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spk03: Good afternoon and welcome to the Semler Scientific 2024 First Quarter Financial Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then 2. Please note this event is being recorded. Before we begin, Semler Scientific needs to remind you that certain comments made during this call may constitute forward-looking statements and are made pursuant to and within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995 as amended. These include statements regarding the expectations for expansion of the business and the development and marketing of additional products, including receipt and time of an additional 501K clearance for quanta flow and investment in emerging growth opportunities. Such forward-looking statements are subject to both known and unknown risks and uncertainties that could cause actual results to differ materially from such statements. Those risks and uncertainties are described in the press release and our SEC filings. The forward-looking statements made today are as of the date of this call, and the company does not undertake any obligation to update the forward-looking statements. If you do not have a copy of today's release, you may obtain one by visiting the investor relations page of the website, SemlarScientific.com. Now I would like to introduce Doug Murphy, Tutorium, CEO of Semlar Scientific. Please go ahead.
spk00: Good afternoon, everybody. Thank you for joining us on our first quarter 2024 results call. We achieved year-over-year earnings growth and ended the quarter with our highest cash protrusion in the history of our company. Now, I'm pleased to introduce our CFO, Renee Cormier, to provide further details. Renee?
spk04: Thank you, Doug. Good afternoon, everyone, and thank you for being part of today's conference call. Today, I'll be presenting an overview of our first quarter 2024 financial results and discussing recent corporate development. Jennifer Oliva Harrington, our COO, will be providing information about our market developments and opportunities. Following our remarks, Doug, Jennifer, and I will be available to address any questions you may have. As mentioned in today's earnings release, we had a very strong quarter of cash generation despite the regulatory-driven year-over-year revenue decline from our PAD product. Even with the decline in year-over-year quarterly revenues, we achieved year-over-year earnings growth in the first quarter 2024 compared to the first quarter of 2023. This achievement is a testament to the hard work of our team. who adjusted spending accordingly to changes in market conditions. We expect that our revenues will reaccelerate if we are successful in our efforts to obtain a new 510K clearance from the FDA that would allow us to market our heart dysfunction product. Now for the details of our first quarter results. Total revenues in Q1 2024 were $15.9 million. a decrease of 13% compared to the first quarter of 2023. Our revenues are driven by continued sales of Quantiflow to existing and new customers to test for peripheral arterial disease, or PAD. Fixed fee revenues were $7.1 million, a decrease of 24% year over year. Variable fee revenues were $8 million, a decrease of 6% year over year. Equipment and other revenues were $0.8 million, an increase of 140% year-over-year. Equipment revenues are primarily sales to variable fee customers, and they remain strong versus historical levels. In March 2023, the Centers for Medicare and Medicaid Services, or CMS, announced the three-year phase-in of the removal of the HPC code relating to PAD without complications from the Medicare Advantage risk adjustment model. 2024 marks the first year of the three-year phase-in of the decreased economics to our managed care customers. For the remainder of 2024, we anticipate our revenues could follow a similar cadence that we saw in 2023, with H1 more heavily weighted versus H2. We are encouraged by the continued testing for PAD given the importance of early diagnosis and treatment that can lead to improved long-term clinical outcomes for patients. In the first quarter of 2024, our three largest customers, including their related affiliates, comprised 45%, 25%, and 11% of quarterly revenue. Operating expenses in Q1 2024, which includes cost of revenue, were $8.9 million. a decrease of 25% year over year. As a percentage of revenues, operating expenses decreased to 56% compared to 66% in 2023 due to continued expense control after our strategic corporate streamlining announced in July last year. We have an outstanding group of leaders and employees here at Simler that remain diligent in ensuring we're focused on cost disciplines without sacrificing the high service our customers have come to expect. We anticipate we could experience a slight uptick in expenses throughout the year as we prepare for the next phase of launching QuantaFlow with expanded use as an aid in the diagnosis of other cardiovascular diseases that is subject to FDA clearance, which we hope to achieve in the second half of 2024. Pre-tax net income was $7.8 million compared to $6.6 million in the prior year. Net income was $6.1 million or 88 cents per basic share and 78 cents per fully diluted share compared to $5 million or 74 cents per basic share and 63 cents per fully diluted share in Q1 2023. We had a record high cash balance at March 31st, 2024 of $62.9 million. Now I'd like to turn the call over to Jennifer to provide a more in-depth discussion of our market developments and opportunities.
