Semler Scientific Inc (SMLR) 2022 Q4 法說會逐字稿

Good afternoon, and welcome to the Semler Scientific 2022 Fourth Quarter and Full Year Financial Results Conference Call. (Operator Instructions) Please note, this event is being recorded.

下午好，歡迎參加 Semler Scientific 2022 年第四季度和全年財務業績電話會議。 （操作員說明）請注意，正在記錄此事件。

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.

在我們開始之前，Semler Scientific 需要提醒您，在本次電話會議期間發表的某些評論可能構成前瞻性陳述，這些評論是根據經修訂的 1995 年《私人證券訴訟改革法案》的安全港條款並在其含義內作出的。其中包括有關業務擴展預期、附加產品的開發和營銷以及 CMS 提前通知的影響的聲明。此類前瞻性陳述受那些已知和未知的風險和不確定性的影響，這些風險和不確定性可能導致實際結果與此類陳述存在重大差異。這些風險和不確定性在新聞稿和我們提交給美國證券交易委員會的文件中有所描述。

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.

今天作出的前瞻性陳述截至本次電話會議之日，公司不承擔任何更新前瞻性陳述的義務。如果您沒有今天發布的副本，您可以通過訪問網站 semlerscientific.com 的投資者關係頁面獲得一份。

Now I would like to introduce Doug Murphy-Chutorian, CEO of Semler Scientific.

下面我想介紹一下 Semler Scientific 的 CEO Doug 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 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.

大家下午好，感謝您加入我們的 2022 年第四季度和全年業績電話會議。今天，我們宣布我已通知董事會，我將辭去首席執行官一職，並將協助過渡期。我將至少在 2024 年任期的剩餘時間內繼續擔任董事會成員。

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 to the next phase of growth and continue to make a difference every day for our customers and the patients that we serve.

我很高興地宣布，Wayne Pan 博士將從 2023 年 4 月 3 日起接替我擔任首席執行官。Wayne 自 2014 年 5 月起擔任董事會成員，擁有廣泛的醫療保健經驗，並相信他將領導和能夠帶領公司進入下一階段的增長，並繼續每天為我們的客戶和我們服務的患者帶來改變。

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.

領導團隊是我的榮幸，我為我們共同打造的企業感到自豪。我們 2023 年第一季度的收入指引是 Semler 歷史上實現的最高季度收入。

So without further ado, I want to introduce you to Dr. Pan. Wayne?

那麼廢話不多說，我想給大家介紹一下潘醫生。韋恩？

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.

謝謝你，道格。我謹代表董事會感謝 Doug 在過去 12 年中對 Semler 的承諾和顯著貢獻。他在公司的發展中發揮了重要作用，我期待著作為董事會成員繼續與他合作。我非常感謝有機會擔任 Semler Scientific 的首席執行官，帶領公司進入下一階段的發展。

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.

我相信 Semler 擁有的診斷工具將開啟心血管護理的新模式，並為我們的股東創造價值。我們的產品將增加可及性，促進健康公平，並能夠及早診斷影響全球數百萬人的進行性疾病。 Semler 將於 2023 年 4 月 18 日在 Needham Virtual Healthcare Conference 上發表演講並主持一對一會議。我期待著闡述我的願景並與投資者社區會面。

I will now hand the call over to Renae.

我現在將把電話交給 Renae。

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.

謝謝你，韋恩。我期待著與您合作。下午好，感謝您今天加入我們。除了 Doug 和 Wayne，和我一起的還有財務和會計高級副總裁 Andy Weinstein；首席營銷官 Dennis Rosenberg。道格、韋恩、安迪、丹尼斯和我將在今天準備好的發言後接受問答。

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.

在這次電話會議上，我們將總結 2022 年第四季度和財年末的財務業績，討論我們市場中的影響因素，討論 2024 年 CMS 預告，概述 2023 年第一季度指導，提供有關 QuantaFlo 產品擴展的詳細信息並發表演講關於 Semler 的其他投資活動。

Now I will turn it over to Andy to describe our financial performance for the fourth quarter and full year 2022. Andy?

現在我將把它交給安迪來描述我們 2022 年第四季度和全年的財務業績。安迪？

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.

謝謝，雷內。請參閱今天收市時發布的新聞稿中描述的財務結果。我們報告了 2022 年的年收入創歷史新高，但與 2021 年相比，我們今年的收入增長有所放緩。我們很高興地看到，與第四季度相比，我們的固定費用和可變費用客戶在 2022 年第四季度的收入增長有所加快2021 年。

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.

