Semler Scientific Inc
NASDAQ:SMLR
Earnings Call Analysis
Q4-2023 Analysis
Semler Scientific Inc
The company is working to obtain FDA clearance to broaden the labeling for its flagship product, QuantaFlo. This effort is expected to extend QuantaFlo's application to aiding in the diagnosis of a range of cardiovascular diseases, with the goal of acquiring the expanded label in the second half of 2024.
Strategic sales and marketing objectives set forth include establishing QuantaFlo as the standard care for PAD due to its clinical benefits in early diagnosis and preventative treatment. Furthermore, the company aims to diversify its customer base by integrating medical centers, more value-based care providers, deeper penetration into the VA system, and expansion into the self-insured employer, pharmaceutical, and retail markets.
The company took a $2.5 million write-off in cost of revenues related to the Insulin Insights investment which influenced the comparison between Q3 and Q4 financials. Despite this one-time event, there was a successful reduction of expenses, and more clear future financial results are expected now that these one-time expenses have been accounted for.
The fixed license fee revenue remained relatively flat for the quarter, reflecting some customer cleanup. Market demand has seen a mixed response from customers, particularly in light of changes to the CMS risk methodology. However, the company is not providing guidance for 2024 but plans to continue expanding the market beyond Medicare Advantage-dependent customers and remain adaptable to market conditions.
There has been progress toward achieving clarity with the FDA on the conditions QuantaFlo can test for, with a general classification as being for cardiovascular diseases. Details on the specific conditions cleared for will likely be available following the anticipated 510(k) clearance in the latter half of 2024.
The company reiterates its commitment to providing clinical benefits through early diagnosis of chronic cardiovascular conditions. By doing so, it plays an essential role in the healthcare ecosystem for patients, physicians, facilities, and payors. Looking ahead, the focus is on preserving and enhancing revenue opportunities and profitability, specifically within the cardiovascular disease domain.
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Good afternoon, and welcome to the Semler Scientific's 2023 Fourth Quarter Financial Results Conference Call. [Operator Instructions] 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 of marketing and additional products, including receipt and timing of an additional 510(k) clearance for QuantaFlo 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, semlerscientific.com. I would now like to turn the conference over to Douglas Murphy-Chutorian, CEO of Semler scientific. Please go ahead.
Good afternoon, everyone. Thank you for joining us for our fourth quarter and full year 2023 results call. Year-over-year, we continue to achieve annual revenue and earnings growth. Now I'm free to introduce our CFO, Renae Cormier, who will provide you with further details. Renae?
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 fourth quarter 2023 financial results and discussing recent corporate development. Jennifer Oliva-Harrington, who leads our marketing, sales and related operations, 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. I'm excited to announce continued growth in revenues and earnings in the fourth quarter 2023. This achievement is a testament to the hard work of our team as well as the ongoing support of our customers, who continue to recognize the clinical benefit and value of our technology. Now for the details of our fourth quarter results. Total revenues in Q4 2023 were $15.1 million, an increase of 9% compared to the fourth quarter of 2022. Our revenues continued to be driven by continued sales of QuantaFlo through existing and new customers to test for peripheral arterial disease or PAD. We believe the promising results that were published in two large independently conducted peer-reviewed study by QuantaFlo customers in 2022 are having an impact. These studies underscore the importance of identifying asymptomatic PAD patients, enabling the implementation of preventative measures. Fixed fee revenues were $8.8 million, a decrease of 2% year-over-year. We saw end of 2023 cleanup of underutilized units by some customers, resulting in a decline. We see continued interest in our products from the existing customers as well as new customers, such as hospitals, value-based care providers and major pharmaceutical and retailer markets. Variable fee revenues were $5.8 million, an increase of 28% year-over-year. We continue to see strong demand from our home risk assessment customers using QuantaFlo for PAD during in-home examination. Equipment and other revenue were $0.5 million, an increase of 71% year-over-year. Equipment revenues remained strong versus historical levels because the majority of equipment sales are to variable fee customers, we believe it is a sign of future potential growth in the fee per test market. In the fourth quarter 2023, our 3 largest customers, including their related affiliates, comprised of 37%, 32% and 11% of quarterly revenue. Operating expenses in Q4 2023, which includes cost of revenue, were $12.5 million, an increase of 23% year-over-year. Our Q4 2023 results included $2.5 million write-off in cost of revenues in the Insulin Insights prepaid licenses and also a $0.6 million impairment of Mellitus investments and other income. While we've continued to market Insulin Insights because we believe in its clinical benefit for diabetic patients, our marketing efforts over the past 3 years have not yielded significant results to date. As a percentage of revenue, operating expenses increased to 83% compared to 74% in 2022 due primarily to the write-offs. Pretax income was $2.8 million compared to $4 million in the prior year. Net income was $4.2 million or $0.62 per basic share and $0.55 per fully diluted share compared to $3.2 million or $0.48 per basic share and $0.41 per fully diluted share in 2022. We had cash, cash equivalents and short-term investments at December 31, 2023, of $57.3 million. Now I'd like to turn the call over to Jennifer to provide a more in-depth discussion of our market development and opportunities. Jen, are you still there?
