Apyx Medical Corp (APYX) 2022 Q4 法說會逐字稿

Hello, and welcome, ladies and gentlemen, to the Fourth Quarter and Fiscal Year 2022 Earnings Conference Call for Apyx Medical Corporation. (Operator Instructions).

女士們，先生們，您好，歡迎參加 Apyx Medical Corporation 第四季度和 2022 財年收益電話會議。 （操作員說明）。

Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including without limitation, those identified in the Risk Factors section of our most recent annual report on Form 10-K and the company's other filings with the Securities and Exchange Commission. Such factors may be updated from time to time in our filings with the SEC, which are available on our website. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise.

在我們開始之前，我想提醒大家，我們今天的評論和對您問題的回答可能包含基於當前管理層預期的前瞻性陳述，並涉及可能導致實際結果與這些結果大不相同的固有風險和不確定性。表明，包括但不限於我們最近的 10-K 表格年度報告的風險因素部分以及公司向美國證券交易委員會提交的其他文件中確定的那些。這些因素可能會在我們向美國證券交易委員會提交的文件中不時更新，這些文件可在我們的網站上找到。我們不承擔因新信息、未來事件或其他原因而公開更新或修改我們的前瞻性陳述的義務。

This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website.

此電話會議還將提及某些未根據公認會計原則或 GAAP 計算的財務指標。我們通常將這些稱為非 GAAP 財務指標。我們網站投資者關係部分的收益新聞稿中提供了這些非 GAAP 財務指標與根據 GAAP 計算和呈現的最具可比性指標的對賬。

I would now like to turn the call over to Mr. Charlie Goodwin, Apyx Medical's President and Chief Executive Officer. Please go ahead, sir.

我現在想把電話轉給 Apyx Medical 的總裁兼首席執行官查理古德溫先生。請繼續，先生。

Thanks, operator. Welcome, everyone, to our fourth quarter and fiscal year 2022 earnings call. I'm joined on today's call by our Chief Financial Officer, Tara Semb.

謝謝，運營商。歡迎大家參加我們的第四季度和 2022 財年財報電話會議。我們的首席財務官 Tara Semb 和我一起參加了今天的電話會議。

Turning to a quick agenda of what we intend to cover today. I'll start by reviewing our fourth quarter revenue results and the factors that contributed to our performance. Then I'll provide you with an update on our operational progress during the fourth quarter and in recent months. Tara will then discuss our fourth quarter fiscal results in detail as well as our financial guidance for 2023, which we introduced in our earnings release today. I'll conclude with some thoughts on our outlook and key areas of focus in 2023 before we open the call for Q&A.

轉到我們今天打算涵蓋的內容的快速議程。我將首先回顧我們第四季度的收入結果以及影響我們業績的因素。然後我會向您提供我們在第四季度和最近幾個月的運營進展的最新情況。然後，Tara 將詳細討論我們第四季度的財務業績以及我們在今天的收益發布中介紹的 2023 年財務指導。在我們開始問答之前，我將對 2023 年的前景和重點關注領域提出一些想法。

Let's get started with a review of our fourth quarter revenue results. Our total revenue in the fourth quarter decreased 25% year-over-year to $12.6 million. These results were approximately $300,000 below the low end of our guidance range we provided in our November earnings call. Our total revenue performance was driven by softer-than-anticipated Advanced Energy sales, which decreased 30% year-over-year to $10.5 million and offset partially by better-than-expected OEM sales, which increased 15% year-over-year to $2.1 million.

讓我們開始回顧我們第四季度的收入結果。我們第四季度的總收入同比下降 25% 至 1260 萬美元。這些結果比我們在 11 月的財報電話會議上提供的指導範圍的低端低了約 300,000 美元。我們的總收入表現受到 Advanced Energy 銷售額低於預期的推動，該銷售額同比下降 30% 至 1,050 萬美元，部分被好於預期的 OEM 銷售額所抵消，OEM 銷售額同比增長 15% 至210 萬美元。

Looking at the performance in our Advanced Energy business in more detail. Global sales of our Advanced Energy products continued to be impacted by business disruption related to the Medical Safety device communication, which was posted by the FDA in March of 2022. While we anticipated continued disruption throughout the fourth quarter, the level of impact was higher than we anticipated, most notably as it relates to global sales of our advanced energy generators. In the fourth quarter, global generator sales decreased nearly 50% year-over-year driven by declines both domestically and internationally. These declines were moderated by a 10% decrease in global handpiece sales.

更詳細地了解我們 Advanced Energy 業務的表現。我們 Advanced Energy 產品的全球銷售繼續受到 FDA 於 2022 年 3 月發布的與醫療安全設備通信相關的業務中斷的影響。雖然我們預計整個第四季度都會持續中斷，但影響程度高於我們預計，尤其是因為它與我們先進的能源發電機的全球銷售有關。第四季度，受國內外銷量下滑的影響，全球發電機銷量同比下降近 50%。這些下降因全球手機銷量下降 10% 而有所緩和。

As we have discussed in prior quarters, generator sales are primarily a reflection of sales to new users of our technology. This aspect of our Advanced Energy business has seen the most notable impact from the safety communication. While the pace of recovery in global generator sales was slower than our guidance had assumed, it is important to recognize that overall demand trends improved versus Q3, with generator sales increasing nearly 40% on a sequential basis.

正如我們在前幾個季度所討論的那樣，發電機銷售主要反映了對我們技術的新用戶的銷售。我們 Advanced Energy 業務的這一方面已經從安全通信中看到了最顯著的影響。雖然全球發電機銷售的複蘇步伐比我們的預期要慢，但重要的是要認識到總體需求趨勢與第三季度相比有所改善，發電機銷售環比增長近 40%。

Looking at our Advanced Energy performance by geographic region in more detail. Sales of our Advanced Energy generators in all markets continued to be more difficult than we had anticipated. In the U.S. specifically, sales of our Advanced Energy products decreased by more than 30% year-over-year with sales of our U.S. generators decreasing by more than 40% year-over-year. Given the confusion in the market related to the safety communication, our reps have continued to find that more time and effort has been required to help potential new customers understand the communication and the safety and efficacy profile of our technology, which has elongated our historical sales cycle.

更詳細地查看我們按地理區域劃分的 Advanced Energy 績效。我們的 Advanced Energy 發電機在所有市場的銷售仍然比我們預期的要困難。特別是在美國，我們 Advanced Energy 產品的銷售額同比下降超過 30%，而我們美國發電機的銷售額同比下降超過 40%。鑑於市場上與安全溝通相關的混亂，我們的代表繼續發現，需要更多的時間和精力來幫助潛在的新客戶了解我們技術的溝通以及安全性和有效性概況，這延長了我們的歷史銷售額循環。

While generator sales to new customers remained impacted in 2022, we were pleased to grow both our total installed base and our active installed base in the U.S. by 20% year-over-year, which speaks to the success of our U.S. sales team has had in engaging with and educating customers since the safety communication was initially posted. Outside the U.S., sales of our Advanced Energy generators decreased by more than 60% year-over-year as we continue to experience weaker than anticipated demand for generators from distributors in key countries, most notably in Europe and Latin America. While distributor demand for handpieces in the fourth quarter varied across international markets we serve, we were pleased to see stronger-than-anticipated handpiece demand from our distributors in several countries in Latin America, Europe and APAC, which resulted in year-over-year growth in international handpiece sales in Q4.

