MiMedx Group Inc (MDXG) 2024 Q2 法說會逐字稿

Greetings and welcome to the MiMedx second quarter 2024 operating and financial results conference call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions) As a reminder, this conference is being recorded.

歡迎參加 MiMedx 2024 年第二季營運與財務績效電話會議。此時，所有參與者都處於只聽模式。正式演講後將舉行簡短的問答環節。（操作員指示）謹此提醒，本次會議正在錄製中。

It is now my pleasure to introduce your host, Matt Notarianni, Head of Investor Relations. Thank you, sir. You may begin.

現在我很高興向您介紹主持人，投資者關係主管 Matt Notarianni。謝謝您，先生。你可以開始了。

Thank you, operator, and good afternoon, everyone. Welcome to the MiMedx second quarter 2024 operating and financial results conference call. With me on today's call are Chief Executive Officer, Joe Capper; and Chief Financial Officer, Doug Rice. As part of today's webcast, we are simultaneously displaying slides that you can follow. You can access the slides from the Investor Relations website at mimedx.com.

謝謝接線員，大家下午好。歡迎參加 MiMedx 2024 年第二季營運與財務績效電話會議。與我一起參加今天電話會議的是執行長喬·卡珀 (Joe Capper)；和財務長道格·賴斯。作為今天網路廣播的一部分，我們同時展示您可以觀看的幻燈片。您可以從投資者關係網站 mimedx.com 存取這些投影片。

Joe will kick us off with some opening remarks and a summary of our operating highlights and Doug will provide a review of our financial results for the quarter. And then Joe will conclude with some additional updates, including a discussion of our financial goals. We will then be available for your questions.

喬將首先致辭並總結我們的營運亮點，道格將回顧我們本季的財務表現。然後喬將總結一些額外的更新，包括討論我們的財務目標。然後我們將回答您的問題。

Before we begin, I would like to remind you that our comments today will include forward-looking statements including statements regarding future sales, adjusted EBITDA, free cash flow and cash balance growth, future margins and expenses and expected market sizes for our products. These expectations are subject to risks and uncertainties and actual results may differ materially from those anticipated due to many factors.

在開始之前，我想提醒您，我們今天的評論將包括前瞻性陳述，包括有關未來銷售、調整後 EBITDA、自由現金流和現金餘額增長、未來利潤和費用以及我們產品的預期市場規模的陳述。這些預期存在風險和不確定性，由於許多因素，實際結果可能與預期有重大差異。

Actual results and market sizes will depend on a number of factors including competition, access to customers, the reimbursement environment, unforeseen circumstances and delays and other factors. Additional factors that could impact outcomes and our results include those described in the Risk Factors section of our annual report on Form 10-K and our quarterly reports on Form 10-Q.

實際結果和市場規模將取決於許多因素，包括競爭、接觸客戶、報銷環境、不可預見的情況和延誤以及其他因素。可能影響結果和我們結果的其他因素包括我們的 10-K 表年度報告和 10-Q 表季度報告的風險因素部分中所述的因素。

Also our comments today include non-GAAP financial measures, and we provide a reconciliation to GAAP measures in our press release, which is available on our website at mimedx.com.

此外，我們今天的評論還包括非 GAAP 財務指標，並且我們在新聞稿中提供了 GAAP 指標的調整表，該新聞稿可在我們的網站 mimedx.com 上取得。

With that, I'm now pleased to turn the call over to Joe Capper. Joe?

至此，我現在很高興將電話轉給喬·卡珀。喬？

Thanks, Matt, and good afternoon, everyone. We thank you for joining us on today's call as we are very pleased to report the results of another solid quarter. For the second quarter, we continued to achieve year-over-year top line growth, albeit at a slower rate.

謝謝馬特，大家下午好。我們感謝您參加今天的電話會議，因為我們非常高興地報告又一個堅實的季度的業績。第二季度，我們持續實現營收年增，儘管成長放緩。

There are two factors that impacted the magnitude of our growth; first, we had a very tough comparison due to our strong performance in Q2 2023; and second, there continues to be dislocation in the private office setting caused by certain competitors and providers utilizing artificially high-priced skin substitutes and questionable business practices targeted at Medicare beneficiaries.

有兩個因素影響了我們的成長幅度；首先，由於我們在 2023 年第二季的強勁表現，我們進行了非常艱難的比較；其次，由於某些競爭對手和提供者利用人為高價的皮膚替代品以及針對醫療保險受益人的可疑商業行為，私人辦公室環境繼續出現混亂。

While less than 25% of our total revenue is tied to Medicare in the private office and adjacent settings, we have felt the impact of this behavior. I assure you we are working on various options in the event no action is taken to curtail these practices. I will speak more on this topic later in the call.

