Neuronetics Inc (STIM) 2022 Q4 法說會逐字稿

Good day, and welcome to Neuronetics Fourth Quarter and Full Year 2022 Conference Call (Operator Instructions). As a reminder, this call is being recorded.

I would like to turn the call over to Mark Klausner, you may begin.

Good morning, and thank you for joining us for the Neuronetics fourth quarter and full year 2022 conference call. Joining me on today's call are Neuronetics' President & Chief Executive Officer, Keith Sullivan; and Chief Financial Officer, 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 or 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 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 non-cash 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 & Chief Executive Officer, Keith Sullivan.

Thank you, Mark. Good morning, and thank you for joining us. I'll begin by providing an overview of our recent performance, followed by an operational update. Steve will then review our financial results. And I'll conclude with some thoughts on 2023 before turning to Q&A.

We are pleased with our performance throughout 2022, a year which included several record quarters and the achievements of key milestones. We shipped over 210 systems to customers, bringing total system shift all time to over 2000. In addition, our efforts to drive increased treatment session utilization has continued to pay off. As of the end of the year, the number of all time treatment sessions surpassed 5.3 million across roughly 145,000 patients. This all contributed to the total revenue growth of 18% for 2022.

Proof that the investments made over the past 2 years in marketing, practice development and patient education initiatives are working. I'm very proud of everything that we have accomplished in 2022, which we capped off by a strong fourth quarter. And I'd like to thank our employees who delivered this high level of success by way of their hard work throughout the year.

For the fourth quarter, total revenue was $18.2 million, up 21% over the fourth quarter of 2021. The strong performance was primarily driven by record treatment session revenue, as well as continued capital equipment sales growth as we seen our programs and initiatives take root. NeuroStar Systems revenue was $4.6 million, up 64% over the fourth quarter of 2021. The success is due to the ongoing hard work of our strong team of area sales managers, who found their groove and nurturing and converting a robust pipeline, which was strengthened by yet another sold out NeuroStar Summit.

The U.S. treatment session revenue was an all time record of $12.5 million, up 11% over the fourth quarter of 2021. This record revenue was the result of positive growth at the local per click sites and was accomplished despite slower than anticipated growth and our largest service provider as they work their way through merger integration. Our per click success was driven by our investments in 5-STARS training program. The expansion of our PHQ-10 tool into more offices and greater availability of practice management training.

Now, turning to our operational highlights. Our first focus area is increasing customer and patient awareness. We once again had a completely sold out NeuroStar Summit in Chicago, attended by 50 participants from 38 different practices. This event received outstanding feedback which led to the conversion of several high quality customers and the growth of our pipeline. The NeuroStar Summit's had proven to be the #1 one event for educating and partnering with new TMS practices.

Our area sales managers have done an excellent job, helping these potential customers, see the benefits NeuroStar can bring to them and their patients. The implementation of our proprietary PHQ-10 Digital assessment tool, which allows our NeuroStar practices to easily identify patients within their practice, who are candidates for and have expressed interest in a NeuroStar treatment has been extremely fruitful. We collected 98,000 PHQ-10s in 2022, and we will continue to enhance this tool to include new features within TrakStar to better manage and identify patients who are candidates for NeuroStar treatment.

Our NeuroStar University in Charlotte, North Carolina continues to receive excellent reviews from our customers. By year end, we had hosted 8 full capacity classes, with attendees representing 75 accounts. And we now have a lengthy waiting list. As we continue to evolve the capabilities of the platform, as well as the support services that we offer our customers, these classes will continue to be highly beneficial for both the new and existing users as we seek to leverage the power of NeuroStar to help more patients suffering from mental disorders.

We have begun to see positive benefits, linked directly to the NSU training classes. Such as the increase of 23% in treatment session utilization and an increase in PHQ-10 utilization from these NSU attendees. Our second focus area is the continued optimization of our commercial organization. In the quarter, we started to see some benefits from the efficiencies gained from our newly implemented Salesforce reporting tool, which helps our PDMs better understand our customers, their patient base and utilization trends.

