Neuronetics Inc (STIM) 2022 Q1 法說會逐字稿

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

I would now like to hand the conference over to your host today, Mark Klausner. Please go ahead.

Good morning, and thank you for joining us for Neuronetics' First 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 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'll begin by providing an overview of the first quarter performance, followed by an operational update. Steve will then review our financial results, and I'll conclude with our thoughts for the balance of 2022 before turning to Q&A.

Starting with the review of the first quarter. Total revenue was $14.2 million, up 15% over the first quarter of 2021, primarily driven by strong capital equipment sales, accelerating new patient starts and solid utilization trends despite the COVID-related headwinds experienced early in the year.

January was significantly impacted by the spike in Omicron cases in the U.S., but the utilization in February and March increased as the environment improved. We have continued to see positive trends across the business in the month of April. U.S. NeuroStar system revenue was $3.6 million, up 108% over the first quarter of 2021, representing the strongest capital quarter since the beginning of the COVID-19 pandemic and the fourth consecutive quarter of sequential growth.

This was driven by improving performance from our full-sized mature capital sales team who have built a robust pipeline since the reorganization of our sales force. We are also seeing continued contribution to system sales from our quarterly NeuroStar Summits. These programs offer potential customers, hands-on product demonstration and educational seminars to optimize their TMS practices. These educational events have proven to be very effective, allowing prospects to meet the NeuroStar team, see a demonstration of its system and understand how our partnership will garner success in their practice.

For the first time, we finished the quarter with over 1,000 active sites due in large part to the positive impacts of the optimization of our sales force over the last 5 quarters and the ongoing refinement of our marketing initiatives. U.S. treatment session revenue was $9.5 million.

Results were impacted by Omicron in January. However, we were encouraged by an acceleration in motor thresholds in February and March, ultimately leading to a record number of motor threshold tests being completed in a quarter. The ramp was partly due to our PHQ10s, our digital patient assessment tool, which allows our NeuroStar practices to easily identify patients within their practice who are candidates for treatment.

In Q1, we also launched a new feature in TrakStar to provide greater visibility into the patient journey, tracking from PHQ10 surveys all the way to treatment.

Now turning to operational highlights. Throughout this quarter, we have focused in 4 areas to drive the growth of the organization. First, increased awareness of customers and patients. During the quarter, we hosted our first NeuroStar Summit of the year in San Diego, which was completely sold out and included over 85 prospective customers, making it our largest summit to date.

We will continue to host these events throughout the year with our next summit taking place in Atlanta during the second quarter. Through patient marketing and our newly launched campaigns, we have been able to increase our reach and provide better access to information on the ways we can benefit patients suffering from treatment-resistant depression.

In March, we launched our new Tap into New Possibility campaign, aiming at driving awareness amongst patients and their caregivers. We have seen strong early traction highlighted by an exponential increase in weekly impressions across digital and social media. We will continue to progress as we move through the year. In addition, we saw positive momentum with all of our customer-focused programs, including our 5-STARS Precision Pulse program and in particular, our PHQ10 surveys.

This proprietary tool is designed to help our customers, identify existing patients within their practices who are candidates for the NeuroStar therapy and are looking for a new alternative to manage their treatment-resistant depression. We have introduced our PHQ10 tool to an increasing number of practices and have continued to advance the experience to maximize its impact. As we improve the process, we look to prudently expand to all of our customers during the year.

In April, we opened NeuroStar University or NSU in Charlotte, North Carolina. NSU is the only industry-specific training center of its kind. And in the coming months, we'll help train and onboard new sales and clinical employees, post company events and importantly, train customers. During the 2-day program, customers will become experts in our proven methodology by focusing on how to achieve the best clinical outcomes for their patients and how to market their NeuroStar business. We believe the benefits of this program reinforced by our practice development team will help ensure the success of NeuroStar within our customers' practices.

To date, NeuroStar University is proving to be a valuable investment. Our sales force is encouraged by the early conversations with customers. As such, we plan to offer a steady cadence of 2 courses per month. Our second focus area is the continued optimization of our commercial organization. During the quarter, we identified an opportunity to provide greater coaching and field-based partnerships with our management team by growing our regional practice managers from 4 to 7.

The addition of these 3 managers allows for smaller teams within smaller geographies, providing more frequent touchpoints and more value to our accounts. Our third focus area is leveraging exclusive commercial partnerships. We have continued to see the positive early benefits of the exclusive agreements signed in late 2021 and expect those to continue to drive incremental system placements and treatment session volumes as we progress through the year.

