Semler Scientific, Inc. (NASDAQ:SMLR) Q4 2022 Earnings Call Transcript

Semler Scientific, Inc. (NASDAQ:SMLR) Q4 2022 Earnings Call Transcript March 21, 2023

Operator: Good afternoon, and welcome to the Semler Scientific 2022 Fourth Quarter and Full Year Financial Results Conference Call. All participants will be in listen-only mode . 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, 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 as well as the impact of the CMS advance notice. Such forward-looking statements are subject to those 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. Now I would like to introduce Doug Murphy-Chutorian, CEO of Semler Scientific.

Douglas Murphy-Chutorian: Good afternoon, everyone, and thank you for joining us for our fourth quarter 2022 and our full year results call. Today, we announced that I have informed the Board that I will be stepping down as CEO and we will be assisting to a transition period. I will continue to serve as a member of the Board at least into the remainder of my 2024 term. And I’m pleased to announce that Dr. Wayne Pan will succeed me as CEO effective April 3, 2023. Wayne has served as a member of the Board since May of 2014, has a broad health care experience and confident that he will lead and be able to lead the company into the next phase of growth and continue to make a difference every day for our customers and the patients we serve.

It has been an honor to lead the team, and I’m proud of the business that we built together. Our first quarter 2023 guidance in terms of revenue represents the highest quarterly revenue that Semler has achieved in its history. So without further ado, I want to introduce you to Dr. Pan. Wayne?

Wayne Pan: Thank you, Doug. On behalf of the Board, I’d like to thank Doug for his commitment and notable contributions to Semler over the past 12 years. He’s been instrumental in the evolution of the company, and I look forward to continuing to work with him as a member of our Board. And I’m very grateful for the opportunity to serve as CEO of Semler Scientific and lead the company into its next phase of growth. I believe Semler has diagnostic tools that will unlock a new paradigm in cardiovascular care as well as create value for our stockholders. Our products will increase access, promote health equity and enable earlier diagnosis of progressive diseases that affect millions of people globally. Semler will be presenting and hosting one-on-one meetings at the Needham Virtual Healthcare Conference on April 18, 2023. I look forward to laying out my vision and meeting with the investor community. I will now hand the call over to Renae.

Renae Cormier: Thank you, Wayne. I look forward to working with you. Good afternoon, and thank you for joining us today. In addition to Doug and Wayne, with me are Andy Weinstein, SVP, Finance and Accounting; and Dennis Rosenberg, Chief Marketing Officer. Doug, Wayne, Andy, Dennis and I will be available for Q&A following today’s prepared remarks. On this call, we will summarize the fourth quarter and fiscal year-end 2022 financial results, discuss the factors at play in our market, talk about the 2024 CMS advance notice, outline Q1 2023 guidance, provide details about the QuantaFlo product extension and speak about other investment activities at Semler. Now I will turn it over to Andy to describe our financial performance for the fourth quarter and full year 2022. Andy?

Andrew Weinstein: Thanks, Renae. Please refer to the financial results described in the press release that was distributed at market close today. We reported record high annual revenue in 2022, but our revenue growth slowed for the year compared to 2021. We are pleased to see the revenue growth accelerated in the fourth quarter of 2022 at both our fixed fee and variable fee customers compared to the fourth quarter of 2021. For the fourth quarter ended December 31, 2022, revenue was $13.8 million, which represents an increase 20% compared to the corresponding quarter in 2021. For the full year ended December 31, 2022, revenue was $56.7 million, an increase of 7% compared to the full year of 2021. In Q4, fixed fee revenues were $9 million, an increase of 14% period-over-period.

For the full year, fixed fee revenues were $34 million, an increase of 11% year-over-year. We continue to grow revenues at our largest customer as well as at other existing and new fixed fee customers. We saw increased interest in our products from hospitals, retail locations and delegated medical groups, which we believe is due, at least in part, to gaining traction from the two major studies published in 2022. In Q4, variable fee revenues were $4.5 million, an increase of 30% period-over-period. For the full year, variable fee revenues were $21.3 million, a decrease of 1% year-over-year. In Q4, equipment and other revenues were $300,000, which was an increase of 96% period-over-period. For the full year, equipment and other revenues were $1.4 million, which was an increase of 42% year-over-year.

