Lifeward Ltd (LFWD) 2022 Q4 法說會逐字稿

Good morning, everyone, and welcome to the ReWalk Robotics Fourth Quarter Earnings Conference Call. (Operator Instructions)

大家早上好，歡迎來到 ReWalk Robotics 第四季度收益電話會議。 （操作員說明）

At this time, I'd like to turn the conference call over to Mike Lawless, Chief Financial Officer. Sir, please go ahead.

此時，我想將電話會議轉交給首席財務官 Mike Lawless。先生，請繼續。

Thanks, Jamie. Good morning, and welcome to ReWalk Robotics Fourth Quarter and Full Year 2022 Earnings Call. I'm Mike Lawless, ReWalk Robotics' Chief Financial Officer. And with me on the call are Larry Jasinski, ReWalk's Chief Executive Officer; and Almog Adar, ReWalk's Vice President of Finance. Earlier this morning, ReWalk issued a press release detailing financial results for the 3 months and full year ended December 31, 2022. This press release and a webcast of this call can be accessed through the Investor Relations section of the ReWalk website at rewalk.com. Before we get started, I'd like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act.

謝謝，傑米。早上好，歡迎來到 ReWalk Robotics 第四季度和 2022 年全年收益電話會議。我是 ReWalk Robotics 的首席財務官 Mike Lawless。與我通話的還有 ReWalk 的首席執行官拉里·賈辛斯基 (Larry Jasinski)；和 ReWalk 的財務副總裁 Almog Adar。今天上午早些時候，ReWalk 發布了一份新聞稿，詳細介紹了截至 2022 年 12 月 31 日的三個月和全年的財務業績。可通過 ReWalk 網站 rewalk.com 的投資者關係部分訪問本新聞稿和本次電話會議的網絡直播.在我們開始之前，我想提醒大家，在今天的電話會議上發表的任何表達對未來事件和公司未來業績的信念、期望、預測、預測、預期或意圖的陳述都可以被視為前瞻性陳述，因為由《私人證券訴訟改革法》定義。

These forward-looking statements are based on information available to ReWalk management as of today and involve risks and uncertainties, including those noted in our press release and ReWalk's filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. ReWalk specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. A replay will be available shortly after completion of the call accessible from the dial-in information in today's press release. The archived webcast will be available in the Investor Relations section of the company's website.

這些前瞻性陳述基於截至今日 ReWalk 管理層可獲得的信息，涉及風險和不確定性，包括我們的新聞稿和 ReWalk 向美國證券交易委員會提交的文件中提到的風險和不確定性。此類前瞻性陳述並非對未來業績的保證。實際結果可能與前瞻性陳述中預測的結果存在重大差異。 ReWalk 明確否認有任何更新這些前瞻性陳述的意圖或義務，除非法律要求。電話會議結束後不久，可通過今天新聞稿中的撥入信息訪問重播。存檔的網絡廣播將在公司網站的投資者關係部分提供。

For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on February 23, 2022 -- 2023, excuse me. Since that date, ReWalk may have made subsequent announcements related to the topics discussed, so please reference the company's most recent press releases and SEC filings for the most up-to-date information. And with that, I'll turn the call over to ReWalk's CEO, Larry Jasinski.

為了那些可能正在收聽重播或存檔網絡廣播的人的利益，本次電話會議於 2022 年 2 月 23 日至 2023 年舉行並錄製，對不起。自該日起，ReWalk 可能會發布與所討論主題相關的後續公告，因此請參閱公司最新的新聞稿和 SEC 備案文件以獲取最新信息。有了這個，我將把電話轉給 ReWalk 的首席執行官拉里·賈辛斯基。

Thank you, Mike. Good morning. Thank you for joining us today. We closed 2022 with positive results in Q4 and more importantly, with progress on each of our major areas of focus to drive the business over the next 3 years. The goals of 2022 were to move forward with CMS, to expand acceptance of direct supply in Germany, to improve the ReWalk system by adding curb and stair-climbing features in the U.S. and with an advanced model of the ReWalk that can improve the user experience and to identify additional product offerings to build our critical and strategic mass that improves our financial performance.

謝謝你，邁克。早上好。感謝您今天加入我們。我們在 2022 年第四季度取得了積極成果，更重要的是，我們在未來 3 年推動業務發展的每個主要重點領域都取得了進展。 2022 年的目標是推進 CMS，擴大德國對直接供應的接受度，通過在美國添加路邊和爬樓梯功能改進 ReWalk 系統，以及改進用戶體驗的先進 ReWalk 模型並確定額外的產品供應，以建立我們的關鍵和戰略質量，從而提高我們的財務業績。

Sales in Q4 were $2.18 million, driven by new VA activity post COVID, the provision of systems from direct supply acceptance in Germany and the growth with the distributed MyoCycle product.

第四季度的銷售額為 218 萬美元，這得益於 COVID 後新的 VA 活動、德國直接供應接受的系統供應以及分佈式 MyoCycle 產品的增長。

The MyoCycle is an excellent example of the efficiency and value of an adjacent offering and a model for adding more products. Mike will address our results further in the financial discussion. During 2022, we requested a benefit category in the public hearings with the Healthcare Common Procedure Coding Systems known as (inaudible) under our established coverage code. CMS has not yet provided the category in pricing but instructed us to begin the process of submitting cases. The first Medicare patient received their system during Q4 and has completed their training program. The category and pricing are still in processing with the Medicare administrative contractor, the MAC.

MyoCycle 是相鄰產品的效率和價值的一個很好的例子，也是添加更多產品的模型。邁克將在財務討論中進一步討論我們的結果。在 2022 年期間，我們在公開聽證會上要求根據我們既定的覆蓋代碼使用稱為（聽不清）的醫療保健通用程序編碼系統的福利類別。 CMS 尚未在定價中提供類別，但指示我們開始提交案例的過程。第一位 Medicare 患者在第四季度接受了他們的系統並完成了他們的培訓計劃。醫療保險行政承包商 MAC 仍在處理類別和定價。

We are now moving ahead with multiple patient submissions and building the required infrastructure to replicate this for a large number of patients on an ongoing basis. In November, BARMER, the second largest statutory health insurer, the SHI in Germany elected to adopt direct supply and withdrew their Federal Social Court challenge. They immediately supplied the individual from the case with the ReWalk system and have moved others forward under the direct supply approach. Our initial submission to the U.S. FDA to expand access for the disabled community by adding stair and curb function was reviewed, and we've received questions in the form of an additional information request for the submission.

我們現在正在推進多個患者的提交，並構建所需的基礎設施，以持續為大量患者復制這一點。 11 月，德國第二大法定健康保險公司 BARMER 選擇採用直接供應並撤回其聯邦社會法院的挑戰。他們立即為案件中的個人提供 ReWalk 系統，並在直接供應方式下推動其他人前進。我們最初向美國 FDA 提交的關於通過添加樓梯和路緣功能來擴大殘疾人社區的訪問權限的申請已經過審查，我們已經收到了提交的附加信息請求形式的問題。

Among the questions was the request for usability data as per new FDA guidelines. We promptly set up and conducted the required study and this additional information was subsequently submitted to the FDA for consideration. In parallel, we also conducted a similar study with the advanced generation of the ReWalk system and will include that information in that submission. The next generation of the ReWalk system includes additional user controls, provision of additional data and utilization for the user and care providers, and enhanced longer-cycle battery system and other design features requested by users over the past few years.

問題之一是根據新的 FDA 指南要求提供可用性數據。我們迅速建立並進行了所需的研究，隨後將這些額外信息提交給 FDA 考慮。與此同時，我們還對先進的 ReWalk 系統進行了類似的研究，並將在該提交中包含該信息。下一代 ReWalk 系統包括額外的用戶控制、為用戶和護理提供者提供額外的數據和使用，以及增強的更長周期電池系統和過去幾年用戶要求的其他設計功能。

Over the course of 2022, we considered a number -- a significant number of paths to increase our critical mass and to develop long-term strategic mass. Our goal is to add products that fit within the neuro rehabilitation segment and that are adjacent to our call points within the clinics and in the home community after clinic treatment or training is completed. With the emphasis on financial value, we are focused on product lines that will be accretive to our financial position in the 12 month or last cycle, offer leverage and synergy and operational cost, and we will contribute to achieving a breakeven profitable position with our current capital. I'd now like to turn the call over to Mike for a review of financial details. Mike?