These tools allow the PDM to help our account set goals and measure their progress towards achieving them. In particular, allowing accounts to more efficiently and more effectively identify and treat people in need from within their own existing patient rate. As planned, we hired 4 additional PDMs earlier this year, due to the new account growth over the course of 2022. These additions will support the growth of our installed base and ensure we provide our customers with the highest level of service and support.

Our third area of focus is leveraging exclusive commercial partnerships. We recently announced an expanded commercial partnership with Greenbrook TMS, which runs through year end 2028. Under the agreement, we will be the exclusive supplier of TMS equipment to Greenbrook. With all other TMS devices being replaced with NeuroStar's as their existing leases expire. This expand partnership will deliver several important synergies, including co-branding, and co-marketing opportunities, enhance patient and clinical awareness, improve patient access to care, and a collaboration on product development and publication.

Importantly, this agreement converts the entire Greenbrook organization including Success TMS to our consumable pricing model, and away from a fixed price one. We will offer our full spectrum of support and programs to Greenbrook centers and practitioners. In particular, we will offer tailor NSU classes and integrate our PHQ-10s and TrakStar to help Greenbrook reach and treat patients more effectively. With the help of this agreement, Neuronetics and Greenbrook will be able to make NeuroStar Advanced Therapy for mental health accessible to a growing number of people who are struggling with mental illness.

Well, we are enthusiastic about the long-term partnership with Greenbrook and our ability to help them drive increased patient volume in their centers. I did want to highlight that we have continued to see disruption resulting from the merger of Greenbrook and Success and the subsequent integration of the 2 businesses. As Steve will mention later, when he provides our guidance, we expect some revenue headwinds in 2023 as they continue to work through combining their company.

Lastly, I want to provide an update with our clinical and regulatory progress. In January, we announced a peer reviewed publication which shows NeuroStar TMS as an effective non-drug treatment for depression with comorbid anxiety. Significant anxiety symptoms are present in the vast majority of depressed individuals. And the majority of patients with anxiety disorders also have associated depression. We were able to study actual results and establish the effectiveness of this crucial therapy option for patients with anxious depression.

Thanks to the strength of TrakStar and the largest clinical dataset for TMS in depression. Now for a quick update on the expanded Medicare coverage. In February, NGS updated their health care policy allowing nurse practitioners and physician assistants who are within their scope of practice to order and provide TMS treatments to their patients with major depressive disorder. This is a welcome change. As we have always recognized the importance of psychiatric nurse practitioners in delivering mental health care. This is especially true now given the shortage of healthcare professional.

In addition, UnitedHealthcare recently announced a positive coverage change, which expands access to NeuroStar therapy, Optum, the behavioral health benefit Manager for United, reduced the number of prior medication failures for TMS eligibility from 4 down to 2 and removed the requirement for a trial of evidence-based psychotherapy. As the largest health care insurer in the country covering 23.8 million lives, UnitedHealthcare's Optum's decision to make NeuroStar more easily accessible and make a real difference in helping to alleviate the burden of drug-resistant depression.

To continue to provide greater access to NeuroStar therapy, we recently expanded our reimbursement team. This larger team will be able to increase our advocacy efforts related to favorable health policies and provide our customers with best-in-class reimbursement and billing support.

In closing, I'd like to express my gratitude to our team for their dedication and perseverance in navigating the challenges of the current operating environment with these. This hard work has enabled us to successfully execute on all initiatives during the year and bring relief to patients suffering from depression. Looking ahead to 2023, we anticipate that the momentum we have built will continue to grow as we build on the solid foundation we have laid throughout 2022.

With that, I'd like to turn the call over to Steve.

Thank you, Keith. Total revenue for the fourth quarter was $18.2 million, an increase of 21% over fourth quarter 2021 revenue of $15 million. U.S. NeuroStar Advanced Therapy system revenue was $4.6 million. Compared to the prior year revenue of $2.8 million, it was up 64%. The company shipped 58 systems in Q4, up from 48 systems shipped in the fourth quarter of 2021. U.S. treatment session revenue was $12.5 million, an increase of 11% over fourth quarter 2021 revenue of $11.2 million. The revenue growth was primarily driven by an increase in utilization, in particular, among our local per click customer segment.

