity if we get FDA approval this year? Yes, I do, but I'm not really looking at that as significantly material to us this year.

[Operator]

[Operator Instructions] Our next question comes from Brian Gagnon with Gagnon Securities.

[Brian Joseph Gagnon, Senior Partner & Portfolio Manager]

Can you hear me okay?

[Arun Swarup Menawat, CEO & Director]

Yes, Brian. Good afternoon.

[Brian Joseph Gagnon, Senior Partner & Portfolio Manager]

All right. So you talked about academic centers and high-volume clinics. Who else is coming to you all or are you reaching out to as potential users of the TULSA device?

[Arun Swarup Menawat, CEO & Director]

Yes. That's a good question. So I think in terms of the teaching hospitals, particularly the one that were part of the TACT trial, so hospitals like Johns Hopkins, UCLA, University of Texas, Indiana, a number of these hospitals are certainly on the list of the teaching hospitals that -- where we are in discussions. Obviously, we are not guaranteeing, but we think that those are certainly we're in advanced conversations. There are a few that were not part of the clinical trial, but they are leading hospitals, systems and...

[Aaron Davidson, CFO & Senior VP of Corporate Development]

High-profile, opinion-leading...

[Arun Swarup Menawat, CEO & Director]

High-profile, opinion leading sites. I think if you look in the U.S. news top 25, I would say these are hospitals that are in that category. I think you can probably imagine Mayo clinic, Yale, a number of big names are -- we're in discussion.

[Brian Joseph Gagnon, Senior Partner & Portfolio Manager]

Excellent. Did I hear you correctly in saying that you thought you'd have 25 under contract by year-end and 15 operational?

[Arun Swarup Menawat, CEO & Director]

So I think at the moment, our projection is 20 contracts and 15 operational for this year.

[Brian Joseph Gagnon, Senior Partner & Portfolio Manager]

Okay. I just wasn't sure if I heard that correctly. All right. So the Scionti clinic, there's been lots of news about them using the device and their opportunity to grow. How do you prioritize allowing a high-volume clinic to grow as rapidly as they want to versus you making sure that they grow properly? Am I asking that question so you understand it?

[Arun Swarup Menawat, CEO & Director]

Yes. I do. We have one of the sites that is coming up. They asked for starting with 3 cases in a day, and we've sort of worked with them to get to 2 for the first day and then 2 the next day and so on. So I think it is really a conversation. And I think that Dr. Scionti, being an expert in ablative therapies himself, was very, very quick in learning the procedure and really doing it properly. And so I think at this point, in his case, the learning curve was really more related to the imaging center because it was an entirely new procedure for the imaging center. So we're kind of looking at it on a one-on-one basis of where the strengths and weaknesses are. And we're being very -- in writing, we kind of write like these are the things we need to accomplish. And on that basis, this is the way we should start. And we have hired -- we have 5 people on staff who we consider to be part of our Profound Genius Services, and they are quite rigorous from writing the workflow for them, doing one-on-one training with the people who will be participating in the delivery of the procedure and so on. So I cannot give you a general-purpose answer, but it's a very -- much a methodical approach that allows them to see that we are being as aggressive as we can. At the same time, we're making sure that everybody is safe and that the procedures will go well.

[Brian Joseph Gagnon, Senior Partner & Portfolio Manager]

Okay. Last question for me. You have a small sales force. How do you prioritize the inbound calls versus going to visit for potential new sales versus getting contracts signed and installation? How are you thinking about that?

[Arun Swarup Menawat, CEO & Director]

Yes. So I think we are being very loyal to the 3 channels that we talked about, so we internally actually have very rigorous goals, which first -- which are the first 5 teaching sites, which are the first 5 imaging centers and which are the first 5 emerging technology specialists, urologists. And so that is exactly how we're prioritizing. As I mentioned, we are spending -- we're basically taking incoming calls. So at the moment, our team is in different phases. So late last year, we were in the phase of educating the sites that called and helping them understand the technology and helping them understand the business model and the start-up process. This year, we're more in the process of here's the contract and which committees we need to go through and what questions we can answer, so it's a more advanced stage. And so that's kind of how we're prioritizing a good bit of our time. The other part that we are doing is we are, in fact, hosting urologists at our offices in Toronto. So that also helps us with not having to have a lot of people travel to different sites. But when they come to visit us, they're able to have a little bit of hands-on experience using a gel phantom instead of a patient. They're able to meet our engineering there with the manufacturing, so it gives them pretty good confidence we can spend enough time with them going over through the start-up program and so on. So that's kind of where our team is spending a majority of our time right now.

[Operator]

I would now like to turn the call over to Dr. Menawat for closing comments.

[Arun Swarup Menawat, CEO & Director]

Thank you so much. And again, welcome to all the new investors who have just recently joined us. And we look forward to updating you at the Q1 analyst call. Thank you.

[Operator]

This concludes today's teleconference. You may disconnect your lines at this time, and thank you for your participation.