在 2022 年的過程中，我們考慮了一些——大量增加我們的臨界質量和發展長期戰略質量的途徑。我們的目標是在診所治療或培訓完成後，添加適合神經康復領域的產品，並在診所和家庭社區內與我們的呼叫點相鄰。由於強調財務價值，我們專注於將在 12 個月或上一個週期中增加我們財務狀況的產品線，提供槓桿作用和協同效應以及運營成本，我們將通過我們目前的能力為實現盈虧平衡的盈利狀況做出貢獻首都。我現在想把電話轉給邁克，讓他審查財務細節。麥克風？

Thanks, Larry. For most of my discussion of the financial results, I'm going to focus on the Q4 performance as our press release and 10-K address the annual results. For the fourth quarter of 2022, ReWalk reported revenue of $2.2 million, up $0.9 million or 75% as compared to $1.2 million in the fourth quarter of 2021. The increase in quarterly revenue was a result of improved sales performance across product lines and geographies. For our core exoskeleton product line, we experienced growth in volumes in both the U.S. and EU both from a year-over-year standpoint versus Q4 '21 and on a sequential basis from Q3 '22.

謝謝，拉里。對於我對財務業績的大部分討論，我將重點關注第四季度的業績，因為我們的新聞稿和 10-K 解決了年度業績。 2022 年第四季度，ReWalk 報告的收入為 220 萬美元，與 2021 年第四季度的 120 萬美元相比增加了 90 萬美元或 75%。季度收入的增長是由於跨產品線和地區的銷售業績改善所致。對於我們的核心外骨骼產品線，與 21 年第四季度和 22 年第三季度相比，我們在美國和歐盟的銷量都實現了同比增長。

We also had strong performance in Q4 from our distributed MyoCycle FES products. We market these as an exclusive distributor to U.S. rehabilitation clinics, VA hospitals and to veterans for home use. Since we started distributing this product line in 2020, we have steadily grown it and achieved revenue of over $0.5 million in Q4, marking by far our highest quarterly performance for this product line. I also want to briefly comment on the annual revenue performance. For the full year 2022, we achieved revenue of $5.5 million as opposed to $6.0 million for the full year 2021.

我們的分佈式 MyoCycle FES 產品在第四季度也有強勁表現。我們作為美國康復診所、退伍軍人醫院和退伍軍人家庭使用的獨家經銷商銷售這些產品。自從我們在 2020 年開始分銷該產品線以來，我們穩步增長並在第四季度實現了超過 50 萬美元的收入，這是我們迄今為止該產品線的最高季度業績。我還想簡要評論一下年度收入表現。 2022 年全年，我們實現了 550 萬美元的收入，而 2021 年全年為 600 萬美元。

The decline in revenue was a result of 2 factors. First, in 2021, we had a large onetime multiple unit shipment to an academic medical center that was a departure from our typical sales and which did not reoccur in 2022. Second, during 2022, we had a significant foreign exchange headwind due to the erosion of the euro-dollar exchange rate. Excluding the impact of these 2 factors, revenue would have increased by 10% in 2022, reflecting growth in our underlying base business.

收入下降是由兩個因素造成的。首先，在 2021 年，我們向一個學術醫療中心運送了大量一次性多單位貨物，這與我們的典型銷售情況不同，並且在 2022 年沒有再次發生。其次，在 2022 年期間，由於侵蝕，我們遇到了重大的外匯逆風的歐元兌美元匯率。排除這兩個因素的影響，2022 年收入將增長 10%，反映出我們基礎業務的增長。

Now I will transition to our pipeline. With the increased revenue performance in Q4, we succeeded in converting some of our near-term opportunities in our pipeline to revenue. During the first quarter of 2023, we will focus our efforts on adding to our commercial pipeline in order to lay the foundation for growth in 2023. These efforts include generating more leads in our traditional reimbursement market segments, such as in the U.S. for individuals covered by the VA or selected workers' compensation insurance and in Germany for individuals covered under the German healthcare system.

現在我將過渡到我們的管道。隨著第四季度收入表現的提高，我們成功地將我們管道中的一些近期機會轉化為收入。在 2023 年第一季度，我們將集中精力增加我們的商業管道，以便為 2023 年的增長奠定基礎。這些努力包括在我們的傳統報銷細分市場中產生更多的潛在客戶，例如在美國，針對所涵蓋的個人由 VA 或選定的工人賠償保險以及在德國為德國醫療保健系統所涵蓋的個人提供。

Additionally, we are focusing a great deal of resources and planning on an anticipated future new market segment, individuals who are Medicare beneficiaries. Within our traditional market segments for the ReWalk product line, the current pipeline of active rentals consists of 16 cases, including 13 in Germany and 3 VA rentals in the U.S. Our overall number of cases in process currently sits at 65 with 49 in Germany and 16 in the U.S. Importantly, these pipeline figures do not include cases that would be eligible for Medicare reimbursement since -- although CMS has established Medicare coverage for exoskeletons, CMS is still in the process of establishing a benefit category designation under which we can be reimbursed.

此外，我們正在集中大量資源並規劃預期的未來新細分市場，即醫療保險受益人。在我們 ReWalk 產品線的傳統細分市場中，目前的活躍租賃管道包括 16 個案例，其中包括德國的 13 個和美國的 3 個 VA 租賃。我們目前正在處理的案例總數為 65 個，其中德國 49 個和 16 個在美國重要的是，這些管道數據不包括有資格獲得醫療保險報銷的案例，因為——儘管 CMS 已經為外骨骼建立了醫療保險覆蓋範圍，但 CMS 仍在建立我們可以報銷的福利類別指定的過程中。

The initial claim that we filed back in November is set in motion process which we believe will create a mechanism for us to be reimbursed by Medicare in the near future. If we successfully worked with CMS to establish an acceptable reimbursement mechanism, we expect to build a pipeline of Medicare-eligible patients, which could meaningfully supplement our future pipeline volumes. Okay. Turning to margins from Q4. Our Q4 '22 gross profit was $0.7 million or 30.8% of revenue, up 4.3 percentage points as compared to $0.3 million or 26.5% of revenue in Q4 '21. This increase was mainly driven by the impact of higher revenue volumes, leveraging our fixed production costs.

我們在 11 月提交的初步索賠已啟動，我們相信這將為我們在不久的將來獲得 Medicare 報銷創造一個機制。如果我們成功地與 CMS 合作建立了一個可接受的報銷機制，我們期望建立一個符合 Medicare 資格的患者管道，這可以有意義地補充我們未來的管道數量。好的。轉向第四季度的利潤率。我們的 Q4 '22 毛利潤為 70 萬美元，佔收入的 30.8%，與 '21' 第四季度的 30 萬美元或收入的 26.5% 相比，增長了 4.3 個百分點。這一增長主要是由於收入增加的影響，利用了我們的固定生產成本。

During Q4 '22, we applied an impairment reserve against certain electronic components in our ReStore inventory due to the potential obsolescence of these parts. If we exclude the impact of this noncash reserve, gross profit would have been $1.2 million or 53.9% of revenue in Q4. Operating expenses in Q4 were $5.7 million, up $1.5 million or 36% as compared to $4.2 million in Q4 '21. Within R&D, spending increased $0.4 million or 59%, primarily due to higher spending on professional services related to the development products for new product introductions expected over the next 12 months.

在 22 年第四季度，我們對 ReStore 庫存中的某些電子元件應用了減值準備金，因為這些部件可能會過時。如果我們排除這一非現金儲備的影響，第四季度的毛利潤將為 120 萬美元或收入的 53.9%。第四季度的運營費用為 570 萬美元，與 21 年第四季度的 420 萬美元相比增加了 150 萬美元或 36%。在研發方面，支出增加了 40 萬美元或 59%，這主要是由於與預計在未來 12 個月內推出的新產品的開發產品相關的專業服務支出增加。

In selling and marketing, spending increased $0.8 million or 44%, primarily due to higher consulting fees associated with the CMS reimbursement progress and greater commercial activity as COVID-related restrictions are lifted, including trade shows, travel and personnel-related expenses. General and administrative expenses grew $0.3 million or 17% as compared to Q4 '21, but did decline sequentially from Q3 '22 as the last of the professional services expenses associated with the expanded 2022 proxy process did not carry over into Q4.

在銷售和營銷方面，支出增加了 80 萬美元或 44%，這主要是由於與 CMS 報銷進度相關的諮詢費用增加，以及隨著 COVID 相關限制的取消，商業活動增加，包括貿易展覽、差旅和人員相關費用。與 21 年第四季度相比，一般和行政費用增加了 30 萬美元或 17%，但與 22 年第三季度相比確實有所下降，因為與擴大的 2022 代理程序相關的最後一項專業服務費用沒有結轉到第四季度。

Our net loss for Q4 '22 was $5.3 million or $0.09 per share as compared to a net loss of $3.9 million or $0.06 per share in Q4 '21. Our non-GAAP net loss for Q4 '22 was $4.9 million or $0.08 per share as compared to $3.6 million or $0.06 per share in Q4 '21. We ended the quarter with $67.9 million in cash and cash equivalents and no debt. We continue to have a strong balance sheet with resources to fund our organic growth, including our efforts to expand access for Medicare beneficiaries to our ReWalk exoskeletons as well as to pursue attractive business development opportunities to distribute or acquire additional complementary products with which we can build and scale and supplement our growth.