In the fourth quarter of 2022, revenue per active site was approximately $11,500 compared to approximately $12,200 in the prior year quarter. Excluding Greenbrook and Success, revenue per active site was consistent year-over-year despite having added approximately a 100 new active sites during the year. Gross margins were 76%, consistent with the fourth quarter of 2021. Operating expenses during the quarter were $21.5 million, an increase of $3.1 million compared to the fourth quarter of 2021.

The increase was primarily driven by our expanded sales force, the opening of NSU, higher-than-expected sales commissions, incremental headcount in product development, investments in clinical as well as increased costs from inflationary pressures. During the quarter, we incurred approximately $2.1 million of non-cash stock-based compensation expense. Net loss for the fourth quarter of 2022 was $8.3 million or $0.31 per share as compared to a net loss of $7.6 million or $0.29 per share during the fourth quarter of 2021.

EBITDA for the fourth quarter of 2022 was negative $6.5 million as compared to negative $6.3 million for the fourth quarter of 2021. As of December 31, 2022, cash and cash equivalents were $70.3 million. We continue to work with our lender, SLR Capital Partners on an updated credit facility. We are on track to close on this new facility in March, 2023.

Now turning to guidance. For the full-year 2023, we expect revenue in the range of $66 million to $72 million. As Keith mentioned, our guidance for 2023 assumes lower treatment session revenue from certain service providers, but continued strength from our local per click customers. For the first quarter of 2023, we expect revenue of $15 million to $16 million. We expect total operating expenses for the full-year 2023 to be in the range of $84 million to $88 million.

For the full-year, we expect cash utilization from operations to decrease year-over-year. Cash utilization will be the highest during the first quarter as it includes our national sales meeting as well as prior year bonus payments, sales commissions and retention costs. Our operating plan continues to show that we will achieve cash flow breakeven with cash on hand. Our path to profitability is still on track, thanks to our projections for top line growth, solid gross margin profile and the careful management of our operating expenses.

I would now like to turn the call back over to Keith.

Thank you, Steve. 2022 was a critical year for Neuronetics as we continue to drive the accelerated adoption of NeuroStar. We have shown that the clinical results are superior. We have made significant investments in building the latest and most talented commercial team in the business. We have demonstrated unmatched ability to support our practices by assisting them with patient education and awareness campaigns to promote long-term success.

To continue that success, we will focus on a number of key initiatives during 2023. One, increasing the number of customers who participate in NeuroStar University; two, working to incorporate a high percentage of customers into co-op marketing; three, creating a network of accounts across the country that follow NeuroStar best practices.

Beginning with increased customer participation in NeuroStar University. As the initial cohort of customers has gone through training at NSU, we have clearly seen the immediate positive benefits at these accounts, including better PHQ-10 uptake and increase treatment session utilization. Because of this, we are working to increase the number of existing and prospective customers attending NSU classes, which provides important education to the providers to allow them to deliver better patient outcomes. The classes are crucial as we continue to develop NeuroStar capabilities and features, such as our expansion into OCD as well as the introduction of D-Tect and the MT Cap.

Going forward, we are offering up to 2 classes per month throughout the year and incorporating attendance costs into our co-op marketing program. Our second focus for 2023 is to incorporate a higher percentage of our customers into our co-op marketing program. There are over 60 customers who are currently utilizing the benefits of our co-op marketing program on a regular basis.

The co-op marketing program is one of a kind in the TMS industry. It provides us with an incremental opportunity to partner with our customers to help support their business and provide patients with access to care through increased awareness with co-branded localized marketing campaigns. Customers who have participated in co-op marketing program have seen an average increase of 4 patients per quarter. We will continue to emphasize the expansion of customer participation throughout the year to bring the benefits of the program to more customers and their patients.