Because the majority of equipment sales are to variable fee customers, we believe it is a harbinger of strength in the fee per test market. In the fourth quarter of 2022, our two largest customers, including their related affiliates, comprised 43.3% and 25.8% of quarterly revenues. For the full year 2022, our two largest customers comprised 40.4% and 29% of annual revenues. In Q4, operating expenses, which includes cost of revenue, were $10.2 million, an increase of 4% period-over-period. For the full year, operating expenses were $39.5 million, an increase of 18% year-over-year. Operating expenses increased for the full year primarily due to increased headcount in line with our business expansion plans, wage inflation and increased insurance and professional fees.

In Q4, pretax net income was $4 million, an increase of $2.3 million or 132% period-over-period. For the full year, pretax net income was $17.7 million, a decrease of $1.8 million or 9% year-over-year. In Q4, net income represents $3.2 million or $0.48 per basic share and $0.41 per fully diluted share, an increase of 113% period-over-period. For the full year, net income was $14.3 million or $2.13 per basic share and $1.79 per diluted share, a decrease of 17% year-over-year. Weighted average basic share count was 6.7 million for Q4 and the full year of 2022. And weighted average diluted share count was 7.9 million for Q4 and 8 million for the full year of 2022. There were no shares repurchased in the quarter. During the fiscal year 2022, we repurchased $5 million worth of shares or 149,000 shares.

We had $15 million remaining under the Board authorized stock repurchase program. We had cash, cash equivalents and short-term investments at December 31, 2022, of $43.1 million, approximately $30.5 million of which is held in short-term U.S. treasury bills at December 31, 2022. We have banking relationships with First Republic Bank and Edward Jones and are taking steps to diversify further. As of December 31, 2022, headcount was 127 employees, and this compares to 124 at the end of the third quarter of 2022. We expect to file our annual report on Form 10-K on or around March 23, 2023. Now I will ask Dennis to provide more color about factors at play in our market and our business activities. Dennis?

Dennis Rosenberg: Thanks, Andy. I first want to reiterate our continuing strong belief in the clinical benefit and importance of the early diagnosis of chronic diseases as a standard of care. As you know, last year, two large independently conducted peer-reviewed studies by QuantaFlo customers were published that underscore strongly the clinical benefit of identifying asymptomatic PAD patients in order to put preventative measures in place. First, the Nevada Paper was published in the Journal of Vascular Surgery. This study is proof of our thesis that testing for PAD in asymptomatic patients is warranted. The study followed over 13,000 asymptomatic Medicare Advantage beneficiaries aged 65 and older for three years approximately 32% of these patients had PAD.

In positive PAD patients versus negative patients, that was independently associated increased risk of 60% to 70% for all-cause mortality and/or morbidity at one year and independently associated increased risk of 40% to 50% for all-cause mortality and/or morbidity at three years. The authors concluded that these findings highlight an enormous potential to realize cost savings by reducing cardiovascular event rates and deploying population-based PAD risk mitigation strategies. The HouseCall studies, which was published in AJPM focus and Open Access Journal jointly launched by the American College of Preventative Medicine and the Association for Prevention Teaching and Research is another significant study, this one conducted by Optum’s in-house HouseCall’s program — in the home HouseCall’s program.

This was a major study of over 192,000 Medicare Advantage beneficiaries aged 65 and older. It confirmed and expanded on the many findings in the Nevada Paper that identification of QuantaFlo positive versus negative status carries increased risk of mortality and major adverse cardiovascular events as well as verified our severity scale in the worse PAD as measured by QuantaFlo conferred a more dire prognosis, which might be a valid reason to retest patients more frequently. It underscores and supports the feasibility and the use of home risk assessments by insurers with a nationwide PAD screening program. Importantly, these studies showed there was a markedly increased risk of mortality and morbidity rights in PAD-positive patients, which would make them more costly to care for if they are not identified early when preventative measures can be put in place.