雖然我們總收入的不到 25% 與私人辦公室和鄰近環境的醫療保險有關，但我們已經感受到了這種行為的影響。我向您保證，如果不採取行動限制這些做法，我們正在研究各種選擇。我將在稍後的電話會議中更多地討論這個主題。

Importantly, the remainder of our business continues to flourish. We believe our industry will and must return to a more rational, data driven, regulatory and reimbursement environment. In the meantime, it is important to realize just how well we have positioned MiMedx to navigate these short-term headwinds, and we expect to emerge on the other side stronger than ever before.

重要的是，我們其餘的業務繼續蓬勃發展。我們相信，我們的產業將會且必須回歸更理性、數據驅動、監管和報銷的環境。同時，重要的是要認識到我們對 MiMedx 的定位有多好，以應對這些短期逆風，並且我們預計在另一邊會比以往任何時候都更強大。

Over the past year, we have orchestrated a significant financial transformation for our company, and we remain laser-focused on executing our strategy, which will ensure success for years to come. This much improved financial profile enables us greater flexibility and optionality as we navigate near-term disruption.

在過去的一年裡，我們為公司精心策劃了重大的財務轉型，我們仍然專注於執行我們的策略，這將確保未來幾年的成功。財務狀況的大幅改善使我們在應對近期顛覆時具有更大的靈活性和選擇性。

Moreover, I am confident we have the right plan and team in place to continue our momentum. As an industry leader we continue to provide input and lobby the relevant governing bodies in an effort to help restore good fiscal governance to the Medicare portion of the private office setting.

此外，我相信我們擁有正確的計劃和團隊來繼續我們的勢頭。作為行業領導者，我們繼續提供意見並遊說相關管理機構，努力幫助私人辦公室環境中的醫療保險部分恢復良好的財務治理。

Now, I'll take a few minutes to discuss the highlights of the second quarter and then update you on the progress we are making regarding our strategic priorities. For the second quarter net sales grew year-over-year by $6 million or 7% to $87 million, marking another solid growth quarter.

現在，我將花幾分鐘時間討論第二季的亮點，然後向您介紹我們在策略重點方面取得的最新進展。第二季淨銷售額年增 600 萬美元，或 7%，達到 8,700 萬美元，標誌著又一個強勁成長季度。

Gross profit was 83%. Adjusted EBITDA was $20 million, or 23% of net sales in the quarter, representing an increase of $6 million over the prior year period. We ended with $69 million in cash, a healthy increase of $21 million in the quarter.

毛利為83%。調整後 EBITDA 為 2,000 萬美元，佔本季淨銷售額的 23%，比去年同期增加 600 萬美元。我們最終獲得了 6,900 萬美元的現金，本季健康成長了 2,100 萬美元。

We began the limited market release of HELIOGEN, which is the commercial name for the bovine-derived particulate we acquired earlier in the year. We were thrilled to announce the well-deserved promotion of Kim Moller, the Chief Commercial Officer for MiMedx.

我們開始在市場上限量發行 HELIOGEN，這是我們今年早些時候購買的牛源顆粒的商業名稱。我們很高興地宣布 MiMedx 首席商務官 Kim Moller 獲得當之無愧的晉升。

Kim has done a remarkable job over the last four years, building the MiMedx commercial organization into the high-performing team it is today. And a few weeks ago we were excited to have Nature's Scientific Reports, which is a leading peer-reviewed journal with a reputation for publishing best-in-class scientific literature, publish a study demonstrating the benefits of MiMedx placental-based allografts in surgical applications where pathological fibrosis results in detrimental scarring and dysfunctional tissue.

Kim 在過去四年中做了出色的工作，將 MiMedx 商業組織打造為今天的高績效團隊。幾週前，我們很高興《自然科學報告》（Nature's Scientific Reports）發表了一項研究，展示了基於MiMedx 胎盤的同種異體移植物在外科應用中的優勢，該雜誌是一家領先的同行評審期刊，以發表一流的科學文獻而聞名。

Turning now to our strategic priorities. As outlined on prior calls, our plan is focused in three areas. First, we will continue to innovate and diversify our product portfolio. We have clearly built a strong core competency in the development and rapid commercialization of products designed to meet emerging physician and patient needs in all sites of care.

現在轉向我們的策略重點。如同先前電話所述，我們的計劃重點在於三個領域。首先，我們將繼續創新並豐富我們的產品組合。我們在產品的開發和快速商業化方面顯然建立了強大的核心能力，旨在滿足所有護理場所新興的醫生和患者的需求。

Two of our most recent product introductions continue to perform at a high-level. AMNIOEFFECT grew nearly 40% year-over-year in the surgical market; and EPIEFFECT, which we launched late last year continued to show significant strength in the private office. Both products have received widespread market acceptance and excellent physician feedback.

我們最近推出的兩款產品持續保持高水準表現。AMNIOEFFECT 在外科手術市場較去年同期成長近 40%；我們在去年年底推出的 EPIEFFECT 繼續在私人辦公室領域展現出顯著的實力。這兩種產品都獲得了廣泛的市場認可和良好的醫生回饋。

Additionally, we continue to make progress building our EPIFIX business in Japan where we posted another quarter of exceptionally high growth. Building on the success of these recent product introductions, we expect a similar performance as we move towards full market release of our first xenograft.

