Zynex, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Zynex fourth quarter 2024 earnings conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Brian Prenevue, Investor Relations for Zynex.

Thank you, Operator, and good afternoon, everyone. Earlier today, Zynex released financial results for the fourth quarter and year ended December 31st, 2024. A copy of the press release is available on the company's website. Joining me today on the call are Thomas Sangard, Chairman, President, and Chief Executive Officer, Dan Moorhead, Chief Financial Officer, Anna Lukczak, Chief Operating Officer, and Donald Gregg, President of Zynex Monitoring Solutions. Before we begin, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events. We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's 2024 Form 10-K and subsequent Form 10-Qs, which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements regarding product development, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I'll now turn the call over to Thomas.

Thanks, Brian, and good afternoon, everyone. Thank you for joining us today for the fourth quarter and full year 2024 earnings call. 2024. was a successful year for Cynics as we continue to grow revenue and drive profitability. We have made strides in diversifying our revenue streams with the addition of several new products, some internally developed and some manufactured, and added private label products primarily in the areas of bracing, cold, and compression products, all a perfect fit for Salesforce's call points in pain and rehab. We've also expanded the focus of our sales force to additional new prescribers of pain and rehab products such as National Change of Workers' Comp and the VA. In a moment, Don Gregg will provide you with an update for our patient monitoring business and the FDA submission of our pulse oximeter. In late 2024, we received positive test results on our NICO pulse oximeter in multiple trials done at Duke University and at the University of California in San Francisco. Human trial completion is an essential step prior to our 510K submission to the FCA. The data from the trials have been excellent in showing how much lower bias the current LED-based compared to how the current LED-based pulse oximeters exhibit, especially for skin with darker pigmentation. The old LED technology leads to inaccurate or inconsistent readings during clinical or critical times for a patient. which has been widely criticized in the media and politically. We believe that our laser-based system is a superior technology and has the opportunity to meaningfully impact patient outcomes. I will let Don Gregg provide more details on the status momentarily. We were recently notified by TRICARE that they were temporarily suspending payments to CYNEX related to a review of prior claims. We have a meeting with them here in early April to get it all sorted out, but cannot at this point provide an estimate on when it will all be resolved. Anna will provide more details during her discussion of operations. Given that TRICARE is a substantial source of reimbursement revenue, we currently have limited visibility in our revenue projections for 2025. And we have taken the most conservative approach to not include revenue in the later part of 2024, where some of those bills were submitted to TRICARE, yet not paid. And in this current quarter forecast, and therefore the corresponding lower revenue numbers. As part of a normal prudent cost containment measure, due to the possibility of a significant decrease in revenue short term, while we accelerate sales to other sales channels We continue to make adjustments to the corporate and sales cost structure to ensure we have optimized our structure and expense profile and are set to continue our long-term growth and profitability. And again, Anna will cover this in more detail. We remain very optimistic about the future of Cynics. The improvement we have made in analytics and operations over the past many years will show significant benefits in the long term. As we continue to diversify the product mix and revenue stream, we believe we can actually better capture the 800 million of identified sales opportunities within our 800 designated sales territories. In the patient monitoring business, we're just before FCA submission, and once cleared, that should generate revenue in a very well-established, multibillion-dollar sales segment. Over the past 29 years since its inception, Our growth has certainly not been in a straight line as long-term shareholders would certainly acknowledge. And the key for us is to keep focused on the long vision of growth and diversification and stay firm regardless of short-term disruptions. We trust that shareholders are on board with this strategy. Our recent challenges in 2024 were Not only introducing new product that so far have collected less than expected, however, we see clear signs of improvement here in early 2025. Our sales force and staff has been restructured and we have made changes to sales management. These improvements are already beginning to take effect and puts us in a good position to deal with the temporary suspension, payment suspension from ThaiCare while we focus on growing in other areas. Fortunately, We are in an industry where our potential call points for our sales force is nearly endless. We are still confident that our non-invasive approach with at-home pain management devices have real growth opportunities to provide non-opioid relief to patients. We remain focused on ramping our hospital monitoring division, which represents a large and growing market opportunity with a better mousetrap than our competitors in the pulse oximeter market. I'll now turn the call over to Anna Locksock to provide a more detailed update on the operations and the status with TRICARE. Anna.