Further, the American Heart Association and American College of Cardiology guidelines clearly recommend routine screening for PAD in patients age 65 and over as well as those age 50 to 64 with risk factors such as smoking and diabetes. These factors demonstrate the difference that QuantaFlo can make for patients and those that care for them. We are encouraged to see increasing interest from a wide range of customers in the QuantaFlo product. We saw not only increased interest in our products from large insurance and home risk assessment companies, but also hospitals, retail locations and delegated medical groups, which we believe is due at least in part to gaining traction from these two major studies. Our sales and marketing goals are to focus on growing our business.

These include further establish our QuantaFlo for PAD product as a standard of care in the industry, given the proven clinical benefits of early diagnosis and preventative treatment. We believe the market for vascular disease testing is larger than our current market penetration. So there is room for continued growth, to make new additions to our customer base, including diversifying our customer base further to hospitals, including the VA, value-based care providers and retailers, expand orders from existing customers, introduce QuantaFlo as an aid to assess heart dysfunction or HD to our customers. And finally, we aim to begin to more broadly market and install Insulin Insights. Now I will turn it back over to Renae to discuss developments at CMS, our Q1 2023 guidance, QuantaFlo HD and other business development activities.

Renae?

Renae Cormier: Thank you, Dennis. As many of you are aware, in early February, CMS issued an advance notice with proposed payment updates for Medicare Advantage programs for 2024, which included some potential changes to treatment of vascular disease under the Medicare Advantage risk adjustment model, creating uncertainty whether all identified patients with PAD will continue to qualify for an increased capitated payment. We have submitted comments on the proposed update to CMS for consideration, citing published research that shows the benefit of early diagnosis and treatment of PAD. It is premature to speculate about the impact to our customers and ultimately our business as CMS will issue the final 2024 rate announcement no later than April 3, 2023.

Regardless of potential changes in reimbursement rates, we believe that QuantaFlo provides important clinical value to our customers in terms of better patient care and potential for future cost savings and identifying positive PAD patients and those with HD. We believe that earlier diagnosis will lead to earlier initiation of preventative intervention and treatment which will save lives and consequently lower health care expenditures. Now turning to guidance for the first quarter ended March 31, 2023. We expect revenue will range from $17.4 million to $17.8 million and pretax net income, which includes interest income of approximately $400,000, to range from $5.6 million to $5.8 million. We are on track to achieve our highest quarterly revenue ever, which we believe is a testament to the clinical value our customers see in using QuantaFlo to aid in the early diagnosis of PAD in their patient population.

In light of the CEO transition and the anticipated final CMS rate announcement, we are not issuing guidance for the year ended December 31, 2023, at this time. Let’s move on to the clinical study that was published in late February 2023 in the Journal of Preventative Medicine. Using QuantaFlo is an aid to assess heart dysfunction or HD. You can find a press release with a link to this study in the Investor Relations portion of our website. Health care providers now have a point of care low-cost, accurate means for detecting potential heart dysfunction in their primary care setting before overt signs of symptoms present. Results were that our tests showed a statistically significant correlation with a p-value of less than 0.01 with trans sporadic echocardiography, which is the gold standard to diagnose heart failure.

For those of you who have been with Semler for a long time, you may recall the prolonged lead times for many of our current customers with the initial adoption of QuantaFlo for PAD. We expect the market uptake process for HD will take time. Other key points regarding this expansion are QuantaFlo HD can be used as an aid to measure chemodynamics related to heart dysfunction. The spectrum of heart dysfunction includes heart failure. Heart failure affects around 6.5 million adults in the U.S. And the lifetime risk of heart failure is estimated to be 1 in 5 at 40 years of age. The number of patients with asymptomatic heart disease exceeds the number of patients with symptomatic heart disease. Published studies have shown there are over 1 million hospitalizations per year in the United States from heart failure, and the annual cost of care exceeds $30 billion.

Mortality rates after hospitalization for heart failure are 31% within 1 year after diagnosis. QuantaFlo HD uses the existing FDA 510k clearance as we anticipated its use many years ago. A medical assistant performs the test in a primary care setting, similar to how one uses QuantaFlo for PAD. Like PAD, asymptomatic HD patients are not routinely tested in the current standard of care because echo is not a screening test. This test is performed by referral in a specialized lab, requires a trained ultra-sonographer to perform the task, it’s about an hour and must be interpreted by a cardiologist. As a specialized procedure, echo is not practical to be performed in primary care offices or in home settings. The sensitivity, specificity and accuracy of QuantaFlo HD all were greater than 88% compared to using echo with strain as a gold standard as the methodology for identifying heart failure.