此外，我們在日本的 EPIFIX 業務建設上繼續取得進展，在日本又一個季度實現了異常高的成長。在這些最近推出的產品取得成功的基礎上，我們預計在我們的第一個異種移植物全面上市時也會有類似的表現。

As a reminder this new product is a 510(k)-cleared, bovine-derived collagen matrix particulate which we have branded HELIOGEN and is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding. During our soft launch the product has been successfully applied in various surgical procedures including Achilles tendon repair.

提醒一下，這款新產品是一種經過 510(k) 清除的牛源膠原蛋白基質顆粒，我們將其命名為 HELIOGEN，適用於處理中度至重度滲出的傷口並控制輕微出血。在我們試推出期間，該產品已成功應用於包括跟腱修復在內的各種外科手術。

That takes me to our second area of focus which is to develop and deploy programs intended to expand our footprint in the surgical market. In the past we've spoken about the importance of generating real-world evidence and scientific research demonstrating support for the use of our placental-based allograft in a variety of surgical procedures.

這讓我想到了我們的第二個重點領域，即開發和部署旨在擴大我們在外科市場的足跡的計劃。過去，我們已經談到了產生真實世界證據和科學研究的重要性，以證明我們的基於胎盤的同種異體移植物在各種外科手術中的使用的支持。

We are currently working with key opinion leaders to produce evidence in surgical case studies, as we know data is especially critical in this part of the market. To that end, the Nature-Scientific Report's article I mentioned earlier is one of the more exciting and significant publications we have seen in quite some time.

我們目前正在與關鍵意見領袖合作，在外科案例研究中提供證據，因為我們知道數據在這部分市場尤其重要。為此，我之前提到的《自然科學報告》的文章是我們在相當長一段時間內看到的最令人興奮和更重要的出版物之一。

The prestige of this journal alone demonstrates the importance of the work. This study evaluated two configurations of MiMedx's proprietary placental-based allografts for their ability to regulate fibrotic processes or scarring of connected tissue.

光是該期刊的聲望就證明了這項工作的重要性。這項研究評估了 MiMedx 專有的基於胎盤的同種異體移植物的兩種配置調節纖維化過程或連接組織疤痕的能力。

The study found that both our dehydrated and lyophilized human amnion/chorion membranes demonstrated in-vitro modulation of collagen production deposition and maturation in support of the hypothesis that amniotic membranes may function to interrupt pathological fibrosis and restore tissue homeostasis.

研究發現，我們的脫水和凍乾的人類羊膜/絨毛膜均表現出對膠原蛋白生成沉積和成熟的體外調節，支持羊膜可能具有中斷病理性纖維化和恢復組織穩態的假設。

The practical implications of these findings are immense. The possibility of reduced scarring or information through the use of MiMedx proprietary technology could enable accelerated and improved quality of healing with decreased incidence of recurrence. This creates the potential for enhanced surgical outcomes from improved functionality to superior cosmetic results simply by incorporating MiMedx proprietary membranes into the procedure.

這些發現的實際意義是巨大的。透過使用 MiMedx 專有技術減少疤痕或資訊的可能性可以加速和提高癒合質量，同時降低復發率。只需將 MiMedx 專有膜融入手術中，就可以提高手術效果，從改進功能到卓越的美容效果。

We are already seeing the real-world benefits of such applications in a number of surgical applications. OB/GYNs for example are using our tissue to help promote healing during C-section closure. And there are numerous other use cases and novel applications starting to develop.

我們已經在許多外科手術應用中看到了此類應用的實際好處。例如，婦產科醫生正在使用我們的組織來幫助促進剖腹產縫合期間的癒合。還有許多其他用例和新穎的應用程式開始開發。

Considering the potential benefits demonstrated in this study and applying that to the tens of millions of surgeries performed in the US annually, the size of the opportunity could be staggering for MiMedx.

考慮到這項研究所展示的潛在好處，並將其應用於美國每年進行的數千萬例手術，對於 MiMedx 來說，機會的大小可能是驚人的。

The importance of this type of research and other supporting investments in order to continue to demonstrate the superiority of our technology cannot be overstated. We have the company's strategic compass pointed squarely in the direction of a greater surgical presence. And we will continue to ramp up necessary clinical and marketing investments to support these opportunities.

為了繼續證明我們技術的優越性，此類研究和其他支持性投資的重要性怎麼強調也不為過。我們公司的策略指南針直接指向擴大外科業務的方向。我們將繼續加大必要的臨床和行銷投資來支持這些機會。

And of course, we're excited to move into full market release of HELIOGEN, our first xenograft particulate, which we will promote for use in surgical cases, where such products may be more appropriate for various reasons. We expect this first xenograft product to provide for greater access into parts of the markets we have historically been precluded from competing.