spk02: Thank you, Renee. Looking ahead, I'm enthusiastic about Semler's potential to support the identification of chronic diseases by our customers, which continues to burden our healthcare system. Cardiovascular disease ranks as a top concern in healthcare expenditures and global mortality, underscoring the imperative need for early identification of cardiac conditions. Our recent announcement in January marked our intent to pursue an additional 510 clearance from the FDA for Quantiflow, seeking to broaden its utility to encompass a wider array of cardiovascular diseases. We anticipate we may receive clearance with the expanded label in the second half of 2024. Upon achieving this regulatory milestone, our strategic focus will expand to effectively showcase this enhanced offering to our existing customer base. In the interim, our commitment remains dedicated to the promotion and selling of Quantiflow as a valuable aid in the diagnosis of PAD. This proactive approach ensures continuity, providing our customers with a trusted solution while positioning us for potential future success in the broader cardiovascular diagnostic market. Through enabling early detection of peripheral arterial disease, we are hopeful that healthcare providers will continue to initiate preventative management programs in chronic cardiovascular disease. We believe that this approach holds the potential to not only save lives, but also lower healthcare expenditures. We continue to envision a healthcare landscape where our technology assumes a central role in delivering healthier outcomes for patients, while concurrently delivering substantial economic value to our customers. Our sales and marketing goals remain focused on further establishing Quantiflo as the standard of care for PAD diagnosis, leveraging the demonstrated clinical benefits of early detection and preventative care, and to continue diversifying our customer base by adding new medical centers, expanding our reach within value-based care providers, fortifying our presence in the VA system, and growing opportunities within additional markets that will benefit from PAD testing. And now Renee will conclude with remarks.
spk04: To achieve this plan, we are reinvesting in emerging growth opportunities with a focus on expanding our customer base for PAD. We believe that these opportunities may hold promise and represent an exciting aspect of our company's future. Additionally, our commitment to research and development remains unwavering, as we prioritize the enhancement of existing products and data services to stay in the forefront of innovation and consistently deliver cutting edge solutions to our customers. Our long-term vision includes extending our reach to encompass additional cardiovascular applications, reflecting our dedication to continuous expansion. A key strength of our technology lies in its portability and accessibility. allowing us to actively contribute to addressing health inequities prevalent in cardiovascular disease. By providing tools that can be utilized in diverse settings, we play a role in breaking down barriers, ensuring that more individuals have access to early detection and intervention. As part of our growth strategy, we are exploring inorganic growth initiatives to further diversify our product portfolio. Through strategic partnerships and exploring new opportunities, We aim to broaden our impact on the market and expand our offerings. We extend our appreciation for your interest in our company and for your continued support as we embark on this journey of innovation. Now, operator, if you could please open the line, Doug, Jen, and I will be happy to address your questions.
spk03: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble the roster. And our first question comes from Brooks O'Neill of Lake Street Capital Markets. Please go ahead.
spk01: Hi, good afternoon, guys. This is Aaron on the line for Brooks. Thanks for taking our questions. I'm interested in the timing and sort of the process to receive the 510 clearance. Obviously, you guys mentioned the second half of this year, but assuming approval, what are sort of the next steps taken after that process?
