Neuronetics Inc (STIM) 2022 Q2 法說會逐字稿

Good day, and thank you for standing by. Welcome to the Neuronetics Reports Second Quarter 2020 Financial and Operating Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your speaker today, Mark Klausner. Please begin.

Good morning, and thank you for joining us for Neuronetics' Second Quarter 2022 Conference Call. Joining me on today's call are Neuronetics' President and Chief Executive Officer, Keith Sullivan; and SVP, Chief Financial Officer and Treasurer, Steve 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 can 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 and Form 10-Q, which will be filed later today. The company disclaims any obligation to update any forward-looking statements 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 US 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 US 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'll begin by providing an overview of the second quarter performance, followed by an operational update. Steve will then review our financial results. I'll conclude with our thoughts for the balance of 2022 before turning to Q&A. Starting with the financial review for the second quarter. Total revenue was $16.3 million, up 15% over the second quarter of 2021, our strongest revenue performance since the fourth quarter of 2019 and our second straight quarter of mid-teens growth. The encouraging performance was primarily driven by a robust capital equipment sales, a solid uptick in utilization and gaining momentum built on our marketing programs. Despite broad macro and market disruption, we saw a marginal impact on our business, which we attribute to our team who has stayed ahead of the shifting environment. U.S. NeuroStar system revenue was $4.4 million, up 70% over the second quarter of 2021, representing 20% growth over the last quarter and our fifth consecutive quarter of sequential growth.

This was fueled by the conversion of a strong pipeline created by our capital sales team, which led to the highest systems sales in 3 years. This was made possible in part by our quarterly NeuroStar Summit, which boosts sales not only during and immediately following the event, but also 6 to 9 months that follow. U.S. treatment session revenue was $11.3 million, up 5% over the second quarter of 2021. Growth was a result of improving utilization rates attributed to the increasing traction of marketing programs, including the tap into new possibilities for depression digital campaign, which has garnered over 144 million impressions since its launch on March 3. And our partnership with Drew Robinson achieved hundreds of millions of new impressions and other initiatives we have put into place over the last 24 months. During the quarter, overall utilization was up 7% year-over-year with per click utilization increasing 15% Offsetting the strong utilization trend was some softness related to the merger of our 2 largest customers, which seems to have disrupted their typical operations during the quarter.

Now turning to operational highlights. Throughout the first half of 2022, we have focused in 4 areas to drive the growth of the organization. First, increasing customer and patient awareness. Our quarterly NeuroStar summit was held in Atlanta, which was once again completely sold out and included over 50 prospective customers. We will continue to host these events throughout the year with our next Summit taking place in Charlotte, North Carolina during the third quarter. One key driver of performance during the quarter and year-to-date was the continued advancement and optimization of our education and awareness programs. The main focus of these programs is to build and grow a successful NeuroStar practice within our customers' existing operations. We know many potential NeuroStar patients exist within these practices today and need to be educated about our technology and its benefits. We are seeing real progress with both our awareness campaign and the PHQ-10 tool as our sales force has had more time to socialize and implement with our existing customers.

Our PHQ-10 tool is gaining traction on a daily basis and continues to be a highly productive tool within the practices where it has been rolled out. We continue to push to have this tool introduced in an increasing number of practices to maximize its impact. As an example, of the type of benefit that we -- this tool can have, we recently launched the PHQ-10 within a single large customer in the Southeast. Within just 2 hours, the practice performed 27 assessments and the site generated over 12 potential patients looking for a nondrug alternative for their depression. We look forward to continuing to optimize the tool and bring it to a greater percentage of our customer base.

In the second quarter, we completed construction of NeuroStar University or NSU, in Charlotte, North Carolina. This revolutionary training center will be used to teach new and existing customers how to become NeuroStar experts, connect with other specialists in their field and grow their practices using clinical education and advanced marketing and consultation techniques. The NSU curriculum has been developed to deliver an immersive experience, providing attendees with a deep understanding of our 5-star program. As a result, we expect to see an improved patient experience and accelerating growth from customers who attend.

Our second focus area is the continued optimization of our commercial organization. We have seen the positive impact from the addition of 3 regional practice managers last quarter, which brought the total to 7. With smaller teams covering smaller geographies, we have been able to provide better service and more frequent coaching to our customers. Going forward, we will hire new managers as needed. Our third focus area is growing the number of exclusive commercial partnerships.