截至 2022 年 12 月 31 日的第四季度，收入為 1380 萬美元，比 2021 年同期增長 20%。截至 2022 年 12 月 31 日的全年，收入為 5670 萬美元，比 2021 年同期增長 7%到2021年全年。

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.

第四季度，固定費用收入為 900 萬美元，同比增長 14%。全年固定費用收入為 3400 萬美元，同比增長 11%。我們繼續增加我們最大客戶以及其他現有和新的固定費用客戶的收入。

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 2 major studies published in 2022.

我們看到醫院、零售點和授權醫療團體對我們的產品越來越感興趣，我們認為這至少部分是由於 2022 年發表的兩項主要研究引起了人們的關注。

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.

第四季度，可變費用收入為 450 萬美元，同比增長 30%。全年可變費用收入為 2130 萬美元，同比下降 1%。

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.

第四季度，設備和其他收入為 300,000 美元，同比增長 96%。全年，設備和其他收入為 140 萬美元，同比增長 42%。由於大部分設備銷售是針對可變費用客戶，我們認為這是按測試收費市場實力的預兆。

In the fourth quarter of 2022, our 2 largest customers, including their related affiliates, comprised 43.3% and 25.8% of quarterly revenues. For the full year 2022, our 2 largest customers comprised 40.4% and 29% of annual revenues.

2022 年第四季度，我們的兩個最大客戶，包括其相關關聯公司，分別佔季度收入的 43.3% 和 25.8%。 2022 年全年，我們最大的兩個客戶分別佔年收入的 40.4% 和 29%。

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.

第四季度，包括收入成本在內的運營費用為 1020 萬美元，同比增長 4%。全年運營費用為 3950 萬美元，同比增長 18%。全年營業費用增加的主要原因是根據我們的業務擴張計劃增加了員工人數、工資上漲以及保險和專業費用增加。

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.

第四季度，稅前淨收入為 400 萬美元，同比增長 230 萬美元或 132%。全年稅前淨收入為 1770 萬美元，同比減少 180 萬美元或 9%。

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.

在第四季度，淨收入為 320 萬美元或每股基本股 0.48 美元和每股完全攤薄後的淨收入 0.41 美元，同比增長 113%。全年淨收入為 1430 萬美元或每股基本股 2.13 美元和每股攤薄收益 1.79 美元，同比下降 17%。

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.

第四季度和 2022 年全年的加權平均基本股數為 670 萬股。第四季度和 2022 年全年的加權平均稀釋股數為 790 萬股。本季度沒有回購股票。在 2022 財年，我們回購了價值 500 萬美元的股票或 149,000 股。根據董事會授權的股票回購計劃，我們還有 1500 萬美元剩餘。

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.

截至 2022 年 12 月 31 日，我們擁有現金、現金等價物和短期投資 4310 萬美元，其中約 3050 萬美元於 2022 年 12 月 31 日以短期美國國庫券形式持有。我們與 First Republic Bank 和Edward Jones 正在採取措施進一步實現多元化。

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.

截至 2022 年 12 月 31 日，員工人數為 127 人，而 2022 年第三季度末為 124 人。我們預計將在 2023 年 3 月 23 日左右提交 10-K 表格年度報告。

Now I will ask Dennis to provide more color about factors at play in our market and our business activities. Dennis?

現在我將請丹尼斯提供更多有關我們市場和業務活動中起作用的因素的顏色。丹尼斯？

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, 2 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.

謝謝，安迪。我首先要重申，我們始終堅信慢性病早期診斷作為一種護理標準的臨床益處和重要性。如您所知，去年發表了 2 項由 QuantaFlo 客戶獨立開展的同行評審研究，這些研究強烈強調了識別無症狀 PAD 患者以採取預防措施的臨床益處。

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 3 years.

首先，內華達論文發表在血管外科雜誌上。這項研究證明了我們的論點，即有必要對無症狀患者進行 PAD 檢測。該研究跟踪了超過 13,000 名 65 歲及以上的無症狀 Medicare Advantage 受益人 3 年。

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 1 year and independently associated increased risk of 40% to 50% for all-cause mortality and/or morbidity at 3 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.

