Neuronetics, Inc.

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 and Chief Executive Officer Keith Sullivan.

Thanks, 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 the rest of 2023 before turning to Q&A. We delivered a solid performance during the second quarter. as our commercial and customer education initiatives have continued to gain traction. U.S. capital sales remain consistent, and despite some of the ongoing headwinds associated with the integration of our two largest customers, our treatment session revenues continue to increase. Total revenue was $17.6 million, up 8% over the second quarter of 2022, primarily driven by strong treatment session growth combined with an on-plan Neurostar system expansion. Neurostar system revenue was 4.5 million. As previously mentioned, our objective is to ship 45 to 50 systems per quarter. As we believe this range enables our team to dedicate sufficient time and resources to ensure the long-term success of our customers with Neurostar. Consistent with this plan, We concluded the quarter by shipping a total of 54 systems. Importantly, nearly half of the Neurostar ship during the quarter were to customers buying their second systems, which points to the value we are delivering to these practices by helping them educate and treat more patients in need. The sustained strength of our capital equipment sales can be attributed to the continued execution by our experienced capital sales team. as well as the positive impacts of our Neurostar summits. Our most recent summit held in Scottsdale, Arizona, was again sold out and ultimately resulted in approximately 20 system sales during the event. These Neurostar summits remain a crucial element of our strategy, providing a platform to educate customers about the impact Neurostar can have on improving patients' lives. The U.S. treatment session revenue was 12.3 million, up 9% over the second quarter of 2022. The strong performance was primarily driven by the 19% year-over-year increase in local consumable utilization, along with the improving performance among our national accounts. Across the board, these results were driven by the positive impacts of our key initiatives, such as Neurostar University, our comprehensive Five Stars training program, the expanded utilization of our PHQ-10 tool, and the increased accessibility of the practice management training. Along these lines, we wanted to provide an update on the progress made at our largest customer, Greenbrook TMS. During the quarter, we continue to see improving performance across active Greenbrook sites. Treatment session volumes and related revenues remain somewhat depressed as a result of their office closures. But we are actively working with the Greenbrook team to address the ongoing challenges stemming from the merger with Success TMS and the integration process. We have collaborated closely with their leadership team at various levels to implement a mutually beneficial strategy moving forward. This included implementing initiatives to enhance awareness, expand patient access to care, and effectively redeploy systems from the recently closed stores. In total, approximately 50 systems were taken out of service, due to store closures, and to date, over 35 of these systems have been relocated into existing stores where they have replaced competitive systems. We expect the remaining systems to have been relocated by the end of the third quarter. Additionally, in support of Green Brook's growth, all of the Green Brook regional vice presidents have attended a Neurostar University class, and we are scheduling their trainers and treaters to attend upcoming classes to provide them with a proven playbook for practice success so they can better serve their patients. As we continue to support the Greenbrook team, we are encouraged by the positive impact that tactics learned at NSU have had as they deployed them in their clinic. While legacy success stores are currently lagging behind Greenbrook stores in terms of performance, We are confident that through education and training efforts, we can help get that portion of the business back on track. We look forward to continuing our strong partnership with Greenbrook as we work together to advance the adoption of PMS as a therapy for mental illness. Now turning to our operational highlights. Our first focus of 2023 is increasing the number of customers who participate in NSU. Neurostar University continues to receive excellent reviews from our customers. By quarter end, we had hosted 13 fully booked classes with over 260 attendees. We are experiencing sustained high demand with all of our courses fully booked out on a three-month rolling basis. In August, we will celebrate the one-year anniversary of the program. which we have updated twice to streamline our customers' experience at NSU to make it as impactful as possible. Our customers continue to derive significant benefits directly from the NSU training session. For example, for sites that became active before January 1st of 2022, Neurostar University attendees have experienced a 68% increase in utilization. whereas non-attendees from that same period only experienced an 8% increase. Additionally, attendees have increasingly leveraged our other programs, such as the Five Stars and Co-op Marketing, which has, over time, led to increased overall performance. This highlights the positive impact of our techniques when properly deployed, empowering practices to better serve their patients. We remain committed to providing the support and training to our customers, ensuring that they can fully leverage their potential. Our second focus for 2023 was to incorporate a higher percent of our customers into the co-op marketing program to continue to build awareness of Neurostar. We have seen the positive impacts of our new co-op marketing program, which launched on April 1st. The program features a prescriptive roadmap of effective marketing tactics to market inside and outside the practice. New marketing and training collateral were created, and we revamped myneurostar.com to digitize the execution of the program. Since its implementation, we've observed increased use of the co-op program, especially by NSU attendees. Existing co-op accounts are also demonstrating increased engagement with the program, with a 27% increase in activity quarter over quarter. This reflects their deeper adoption of and partnership with our platform. Additionally, participating co-op accounts saw a notable increase in utilization sequentially. This enhanced program is driving growth and increasing patient access to Neurostar therapy. Our third and final focus area for 2023 is creating a network of accounts across the country that follow Neurostar best practices. This program will provide the opportunity for our customers to be part of a premier group that demonstrate their commitment to providing the best patient experience and care with Neurostar. After soliciting feedback from our Neurostar patient advocates and 800 people who have been diagnosed with depression, we are branding this program the Better Me Guarantee and intend to launch it in the third quarter of this year. By establishing specific benchmarks, such as delivering consistently high levels of service and expanding patient marketing efforts within and outside the practice, we anticipate observing tangible advancement among customers who fully leverage the distinctive benefits of being a Better Me Guarantee provider. We will expand on the specifics of this program on our third quarter earnings call. Shifting gears to an update on the clinical and regulatory efforts. In June, we announced the 510 clearance for the OCD MT-CAP technology for Neurostar. This unique innovation streamlines the treatment process by simplifying coil placement and reducing steps involved in determining a patient's motor threshold. The OCD-CAP complements Neurostar's existing capability positioning it as the only TMS . This advancement signifies our commitment to delivering the latest technology to optimize treatment efficiency and provide effective care for individuals struggling with OCD. We are continuing to work to expand the use for our unique therapy. We have recently filed a 510 submission with the FDA seeking to expand our potential patient population. While we don't want to comment on the specifics of the filing for competitive purposes, we do expect to hear back from the FDA on the filing by the end of the year and look forward to sharing progress as it occurs. Moving to reimbursement, we are pleased to announce Blue Cross Blue Shield of Michigan has expanded eligibility for depression patients to receive TMS treatment. This policy update reduces the requirement of attempted antidepressant medications from four to two prior to TMS treatment eligibility. By prioritizing early access to relief, Blue Cross Blue Shield of Michigan is enabling millions of people to benefit from our therapy. This policy change reflects the growing recognition by commercial and government payers of the need for enhanced mental health coverage, particularly in light of the nationwide shortage of mental health care providers. Additionally, Aetna, one of the largest healthcare plans in the country covering over 16.8 million lives, has implemented changes that will make our treatment more accessible. Aetna now allows TMS treatment to be ordered and conducted under the supervision of behavioral health nurse practitioners. Also, Aetna has removed the four-month psychotherapy trial requirement before a patient can receive their initial TMS treatment, making it easier for individuals to start their treatment sooner. The latest update from Aetna Opening up access to care through nurse practitioners and reducing eligibility requirements is a step forward and builds on the momentum we have seen with other commercial and government payers, expanding coverage for TMS therapy. We are pleased with the achievements made in the second quarter. Our commercial team received strong support through effective marketing initiatives. comprehensive training program, and dedicated practice assistance, which all contributed to our success. I appreciate the ongoing dedication of our entire organization and their efforts in strengthening our leadership position in the industry. With that, I'd like to turn the call over to Steve.

