Good morning, ladies and gentlemen, and welcome to the Neuronetics reports Fourth Quarter and Full Year 2020 Financial and Operating Results Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to turn the conference over to your host, Mr. Mark Klausner. Please go ahead, sir.

Good morning, and thank you for joining us for Neuronetics fourth quarter 2020 conference call. A replay of this call will be available on our website for 30 days. Joining me on today's call are Neuronetics President and Chief Executive Officer, Keith Sullivan; and Chief Financial Officer, Stephen Furlong. Before we begin, I would like to caution listeners that certain information discussed by management during this conference call will include forward-looking statements covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to our business, strategy, financial and revenue guidance, the impact of COVID-19 and other operational issues and metrics. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the Company's business. For a discussion of risks and uncertainties associated with Neuronetics' business, I encourage you to review the Company's filings with the Securities and Exchange Commission, including the Company's annual report on Form 10-K, which will be filed after the close of market today. The Company disclaims any obligation to update any forward-looking statement made during the course of this call, except as required by law. During the call, we'll also discuss certain information on a non-GAAP basis, including EBITDA. Management believes that non-GAAP financial information taken in conjunction with U.S. GAAP financial measures provide useful information for both management and investors by excluding certain noncash and other expenses that are not indicative of trends in our operating results. Management uses non-GAAP financial measures to compare our performance relative to forecast and strategic plans to benchmark our performance externally against competitors and for certain compensation decisions. Reconciliations between U.S. GAAP and non-GAAP results are presented in the tables accompanying our press release, which can be viewed on our website. With that, it's my pleasure to turn the call over to Neuronetics' President and Chief Executive Officer, Keith Sullivan.

Good morning and thank you for joining us. I will provide an overview of our fourth quarter performance and discuss the progress we made on our near-term focus areas. Steve will then give our fourth quarter financial results, and I'll conclude with our thoughts on 2021 before turning to questions and answers. Starting with the review of the fourth quarter. Total revenue was $15.6 million, slightly ahead of our January preannouncement of $15 million to $15.5 million. On a sequential basis, revenue was up 25% over the third quarter of 2020, driven by growth in both system sales and treatment session revenue. While total revenue was down year-over-year, we are encouraged by the continued recovery of the business and the momentum we have built going into 2021. On the capital equipment side, U.S. NeuroStar Advanced Therapy system revenue grew by 42% over the third quarter of 2020. Our fourth quarter is seasonally strong quarter, and we did see some pent-up demand from the second and third quarters convert into sales, in addition to some customers looking to take advantage of the Section 179 Tax Incentive prior to year-end. Total treatment session revenue was up 21% over the third quarter of 2020 and was down only 2% compared to the fourth quarter of 2019. We did not experience the typical seasonal decline in treatment sessions between Thanksgiving and New Year's due to the reduction in patient travel during COVID. Turning to the fourth quarter operational update. The most notable achievement during the quarter was the completion of our market research study. As previously mentioned, we engaged a market research firm to identify the proper target audience, the messaging that resonates with them and the most efficient way to communicate with them. Ultimately, our goal is to take this information, analyze it…

Thank you, Keith. COVID was the big driver for all year-over-year comparisons. So in this unusual period, we will be discussing sequential changes to illustrate the pace of our recovery. Total revenue for the fourth quarter was $15.6 million, up 25% over the third quarter of 2020. U.S. NeuroStar Advanced Therapy system revenue was $3.6 million, up 42% over the third quarter of 2020, driven by a 38% increase in the number of systems sold. Compared to the prior year, fourth quarter U.S. NeuroStar Advanced Therapy system revenue was down 33%. In the quarter, the Company sold 54 systems, down from 78 in the fourth quarter of 2019. U.S. treatment session revenue was $11 million, up 21% over the third quarter of 2020. Compared to the prior year, U.S. treatment session revenue was down just 2%. The strong treatment session performance was due to a significant decrease in travel between Thanksgiving and year-end holidays, which enabled patients to start or continue therapy during this historically slow period. In line with our new commercial strategy, we are utilizing U.S. treatment session revenue per active site to discuss trends in utilization. This metric better aligns with our patient-focused strategy to have NPCs focused on driving awareness and patient education, leading to overall account growth rather than revenue per system. Over time, with some level of seasonality, as we continue to execute on our strategy, U.S. treatment session revenue per site figure should improve. We calculate this metric by dividing total U.S. treatment session revenue by the beginning of the quarter active sites. In the fourth quarter of 2020, revenue per active site was approximately $12,133 compared to approximately $13,497 in the prior year quarter. Sequentially, we experienced a 19% increase increasing from $10,217 per site in Q3 2020. The new metric, along…