We recently initiated a partnership with Elevion Health Centers, an Arkansas-based network of full-service mental health clinics. Under the agreement, Neuronetics will be the exclusive supplier of new TMS equipment to Elevion and its affiliates. Elevion, who previously used competitive systems elected to switch to NeuroStar after attending our most recent summit. They made the change because of our ongoing support, training and marketing initiatives. Their purchase of several systems will help expand their footprint across multiple states.

As many of you are aware, our 2 largest national accounts merged in July, which speaks to the promise of the TMS market and solidifies NeuroStar's leadership position. This new entity will give NeuroStar an even bigger footprint and be supported by shared operational expertise and patient marketing capabilities, which we believe will help drive growth across approximately 245 NeuroStar systems in over 200 sites.

Lastly, I want to provide an update on our clinical and regulatory progress. In May, we received FDA clearance for NeuroStar as an adjunct treatment for adult patients suffering from obsessive compulsive disorder. Importantly, this new indication can be remotely enabled on our customers' existing NeuroStar systems at no charge. Our 2-stage launch is currently underway. During the quarter, we identified 40 practices for the limited pilot. And in early July, started training at these sites and are in the process of optimizing the clinical and marketing and commercial aspects of OCD. The next phase of our launch is on track and expected to begin in the fourth quarter of 2022. We will then start to roll out this indication to all of our customers.

Subsequent to the end of the quarter, we also received clearance from the FDA for a new NeuroStar indication to treat anxiety symptoms for adult patients who suffer from MDD also known as anxious depression. Importantly, this submission to the FDA leveraged real-world data from TrakStar, our exclusive database of patient outcomes. This database includes over 134,000 patients who have completed more than 4.8 million treatment sessions. With this new indication, we will be able to present data to physicians from over 1,200 patients across numerous studies. Which consistently show that NeuroStar can improve anxiety symptoms in MDD patients. This new indication does not require any additional clinical training and is covered under the current reimbursement codes and coverage policies. Anxiety symptoms are seen in a sizable portion of MDD patients estimated to be more than 50% prevalence. These anxious depression patients are more prone to experience severe depression and suicidal thoughts.

In addition to these recently cleared new indications, we have just submitted a novel method to speed up and improve the effectiveness of our motor threshold process for both patients and health care professionals. This new product is patent pending, and upon FDA clearance will be compatible with the entire installed base of NeuroStar systems. We anticipate releasing additional information on this update later this year. Over the last 2 years, we have significantly expanded our indications for use to include OCD and anxious depression. Our ability to deliver this rapid expansion of indications is largely due to our ability to leverage the huge repository of real-world data collected in TrakStar to efficiently and effectively receive clearances. This validates the FDA's willingness to include real-world data and clearance decisions. Because of this, we continue to view TrakStar as an incredibly powerful tool, which our clinical and regulatory teams will continue to use to engage with the FDA to advance our regulatory strategy on potential new indications.

Before turning the call over to Steve, I wanted to provide an update on the recent progress made regarding reimbursement. As announced in mid-July, there is a series of health care policy updates announced that increased patient accessibility to NeuroStar. These policy updates include First Coast and Novitas Medicare administrative contractors that are changing local coverage determination to reduce the number of prior medication failures for TMS eligibility from 4 down to one for patients suffering from MDD.

First Coast coverage area includes 2 million Medicare beneficiaries, more than 74,000 physicians and 247 hospitals that serve Medicare patients. Novitas coverage includes over 8 million covered lives in over 10 states. There is also an additional proposed change that could remove the requirement for a previous psychotherapy trial.

We also have received a number of other positive policy decisions related to both MDD and OCD, including Highmark Blue Cross Blue Shield publishing coverage for OCD affecting 6.9 million members. Select Health, publishing their first TMS policy for MDD, which impacts 981,000 members and Pacific source, removing the MDD preauthorization requirements for their Medicare Advantage plan members.

Overall, I am very pleased with our performance throughout the first half of 2022. Despite the macro changes that have impacted health care providers and their patients, we have continued to execute. The ongoing positive customer and patient reaction confirms that our commercial, clinical and regulatory strategies are working. This is largely due to our hard-working and committed employees who have kept us ahead of the current complexity of the operating environment. We look forward to continuing to help our customers provide treatment to their patients suffering from mental health disorders. With that, I'd like to turn the call over to Steve.