Thank you, Keith. Unless otherwise noted, All performance comparisons are being made for the second quarter of 2023 versus the second quarter of 2022. Total revenue was $17.6 million, an increase of 8% over prior year revenue of $16.3 million. U.S. Neurostar Advanced Therapy System revenue was $4.5 million. versus $4.4 million in the prior year. We shipped 54 systems, down from 58 systems in 2022. As Keith noted, our current strategy is to ship between 45 and 50 systems per quarter. US treatment session revenue was $12.3 million, an increase of 9% over 2022 revenue of $11.3 million. the revenue growth was primarily driven by strong performance within our consumable customer segment. In the second quarter of 2023, revenue per active site was approximately $11,390 compared to approximately $11,280 in the prior year quarter. We are highly encouraged by the fact that despite a material increase in active sites Compared to this time last year, we were able to maintain revenue per site. We see this as evidence that our programs and initiatives are working. Gross margins were 72.5% compared to 75.3% in the prior year quarter. The decline in gross margin was driven by an increase in amortization expense associated with the latest product release. We also incurred one-time expenses related to our transition to a new contract manufacturer. Without these expenses, gross margins would have been 75.6%. Operating expenses during the quarter were $20.1 million, a decrease of $2 million, or 9%, compared to $22.1 million in the second quarter of 2022. In May, our ELP met to review and justify 2023 operating expenses. Consistent with the results achieved with a similar exercise in 2022, the team identified over $4.5 million in expense savings in the balance of 2023. some of which will be offset by increased co-marketing expenses related to Greenbrook. As a result, we have achieved a net reduction of $2.2 million in expenses, demonstrating our commitment to prudent financial management. During the quarter, we incurred approximately $2 million of non-cash stock-based compensation expense. Net loss for the quarter was $4.9 million or 17 cents per share as compared to a net loss of $10.4 million or 39 cents per share in the prior year quarter. EBITDA was negative $3.3 million as compared to negative $9.1 million in the prior year quarter. In the quarter, our EBITDA loss was reduced by $2.9 million related to the recognition of the employee retention credit. As of June 30, 2023, cash and cash equivalents were $45.9 million. We incurred significant expenses related to our contract manufacturing transition and also recognized significant capital revenue in June. which increased our accounts receivable balance at quarter end. As a reminder, we converted $6 million of Greenbrook accounts receivable into a senior secure loan on which Greenbrook has started making principal and interest payments. Now turning to guidance. For the full year, we now expect revenue in the range of $69 million to $73 million. increasing the bottom end of the range by $1 million. For the quarter, we expect revenue of $17 million to $18 million. We now expect total operating expenses for the year to be in the range of $82 million to $86 million, improved from prior guidance of $84 million to $88 million. We remain confident in our operating plan, which indicates that we will reach cash flow breakeven with our current cash on hand. Our path to profitability remains steady, supported by our projections for top-line growth, a strong gross margin profile, and diligent management of operating expenses. I would now like to turn the call back over to Keith.

