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spk06: Good afternoon, ladies and gentlemen, and welcome to the Zynex first 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 Quinn Callanan from MZ North America. Please go ahead.
spk10: Thank you, Operator, and good afternoon, everyone. Earlier today, Zynex released financial results for the first quarter and in March 31st, 2024. A copy of the press release is available on the company's website. Joining me on today's call are Thomas Engard, Chairman, President, and Chief Executive Officer, Dan Moorhead, Chief Financial Officer, Anna Lusak, 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 2023 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 limitations, 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.
spk05: Thank you, Gwyn. And good afternoon, everyone. Thank you for joining us today for the first quarter 2024 earnings call. The first quarter was highlighted by ongoing revenue momentum up 10% from the prior year. and being the eighth straight quarter of record high order numbers. Revenue of approximately $1 million was delayed in the quarter from the impact of Change Healthcare's cyber event that presented a significant disruption to claims flow across the entire healthcare sector. Due to the event, payments from a large group of our payers were delayed, causing our revenue to come in slightly lower than expected. We expect to recognize that revenue over the rest of the year and we are reaffirming the 2024 guidance of at least 227 million. I also want to highlight that we had 2.1 million in positive cash from operations in the first quarter and increase from the prior year. Our team continues to drive revenue higher and deliver significant earnings and free cash flows as we continue to expand our sales force investing in our new products in Cynics monitoring and also combating wage inflation like many others in the industry. Our sales force has continued to expand the market each quarter, enabled by a strong team and with a compelling product portfolio. The first quarter orders increased 23% year-over-year, And we are confident that our sales team, as they continue to scale, that our revenue and earnings will continue to grow. To help drive this order growth, we received clearance from the FDA for our new M-Way, new muscular electrical stimulation device, now in production and shipping to patients. In addition to the impressive results from our profitable pain management division, CMS, or Sinex Monitoring Solutions, continue to move forward in the first quarter with the further development of our blood and fluid monitor and our laser-based pulse oximeter. We're excited to announce FDA clearance last year for our second-generation blood and fluid monitor and non-invasive and wireless technology targeted to improve patient outcomes with better fluid management in hospital settings. We continue to collect additional data in clinical trials and Don Gregg will provide further updates on this product in his prepared remarks. In addition to our blood and fluid monitor, we have three other products in the pipeline in our pre-revenue hospital monitoring products division. A laser-based pulse oximeter called NICO, non-invasive co-oximeter, a monitor for early detection of sepsis, and a non-invasive laser-based monitor of total hemoglobin levels, the HEMOX. During the quarter, we continue to make strong progress for the NICO with several major device components and a verification study being now beginning in the middle of 2024. We now expect to submit an application to the FDA for our laser-based pulse oximeter in the fourth quarter of 2024 due to the timing of the verification study. Overall, we continue to make great progress in the patient monitoring division, which we believe will have game-changing growth potential for the company. Looking ahead, we're making significant progress building on our holistic, non-invasive approach with at-home pain management devices and also diversifying with new products. We're expanding our direct sales force that are delivering accelerating and high recurring revenue as we continue to execute operationally and strategically. In tandem, we are focused on ramping our hospital monitoring division, which represents a large and growing market opportunity. We expect consistent growth and strong financial performance also in 2024, following the double-digit growth that we have produced year over year. We also expect additional catalysts and regulatory milestones during the year as we work to execute on our strong pipeline of new products. We look forward to additional updates in the months to come as we build our sales force and execute on our growth objectives to improve the quality of life of patients suffering from debilitating pain or illness and bringing long-term value for our shareholders. With that, I will now turn the call over to Anna Luxart, our Chief Operating Officer, for a more detailed business update.