Thank you, Thomas. As Thomas mentioned, we were notified by TRICARE of a temporary suspension of payments if they complete their review. From a reimbursement perspective, TRICARE is one of our largest insurers. We're currently working through the reinstatement process and have a meeting with the Defense Health Agency to present our appeal. in early April, but worst case, it could take as long as 12 months to complete. TRICARE represents between 20 to 25% of our revenue, so this is a significant reduction in revenue if the suspension were to be upheld. I think it is important to note a few things relative to this news. We completed an audit with TRICARE as recently as 2022. In this audit, we made all of the necessary adjustments to billing practices that were outlined and we haven't heard anything further since that time. We have demonstrated that we fully comply with those adjustments and have a good cause for eventually continued business as usual with TRICARE. During this temporary suspension, we remain in network with TRICARE and are expected to continue processing new and existing claims for treatment for TRICARE patients. In fact, TRICARE has said that they want current and new patients to continue receiving care through this process per our contract. If or when the reimbursements begin again, TRICARE would be responsible for paying all of the claims that have been processed during that temporary hold, which would show significantly increased revenue once received. Moving on to operations. We're also restructuring our organization and staff levels, which will decrease overall staff by 15% and primarily affects employees in our corporate office, along with other expense reductions made during the second half of 2024. and Q1 2025 will result in annual savings of approximately $35 million. This is a normal and good business practice that all companies constantly undergo. In 2024, we trimmed the sales force to ensure we have the right reps in place to put us in the best position moving forward. As of December 31st, we had a sales force of approximately 330 people, as compared to the beginning of 2024, where we had approximately 475 people. Progress takes time, but we have seen positive trends. Revenue increased 4% in 2024, and order growth was 16% in the year. The total number of reps was down, but the revenue per rep increased 22% to 490,000 on average in 2024. I'll now turn the call over to Don Gregg to provide a more detailed update on the patient monitoring business. Don.

Thank you, Anna. I want to provide an update on the progress of our NICO pulse oximeter. Although our FDA submission has been delayed into 2025, we are closing on major milestones to commercialize the NICO pulse oximeter. NICO verification human trials completed in fourth quarter of 2024 at Duke University with positive results as planned. Xynex's NECO pulse oximeter utilizes precise laser technology to measure blood oxygenation levels directly as opposed to current LED pulse oximeter products, which only estimate oxygenation levels. LED pulse oximeters have been shown to mismeasure oxygen levels in several populations, most prominently in individuals with darker skin pigmentation. We presented a poster of our study from the University of California San Francisco Hypoxia Lab at Anesthesiology 2024 in the fourth quarter. Four NICO pulse oximeters and two different commercially available LED-based pulse oximeters were used on each participant. Conclusions from the study showed the NICO pulse oximeter did not demonstrate a bias for dark pigmented participants compared to lightly pigmented participants. By comparison, conventional LED-based pulse oximeters in the present study read falsely higher on darkly pigmented participants, specifically at lower oxygen saturation levels. There have been published studies starting in the 1980s that detail how these inaccuracies were associated with disparities in care. Completed human trials were one of the last major milestones to complete prior to the FDA 510 submission. In late 2024 and into 2025, NECOS have been undergoing third-party regulatory ISO testing for compliance to safety and electrical standards. At this point, we anticipate FDA submission in the next 30 to 60 days following that completion. Based on historical submissions, approval takes approximately six months, which would mean a potential fourth quarter 2025 clearance, barring any uncertainty of FDA review resources. Also, in December of 2024, we announced our membership in the Open Oximetry Project, a nonprofit oximetry partnership of research organizations and industries created to improve the safety and precision of pulse oximeters in all populations. Xynex is pushing to be a key industry partner to all clinicians and show how the NECO pulse oximeter technology inherently solves the current market challenges, especially skin pigmentation bias. while bringing new precision medicine forward in the field of pulse oximetry. In summary, we've achieved major milestones in Q4 of 2024 on NICO commercial development, clinical verification, and we are very close to FDA 510K submission. Patient monitoring is a multi-billion dollar market that we believe we can enter with a superior product that can meaningfully improve care to a broad range of patients when they need it most. I will now turn the call over to Dan Morehead, Chief Financial Officer, for a more in-depth look at the quarter's financial performance.

Thanks, Don. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and year ended December 31st, 2024. Net revenue was $46 million compared to $47.3 million in the fourth quarter of 2023. Device revenue was $14.8 million compared to $16.3 million in the fourth quarter of last year. Supplies revenue was $31.2 million, up from $31 million in the fourth quarter of last year. Device revenue was lower during the quarter due to some product mix shift to lower priced products such as braces and other products that have lower price points than Next Wave devices. Gross profit in the fourth quarter was $36 million, or 78% of revenue, as compared to $37 million, also 78% of revenue in 2023. Sales and marketing expenses were $19.3 million in the fourth quarter of 2024, compared to $21.7 million in the same period in 2023. The primary contributor to the decrease in sales and marketing expenses was our headcount reduction of roughly 140 sales team members. G&A expenses were $17.3 million in the fourth quarter of 2024 compared to $13 million last year, largely due to ZMS increased expenses and professional fees. Net loss was $615,000 or two cents per share in the fourth quarter of 2024 compared to net income of $1.2 million or four cents per share in Q4 of 23. Adjusted EBITDA for the three months ended December 31st, 2024 was $584,000 as compared to $9.9 million in the quarter ended December 31st, 2023. Cash flows from operations were $2.4 million in Q4 and $12.7 million for the full year. The cash flow in the quarter and year increased our cash on the balance sheet to $39.6 million, up 5% from Q3's balance of $37.6 million. Working capital was 58.3 million as of December 31st. With that, I'll now turn the call back over to Thomas.