Thank you, Steve. We've made significant progress in the first half of the year. The list of achievements is long, and it reflects our team's dedication and hard work towards achieving our goals. Some of our accomplishments include focusing on maximizing revenue growth while efficiently reducing expenses, surpassing our targets on capital placements, heightened attention on Greenbrook, aiming to bring their utilization back up to previous high levels and receiving excellent reviews and fully booking all NSU classes, which has increased attendee utilization compared to non-attendees. Additionally, our clinical data supports the efficacy of NeuroStar for adult patients with anxious depression, and we've achieved positive policy decisions reducing prior medication failures for TMS eligibility, and enabling non-physician practitioners to order and administer TMS therapy. We've also made notable product developments, enhanced internet connectivity capabilities, and software for TRACKSTAR. On the regulatory front, we obtained 510 clearance for the OCD MP-CAP. and recently submitted for a new label expansion. Furthermore, we secured $60 million in new debt financing and successfully improved gross margins by switching contract manufacturers. As we move into the second half, we are eager to build upon the momentum. Our proven track record of execution gives us confidence in our ability to continue to deliver solid results. We remain focused on growing the number of customers who take part in Neurostar University, working to incorporate a higher percentage of customers into co-op marketing programs and create a network of accounts across the country that follow Neurostar best practices. With a well-defined strategy in place, we aim to accelerate the adoption of Neurostar and provide relief to more patients suffering from mental health disorders. With that, I'd like to open the line for questions.

Thank you. As a reminder, if you would like to ask a question at this time, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile our Q&A roster. Our first question is going to come from the line of Margaret Kayser with William Blair. Your line is open. Please go ahead. Hey, good morning, everyone.

Thanks for taking the question. I wanted to start to talk about the accounts that purchased the second system. So half of the placements this quarter coming from that really seems like a meaningful increase. Are these national accounts or group practices, and then how should we think about their productivity ramp relative to a more traditional new site?

How are you doing, Margaret? This is Keith. The accounts that purchase second systems were mostly private offices. National accounts have not purchased any systems in the last couple of quarters. These are physicians that have gotten to the level where they're doing six or seven treatments per day on their device and at that level they're starting to run into scheduling conflicts with patients and they need a second system to support that demand.