當然，我們很高興能夠進入 HELIOGEN 的全面市場發行，這是我們的第一個異種移植顆粒，我們將推廣其用於外科手術病例，由於各種原因，此類產品可能更適合。我們預計第一個異種移植產品將為我們進入歷史上無法競爭的部分市場提供更多機會。

Our third initiative is to introduce programs designed to enhance customer intimacy. As a reminder, the primary focus of this initiative is to develop programs, which improve relationships and ultimately lower our customer churn.

我們的第三項措施是推出旨在增強客戶親密度的計畫。提醒一下，該計劃的主要重點是製定計劃，改善關係並最終降低客戶流失率。

In our markets customer turnover is high relative to other industries which impacts margins. We believe we have an opportunity to change this dynamic and build much stickier associations through an expanded customer-centric offering thereby increasing the lifetime value of each customer.

在我們的市場中，客戶流失率相對於其他產業而言較高，這會影響利潤率。我們相信，我們有機會改變這種動態，並透過擴大以客戶為中心的產品建立更具黏性的關聯，從而提高每個客戶的終身價值。

The long-term plan is to embed a customer-centric mindset and processes in all facets of the organization from product development to inventory visibility and account management. As mentioned a few months ago, we recently launched MIMEDX Connect our new customer portal providing a far more streamlined digital connection with referring practices.

長期計劃是將以客戶為中心的思維方式和流程嵌入到組織的各個方面，從產品開發到庫存可見性和帳戶管理。正如幾個月前提到的，我們最近推出了 MIMEDX Connect 我們的新客戶門戶，透過推薦實踐提供了更簡化的數位連接。

The adoption rate is exceeding our expectations with nearly 25% of our active customers now using MIMEDX Connect to interface with the company for processes such as insurance verification and product ordering. We will continue to enhance the feature set platform and believe it will eventually become another distinct competitive advantage for the company.

採用率超出了我們的預期，近 25% 的活躍客戶現在使用 MIMEDX Connect 與公司進行交互，以進行保險驗證和產品訂購等流程。我們將繼續增強功能集平台，相信它最終將成為公司另一個明顯的競爭優勢。

Now let me turn the call over to Doug for more detail on our financial results. Then I will close with comments about the private office reimbursement dynamic and full year guidance. Doug?

現在讓我將電話轉給道格，以了解有關我們財務表現的更多詳細資訊。然後我將以有關私人辦公室報銷動態和全年指導的評論作為結束語。道格？

Thank you, Joe and good afternoon to everyone on today's call. Thank you for joining us. I'm pleased to once again share our results with you all today. As a reminder, as Matt mentioned, many of the financial measures covered in today's call are on a non-GAAP basis, so please refer to today's earnings release for further information regarding our non-GAAP reconciliations and disclosures.

謝謝喬，今天電話會議的大家下午好。感謝您加入我們。我很高興今天再次與大家分享我們的成果。提醒一下，正如馬特所提到的，今天的電話會議中涵蓋的許多財務指標都是基於非公認會計原則的，因此請參閱今天的收益發布，以了解有關我們的非公認會計原則調節和披露的更多資訊。

Beginning this quarter, in order to increase visibility, we added a few tables in the back of our press release that break out our non-GAAP adjustments by expense line item. I encourage you to review these materials alongside my comments today.

從本季開始，為了提高可見性，我們在新聞稿後面添加了一些表格，按費用項目列出了我們的非公認會計準則調整。我鼓勵您今天回顧這些資料和我的評論。

Additionally, and as a reminder, during the fourth quarter last year we bifurcated our GAAP financial reporting to reflect the current and historical results of our recently disbanded regenerative medicine segment as discontinued operations.

此外，提醒一下，在去年第四季度，我們將我們的公認會計準則財務報告分為兩部分，以反映我們最近解散的再生醫學部門作為已終止業務的當前和歷史結果。

Accordingly, my comments today on our second quarter 2024 results are made on a continuing operations basis and exclude the historical cost of the regenerative medicine business unit, which was suspended beginning in late Q2 2023. For a full discussion of the impact of these discontinued operations, please refer to our most recent 10-K and 10-Q filings.

因此，我今天對 2024 年第二季業績的評論是在持續經營的基礎上做出的，不包括從 2023 年第二季末開始暫停的再生醫學業務部門的歷史成本。有關這些已終止業務的影響的完整討論，請參閱我們最新的 10-K 和 10-Q 文件。

Moving on to the results. Our second quarter 2024 net sales of $87 million, represented 7% growth compared to the prior year period. As Joe mentioned in his remarks, there were several factors that drove this performance in the quarter, and I would like to provide some additional color on each of them.

繼續看結果。我們 2024 年第二季的淨銷售額為 8,700 萬美元，比去年同期成長 7%。正如喬在演講中提到的，有幾個因素推動了本季的業績，我想對每個因素提供一些額外的解釋。

By product category, net sales growth was relatively balanced between our wound and surgical businesses, particularly when you consider certain anomalies. Second quarter wound sales of $58 million grew 8% versus the prior year period and second quarter surgical sales of $30 million grew 6% as reported and 13% excluding AXIOFILL and the sales of the dental product in the prior year period. Two of the standout contributors in the quarter were our AMNIOEFFECT and EPIEFFECT products which continue to gain traction in the surgical and wound markets respectively.