雖然 2022 年對新客戶的發電機銷售仍然受到影響，但我們很高興在美國的總裝機量和活躍裝機量同比增長 20%，這說明我們的美國銷售團隊取得了成功自最初發布安全通訊以來，與客戶進行互動和教育。在美國以外，我們 Advanced Energy 發電機的銷售額同比下降超過 60%，因為我們繼續經歷主要國家（尤其是歐洲和拉丁美洲）的分銷商對發電機的需求低於預期。雖然我們所服務的國際市場在第四季度的經銷商對手機的需求各不相同，但我們很高興地看到我們在拉丁美洲、歐洲和亞太地區幾個國家的經銷商對手機的需求強於預期，這導致同比增長第四季度國際手機銷量增長。

Shifting to a discussion of our operational performance in the fourth quarter and recent months. During the fourth quarter, our team remained focused on the 2 primary objectives that we outlined on our most recent earnings call. First, we remain focused on engaging with potential U.S. customers and our existing OUS distributors to clarify potential confusion related to the safety communication. As a reminder, in 2022, we obtained 2 new specific clinical indications, an indication for use in dermatological procedures for the treatment of moderate to severe wrinkles and rhytides and an indication to approve the appearance of lax or loose skin in the neck and submental region.

轉向討論我們在第四季度和最近幾個月的運營業績。在第四季度，我們的團隊仍然專注於我們在最近一次財報電話會議上概述的兩個主要目標。首先，我們仍然專注於與潛在的美國客戶和我們現有的 OUS 分銷商接觸，以澄清與安全溝通相關的潛在混淆。提醒一下，在 2022 年，我們獲得了 2 個新的特定臨床適應症，一個用於治療中度至重度皺紋和皺紋的皮膚病學程序的適應症，以及一個批准頸部和頦下區域出現鬆弛或鬆弛皮膚的適應症.

Following our receipt of these 2 510(k) clearances, the FDA issued updates to the safety communication with revisions to reflect each new indication. With this as a backdrop, during the fourth quarter, our team continued to -- their work to communicate these important developments, leveraging our updated marketing and educational materials, ensure prospective customers understand the overall safety and efficacy profile of our products as supported by our IDE clinical studies, real-world evidence and over 50 clinical publications and address any questions related to the safety communication.

在我們收到這 2 510(k) 許可後，FDA 發布了安全通訊更新和修訂，以反映每個新適應症。以此為背景，在第四季度，我們的團隊繼續——他們的工作是傳達這些重要的發展，利用我們更新的營銷和教育材料，確保潛在客戶了解我們產品的整體安全性和有效性概況，並得到我們的支持IDE 臨床研究、真實世界證據和 50 多篇臨床出版物，並解決了與安全溝通相關的任何問題。

The process has been more prolonged outside of the U.S. given our indirect commercial model. With this in mind, we were pleased to host our first Latin America users meeting in early November, which I was able to attend personally. This in-person meeting provided us with the opportunity to directly address the topic of the safety communication, clarify any potential misconceptions and explain clinical and real-world data supporting our Advanced Energy products. The event was also -- the event also included a series of presentations and discussion panels with our KOLs, which proved to be very interactive, providing our customers in Latin America region with the opportunity to learn from their peers.

考慮到我們的間接商業模式，該過程在美國以外的時間更長。考慮到這一點，我們很高興在 11 月初舉辦了我們的第一次拉丁美洲用戶會議，我能夠親自參加。這次面對面的會議為我們提供了直接討論安全溝通主題、澄清任何潛在誤解並解釋支持我們 Advanced Energy 產品的臨床和現實數據的機會。該活動還 - 該活動還包括與我們的 KOL 進行的一系列演示和討論小組，這被證明是非常互動的，為我們在拉丁美洲地區的客戶提供了向同行學習的機會。

Overall, the meeting was very productive and well attended, contributing to our strong handpiece sales in Latin America during the fourth quarter. With respect to our second primary objective, we obtained -- we continue to advance our regulatory strategy to secure additional 510(k) clearances related to the use of our Renuvion technology in cosmetic surgery procedures. During the fourth quarter, our team engaged with the FDA to obtain their feedback on a proposed 510(k) submission for a specific clinical indication for the use of the Renuvion APR handpiece for the coagulation of subcutaneous soft tissues where needed, following liposuction.

總的來說，這次會議非常富有成效，出席人數眾多，為我們第四季度在拉丁美洲的強勁手機銷售做出了貢獻。關於我們的第二個主要目標，我們獲得了——我們繼續推進我們的監管戰略，以確保與在整容手術中使用我們的 Renuvion 技術相關的額外 510(k) 許可。在第四季度，我們的團隊與 FDA 進行了接觸，以獲取他們對擬議的 510(k) 提交的反饋，該申請針對特定臨床適應症使用 Renuvion APR 手柄在抽脂後需要時凝固皮下軟組織。

We believe receiving clearance for this indication will address the remaining limitations of the safety communication. We submitted our related pre-submission request to the FDA in September and received the agency's formal response and feedback in December. This feedback was incorporated into our request for 510(k) clearance, which we submitted at the end of January and announced via press release on February 1. Our request for 510(k) clearance is supported by substantial evidence demonstrating the safety of our Renuvion APR handpiece when used following liposuction procedures, including data from our IDE clinical study in skin laxity as well as real-world evidence.

我們相信獲得對該適應症的許可將解決安全通信的剩餘限制。我們在 9 月向 FDA 提交了相關的預提交請求，並在 12 月收到了該機構的正式回復和反饋。該反饋已納入我們於 1 月底提交並於 2 月 1 日通過新聞稿宣布的 510(k) 許可請求。我們的 510(k) 許可請求得到了大量證據的支持，證明我們的 Renuvion 是安全的在吸脂手術後使用的 APR 手機，包括來自我們 IDE 皮膚鬆弛臨床研究的數據以及真實世界的證據。

As it relates to our real-world evidence, we were able to conduct an analysis of the use of Renuvion following liposuction, leveraging data from a large set of retrospective chart reviews. Our data set included treatment data from more than 480 patients and 1,180 areas of the body. Importantly, when this data was compared to real-world evidence for liposuction treatments gathered in literature review, our analysis demonstrated that there were no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone.