spk00: Thank you, Thomas. Zynex's Pay Management Division had another impressive quarter with 20% order growth. Revenue grew 10% year over year but was lower than expected due to the changed healthcare cyber attack causing delays in payments from a large group of payers. The disruption caused by the cyberattack impacted our ability to submit claims and cost suspension and claim payments for several commercial payers. However, we expect to recover the shortfall over the remainder of 2024. As Thomas mentioned, we also received FDA clearance for the M-Wave, our next generation NMES. The M-Wave is set to replace its predecessor, the E-Wave, which has been fundamental in NMES treatments across the U.S. since 1998. The E-Wave has helped thousands of patients with muscle-related issues such as drop foot, quad rehabilitation, shoulder subluxation, and hand rehabilitation. The M-Wave is designed to improve the way patients manage their neuromuscular conditions. With advanced features and a user-friendly design, the M-Wave allows patients to be treated in a clinical or home setting with ease. The compact and lightweight design of the M-Wave ensures portability and easy integration into patients' recovery routines. The user-friendly interface and ease of use when designing a customer electrotherapy regimen will encourage an even broader adoption of our therapeutic products. NMES treatments have several uses, including adding recovery from surgery, managing chronic conditions, and even enhancing exercise performance in healthy individuals. We continue to refine our sales force to maximize productivity and related profitability. At the end of Key 1, we had approximately 450 sales reps as we continue to hold reps to strict targets and exit underperformers. We also continue to thoroughly screen new reps to ensure they meet the criteria, which we believe will make them successful. Having built a strong pipeline to prescribers who see patients in pain and in need of rehab, we are now focused on diversifying our revenue streams with our current line of rehabilitation products, which include low back support, bracing, cervical traction, and the recent additions of the Zynex Pro Hybrid LSO versus a 3-in-1 spinal orthosis and the Zynex Dynacomp Cold Compression that combines cold therapy and compression to accelerate recovery. Our expanded portfolio of rehabilitation products now makes up approximately 25% of all orders, up from 15% a couple years ago. Revenue per rep on an annualized basis in Q1 was approximately $410,000, an increase of 7% over 2023. As our team continues to mature, we expect to drive sales efficiency higher. I look forward to another profitable year for the Pay Management Division in updating you all on our market expansion and future calls. I'll now ask Don Bragg, President of Zynex Monitoring Solutions, to provide updates related to that business division.
spk08: Thank you, Anna. With our monitoring products, we are looking to leverage this management team's past success at building businesses to grow a second line of products with a much larger market opportunity to add comparable profitability. Zynex has the technologies and strategies necessary to make a successful entrance into this new product line, but acquiring FDA clearance is a unique process that many here at Zynex have experienced successfully traversing. The fluid monitoring product by our CM line of monitors is a precursor technology for our sepsis monitoring. Our CM technology is introduced to operating rooms entirely new capabilities that could alter the standard of care and ultimately improve the welfare of patients. Recently we completed important R&D milestones for the new CM 1700 development measuring patient signals and saw significant improvements over previous CM 1500 and 1600 devices. We are planning on upcoming clinical trial to demonstrate the improvements of the new hardware and the first prototype for the CM1700 is currently in design. We continue to consult with experts, key opinion leaders, and thought leaders in the space to refine the capabilities of our non-invasive products and ensure maximum uptake by potential future customers. We expect that building a successful standalone fluid monitoring market will be a longer-term effort than our other new monitoring products, but we believe strongly in the benefits patients will experience and the value proposition provided by the technology. Our non-invasive laser pulse oximetry line, including NICO and Hemox, continues progressing positively. We currently expect to submit NICO to the FDA in the fourth quarter of 2024, depending on a successful verification study now being conducted in the second half of the year due to availability of our university lab partner. Our lab partner is a premier research institution in the area of oximetry. We are honored to be partnered with such a renowned institution and believe the results will help propel NECO toward FDA approval and oximetry improvements for society. As we prepare for NECO's verification study, much of our focus has turned to our manufacturing capabilities. At this time, major components are on track to manufacture and produce NECO systems. We are working diligently to engage experts, key opinion leaders, and professional societies to raise awareness of the science of laser pulse oximetry. We recently finalized our go-to-market strategy in this space along with developing marketing execution strategies. Considering the competitive dynamics in this space, we refrain from detailing our initial go-to-market until closer to product launch. I will now turn the call over to Dan Morehead, Chief Financial Officer, for a more in-depth look at financial performance for the quarter.
spk04: Thanks, Don. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter of 2024. After commenting on our financial results, Thomas will review our guidance for 2024. In the first quarter, orders increased 23% year-over-year to the highest number of orders in company history for the eighth consecutive quarter. Net revenue was $46.5 million compared to $42.2 million in the first quarter of 2023. Device revenue was $14 million compared to $11.9 million in the first quarter of last year. Supplies revenue was $32.5 million up from $30.2 million in the first quarter of last year. Gross profit in the first quarter was $37.2 million or 80% of revenue as compared to $32.9 million or 78% of revenue in 2023. Sales and marketing expenses were $23.4 million in the first quarter of 2024 compared to $21.2 million in the same period in 2023. G&A expenses were $13.3 million in the first quarter of 2024 compared with $11.4 million last year. Net income was $10,000 and produced zero cents per diluted share in the first quarter of 2024 compared to net income of $1.6 million or 4 cents per diluted share in 2023. Adjusted EBITDA for the three months ended March 31st, 2024 was 1.7 million compared to 1 million in the quarter ended March 31st, 2023. We ended first quarter with 32.9 million of cash on the balance sheet and working capital of 56.2 million. Cash flows from operations in the three months ended March 31st, 2024 increased 7% year over year to 2.1 million. In the first quarter, we continued our stock buyback and repurchased 13.4 million of common stock, and over the last 24 months, we've purchased 78.5 million. We continue to balance deploying cash generated between investing in our business and returning cash to shareholders. We believe both offer attractive return profiles. The continuing buyback reflects our belief in our management team, the growth opportunities for both divisions, and that we remain committed to creating shareholder value in the near and long term. With that, I'll turn the call back over to Thomas.