按產品類別劃分，我們的傷口和外科業務之間的淨銷售額成長相對平衡，特別是當您考慮到某些異常情況時。據報道，第二季傷口銷售額為5,800 萬美元，較上年同期成長8%，第二季外科銷售額為3,000 萬美元，成長6%，不包括AXIOFILL 和去年同期的牙科產品銷售額，成長13%。本季度的兩個突出貢獻者是我們的 AMNIOEFFECT 和 EPIEFFECT 產品，它們分別繼續在外科和傷口市場中獲得關注。

Turning to our results by site of service. While we saw positive growth in all of our sites of service during the quarter, as Joe mentioned, we have seen a sizable increase in competitive behavior related to the sale of artificially high-priced products in the private office setting for Medicare beneficiaries.

轉向我們按服務站點劃分的結果。正如喬所提到的，雖然我們在本季度所有服務站點都實現了積極增長，但我們也看到，與在私人辦公室環境中為醫療保險受益人銷售人為高價產品相關的競爭行為大幅增加。

This has resulted in a deceleration in our growth rate compared to the first quarter of 2024 in each of these associated care settings. These competitive pressures resulted in higher-than-normal levels of employee and customer churn, beginning about midway through the second quarter.

與 2024 年第一季相比，這導致我們在這些相關護理機構的成長率有所放緩。這些競爭壓力導致員工和客戶流動率高於正常水平，大約從第二季中期開始。

Additionally, the introduction of the proposed LCDs during the quarter prompted the beginning of some changes in behavior for portions of the private office site of service. But clearly as evidenced by the performance of artificially high-priced skin substitute, this continues to pose a challenge in the marketplace for us.

此外，本季擬議的 LCD 的推出促使私人辦公服務站點的部分行為開始發生一些變化。但正如人為高價皮膚替代品的表現所明顯證明的那樣，這繼續對我們的市場構成挑戰。

Finally, as I mentioned earlier and to a lesser extent, our sales of AXIOFILL declined on a year-over-year and sequential basis. While we still have a number of loyal accounts routinely using and ordering this product, our ongoing matter with the FDA is having an impact on this product line's performance with certain customers.

最後，正如我之前提到的，我們 AXIOFILL 的銷售額比去年同期和連續下降，但程度較小。雖然我們仍然有許多忠實的客戶經常使用和訂購該產品，但我們與 FDA 之間持續存在的問題正在對該產品線在某些客戶中的表現產生影響。

The AXIOFILL matter with the FDA remains on schedule and will likely drive toward a ruling from the court later this year or early next year. Taken together, these items softened our otherwise strong momentum in many market sectors and regions.

與 FDA 的 AXIOFILL 案仍在按計劃進行，法院可能會在今年稍後或明年初作出裁決。總而言之，這些項目削弱了我們在許多市場領域和地區原本強勁的勢頭。

Our second quarter 2024 gross profit was about $72 million compared to $68 million last year. Our gross margin was 83%, down slightly compared to the prior year period due in part to incremental amortization expense from intangible assets acquired in the HELIOGEN transaction. Excluding this $400,000 impact, our gross margins were flat compared to the second quarter of 2023.

我們 2024 年第二季的毛利約為 7,200 萬美元，而去年為 6,800 萬美元。我們的毛利率為 83%，與去年同期相比略有下降，部分原因是 HELIOGEN 交易中收購的無形資產的攤銷費用增加。排除這 40 萬美元的影響，我們的毛利率與 2023 年第二季持平。

Turning to our operating expenses. Selling, general and administrative expenses or SG&A was $55 million in the second quarter compared to $52 million in the prior year period. SG&A was 64% of our net sales in both periods.

轉向我們的營運費用。第二季銷售、一般和管理費用或 SG&A 為 5,500 萬美元，而去年同期為 5,200 萬美元。SG&A 占我們兩個時期淨銷售額的 64%。

The increase in SG&A was related primarily to a variety of higher commercial expenses including commissions, costs associated with the HELIOGEN launch, and increased other costs including legal fees in the quarter compared to the prior year period offset by spending efficiencies in other areas.

SG&A 的增加主要與各種較高的商業費用有關，包括佣金、與HELIOGEN 推出相關的成本，以及本季與去年同期相比增加的其他成本（包括法律費用），但被其他領域的支出效率所抵消。

Our second quarter R&D expenses were $3 million or about 3% of net sales compared to $4 million or about 5% of net sales in the prior year period. With our EPIEFFECT RCT underway, we continue to expect our R&D spend to modestly increase on a relative basis compared to 2023 to mid-single-digits as a percentage of net sales.