由於它與我們的真實世界證據相關，我們能夠利用大量回顧性圖表審查中的數據，對吸脂術後 Renuvion 的使用進行分析。我們的數據集包括來自 480 多名患者和 1,180 個身體部位的治療數據。重要的是，當將這些數據與文獻綜述中收集的吸脂治療的真實證據進行比較時，我們的分析表明，與單獨吸脂相比，吸脂手術後的 Renuvion 手術沒有新的或增加的風險。

During the fourth quarter, we also completed and submitted our request for an additional 510(k) clearance to obtain an indication related to the use of the Renuvion APR handpiece for the contraction of soft tissue, including subcutaneous tissue where needed on the body. On February 27, we were pleased to receive clearance for this indication, further demonstrating the safety and effectiveness of our Renuvion technology when used to contract soft tissue. We were pleased with the strong progress our regulatory team has made in this past year and in recent months as we continue to secure clearances supporting the safe and effective use of our Advanced Energy products.

在第四季度，我們還完成並提交了額外的 510(k) 許可申請，以獲得與使用 Renuvion APR 手機收縮軟組織（包括身體需要的皮下組織）相關的適應症。 2 月 27 日，我們很高興獲得該適應症的許可，進一步證明了我們的 Renuvion 技術用於收縮軟組織時的安全性和有效性。我們對我們的監管團隊在過去一年和最近幾個月取得的巨大進展感到高興，因為我們繼續獲得許可，支持安全有效地使用我們的 Advanced Energy 產品。

In addition to these efforts, I'd like to share an update on the important operational progress we have made on several other fronts to position Apyx Medical for improved financial performance in 2023. During the fourth quarter, our sales and marketing teams continued their efforts to prepare for the commercial launch related to the use of our Renuvion technology for the 2 new clinical indications that we secured in 2022. As a reminder, these 2 new clinical indications enable us to market our technology to both surgeons and potential patients for use in approximately 200,000 neck contouring procedures and 200,000 wrinkle reduction procedures, we estimate are performed in the U.S. each year.

除了這些努力之外，我還想分享我們在其他幾個方面取得的重要運營進展的最新情況，以定位 Apyx Medical 在 2023 年改善財務業績。在第四季度，我們的銷售和營銷團隊繼續努力為我們在 2022 年獲得的 2 個新臨床適應症使用我們的 Renuvion 技術相關的商業發布做準備。提醒一下，這 2 個新的臨床適應症使我們能夠向外科醫生和潛在患者推銷我們的技術以用於我們估計每年在美國進行大約 200,000 次頸部輪廓整形手術和 200,000 次除皺手術。

I am very pleased to announce that we began our launch for both indications on January 3. In tandem with this launch, we introduced our first direct-to-consumer brand campaign titled ThisIsMe. Our launch and direct-to-consumer brand campaign are supported by a nationwide campaigns featuring digital advertising on multiple platforms, social media initiatives and a dedicated patient-focused website, all designed to raise awareness of Renuvion and highlight the benefits of our technology. While we remain in the early months of this launch, the feedback we have received from surgeons and patients has been very positive.

我很高興地宣布，我們於 1 月 3 日開始針對這兩種適應症進行發布。與此次發布同時進行的是，我們推出了首個直接面向消費者的品牌活動，名為 ThisIsMe。我們的發布和直接面向消費者的品牌活動得到了全國范圍內的活動的支持，這些活動包括多個平台上的數字廣告、社交媒體活動和以患者為中心的專門網站，所有這些活動都旨在提高對 Renuvion 的認識並突出我們技術的好處。雖然我們仍處於此次發布的最初幾個月，但我們從外科醫生和患者那裡收到的反饋非常積極。

In advance of launch, we were also pleased to see our technology featured in 2 popular television series focused on cosmetic procedures during the fourth quarter. The E! channel series, Botched and TLC series Awake Surgery. On the new product front, we completed preparations for the commercialization of our next-generation Renuvion generator, the Apyx One Console. In designing the Apyx One Console, our product development team worked closely with members of the surgeon community. Our overarching goal was to enhance the functionality, ease of use and overall experience for our surgeon customers.

在推出之前，我們還很高興地看到我們的技術在第四季度出現在兩部以整容手術為重點的熱門電視連續劇中。電子！通道系列、Botched 和 TLC 系列喚醒手術。在新產品方面，我們完成了下一代 Renuvion 發電機 Apyx One 控制台的商業化準備工作。在設計 Apyx One 控制台時，我們的產品開發團隊與外科醫生社區成員密切合作。我們的首要目標是為我們的外科醫生客戶增強功能、易用性和整體體驗。

With this in mind, the Apyx One Console features key enhancements, including adaptive and intuitive touch screens, procedural precepts for specific parts of the body, cloud connectivity, data logging and sharing, remote upgrade capabilities and system diagnostics and an advanced gas system that measures and monitors gas volume and usage. In addition to these features, Apyx One is also designed to be compatible with future generations of our Renuvion handpieces. Following our launch in late January, the Apyx One is now available in the U.S., and we have introduced an upgrade program for all of our existing U.S. users.

考慮到這一點，Apyx One 控制台具有關鍵增強功能，包括自適應和直觀的觸摸屏、身體特定部位的程序規則、雲連接、數據記錄和共享、遠程升級功能和系統診斷以及先進的氣體系統，可測量並監控氣體量和使用情況。除了這些功能外，Apyx One 還設計為與我們未來幾代的 Renuvion 手機兼容。自 1 月下旬推出後，Apyx One 現已在美國上市，我們為所有現有美國用戶推出了升級計劃。

Lastly, in addition to our progress on the commercial, regulatory and new product development fronts, we have made important progress in recent months to enhance our balance sheet. In January, we were notified that the IRS had completed their examination of our federal income tax returns for 2018, '19 and '20 and approved that our cash tax refunds of at least $7.5 million be processed. We continue to await the receipt of these funds. On February 21, we announced a new 5-year agreement with MidCap Financial for a credit facility of up to $35 million. The facility includes a senior secured term loan of up to $25 million and a revolving line of credit up to $10 million. At closing, tranche 1 of the term loan provided us with approximately $8 million of net proceeds.

最後，除了我們在商業、監管和新產品開發方面取得的進展外，我們最近幾個月在改善資產負債表方面也取得了重要進展。 1 月，我們獲悉美國國稅局已完成對我們 2018 年、19 年和 20 年聯邦所得稅申報表的審查，並批准處理我們至少 750 萬美元的現金退稅。我們繼續等待收到這些資金。 2 月 21 日，我們宣布與 MidCap Financial 達成一項為期 5 年的新協議，提供高達 3500 萬美元的信貸額度。該貸款包括高達 2500 萬美元的高級擔保定期貸款和高達 1000 萬美元的循環信貸額度。交易結束時，第一期定期貸款為我們提供了大約 800 萬美元的淨收益。

On March 15, we filed an 8-K disclosing our entry into a sale and leaseback agreement, which further strengthens our balance sheet and financial condition. Under the terms of the agreement, the company sold our property located in Clearwater, Florida, including the building that houses our offices and manufacturing facility to VK Acquisition LLC for gross proceeds of $7.65 million. The agreement is subject to customary due diligence and inspection period over the next 35 days. Upon closing, we would expect to receive cash of approximately $6.7 million in proceeds from the sale of the -- from the sale transaction, net of commissions, expenses and first year deposit of our rent expense.