Turning to our third and final focus for 2023. Creating a network of accounts across the country that follow NeuroStar best practices. Over the past few years, our company has made significant investment in the organization and the development of best practices for each customer to market effectively and drive long-term growth. We would like to take certain aspects of these proven practices to a broader network of our accounts. As we look ahead to 2023, we want to set certain standards across the accounts we serve such as offering consistently high levels of service and increasing patient marketing within their offices.

We expect to see these standards in customers who fully utilize the uniqueness of the NeuroStar offering and our approach to the market. We will continue to follow our plan in 2023. We have done tremendous work over the last 2 years to set ourselves up for success, and we have the strategy in place to drive the accelerated adoption of NeuroStar and bring relief to more patients suffering from mental health disorders.

With that, I'd like to open the line for questions.

(Operator Instructions) Our first question comes from Bill Plovanic with Canaccord.

So obviously, I think the biggest question is on guidance and Greenbrook. One, what do you contemplate at the low-end and high-end in terms -- how does that reflected with Greenbrook? Kind of what percentage of your revenues are they today? And what do you expect out of that versus kind of the rest of your business?

Bill, this is Steve. Obviously, with the press release yesterday, we did have to scramble and adjust guidance. At this point, all we know is they do anticipate closing 50 stores with a 10% impact on revenue. We don't know the mix. We don't know which stores in NeuroStar. We don't know which percentage of revenue is Spravato versus TMS. And so, we took the approach really based on their contributions in 2022 versus our expectations in 2023 for growth.

I think we're in a wait-and-see mode at this point. So you saw in our -- well, you haven't seen in (inaudible) yet, but you will. They're a little bit north of 20% of our business. So we believe the $66 million to $72 million range is appropriate at this time. You can also see we did expand the range in revenue from our typical $4 million for the year to $6 million.

Again, we just need to see how this plays out through the month of March and into the early part of Q2. Greenbrook announces the end of March, and maybe there'll be some more clarity into their plans and how it impacts us.

Well, Steve I'll asked in another way. What do you expect out of your core business in 2023? Historically, if I look back, you grew 18% in '22, 12% in '21. And I even think a lot of the growth as we exited '22 was out of the non-Greenbrook businesses. So given that's 80% of your business, kind of what was the contemplation of growth out of that core business as you think about 2023?

Yes. I think it will be consistent with what we saw in the second half of 2022. So in that 20% range, again, if you look at our Q4 number, 21% over prior year, that was negatively impacted by Greenbrook and Success's performance. So the per click consumables segment and some of the other segments are performing quite well. So again, I think it will be in that 20% range.

And then last on this guidance question and then I'll jump back in. It's just how do we think about kind of the capital versus disposable especially getting our hands around like the assumptions probably given they're shut down 50 centers, they can move capital around, how do we think about capital in 2023 versus disposable?

Sure, Bill. Yes. Capital is going to be consistent with 2022. So we've communicated between 45 and 50 systems a year. We did slightly more than that last year. And we anticipate that consistent level in 2023. So there won't be an impact from the Greenbrook integration efforts. We also expect international revenues to be flat. So all of the growth in '23 will be related to treatment sessions.

I mean, 45 to 50 systems a quarter, not for the full-year, correct?

Correct, yes.

Our next question comes from Adam Maeder with Piper Sandler.

wanted to follow-up a little bit on the guidance line of question. And I guess I'll ask you about kind of cadence. You obviously gave Q1 guidance, maybe a hair lighter than expected. But just kind of help us think through kind of how you see your business kind of progressing over the year? Maybe we'll start there and then I have a follow-up or 2?

Thanks, Adam. Yes, if you look at our historical performance, and I go back to 2018, so the year prior to IPO, our revenue cadence by quarter is -- Q1 is 21% to 22% of annual revenue. Q2 is about 24% to 25% Q3, 25% to 26%. And then Q4 is always our strongest quarter at 28% to 29%. And so Q1, we always have the reset of deductibles. Patients have to go through and get their benefits investigations redone. And so, the internal teams here have been processing about 400 or so BIs a week, and that's continued into early March. So that's really the biggest pressure on Q1. But again, it's very typical for the past 5 years.

