Zynex, Inc. Price & Performance (ZYXI)

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. Good afternoon, everyone.

Thank you for joining us today for the fourth quarter and full year twenty twenty four earnings call. 2024 was a successful year for Zynex 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 private label products primarily in the areas of bracing, cold and compression products, all a perfect fit for our sales forces CallPoints. In pain and rehab. We've also expanded the focus of our sales force to additional new prescribers 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 and the FDA submission of our Pulse Oximeter. In late twenty twenty four, 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 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 would like to go and Greg provide more details on the status momentarily. We were recently notified by TRICARE that they were temporarily suspending payments to Zynex 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 to her during her discussion of operations. Given that TRICARE is a substantial source of reimbursement revenue, we currently have limited visibility in our revenue projection for 2025.

And we have taken the most conservative approach to not include revenue in the later part of 2024 where some of those builds 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, we 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. [indiscernible] 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, collaboration, 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 we believe it can actually better capture the $800,000,000 of identified sales opportunities within our 800 designated sales territories. In the patient monitoring business, we have just before FDA submission and once cleared, that should generate revenue in a very well established multibillion dollar sales segment.

Over the past twenty nine years since 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 products that so far have collected less than expected, however, we see clear signs of improvement here in early twenty twenty five.

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 Tycare. 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 will 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 mask trap than our competitors in the pulsaroximidar market. I'll now turn the call over to Analoxo to provide a more detailed update on the operations and the status with TRICARE.

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 twelve months to complete. TRICARE represents between 20% of our revenues. So this is a significant reduction in revenue if this is 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 and have a good cost for eventually continued business as usual with TRICARE. During this temporary suspension, we remain in network with TRICARE and are expecting 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 for 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 affect employees in our corporate office along with other expense reductions made during the second half of twenty twenty four and Q1 twenty twenty five will result in annual savings of approximately $35,000,000 This is a normal and good business practice that all companies constantly undergo. In 2024, TRIM to sales force to ensure we have the right reps in place to put us in the best position moving forward. As of December 31, we had a sales force of of approximately three thirty people as compared to the beginning of twenty twenty four where we had approximately four seventy five 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 Grad, 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 NNEPCO Pulse Oximeter. [indiscernible] [indiscernible] Although our FDA submission has been delayed into twenty twenty twenty five, we are closing on major milestones to commercialize the Neopold Oximeter. NICO verification human trials completed in in fourth quarter of twenty twenty four at Duke University with positive results as planned. Zynex Niko 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 mis measure 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 twenty twenty four in the fourth quarter. Four nickel pulse oximeters in 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 five ten submission. In late twenty twenty four and into 2025, NICOS 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 thirty to sixty days following that completion.

Based on historical submissions, approval takes approximately six months, which would mean a potential fourth quarter twenty twenty five clearance barring any uncertainty of FDA review resources.

Also in December of twenty twenty four, we announced our membership in the open oximetry project non profit oximetry partnership of research organizations and industries created to improve the safety and precision of pulse oximeters in all populations. Zynex is pushing to be a key industry partner to all clinicians and show how the NicoPulse 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 twenty twenty four on nickel commercial development clinical verification and we are very close to FDA five ten submission. Patient monitoring is a multibillion 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 Moorhead, 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 12/31/2024.

Net revenue was $46,000,000 compared to $47,300,000 in the fourth quarter of twenty twenty three. [indiscernible] Device revenue was $14,800,000 compared to $16,300,000 in the fourth quarter of last year.

Supplies revenue was 31,200,000.0 up from $31,000,000 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 have lower price points than Zynex Wave devices. Gross profit in the fourth quarter was $36,000,000 or 78% of revenue, compared to $37,000,000 dollars also 78% of revenue in 2023.

Sales and marketing expenses were $19,300,000 in the fourth quarter of twenty twenty four, compared to $21,700,000 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 teams sales team members. G and A expenses were $17,300,000 in the fourth quarter twenty twenty four compared to $13,000,000 last year largely due to ZMS increased expense Net loss was $615,000.02 per share in the fourth quarter of twenty twenty four, compared to net income of $1,200,000 or $0.04 per share in Q4 of twenty twenty three. Adjusted EBITDA for the three months ended 12/31/2024, was $584,000 as compared to $9,900,000 in the quarter ended 12/31/2023. Cash flows from operations were $2,400,000 in Q4 and $12,700,000 for the full year. The cash flow in the quarter and year increased our cash on the balance sheet to $39,600,000 up 5% from Q3's balance of $37,600,000 Working capital was $58,300,000 as of December 31.