Yeah, thank you, Dan. The beginning of 2025 was certainly not as smooth as we had hoped, but we are optimistic about the long-term prospects of the company and the opportunities we have going forward. That still has not changed. Because of the uncertainty surrounding payments short-term from Tricare, we will not be providing full 2025 annual guidance yet, given the lack of visibility surrounding the temporary payment suspension. We are obviously still in network with TRICARE and continue to accept new prescriptions for the instructions. When we learn more information throughout the year, we'll be better able to communicate expectations and update everyone. At this stage, we anticipate the first quarter this year revenue of approximately $30 million. We will likely have a net loss in the first quarter ranging between 9 and 10 million as a result of not all restructuring having taken effect yet. Throughout this year, we will look to make adjustments to the cost structures as needed. Fundamentally, with or without TRICARE as a payer, we still have a rock solid business that will continue to grow towards revenues of $800 million plus in the pain management division. Our diversification into the patient monitoring area is set to start adding revenue late this year and next year pending FDA clearance. We're incredibly proud of the growth that we have consistently demonstrated over the past several years. Just 10 years ago, our revenues were nearly 20 times lower than now. And in the meantime, we've been able to buy back over $80 million worth of stock in the open market And we had a cash balance of $40 million at the end of 2024. Well, 10 years ago, we were scraping the bottom of our bank account daily to pay our bills. Looking forward, we believe we have additional customers and revenue streams that can drive further growth. The business we have created and the profitability we're able to generate allows us to have a high degree of flexibility to allocate capital in several ways and deal with temporary difficult situations like this. We have shown the ability to adjust to market, customer and reimbursement changes, and continue to invest in our business and return cash to shareholders. With that, operator, please open the call up for questions.

Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star followed by the number one on your touchstone phone. you will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star followed by the number two. If you are using a speakerphone, please make sure you lift your handset before pressing any keys. The first question comes from the line of Jeffrey Cohen from Lindenburg. Please go ahead.

Well, hi. Thanks for taking our questions. Just a couple from Aaron. So when you talk about the staff reductions of 15-ish percent, Could you give us a sense of what was accomplished in the fourth quarter, and then also give us a sense of how that will affect your two OPEX lines, both the sales line and the G&A line?

Yeah, I would say we probably did, if you're looking at the $30-plus million in annual savings, I would say a little less than half of it was done during 2024, but you wouldn't see all of it because obviously you're looking at run rates and those types of things. So a lot of those were implemented in the second half and then the remaining pieces were done in Q1 with some of that coming late in Q1. So if you're looking at sales expenses and those types of things, as far as run rate, Q4 sales we just posted You know, $19.3 million, I think, you know, that number is definitely coming down, and that has been coming down for the past few quarters, as you know. So it's probably down, you know, $1.5 million to $2 million on the run rate going forward. And then GNA, you're going to see about the same thing, down a couple million dollars a quarter based on what we did in Q4. And those will actually – continue to come down in Q2 a little bit as well. Like I said, a lot of those changes were put in at the end or middle to end of Q1.

Yep, so I guess the M30 on an annual basis for 2025, does it hit both the sales and marketing as well as the G&A the same percentage, or is it going to be more heavily weighted on the sales and marketing line?

No, it'd be more on the G&A, because the G&A is a smaller number too. So it's going to be a bigger number out of the smaller number. Sales was already decreasing based on, you know, the trimming that Anna talked about and those types of things. So I think as a percentage, it's going to be more on the G and a line, but both are going to be decreasing by, you know, like I said, run rate, you know, you're looking at close to 2 million compared to what we did in Q4.

Got it. Okay. And then secondly, maybe for, uh, for Thomas or for Dawn, um, Could you hypothesize with us a little bit about NICOCs and the commercial path to market that you're anticipating? Are you hypothesizing going direct yourselves with a commercial organization, or are you hypothesizing partners or different setups for different channels?

So this is Don. We have a strategy that actually leverages all three of those. As you look at penetrating the market as we would get clearance and potentially in Q4, 2026 certainly would be the year of ramp for that. We have been in discussions with potential partners, not just distribution partners, but partners that would potentially take the device and put it in their sales bag. We have had discussions through what it would look like as part of a direct sales force and where we would start with particular hospitals and IDNs. And then third of all, we have looked at an indirect sales force of potential 1099s of organizations that sell both capital and disposable equipment in this. And so we're poised to be ready to pull the trigger when we have clearance and covered the entire plan with Thomas and our executive leaders.

