Good day, ladies and gentlemen and welcome to the Profound Medical Third Quarter 2020 Financial Results Conference Call and Webcast. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host, Stephen Kilmer. Sir, the floor is yours.

And apologies, 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, as expected, expects, scheduled, intends, contemplates, anticipates, believes, proposes or variations including negative variations of such words and phrases or states that certain actions, events or results may, could, would, might, 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, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed, except as guaranteed by – 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 will now turn the call over to Aaron.

Good afternoon, everyone and welcome to our third quarter 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 third quarter 2020 financial results. To streamline things, all the numbers I will mention have been rounded and are therefore approximate. For the 3-month period ended September 30, 2020, the company recorded revenue of $3 million, an increase of 337% from $682,000 in the third quarter of 2019. Expenditures for research and development increased $1.3 million for the 3 months ended September 30, 2020, compared to the same period in 2019. The increase was attributed to higher spending on materials and R&D projects for technology improvements and upgrades, options awarded to employees and R&D personnel, in addition to the ineligibility of scientific research and education – and Scientific Research and Experimental Development or SR&ED credits, tax credits from the government of Canada. This was offset by decreases in consulting fees and travel. General and administrative expenses for the third quarter of 2020 were higher by $427,000 compared to the 3 months ended September 30, 2019. The increase was attributed to higher salaries, option awards – options awarded to employees, insurance costs associated with being NASDAQ-listed and software costs due to COVID-19 and annual subscriptions. This was offset by decreases in consulting fees associated with onetime NASDAQ listing costs incurred in 2019 and travel expenses related to COVID-19 restrictions. Overall, the company recorded a third quarter 2020 net loss of $8.1 million or $0.43 per common share compared with a net loss of $6.3 million or $0.57 per common share for the same 3-month period in 2019. During the third quarter of 2020, 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 $46 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. As of September 30, 2020, Profound had cash of $110.4 million. I would like to close by saying that our performance this quarter speaks to the strength of our technology and our business model, but we remain cautious in the near term mainly due to the uncertainty surrounding COVID-19. With that, I will now turn the call over to Arun.

Thank you, Aaron. As we mentioned in today’s press release announcing the Q3 results, our recent financing, combined with the increasing interest in our technology from opinion-leading hospitals and independent imaging centers, enables us to strategically and responsibly lay the groundwork to drive significant adoption of the TULSA procedure. We’re bolstering our management team, field force, clinical development programs and manufacturing capacity. With respect to adding talent, we recently welcomed two very experienced senior management team members. Jacques Cornet, our new VP of Marketing and Business development, is leading patient recruitment and digital marketing strategies as well as relationships with our MR partners. Jacques joined us from Philips, where he was VP of Sales and Marketing of one of the Healthcare division. He has more than 25 years of experience in global leadership roles, in-depth knowledge of global imaging systems market including health care IT and a broad network of contacts at leading-edge hospitals and health care organizations within the United States. Most importantly, Jacques and I have worked together in the past and have known each other personally for over 20 years. Welcome, Jacques. In addition, I am very pleased to welcome Michael Mydra, who joins us as of Monday as VP, Head of Global Market Access and will take on the dedicated role of leading TULSA’s reimbursement strategies. Michael joins us from Boston Scientific, where he was the VP of Global Market Access and Reimbursement for all of the company’s urologic products. Prior to that, Michael led reimbursement strategies at Augmenix, which developed the SpaceOAR device to reduce side effects associated with prostate cancer. Michael has more than 20 years of startup and large company medical device and health plan reimbursement experience. Welcome, Michael. The senior management team at Profound reflects a good mix of relevant experience and…

Thank you. [Operator Instructions] And our first question comes from Raj Denhoy from Jefferies. Go ahead.

Hi, good afternoon. I wonder if, Arun, maybe I could start with any changes on the reimbursement front. There have been some talk of some hospitals using established codes to try and build for the TULSA procedure, and yet we hadn’t heard whether that had been successful or not or they had been paid under those codes. Have you – do you have any updates you want to share today?