Patients that have been identified as positive with QuantaFlo HD will need to have additional diagnostic tests to determine the underlying type of heart dysfunction. The goal is for health care providers to have a better chance of encouraging patients to adopt healthier lifestyles and optimize proven guideline-directed medical therapies earlier with the potential of improving long-term health outcomes. Currently, there are CPT reimbursement for echocardiography and HCC diagnostic codes for heart dysfunction. Moving on to our R&D goals. We continue to be — to upgrade the existing product and data services, to commercialize other internally developed services and products and find other potential investments to diversify our product pipeline, which is the recent investments we have made in the diabetes space.

As you know, diabetes is a large market with over 35 million people diagnosed in the United States, growing at 4% to 5% a year. In addition, 96 million people have prediabetes. To-date, our diabetes portfolio includes investments and a distribution agreement with Mellitus, whose platform Insulin Insights offers an algorithm that helps primary care physicians titrate insulin for type 2 diabetic patients. This partnership gives us exclusive marketing rights in the United States and Puerto Rico. Initial installations and new sales continue to make progress. Revenues have started but are not yet material to date. Type 2 diabetics on insulin represented a difficult patient population to manage as these patients often have found oral therapy alone has not been enough to adequately control their blood glucose.

Insulin if incorrectly dosed can cause complications that can lead to emergency room visits and unplanned hospitalization. Primary care physicians find value with Insulin Insights because by approximately easily adjusting insulin levels in type 2 diabetic patients, patients who have less risk of adverse complications with insulin use. Have improved control of their blood glucose levels, we’re pleased with fewer complications from diabetes and overall better clinical outcomes. In addition, plans have the potential to save on total cost of care and medication costs, as well as achieving higher star quality measures as patients have improved HbA1c levels, demonstrating that their diabetes is under good control. In December 2022, we announced a commitment to invest up $5 million in Monarch, a privately held company through the purchase of a senior secured convertible promissory notes.

Repayment of the note is secured by first priority interest in all of Monarch assets. Monarch is a digital health company whose proprietary endo tool glucose management system offers a technology-enabled approach to inpatient glycemic management. The Software-as-a-Service solution if FDA 510(k) cleared, patent protected and installed in more than 100 health systems across the United States. As of December 31, 2022, Monarch had borrowed $3.5 million out of the $5 million committed principal amount of the notes. In addition, $500,000 has been drawn post year-end. Although we do not have any distribution agreement in place with Monarch, we believe our recent investment provides us the opportunity to round out our diabetes portfolio and complement our outpatient diabetes management tool with its approach to improve inpatient diabetes management.

In closing, I want to reiterate that regardless of policy changes affecting reimbursement and other market forces beyond our control, our fundamental value to our customers is and always has been the clinical value of earlier diagnosis of chronic progressive cardiovascular condition and improved simpler management of diabetes. Despite the changes that will always exist in health care reimbursement, there will still be patients, physicians, facilities and payers. Our offerings have a strong clinical value that all of these stakeholders will need in order to improve clinical outcomes and reduce health care costs. Because we have developed technology that is portable and accessible, we are also part of this solution to reduce health inequity that currently exists in cardiovascular disease.

Our management team has the experience and resilience to make appropriate adjustments to our ongoing growth strategy as market conditions change. We also understand that changes in government policy may take time to be fully implemented. We are confident that our mission to improve clinical outcomes and reduce total cost of care in patients with cardiovascular disease and diabetes will remain relevant to our stakeholders for the foreseeable future. As Wayne mentioned, we’ll be presenting and taking one-on-one meetings at the upcoming 22nd Annual Needham Virtual Health Care Conference on April 18, 2023. Thank you for your interest in the company and your continuing support. Now operator, please open the line. Doug, Wayne, Andy, Dennis and I will be happy to address your questions.