Thank you, Steve. Before providing our thoughts on strategic priorities for 2021, I wanted to discuss some of the activities that have occurred since the beginning of the year. As noted earlier, we kicked off the year with our national sales meeting in January, which was held in person in Orlando, Florida. Over 100 people attended the weeklong meeting, which started on a Monday when we rolled out the new revised compensation plans to the team and ended on a Friday afternoon. We felt that hosting this event in person was critical to introduce new programs and generate the excitement needed to be successful going forward. We took the utmost precautions when putting on the event to ensure the safety of those employees who attended as well as people who would come in contact with them after the fact. All attendees were required to produce multiple negative tests before arriving, pass a rapid test upon arrival and then go through daily monitoring protocols, including temperature screening and contact evaluation forms. Throughout the event, we had a medical team on staff, and we required everyone to strictly adhere to the guidelines related to face coverings and social distancing. Attendings were also required to get a COVID test after they returned home, and I'm pleased to report that 100% of these tests were negative. A major theme of our meeting was understanding the MDD patients journey and how the NeuroStar treatment can help them. Over the last several months, we went through an exhaustive exercise to gain thorough insight into the patient journey for someone suffering for major depressive disorder. If someone can't sleep because of the medication that they're on and begins to do research on treatment alternatives, what happens to the patient from that point, up until they complete their…

[Operator Instructions] Your first question comes from Margaret Kaczor with William Blair.

I'd love to start off on the short term. So did you guys see sites requote through the last COVID wave were pretty steady improvements? And really, the genesis of the question is. What does this mean for the first half and first quarter guidance in terms of that mix systems versus consumables? It just seems like that sequential revenue change that's implied in guidance is maybe down a little bit more than what we saw in '18 and '19, so I didn't know if that was conservatism or driven by something else.

Thank you, Margaret. This is Steve. Yes. So our first quarter, it really is tough on the treatment session side. And so while we didn't see the seasonal decline that we've experienced in '18, '19, we did see it in the first part of '20. And so that last week of December was very light, and it has taken the better part of January to start rebounding. Recent trends do indicate that the year-over-year increases are very encouraging. And so as we track '21 performance versus both '20 and '21, we are above prior year levels at this point. So there may be a little conservatism built into it, but we did get off to a slower-than-expected start. On the capital component of the business, we currently have 19 really new BDMs out in the field right now. They joined us January 4. As a reminder, they were trained prior to the National Sales Meeting, so they didn't have an opportunity to go out and prospect. Since the National Sales Meeting, when they were able to go out and prospect, the level of activity has been extremely impressive. The issue is these sales aren't a one visit type of close, and so it will take multiple visits for the new BDMs to get out there and transact business. Again, based on the level of activity we've seen post the sales meeting, we do expect an extremely strong March. So again, we knew this was going to be a slow quarter. There's a lot going on, a lot of change, a lot of newness in all aspects of the commercial team. I mean we're still holding to our full year number and very encouraged from what we've seen in the four weeks since the National Sales Meeting.

Okay. And since I couldn't quite get a sense if maybe the treatment revenues, was a mid-single-digit number, about accurate, maybe to start out the year. And then just kind of bigger picture, Keith, you talked about the productivity per rep starting to hit towards the end of the year. What is that number for you? Is it 10 annualized systems per rep, up 15 more? And then how are you looking at that one patient per month per account, is that in guidance as well?