spk05: Thank you, Dan. We've had a strong start to Q2, and with the continued growth in orders and with the delayed revenue recognition we expect in the second quarter of 2024, to see revenue of 52 million, which is approximately 16% greater than the second quarter of 2023, and to see diluted earnings per share of 8 cents per share. As for our 2024 outlook, we expect total revenue to be approximately 227 million, representing a growth of approximately 23% over 2023, and diluted earnings per share of approximately 50 cents a share. We're incredibly proud of the growth that we have consistently demonstrated over the past several years. Top line revenue has produced high levels of profitability and free cash flows, which has allowed us to expand our sales force, launch a new business to diversify our revenue stream, and continue repurchasing our shares in the open market. The business we have created and the profitability we're able to generate allows us a high degree of flexibility to allocate capital in several ways. We have the ability to continue investing in our business and return cash to shareholders simultaneously. We believe both these avenues will produce substantial shareholder value. And with that, operator, please open the call up for questions.
spk06: Thank you. Ladies and gentlemen, we will now begin the question and answer session. Should you have a question, please press star one on your touchtone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, please press star two. If you're using a speakerphone, please lift the handset before pressing any keys. One moment, please, for your first question. Your first question comes from Jeff Cohen of Leidenberg Salmon. Your line is already open.
spk09: Good afternoon, everyone. How are you? Hi, Jeff.
spk05: How are you?
spk09: Just a few questions from our end. So tell me, should you call out $0.50 for the year on that $2.77 revenue? Any assumptions there? On future show approaches, any commentary on April or balance of the year? And is some of that factored in when reaching that?
spk05: Yeah, I mean, obviously, orders grew well in the first quarter. We can see now that orders grown in April compared to April of last year, approximately 25%. So we continue the cadence of order growth. We also see more and more, Anna was mentioning in the first quarter, that our other products in the next wave were up to 25%. It's now sitting at around 27%, 28%. And we continue to grow the orders and the revenue from other products than just the next wave, which all is going to put us in a better position other than the products we're obviously working on creating diversification with the other division. So all in all, we're fine up into the years that we can be fairly confident on the 50 cents a share in terms of the bottom line and continue the revenue growth. Okay, got it.
spk09: Could you talk a little bit about M-Wave being in production. It's being, they're being shipped out, and are their shipments generally going for new users, new prescriptions, or existing users?
spk05: It's all new prescriptions, and in the past, we were, for those indications, we were getting the prescriptions for the E-Wave, which was a 25-year-old product that was still in production. This The M-Wave, which is largely replacing it, it's much easier to use. It also looks more elegant and it looks easy to use. The output performance is still basically making it the most powerful neuromuscular electrical stimulator on the market. So it's directly replacing that. The production is on running. We have good inventory. inventory levels and everything looks just as it was planned on that product.
spk09: Got it. Do you anticipate that M-Wave could become a material portion relative to next wave over the next year or two?
spk05: No, it'll be the same ratio of what What we see physicians prescribe, it'll be just a few percent of our auto-production. That won't change. The next wave is such a versatile product that when it's, say, less complex neuromuscular electrical stimulation needs, it's often something that the physician prescribes rather than going to the very versatile M-Wave.
spk09: Okay, got it. I guess my last question is for you, Thomas or Donald, just talk about the hospital-based products and some timelines. It's sounding like the NECO laser-based pulse ox could be first of the four to be commercial in the marketplace, and would you anticipate then that the blood fluid monitor 1700, after going through some further analysis, would be concurrent to that or follow that perhaps in 25?