我們 22 年第四季度的淨虧損為 530 萬美元或每股 0.09 美元，而 21 年第四季度的淨虧損為 390 萬美元或每股 0.06 美元。我們 22 年第四季度的非公認會計原則淨虧損為 490 萬美元或每股 0.08 美元，而 21 年第四季度為 360 萬美元或每股 0.06 美元。我們在本季度結束時擁有 6790 萬美元的現金和現金等價物，並且沒有債務。我們繼續擁有強大的資產負債表，擁有為我們的有機增長提供資金的資源，包括我們努力擴大 Medicare 受益人使用我們的 ReWalk 外骨骼的機會，以及尋求有吸引力的業務發展機會來分銷或收購我們可以用來構建的額外補充產品並擴大和補充我們的增長。

Since the initiation of a share repurchase program in Q3 '22, we have repurchased $3.3 million of stock, representing about 6% of total shares issued. Our initial 6-month authorization from the Israeli court for the repurchase program expired in January of this year, so we filed a motion with the court for permission to continue with repurchases for a second 6-month period, and we received approval of this from the court. Upon exit from our trading blackout 2 days following the date of this call and the earnings release, we will be eligible once again to repurchase shares, and we expect to monitor equity market conditions and evaluate potential buyback activities as needed.

自 22 年第三季度啟動股票回購計劃以來，我們已經回購了 330 萬美元的股票，約佔已發行股票總數的 6%。我們從以色列法院獲得的最初 6 個月的回購計劃授權於今年 1 月到期，因此我們向法院提交了一項動議，要求允許在第二個 6 個月的期限內繼續回購，我們得到了來自以色列法院的批准。法院。在本次電話會議和收益發布日期後 2 天，我們的交易禁售期結束後，我們將再次有資格回購股票，我們希望監測股票市場狀況並根據需要評估潛在的回購活動。

With that, I'd like to turn the call back to Larry for further comments.

有了這個，我想把電話轉回給拉里，以徵求進一步的意見。

Thank you, Mike. Our goals for 2023 are: one, to achieve sales growth via our CMS and VA activity, along with adding more commercial insurers in Germany; two, to expand our product offering through distribution and acquisition and to leverage these activities to move towards breakeven profitable operations with our current capital. The internal sales growth will build upon the 2022 progress on direct supply in Germany, with the placement of systems with U.S. Medicare program with CMS and with expansion to more VA centers.

謝謝你，邁克。我們 2023 年的目標是：第一，通過我們的 CMS 和 VA 活動實現銷售增長，同時在德國增加更多的商業保險公司；第二，通過分銷和收購擴大我們的產品供應，並利用這些活動以我們現有的資本實現盈虧平衡。內部銷售增長將建立在 2022 年德國直接供應進展的基礎上，將系統與 CMS 的美國 Medicare 計劃一起放置，並擴展到更多 VA 中心。

Other growth drivers will be technical and regulatory advancements of the ReWalk exoskeleton and expansion of the company through the addition of product lines. To measure our progress in 2023, I have 7 areas I'd like to highlight. Number 1, expansion of CMS case submissions. We are building our infrastructure for qualifying and processing claims within the expected requirements of the regional MAC with CMS. These are extensive submissions to ensure patient selection is optimal to become successful rewalkers. This approach will benefit the user, CMS, other insurers and the company with successful use of the product.

其他增長動力將是 ReWalk 外骨骼的技術和監管進步以及公司通過增加產品線進行擴張。為了衡量我們在 2023 年取得的進展，我想強調 7 個領域。第一，擴展 CMS 案例提交。我們正在構建我們的基礎設施，以便在具有 CMS 的區域 MAC 的預期要求範圍內對索賠進行資格審查和處理。這些是廣泛的提交，以確保患者選擇成為成功的 rewalkers 的最佳選擇。這種方法將使用戶、CMS、其他保險公司和成功使用該產品的公司受益。

We will target between 35 to 50 CMS submissions in 2023 by building an infrastructure to expand that significantly in 2024 and 2025. Until late 2022, our U.S. coverage was limited to the VA SOP, which comprised approximately 10% of the spinal cord injury market. Spinal cord injury occurs in a younger population in 5 years post injury. Approximately 30.9% of the spinal cord injury market is covered under Medicare and another 25.2% are covered under Medicaid. We also anticipate the progress to CMS will be considered by private payers and we will begin contacts with private insurers as the market develops.

我們將在 2023 年通過建立基礎設施以在 2024 年和 2025 年顯著擴大 CMS 提交的目標，目標是在 2023 年提交 35 至 50 份 CMS。直到 2022 年底，我們的美國覆蓋範圍僅限於 VA SOP，它約佔脊髓損傷市場的 10%。脊髓損傷發生在受傷後 5 年內的年輕人群中。大約 30.9% 的脊髓損傷市場由醫療保險覆蓋，另外 25.2% 由醫療補助覆蓋。我們還預計 CMS 的進展將被私人付款人考慮，隨著市場的發展，我們將開始與私人保險公司聯繫。

These activities allow us to develop this market with the new access to a larger audience. As an example, many clinicians we speak with have been unwilling to write a prescription for a product that was unlikely to be accessible via coverage to the individual. With coverage expanding through CMS and others access to this technology is becoming realistic, which will allow the development of referring for the patients who want to ambulate with an exoskeleton system. We currently have over 170 previously screened CMS leads that are being requalified for submissions. Our lead base was very limited in the pandemic period as this population is a high-risk group.

這些活動使我們能夠通過接觸更多受眾的新渠道來開發這個市場。例如，我們採訪過的許多臨床醫生都不願意為不太可能通過個人保險獲得的產品開處方。隨著通過 CMS 和其他方式擴大覆蓋範圍，獲得該技術變得越來越現實，這將允許為想要使用外骨骼系統走動的患者開發轉診。我們目前有超過 170 個先前篩選過的 CMS 潛在客戶正在重新獲得提交資格。由於這一人群是高危人群，我們在大流行期間的先導基地非常有限。

We will now seek to expand our lead gathering efforts through digital promotion, trade shows and by building referral efforts with key opinion leaders. Number 2, expansion of VA training centers. As the resources and VA medical centers, the VMACs are becoming increasingly active post COVID, we are working closely with the VA to expand both the number of VMACs that can actively qualify and conduct or manage exoskeleton training and the use of qualified and contracted community-based provider groups that may be more conveniently geographic for veterans. There are currently 3 active reliable centers in the United States, and our goal is to expand that by at least 6 over the remainder of the calendar year 2023.

我們現在將尋求通過數字推廣、貿易展覽和與主要意見領袖建立推薦努力來擴大我們的領先收集工作。第二，擴建 VA 培訓中心。作為資源和 VA 醫療中心，VMAC 在 COVID 後變得越來越活躍，我們正在與 VA 密切合作，以擴大能夠積極獲得資格並進行或管理外骨骼培訓的 VMAC 的數量，以及使用合格和簽約的社區-基於提供者團體，對於退伍軍人來說可能在地理上更方便。美國目前有 3 個活躍的可靠中心，我們的目標是在 2023 年的剩餘時間里至少增加 6 個。

Number 3, in Germany, we will seek to add additional groups to our direct supply contracts now that we are post the acceptance of the direct supply from the court proceedings. We also must reestablish our lead base post COVID with a shift towards digital promotion, working with local society and the reemergence of trade shows in full in 2023. Number 4, product acquisition. We have identified product lines and entities that have interest and that would financially benefit from operating within a consolidated enterprise infrastructure focused on neuro rehabilitation. The profile for this strategy is to work with adjacent, accretive, advanced technologies that support the clinics and the patient community.

第三，在德國，我們將尋求在我們的直接供應合同中增加更多的組，因為我們正在接受法院程序中的直接供應。我們還必須重建我們在 COVID 後的領先基地，轉向數字推廣，與當地社會合作，並在 2023 年全面恢復貿易展覽。第四，產品採購。我們已經確定了感興趣的產品線和實體，並且可以從專注於神經康復的綜合企業基礎設施中運營中獲得經濟利益。該策略的概況是與支持診所和患者社區的相鄰的、增值的、先進的技術合作。

These considerations have a high priority and we have a banking partner assisting in the analysis, transaction considerations and completing these efforts. We will report on these initiatives as they reach conclusions. Number 5, organic product improvements. A significant user limitation exists when a ReWalker is walking and they then encounter our curb or stairs that prevents access. Examples include visiting a friend's home with steps or stairs or locations where curb cutouts, ramps or elevators are not available.