我們第二季的研發費用為 300 萬美元，約佔淨銷售額的 3%，而去年同期的研發費用為 400 萬美元，約佔淨銷售額的 5%。隨著 EPIEFFECT RCT 的進行，我們繼續預計，與 2023 年相比，我們的研發支出將在相對基礎上小幅增加，佔淨銷售額的百分比達到中個位數。

Income tax expense for Q2 2024 was $6 million, reflecting an effective tax rate of 24%. This is roughly in line with our 25% long-term non-GAAP expected effective tax rate that we utilize going forward.

2024 年第二季的所得稅費用為 600 萬美元，實際稅率為 24%。這與我們未來使用的 25% 長期非 GAAP 預期有效稅率大致一致。

Our second quarter GAAP net income inclusive of the results of our discontinued operations was $18 million compared to $1 million in the prior year period. Our GAAP net income for the second quarter was driven in large part by benefits we recorded associated with the resolutions of matters involving former officers.

我們第二季的 GAAP 淨利（包括已終止經營業務的業績）為 1,800 萬美元，而上年同期為 100 萬美元。我們第二季度公認的會計原則淨利潤在很大程度上是由我們記錄的與涉及前官員的事項決議相關的收益所推動的。

Adjusted net income for the quarter was $11 million or $0.08 per share compared to $6 million or $0.03 per share in the prior year period. Second quarter 2024 adjusted EBITDA was $20 million or 23% of net sales compared to an adjusted EBITDA of $14 million or about 17% of net sales in the prior year period.

本季調整後淨利為 1,100 萬美元，即每股 0.08 美元，去年同期為 600 萬美元，即每股 0.03 美元。2024 年第二季調整後 EBITDA 為 2,000 萬美元，佔淨銷售額的 23%，而去年同期調整後 EBITDA 為 1,400 萬美元，約佔淨銷售額的 17%。

Turning to our liquidity. The strong free cash flow generated by our business reached its highest level in the history of the company during the second quarter at $22 million, nearly the entire amount of free cash flow we generated in all of 2023.

轉向我們的流動性。我們的業務產生的強勁自由現金流在第二季度達到了公司歷史上的最高水平，達到 2,200 萬美元，幾乎是我們 2023 年全年產生的自由現金流的全部金額。

This enabled us to grow our net cash balance to $50 million by the end of the second quarter, marking yet another significant improvement in our balance sheet as we work to strengthen our position in order to have the optionality to make investments in a number of different ways that we believe will unlock shareholder value.

這使我們能夠在第二季末將淨現金餘額增加到5000 萬美元，這標誌著我們的資產負債表再次顯著改善，因為我們正在努力加強我們的地位，以便可以選擇在許多不同的領域進行投資。

I will now turn the call back to Joe. Joe?

我現在將把電話轉回給喬。喬？

Thanks, Doug. As you have just heard, we had another solid quarter. Net sales were $87 million or 7% in the quarter. Gross profit was 83%. Adjusted EBITDA was $20 million or 23% of net sales in the quarter. We ended with $69 million in cash. We began a limited market release of HELIOGEN, our first xenograft product, and we were excited to see the Nature publication and it’s foreshadowing of the vast potential for future applications of our allografts.

謝謝，道格。正如您剛剛聽到的，我們又度過了一個穩健的季度。該季度淨銷售額為 8,700 萬美元，佔 7%。毛利為83%。調整後 EBITDA 為 2,000 萬美元，佔本季淨銷售額的 23%。我們最終獲得了 6900 萬美元的現金。我們開始在市場上限量發行我們的第一個異種移植產品 HELIOGEN，我們很高興看到《自然》雜誌的發表，它預示著我們的同種異體移植未來應用的巨大潛力。

Now let's return to a discussion of the reimbursement situation in the private office. On my very first MiMedx earnings call, a year and half ago, we provided commentary on challenges we were facing in the private office and adjacent care settings due to what we described at the time as certain participants using loopholes in the Medicare reimbursement system in order to provide sizable financial incentives to physicians for using their products.

現在我們回到私人辦公室報銷情況的討論。在一年半前的第一次MiMedx 財報電話會議上，我們對我們在私人辦公室和鄰近護理環境中面臨的挑戰進行了評論，因為我們當時描述的是某些參與者利用醫療保險報銷系統中的漏洞為使用其產品的醫生提供可觀的經濟誘因。

Since that time, the situation has gotten dramatically worse as a result of new and intricate schemes designed with the express purpose of self-enrichment by massively overbilling CMS for products with sparse supporting clinical data. Frankly, I'm shocked this has been allowed to persist for so long but remain optimistic it will be addressed in the very near future.

從那時起，由於新的、複雜的計劃的設計，其明確的目的是透過對支援臨床數據稀疏的產品大幅超額收取 CMS 費用，從而實現自我充實，情況變得更加糟糕。坦白說，我很震驚這個問題持續了這麼長時間，但我仍然樂觀地認為這個問題將在不久的將來得到解決。

To put this crisis in perspective, CMS payments for skin substitutes increased by over 260% or $2.5 billion in a single year from approximately $1.5 billion in 2022 to $4 billion in 2023. In recent months the situation has reached a frenzied state causing tremendous disruption and dislocation in the market and MiMedx is not immune.