Okay. I appreciate that color, Steve. And I guess just one more on the guidance, and then I have a follow-up. But just kind of -- obviously, a lot of focus on the Greenbrook announcement yesterday and kind of how that impacts you guys. But if we just kind of look back more broadly, it sounds like you are very confident in the business ex-Greenbrook. So I guess one question I have just on the macro is, how are you thinking about this year 2023 and a potential recessionary environment? Is anything factored into the guidance there? Are you allowing for some additional conservatism? Just kind of maybe walk through the philosophy on the outlook?

Yes. I mean, there is -- there are no recessionary impacts in our guidance. I'm sure you remember, Adam, at your conference in New York that I communicated we were comfortable with where the consensus was for the year, and that was in that $73 million range. We were also anticipating mid- to high teen growth year-over-year. Again, the Greenbrook press release yesterday was a little bit surprising. And so I think we need just some time to work through the impact. Otherwise, you saw performance in Q3 and Q4, even with, I would say, no to slow growth from them, we were still at that 20% level.

And I think we're confident that we'll be able to maintain that in the other segments.

Adam, it's Keith. From a marketing standpoint, we have been working closely over the past couple of months with the Greenbrook team, putting together a plan on how they would attend NSU, how they would market within their practices, how we would help them get PHQ-10s in. So there was some hints of the closing of the stores. But I believe that we have put together a solid plan with Bill and his team to see if we can take the remaining stores and get them back up to their prior service levels.

Appreciate the color, guys. And one last one, if I may, just on some of the payer changes, expanded Medicare coverage and the United news from this week streamlining therapy. Maybe just kind of how do you think about the impact from those developments? Is this something that can impact the business near-term or do you think we need several quarters to kind of see any tailwind ultimately materialize?

Adam, on the reimbursement side, I think with UnitedHealthcare dropping from 4 to 2, it is a great sign. Many of the other payers follow what UnitedHealthcare does. As recently as last fall, Aetna went from 2 to 4 because that's where UnitedHealthcare was. So we are hoping that the other payers drop their requirements too and follow UnitedHealthcare's lead. Quite honestly, there are plenty of patients out there that have failed for drugs. So we're not in a -- there's no shortage. It does expand the market when we drop it down to 2.

And I think our hope now is that United and the other payers make it easier to go through the prior authorization process. So it does expand our market. It does help our patients. Now we need to help our accounts with simplifying prior authorization.

Your next question comes from Malgorzata Kaczor Kaser with William Blair.

Chime in with all my colleagues on the guidance side, so apologies for that. But I guess one more, and it's kind of a simple one. I guess, what gets you to the high and the low end of the range because it's obviously quite broad. So -- and more specifically, I guess, do you need Greenbrook to improve to get to that high end of the range or can the base do that? And then kind of a similar question on the low end of that range?

No, I don't -- Margaret, I think we need some contribution from Greenbrook and based on the release in their revenue haircut related to the 50 stores, we don't need any incremental growth from Greenbrook to get to either one of those figures. And so that should really be the growth from the other segments and would represent that 20% target.

So sorry, the 20% growth from the other figures, I mean, again, it's a wider range. So is 20% kind of the midpoint of the range? And then the 2 kind of high and low end, depending on the base, is that better or Greenbrook is better or worse? Am I understanding that right?

Yes. I think it represents the midpoint.

Okay. Perfect. And then I wanted to follow-up on the strategies because you spent a lot of time both at the beginning of the end, kind of walking through that in 2022 and kind of the goals for 2023, PHQ-10 (inaudible) et cetera. Is 2023 a year where those efforts, I guess, can scale on a broader basis where you can get maybe 2x or 3x or 20% of the base through those or is it just kind of more of a continuation with some solid growth and engagement?

Thanks for the question, Margaret. I think if we look at the NSU, we have seen the accounts that come through NSU adopt almost all of our programs on a universal basis. And as a result, their business has gone up. So I think that we -- our focus is to try and get more of our accounts through the NeuroStar University program. And I think that we have seen our number of accounts that are using the PHQ-10s just in the fourth quarter went from a little over $300 million to $450 million. So it is gaining traction. So I think 2023 is going to be a standout year for it. And I think that we can anticipate some that, that is going to be what's going to help us drive the growth.