Okay, and the productivity ramp and increase seems like maybe that should be a little faster than normal given they're already familiar with the system. Is that fair?

Yes, it is. And I think, you know, they've already, most of these accounts have already been to NSU. They understand exactly how to speak to their patients and get them into the chair. So, these are the accounts that have really accelerated. I think we've said in the past, that it typically takes six months for accounts to get their system and get it up and running. And we have worked hard over the past several quarters to reduce that. So we're now in the 90 to 120 days range to get new accounts up and running.

OK. That's helpful. And what I'm trying to pair into, you referenced the 68% increase in utilization for attendees from NSU. That's a pretty meaningful increase. You're referencing those sites are the ones that are coming back, I guess, for second system purchases. So as we think about both the next several quarters in 2024, is this something that you can see to pick up traction where more of the accounts attend NSU? And then I have one more follow up and we'll hop back in.

The simple answer is yes. We're putting an emphasis and we're using the stat that you just mentioned, the 68% increase, to get more accounts there. Quite honestly, we've held 15 classes now and we are getting repeat customers coming back. We are using this data to get our legacy accounts and all the new accounts to come to NSU as soon as possible.

Okay. So just last question for me, just because these steps do seem pretty meaningful. Can you give us a sense of, I guess, what the revenue per account would have been this quarter or this year, excluding Greenbrook or excluding the national accounts? You know, as we kind of lap the Green Book headwinds, obviously, that'll maybe be a better signal of what that underlying business can do. Thank you.

Hi, Margaret. This is Steve. We haven't done that math yet, but we did have, you know, 50 or so Green Book office closures. So... the revenue per site would obviously be a bit lower. But we'll have to go back and quantify that for you and get back to you.

Okay. Thank you, guys. Thank you. And one moment for our next question. Our next question is going to come from the line of Bill Plovenick with CG. Your line is open. Please go ahead.

Hi, it's Zachary Deon from Build Today. Thank you for taking the question. So you've talked a lot about easier payer rules with Blue Cross Blue Shield and the Aetna improvements. Can you possibly quantify that importance and think about when it comes to other commercial payers beyond Aetna, what percent of them do you think will get a similar policy update and how can that drive revenue and other financial metrics. Thank you.

Well, good morning. We are very encouraged by the changes in the policies. You know, the biggest one that we had was back in March when UnitedHealthcare went from four drugs to two, and I think most of the other payers are going to follow suit with it. I think we've said in the past that there are plenty of patients out there that have failed four drugs, and we are making a concerted effort to drive awareness to those patients. What the reduction in failed drugs means to those patients is they can get into the chair sooner. So we have a large patient population for us to treat, the payers are just making it easier for them to get it. So I think our job and the physician's job is to help drive that awareness.

Great. Thank you very much.

Thank you.

And our next question is going to come from the line at a meter with Piper Sandler. Your line is open. Please go ahead.

Hey, Keith. Hey, Steve. This is Simran on for Adam. Thank you for taking the question. I guess I'll start off on just the sessions business. Can you provide a bit more color on what you saw from treatment sessions volumes and how that progressed over Q2 and into, you know, July and August so far? And I'd be curious to know what your expectations for this part of the business look like once you kind of have the rest of the Greenbrook systems relocated and sort of ramping back up.

Good morning. This is Keith. The systems that have been moved for Greenbrook have, as I said, over 35 of them have been shipped to new locations. Not all of them have been trained yet. And so we are working through getting all of the systems placed, and we have prioritized getting training to those sites that have been using competitive systems so that we can get them up and running. In the past, Greenbrook was able to generate in the neighborhood of four to six patients per day per system. And we want to get them back to that level, and we're working with Bill Leonard and his team to help get them to that level. For our other accounts that are growing in utilization, the ones that per click accounts at the 19% growth, those accounts are the ones that are following our roadmap to success, which includes going to NSU, which includes following through on the PHQ-10s, and using our co-op marketing to be able to make sure that their website is in shape, make sure that their social media platform follows ours, and they're buying the proper Google AdWords to drive greater awareness.

Okay, perfect. That's helpful. And then for my follow-up, The guidance kind of implies a sequential step up of around 16% from Q3 to Q4 at the midpoint, which is perhaps a bit deeper than what we've seen in past years. So I guess, you know, what kind of informs that level of confidence and can you walk us through your assumptions baked in for the fourth quarter?