Raj, I think I can only share today that, certainly, the newer hospitals that we are signing up are – continue to think that the recommendation that we’re making is consistent with their thinking. We are also hearing that there are certain other ancillary codes they can use in addition to the C code that we are recommending. So I would – I don’t have any update with respect to the number of patients that may have been – where these codes have been used as of yet. I would say, and to be honest, I didn’t expect that we would be there by now. So I would say we will update you in the year-end call, and I do think that by that time, we will have a better update on that front for you.

Okay, that’s helpful. Maybe just a second question, you mentioned the pipeline for new sites is still pretty healthy into the back half of the year or the rest of the year, right? We have a month or so, 2 months left. Do you have a sense of where you might settle out this year? You mentioned you’re at 6 sites. I think you also said that in your prepared remarks that you’ll add them when they start treating. So when do you think we will get additional sites that will be treating patients?

Raj, I think originally, what – when the COVID thing has started, I think our team, we all felt that 3 to 6 months was a good time frame in terms of sort of movement backwards. And based on Q3 performance, we kind of felt like, okay, it could be closer to 3 months rather than 6. But again, because of resurgence, I’m a little bit concerned. Having said that, I do think that it’s possible that we could get to up to 10 sites this year, but I would say, still, it’s not a commitment to be cautious, but we certainly have additional agreements. And if the hospitals remain open and we can install and train, it’s certainly possible.

Okay. That’s helpful. I will leave it there for others. So appreciate it. Thank you.

Thank you, Raj.

And our next question comes from Andre Uddin. Go ahead, Andre.

Good afternoon, Andre.

Hi, this is Toby Ma for Andre Uddin. I just have two questions. First question for Arun, I was wondering if you can talk about the average number of procedures performed per week per imaging center in Q3? And how was that number in Q3 compared to the second quarter and the first quarter? And then my second question is for Aaron. And the R&D expense increased in Q3. So how should we think about R&D expense in Q4 and the next year? And I will stop here. Thank you.

Sure. Let me answer your question from the perspective of per site. So certainly, the number of total number of procedures in this last quarter, Q3, is higher than what we had in Q2. But I think that, again, because we’re in start-up and all of these macro factors at the moment, the way we look at it, is what’s the utilization per site which we think is actually quite meaningful and I think that we are fairly comfortable that, originally, we thought that the first 12 months of site will be approximately 40 procedures. I think at the last call, we talked about that maybe that number is closer to 50. I think at the moment, we’re probably feeling that number might actually be closer to 60, 65 for the year. So the patients continue to be treated. The sites continue to increase the variety of the patients they are treating. So I think that might sort of answer your question overall basis, that the trajectory is certainly in the direction of additional procedure. And again, I think with all of these macro factors, there might be some minor ups and downs, and we will obviously ride through it. But I think in the long haul, achieving higher numbers than what I talked about 12 months after the installs is we still continue to think that those are realistic goals. Aaron, you might want to go with your question.

Our next question comes from Josh Jennings from Cowen. Go ahead, Josh.

Yes, sorry, this is actually Neil on for Josh. Yes. I think a couple of my questions got answered already. But just one thing I was going to ask was just about the, I guess, the payment per procedure model, like how that’s potentially enhancing the sales process, if you have any color or updates there.