Our next question comes from Daniel Stauder with GMP Securities.

Just touching back on the previous question surrounding the coverage policy updates. You mentioned this creates a larger funnel of patients and on the market. But do you feel that the coverage criteria has been a gating factor for adoption in the past?

I think what slows down our implementation within a practice is getting physicians credentialed and onto the insurance programs. So that's the #1 factor. Number 2 is getting the reimbursement actually paid. And the struggle that we have is that every single patient has to go through a prior authorization process with some of the payers that simple with other payers, they rejected at a hand and then you have to do an appeal. Typically, they approve the appeal if the patient has met all the criteria.

So yes, it is a gating factor here. But quite honestly, I think with the moves in Medicare and now UnitedHealthcare leading the way, I think we're encouraged that they are finally recognizing that they need to make the access to care simpler.

And then just one follow-up for me. You've called out higher utilization in your per click segment as a driver of treatment session revenues for a few quarters here. I think double-digits in the last 2 quarters. But you can highlight some of your initiatives that are driving this. But if you could point to 1 or 2 aspects that's really leaving the chart here, what would those be? And then what could this look like in 2023?

So I think the couple points that helped drive that utilization. Number 1 is our practice development managers. We have invested heavily into a team of people. Right now, we have 47 of them that our -- each account is assigned to one of our practice development managers and each one of those managers is responsible to generate awareness, education and help capture those patients within the practice and educate their staff from the front desk to the treater on exactly how to do that education.

So I think our practice development managers are the tip of the spear for us. And they are the ones that are deploying the PHQ-10s in the practice who are doing the 5-STARS to Success, which is a pure education at various levels within the practice, including marketing. So I think those are really our driving force. We rely heavily on our practice development managers and now NeuroStar University to help educate the accounts.

Our next question is a follow-up from Bill Plovanic with Canaccord.

Just to ask the question again on the Greenbook. I mean, as I reread the announcement, while they're shutting down a lot of centers, they say that it's only a little over 10% of the revenues. And if I do back of the napkin math, just based on some of the commentary, it sounds like at the low end, you're looking for Greenbrook down closer to 25% to 30%. If you're assuming at the midpoint, the rest of your business is growing 20%. Is that the trends you're seeing in the business today at Greenbrook or given the newness of the information, you're kind of -- the low end of the guidance is almost assuming a worst-case scenario just because you don't have a lot of information upon which to make that decision today?

So Bill, we monitor the utilization on all segments of our accounts every single week. And Greenbrook's utilization has decreased over the past 5 months. which I think, as we've said before and they have said, I think it's expected that there would be some disruption. But we saw a significant amount of decline in their growth in Q4. And we were able to grow in spite of it. I think that if we are able to deploy the trainings and the education that we are doing with the rest of our accounts into Greenbrook, which I think Bill, is very, very supportive of us working closer together to get that done. I think we can help them get back on track. But we did see the decline in the third and the fourth quarter.

And then just clarity on the impact of the NGS starting on April 1, getting the nurse practitioners to order entry. How important or significant is that?

It's a great question. So we have been looking state-by-state, payer-by-payer at the opportunity that's out there with nurse practitioners. Some of the states have, say that nurse practitioners have full authority if they have been under the guidance of a psychiatrist for 5 years. During the pandemic, Virginia, as an example, lowered the requirement under a psychiatrist to 2 years, but they have since reversed that and gone back to 5.

So there are areas of the country where nurse practitioners are allowed to diagnose the patient to do the motor thresholds and to treat. And we are beginning the process of identifying what areas that is and then how we're going to educate those nurse practitioners on the opportunity to help their patients.

Thank you. There are no further questions at this time. I'd like to turn the call back over to Keith Sullivan for closing remarks.

Thank you again for joining us today. We look forward to updating you on our next quarterly call. Thank you all.

Ladies and gentlemen, this does conclude the program. You may now disconnect. Everyone, have a great day.