Okay, perfect. That does it for us. Thanks for taking our questions.

Your next question comes from the line of Shagan Singh from RBC. Your line is now open.

Hey, good afternoon. This is Avian for Shadoon. I have a few questions. First, what was the nature of the 2022 audit by TRICARE related to billing practices? And I guess, why didn't you have any visibility to TRICARE ahead of time before this happened?

So the nature of the audit was a routine post-payment audit. It's very common from most insurance companies. And the type of adjustments that were suggested during the audit were also fairly standard. So nothing major was identified or adjusted.

Okay. I guess that's helpful. You only gave Q1 sales guidance, not 2025, obviously, but why don't you have the visibility into sales? You have still 75% of your business or so that is being reimbursed. Could there be a domino effect? What conversations are you having with other payers?

No, there's really no connection here. This is totally isolated. We do obviously internally have some numbers that if TRICARE end up never paying us anything or if they don't start picking up payments until the end of the year, we're pretty confident that at some point throughout the year we'll eventually get through this conversation with them and basically prove that, hey, we did everything you asked for. What's your problem? It's been very unclear exactly what it is they're looking for. And because TRICARE is such a big part of our revenue, the difference in the guidance we would give is many tens of millions of dollars, if not more than $50 million. So therefore, we'd like to have a little more clarity into our dialogue with TRICAP before we get to revenue guidance. What we are doing is to make sure in a worst case scenario, let's keep doing what we always should be doing. Make sure we trim expenses and restructure the organization to be able to handle even worst case scenarios.

Okay. Great. And the last question is, what's your plan, like, to present at this April meeting with TRICARE? Have they told you any details on what they – are they requesting anything, or do you have, I guess, data to show them to, you know, whatever to help them, you know, figure it out, whatever it is that they exactly need from you?

Yeah, they gave us some vague guidance on what they're looking for. It's still very unclear what exactly their problem is. But we have lots of data to present to them specifically regarding policies that we're following. We will be referring back to the 2022 audit and the findings of that audit and adjustments. There were some directions we received during the audit that we'll be highlighting in that presentation. That's mainly going to be our focus.

Thank you.

Your last question comes from the line of Yi Chen from HC Wainwright. Please go ahead.

Thank you for taking my questions. Could you comment on what specific factors that triggered Tricare to start reviewing your prior claims? And is it a typical practice that during the review process, payers would temporarily suspend payments?

We're unclear on specific triggers at this point because they haven't communicated clearly what the issue is. As far as these type of reviews, I mean, post-payment reviews among payers are very common. We undergo multiple audits or post-payment reviews from several different payers on a monthly basis. Payment suspension is somewhat common. It's not the usual practice, but it happens with other payers as well.

So are you worried that other payers could potentially follow TRICARE and start reviewing claims and suspend payments to you?

We don't see any connection. I mean, it's across the board. We deal with 3,000 insurance companies all the time. And these things happen with small insurance companies, large insurance carriers. TRICARE is a big one, obviously. So therefore, we are taking this very conservative approach. But these guys all operate very independently. There's really no connection. And this is a government payer. It's not in the private sector. So there's already there, but a big disconnect.

And just trying to clarify, did you mention that this kind of process could potentially take up to 12 months to resolve?

Yes, the letter from Defense Health Agency stated this is a temporary payment suspension, and it could be up to 12 months. But we are given an opportunity to present an appeal within 30 days, which we have a meeting scheduled in the beginning of April. and we'll know more after that meeting.

And yet they have the nerve to demand that we still treat and send supplies to existing patients and keep accepting new patients and treat them 100% like we always have, except they don't send us payment in the meantime. Not very nice, but that's the reality, at least for now.

Does claims made to TRICARE cover specific territories in the country or it's across the country?

They're national. They're across the country.

Yeah. Actually, one of their letters had an interesting statement in it that one of their very valued providers and they really appreciate working with us.

Okay.

Thank you. Obviously, we provide opioid-free pain management to TRICARE patients. It's obviously a pretty big deal for what we do for all those patients.

Great. Thank you for taking my question.

There are no further questions at this time. I'd like to turn the call over to Thomas Sandgaard for closing remarks. Sir, please go ahead.

Yeah, thank you for joining us today. Although disappointing, we're still overall long-term pleased with our performance and where things are headed. And last year, obviously, we ended up with a decent financial result and the consistent growth that our team is delivering. We look forward to leveraging our momentum and the changes we're making to the organization and the direction of our sales force throughout 2025. And we look forward to speaking to you at upcoming investor events. Appreciate your time and interest in Sinex. Have a great day.

This concludes today's conference call. Thank you very much for your participation. You may now disconnect.