3 月 15 日，我們提交了一份 8-K 文件，披露了我們簽訂的售後回租協議，這進一步加強了我們的資產負債表和財務狀況。根據協議條款，該公司以 765 萬美元的總收益將我們位於佛羅里達州克利爾沃特的財產，包括我們辦公室和製造設施所在的大樓出售給 VK Acquisition LLC。該協議將在接下來的 35 天內接受慣常的盡職調查和檢查。交易完成後，我們預計將從出售交易中獲得約 670 萬美元的現金，扣除佣金、費用和第一年的租金押金。

We believe the $8 million of net proceeds from tranche 1 of our term loan, the $6.7 million of cash from our sale and leaseback transaction and the expected $7.5 million in tax refunds, together with potential future borrowings from our term loan and available borrowings on our revolver facility provide ample liquidity to fund our strategic growth initiatives over the near term, as we work to achieve our longer-term goals of generating sustainable profitability and strong free cash flow generation in the future. Stepping back, while 2022 ultimately provided to be more challenging than we had anticipated, we remain pleased with the continued passion we have seen for our technology from our customers. Despite difficult circumstances, our team has achieved notable progress across many key aspects of our strategy, as I just discussed.

我們相信我們的定期貸款第 1 部分的 800 萬美元淨收益、售後回租交易的 670 萬美元現金和預期的 750 萬美元退稅，以及我們定期貸款的潛在未來借款和我們的可用借款循環貸款提供充足的流動性來為我們的短期戰略增長計劃提供資金，因為我們努力實現我們在未來產生可持續盈利能力和強勁自由現金流的長期目標。退一步說，雖然 2022 年最終比我們預期的更具挑戰性，但我們仍然對客戶對我們技術的持續熱情感到高興。儘管處境艱難，但正如我剛才所討論的，我們的團隊在我們戰略的許多關鍵方面取得了顯著進展。

We believe these achievements position Apyx Medical for a return to driving strong sales growth and important improvements in our profitability profile, with the ample liquidity to fund our strategic growth initiatives in the near term as we progress towards our longer-term financial goals. I will discuss our 2023 outlook and related priorities further in a minute. But first, let me turn it over to Tara to review our quarterly financial results and 2023 guidance. Tara?

我們相信，這些成就使 Apyx Medical 能夠重新推動強勁的銷售增長和盈利狀況的重要改善，並在我們朝著長期財務目標邁進的同時，擁有充足的流動性為我們的戰略增長計劃提供資金。我將在一分鐘內進一步討論我們的 2023 年展望和相關優先事項。但首先，讓我把它交給 Tara 來審查我們的季度財務業績和 2023 年的指導方針。度母？

Thanks, Charlie. I will begin my review of our financial performance at the gross profit line since Charlie covered our revenue results. Gross profit for the fourth quarter of 2022 decreased $3.9 million or 32% year-over-year to $8.2 million. Gross profit margin was 65.3% compared to 72.2% in the prior year period. The decrease in our gross margin was driven primarily by changes in the sales mix between our 2 segments, product mix within our Advanced Energy segment and higher cost to manufacture inventory as we continue to experience increased material and shipping costs. These headwinds to our gross margin performance were partially offset by geographic mix within our Advanced Energy segment with domestic sales comprising a higher percentage of total sales and by the increased mix of newer product models.

謝謝，查理。自查理報導我們的收入結果以來，我將從毛利潤線開始審查我們的財務業績。 2022 年第四季度的毛利潤為 820 萬美元，同比下降 390 萬美元或 32%。毛利率為 65.3%，去年同期為 72.2%。我們毛利率的下降主要是由於我們兩個部門之間銷售組合的變化、我們先進能源部門的產品組合以及隨著我們繼續增加材料和運輸成本而增加的製造庫存成本。這些對我們毛利率表現的不利因素被我們 Advanced Energy 部門的地域組合部分抵消，國內銷售額佔總銷售額的比例更高，以及新產品型號組合的增加。

Operating expenses increased $0.3 million or 2% year-over-year to $14.2 million. The increase in operating expenses year-over-year was driven by professional services expenses and research and development expenses, which each increased by $0.3 million. These increases were partially offset by a $0.2 million decrease in SG&A and a $0.1 million decrease in salaries and related costs. Our operating expenses came in approximately $0.7 million above what our low end of guidance had assumed driven by higher-than-anticipated SG&A and professional service expenses related to higher insurance and legal expenses and higher consulting fees, respectively.

營業費用同比增長 30 萬美元或 2% 至 1,420 萬美元。營業費用的同比增長是由專業服務費用和研發費用推動的，這兩項費用分別增加了 30 萬美元。這些增長部分被 SG&A 減少 20 萬美元和薪金及相關成本減少 10 萬美元所抵消。我們的運營費用比我們的低端指導假設高出約 70 萬美元，這是由於高於預期的 SG&A 和專業服務費用，分別與更高的保險和法律費用以及更高的諮詢費用相關。

Loss from our operations for the fourth quarter of 2022 increased $4.2 million or 251% year-over-year to $5.9 million. Total other income net was $19,000 compared to total other expense of $0.2 million in the fourth quarter of 2021. Income tax expense was $0.2 million compared to $0.1 million in the fourth quarter of 2021. Net loss attributable to stockholders was $6 million or $0.17 per share compared to $2 million or $0.06 per share for the fourth quarter of 2021. Adjusted EBITDA loss for the fourth quarter of 2022 was $4.1 million compared to $0.3 million in the prior year period.

2022 年第四季度，我們的運營虧損增加了 420 萬美元，即 251%，達到 590 萬美元。其他總收入淨額為 19,000 美元，而 2021 年第四季度其他總費用為 20 萬美元。所得稅費用為 20 萬美元，而 2021 年第四季度為 10 萬美元。歸屬於股東的淨虧損為 600 萬美元或每股 0.17 美元相比之下，2021 年第四季度為 200 萬美元或每股 0.06 美元。2022 年第四季度調整後的 EBITDA 虧損為 410 萬美元，而去年同期為 30 萬美元。

As a reminder, we provided a detailed reconciliation from net loss attributable to stockholders to non-GAAP adjusted EBITDA loss in our earnings press release this morning. As of December 31, 2022, the company had cash and cash equivalents of $10.2 million compared to $30.9 million as of December 31, 2021. Cash used in operations in 2022 was $20.3 million compared to $10.4 million last year. The increase in use of cash from operations is primarily attributable to the year-over-year increase in net loss and a roughly $3.5 million increase in cash used for working capital, driven primarily by strategic investments in our inventory to ensure our ability to meet demand amidst the challenging global supply chain environment, offset partially by better accounts receivable collections compared to the prior year period.