Yes. No, we’re happy to. I think that it’s actually a great question because when we started marketing TULSA and we treated our first patient in January this year, at the time, our VP of Sales, Abbey, she was – she and Aaron sort of joined hands to come up with a business model that was much more flexible. If the hospital wanted to rent the system, we were prepared to do that and so on. And you do that, obviously, when you start. But based upon the feedback that we received, the utilization that we’re seeing, we have gone strictly to a recurring revenue model now, and that is the only option that our sales team is offering to the market. And generally, the agreements at the moment are all 7,000 or higher per patient. And I think your – our analysts and investors, factors can go up and down a little bit, but I would be a little bit conservative in modeling. But at least at the moment, they’re all in 7 or higher range. And in addition to the business model, we are much more rigorous in the way we present the model in the sense that the Profound Genius Services is the way really we are presenting, and that is an on inclusive model where we support them with very strong clinical scientists upfront. And these scientists are not just there to support the cases, but they’re there to help them conduct a variety of cases so they can start with a salvaged prostate and then move to a whole gland prostate and move to a higher risk patient and so on and so on. And I think that strategy that we’re using is partly designed to ultimately drive utilization. We’re also, through our tulsaprocedure.com website and additional efforts underway, helping with patient recruitment and so on. We have added reimbursement support with Michael joining us as well. So there is a set of offering, and we are offering this as a bundled service with this recurring revenue charge. That’s the model that we have settled on. Aaron, do you have any other comments?

Yes. I would just say that we have a single deal that was our first – or our second deal that was not a 100% paper procedure. It was rental and paper procedure. Since then we’ve only done paper procedure. We don’t anticipate doing anything else. And Arun’s being conservative on the amount we – our price has been $7,710 per procedure consistently. Arun’s saying, over time, the volume commitments and things that may – there may be somebody trying to negotiate hard, and we’ll listen. But that’s the model, and we’re very pleased with it. We’re making great progress. We believe that model in these times is a real winner and that the barriers to entry for a new program to startup are minimal. The capital requirements associated with our equipment and that have been relieved, and we’re being very choosy as to where we want to set up to make sure we’re confident they’re going to be a high utilization site. And long term, we want to own it, and it’s in their best interest because through our Profound Genius Services model, we’re going to make sure they have very successful procedures, happy physicians and happy patients.

And our next question comes from Frank Takkinen from Lake Street Capital. Sorry, go ahead.

Hey, thanks for taking my questions. So just a couple for you here today. Starting on the sales funnel, I heard your commentary about potentially getting to 10 by the end of the year, albeit with a little bit of uncertainty due to COVID. But was hoping you could talk about the funnel on a little bit longer term basis and see what kind of sight line you can give us into potentially how many sites you could be looking at for 2021. And if you could even go even a little bit more granular into where you are seeing the majority of that interest, whether that is imaging centers, teaching hospitals or specialized urologists?

Sure, Frank. Good afternoon. I will share a couple of thoughts, but I think Aaron might want to chime in as well at some point. So Frank, I think the way – what our – I will just quickly go over 2020 strategy, and the strategy really was let us start with the early adopters who are current users of alternate technologies and then see if we can get traction with them. And then with the imaging center strategy to see all of the hypothesis that we put together in 2019, can we convert that into reality? And at the same time, we felt that we needed to have opinion-leading sites because for the long haul, it drives credibility and so on. So this is the three pronged approach that we are taking, and we feel so far that this strategy is working. And so the guidance that we provided to our sales team is that we want to then start to see additional adoption in each of these three, I call them, channels or you could call them segments, but we would like to see additional adoption in each of these. And I think going forward, that is more than likely what you will see in next year, that additional imaging center sites with even larger companies will continue to come on there in our pipeline, additional early adopters who are – who have now seen it enough and are quite excited about starting their own programs. And I think now that we have traction with some of the opinion-leading sites, we do have a pipeline of other teaching hospitals, and we’ll hear about them within the next 90 days or so. And so I think I cannot give you specific numbers, but what I can tell you is the fact that we started out in this difficult year, the COVID year, the fact that we are gaining traction even as the window opened a little bit in the third quarter as we were able to get a number of contracts signed. It gives us confidence. But at the moment, it doesn’t give us the ability to really forecast the numbers yet. And again, Aaron, you might have additional comments.

I actually don’t have a lot to add other than, well, we are – we think commercially long term, our – the bigger commercial opportunities in the imaging centers. We are pleasantly seeing a high level of activity at academic and opinion leader sites and believe we are carefully selecting those sites as well. The ones that we believe, for the most part, will be high-volume centers as well. And so we are optimistic at this point.