Thank you, Keith. Total revenue for the second quarter was $16.3 million, an increase of 15% over second quarter 2021 revenue of $14.2 million. U.S. NeuroStar Advanced Therapy system revenue was $4.4 million. Compared to the prior year revenue of $2.6 million, it was up 70%. The increase was primarily driven by a strong capital pipeline by a maturing sales force and NeuroStar Summits. In the quarter, the company sold 59 systems, up from 36 systems in the second quarter of 2021. U.S. treatment session revenue was $11.3 million, an increase of 5% over second quarter 2021 revenue of $10.8 million, driven by an increase in treatment session volumes relative to the prior year, specifically an uptick in per-click customer utilization. In the second quarter of 2022, revenue per active site was approximately $11,300 compared to approximately $12,000 in the prior year quarter. As a reminder, we calculate this metric by dividing total U.S. treatment session revenue by the beginning of quarter active sites.

Gross margin was 75% compared to the second quarter 2021 gross margin of 81%. The decline was due to the increase in NeuroStar capital mix year-over-year. Operating expenses during the quarter were $22.1 million, an increase of $4.1 million compared to the second quarter of 2021. The increase was primarily driven by the implementation of new marketing initiatives, costs related to our expanded sales force and increased costs from inflationary pressures. During the quarter, we incurred approximately $2.2 million of noncash stock-based compensation expense. Net loss for the second quarter of 2022 was $10.4 million or $0.39 per share as compared to a net loss of $7.5 million or $0.29 per share during the second quarter of 2021. EBITDA for the second quarter of 2022 was negative $9.1 million as compared to negative $6.3 million for the second quarter of 2021. Moving now to the balance sheet. As of June 30, 2022, cash and cash equivalents were $70.9 million. Subsequent to the end of the quarter, we collected $10.5 million in loan principal following the completed merger of Greenbrook and Success TMS.

Now turning to guidance. For the full year 2022, we now expect revenue in the range of $60 million to $62 million. For the third quarter of 2022, we expect revenue of $14.5 million to $15.5 million. We continue to expect to see year-over-year growth in each of the remaining quarters, along with a more normalized seasonal pattern with a slowdown in the third quarter before a strong fourth quarter, which is typically the largest of the year. We now expect total operating expenses for the full year 2022 to be in the range of $86 million to $88 million as a result of cost justification initiatives. I would now like to turn the call back over to Keith.

Thank you, Steve. We are very optimistic about what the second half of 2022 will bring. Our focus will remain on increased customer and patient awareness, the continued optimization of our commercial organization, leveraging exclusive commercial partnerships and clinical and regulatory progress. I'm extremely confident in our team's ability to take advantage of this opportunity that lies ahead to help treat the growing number of patients suffering with metal health disorders. The reason we are the market leader in TMS therapy for mental health disorders is that we have been able to build a team made up of industry best and brightest. And I would like to thank each and every one of them for their dedication and commitment to delivering innovative solutions for patients. With that, I'd like to open the line for questions.

(Operator Instructions) Our first question comes from Adam Maeder of Piper Sandler.

Congrats on the progress. Solid treatment number and utilization improvement in Q2. I think you did note some softness around your 2 largest customers, Greenbrook and Success due to the pending merger. Just wondering if you're able to give any more color on volumes there. It sounds like the treatment number could have been even better if not for this transient headwind? And then how do you expect volumes at this newly created entity to trend in Q3 and Q4? And then I have a follow-up or 2.

Well, thanks, Adam. I think it's natural that when 2 companies are going through a merger that they're going to experience some disruption. I have full confidence that the combination of Success TMS and Greenbrook is going to be a huge winner. So I think that this -- I see this blip as temporary, and I think that it may continue as they go through their integration for the next few months. But at the end of the day, it's going to be a winner for them, for us and the whole industry. So I don't see it as a big deal.

Okay. That's helpful, Keith. Appreciate that. And then maybe just to flip over to the system side. So really strong capital quarter, maybe just talk a little bit more about what drove the strength there? It sounds like pretty good pipeline conversion. And then as we look ahead, how do you think about the Capex environment just given some of the macro landscape? I think you previously talked about 200 to 250 systems per year as being a good framework for models. So just wondering if that still holds.

So they -- I think we started talking about it last year when we brought on the new team that they started with pretty much a 0 pipeline, and it would build over the quarters and it has. We started out at 24 systems in Q1 of last year and built every quarter since then. So I think we have a robust pipeline right now. It continues to grow through the efforts of our great marketing team and through the NeuroStar summits that we have. So I know that there's softness in the economy, but currently, we have a pretty strong pipeline with backups to it. So we're pretty confident that $240 million to $250 million is still a good number for us.