提醒一下，我們在今天上午的收益新聞稿中提供了股東應占淨虧損與非 GAAP 調整後 EBITDA 虧損的詳細對賬。截至 2022 年 12 月 31 日，公司擁有現金和現金等價物 1020 萬美元，而截至 2021 年 12 月 31 日為 3090 萬美元。2022 年運營中使用的現金為 2030 萬美元，而去年為 1040 萬美元。運營現金使用量的增加主要是由於淨虧損同比增加以及用於營運資金的現金增加了約 350 萬美元，這主要是由於我們對庫存的戰略投資，以確保我們滿足需求的能力在充滿挑戰的全球供應鏈環境中，與去年同期相比，應收賬款收款情況有所改善，部分抵消了這一影響。

Turning to a review of our 2023 financial guidance, which we introduced in our earnings press release today, for the 12 months ending December 31, 2023, we expect total revenue in the range of $58 million to $61 million, representing growth of 30% to 37% year-over-year. Our total revenue guidance range assumes Advanced Energy revenue of $50 million to $53 million, representing growth of approximately 36% to 44% year-over-year and OEM revenue of approximately $8 million, representing growth of approximately 4% year-over-year.

回顧我們在今天的收益新聞稿中介紹的 2023 年財務指南，截至 2023 年 12 月 31 日的 12 個月，我們預計總收入在 5800 萬美元至 6100 萬美元之間，增長 30% 至同比增長 37%。我們的總收入指導範圍假設 Advanced Energy 收入為 5000 萬美元至 5300 萬美元，同比增長約 36% 至 44%，OEM 收入約為 800 萬美元，同比增長約 4%。

In terms of our profitability guidance for fiscal year 2023, we expect net loss attributable to stockholders of approximately $14 million compared to $23.2 million last year. Our formal financial guidance for 2023 incorporates the following considerations for modeling purposes. First, gross margins of approximately 65% to 67% this year compared to 65% last year. We expect tailwinds to our gross margin as our revenue mix favors the Advanced Energy segment and our U.S. growth exceeds growth in sales to customers outside the U.S. We also expect continued margin tailwinds related to product mix within our Advanced Energy segment. These tailwinds are expected to be partially or fully offset by year-over-year headwinds related to raw materials inflation, changes in foreign currency exchange rates against the U.S. dollar and, to a lesser extent, incremental rent expense related to our sale-leaseback transaction.

就我們 2023 財年的盈利指引而言，我們預計歸屬於股東的淨虧損約為 1400 萬美元，而去年為 2320 萬美元。我們的 2023 年正式財務指南包含以下建模考慮因素。首先，今年的毛利率約為 65% 至 67%，而去年為 65%。由於我們的收入組合有利於 Advanced Energy 細分市場，而且我們在美國的增長超過了對美國以外客戶的銷售增長，我們預計毛利率將受到推動。我們還預計，與 Advanced Energy 細分市場內的產品組合相關的利潤率將持續上漲。這些順風預計將部分或全部被與原材料通脹、外幣兌美元匯率變化以及與我們的售後回租交易相關的增量租金支出相關的同比逆風部分或全部抵消.

Second, the year-over-year change in operating expenses to range between a decrease of 1% to growth of 5%. Third, total interest and other loss of approximately $1.4 million in 2023 compared to total interest and other income of approximately $0.7 million last year. Total interest and other loss in 2023 includes net interest expense of approximately $1.7 million and a $350,000 gain in our other income loss line related to the lapse of the statute of limitations on our joint and several payroll liability. Fourth, income tax benefit of approximately $2.2 million compared to an expense of $0.4 million last year.

其次，營業費用的同比變化在下降 1% 到增長 5% 之間。第三，2023 年的利息和其他損失總額約為 140 萬美元，而去年的利息和其他收入總額約為 70 萬美元。 2023 年的總利息和其他損失包括約 170 萬美元的淨利息支出和與我們的連帶工資責任的時效失效相關的其他收入損失項目中的 350,000 美元收益。第四，所得稅收益約為 220 萬美元，而去年的支出為 40 萬美元。

We also expect noncash depreciation and amortization of approximately $0.7 million noncash stock-based compensation of approximately $6 million, noncontrolling interest of approximately $125,000 and weighted average diluted shares outstanding of approximately 34.8 million shares. And for the first quarter of 2023, we anticipate total revenue in the range of $10.8 million to $11.2 million driven by a decrease in Advanced Energy sales in the range of approximately 21% to 17% year-over-year, offset partially by growth in OEM sales of approximately 34% year-over-year.

我們還預計非現金折舊和攤銷約為 70 萬美元，非現金股票補償約為 600 萬美元，非控股權益約為 125,000 美元，加權平均稀釋後流通股約為 3480 萬股。對於 2023 年第一季度，我們預計總收入將在 1080 萬美元至 1120 萬美元之間，這是由於先進能源銷售額同比下降約 21% 至 17%，部分被增長抵消OEM 銷售額同比增長約 34%。

Finally, our formal financial guidance for 2023 assumes we end the year with at least $18 million in cash and cash equivalents and restricted cash on our balance sheet as of December 31, 2023. This cash projection for the year ended 2023 includes a number of key assumptions and discrete items to bear in mind when evaluating our financial condition. First, we expect normalized cash used in operating and investing activities of approximately $14.5 million in 2023. This reflects our expectation for GAAP net loss of $14 million, $0.5 million of CapEx and that are noncash items, including depreciation and amortization and stock comp expense as well as noncash amortization related to our debt facilities are offset by cash used in working capital this year.

最後，我們對 2023 年的正式財務指導假設，截至 2023 年 12 月 31 日，我們的資產負債表上至少有 1800 萬美元的現金和現金等價物以及受限制的現金。這一對 2023 年終了年度的現金預測包括一些關鍵評估我們的財務狀況時要牢記的假設和離散項目。首先，我們預計 2023 年用於經營和投資活動的標準化現金約為 1450 萬美元。這反映了我們對 GAAP 淨虧損 1400 萬美元、資本支出 50 萬美元以及非現金項目的預期，包括折舊和攤銷以及股票補償費用以及與我們的債務融資相關的非現金攤銷被今年用於營運資金的現金所抵消。

Second, our cash projection for the year ended 2023 includes a onetime benefit to working capital of $7.5 million related to the tax refund discussed earlier and a onetime benefit to cash flow from investing activities of $6.7 million related to the sale-leaseback transaction. Third, our cash projection for the year ended 2023 includes the $8 million of net proceeds we received from tranche 1 of our term loan, but assumes no additional borrowings on either the term loan or the revolver in 2023.

其次，我們對截至 2023 年的現金預測包括與之前討論的退稅相關的 750 萬美元營運資本一次性收益以及與售後回租交易相關的 670 萬美元投資活動現金流的一次性收益。第三，我們對截至 2023 年的現金預測包括我們從第一期定期貸款中收到的 800 萬美元淨收益，但假設 2023 年沒有任何定期貸款或循環貸款的額外借款。

With that, I'll turn the call back to Charlie for closing remarks.