Got it. And then I apologize, I was jumping between calls, but I heard you right at the tail end talking about the extension of the TACT trial. So I just wanted to follow up on what you said there exactly. I want to see if you said another 35 patients being enrolled and then the time line around that as well as how that coincides with applying for a temporary reimbursement code?

Yes. So Frank, you are right. The idea is that we will – we want to be able to do a parallel approach, where we continue to have additional publications. And we need a certain number of patients, particularly U.S. patients, and all of this is designed to be able to apply for a CPT code at the right time. In parallel to that, and I explicitly on purpose spend more time today on the clinical side because the clinical data is now starting to come out, and it is, as you could hear from us, is quite impressive. So I think what you will see is we will – by extending this trial, it sort of shortens the time that we need to be able to apply for the CPT code rather than having to do a separate trial. But at the same time, we think to drive coverage where the payers have significant evidence so that paying properly for this procedure becomes a straightforward decision for them, we will continue to do additional trial. And I think you will hear from us every quarter now on advancement on clinical data as well as new trials that were started. So that’s certainly – the CPT code is the main purpose behind it. And to your second part of your question, these additional clinical trials and the fact that you saw the variety of different publications, so you heard me talk about the fact that we’re even now are able to use this technology on patients who are palliative, and certainly, we have a number of patients who have been treated who are radiorecurrent cases, they are treated on advanced prostate cancer as well as mid-level prostate cancer and those what we call extreme DPH. All of this is designed to ultimately achieve broad coverage, and that’s our strategy.

Okay, that makes sense. And then if I could just sneak one more in. R&D was up this quarter. And as expected, as you guys are investing in the business, products and trials and whatnot, so I completely understand that. But just curious on how you’re feeling about R&D on a go-forward basis. Do you view the 4 7 as more of a baseline? Or was there maybe some one-off expense in there where we could see that come in a little bit over the next quarter as well as 2021?

Aaron, I appreciate if you took care of that question.

Sure, yes. So with the financing in July, the part of the discussion around that was accelerating the support for reimbursement through clinical trials and accelerating the generational improvement of our systems. So there will be some uptick in both engineering R&D and clinical trial R&D over the course of the next 18 months.

Okay, that makes sense. Thanks for taking my questions, and congrats on all the progress this quarter.

Thank you.

Thank you.

And our next question comes from Rahul from Raymond James. Go ahead.

Hi, Rahul.

Hi good afternoon Aaron. Thank you so much for taking my question. So I guess my first question is I noticed that you are starting to break out revenue based on products, recurring revenue and service. Now recognizing that, of course, the model has been evolving with time, and of course, that’s going to become more resolved, are you able to provide us with – let us know how are we supposed to think about the numbers as we are seeing right now. Because if you back them out, it does – it seems like an underestimate of what your actual utilization rate is. So maybe you can give us a little more clarity there?

Yes. So Rahul, we have actually – that’s consistent the way we have been breaking out if you go back through in the quarterly materials. I would tell you I wouldn’t read too much into it yet. We are not providing guidance at this point. And I wouldn’t read too much into it because, frankly, some of those lines are a little confusing between European model that isn’t per procedure but is per disposable and capital, Japanese revenues that are capital and disposables and then U.S. numbers that are almost all procedure revenue. I think it’s probably going to be a year before we’ll – or so before we’ll be able to point to it and be able to be a little more descriptive. It’s just a little too lumpy at this point. We don’t want to confuse people with lumpy revenue between the various buckets. The capital sales, when you have a capital sale in Japan or something, it creates very lumpy revenue if you were to break it down too much and try to read too much into it. I would look more at sites installed and under contract and treating, and I would look at revenue more generically. And then in the next 12 to 18 months, we’ll be able to – hopefully be able to start giving you more granular understanding. But at this point, we don’t want the lumpiness to be misleading to people.