With that, I'll now turn the call back over to Thomas.

Yes. Thank you, Dan. The beginning of twenty twenty five was certainly not as smooth as we had hoped. 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 for TRICARE, we will not be providing full 2025 annual guidance yet. Given the lack of visibility surrounding the temporary payments suspension. We are obviously still in network with TRICARE. And continue to accept new prescriptions per their 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 $30,000,000 We will likely have a net loss in the first quarter ranging between $9,000,000 and $10,000,000 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 $800,000,000 plus the pain management division. Our diversification into the patient monitoring area is set to start adding revenue later this year and next year pending FDA clearance. We're incredibly proud of the growth that we consistently demonstrated over the past several years. Just ten years ago, our revenues were nearly 20 times lower than now. And in the meantime, we've been able to buy back over $80,000,000 worth of stock in the open market And we had a cash balance of €40,000,000 at the end of 2024. Well, ten years ago, we were scraping the bottom for 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.

First question comes from the line of Jeffrey Cohen from Ladenburg. Please go Hi, thanks for taking our questions.

Just a couple from our end. So, when you talk about the stock reductions of 15 ish percent, 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 your two OpEx lines, both the sales line and the G and A line? [indiscernible] I would say the we probably did if you're looking at $30.30 plus million dollars 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 things. So they were 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 as if you're looking at sales expenses and those types of things, As far as run rate, Q4 sales, we just posted $19,300,000 I think it's 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 $1,500,000 to $2,000,000 on the run going forward. And then G and A, you're going to see about the same thing, down a couple of million dollars a quarter based on what we did in Q3 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 Yes. So I guess the N30 on an annual basis does it hit both the sales and marketing as well as the G and 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 and A because the G and A is smaller number too. So it's going to be a bigger number out of this smaller number. Sales was already decreasing based on 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 like I said, run rate, you're looking at close to $2,000,000 compared to what we did in Q4.

Got it. Okay. And then secondly, maybe for Thomas or for Don, could you hypothesize with us a little bit about NIACOX 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.

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 and our executive leaders.

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

Your next question comes from the line of Shagun Sef from RBC. Your line is now open. Hey, good afternoon. This is Avian for Shagun. I have a few questions. First, what was the nature of the 2022 audit by TRICARE related to billing practice? Practices. And I guess why didn't you have any visibility TRICARE ahead of time before this happened? [indiscernible] 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.

Could you I guess that's helpful. Why don't you just have 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 are if TRICARE end up never paying us anything or if [indiscernible] don't start picking up payments until the end of the year.

We're pretty confident that at some point throughout the year, they will we'll eventually get through this conversation with them and basically prove that, hey, we did everything you asked for, what you your problem? It's been very unclear exactly what it is. They're looking for. So and because TRICARE is such a big part of our revenue, we obviously the difference in the guidance we will give is many tens of millions of if not more than $50,000,000 right. So So therefore, we'd like to have a little more clarity into our dialogue with TRICARE before we get to revenue guidance. What we are doing is to make sure in a worst case scenario, let's 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 [indiscernible] you know, whatever to help help them figure it out, whatever it is that they exactly need from you.

Yes. They gave us some vague guidance on what they're looking for. It's still very unclear whether exactly their problem is. But we have lots of data to present to them on 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 that audit that will be highlighting in that presentation. So that's mainly going to be our focus.

Thank you.

Your last question comes from the line of Yi Chen from H. C. 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 it happens with other payers as well.

So are you worried that the 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 every all the time And these things happen with small insurance companies, large insurance carriers. TRICARE is a big one. Obviously, therefore, we are taking this very conservative approach, but there's these guys all operate very independently. There's really no no connection. And this is a government payer This is not in the private sector. So there's that's already there. [indiscernible] And just trying to clarify, did you mention that this kind of process could potentially take up to twelve months to resolve? The letter say? Yes. The letter from Defense Health Agency stated this is a temporary payment suspension and it could be up to twelve months But we are given an opportunity to present an appeal within thirty days, which we have a meeting scheduled in the 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 don't send us payment in the meantime. That's the reality for at least for now. [indiscernible] 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.

Actually one of their letters [indiscernible] [indiscernible] were 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. 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.

Yes. 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 are 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 Zynex and have a great day.

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