這些考慮因素具有很高的優先級，我們有一個銀行合作夥伴協助分析、交易考慮因素並完成這些工作。我們將在這些舉措得出結論時對其進行報告。第五，有機產品改進。當 ReWalker 正在行走時，存在一個重要的用戶限制，然後他們會遇到我們阻止訪問的路緣或樓梯。示例包括拜訪有台階或樓梯的朋友家，或拜訪沒有路邊切口、坡道或電梯的地方。

Addition of the curb/stair function is under review at the FDA from our submission in 2022. We have responded in full to the FDA's additional information request and are prospectively preparing training programs for a launch in 2023. This is subject to completing a successful FDA review. On the next advancements of the ReWalk system, we are in finalization of late-stage development and final preparation for FDA submission. We expect to submit this for FDA review and CE review in the second half of 2023.

根據我們在 2022 年提交的申請，FDA 正在審查增加路緣/樓梯功能。我們已對 FDA 的額外信息請求做出全面回應，並準備在 2023 年啟動培訓計劃。這取決於成功完成 FDA審查。關於 ReWalk 系統的下一步進展，我們正在完成後期開發和提交 FDA 的最後準備工作。我們預計在 2023 年下半年將其提交 FDA 審查和 CE 審查。

Number 6, data expansion. For our stroke technology designs, we are supporting the independent study of a comparison of the motor and cable-driven system of a plantar flection focused technology to the existing ankle foot orthosis technologies commonly known as AFOs. Our targeted base technology for a home, community use design has been named the ReBoot. We have previously been granted a breakthrough designation that would have included some Medicare coverage at that time. That program has since been deferred by the U.S. Government and replacement programs are being considered, but we no longer expect that path as the likely coverage pathway for this innovative design.

第六，數據擴展。對於我們的行程技術設計，我們正在支持獨立研究，將足底屈曲聚焦技術的電機和電纜驅動系統與通常稱為 AFO 的現有踝足矯形器技術進行比較。我們針對家庭、社區使用設計的目標基礎技術被命名為 ReBoot。我們之前曾獲得過一項突破性的認定，其中包括當時的一些醫療保險覆蓋範圍。該計劃已被美國政府推遲，並且正在考慮替代計劃，但我們不再期望該路徑作為這種創新設計的可能覆蓋路徑。

As we have conducted a parallel reimbursement review, we believe this design may be covered within existing codes if our data demonstrates the benefit of this technical innovation over an AFO. This initial study is a pilot to support consideration of a larger company-sponsored randomized clinical trial. For our ReWalk SCI product, we supported a grant to the VA considering the medical cost of a ReWalk ambulator to the medical outcome of a matched profile wheelchair user. That data will be presented and published during 2023.

由於我們進行了平行的報銷審查，我們認為如果我們的數據證明這種技術創新比 AFO 有好處，那麼這種設計可能會包含在現有規範中。這項初步研究是一項試點，旨在支持考慮由公司發起的一項更大的隨機臨床試驗。對於我們的 ReWalk SCI 產品，考慮到 ReWalk 救護車的醫療成本與相匹配的輪椅使用者的醫療結果，我們支持向 VA 撥款。該數據將在 2023 年期間呈現和發布。

And number 7, financially, 2023 includes further investment in reimbursement to complete the submission definitions to provide the processing infrastructure to allow patient access and to provide growth for the company. In addition, as our mission and position expand, we have increased our investment to support investor relations to broaden the communication and reach to the investment community. In conclusion, our overall direction is to succeed with the core SCI product line as insurance access is more widely accepted and to build both critical and strategic mass as a consolidator that will meet the broader needs in the clinic and in the community for neuro rehabilitation.

7 號，在財務上，2023 年包括進一步投資報銷以完成提交定義，以提供處理基礎設施以允許患者訪問並為公司提供增長。此外，隨著我們的使命和地位的擴大，我們增加了投資以支持投資者關係，以擴大與投資界的溝通和影響。總之，我們的總體方向是在核心 SCI 產品線取得成功，因為保險獲得更廣泛地接受，並建立關鍵和戰略質量作為整合者，以滿足診所和社區對神經康復的更廣泛需求。

We understand and are seeking to complete this level of expansion and growth to breakeven profitability on our current capital. We are going in the right direction, and I wish to thank the team for the results in 2022 and how they are building upon them in 2023. I also wish to thank our shareholder base for their continued commitment in supporting these life-changing technologies and their support as we expand this business in 2023 and 2024. I look forward to providing further updates during 2023.

我們了解並正在尋求完成這種擴張和增長水平，以實現我們現有資本的盈虧平衡。我們正朝著正確的方向前進，我要感謝團隊在 2022 年取得的成果以及他們在 2023 年取得的成果。我還要感謝我們的股東基礎對支持這些改變生活的技術的持續承諾和他們支持我們在 2023 年和 2024 年擴展這項業務。我期待在 2023 年提供進一步的更新。

At this point, operator, we're prepared to take and answer all questions if we could move to that process.

在這一點上，運營商，如果我們可以進入該流程，我們已準備好接受並回答所有問題。

(Operator Instructions)

（操作員說明）

And our first question today comes from Swayampakula Ramakanth from H.C. Wainwright.

我們今天的第一個問題來自 H.C. 的 Swayampakula Ramakanth。溫賴特。

This is RK from H.C. Wainwright. So it looks like you had a fantastic fourth quarter and seemed to have got the (inaudible) with interest in '23 as well. Larry, you stated 7 different things that you're hoping to execute over the rest of the year. So given the 2 positives from last year, especially from the CMS and also from the German court, can you just highlight some of the progress that you're making beyond the initial success, in the sense, you said you submitted one application to the MAC. How well are they progressing? Is the progress encouraging enough that you can go forward with the additional submissions?

這是 H.C. 的 RK。溫賴特。所以看起來你有一個很棒的第四節並且似乎也對'23感興趣（聽不清）。拉里，你說了 7 件不同的事情，你希望在今年餘下的時間裡執行。因此，考慮到去年的 2 個積極因素，特別是來自 CMS 和德國法院的積極因素，你能否強調你在初步成功之後取得的一些進展，從某種意義上說，你說你提交了一份申請給蘋果。他們進展如何？進展是否足夠令人鼓舞，您可以繼續提交額外的材料？

And on the German court side, you said the insurance company over there has given -- has started working through the applications for their insured lives. How is that going forward? What is the expectation in terms of revenue run from that particular workers' comp insurance? Sorry for the long question.

在德國法院方面，你說那邊的保險公司已經 - 已經開始處理他們被保險人的申請。進展如何？該特定工人補償保險的收入預期是多少？很抱歉這個問題很長。

Long question, but I took notes. So I think I'll remember everything or at least most of it. And first, yes, it was a good quarter and the 7 targets, we believe are very achievable for us this year, the things that I highlighted at the backend and I'll update those every quarter. Regarding, first, the MAC process and the progress. Submitting the first case is the hardest because you're interpreting and win everything and trying to establish the standards for that case. And we use that as a base for okay, how do we construct the rest of them.

很長的問題，但我做了筆記。所以我想我會記住一切，或者至少記住大部分。首先，是的，這是一個很好的季度和 7 個目標，我們相信今年對我們來說是可以實現的，我在後端強調的事情，我將每個季度更新一次。關於，首先，MAC 過程和進展。提交第一個案例是最困難的，因為您正在解釋並贏得一切，並試圖為該案例建立標準。我們將其用作好的基礎，我們如何構建其餘部分。

And that's really been a lot of infrastructure building and also to make sure that we comply in every way as a Medicare supplier. We are an accredited supplier and that requires everything from -- everything must be handled perfectly relative to HIPAA compliance and how we're handling data in the systems that we have. So there was a lot of internal auditing preparation for the go-live mindset. And that's really the great value of Case 1 because Case 1, we put more effort in than we probably put in anything for a long time relative to a single case to make sure we have that structure because we're not trying to set this up for just one case. We are trying to set it up to do, as I said, 35 to 50 this year.

這確實是大量的基礎設施建設，也是為了確保我們作為 Medicare 供應商在各方面都遵守規定。我們是一家經過認證的供應商，這要求一切——一切都必須得到完美處理，以符合 HIPAA 合規性以及我們如何處理我們擁有的系統中的數據。因此，為上線心態做了很多內部審計準備工作。這確實是案例 1 的巨大價值，因為在案例 1 中，我們投入的精力比我們可能在很長一段時間內投入的任何東西都多，以確保我們擁有該結構，因為我們沒有嘗試設置它只有一個案例。正如我所說，今年我們正努力將其設置為 35 到 50。

So it's been a process development. So from an internal side, we've come a long way. On the MAC side, the case is moving forward, but I don't have anything I can report at this time. The most important thing is the user has their system, they have completed their training, and the completion of the process is now being worked with them. And so that's as much as I can give you on the first part.

