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 and then use it to develop optimal tool and business development strategies to help educate customers on the benefits of NeuroStar Advanced Therapy for mental health, and ultimately, drive increased patient volume. I'd like to highlight some of the key takeaways from the study.

First, awareness of NeuroStar Advanced Therapy for mental health as a safe, effective, non-drug therapy for the treatment of MDD is extremely low. Furthermore, even among patients who are under the care of a physician and have previously failed multiple courses of drugs, awareness of TMS as a treatment option is also very low.

This points to a significant opportunity to engage a largely untapped patient population and help bring relief to a huge number of patients suffering from drug-resistant MDD. We believe this lack of awareness can be addressed on both the patient and the health care provider side, which is factored into our strategy going forward.

From a market definition perspective, we identified a group of approximately 8 million patients suffering with depression in the U.S. or roughly 48% of the total MDD population who are good candidates for NeuroStar Advanced Therapy for mental health.

This group includes patients up to 70 years old that are unhappy about how they feel and their quality of life as a result of their current drug regimen, and they have a strong desire to do what is possible to treat their depression.

When we describe the benefits of NeuroStar, these patients were highly interested and would consider it as a treatment option. Historically, our average patient has been a woman in their 50s who tends to respond to traditional media sources like television and radio ads. There is a broader demographic that is highly active online.

They will use social media to find a better alternative treatment and are willing to take action to explore these treatments. With this research completed, we now have a much better understanding of who our target patients are, how to effectively reach them and how best to communicate with them.

In addition to the development of the new communication strategy, we went through a process of optimizing our sales force. As part of that, we have added 28 new hires since January 1; 18 BDMs, or business development managers; 10 NPCs, or NeuroStar practice consultants. This brings our total number of BDMs to 22 and NPCs to 27.

The group of new hires immediately went through 2.5 weeks of virtual training and then spent a week out in the field ahead of our sales force kickoff meeting in mid-January. These new hires all have a track record of success in prior roles, working with the capital equipment and ongoing treatment session model.

We are very excited about the level of talent we have been able to attract, which speaks to the level of enthusiasm there is in the market for our company, our technology and the opportunity. Typically, the ramp to full productivity is approximately six to nine months. We expect this new class to begin being productive during the second quarter.

In December, we announced that we received FDA clearance for our Touch Star treatment, a three-minute treatment protocol used with our NeuroStar Advanced Therapy system.

Our hope is that this third treatment protocol, in addition to the 38-minute and 19-minute options, will mean even more patients in need will have access to NeuroStar Advanced Therapy to help them in the battle with depression.

We are currently working with a group of KOLs to determine how best to utilize the three-minute protocol, with the TMS treatment paradigm for depression. Overall, we are pleased with our performance during the fourth quarter and what we were able to accomplish during what has been a universally challenging year.

The organization went through a significant reorganization during the early part of 2020, followed by a management transition in the middle of the year and then a change in focus from a capital-based company to a patient-focused company, all of which occurred during the uncertainty of COVID.

Despite all of that, we have built a tremendous foundation to grow from going into 2021 and beyond, and we are incredibly excited to take what we have learned over the past few months and begin the process of building awareness of NeuroStar as a treatment for depression. With that, I'll turn the call over to Steve..

first, through the amendment of our credit facility with Solar Capital Partners, which gave us greater flexibility to withstand disruptions from COVID-19 and pursue our growth strategy; and second, through the closing of an underwritten public offering of common stock, including the full exercise of the over-allotment option resulting in net proceeds of $80.6 million to the Company.

Pro forma for these activities, our cash at year-end would have been $129.6 million. Now turning to guidance. For the full year 2021, we expect revenue in the range of $58 million to $62 million. For the first quarter of 2021, we expect revenue in the range of $11 million to $12 million.

Our guidance assumes that COVID headwinds subside as we progress through the year and there are no major resurgences in the U.S. that impact our customers or patients.

On a quarterly basis, we expect the first quarter will be the lowest revenue quarter of the year, in line with typical seasonality, driven by the resetting of patients' deductibles as well as the resetting of our customers' capital budgets.

We expect that as COVID restrictions are lifted and the vaccine becomes more widely available during the year, we should see a pickup in new customer starts. In addition, we expect that our newly hired BDMs and NPCs will begin to have a modest positive impact on revenue in the second quarter.

Moving into the second half of the year, we would expect their contribution to increase as they gain experience and progress towards full productivity. The Company projects total operating expenses for the full year 2021 to be in the range of $62 million to $66 million.

In line with our strategy, we are going to prudently increase our investments during the year to support top line growth. I would now like to turn the call back over to Keith..

one, building awareness and teaching accounts how to educate patients on the benefits of NeuroStar; and two, executing on our clinical and regulatory strategy.

Taken together, we believe that this will educate additional patients, resulting in increase treatment session revenue over the long run and that focusing on initiatives to drive increased pull-through will ultimately make the process of selling new systems easier.

As we went through in detail earlier on the call, we have crafted a new communication strategy, realigned the priorities of our commercial organization and developed partnership programs aimed at building awareness and educating both patients and customers on the benefits of NeuroStar.

The application of new initiatives have already begun, and we expected to see continued acceleration of growth as we progress through the year. We have seen early success with our new messaging and customer programs through the results of a targeted call center effort we ran during January with nine individual psychiatrist accounts.

While we are not going into the details, we are very excited that the new messaging we tested has been able to get people to act and seek treatment with NeuroStar Advanced Therapy for mental health. Our second focus is executing on our clinical and regulatory strategy.

We recently hired a new Vice President of Clinical, and we intend to put into place a new, efficient, effective clinical strategy that not only supports our commercial goals, but also supports our longer-term regulatory strategy. In January, we announced that our outcomes registry now included data from over 10,000 patients.

The number is large and impressive, but it's only part of the story. The fact is we've treated over 90,000 patients. This creates an even greater database of patient data we can mine.

We will leverage all of this data to help us drive commercial adoption, aid in payer reimbursement changes and potentially support indication expansion efforts in the U.S. and regulatory filings in the international markets. In closing, I am very excited about the future of Neuronetics.

We have generated a tremendous amount of momentum during the second half of 2020 and thus far in 2021. I can feel the energy throughout the organization as we are finally able to transition from the rebuild mode in 2020 into the execution mode in 2021.

We have a massive opportunity in front of us, and we will work diligently to bring the benefits of NeuroStar Advanced Therapy to all of the patients suffering from drug-resistant depression. I would now like to open the line for Q&A..

[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..