從這場危機的角度來看，皮膚替代品的 CMS 支付金額在一年內增加了 260% 以上，即 25 億美元，從 2022 年的約 15 億美元增加到 2023 年的 40 億美元。近幾個月來，這種情況已經達到了瘋狂的狀態，為市場帶來了巨大的破壞和混亂，MiMedx 也無法倖免。

While we have been fairly successful at holding this pressure at bay, the impact from what we consider improper business practices has been metastasizing. As a result, we have experienced above-average employee and customer attrition, as people leave in pursuit of what could be fool's gold.

雖然我們在控制這種壓力方面相當成功，但我們認為不當商業行為的影響一直在擴散。結果，我們的員工和客戶流失率高於平均水平，人們為了追求愚人金而離開。

The abuse of practices in the skin substitute market have caught the attention of the Department of Justice, which last month announced a massive case involving the criminal prosecution of several individuals who were allegedly running a scam to overbill Medicare for skin substitutes. The problem has gotten too big to ignore and needs to be addressed.

皮膚替代品市場的濫用行為引起了司法部的注意，該部上個月宣布了一起大規模案件，涉及對幾名涉嫌實施騙局以超額收取皮膚替代品醫療保險費用的個人進行刑事起訴。這個問題已經變得太大而不容忽視，需要解決。

While we applaud the enforcement action to round up bad actors, we are in desperate need of action on the payer front to close the barn door.

雖然我們對圍捕不良行為者的執法行動表示讚賞，但我們迫切需要在付款人方面採取行動來關閉穀倉門。

Just prior to our call a few months ago all seven of the Medicare Administrative Contractors or MACs published proposed Local Coverage Determinations or LCDs in unison which would in effect create a national coverage policy.

就在我們幾個月前召開電話會議之前，所有七個醫療保險行政承包商或 MAC 一致發布了擬議的地方覆蓋決定或 LCD，這實際上將創建一項全國覆蓋政策。

As a reminder the proposed LCDs call for a utilization cap of four skin substitute applications per case with an allowance for additional applications based on medical necessity in instances when a patient's wound needs more help achieving closure.

提醒一下，建議的 LCD 要求每個病例使用 4 次皮膚替代品的使用上限，並在患者傷口需要更多幫助實現閉合的情況下，根據醫療需求允許進行額外的應用。

The proposed LCDs would also limit the number of products approved for reimbursement at 15 based on published, nonbiased clinical evidence and would prohibit reimbursement for over 180 other products.

擬議的 LCD 還將根據已發布的、無偏見的臨床證據，將批准報銷的產品數量限制在 15 種，並禁止對 180 多種其他產品進行報銷。

Two of our three products offered in the private office, including our flagship EPIFIX product are among the 15 approved for reimbursement. The third EPIEFFECT is not on the list due to a lack of sufficient published evidence. However, we now have a highly-powered randomized controlled trial underway for EPIEFFECT, which should lead to coverage in the future.

我們在私人辦公室提供的三種產品中，有兩種​​（包括我們的旗艦產品 EPIFIX 產品）屬於 15 種批准報銷的產品之列。由於缺乏足夠的公開證據，第三個 EPIEFFECT 並未出現在清單中。然而，我們現在正在進行一項針對 EPIEFFECT 的高效隨機對照試驗，這應該會在未來得到報告。

The industry appears to be appropriately moving towards a requirement to produce clinical evidence to prove efficacy as products come to market. Given our long-term commitment to evidence-based medicine this plays to MiMedx's strength. It was a comment period which ended June 8. In addition to providing comments to the MACs we've made recommendations directly to CMS and other stakeholders.

該行業似乎正在適當地朝著產品上市時提供臨床證據以證明功效的要求邁進。鑑於我們對實證醫學的長期承諾，這發揮了 MiMedx 的優勢。這是一個於 6 月 8 日結束的評論期。除了向 MAC 提供意見外，我們還直接向 CMS 和其他利害關係人提出建議。

We are now awaiting word from the MACs on their plans for implementation of the LCDs. A few weeks ago CMS published the proposed 2025 physician fee schedule which does not include proposed changes to the pricing methodology for skin substitutes.

我們現在正在等待 MAC 的消息，以了解其實施 LCD 的計劃。幾週前，CMS 發布了擬議的 2025 年醫生費用表，其中不包括對皮膚替代品定價方法的擬議變更。

That being the case, implementation of the LCDs in a format similar to what has been proposed is the most likely near-term mechanism for Medicare to rein in this runaway spend. This will cause some level of disruption in the market at least in the short term.

在這種情況下，以類似於所提議的格式實施 LCD 是 Medicare 控制這種失控支出最有可能的近期機制。至少在短期內，這將導致市場出現一定程度的混亂。

However, given the balance of our product portfolio, our commitment to evidence-based medicine and our much improved financial profile I believe we are well positioned to navigate the changes and expect us to benefit in the end under a more rational reimbursement structure.