這些患者中約有 32% 患有 PAD。在陽性 PAD 患者與陰性患者中，這與 1 年時全因死亡率和/或發病率風險增加 60% 至 70% 獨立相關，並且與全因死亡率和/或發病率風險增加 40% 至 50% 獨立相關或 3 年發病率。作者得出結論，這些發現突出了通過降低心血管事件發生率和部署基於人群的 PAD 風險緩解策略來實現成本節約的巨大潛力。

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 HouseCalls program -- in the home HouseCalls program. This was a major study of over 192,000 Medicare Advantage beneficiaries aged 65 and older.

HouseCall 研究發表在美國預防醫學學院和預防教學與研究協會聯合發起的 AJPM 焦點和開放獲取期刊上，這是另一項重要研究，該研究由 Optum 的內部 HouseCalls 計劃進行——在家庭 HouseCalls 程序。這是一項針對 192,000 多名 65 歲及以上的 Medicare Advantage 受益人的大型研究。

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.

它證實並擴展了內華達論文中的許多發現，即 QuantaFlo 陽性與陰性狀態的鑑定會增加死亡率和主要不良心血管事件的風險，並驗證了我們在更嚴重的 PAD 中的嚴重程度等級，如 QuantaFlo 所測量的，預後更差，這可能是更頻繁地重新測試患者的正當理由。它強調並支持保險公司通過全國性 PAD 篩查計劃進行家庭風險評估的可行性和使用。重要的是，這些研究表明，PAD 陽性患者的死亡率和發病率風險顯著增加，如果在可以採取預防措施時未及早發現，這將使他們的護理成本更高。

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 aged 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.

此外，美國心臟協會和美國心髒病學會指南明確建議對 65 歲及以上的患者以及 50 至 64 歲有吸煙和糖尿病等危險因素的患者進行 PAD 常規篩查。這些因素證明了 QuantaFlo 可以為患者和照顧他們的人帶來不同。

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 2 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.

我們很高興看到廣大客戶對 QuantaFlo 產品越來越感興趣。我們不僅看到大型保險和家庭風險評估公司對我們的產品越來越感興趣，而且醫院、零售店和授權醫療集團也對我們的產品感興趣，我們認為這至少部分是由於這兩項主要研究的吸引力。我們的銷售和營銷目標是專注於發展我們的業務。考慮到早期診斷和預防性治療的臨床益處，這些包括進一步將我們的 QuantaFlo for PAD 產品確立為行業護理標準。

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.

我們相信血管疾病檢測市場比我們目前的市場滲透率更大。因此，我們有持續增長的空間，可以增加我們的客戶群，包括將我們的客戶群進一步多樣化到醫院，包括 VA、基於價值的護理提供商和零售商，擴大現有客戶的訂單，引入 QuantaFlo 以幫助為我們的客戶評估心臟功能障礙或 HD。最後，我們的目標是開始更廣泛地營銷和安裝 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?

現在我將把它轉回 Renae 討論 CMS 的發展、我們的 2023 年第一季度指南、QuantaFlo HD 和其他業務發展活動。雷內？

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.

謝謝你，丹尼斯。正如你們中的許多人所知，2 月初，CMS 發布了一份預先通知，其中包含 2024 年 Medicare Advantage 計劃的擬議付款更新，其中包括 Medicare Advantage 風險調整模型下血管疾病治療的一些潛在變化，造成是否所有確定的不確定性PAD 患者將繼續有資格獲得增加的按人頭付費。我們已經提交了對 CMS 提議更新的評論以供考慮，引用了顯示 PAD 早期診斷和治療益處的已發表研究。由於 CMS 將在 2023 年 4 月 3 日之前發布最終的 2024 年費率公告，因此推測對我們的客戶以及最終我們的業務的影響還為時過早。

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.

無論報銷率的潛在變化如何，我們相信 QuantaFlo 為我們的客戶提供了重要的臨床價值，包括更好的患者護理和未來成本節約的潛力，以及識別陽性 PAD 患者和 HD 患者。我們相信，早期診斷將導致更早開始預防性干預和治療，從而挽救生命並降低醫療保健支出。

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.

現在轉向截至 2023 年 3 月 31 日的第一季度的指導。我們預計收入將在 1740 萬美元至 1780 萬美元之間，稅前淨收入（包括約 400,000 美元的利息收入）將在 560 萬美元至 580 萬美元之間。我們有望實現有史以來最高的季度收入，我們認為這證明了我們的客戶在使用 QuantaFlo 幫助其患者群體早期診斷 PAD 方面所看到的臨床價值。

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.