Right, right. That makes sense. Thank you so much. And then so my second question then is, Arun, it’s great to sort of hear a little more about the data that is being published over the last quarter. And now with the broadened utility in BPH and in salvaged patients, are you hearing from the existing sites that they are also starting to use the device more broadly in these other indications in patient pay procedures? And also just going to shoot on a second question in there is that the R&D burn has gone up a little bit, and should we be thinking about that continuing to be a little bit higher because you are continuing to support that R&D in those additional clinical trials?

Yes, Rahul. So I think the short answer to your question is yes. But again, the question is that in the U.S., we only have two sites with more than six months on the third site with about a quarter worth of experience. But even the newer sites, I think there is beginning to be recognition that this is a very flexible technology. Certainly, the current site, the older sites are moving the product for BPH and for a variety of prostate cancer. So yes, I think the breadth or the flexibility of the technology is certainly one of the reasons why, as I was saying before, I think that the actual utilization is slightly better than what we had originally anticipated. And I think based upon this data, I do think that we should – our strategy certainly is to – as part of our Profound Genius Service to continue to educate our sites to help them broaden the use of the technology. With respect to your second question on the R&D spend so on, I think Aaron is better suited than I am.

Okay. Thanks, Arun. So Rahul, I would say twofold. One, I will go back for one second, and I’d say we’re seeing a very nice, consistent feedback to the sites to even start treating with cancer. Patients come back and say, "Gee, thanks for treating my cancer, doc. But my BPH, this is amazing. It’s resolving all my BPH symptoms or most of them as well." It’s been a fairly consistent message we hear over and over, and it’s just nice to see, and it builds confidence in the physician and in us in BPH as a market opportunity. And in the physician’s hands, they see and hear that from the patient, it’s very positively self-reinforcing. Secondly, on the stand, as I was mentioning with Cowen’s questions, you will see us – we have made a conscious decision, and you saw it in the press release and in the prepared remarks, we have made a conscious decision to increase our level of investment in R&D and sales and marketing over the course of the next 12 to 18 months. After completing our financing in July, you will see an uptick in our spending there. We believe it’s very careful, well thought-out investments to support and accelerate growth.

That’s great. Thanks very much for including me in the question queue.

Thanks Rahul. We really appreciate your interest.

And we have another question from Raj Denhoy from Jefferies. Go ahead, one moment you are live.

Sorry thank you. Apologies for coming back in, but I just wanted to clear something up. So in the paper procedure revenue that you reported, it was about CAD 134,000. If one looks at that on a procedure basis, given that you’ve mentioned their USD 7,710 for a procedure that equates to about 13 procedures if I’m doing the math correctly. And so one is that right? And then when you think about...

No, no.

Okay.

No, because one of our first sites and remember we only had two, three sites really doing procedures in a meaningful way and now we have more one coming on. One of them was a rental and per procedure at a lower rate. So unfortunately, right now, the small numbers are confusing things. It will take 12 to 18 months before you can start reading into those numbers. Some of that revenue is being recorded as rental and not in that bucket, So it’s confusing. I apologize. But unfortunately, it was right after that. We locked in and said, okay, no more rentals. We are only doing paper procedures. But right now, it’s skewing the numbers inappropriately if you try to read into to it.

Understood. But I guess what might clear up is if you would perhaps give us some directionality in terms of what procedures are actually doing. I doubt you will go there, but is that something you could provide in terms of how many procedures you actually did in the quarter?

Again, I think we are a little early because I think in the course of the next 12 to 18 months, we will do that.

We will. And I think today, we can only say you that real numbers are significantly higher than what you just mentioned.

Yes.

Understood okay. I appreciate it. Just wanted to clear it up. Thank you.

[Operator Instructions] And there appears to be no further questions. I would now like to turn the floor back over to management for any closing remarks.

Thank you. Thank you for listening to us. Sorry, the start was a little bit messed up, but we are looking forward to updating you, I guess, at the year-end call next year. Thank you.

Thank you. This does conclude today’s conference. We thank you for your participation. You may disconnect your lines at this time, and have a wonderful day.