所以這是一個過程開發。所以從內部來看，我們已經走了很長一段路。在 MAC 方面，案件正在向前推進，但我目前沒有任何可以報告的內容。最重要的是用戶有他們的系統，他們已經完成了他們的培訓，現在正在與他們一起完成這個過程。所以這就是我在第一部分能給你的。

The second part, the German court. The reaction by BARMER was what we hoped it would be and that the individual who was the core case, got his unit and he's walking. And so that is a big success at least from the view of the individual. And then the other cases they had that were open have been quickly moved forward. So that tells us that, yes, they completely accepted what they said they would do. The contract process in Germany is very important to us, and it is sort of an annualized or periodic thing. And as we are now redoing our contracts with many groups relative to things such as pricing and some other details that change year-over-year, we would hope to bring some of these other groups that are not under contract, under contract. So that is our goal and that is other conversations that are underway.

第二部分，德國法庭。 BARMER 的反應是我們希望的那樣，作為核心案例的那個人得到了他的單位，他正在走路。因此，至少從個人的角度來看，這是一個巨大的成功。然後，他們處理的其他未決案件迅速向前推進。所以這告訴我們，是的，他們完全接受了他們所說的他們會做的事情。德國的合同流程對我們來說非常重要，它是一種年度化或週期性的事情。由於我們現在正在與許多團體重新簽訂與定價和其他一些逐年變化的細節相關的合同，我們希望與其他一些沒有簽訂合同的團體簽訂合同。所以這是我們的目標，也是正在進行的其他對話。

And between now and sometime in Q2, those should reach a conclusion with them either joining or not joining the contracts. Fundamentally, there is a benefit to them and to us for them to be under contract, but they still have to make a decision to do it, and it just makes it easier to process. So the German one is moving also forward in a way that we believe will help us for the 2023 revenue.

從現在到第二季度的某個時候，這些人應該與他們達成結論，要么加入或不加入合同。從根本上說，與他們簽訂合同對他們和我們都有好處，但他們仍然必須做出決定，這只會讓處理過程更容易。因此，德國人也在以一種我們認為將有助於我們實現 2023 年收入的方式前進。

And then this court case where BARMER, fortunately for you, walked away from the case. Does that lay as a strong precedent within Germany's workers' comp, so that now -- and now you have a potential for success with other workers' comp. Is that the case? Or is it still going to be individually each workers' comp insurance can make a decision independent of what happened in the BARMER's court case?

然後在這個法庭案件中，BARMER 幸運地離開了案件。這是否成為德國工人補償中的一個強有力的先例，所以現在 - 現在你有可能在其他工人補償中取得成功。是這樣嗎？還是每個工人的補償保險仍然可以獨立於 BARMER 法庭案件中發生的事情做出決定？

One quick clarity. BARMER is a statutory health insurer. So it's more of the general public insurance and private insurance that goes through their German health system. The workman's comp in Germany is the DGUV, and we have a contract with them. So our workman's comp in Germany is well established. Relative to the statutory health insurers environment where your question was, they will make a decision as to whether they enter the contract and other groups typically have a decision whether or not they join a contract.

一個快速的清晰度。 BARMER 是一家法定健康保險公司。因此，更多的是通過他們的德國醫療系統的一般公共保險和私人保險。德國的工人補償是 DGUV，我們與他們有合同。所以我們在德國的工人薪酬已經很成熟了。相對於您提出問題的法定健康保險公司環境，他們將決定是否簽訂合同，而其他團體通常會決定是否加入合同。

But we do not believe there's a strong basis for any of them to challenge whether or not -- if they supply these, whether they're on direct supply or not. There is -- as BARMER withdrew and accepted, there is no formal court case decision. So I can't say there's a court case that is a precedent. However, because that one had gone so far and the #1, 2, 3 insurers in Germany now have all accepted this, it would be difficult for others to claim that it is not the standard in the industry. But I can't say there's a specific precedent if that answers your question.

但我們認為，他們中的任何一個都沒有強有力的基礎來挑戰是否——如果他們提供這些，他們是否直接供應。有 - 由於 BARMER 撤回並接受，因此沒有正式的法庭案件裁決。所以我不能說有一個法庭案件是先例。然而，由於那個已經走到了盡頭，德國排名第一、第二、第三的保險公司現在都接受了這一點，其他人很難聲稱這不是行業標準。但如果這能回答您的問題，我不能說有具體的先例。

I have one more 2-part question, and then I'll step back into the line. In terms of the VA expansion that you're talking about, VA training center expansion that you're talking about, is there more color you can provide us, in the sense, I believe if I took my notes right, there are 16 cases in rentals out there. I'm guessing most of them are from the VA. Is -- should we expect that to increase as you continue to expand these training centers? And the second part of the question and a little bit different. On the MyoCycle product distribution, which was strong in the Q4 increasing greater than $0.5 million. Is that something that can be sustainable over '23 and beyond? Or is this one of those one-off things that you -- we have to wait and watch as the quarters progress?

我還有一個由兩部分組成的問題，然後我會回到隊列中。就您所說的 VA 擴建而言，您所說的 VA 培訓中心擴建，您是否可以為我們提供更多顏色，從某種意義上說，我相信如果我記對了，有 16 個案例在外面的租金。我猜他們中的大多數來自 VA。是 - 我們是否應該期望隨著您繼續擴大這些培訓中心而增加？和問題的第二部分有點不同。關於 MyoCycle 產品分銷，該產品在第四季度表現強勁，增幅超過 50 萬美元。這是否可以在 23 世紀及以後持續下去？或者這是你的那些一次性的事情之一 - 我們必須等待並觀察季度的進展？

Okay. Thank you. I'll start with the VA. We still have a good number of veterans waiting in line for training or waiting to move through processing at the VA. And a lot of the limitation has been around either available personnel to train or geographic location. So this expansion with the VA -- presently, we have 3 really reliable centers that can take care of patients, but that only covers 3 parts of the United States, and they're mostly in the Central, South and Southeast, which we need to expand it more geographically, so the veterans in places that do not have access are there. And what we've gotten in one of our more recent successes was with the program where the community care networks were able to get a BA to cover it, but the training was done locally at a community care networks.

好的。謝謝。我將從 VA 開始。我們仍有大量退伍軍人排隊等待接受培訓或等待在 VA 進行處理。很多限制都圍繞著可供培訓的人員或地理位置。退伍軍人事務部的擴張——目前，我們有 3 個非常可靠的中心可以照顧病人，但這只覆蓋了美國的 3 個地區，而且它們主要位於我們需要的中部、南部和東南部在地理上擴大它，所以那些無法進入的地方的退伍軍人就在那裡。我們最近取得的成功之一是社區護理網絡能夠獲得學士學位來涵蓋它的計劃，但培訓是在社區護理網絡本地完成的。

So this expansion of 6 additional centers that are utilizing it will provide us ability to get to more patients because we just have patients that are in locations that cannot currently get their training done. And what's different now post-COVID with very few exceptions, the VAs are fully reopened, and we have found them much more interested in moving with these community care networks where they didn't have the resource or the people to do it. So the VA, I think is, if you're a veteran now, it's a good time to go back and reach to these groups where you will be able to get training and move to the process if you're a qualified patient.

因此，這 6 個正在使用它的額外中心的擴展將使我們能夠接觸到更多的患者，因為我們只有患者位於目前無法完成培訓的地方。在 COVID 之後，現在有什麼不同，除了極少數例外，VA 已完全重新開放，我們發現他們更感興趣的是在他們沒有資源或人員的情況下與這些社區護理網絡一起移動。所以 VA，我認為，如果你現在是一名退伍軍人，現在是回去接觸這些團體的好時機，如果你是一名合格的患者，你將能夠在那裡接受培訓並進入流程。

On the MyoCycle, first, it's a really good product and it works easily for the exact same patients we already call on. So a ReWalk user very commonly also would benefit with the MyoCycle and the VA covers them. So we do believe it's sustainable. I don't know what the exact quarter-to-quarter number, but the year-over-year product line has very good potential and expectation that it would grow. And that's the type of products that we think fit nicely with us. So sustainable, yes, on an annual basis.

在 MyoCycle 上，首先，它是一個非常好的產品，它很容易為我們已經拜訪過的相同患者工作。因此，ReWalk 用戶通常也會受益於 MyoCycle，而 VA 涵蓋了他們。所以我們相信它是可持續的。我不知道確切的季度數字是多少，但同比產品線具有非常好的潛力和增長預期。這就是我們認為非常適合我們的產品類型。如此可持續，是的，每年一次。

Our next question comes from Martin Pollack from KMTR.