鑑於 CEO 交接和預期的最終 CMS 利率公告，我們目前不發布截至 2023 年 12 月 31 日止年度的指引。

Let's move on to the clinical study that was published in late February 2023 in the Journal of Preventative Medicine using QuantaFlo as 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.

讓我們繼續進行 2023 年 2 月下旬發表在《預防醫學雜誌》上的臨床研究，該研究使用 QuantaFlo 作為評估心功能障礙或 HD 的輔助手段。您可以在我們網站的投資者關係部分找到一份新聞稿，其中包含指向該研究的鏈接。

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 transthoracic echocardiography, which is the gold standard to diagnose heart failure.

醫療保健提供者現在有一種低成本、準確的護理點方法，可以在出現明顯的症狀跡象之前，在他們的初級保健機構中檢測出潛在的心臟功能障礙。結果是我們的測試顯示與經胸超聲心動圖小於 0.01 的 p 值具有統計學顯著相關性，這是診斷心力衰竭的金標準。

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.

對於那些長期與 Semler 合作的人，您可能還記得我們許多當前客戶最初採用 QuantaFlo for PAD 時交貨時間延長的情況。我們預計 HD 的市場接受過程需要時間。

Other key points regarding this expansion are QuantaFlo HD can be used as a premeasured chemodynamics related 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.

關於此擴展的其他關鍵點是 QuantaFlo HD 可用作與心臟功能障礙相關的化學動力學預測。心功能障礙的範圍包括心力衰竭。在美國，心力衰竭影響著大約 650 萬成年人。在 40 歲時，心力衰竭的終生風險估計為五分之一。無症狀心髒病患者的數量超過有症狀心髒病患者的數量。

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.

已發表的研究表明，美國每年有超過 100 萬人因心力衰竭住院，每年的治療費用超過 300 億美元。因心力衰竭住院後診斷後 1 年內的死亡率為 31%。

QuantaFlo HD uses the existing FDA 510(K) 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 ultrasonographer to perform the task, takes about an hour and must be interpreted by a cardiologist.

正如我們多年前預期的那樣，QuantaFlo HD 使用現有的 FDA 510(K) 許可。一名醫療助理在初級保健環境中執行測試，類似於使用 QuantaFlo 治療 PAD 的方式。與 PAD 一樣，無症狀的 HD 患者在當前的護理標準中並未進行常規檢測，因為迴聲不是篩查檢測。該測試通過轉診在專門實驗室進行，需要經過培訓的超聲醫師來執行任務，大約需要一個小時，並且必須由心髒病專家進行解讀。

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.

作為一種專門的程序，迴聲在初級保健辦公室或家庭環境中執行是不切實際的。與使用應變回波作為金標準作為識別心力衰竭的方法相比，QuantaFlo HD 的靈敏度、特異性和準確性均高於 88%。已被確定為 QuantaFlo HD 陽性的患者將需要進行額外的診斷測試以確定心功能障礙的潛在類型。

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.

目標是讓醫療保健提供者有更好的機會鼓勵患者採用更健康的生活方式，並儘早優化經過驗證的指南指導的醫療療法，從而有可能改善長期健康結果。目前，超聲心動圖有CPT報銷，心功能不全有HCC診斷碼。

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.

繼續我們的研發目標。我們繼續——升級現有的產品和數據服務，將其他內部開發的服務和產品商業化，並尋找其他潛在的投資來使我們的產品管道多樣化，這是我們最近在糖尿病領域進行的投資。如您所知，糖尿病是一個巨大的市場，在美國有超過 3500 萬人被診斷出糖尿病，並以每年 4% 到 5% 的速度增長。此外，還有 9600 萬人處於糖尿病前期。

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.

迄今為止，我們的糖尿病產品組合包括投資和與 Mellitus 的分銷協議，其平台 Insulin Insights 提供了一種算法，可幫助初級保健醫生為 2 型糖尿病患者滴定胰島素。這種夥伴關係賦予我們在美國和波多黎各的獨家營銷權。初始安裝和新銷售繼續取得進展。收入已經開始，但迄今為止還不是很重要。

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, which leads to fewer complications from diabetes and overall better clinical outcomes.