To date, we have announced 5-year commercial agreements with our 3 largest customers, Greenbrook TMS, Success TMS and Transformations. Our commercial agreement with Greenbrook TMS, the country's largest TMS provider, we'll see them purchase all of their new TMS devices for on-label treatments exclusively from Neuronetics in support of both our and Greenbrook's growth targets, Greenbrook will promote the use of NeuroStar Advanced Therapy systems in their centers. And in turn, we will be providing increased staff and patient education on the benefits of this treatment and joint marketing expansion.

This education will include invitations to NeuroStar University and PDM visits supported by co-op marketing dollars. Greenbrook has been a great partner for us for many years, and we look forward to continuing to work alongside their organization to reach more patients seeking treatment for their depression. Recently, we announced a 5-year commercial agreement with Transformations Care Network, the nation's third-largest mental health care provider.

Mutually beneficial growth targets supported by co-op marketing will drive increased collaboration between our organization. Transformations has been a valuable long-term partner and increasing our relationship with them is a significant step to build broader awareness of the benefits of NeuroStar, improve patient access and accelerate commercial adoption.

In the fourth quarter of 2021, we announced a 5-year contract extension with Success TMS, one of our longest-standing accounts. As part of this agreement, Success TMS will exclusively utilize our NeuroStar Advanced therapy for mental health systems. So why have some of the largest TMS providers in the country decided to sign long-term commercial agreements with us? It's not just the fact that we delivered the best clinical outcomes for patients, offer the best-in-class education and training. It's our ability to build awareness and improve patients' access to care. Our marketing and support initiatives are unparalleled among our competitors as we are uniquely invested in driving the long-term success of our partners in improving mental health outcomes. We look forward to the continued impact of these and other recently announced commercial agreements throughout the year.

Lastly, I wanted to provide an update on our clinical and regulatory progress. As announced Tuesday, the FDA has granted clearance for NeuroStar as an adjunct treatment for the adult patients suffering from obsessive-compulsive disorder. In the United States, over 4 million adults suffer from OCD, and approximately half of those patients have serious impairment. Importantly, this new indication can be remotely enabled on our customers' existing NeuroStar system, allowing NeuroStar to treat even more patients suffering from debilitating mental health disorders. We have planned a 2-stage launch beginning immediately with a limited pilot in approximately 40 practices. This will enable us to work closely with a select group of leading treatment centers to optimize the clinical, marketing and commercial offering within the practice. The next phase of our launch expected to begin in the third quarter of 2022 will roll out this new indication to the entire installed base of NeuroStar Partners.

I would like to thank our team, including our clinical and regulatory group for the amazing work they did to achieve this critical milestone. We have a second pending 510(k) application with the FDA, and we have been working collaboratively with the agency to address their questions. We are pleased with the progress we are making on the submission.

We also filed a lawsuit in Federal Court yesterday against BrainsWay, alleging that they have mischaracterized our efficacy data. We believe BrainsWay used inappropriate scientific methodology to present comparative effect size data on an apples-to-oranges basis, designed to hurt our business. And this mischaracterization will mislead medical professionals, patients and other TMS providers.

Obviously, we take this very seriously. Because this is pending litigation, we cannot make further comments at this time. We are pleased with what we have been able to accomplish thus far in 2022. We drove strong revenue performance despite a tough environment at the beginning of the year, while also continuing to deliver on our operational objectives.

The momentum we have generated over the last few quarters has only accelerated in recent months as a result of the achievement of some key milestones. During the quarter, as a result of our sales and marketing efforts, we surpassed the 4.5 million treatment session mark and now have over 125,000 patients treated all time. In addition, we signed our exclusive agreement with Greenbrook TMS. This week, we signed a 5-year agreement with Transformation. And as we mentioned earlier, received our FDA clearance for OCD. These achievements will continue to build on the long-standing leadership position of Neuronetics. We look forward to our continued execution during the balance of the year as we seek to bring relief to even more 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 first quarter was $14.2 million, an increase of 15% over first quarter 2021 revenue of $12.3 million. Total U.S. revenue also increased by 15%, and international revenue increased by 37% over the prior year quarter. The U.S. international revenue growth were each driven by an increase in NeuroStar Advanced Therapy system sales.

U.S. NeuroStar Advanced Therapy system revenue was $3.6 million. Compared to the prior year revenue of $1.8 million, it was up 108%. The increase was primarily driven by a robust and consistent capital pipeline due to our maturing sales force in NeuroStar Summits. In the quarter, the company shipped 48 systems, up from 23 systems in the first quarter of 2021 with a significant portion going into existing customers, who, based on patient growth needed additional NeuroStar systems. U.S. treatment session revenue was $9.5 million, a decrease of 2% over first quarter 2021 revenue of $9.6 million.