有了這個，我會把電話轉回給查理，讓他發表結束語。

Thanks, Tara. As mentioned, our 2023 revenue guidance assumes total revenue growth of at least 30% year-over-year to $58 million, driven primarily by Advanced Energy growth of at least 36% year-over-year to $50 million. In 2023, the low end of our revenue guidance assumes improving year-over-year sales results as we progress through the year with the stronger Advanced Energy year-over-year growth trends in the second half versus growth trends in the first half. We expect strong contributions to growth from improving generator sales, most notably in the U.S. as we move through the year. We also expect improving handpiece sales trends in both the U.S. and OUS as we move through the year.

謝謝，塔拉。如前所述，我們的 2023 年收入指引假設總收入同比增長至少 30% 至 5,800 萬美元，這主要受 Advanced Energy 同比增長至少 36% 至 5,000 萬美元的推動。到 2023 年，我們的收入指引的低端假設隨著我們在這一年中取得進展，下半年 Advanced Energy 的同比增長趨勢與上半年的增長趨勢相比，銷售業績將有所改善。我們預計發電機銷售的改善將對增長做出強勁貢獻，尤其是在美國，因為我們將度過這一年。我們還預計，隨著這一年的推進，美國和美國的手機銷售趨勢都會有所改善。

We expect this improving performance to be driven by the recent and continued efforts of our team to raise awareness and educate the market on the safety and efficacy of our Renuvion technology with important tailwinds related to the recent commercial launch of our Renuvion clinical indications obtained in 2022 and our related consumer-focused marketing activities. Our recently obtained 510(k) clearance received for the use of Renuvion APR handpiece for the contraction of soft tissue and the recent commercial launch of our new Renuvion Apyx One generator. Importantly, the low end of our Advanced Energy revenue guidance assumes no change in the FDA safety communication as it stands currently.

我們預計，這種改善的表現將受到我們團隊最近和持續努力的推動，以提高人們對我們 Renuvion 技術的安全性和有效性的認識並教育市場，以及與最近我們在 2022 年獲得的 Renuvion 臨床適應症的商業發布相關的重要順風以及我們相關的以消費者為中心的營銷活動。我們最近獲得了 510(k) 許可，因為使用 Renuvion APR 手機來收縮軟組織以及最近商業推出我們的新型 Renuvion Apyx One 發生器。重要的是，我們 Advanced Energy 收入指南的低端假設 FDA 安全通信目前沒有變化。

In addition to driving both adoption and utilization of our Advanced Energy products by leveraging these important tailwinds in 2023, we remain focused on continuing our strong pace of operational progress by executing on the following strategic initiatives. First, we remain focused on advancing our regulatory strategy to address the remaining limitations of the safety communication and improve our ability to market our technology. Second, we will continue to enhance our Renuvion product portfolio by working to bring new technologies like our Apyx One Console to market. And third, we will further expand our portfolio of clinical evidence supporting the use of our new products.

除了在 2023 年利用這些重要的順風推動我們 Advanced Energy 產品的採用和利用外，我們仍然專注於通過執行以下戰略計劃來繼續我們強勁的運營進展步伐。首先，我們仍然專注於推進我們的監管戰略，以解決安全通信的剩餘局限性，並提高我們的技術營銷能力。其次，我們將通過努力將 Apyx One 控制台等新技術推向市場，繼續增強我們的 Renuvion 產品組合。第三，我們將進一步擴大支持使用我們新產品的臨床證據組合。

And fourth, we will continue to closely manage our expenses and drive progress towards improving profitability while evaluating additional non-dilutive opportunities to further enhance our balance sheet condition. As our guidance implies, in 2023, we expect to reduce our net loss attributed to stockholders by more than 40% year-over-year, and I want to emphasize that driving, improving cash flow from operations is a 2023 priority for our organization as part of our multiyear initiative to generate strong free cash flow on a sustainable basis in the future.

第四，我們將繼續密切管理我們的費用並推動提高盈利能力，同時評估其他非稀釋性機會以進一步改善我們的資產負債表狀況。正如我們的指導意見所暗示的那樣，到 2023 年，我們預計歸因於股東的淨虧損同比減少 40% 以上，我想強調的是，推動、改善運營現金流是我們組織 2023 年的首要任務，因為我們多年計劃的一部分，旨在在未來可持續地產生強大的自由現金流。

Through our recent achievements and continued progress on the initiatives I've outlined, we look forward to returning to our historical cadence of strong growth and our trajectory of progress towards profitability in 2023. Moreover, with unique technology supported by a strong portfolio of clinical evidence, large and rapidly growing addressable markets that we are just beginning to penetrate and a dedicated team of employees, we remain excited about the future prospects in the years to come as we drive innovation in the cosmetic surgery market.

通過我們最近取得的成就和我所概述的舉措的持續進展，我們期待在 2023 年回到我們強勁增長的歷史節奏和我們實現盈利的進步軌跡。此外，憑藉強大的臨床證據組合支持的獨特技術，我們剛剛開始滲透的龐大且快速增長的目標市場和敬業的員工團隊，我們對未來幾年的未來前景感到興奮，因為我們推動了整容手術市場的創新。

I'd like to conclude my remarks today by thanking our employees and distributors for their efforts and thanking them for the progress they've achieved amidst a challenging year. I'd like to thank our customers, investors and everyone on today's call for their continued support of Apyx Medical.

最後，我想感謝我們的員工和分銷商的努力，並感謝他們在充滿挑戰的一年中取得的進步，以此來結束我今天的發言。我要感謝我們的客戶、投資者和今天電話會議上的每一個人，感謝他們對 Apyx Medical 的持續支持。

With that, operator, let's now open the call for questions.

話雖如此，接線員，現在讓我們開始提問。

(Operator Instructions) And our first question will come from Matthew O'Brien with Piper Sandler.

（操作員說明）我們的第一個問題將來自 Matthew O'Brien 和 Piper Sandler。

Either Charlie or Tara, can you just talk about the guidance for the year, especially in light of the Q1 commentary? Because as I look back historically, the company in Q4 of '21 did about $16 million in total sales. You'd have to do about that for the rest of the year, Q3 through -- sorry, Q2 through Q4 to hit the low end of your guidance range. So it just seems like after a year of difficult visibility, there's a lot of ramp that's built in, especially in the back half of the year to get even to the low end of the guidance. So why do that coming off such a tough year and what gives you all that confidence?

無論是查理還是塔拉，你能談談今年的指導，特別是根據第一季度的評論嗎？因為當我回顧歷史時，該公司在 21 年第四季度的總銷售額約為 1600 萬美元。你必須在今年餘下的時間裡做這件事，從第三季度到——抱歉，從第二季度到第四季度，才能達到你的指導範圍的低端。因此，似乎在經歷了一年的艱難可見度之後，內置了很多斜坡，尤其是在今年下半年，甚至達到了指導的低端。那麼，為什麼要度過如此艱難的一年，是什麼給了你所有的信心？

Yes. Thanks, Matt. I appreciate the question. So the first thing is that we are confident in our ability to grow AE at least [36%]. And the reason that we're confident for that is for a few reasons. We actually have multiple tailwinds for growth. And the first is, remember, we just started in January, our commercialization related to the 510(k) that we obtained earlier in '22. And this is the first time that we have been able to market directly to patients to be able to talk to them about the benefits of Renuvion for these specific procedures. And that, we believe, will develop and have tailwinds in 2023.