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Q&A Session

Operator: Our first question comes from Brooks O’Neil with Lake Street Capital Markets. Please go ahead.

Brooks O’Neil: Thank you and good afternoon, Doug, Dennis, Renae, Andy and Wayne. I think this might be the first call I had to say hi to five different people, but I think its . So, Doug, I wanted to just say I think you’ve done a tremendous job as CEO. You’ve laid the foundation under what I believe is today and will ultimately become a fantastic company. I believe Semler is going to play a key role in the future of health care diagnosis and treatment. And I just wish you every congratulation for all you’ve accomplished as CEO of this company.

Douglas Murphy-Chutorian: Thanks, Brooks.

Brooks O’Neil: Of course, of course. It’s been a pleasure to work with you, and I look forward to continuing to work with you going forward. Now I have a couple of quick questions. I guess the first one, and I understood all that you all said in the prepared remarks. But I’m curious if you can or will offer any color with regard to customer reaction to the advanced notice. I mean, I know it’s premature. We haven’t seen the final notice, and there’s still a long time before the ultimate implementation of whatever pricing people put in place. But in general, can you say anything about how your customers have responded as it relates primarily to using QuantaFlo going forward?

Renae Cormier: Sure, Brooks. I can start with that. So as you know and what we’ve discussed, it really is too early to speculate at this time what will happen because we don’t even know what the final rates will come out at. But as you can see from our Q1 guidance, our customers are continuing to use our products. And we believe that our customers use our products because of the clinical benefits and potential cost savings in addition to any risk adjustment payment they may receive because in general, prevention is very important, as you know. So we actually continue to work closely with our customers, remain in contact with them and committed to providing the reliable and accurate testing. Also, as we have talked about this quarter and also prior quarters, we do have many customers that don’t participate in the Medicare Advantage program where we can shift resources to. And on top of that, we do have QuantaFlo HD and Insulin Insights to market.

Brooks O’Neil: Sure. Great. Thank you for that color, Renae. So second question, and again, I recognize you spoke to this to some degree in the prepared remarks, but as we try to think about how quickly you might be able to begin recognizing revenue related to the heart failure indication, can you give us any sense? Is it all reasonable to think you might see some revenue in 2024 related to that opportunity?

Renae Cormier: So we’re not giving guidance for 2023 currently.

Brooks O’Neil: I know, I know.

Renae Cormier: But we are in contact with our customers of all sizes, and we have gotten very positive initial feedback on that. We aren’t talking specifically about what implementations may be starting or tests that are going on. But we do believe that it may take time to roll out. Again, you’ve been with us for a long time. Obviously, we do have customers in place, but we do anticipate that it could take some time to roll out a significant level.

Brooks O’Neil: Sure. Okay. I’m just going to ask one more, and I’m just curious about this. Obviously, one of the unique and special approaches that Semler has taken to the marketplace is primarily working with Medicare Advantage market participants, and that’s worked incredibly well, in my opinion, been a brilliant strategy. Now with the advanced notice and some indication of how our friends in the United States government are thinking about taking good care of these patients, have you considered sort of going a more traditional route at least maybe as a complement where you might seek to establish some kind of reimbursement code for doctors who perform your test or hospitals or health systems, whatever? I’m just curious if you’d consider that and if you have, how you think about that?

Renae Cormier: Sure. Maybe I can — if I can hand that over to Dennis, how we’ve handled that historically and where we might go in the future.

Dennis Rosenberg: Yes, we certainly looked at that, Brooks. And the other thing that we’re doing even prior to the advanced notice that we are — see as a favorable situation is the general broadening of our customer base. So we’ve remained strong in the Medicare Advantage health plans and directly with the insurers, but also this broadening to the other areas that we’ve mentioned, hospitals and delegated medical groups and others, retail, for example. So we think that there’s a big opportunity to continue to install QuantaFlo in the health care system in general despite any changes that may or may not occur with the current reimbursement scenario. So we certainly have looked at all the options and are actively exploring what we think are the best opportunities to continue the growth. And as you know, the move to what we always talk about, making QuantaFlo standard of care.

Brooks O’Neil: Absolutely, make sense. Thank you for taking my question.