Okay. Great. And good to hear. And maybe if I can just squeeze in one last one. I'll ask about First Coast and Novitas and the proposed policy updates there. Do we know exactly when we'll get a final decision, i.e., if those will become kind of official policy? And then would you expect other MACs to follow Novitas' in some ways, kind of looked at as a bellwether. So maybe just kind of level set us on the situation there and any potential impact to the business. Thanks again and congrats on the progress.

Thanks. I really can't tell you whether the other MACs are going to follow. If we look at history, they have so we're hoping that it goes across the board. When all of these things become final, they have a review period and then they have a question period, and then they make it final. So we're hoping that all of the changes become put into place, hopefully by the end of the year.

And our next question will come from Malgort Kaczor of William Blair.

Maybe just a big picture one to start. In other words kind of this quarter you are more concise on the commercial regulatory player, I'm trying to think that you didn't put out next quarter with updates. But can you give us some context, I guess, over when do you start to impact growth more materially especially on the utilization maybe revenue versus your side. And I'm just trying to get a sense of kind of step one in terms of doing the foundation or further along and which of those updates will be the most material in EBITDA.

Margaret, I -- we couldn't hear you very well. It was a little garbled. So are you able to repeat the question.

Sure. Can you hear me any better?

A little. Give it a shot.

Can you hear me?

Yes, we can.

Okay. I just wanted to kind of talk about the updates that we've heard this quarter because you hit on so many whether they're kind of marketing, commercial, regulatory. So can you give us some context over when the impact in these growth specifically utilization growth or revenue per system growth will occur? And is there one of these that you think is more growth in your view to today's metrics?

Yes. That's a good question. I think the utilization growth and the revenue growth has really come out of our marketing efforts. Utilization growth and the revenue growth has really come out of our marketing efforts and our PHQ-10s, and our focus on patients within the practice rather than patients coming out of the airwaves.

I think that with -- as we said in the prepared remarks, there are plenty of patients that have failed 2 to 4 drugs within the practices. And the physicians have not been very good at being able to speak to them and educate them and then convert them to a NeuroStar patient. So I would say that if I look at what makes the biggest impact for us, it's our marketing efforts within the practice. It's our marketing efforts surrounding the practice in our PHQ-10s.

And similar to the growth in our system revenue, we anticipate that with each quarter, our revenue has continued to grow on the treatment session side. And quite honestly, there is a little bit of buying patterns that we have to change within our practices. Some of them are used to buying on a per patient or even a partial patient basis. And we are through our programs working to really align their purchasing with the our quarter and with our programs.

Okay. That's helpful. And maybe to follow up a little bit more on the capital side as well. Obviously a great number, our sales reps sort could be a number on the capital side, seems like it has been 11 throughout this quarter. So as we look forward, what do you think a good number there should be? And maybe what's being assumed in guidance for the second half of this year?

So we're still targeting the 240 to 250 systems for the year. I think we're on track to do that. I said the last couple of quarters that if we're able to get 45 to 50 systems every single quarter, we're good. This quarter, we got higher than that. And I do want to be cautious in that we have to be able to train them and make sure that we get them up and running. And I think at the current levels, even at 59 for this quarter, I think we can focus our efforts and our teams and make sure everybody gets the attention they need.

And our next question will come from William Plovanic of Canaccord Genuity.

So a couple of questions here. First, just capital sales for robust, obviously, the pipeline's filling, but also ASP is lifting. And was there anything onetime in the quarter? I mean your ASP is getting close to 74,000, 75,000 a system. Is this sustainable? Is it the impact of kind of all the marketing programs and everything you've done in terms of the value add versus discounting to sell systems?

So I think the programs that we have been talking about now for almost 2 years are gaining more and more traction. And I think we see it through our NeuroStar Summits. I mean we are right upfront with them talking about treatment sessions but we then talk about every single thing that we do to help make them successful within their practice and outside of their practice. So I think that at the end of the day, the price of the system and if it's $5,000 up or $5,000 down, it's negligible in a lease payment. So it's really not the issue for us. So our ASPs have been going up steadily, and we're -- I don't see that changing at all.

Great. Thank you. And then on the PHQ-10 tool, I mean, this sounds like it's been almost revolutionary for you. And I think the commentary was you're getting great traction in the sites that are utilizing it. So my question is, what percentage of your sites are utilizing the PHQ-10 today?

It's about 250 of our sites.