The decline was the effect of COVID-19 cases and restrictions primarily in January. In the first quarter of 2022, revenue per active site was approximately $9,870 compared to approximately $10,512 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 for the first quarter of 2022 was 75.4% compared to the first quarter 2021 gross margin of 81.9%. The decrease was primarily due to the mix of higher capital and international sales. Operating expenses during the quarter were $20.8 million, an increase of $3.8 million compared to the first quarter of 2021. The increase was primarily driven by the implementation of new marketing initiatives and personnel costs related to our expanded sales force.

During the quarter, we incurred approximately $2.2 million of noncash stock-based compensation expenses. Net loss for the first quarter of 2022 was $10.8 million or $0.41 per share as compared to a net loss of $7.9 million or $0.31 per share during the first quarter of 2021. EBITDA for the first quarter of 2022 was negative $9.5 million as compared to negative $6.6 million for the first quarter of 2021.

Moving to the balance sheet. As of March 31, 2022, cash and cash equivalents were $80.8 million. Due to typical seasonality, we expect first quarter cash burn to be the highest of the year, stepping down throughout the rest of the year.

Now turning to guidance. For the full year 2022, we continue to expect revenue in the range of $58 million to $62 million. For the second quarter of 2022, we expect revenue of $15 million to $16 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. As we highlighted on our fourth quarter call, during 2022, we are accelerating our investment into sales and marketing as well as R&D initiatives to support continued growth.

But in the near and long term, for the full year, we continue to expect total operating expenses to be in the range of $86 million to $90 million. We previously discussed our roadmap to profitability, which includes achieving EBIT breakeven in 2024. We remain on track to achieving this goal, and we will continually look to optimize the organization, in order to stay ahead of the challenging macro environment. I would now like to turn the call back over to Keith.

Thank you, Steve. As we look to the balance of 2022, I'm extremely confident in our ability to deliver accelerated adoption through the continued execution of our strategic plan. We'll remain focused on driving increased awareness among customers and patients, optimizing our commercial organization, leveraging our exclusive partnerships and executing on our clinical and regulatory strategy. The global pandemic has caused a sharp rise in certain mental health disorders, in particular, depression. With the World Health Organization estimating a 25% increase in prevalence, significantly increasing the size of what was already a massively underserved patient population with the industry's best TMS platform, superior clinical outcomes, unparalleled practice support and a supportive balance sheet, we are uniquely positioned to deliver on our mission to bring relief to millions of patients suffering from mental health disorders. With that, I'd like to open the line for questions.

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

Congrats on the nice start to the year. A couple from me guys. Maybe just to start, I wanted to ask about the OCD label expansion and potential impact there to your business. How helpful is that with the customer base now to be able to kind of market for this condition? And I think I heard limited launch in Q2, full launch in Q3. So maybe just talk through how we should be thinking about potential treatment sessions and revenue associated with OCD as that ramps going forward?

Adam, this is Keith. We are excited about the OCD opportunity. I think we have, over the past several months, done a market analysis and looked at the opportunity and how we would approach the market. From a treatment standpoint, we are going to prudently roll this out to, as we said in our press release, 40 accounts and then deploy it to the rest of the customers in the beginning of the third and throughout the third quarter. So we think that there is an opportunity there. We have to drive awareness. I think there's less awareness for a treatment for OCD than there is for depression. So we have some work in the field to do before it's a meaningful part of our business, but we think in 2023 and 2024, it will contribute to our top line growth.

Got it. Okay. That's very helpful color, Keith. Appreciate that. And then for the next one, just on capital, capital, very nice quarter, strongest since Q4 2019 from what we can tell. Maybe just talk a little bit more about kind of what drove the capital strength in Q1? What are we seeing more broadly in terms of capital environment or appetite for customers? I mean, it seems healthy. And then if we just kind of run rate Q1 capital going forward, we get a number that's kind of well above what we are modeling for the full year. So maybe just kind of help frame up expectations on the capital front going forward? And then I have one quick follow-up.

So we're excited about our progress with capital. I think at this time last year, we said that we would -- that our team had entered into the field with a pipeline that didn't exist, and they would have to build it over time and that they would finish the year with strong numbers, which they did in Q4 and followed up in Q1. So I think our -- we have a robust pipeline right now that is continuing to be filled with our NeuroStar summits. So those summits are highly popular. We're the one in Atlanta that we are going to do in a few weeks is about 3/4 of the way full, and we expect it to be completely sold out also.