spk08: Sure. I think, Jeff, a couple of things on this. One is that NECO is progressing well in its milestones. We've had a university lab partner preparing for our verification. We've had to move some dates with them. Therefore, we're in the back half of the year. So NECA will be the first product that will be commercialized. And I think we've said this in the past, that that's a 2025 revenue story. And there is a product called Hemox, which is a derivative of that, that adds a couple other important parameters that takes pulse oximetry into different care areas and call points due to those specific parameters. It is a follow-on product to NECO. It is similar to a commercialization strategy that the blood and fluid monitor is. We achieved an important milestone last year with getting clearance for the CM1600, and the CM1700 hardware is improved from both the 1500 and 1600. We believe that that'll be a follow on to the NICO commercialization. We're in development of that at this point and then in specific clinical trials as we continue to prove out the fluid responsiveness of the signals in the system.
spk09: So I guess on the hemoglobin hemox could be earlier. as compared to the CM1700 and second in the pipeline, or do you still feel that the blood fluid monitor would be second?
spk08: I just want to give you some guidance, Jeff, that I think they're probably similar. Okay. And we are working diligently on the technology of the NECO platform, which enables both NECO and Hemox. So I don't know if I have a full timing answer there for you, because we have... You know, we have real work to do in R&D on both of those.
spk09: Okay. No, that's certainly clear enough. I just wanted that additional clarification. So I think that does it for us. Thanks for taking the questions.
spk08: Appreciate that.
spk06: Your next question comes from Shagun Singh of RBC. Your line is already open.
spk07: Hey, good afternoon. This is Avi on for Shadoon. Thanks for taking my questions. The first one is on the underperformance because of the cyber attack. You called out it was a $1 million revenue impact or so. Can you break out how much of that was in supplies versus devices? And as a follow-up, is there anything that we should expect in Q2 for an impact?
spk04: The breakout is going to be similar to our normal breakout. So the device supplies, you know, we're running kind of 25 to 30 percent on device and the opposite of that on supply. So, it should be similar to that. And Anna can comment on Q2.
spk01: We're expecting to recover from it throughout 2024. We should start seeing the claims go through and recover throughout Q2 as well.
spk07: Okay, great. One last one for me. Can you update us on the strategic review process? Where are you in the process? If we can expect any news on that front. And you've potentially talked about going private. Where are you on those conversations? Anything you can share would be great.
spk05: Yeah, the conversations are very advanced. We are, as you mentioned, looking at a going private scenario. And we certainly hope that we can bring that to conclusion. There's a lot of moving parts in a large transaction like that. But it's looking very positive. And if we can bring it to completion, I believe the company will have a partner there that can add a lot of value. So I'd say I'm very pleased with how things are progressing there.
spk06: Your next question comes from Yi Chen of HC Wainwright. Your line is already open.
spk02: Hi. Thank you for taking my question. Regarding the cyber incident, do you have any reason to believe that could occur again later this year?
spk03: I don't know that we have information on it.
spk04: Obviously, it happened at a level outside of Zynex. with a very large provider. So I don't know that we have information that could say whether it could recur later this year or not, but we wouldn't expect it to.
spk05: Yeah, I mean, there were thousands of companies like ours that got impacted. And it's more of a clearinghouse. It's where the claims go through and then get distributed to a very large number of insurance companies. And how much... That clearinghouse or other clearinghouses that we're also using have improved their cyber protection. That's hard to say. Hopefully it won't happen again and these guys are more on top of it than the bad guys.
spk02: Got it. Thank you. And with respect to the blood volume monitor, it has obtained FDA clearance for a while. I mean, do you have any plan in the near term to commercialize it? Or if not, is it a better way to generate profit from this product by licensing it out?
spk08: It's a good question, Yichen. Currently, we don't have commercialization plans for the CM-1600 because that was an R&D milestone. There's a lot of strategy in how we do our predicates and get clearance through the FDA. And therefore, we have a development for the next major milestone, which we believe is a commercial product for the CM-1700. And at this point, we aren't entertaining, per se, licensing the technology of the CM-1600 We think it's a potential game changer in the market, and we would like to commercialize that as a Zynex monitoring.
spk02: Okay. And last question. So, it reminds us, how much amount is still left for Shibibank?
spk03: On the current plan, we did $20 million, and we announced that, you know, after the Q4 announcement, which was in March.
spk04: And that was a $20 million plan. We still have about $15 million left on that.
spk03: Okay. Thank you.
spk06: There are no further questions at this time. I would hand over the call to Thomas Sandgaard, Chief Executive Officer. Please go ahead.
spk05: Thank you for joining us today. We are pleased with our performance this quarter and the consistent growth our team is delivering. We look forward to leveraging that momentum throughout the rest of the year and speaking to you at upcoming investor events. We appreciate your time and interest in SionX. Have a great day.
spk06: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.
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