我們的下一個問題來自 KMTR 的 Martin Pollack。

Just several questions. I'll kind of break it down into a couple more about the actual Germany court decision and then maybe talk about a few of the financial ramifications of actually what we're seeing is numbers. On a German court, is there a way for you to describe, if not immediately, the number of leads that you would be expecting since the insurance coverage is so broad now?

只是幾個問題。我會把它分解成更多關於德國法院實際判決的內容，然後也許會談談我們所看到的實際數字的一些財務影響。在德國法庭上，您是否有辦法描述（如果不是立即的話）由於現在的保險範圍如此廣泛，您期望的線索數量？

You think that the German court business -- the German business would be significantly higher multiples, higher than what it is today. So maybe it's a matter of just describing that via leads and what could end up being a '24/'25 sales revenue type number. That would be very useful to know because I think that decision was not well received by the marketplace, had a very little impact on the company's stock price back to overall stock that declined somewhat after that period. So please explain that German court decision and its long-term impact?

你認為德國法院業務——德國業務的倍數要高得多，高於今天的水平。因此，也許這只是通過潛在客戶進行描述的問題，最終可能會成為“24/”25 銷售收入類型數字。知道這一點將非常有用，因為我認為該決定並未受到市場的歡迎，對公司股價影響很小，回到在那段時間後略有下降的整體股票。那麼請解釋一下德國法院的判決及其長期影響？

Okay. I'll start with that. Well, first, the German court case was withdrawn, so there wasn't a formal decision, but it was a clear acceptance by the #2 insurer. So it was a good outcome, especially for the patient. The impact of that is we saw the court cases that were in line for direct supply, direct process through. So that's a good sign. Now I think you have hit the most important point. What -- how does that translate to leads and growth for '23, '24, '25 and we have not done well in leads with Germany during the COVID period. We literally were in a desert for most of the last 2 years relative to leads with no trade shows and a population that has -- it's a higher risk during the COVID period.

好的。我會從那個開始。好吧，首先，德國法院的案件被撤回，所以沒有正式的決定，但這是 #2 保險公司的明確接受。所以這是一個很好的結果，尤其是對患者而言。其影響是我們看到了符合直接供應、直接流程的法庭案件。所以這是一個好兆頭。現在我認為你已經達到了最重要的一點。什麼——這如何轉化為 23 年、24 年、25 年的領先優勢和增長，而在 COVID 期間我們在德國的領先優勢方面做得不好。在過去 2 年的大部分時間裡，我們實際上都處於沙漠中，相對於沒有貿易展覽的領導者和擁有的人口來說——在 COVID 期間風險更高。

So we've got to rebuild that lead element, and that is a lot of our early focus to get those leads going to get and get these cases back into the insurers at much higher numbers. So our early focus in 2023 and 2024 is -- and we think we're going to have trade shows in full again, is to build back to the lead levels we saw pre-pandemic, then those would translate into things that are more easily processed through the insurers with the acceptance of direct supply.

所以我們必須重建那個領先元素，這是我們早期的重點，讓這些線索能夠獲得併讓這些案件以更高的數量回到保險公司。因此，我們在 2023 年和 2024 年的早期重點是——我們認為我們將再次全面舉辦貿易展，恢復到我們在大流行前看到的領先水平，然後這些將轉化為更容易的東西通過保險公司處理並接受直接供應。

So the impact is going to be there, but it's going to be there more later this year. Our cycle time for most of these patients still remains 6 to 12 months depending on the specifics of all the individuals from the time they think about it to the time they've been training. So that building of leads this year will be an important measurement. It will impact sales some this year, but it will impact sales if we do it effectively more in the out years.

所以影響將會存在，但今年晚些時候會更多。我們對大多數這些患者的周期時間仍然是 6 到 12 個月，具體取決於從他們考慮到他們接受培訓的所有個人的具體情況。因此，今年建立的潛在客戶將是一項重要的衡量標準。它會影響今年的銷售，但如果我們在未來幾年更有效地做到這一點，它將影響銷售。

Yes. Let's deal with some of the financial ramifications of what we're seeing. 2022 closed with about $21 million of operating expenses broken down between R&D, marketing, sales and SG&A. You look back at 2021, actually even '19, you were running about $13 million, which explains why as bad as things have been at that time, you were generating an operating loss of $12 million to $13 million per year. We're certainly looking at considerably higher loss, which means that the cash is considerable. So as we look forward, if you could talk about maybe the absolute type number, what is SG&A on a normalized basis going forward with your plans?

是的。讓我們來處理我們所看到的一些財務後果。 2022 年結束時，研發、營銷、銷售和 SG&A 之間的運營費用約為 2100 萬美元。回顧 2021 年，實際上即使是 19 年，你的運營成本也約為 1300 萬美元，這就解釋了為什麼當時的情況如此糟糕，但你每年產生 1200 萬至 1300 萬美元的運營虧損。我們當然會看到更高的損失，這意味著現金相當可觀。因此，當我們展望未來時，如果您可以談談絕對類型編號，那麼 SG&A 在標準化基礎上推進您的計劃是什麼？

Clearly, you have plans to grow a number of those -- the number of expenses may be rising. But are you likely to be on running revenues during that time, so we should realistically expect further losses this year even worse than possibly 2022. I mean, I'm really looking to see how you think about SG&A because you also talk about ultimately a model that can go to breakeven. Was that an acquisition, is your model a model that can actually do that? And when do you expect that to happen?

顯然，您計劃增加其中的一些——費用的數量可能會增加。但是在那段時間你是否有可能保持營業收入，所以我們應該現實地預計今年的進一步虧損甚至可能比 2022 年還要糟糕。我的意思是，我真的很想看看你對 SG&A 的看法，因為你最終也談到了可以達到收支平衡的模型。那是一次收購嗎，你的模型是一個真正可以做到這一點的模型嗎？你預計什麼時候會發生？

There's parts of that for me and parts of that for Mike. I think looking backward on some of the operating expenses, I'll let Mike start there, and I'll pick up on the other side.

對我來說有一部分，對邁克來說有一部分。我認為回顧一些運營費用，我會讓邁克從那裡開始，然後我會在另一邊接手。

Yes. So I would say that we did see an increase in spend in 2022 versus 2021, and much of that was related to several factors. One was gearing up and entering into this process of submitting claims to Medicare. As Larry had described, that's quite -- for the first time, that's quite a costly and time-consuming process to do it correctly. And so we had to invest in resources to be able to be in a position to be able to do that. Another factor was that we were completing several product improvements and new product -- for new product introductions in 2023 and in probably early 2024. So there are some product improvements going on. So there's some R&D spend that increased as a result of that factor.

是的。所以我想說，我們確實看到 2022 年的支出比 2021 年有所增加，其中很大一部分與幾個因素有關。一個人正在準備並進入向醫療保險提交索賠的過程。正如 Larry 所描述的那樣，這是第一次，這是一個相當昂貴且耗時的過程才能正確地完成它。因此，我們必須投資資源才能做到這一點。另一個因素是我們正在完成多項產品改進和新產品——在 2023 年和可能在 2024 年初推出新產品。因此正在進行一些產品改進。因此，由於這個因素，一些研發支出增加了。

So I would say that those were the 2 primary things. We're really gearing up commercially for -- and then the third thing was gearing up commercially for being able to sell to an expanded market being the Medicare market in addition to the existing markets that we sell now. So yes, there was an increase in investment between 2021 and '22, but that's all related to these key priorities that we've talked about. And it's gotten to this point now where we really feel like we're very close to the finish line or very close to the goal line, if you want to use a football analogy. So I would expect that once we can normalize the process and increase the volumes of patient submissions to Medicare that -- the revenue is going to build off of that and these investments will begin to pay off.

所以我會說這是兩個主要的事情。我們真的在商業上做準備——然後第三件事是在商業上做準備，除了我們現在銷售的現有市場之外，還能夠銷售到擴大的市場，即醫療保險市場。所以是的，2021 年到 22 年間投資有所增加，但這都與我們討論過的這些關鍵優先事項有關。現在已經到了這個地步，如果你想用足球來類比的話，我們真的覺得我們離終點線很近了，或者離球門線很近了。因此，我希望一旦我們能夠使流程正常化並增加向 Medicare 提交的患者數量——收入將以此為基礎，這些投資將開始得到回報。

Are you suggesting that, let's say, the new normal for the SG&A may in fact be even lower going forward because of these kind of onetime situations that we had last year? It would be great to see that because clearly, it's -- if you continue to be at this level or even higher, you would have to have a significant growth in revenues just to be able to maintain certainly not burn more cash than you're doing already. So the only other question is, I will say, what I felt was quite positive in these results in terms of the cash uses I see for this quarter was considerably lower considering you said there were about $3.3 million of spend on the share repurchase. Was that what you said? I think I saw that in the comment.