And how many total sites do you have again?

1,044.

So about 1/4 of the sites. Okay. Excellent. And then just lastly, in terms of the guide, it seems like you're bringing the quarter down it's not a big fourth quarter up from this quarter. Is there something you're seeing or we should be thinking about? Or is this just given COVID and all the other headwinds out there, just kind of want to make sure you bake everything in.

Hey, Will, it's Steve. Historically, the third quarter is usually flat to slightly down compared to Q3. And so that was a component of our guide for the current quarter. And for the year, yes, there's still lingering impacts with inflation and other factors. But we did pull up the low end of the range from 58 to 60 so we're pretty confident with that midpoint right now.

And our next question will come from Marie Thibault of BTIG.

I wanted to ask my first one here on the treatment session revenue per active site. I understand it was down a little bit year-over-year just because the installed base has been growing so quickly. But if you were to exclude some of the softness around the Greenbrook and Success merger and sort of think forward to when some of this starts to catch up with the fast expansion installed base. What do you think is kind of the right growth for treatment session revenue per active site given utilization I think, was around 7% this quarter?

I think our revenue growth should be matching our utilization growth, which this quarter on a per click basis was 15%. So I think it's harder for us to grow the fixed price accounts so a lot of our efforts are going on to the per click side of the business. And I think we expect that to grow at the 15% rate at least.

Okay. Very helpful. And then you mentioned quite a few new initiatives, things like NeuroStar University, which sounds exciting. How do you expect to sort of control spend in the back half given some of these new efforts? I think we're at about half of what you're expecting to spend in operating expenses for the year. So maybe you can tell us about any puts and takes on that metric.

Hey, Marie. it's Steve. Yes. So we just went through a pretty extensive forecasting exercise for the remainder of the year. It was really a reconciliation or a justification of what was in the budget and what the expectation is now. You saw we did take down the high end of OpEx and reduce the range a little bit. I would say if we didn't have some of the impacts of inflation and some higher costs related to COGS, that number would have been even lower. So I think we're very comfortable with where we're at. The team is aligned with the new program spend and what we need to do from an R&D and clinical perspective. So we're pretty comfortable with that range right now.

And the NeuroStar university costs are all built into our budget. That was planned.

Okay. Perfect. One last quick one, if I can sneak it in here. I don't think I heard you reiterate a target of EBIT breakeven in 2024. Is that still a goal, something you're still working toward?

Yes. Yes, it is.

Thank you. And our last question will come from the line of Dave Turkaly from JMP.

Keith, I know you're not going to want to answer this, but I'll try anyhow. With the 2 new indications, can you give us some thoughts in terms of even if it's 2023, I don't know, 2024, like what percent of your mix are you planning on? I mean, could this be 5% or 10% additional on top of what you can do in MDD? Or how are you thinking about these new launches and their impact?

So I think our discussion around OCD has been that we would expect a few million dollars over the next few years. It's really an opportunity for our physicians to add opportunities to treat patients that are within their patient base that are battling OCD. So I don't anticipate it is going to be a majority, even 5% of our business, but it will be meaningful to the physicians that have patients that battle with OCD. Our opportunity out there is really patients with depression, and we're seeing it, and we're seeing them raising their hands and asking for help. And we're training our accounts on how to get to them.

Got it. When you look at the protocol, I just want to confirm this. I think it's the same or very similar and I think you mentioned in the release that insurers are sort of paying, I believe, the same amount for these new indications or at least for some of them. And I imagine you charge the same, but just in terms of the actual positioning and the therapy, are there differences? Or is this going to be pretty much just like MDD?

They use the same codes. And patients with depression often suffer with anxiety also so they use the same codes. There is a different motor threshold test for OCD and that's what we are educating our accounts on now. But outside of that, it's the exact same thing.

And I guess, lastly, you mentioned or I guess, your slide share mentioned that for OCD, some of the other competitors, you need to buy something else. Are they treating something differently? Are they targeting a different area in the brain or why do they need that? And is that a big advantage for you?

Some of our competitors need a second coil to be able to treat and so the physicians have to buy that from them. For us, it's a software push and we're able to enable it remotely, but we are controlling that through the training. As we train them, we enable it on their system at no charge.

I would now like to turn the conference back to Keith Sullivan for closing remarks.

Thank you, operator. And thank you for joining us on the call today. We look forward to updating you on our progress in the next quarterly call.

This concludes today's conference call. Thank you for participating. You may now disconnect.