Sorry. Thank you, Renae. As I look into the future, I'm excited about Semler's potential to support the identification of chronic diseases by our customers, which is a large burden on our health care system. Cardiovascular disease is the #1 cost to the health care system as well as the #1 cause of death worldwide, which makes early detection of chronic cardiac conditions so critical. In January, we announced we are seeking a new 510(k) clearance from the FDA to broaden the labeling for QuantaFlo, extending its application to include aiding in the diagnosis of other cardiovascular diseases. We aim to receive clearance with this expanded label in the second half of 2024. Upon achieving this milestone, our focus will shift towards effectively upselling our existing customer base with this enhanced offering. In the interim, we remain dedicated to the promotion and sales of QuantaFlo as a valuable aid in the diagnosis of PAD. Its proactive approach ensures that we continue providing our customers with a trusted solution while positioning ourselves for future success in the broader cardiovascular diagnostic market. By supporting early diagnosis of peripheral arterial disease, we are hopeful that health care providers will initiate preventative management of chronic cardiovascular disease. We believe that this proactive approach may save lives and also lower health care expenditures. As we set our sights on the future, we envision the health care landscape where our technology plays a pivotal role in shaping healthier outcomes for patients, while delivering substantial economic benefits to our customers. Our sales and marketing goals are to further establish QuantaFlo for PAD as a standard of care given the proven clinical benefits of early diagnosis and preventative treatment, and to diversify our customer base by adding medical centers, additional value-based care providers, penetrating deeper into the VA system, and growing the self-insured employer, pharmaceutical and retail markets. And now Renae will give our concluding remarks. Renae?
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 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, sustain 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 and equities 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 offering. We extend our gratitude for your interest in our company and appreciate 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.
[Operator Instructions] Our first question comes from Brooks O'Neil with Lake Street Capital Markets.
I appreciate all the prepared remarks. I guess I'll start off by just asking, it looks to me like the $2.5 million write-off of the Insulin Insights investment may have obscured to some extent, the benefit of the 30% expense reductions you were targeting for the company. Can you just give us a quick update on whether you were successful in taking the 30% expenses out of your expense base this year?
Sure. So you're right, it does obscure the numbers there. And the $2.5 million write-off is in cost of revenues. And there are -- some noise between Q3 and Q4 between when we had some expenses or reversals and the Q4 expenses. So we were able to take out these expenses, and you should see that more clearly going forward as we won't have these onetime items.
Okay. Good. And then just thinking about the business and the report, the fixed license fee is pretty flat this quarter. Would you say, as I think you mentioned in your prepared remarks, some cleanup from customers, but how would you evaluate the demand environment for the fixed fee side of the business, obviously, in light of the changes to the CMS risk methodology?
Sure. So we are in constant contact with our customers. And we've had reaction from customers that has been mixed. So as you saw, we aren't giving guidance for 2024. But we do believe that the motivation to do testing is still there, although less for some customers as the phasing in with that CMS decision that you referred to. So we do continue to expand our market with customers that are not dependent on Medicare Advantage. And going into 2024, we will remain nimble and adjust according to market conditions.
So I mean just trying to follow up on this a little bit, Renae. You would say right this minute, you're not seeing much in the way of new interest from MA plan sponsors and there could be some softening of demand from existing customers in that arena. Is that a fair way to characterize it?
I don't know that I would go into that specific a detail. But when we're looking at expanding our market, we are looking to expand outside the Medicare Advantage space. So in the other spaces that we've talked about before, like the hospital systems, retail pharmaceutical markets and then also delegated medical groups.
Okay. And would you say -- I'm just trying to think this through quickly on the fly. I've always had a sense one of the appeals of the MA market is that you didn't need to get any kind of a specific reimbursement decision from the payors to reimburse doctors for providing the test. Do you see in the future a need or opportunity to pursue, what I might call, a more traditional route to revenue generation reimbursement for your service, your debt?
Right. So not at this time in some of these markets that we're going after are more in the value-based care side. And so looking at the perspective of identifying these patients early to preventative measures in place ahead of time of major events that can be very costly.
Sure. That makes all the sense in the world. Okay. Let me switch gears for a second and just obviously, you commented about the 510(k) submission for heart dysfunction. One of the things that I think I recall from your press release is talking about the decision to submit a new 510(k) is the -- is sort of the opportunity to be more clear about the conditions that QuantaFlo can test for. Have you been able to achieve any clarity either in your own minds or in conversation with the FDA about the kinds of tests, cardiovascular tests that QuantaFlo might work for?
We have. And so what we talk about at this time is we're just broadly classifying it as cardiovascular diseases. And as we progress into the second half, we hope to have this 510 clearance at that time, and then we will be able to talk in more detail about what it's specifically cleared for.
Okay. That makes sense to me. And maybe I'll just ask you one broad one. I'm just curious. I know you're in a unique position as you interact with the MA plan sponsors out there. And frankly, as you mentioned, the value-based care providers. How would you say people are evaluating the changes the government has put in place for the risk model for MA reimbursement? Is it changing people's behavior in substantial way? Or are the changes more tweaks to the basic methodology? How do you read it right now?
Sure. So it's hard to classify it as one particular thing because we are getting different reactions from different customers. And as you saw in 2023, we did have record revenues for the year. So as the year progressed, we still continue to see testing from our customers, both the existing customers and new customers. So as we work through 2024, again, we're going to adjust according to market conditions. But there aren't really clear reactions from customers as they have been mixed.
This concludes our question-and-answer session. I would like to turn the conference back over to Renae Cormier for any closing remarks.
Thank you, Dave. 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 payors in an evolving health care landscape. Moving forward, our primary objective remains set back 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. Goodbye.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.