spk04: Sure. Hi, Aaron. Thanks for the question. And so as we had released earlier in the year in January, we did announce our intention to file for the 510 clearance. At this point, it's kind of out of our hands on timing. So it's up to the FDA and their approval process. As we said, we do anticipate that we will receive approval in the second half of this year. And once we do that, we can start marketing it to our customers. We can't market it before then. And we do anticipate that it will take time for the product to gain traction and that we don't anticipate significant revenues in 2024. We will start to market this to our existing customers. They've already are familiar with our product. It's the same unit. It's just a software push and upgrade to the unit. And our customers have worked with us, you know, for many years and they're familiar with us.
spk01: Okay, that makes sense. And then do you have any additional color regarding, you know, what specific conditions that Quantifold might identify, you know, in reference to the 510 clearance? Or is it still a little bit too early to speak on that?
spk04: And so it will be surrounding heart dysfunction. A specific wording will come out once we get the actual clearance.
spk01: Okay. Gotcha. Understood. And then, Renee, how would you classify the current demand environment? And I guess as just sort of a follow-up to that, have you lost customers or, I mean, expect to lose a significant amount of customers in relation to the PAD product?
spk04: I would say that we still do have demand for our products. So the reaction from our customers has been somewhat mixed. So with 2023 being the first year of the phase-in, or sorry, with 2024 being the first year of the phase-in of the new CMS rate announcement, the economics have changed to some of our managed care customers. So the extra reimbursement is being reduced. not only for the asymptomatic PAD, but this reimbursement was cut in 2024 by about 33%. And while our revenues are not directly linked to the CMS payments to our customers, some of the largest customers were offered additional volume pricing tiers. So we are seeing continued testing, but we also did see some cleanup of underutilized units. We are still getting new customers, and the clinical value of testing remains the same. And we think it's unfortunate that CMS did not recognize this, that the clinical benefit of early detection by putting preventative measures really supports better outcomes.
spk01: Okay, understood. Appreciate all that color. And then, you know, obviously you guys have developed and maintained a healthy balance sheet, you know, with the record cash balance this quarter. You might have mentioned this a little bit in your prepared remarks, but have you had any conversations on any inorganic opportunities? I'd just love to get some more thoughts on potential uses of cash as we move forward throughout the year here. Thanks for taking the questions.
spk04: Sure. Really, when we're looking at our cash, there's three areas that we're looking at. First and foremost is reinvesting back into our product. An example of this is the you know, heart dysfunction, 510K clearance that we're going after. The second, as you mentioned, is in organic growth activities. We do have a robust pipeline, but as you know, these things take time. So we are going to be very diligent in what we're doing and what we're looking at. Our board has a lot of experience in capital allocation and they are closely aligned with management and shareholders in trying to make sure that we carefully approach any acquisition that we may have. And then the third piece with our cash could potentially be share buybacks. So we do have a $20 million share buyback that's authorized by the board. We have bought back $5 million already, so we do have $15 million authorized in share repurchases. So that's something else that the board will access looking at with capital allocation and, you know, depending on the market circumstances.
spk01: Okay, understood. Super helpful. And then just a quick one for modeling purposes. I think that I caught this correctly, but you mentioned in terms of revenue cadence, it should follow a sort of similar cadence to 2023. Did I catch that correctly?
spk04: Yes, we think it'll follow a similar cadence where H1 will be more heavily weighted than H2.
spk01: Gotcha. Okay, I'm very helpful. Thanks for taking the questions again.
spk04: Sure, thank you.
spk03: This concludes our question and answer session. I'd like to turn the call back over to Renee Cormier for any closing remarks.
spk04: Thank you. As we wrap up this conference call, we want to emphasize our ongoing commitment to delivering clinical benefits through earlier diagnosis of chronic cardiovascular conditions. The continued recognition of the value of this approach by our customers underscores the crucial role our technology plays for patients, physicians, facilities, and payers in an evolving healthcare landscape. Moving forward, our primary objective remains to preserve and strengthen our current revenue opportunities and profitability within the chronic disease space with a focus on cardiovascular diseases. We appreciate your participation in today's discussion and thank you for your ongoing support.
spk03: The conference is now concluded. Thank you for attending today's presentation and you may now disconnect.
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