So I think that our target is to continue to hit somewhere around 50 units a quarter. It doesn't do us any good to put a system in the field. If we're not able to get it active and being used and make that physician successful with it. So through our marketing efforts, through our practice development team and now with NeuroStar University, we feel that somewhere between 200 and 250 systems a year is a good cadence for us to be able to focus our teams on.

Very helpful color. And if I can just squeeze in one last one. It's on the federal lawsuit against the competition, one of your competitors. I know you're limited in terms of what you can say here, but maybe I'll just try and ask a couple of background procedural questions. So first, as it relates to timing, why now? Why is now kind of the right time to litigate? And then how do we think about potential time lines and path forward here?

Well, yes, as far as timing, it -- when the information surfaced several weeks ago, we had to do our research to make sure that our beliefs were accurate. And I think the timing of it is we have determined that they mischaracterized our data. We have to defend the information that we have put out into the field, and we are going to protect our data and defend anybody who tries to mischaracterize it. So I really can't say any more than that. The timing is because we came to the decision a week or so ago that we were in a good position to put the lawsuit out there.

Okay, Keith. And sorry, just any thoughts on kind of how this plays out from a time line perspective going forward? Or is that -- is it too early to kind of have a good handle on time lines?

No, I think it's too early to comment on that.

Our next question comes from Bill Plovanic with Canaccord.

A couple of questions for me. First of all, I'd just like to -- as we think about the guidance you provided and maybe the momentum in the business, I mean, crossing that 5,000 patient threshold given that January was fairly low, kind of just trying to triangulate, it seems like the math on the guidance might be a little conservative. Just what are the puts and takes that you're thinking of as you think about Q2 and then maybe the full year? And then I have a couple of follow-ups.

Thanks, Bill. It's Steve. Yes, I'm not sure where the 5,000 came from. But regarding puts and takes, we still are a little bit impacted by the pandemic, first-hand experience, my daughter added junior pram, which was deemed to be a super spreader event, where 200 students out of 225 caught Omicron. Now it is much milder than in the past, but it still does have an effect on our practices in patients.

Q1 came in on budget and higher than guidance. So we're very comfortable with where we're -- where we ended Q1 and where we're currently at with Q2. Again, Q3 is a seasonally flat quarter relative to Q2, and then we really picked things up at the end of the year. So I don't view it as conservative. I view it as really consistent with what we put out in March. And really, there's -- the variables and our thoughts haven't changed since a few months ago.

Great. And then just I think you mentioned on the first -- on the call, just cash usage seemed a little higher than normal in the first quarter. Is there anything you'd like to call out or we should think of? I think if I look at the year ago, it was about, I think, about $5 million less in cash usage. And I don't know if it was an inventory buildup or anything specific there?

Yes. I mean there were 3 primary drivers for that increase in cash burn. One is the P&L loss of $10.8 million. We had to fund that. And then we did have a $1.5 million increase in inventory and so with our product development team and manufacturers, we released Version 3.6 in October, and we'll have version 3.7 coming out in the summer. It does put strains on inventory.

We have to purchase some parts at risk. And we're continually working around some obsolescent issues. But we think the inventory will be relatively flat to where we ended in Q1. And then also, you saw we did have a slight increase in AR, primarily driven by some of our larger customers just managing their own cash, but we work closely with them, and we're confident that we'll be able to bring that down by the end of Q2.

Okay. And then finally, just -- I mean, May is depression month. Just what are your plans? Do you have any special projects, any major events or marketing programs for the month?

Yes, Bill, this is Keith. Thanks for asking. Yes, it's an exciting time for us. I think we have talked about our new campaign that we rolled out in the first quarter, which has tapped into a new possibility for depression that has now been launched over all of our marketing channels, including digital and paid search and all the resources that have been also put into our practices. We've recently rolled out what we have told our practices is the purple box. And within the purple boxes, all the materials that they would need to market and educate their patients within their practice.

And so far, the reception to that within our customer base has been phenomenal. They can't wait for the box to show up. And lastly, on March 2, we launched our partnership with Drew Robinson. Drew Robinson is a mental health advocate, but it was also a former major league baseball player, who, even though he was able to rise to the top of his game in Major League Baseball, he still suffered with depression from the time he was a small child, ultimately, ending in a suicide attempt when the COVID-19 pandemic started in April of 2020. Fortunately, he survived. And he is now a huge mental health advocate. He has agreed to be a spokesperson for us and we will be utilizing Drew across all of our marketing channels. So we're excited to have them as part of our team.