So Margaret, I prefer not to give the exact number for what our quotas are for our capital team, but it is north of $1 million per rep. And I think that our pace of activity in the field as tracked through our dynamics database indicates that we are putting opportunities into that pipeline to support those quotas, so.

Okay. Yes. And again, if I can just follow-up with Steve, is the mid-single potential for NeuroStar treatment growth in the first quarter possible? I'm just trying to think about that mix so we make sure that we're kind of in the right ballpark relative to what you all are planning on.

So year-over-year, Margaret, I think it's going to be fairly flat compared to '20, significantly down, obviously, from Q4.

Our next question comes from Bill Plovanic with Canaccord.

Great. So Keith and Steve, you had the sales meeting about a month ago, and they've been out in the field for four weeks. I'd just like to get some feedback on, what has the feedback been from that? What have the learnings been from that? Is there anything you need to emphasize or deemphasize as you kind of get out of the gates here?

So our learning on the capital side is that physicians that we are able to get to through either video conferencing or in person are exactly as we thought they would be, nervous about spending $100,000 on a piece of equipment in their practice and how they are going to be successful. So I think the messaging around all of the programs that we have rolled out on how we are going to generate awareness and patients into the practice is resonating very well with these new accounts. On the NPC side, I think that the feedback that we're getting is that the programs, as we are rolling them out, is a welcome addition. They have been asking for it for the last several years and the fact that it is now organized, prescriptive, has measurements all along the way and most of the work is done by our great NPC team, I think has been a huge welcome sigh of relief to our existing accounts.

And in terms of the awareness programs, is there a -- I wonder if we could get some detail on that. Just is that incremental from what you were doing in the fourth quarter? Have you added any new types of channels that were not in place before? And kind of where are you in the rollout of that?

So we have -- we received our market research back on December 15. We have taken those learnings and given them to our agent -- our creative agencies to start creating the materials that will be rolled out within the practice and the assets that would be rolled out outside of the practice, both socially, digitally and elsewhere. So I think throughout the first half of the year, most of those assets will be rolling out, so it will be a constant level of excitement for both our reps and our accounts.

Great. And then just last question for me is, you talked about the new data burst approval back in December and the rollout of that. I was just wondering if you could help us understand what's -- I understand the time going from 40 minutes roughly to 20 minutes to 3 minutes, but what does that mean for the practice and the patient? I mean the patient still has to travel to get to the site, and so it will cut some time off for them, which is never a bad thing. But let me just kind of understand, how is the feedback plan or the reception from that approval? And how are you rolling that out to the physician channel?

Terrific. So as I think we've talked about before, Bill, the -- even though it's a 36 course of treatments, five days a week for seven weeks, our dropout rate is under 3%. So that -- it may appear to be inconvenient, but it does seem to be okay with the patients, I don't think that the TouchStar treatment is going to reduce that. What we are trying to find out from physicians is how best this should be deployed in the field, and we are learning from accounts that have been using a data burst in the past that some of them are using it as a maintenance treatment, others are using it as a supplemental treatment. So I think our position right now is we are working with a team of KOLs to actually determine how and when this should be rolled out.

Your next question comes from Marie Thibault with BTIG.

The first question, if I could, on full year guidance. I think when we spoke with you on the Q3 call, there was some hope that you might be able to return to nearly or possibly even exceed 2019 levels. I know that wasn't formal guidance, but something that was sort of tossed up there, so wanted to get your sense of perhaps what is sort of making up the gap between 2021 guidance and 2019 levels in terms of whether that's conservatism, the pandemic or something else?

Marie, this is Steve. Thank you for the question. I guess the language we did use was approaching 2019 levels, and our expectations and enthusiasm for '21 hasn't changed. And so the guidance of 58% to 62%, we felt gives us a little bit of flexibility to get to 2019 levels and hopefully, do better depending upon how the environment reacts to what we're rolling out. But no, our expectations haven't changed. We had a great sales meeting, the receptiveness to the pilot group that have seen some of the programs as well as the initial feedback from our call center users, again, we believe we're right on track to what we had previously communicated.