你是說，比方說，由於我們去年遇到的這種一次性情況，SG&A 的新常態實際上可能會更低？很高興看到這一點，因為很明顯，如果你繼續保持這個水平甚至更高，你就必須有顯著的收入增長才能維持肯定不會消耗比現在更多的現金已經在做。所以唯一的另一個問題是，我會說，考慮到你說有大約 330 萬美元的股票回購支出，我認為本季度的現金使用量相當低，我認為這些結果非常積極。是你說的嗎？我想我在評論中看到了。

Yes, that's the cumulative amount, yes.

是的，這是累計金額，是的。

Okay. But -- so I didn't see the cash statement, but it looked to me, cash use would have been much better than we saw in the previous quarter or 2. Cash use was more like $3 million maybe for the quarter?

好的。但是 - 所以我沒有看到現金報表，但在我看來，現金使用情況會比我們在上一季度或第二季度看到的要好得多。本季度的現金使用情況可能更接近 300 萬美元？

We had significant also expenses in Q2 and Q3 related to the expanded proxy challenge that we had. So that unfortunately required us to divert a lot of resources that otherwise could have been spent on growing the business or preserving that capital. So it's also another factor that drove some of the increase from '21 to '22 that we hope will not repeat itself.

我們在第二季度和第三季度也有大量支出與我們擴大的代理挑戰有關。因此，不幸的是，這要求我們轉移大量資源，否則這些資源本可以用於發展業務或保留資本。因此，這也是推動從 21 年到 22 年增長的另一個因素，我們希望這種情況不會重演。

So would you say that as we're looking at cash burn, which clearly at this point is just the thing that's going to continue, the hope is that we're not going to be running into the kind of numbers we saw in '22 overall. But do you think that, call it, sustainable cash use, even share repurchases could be about $12 million, $13 million. Is that more likely to be the kind of number that you're thinking about annually? Are we back to that kind of earlier level since you've done a lot of this forward spending already? I mean there's a big difference in terms of how quickly this cash is going away.

所以你會說當我們正在研究現金消耗時，這顯然是在這一點上繼續下去的事情，希望我們不會遇到我們在 22 年看到的那種數字全面的。但你認為可持續現金使用，甚至股票回購可能約為 1200 萬美元、1300 萬美元。這更有可能成為您每年考慮的那種數字嗎？自從你已經做了很多這樣的遠期支出後，我們回到了那種早期的水平嗎？我的意思是，在這些現金消失的速度方面存在很大差異。

Yes, I think it's -- until we get a better sense for the ramp -- for the timing and our anticipated Medicare coverage and benefit establishment and the ramp associated with that benefit, it's a little premature for us at this stage to comment on full year numbers. But I would say that certainly, we will be exiting the year in a -- we anticipate we'll be exiting the year in a much better position than we are right now because we will have that expanded market with that much larger revenue potential.

是的，我認為這是——直到我們更好地了解斜坡——對於時間和我們預期的 Medicare 覆蓋範圍和福利建立以及與該福利相關的斜坡，我們在現階段對全面評論還為時過早年份數字。但我肯定會說，我們將在今年結束 - 我們預計我們將以比現在更好的狀態退出今年，因為我們將擁有更大的收入潛力的擴大市場。

Last question, just -- maybe this is more Larry outlook. Your outlook in previous quarters, the last one was that based on your -- what you were seeing revenue growth would continue. And then last quarter, apparently, that did not happen. When you think about full year outlook, with all these things going on, with all the opportunities, is there any reason why you wouldn't be able to make a more clear statement about growth for 2023? And at the same time, just make a comment about acquisition opportunities. It seems that an acquisition, another vertical for the company is essential, even if it's an adjacency, clearly would be great.

最後一個問題，也許這更像是 Larry 的觀點。你對前幾個季度的展望，最後一個是基於你所看到的收入增長將繼續的。然後上個季度，顯然，這並沒有發生。當你考慮全年展望時，所有這些事情都在發生，有所有的機會，你有什麼理由不能對 2023 年的增長做出更明確的陳述？同時，就收購機會發表評論。似乎收購，公司的另一個垂直領域是必不可少的，即使它是相鄰的，顯然也會很棒。

But the ability to integrate a company provide some stable revenues and maybe income would make a lot of sense, quite a bit of sense while you're building this tremendous growth engine, which I think is very powerful, but it may still take 2, 3 years for us to see the full effect. So why not in the interim really get down to an acquisition? And is there one that -- 1 or 2 that you're actually dealing with or negotiating with because I think we were led to understand in previous calls that, that's a very big factor in your expectations, locking down an acquisition using the current cash balance that you have?

但是整合一家公司的能力提供了一些穩定的收入，也許收入會很有意義，在你建立這個巨大的增長引擎時相當有意義，我認為它非常強大，但它可能仍然需要 2， 3年讓我們看到完整的效果。那麼，為什麼不在此期間真正開始進行收購呢？有沒有一個 - 1 或 2 你實際上正在處理或談判，因為我認為我們在之前的電話中被引導理解，這是你期望的一個非常重要的因素，使用當前現金鎖定收購你有餘額嗎？

Okay. Martin, I'll comment on that. Yes, I'll try to comment properly on these for you. On 2023 growth, the biggest variable to us is the timing of when CMS will process and pay. So a lot of our focus this year is fill the funnel. That's why you want to do the 35 to 50 submissions. Remember, we placed one last year, and that's one in our whole history relative to CMS. That was the first one. So this year, there'll be up to another 49 more. How many of those may make it or not make it through the process, we can't forecast that yet.

好的。馬丁，我會對此發表評論。是的，我會盡力為您正確評論這些。關於 2023 年的增長，對我們來說最大的變量是 CMS 處理和支付的時間。因此，我們今年的重點是填充漏斗。這就是為什麼您想進行 35 到 50 次提交。請記住，我們去年放置了一個，這是我們與 CMS 相關的整個歷史中的一個。那是第一個。所以今年，還會有多達 49 個。其中有多少人可能通過這個過程成功或失敗，我們還無法預測。

But there's reason to be optimistic, but I just don't have any time lines that I can give you out of the final details with CMS at this point. On the acquisition side, when we look at the infrastructure we've built that can manage everything from the complexity of Medicare claims and the complexity of a product for spinal cord injury, we have a particularly strong team. And what we learned under adding a product with -- like the MyoCycle through the distribution agreement was that we were able to very effectively do that, and it helped leverage our cost. So what we're looking to do, part of this is we must grow SCI, we will grow SCI. We've got all the pieces going the right way.

但我們有理由保持樂觀，但目前我沒有任何時間表可以為您提供有關 CMS 的最終細節。在收購方面，當我們審視我們建立的基礎設施時，我們可以管理從復雜的醫療保險索賠到復雜的脊髓損傷產品的一切，我們擁有一支特別強大的團隊。我們在添加產品時學到的東西——比如通過分銷協議的 MyoCycle，我們能夠非常有效地做到這一點，它有助於平衡我們的成本。所以我們想要做的，其中一部分是我們必鬚髮展 SCI，我們將發展 SCI。我們已經把所有的部分都按正確的方式進行了。

Putting some things parallel to that makes a great deal of business sense. We have put in extensive amount of effort and spoken with many potential groups in the landscape, but there's nothing I can comment more on that at this time that there -- we have interest and others have interest. We've got to see if something makes sense at the end of the day, and we'll report it if we get there.

將一些事情與此並行進行具有很大的商業意義。我們已經付出了大量的努力，並與該領域的許多潛在團體進行了交談，但目前我對此無話可說——我們有興趣，其他人也有興趣。我們必須在一天結束時看看某些事情是否有意義，如果我們到達那裡，我們會報告它。

Because essentially, with regard to outlook at this point, you're not really -- things that look good, but you're not committing yourself to a growth outlook for 2023. Is that the way to understand your comments or you just don't want to talk about outlook because you just said that...

因為從本質上講，就目前的前景而言，你並不是真的 - 看起來不錯，但你並沒有致力於 2023 年的增長前景。這是理解你的評論的方式還是你只是不不想談論前景，因為你剛剛說了......

Well, I'll try to be more specific. We will grow, we believe. Our numbers will be bigger this year than last year, and we have a particular goal in our plan, but we don't give public guidance on it. The question to us is how much we grow and how quickly? But this will be a growth year. We're very comfortable with that.