是的。謝謝，馬特。我很欣賞這個問題。所以第一件事是我們對我們至少增長 AE 的能力充滿信心 [36%]。我們對此充滿信心的原因有幾個。我們實際上有多個增長的順風。首先是，請記住，我們在一月份才開始，我們的商業化與我們在 22 年初獲得的 510(k) 相關。這是我們第一次能夠直接向患者推銷，以便能夠與他們討論 Renuvion 對這些特定程序的好處。我們相信，這將在 2023 年發展並帶來順風。

Second, our latest 510(k) clearance that we just obtained in February, this allows us to market the use of our Renuvion handpiece for the contraction of soft tissue anywhere on the body as needed. And so that is another piece of marketing that we will be able to talk about and do as we move forward in 2023. And third, we actually just launched our new Apyx One generator, which obviously features multiple enhancements and gives the team another reason to engage with potential customers. And not only will it do that is for the first time, we will have a source of revenue for upgrades associated with that from existing customers.

其次，我們剛剛在 2 月份獲得的最新 510(k) 許可允許我們將 Renuvion 手機用於根據需要收縮身體任何部位的軟組織。因此，這是我們在 2023 年前進時可以談論和做的另一項營銷。第三，我們實際上剛剛推出了新的 Apyx One 生成器，它顯然具有多項增強功能，並為團隊提供了另一個理由與潛在客戶互動。這不僅是第一次這樣做，我們還將獲得與現有客戶相關的升級的收入來源。

So we've made important progress in educating our users, potential new customers, and we believe that these effects will help us in 2023. And importantly, that our low end of our guidance still assumes no change in the FDA safety communication. And we also expect improving trends and contributions for our Advanced Energy growth to our existing OUS distributors, too. So we believe that we've got a lot of new tailwinds behind us. We also were faced with easy comparisons in the second through fourth quarter as far as percentages go, and we believe that we can get back to growing this business in 2023.

因此，我們在教育用戶和潛在新客戶方面取得了重要進展，我們相信這些影響將在 2023 年對我們有所幫助。而且重要的是，我們指南的低端仍然假設 FDA 安全溝通沒有變化。我們還期望我們的 Advanced Energy 增長對我們現有的 OUS 分銷商的改進趨勢和貢獻。因此，我們相信我們身後有很多新的順風。就百分比而言，我們在第二季度到第四季度也面臨著簡單的比較，我們相信我們可以在 2023 年恢復業務增長。

Got it. And then that kind of -- one part of the response there dovetails into the second question, just on Apyx One and the new generator. Can you give us a sense for what that replacement cycle might look like? I don't know. I'm sure you don't want to give us the number of customers you have, but what level of upgrade or revenue opportunity you see there in '23 and even in '24 as well?

知道了。然後那種 - 那裡的回應的一部分與第二個問題相吻合，只是關於 Apyx One 和新的發電機。您能告訴我們更換週期可能是什麼樣子嗎？我不知道。我確定您不想告訴我們您擁有的客戶數量，但是您在 23 年甚至 24 年看到了什麼樣的升級或收入機會？

And you are correct of talking about it in '23 and '24 because it will be a multiyear program to upgrade everybody. I think the important thing for the Apyx One and the important thing to remember there is that this for the first time is really a console, a surgical console that was designed by members of this community, i.e., plastic surgeons to be able to function and do the body contouring procedures that they're looking to do. And so we will be upgrading for a fee to our existing users and we will not be giving any of those away.

你在 23 和 24 年談論它是正確的，因為這將是一個升級每個人的多年計劃。我認為對於 Apyx One 來說重要的是，重要的是要記住，這是第一次真正成為一個控制台，一個由這個社區的成員設計的手術控制台，即整形外科醫生能夠發揮作用和做他們想做的塑身手術。因此，我們將向現有用戶收取一定費用進行升級，我們不會放棄任何這些用戶。

And we are right in -- we're building production as we speak in 2023. And we right now are continuing to offer both the Apyx One and the RS3, but we intend to be selling the Apyx One fully by year-end, and we'll continue to sell the RS3 generator internationally. But the upgrade itself will be a new revenue source that we have actually never had here at Apyx. So we're excited about what this means for us, what this brings to our customers. And the other thing, too, about Apyx One is it will drive all future new instrumentation also.

我們就在——我們正在建設生產，就像我們在 2023 年所說的那樣。我們現在繼續提供 Apyx One 和 RS3，但我們打算在年底前完全銷售 Apyx One，並且我們將繼續在國際上銷售 RS3 發電機。但升級本身將成為我們在 Apyx 從未有過的新收入來源。所以我們很高興這對我們意味著什麼，這給我們的客戶帶來了什麼。關於 Apyx One 的另一件事是它也將驅動所有未來的新儀器。

Our next question is from Matt Hewitt with Craig-Hallum Capital Group.

我們的下一個問題來自 Craig-Hallum Capital Group 的 Matt Hewitt。

Maybe just a follow-on on the revenue side a little bit. As you have launched these new marketing campaigns here recently, what has been the feedback and the response from the markets that you've been specifically targeting? Are you seeing that in the sales and the utilization? Or any color that you could provide there?

也許只是收入方面的後續行動。由於您最近在這裡發起了這些新的營銷活動，您特別針對的市場的反饋和反應是什麼？您是否在銷售和利用率中看到了這一點？或者你可以在那裡提供任何顏色？

Yes. Look, we are still in the initial months of our direct-to-consumer campaign. So I want to be clear there and make sure that we're -- as we sit here today, we're 2.5 months into this. But the feedback that we have gotten from surgeon customers and patients has been very, very positive that the ThisIsMe campaign is resonating with them. And when you're looking at this campaign and really if you're stripping things down from this campaign, what really is hitting home is the fact that people want to look like they look. They want to look natural. They don't want to be full of fillers and all kinds of things. They want a natural look. They just want to look younger. And that's exactly what the Renuvion technology is allowing doctors to do is to bring that. And that is the whole -- that is the whole genesis, if you will, of the ThisIsMe campaign, and it's really resonating both with the consumer side and the physician side.

是的。看，我們仍處於直接面向消費者活動的最初幾個月。所以我想說清楚，並確保我們 - 正如我們今天坐在這裡一樣，我們已經進行了 2.5 個月。但我們從外科醫生客戶和患者那裡得到的反饋非常非常積極，ThisIsMe 活動引起了他們的共鳴。當你看這個活動時，如果你真的從這個活動中剝離一些東西，真正擊中要害的是人們想要看起來像他們的樣子。他們想要看起來自然。他們不想充滿填充物和各種各樣的東西。他們想要自然的外觀。他們只是想看起來更年輕。而這正是 Renuvion 技術允許醫生做的就是帶來它。這就是整個 - 如果你願意的話，這就是 ThisIsMe 活動的整個起源，它確實在消費者方面和醫生方面產生了共鳴。

That's helpful. And then maybe my follow-up. In the OUS markets, it sounds like you're starting to see some recovery in the utilization, but that it's the generators that are the lag there. What are you hearing from your distributor partners as you've received a couple of approvals, I mean, are they literally just waiting for this last piece? And at that point, they've said they'll come back? Or what do you think is going to be the catalyst to get them to come back full?