使用胰島素的 2 型糖尿病患者代表了一個難以管理的患者群體，因為這些患者通常發現僅靠口服治療不足以充分控制他們的血糖。胰島素如果劑量不當會導致並發症，從而導致急診室就診和計劃外住院。初級保健醫生髮現 Insulin Insights 的價值，因為通過大致輕鬆地調整 2 型糖尿病患者的胰島素水平，使用胰島素不良並發症風險較低的患者改善了對血糖水平的控制，從而減少了糖尿病並發症和整體更好的臨床結果。

In addition, plans have the potential to save on total cost of care and medication costs as well as achieving higher key to star quality measures as patients have improved HbA1c levels, demonstrating that their diabetes is under good control.

此外，計劃有可能節省總護理成本和藥物成本，並實現更高的關鍵質量指標，因為患者的 HbA1c 水平得到改善，表明他們的糖尿病得到了良好的控制。

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 is FDA 510(k) cleared, patent protected and installed in more than 100 health systems across the United States.

2022 年 12 月，我們宣布承諾通過購買優先擔保可轉換本票向私營公司 Monarch 投資 500 萬美元。票據的償還以所有 Monarch 資產的優先權益為擔保。 Monarch 是一家數字健康公司，其專有的內窺鏡工具葡萄糖管理系統為住院患者的血糖管理提供了一種技術支持的方法。軟件即服務解決方案已獲得 FDA 510(k) 批准、專利保護並安裝在美國 100 多個衛生系統中。

As of December 31, 2022, Monarch had borrowed $3.5 million out of the $5 million committed principal amount of the note. 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.

截至 2022 年 12 月 31 日，Monarch 已從票據承諾的 500 萬美元本金中藉入 350 萬美元。此外，年底後還提取了 500,000 美元。儘管我們與 Monarch 沒有任何分銷協議，但我們相信我們最近的投資為我們提供了機會來完善我們的糖尿病產品組合，並通過其改善住院糖尿病管理的方法來補充我們的門診糖尿病管理工具。

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.

最後，我想重申，無論政策變化如何影響報銷和我們無法控制的其他市場力量，我們對客戶的基本價值始終是慢性進展性心血管疾病的早期診斷和更簡單的糖尿病管理的臨床價值.儘管醫療保健報銷始終存在變化，但仍然會有患者、醫生、設施和付款人。我們的產品具有強大的臨床價值，所有這些利益相關者都需要這些價值來改善臨床結果並降低醫療保健成本。

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.

由於我們開發了便攜且易於使用的技術，我們也參與了該解決方案，以減少目前存在於心血管疾病中的健康不公平現象。我們的管理團隊擁有豐富的經驗和應變能力，可以隨著市場條件的變化對我們的持續增長戰略進行適當調整。我們也理解政府政策的變化可能需要時間才能完全實施。我們相信，在可預見的未來，我們改善心血管疾病和糖尿病患者臨床結果並降低總護理成本的使命仍將與我們的利益相關者相關。

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.

正如 Wayne 所提到的，我們將在即將於 2023 年 4 月 18 日舉行的第 22 屆年度 Needham 虛擬醫療保健會議上進行展示和一對一會議。

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.

感謝您對公司的關注和一如既往的支持。現在接線員，請打開線路。 Doug、Wayne、Andy、Dennis 和我很樂意回答您的問題。

(Operator Instructions) Our first question comes from Brooks O'Neil with Lake Street Capital Markets.

（操作員說明）我們的第一個問題來自 Lake Street Capital Markets 的 Brooks O'Neil。

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 congratulations for all you've accomplished as CEO of this company.

所以道格，我只想說我認為你作為 CEO 做得非常出色。你們為我所相信的今天奠定了基礎，最終將成為一家出色的公司。我相信塞姆勒將在未來的醫療保健診斷和治療中發揮關鍵作用。我祝賀你作為這家公司的首席執行官所取得的一切成就。

Thank you.

謝謝。

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.

當然，當然。很高興與您合作，我期待著繼續與您合作。

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?

現在我有幾個簡單的問題。我猜是第一個，我理解你們在準備好的發言中所說的一切。但我很好奇您是否可以或願意提供有關客戶對提前通知的反應的任何顏色？我的意思是，我知道現在還為時過早。我們還沒有看到最終通知，距離人們制定的任何定價最終實施還有很長一段時間。但總的來說，您能否談談您的客戶的反應，因為這主要與未來使用 QuantaFlo 相關？

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 as. 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.

當然，布魯克斯。我可以從那開始。因此，正如您所知以及我們所討論的那樣，現在推測會發生什麼還為時過早，因為我們甚至不知道最終利率會是多少。但正如您從我們的第一季度指南中看到的那樣，我們的客戶仍在繼續使用我們的產品。我們相信我們的客戶之所以使用我們的產品，是因為除了他們可能收到的任何風險調整付款外，還有臨床益處和潛在的成本節約，因為一般來說，預防非常重要，正如你所知。

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.