Okay. Understood. And then on expenses, curious if you plan to do additional hiring or what else might be part of the OpEx investments this year?

At this point, most of the incremental hires between '20 and '21 are on board. I believe we have a handful left in a few of the departments, but there will not be open the flood gates due to the follow-on activity that we had in February. So we will see some increases in marketing spend, discretionary, but not necessarily full-time heads.

Okay, perfect. One last one, if I may. You put out strong data that was published in brain stimulation last week, and I think we've seen some encouraging data coming out over the last of quarters or so, so would love to hear about how Neuronetics is thinking about the core MDD indication as well as the potential for additional indications this year.

So Marie, we are planning, as we said on the last call, to use our 90,000-patient database to be able to speak to the FDA about retrospective studies to look at other indications. So, so far, the FDA has been willing to talk to us about it, and we are -- we have requested a meeting with them to formally present it to them. So I think that is our use of the data and our first target, we should know something towards the second half of the year, third quarter.

Your next question comes from Matt O'Brien with Piper Sandler.

This is Coreen on for Matt. So first, thanks for all the color on guidance, but we were wondering, how should we be thinking about your international business contributing in 2021, especially with Japan ramping?

Yes. So our international business is actually primarily in Japan, but also in Korea. Both those countries right now are essentially shut down due to COVID. Japan was supposed to reopen February 7, that got pushed out to March, and Korea is really suffering the same set of circumstances. Right now, it's more of a timing impact on our forecast and guidance. So from a full year perspective, our expectation is they will hit what they signed up for in 2021. Again, there may be some timing between Q1 and Q2 as they start to reopen their individual countries.

Great. And lastly for me, you've mentioned a number of things contributing to growth. Can you just highlight what you believe to be the biggest growth driver to session sales this year and which will start continue to drive the top line growth in the coming years?

I think our programs that we rolled out at the sales meeting that are all focused on driving awareness and driving and putting patients into the practices, educating them on the benefits of NeuroStar and then if appropriate, having them treated, I think all of those programs in combination are what is going to drive our growth going forward. So -- and as I said in the remarks, I think if -- when we start to gain traction with these programs in the field, it will give us a softer landing to be able to place more systems into new accounts.

Your final question comes from David Turkaly with JMP Securities.

This is actually Danny on for Dave. Just a few quick ones for me. Just following up on TouchStar and its three-minute protocol, it sounds like you're still formulating your approach here. But in both the near and long term, what do you think will be the biggest impact from TouchStar? Is that something your existing customers have been asking for should help drive competitive conversions? Or do you expect it more so to attract psychiatrists not currently utilizing TMS?

Dan, we have talked to 10 physicians over the course of the last few months on their utilization of this three-minute protocol. It looks like the most common use for it is as a maintenance treatment post a full course of NeuroStar treatment. So I think, again, we need to find out where the majority of physicians lie with that and possibly do a little work to find out if that's exactly where it should be used, but that's the road we're going down at the moment. We're going to listen to the KOLs on it.

Great. Great. And then just one follow-up for me. We know that several payers updated their pharmacotherapy criteria last year moving requirements for -- from failed drugs from four to two. I guess if we can just get any updates here, is there any known time frames that you could expect that some of might announce something new? And then what's driving this going forward?

So I recently had a call with the Head of the TMS Society to talk about exactly this. How can we use our vast database to be able to help them go to the payers and support a drop from four drugs to two drugs or two drugs to one drug. So we are in the process of looking at how to put that data together. We have hired a consultant to help us do that, so I can't give you a time line right now. I can just tell you that there's a lot of physicians and the society that are interested in it.

There are no further questions at this time. I will now turn the call back over to Keith Sullivan.

Thank you, operator, and thank you again for joining us on the call today. I look forward to updating you on our progress in the next quarterly call, and I hope you are safe. Thank you.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation, and have a wonderful day. You may now disconnect.