好吧，我會嘗試更具體。我們會成長，我們相信。今年我們的人數會比去年多，我們的計劃中有一個特定的目標，但我們不會就此給出公開指導。對我們來說，問題是我們增長了多少以及增長的速度有多快？但這將是增長的一年。我們對此很滿意。

(Operator Instructions)

（操作員說明）

And our next question comes from Charles (inaudible) from GTM.

我們的下一個問題來自 GTM 的查爾斯（聽不清）。

I appreciate an excellent job on actually the revenue and actually turning the company around. Again, the people out there, the handicapped community is probably happy that you guys are doing a great job at everything. My first question comes from the FDA 510 you guys have sitting over there at the FDA. Does it -- when they -- if it does get approved, again, I hope it does, what kind of an impact will that put on the product and the sales going forward? And is there any competitors out there that are using something similar to what's already out there in the marketplace?

我很欣賞在實際收入和實際扭轉公司局面方面所做的出色工作。再一次，那裡的人，殘疾人社區可能很高興你們在每件事上都做得很好。我的第一個問題來自你們坐在 FDA 那邊的 FDA 510。它會 - 當他們 - 如果它確實獲得批准，我希望它再次獲得批准，這會對產品和未來的銷售產生什麼樣的影響？是否有任何競爭對手正在使用與市場上現有產品類似的產品？

Well, first, the biggest impact is the user has given access to places they can't go, and that's why we're here. What will it do for sales? I believe as we are expanding, particularly with CMS that, that is an innovative feature and why we were given a breakthrough designation by FDA for that stairs-climbing component, it should have an impact and help us pull more patients through the system. Competitively, there is not a product in the world other than ours that can do this. So it puts us also in a competitive position that is advantageous for the home user that wants that type of access.

好吧，首先，最大的影響是用戶允許訪問他們不能去的地方，這就是我們在這裡的原因。它將為銷售做什麼？我相信，隨著我們的擴展，尤其是 CMS，這是一項創新功能，也是我們獲得 FDA 對爬樓梯組件的突破性指定的原因，它應該會產生影響並幫助我們通過該系統吸引更多患者。在競爭方面，世界上沒有任何產品可以做到這一點。因此，這也使我們處於競爭地位，這對需要這種訪問權限的家庭用戶來說是有利的。

Excellent. And another quick question would be, I know Brooks Rehabilitation has been a big fall of yours, and they have a lot of your suits, they do a lot of work with it. What's the status with them? Are they still pushing themselves there, working with it? And also, have you guys ever considered leasing some of the suits out to some of the training tenants to get them indoor and get more of a public market in mind on that?

出色的。另一個簡短的問題是，我知道 Brooks Rehabilitation 是你的一大敗筆，他們有很多你的訴訟，他們用它做了很多工作。他們什麼情況？他們是否仍在將自己推向那裡，與之合作？而且，你們有沒有考慮過將一些西裝出租給一些培訓租戶，讓他們在室內使用，並考慮到更多的公共市場？

I'm going to answer on the first part of your question on the leasing suits, that has been an option we've offered at points in time, and that may expand as we get more training centers going under CMS because I think that would work. The first part of your question, I wasn't sure who you were referencing. I didn't hear that clearly.

我將回答你關於租賃訴訟的問題的第一部分，這是我們在某個時間點提供的一個選項，並且隨著我們讓更多的培訓中心在 CMS 下進行，這可能會擴大，因為我認為這會工作。你問題的第一部分，我不確定你指的是誰。我沒聽清楚。

It was Brooks Rehabilitation, I believe they're in (inaudible) product update. Are they still doing it and are they expanding? Are they still pushing it?

這是 Brooks Rehabilitation，我相信他們正在進行（聽不清）產品更新。他們還在這樣做嗎？他們在擴張嗎？他們還在推動它嗎？

I haven't worked with Brooks recently. They've been a great center, and I know some really good outcomes that are out of there. I will ask my local rep as to what they've done in the last few weeks or months. But as far as I know, they're still in great standing and an outstanding center. I know a couple of the patients, in fact, one of them was here and helped us in our usability studies recently, and they were well trained. Sorry, I can't be more specific than that.

我最近沒有和布魯克斯一起工作過。他們一直是一個偉大的中心，我知道那裡有一些非常好的結果。我會詢問我當地的代表他們在過去幾週或幾個月裡做了什麼。但據我所知，他們仍然享有盛譽，是一名出色的中鋒。我認識幾個病人，事實上，他們中的一個最近在我們的可用性研究中幫助了我們，他們訓練有素。抱歉，我不能說得更具體了。

No, no, no. You didn't actually. So the final question is the acquisitions. I know you had a lot of it. Are you guys looking at the acquisitions outside? I know you've got to be selective. And obviously, I know the competitive marketplace out there, it seems like there's a couple of 1, 2, 3 of the big players out there and a lot of -- the FDA has approved some new suits in the marketplace, and you must have seen that. The acquisition, are you guys looking for something that's similar to what your product is? Or are you looking for something totally different, I mean, to add to your product line?

不不不。你實際上沒有。所以最後一個問題是收購。我知道你有很多。你們在看外面的收購嗎？我知道你必須有選擇性。顯然，我知道那裡競爭激烈的市場，似乎有 1、2、3 個大公司，還有很多——FDA 已經批准了市場上的一些新訴訟，你必須有看到了。收購，你們在尋找與你們的產品相似的東西嗎？或者您正在尋找完全不同的東西，我的意思是，添加到您的產品線？

We believe we're the market leader with the exoskeleton and the developments we have going around it for SCI that will be -- stay ahead of our competition. So we're not looking to acquire something that's really that close in. But we are in the clinics for spinal cord injury patients, for stroke patients, for MS patients and companies that have products that can help those populations, we have a good infrastructure to help them be more successful in selling. Those are more of the things we're looking at.

我們相信我們是外骨骼的市場領導者，我們為 SCI 所做的開發將 - 保持領先於我們的競爭。所以我們不打算收購真正接近的東西。但我們在脊髓損傷患者、中風患者、多發性硬化症患者的診所和擁有可以幫助這些人群的產品的公司中，我們擁有良好的基礎設施幫助他們更成功地銷售。這些是我們正在關注的更多內容。

So we're trying to stay in the neighborhood, in the universe which we understand and have talent in. But we believe we already have a market-leading technology and can keep advancing that if we can build the referral network and the market creation side of this through access. So we're not looking to add more exoskeletons for SCI, but we certainly want to help other patients that -- in this clinic community that go home. I can't be more specific than that, but those are the types of things we're looking for.

因此，我們正努力留在附近，在我們了解並擁有人才的宇宙中。但我們相信我們已經擁有市場領先的技術，並且如果我們能夠建立推薦網絡和市場創造方面，我們可以繼續推進這一點這通過訪問。所以我們不打算為 SCI 添加更多的外骨骼，但我們當然想幫助其他患者——在這個診所社區中回家。我不能比這更具體，但這些是我們正在尋找的東西類型。

Well, congratulations. I think your company is in the best shape it's been in, in a long time, and I think you guys are going in the right direction. So keep up all the great work. And thanks for helping all the patients out there.

嗯，恭喜。我認為貴公司在很長一段時間內處於最佳狀態，而且我認為你們正朝著正確的方向前進。所以保持所有偉大的工作。並感謝您幫助那裡的所有患者。

Thank you. Thank you for the comments.

謝謝。謝謝你的意見。

Thank you.

謝謝。

And ladies and gentlemen, with that, and showing no additional questions, I'd like to turn the floor back over to the management team for any closing remarks.

女士們，先生們，說到這裡，沒有其他問題了，我想把發言權交還給管理團隊，聽取任何結束語。

Jamie, thank you very much for the call. For everybody that joined us today, I appreciate and for anyone who listens to this, please feel free to come forward with us and ask questions. We -- as I have indicated, I laid out 7 goals for this year. We're going to report on those quarterly, so you can measure how we're doing and the progress that we're making. So I thank you for your time, and please reach out if you have other questions as we are going to expand our outreach to our investors going forward.

傑米，非常感謝你的來電。對於今天加入我們的每個人，我都很感激，對於任何聽到這個的人，請隨時與我們一起前來提問。我們——正如我所指出的，我為今年制定了 7 個目標。我們將每季度報告一次，這樣您就可以衡量我們的表現和取得的進展。因此，感謝您抽出寶貴時間，如果您有其他問題，請與我們聯繫，因為我們將在未來擴大與投資者的聯繫。

Thank you.

謝謝。

And ladies and gentlemen, with that, we'll end today's presentation. We thank you for joining. You may now disconnect your lines.

女士們先生們，我們將結束今天的演講。我們感謝您的加入。您現在可以斷開線路。