因此，我們實際上繼續與客戶密切合作，與他們保持聯繫，並致力於提供可靠和準確的測試。此外，正如我們在本季度和前幾個季度所討論的那樣，我們確實有許多客戶沒有參與我們可以轉移資源的 Medicare Advantage 計劃。最重要的是，我們確實有 QuantaFlo HD 和 Insulin Insights 推向市場。

Sure. Great. 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?

當然。偉大的。所以第二個問題，我知道你在準備好的評論中在某種程度上談到了這一點，但是當我們試圖考慮你可能多快能夠開始確認與心力衰竭適應症相關的收入時，你能給我們任何嗎？感覺？認為您可能會在 2024 年看到與該機會相關的一些收入是否合理？

So we're not giving guidance for 2023. 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 at a significant level.

所以我們沒有給出 2023 年的指導。但我們正在與各種規模的客戶保持聯繫，我們已經得到了非常積極的初步反饋。我們並沒有具體討論可能開始的實施或正在進行的測試。但我們確實相信推出可能需要時間。再一次，你已經和我們在一起很長時間了。顯然，我們確實有客戶，但我們確實預計可能需要一些時間才能大規模推出。

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.

當然。好的。我只是想再問一個，我只是對此感到好奇。顯然，塞姆勒在市場上採取的一種獨特而特殊的方法主要是與 Medicare Advantage 市場參與者合作，在我看來，這非常有效，是一個絕妙的策略。

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?

現在有了預先通知和一些跡象表明我們在美國政府的朋友們正在考慮如何照顧好這些病人，你是否考慮過走更傳統的路線，至少作為一種補充，你可能會尋求建立一些醫生的報銷代碼，誰執行你的測試或醫院或衛生系統，等等？我只是想知道您是否會考慮這一點，如果您考慮過，您是如何考慮的？

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.

當然。也許我可以——如果我能把它交給丹尼斯，我們在歷史上是如何處理它的，以及我們未來可能會去哪裡。

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.

是的，我們當然看過那個，布魯克斯。甚至在我們提前通知之前我們正在做的另一件事 - 認為有利的情況是我們的客戶群的普遍擴大。因此，我們在 Medicare Advantage 健康計劃和直接與保險公司保持強勢，但也擴大到我們提到的其他領域，醫院和授權醫療集團以及其他領域，例如零售。

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.

因此，我們認為，儘管當前的報銷方案可能會或可能不會發生任何變化，但總體上仍有很大機會繼續在醫療保健系統中安裝 QuantaFlo。因此，我們當然已經研究了所有選項，並正在積極探索我們認為是繼續增長的最佳機會。如您所知，轉向我們一直談論的話題，使 QuantaFlo 成為護理標準。

This concludes our question-and-answer session. I would like to turn the conference back over to Renae Cormier for any closing remarks.

我們的問答環節到此結束。我想將會議轉回給 Renae Cormier 做閉幕詞。

Thank you for joining us today. Doug, I wanted to express my sincere gratitude for the opportunity to work with you and get to know you better over the past year. Your vision, determination and leadership have been truly impressive, and it is amazing to see the business you have built. I will always be grateful for the mentorship and guidance you have provided me, and I know this marks the end of an era for Semler. I will miss your contributions and leadership, but I'm excited to continue working with Wayne to build on the foundation you've laid. On behalf of the entire Semler team, we wish you all the best in this next chapter of your life.

感謝您今天加入我們。道格，我想對過去一年有機會與您合作並更好地了解您表示衷心的感謝。你的遠見、決心和領導力確實令人印象深刻，看到你所建立的業務令人驚嘆。我將永遠感謝您為我提供的指導和指導，我知道這標誌著 Semler 時代的結束。我會想念你的貢獻和領導能力，但我很高興能繼續與韋恩合作，在你奠定的基礎上再接再厲。我們代表整個 Semler 團隊，祝愿您在人生的下一個篇章中一切順利。

Thank you for the kind words, Renae.

謝謝你的客氣話，Renae。

Thank you, everyone. This concludes our call.

謝謝大家。我們的通話到此結束。

Thank you. Bye.

謝謝。再見。

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

會議現已結束。感謝您參加今天的演講。您現在可以斷開連接。