這很有幫助。然後也許是我的後續行動。在 OUS 市場，聽起來您開始看到利用率有所回升，但那裡的滯後是發電機。當您收到一些批准時，您從您的經銷商合作夥伴那裡聽到了什麼，我的意思是，他們真的只是在等待最後一件嗎？那時，他們說他們會回來？或者你認為什麼會成為讓他們滿載而歸的催化劑？

Yes. No, it's a really good question. And remember that worldwide, we grew generators, we grew our installed base in our active -- or in the U.S., actually, we grew our installed base and our active installed base 20% even through all the things at the safety notice. And outside the United States, it's a little bit tougher because of our indirect model. But yes, I think the -- when we were down in Brazil, the part that was tough for the Latin American audience to understand was the part of the safety notice where it said, do not use after lipo. And after talking through that and walking them through that and the customers through that, we made a lot of headway there and a lot of understanding on exactly what was going on.

是的。不，這是一個非常好的問題。請記住，在全球範圍內，我們增加了發電機，我們增加了我們活躍的安裝基數 - 或者在美國，實際上，我們增加了我們的安裝基數和我們的活躍安裝基數 20% 即使通過安全通知中的所有事情。在美國以外，由於我們的間接模型，它有點困難。但是，是的，我認為——當我們在巴西的時候，拉丁美洲觀眾很難理解的部分是安全通知的一部分，上面寫著，不要在抽脂後使用。在討論並引導他們和客戶完成之後，我們在這方面取得了很大進展，並且對到底發生了什麼有了很多了解。

And I think that's why we saw such a strong fourth quarter in Latin America, and we would expect improving trends in a lot of different areas as we move forward this year. And I think that once we are able to get through of all of this, I think that, yes, that will take care of any existing markets that are out there today.

我認為這就是我們在拉丁美洲看到如此強勁的第四季度的原因，我們預計隨著今年的前進，許多不同領域的趨勢都會有所改善。而且我認為，一旦我們能夠完成所有這些，我認為，是的，這將照顧到今天存在的任何現有市場。

Our next question is from Frank Takkinen with Lake Street Capital Markets.

我們的下一個問題來自 Lake Street Capital Markets 的 Frank Takkinen。

I wanted to first start with one on the most recent 510(k) clearance. Can you just speak to whether or not that actually technically does cover use after liposuction and whether or not there could be a potential amendment to the safety notification that's out there right now based on that 510(k) in advance of the actual specific lipo 510(k)?

我想首先從最近的 510(k) 許可開始。你能不能談談這在技術上是否確實涵蓋了吸脂術後的使用，以及是否可以根據實際特定的 lipo 510 之前的 510(k) 對目前的安全通知進行潛在的修正(k)?

Yes. So I'm not going to answer the second question. Obviously, we are working with the agency and doing everything we can to the agency to make sure that they are comfortable with the safety and the efficacy profile of our technology. And so that remains obviously a huge focus for us. But when you're talking about the second indication that we just obtained on February 27, it has the contraction of soft tissue everywhere on the body and as needed. And so the real question is, is it needed after liposuction. And if the answer to that is yes, then that 510(k) suffices for that.

是的。所以我不打算回答第二個問題。顯然，我們正在與該機構合作，並儘我們所能向該機構確保他們對我們技術的安全性和有效性概況感到滿意。因此，這顯然仍然是我們關注的焦點。但是當你談到我們在 2 月 27 日剛剛獲得的第二個跡象時，它會在身體各處根據需要進行軟組織收縮。所以真正的問題是，抽脂後是否需要它。如果答案是肯定的，那麼 510(k) 就足夠了。

And so it was an important 510(k) for us to get. It obviously shows that the agency believes that the technology is safe and effective. And now we, as an organization, are still working through with the agency, and we still have our submission in that we submitted at the end of January.

因此，這對我們來說是一個重要的 510(k)。這顯然表明該機構認為該技術是安全有效的。現在，作為一個組織，我們仍在與該機構合作，我們仍然有我們在 1 月底提交的意見書。

Okay. That's helpful. And then just for my second one, maybe on the cash balance, assuming the sale leaseback closes and including the $8 million from MidCap, I've got you had pro forma around the $25 million using year-end cash. Is that enough to drop the going concern? Or do you still need the tax credit to have that going concern drops?

好的。這很有幫助。然後只是我的第二個，也許是現金餘額，假設銷售回租結束，包括來自 MidCap 的 800 萬美元，我已經讓你有大約 2500 萬美元的年終現金預估。這足以放棄持續經營嗎？還是您仍然需要稅收抵免才能使持續經營下降？

Well, we expect to end, again, the year 2023 with $18 million in cash and that's normal -- based on normalized operating investing activities of $14.5 million in 2023, $500,000 of which is CapEx. And it also assumes that our noncash items, including depreciation and amortization are offset by cash used in working capital. And we do have the discrete items, the sale leaseback and the tax refund as well as the net proceeds of $8 million on our loan. We are not assuming in our guidance anything on additional borrowings on either of the term loan or the revolver in 2023.

好吧，我們預計到 2023 年將再次以 1800 萬美元的現金結束，這很正常——基於 2023 年 1450 萬美元的正常運營投資活動，其中 50 萬美元是資本支出。它還假設我們的非現金項目（包括折舊和攤銷）被營運資金中使用的現金抵消。我們確實有離散項目、售後回租和退稅以及 800 萬美元的貸款淨收益。我們在我們的指導中沒有假設任何關於 2023 年定期貸款或循環貸款的額外借款。

As we progress through that and those things do happen, the tax refund comes in, and we do close on the sale leaseback, that should remove the need to disclose anything. And I just want to clarify that the disclosure in our 10-K was that we assessed the conditions and the potential environment to create a going concern. But all of these things that we just -- that I just talked about, we believe and management disclose that we believe that all of these things alleviate the risk of a going concern, and that was agreed upon by our auditors in the 10-K.

隨著我們的進展，這些事情確實發生了，退稅進來了，我們確實結束了售後回租，這應該消除了披露任何信息的需要。我只是想澄清一下，我們 10-K 中的披露是我們評估了創造持續經營的條件和潛在環境。但是我們剛剛 - 我剛才談到的所有這些事情，我們相信並且管理層透露我們相信所有這些事情都會降低持續經營的風險，並且我們的審計師在 10-K 中同意了這一點.

We are showing no further questions in the queue at this time. That does conclude our conference for today. Thank you for your participation.

我們目前不會在隊列中顯示更多問題。我們今天的會議到此結束。感謝您的參與。