Our next question comes from Margaret Kaczor with William Blair.

This is Brandon on for Margaret. I wanted to focus first on utilization. I know there was an impact of COVID in January. It might be helpful if you guys could give a little bit more color maybe if you're willing, on a monthly basis. So what we're really just trying to understand is you have a lot of commercial investments going on, they're starting to mature. So as the end market started to normalize in February and March, were you starting to see some year-over-year growth in terms of disposables there? And then because we're frankly also just trying to understand what that trend should be through the rest of the year from here on the disposable side.

Yes. Brandon, I hope Margaret is doing well. It's a really good question. And the difference between previous quarters and January was that our offices didn't shut down. Their patient population slowed down. So their utilization and their motor thresholds were slower than we had expected. But the office has remained open. And as a result, we were able to sell systems into them and still do training and education for their staff. So that was a huge bonus for us. What -- we look at our utilization on a weekly basis across all of our customer base from the fixed price to our national accounts to our per click customers.

Starting in the second week of February, all of the numbers on utilization started to pick up. And then we look at our motor thresholds the same way and all of those picked up. So we are currently at one of the highest points on a weekly basis for our motor thresholds across the board. So that's what gives us the level of excitement that we have right now.

Got it. That's helpful. And as you place -- the commentary around the system placements was really encouraging and well ahead of kind of what we were expecting in terms of productivity this year. Curious if you could talk a little bit about -- since you kind of had strong leads when you're placing these systems, are they maybe ramping in terms of utilization quicker than historically? Or should we think about there's a big bolus of systems that might be coming in, there might be a little bit of dilutive utilization over ramp in 6 to 12 months. I'm not sure if that's an accurate time line, but correct me if I'm wrong. So just thoughts on ramping of these new big numbers of systems.

So when we place a system into a new customer, somebody that has not done TMS before, the biggest challenge and the longest lead time is getting them credentialed and up and running on getting the payers to give them reimbursement. And right now, we're seeing that time line to be at about 90 days from the time that we deliver the system into their office. So we are able, during that 90-day period to do all the training of the staff that we need to do to educate -- start educating their patients and start their marketing programs. But that's the longest lead time that we have.

And we have a question from Marie Thibault with BTIG.

I wanted to try to get a better feel for how some of your commercial initiatives are working. And in particular, the 5-STARS' success, could you give us an update on how some of those earlier centers have evolved with that program early on are doing now in terms of volume, in terms of utilization, in terms of engagement with the treatment.

It's -- so as we've said in the past, everybody is involved in the 5-STARS to success. It's just how far they've progressed. And just as a reminder, the first STAR is getting them up and running, getting their system going and getting them up on reimbursement. The second STAR is getting their front desk trained, they're treater trained and then the physician trained and pretty much in that order. And then the third is getting their office set up so that they can start to receive patients and do -- start their marketing efforts.

So I think we have the majority of our customers through STAR 3 and going into STAR 4. Our fourth STAR is really internal practice marketing and that has been our focus when -- over the last 6 months. We have -- we believe that we have broadened the awareness out there from under 9% to about 15%. We have a target to get it higher this year, closer to 20. And I think we're on track to do that, but we are driving that awareness so that when a patient goes into a physician's office and sees the material and as talked to by the physician about a NeuroStar, the first thing that they're going to do is go home and Google it.

And we want to make sure that there is information out there and that our website corresponds to that and then the physician that they are seeing has the same look and feel that we do. So we're pretty far along in deploying the 5-STARS to all of those customers. And then the second program is our Precision Pulse, which I think the biggest attraction to that program is our co-op marketing. And that continues to grow every single quarter. So we're very pleased with the level of participation of our accounts in both of those programs.

Okay. A follow-up here on the OCD indication, certainly congrats on getting that clearance. Can you remind me what the reimbursement environment looks like here in the U.S. for NeuroStar annual fee?

So the -- there are a few of the payers and a few of the MAX that are paying for OCD. They're paying at the same level that they do for depression and they're using the same codes. We just need to work to broaden that to all of the major payers across the country. And we have brought on board a woman whose sole responsibility is to help us in the reimbursement arena and get that -- get broader acceptance by the payers.

Okay. Great. And one very quick follow-up, probably for Steve. Could you give us the exact number of active sites? I heard you say over 1,000, we just like to have it for a model that you can offer it.

This is Keith again. It's 1,008.

That concludes our question-and-answer session for today. I will now turn the call back to Keith Sullivan for closing remarks.

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

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