Hi, this is Steve. Yes, if I go back and look at 2022, for example, the third quarter was slightly higher than the second quarter. And that's what we're anticipating this year. And then Q4 was up just under $2 million from Q3 to Q4. And that's the similar assumption and seasonality we're expecting in 2023. Q4 is always our strongest capital quarter. and we do have a significant number of treatment session programs that accompany the capital sales. And so it's really just the normal cadence for the final six months. We do see Greenbrook, their performance to be consistent compared to the first half of this year. As Keith alluded to, the transition from Moving Neurostars from storage into active units is a little time consuming. We do have to have our field service engineers deinstall and install. Many of these accounts that the systems are going into were formerly BrainsWay sites, so there is a significant training effort that goes into these. There could be upside depending upon the speed and training activities. But again, we really don't think the lift in Q4 is significant. Now, as a reminder, we've been growing almost double digits, and that's, again, reflective in that Q4 performance forecast.

Okay, thank you. And if I could just squeeze one last one on gross margin really quickly. So you hit on some of the impacts, you know, with the one-time expenses related to the new contract manufacturer. But how should we think about the levels of gross margin as we look out over the second half of the year and into 2024?

Yes. We'll see, I would say, gradual improvements in Q3 and Q4 of this year. And then once our new contract manufacturer is really up and running in 2024, Again, we're going to see gross margins inching up to that 80% range. And so we have a number of cost reduction efforts underway, that transition, as well as an increasing treatment session revenue versus capital revenue product mix, which also helps margins. So we are confident we're going to get up to that 80% range in 2024.

Thank you.

You're welcome.

Thank you. And one moment for our next question. Our next question is going to come from the line of Daniel Stoddard with JMP Securities. Your line is open. Please go ahead.

Great. Thanks. So just real quick, Revenue Proactive site you talked about is up modestly this quarter back into that mid-11,000s. But I guess, could you just remind us how you think about this metric? Any expectations for this year or the exit into exit 2023 and any, you know, broader near to midterm targets for these levels and, you know, what's a comfortable core here that you expect to reach over time? Thanks.

Hey Danny, it's Steve. I mean, this is one of the key metrics. It really does highlight the performance of an individual site. I would say with a lot of the activities and initiatives we have, that number will continue to increase. It is a bit variable depending upon the system sold into existing sites and also the different customer segments. So the local consumable segment continues to shine for us, and that's really the focus of many of our initiatives. And so we would expect that to get maybe 20% higher as we work through next year. So I was going to say, Danny, if you look at the average treatment sessions done on a system, it's still the upside getting to that six or seven per system, which is pretty much capacity. There is significant runway in that number compared to where we are right now, and obviously that will translate into a much higher revenue per site calculation.

Great. Thank you for that. And then just one more on cash usage. You had some one-time items here in the first half of the year, but just any more color you could give us on cash burn rate in the back half of this year as well as your rate exiting 2023 would be very helpful. Thanks.

Sure. So we actually had a very good push in AR collections this quarter, but it was masked by, I would say, a pretty healthy June. And so you can see in our zero to 30 day receivable balance, you know, it's up significantly, which is reflective of the number of systems we shipped. in the final month. We do expect leverage with AR and also inventory as we work towards Q4. You also saw in the press release that we did submit for our employee retention credit with the IRS. So that was prepared by KPMG. So we're pretty confident we'll have that in hand either late Q4 or early Q1. So that will help. And so we're expecting a modest burn in Q3. Again, pretty much a function of shipment timing and also collections of the activity in June. It's usually a lower burn for us anyway. And then Q4 should be pretty close to cash burn neutral. Again, we're going to have historically the strongest quarter of the year and it will be somewhat subjected to timing of the revenue mix that goes out the door in December. So we think we're going to end the year low to mid-40s in cash. Again, as we've been communicating, the plan is to hold operating expenses flat in 2024 and then continue to grow the top line. And so if we can get, for example, Greenbrook and some other accounts back to their normal cadence, You know, we think our top line can get to where the top line growth can get to where we were expecting this year, you know, in that mid-teen range.

Great. Thank you very much. You're welcome.

Thank you, and I'm showing no further questions, and I'd like to hand the conference back over to Keith Sullivan for any closing remarks.

Thank you very much, Operator. Thank you all for your interest in neuronetics. We look forward to updating you on our next quarter to call.

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