然而，考慮到我們產品組合的平衡、我們對實證醫學的承諾以及我們大大改善的財務狀況，我相信我們有能力應對這些變化，並期望我們最終在更合理的報銷結構下受益。

In terms of guidance, we think the prudent thing to do at this point is to update our full year revenue growth guidance bringing it from the low double digits to the mid to high single digits. To reiterate, while less than 25% of our business is in the effective care settings, our second half overall performance will be impacted by whether or not the MACs implement the proposed LCDs.

在指導方面，我們認為目前謹慎的做法是更新我們的全年收入成長指導，將其從低兩位數調整為中高個位數。重申一下，雖然我們的業務只有不到 25% 是在有效的護理環境中，但我們下半年的整體業績將受到 MAC 是否實施擬議的 LCD 的影響。

Again, we see the implementation as a net positive for MiMedx but until CMS provides some clarity on the path forward, we have to plan for continued disruption. Obviously, we will revisit expectations as we learn more.

同樣，我們認為實施對 MiMedx 來說是積極的，但在 CMS 明確前進道路之前，我們必須為持續的顛覆做好計劃。顯然，隨著我們了解更多，我們將重新審視期望。

I want to stress that this fine-tuning is specifically linked to this very acute reimbursement issue with the private office and adjacent settings and in no way diminishes our excitement about the long-term prospects for the business and specifically, our ability to grow the top line in the low double digits with a strong adjusted EBITDA profile above 20%, once we have cleared this challenge.

我想強調的是，這種微調與私人辦公室和鄰近環境的這一非常嚴重的報銷問題特別相關，並且絕不會削弱我們對業務長期前景的興奮，特別是我們發展頂尖人才的能力一旦我們克服了這個挑戰，調整後的EBITDA 狀況將保持在低兩位數的水平，超過20%。

Importantly, the LCDs do not affect the efforts and strategy underpinning our surgical business which we think has a bright future with a large and growing addressable market, particularly as we expand our product portfolio and leverage the science supporting the superiority of our technology as demonstrated in the Nature publication.

重要的是，液晶顯示器不會影響支撐我們外科業務的努力和策略，我們認為外科業務有著光明的未來，擁有龐大且不斷增長的潛在市場，特別是當我們擴大我們的產品組合併利用支持我們技術優勢的科學時，如自然出版物。

In closing, I would like to congratulate and thank the entire MiMedx team for delivering another solid quarter. I am confident we will navigate the current challenges we discussed and continue to stay focused on helping to improve the lives of the many people who are treated with our growing portfolio of products.

最後，我要祝賀並感謝整個 MiMedx 團隊又交付了一個穩定的季度表現。我相信，我們將應對我們討論的當前挑戰，並繼續專注於幫助改善許多接受我們不斷增長的產品組合的人們的生活。

With that, I would like to open the call to questions. Operator, we are now ready for our first question. Please proceed.

接下來，我想開始提問。接線員，我們現在準備好回答第一個問題。請繼續。

Thank you. We will now be conducting a question-and-answer session. (Operator Instructions) Ross Osborn, Cantor Fitzgerald.

謝謝。我們現在將進行問答環節。（操作員指示）羅斯·奧斯本、坎托·菲茨杰拉德。

So starting off would be curious to hear, if you think you've seen the worst of the attrition of customers and sales force due to highpriced products. And then going off of this, how should we think about revenue cadence for the balance of the year to get to your mid to high single-digit guidance?

因此，如果您認為您已經看到由於高價產品而造成的客戶和銷售人員流失最嚴重的情況，那麼一開始您會很想知道。然後，我們該如何考慮今年剩餘時間的收入節奏，以達到中高個位數的指導？

Yeah. I do think we've seen the worst of it. We had kind of a bolus of activity in the second half of the second quarter like I mentioned in my commentary, higher-than-normal customer churn and employee turnover. So we moved pretty rapidly to kind of limit the damage there rebuild in the areas that were most affected.

是的。我確實認為我們已經看到了最糟糕的情況。正如我在評論中提到的，我們在第二季度後半段進行了一系列活動，客戶流失率和員工流動率高於正常水平。因此，我們迅速採取行動，以限制在受影響最嚴重的地區進行重建的損失。

Frankly, it was concentrated in a handful of areas which made it a little bit more difficult to cover with adjacent folks. So we've worked through that. We think we're in pretty good shape now and expect that the worst of it is behind us.

坦白說，它集中在少數幾個區域，這使得與鄰近的人一起覆蓋變得更加困難。所以我們已經解決了這個問題。我們認為我們現在的狀況非常好，並且預計最糟糕的時期已經過去了。

But that being said, there's still an awful lot of activity around the sales of these as we refer to as artificially high-priced products. So we're going to battle through it. The best thing that could happen is that the government takes some sort of remedial action as soon as humanly possible. We had hoped to see it in the physician fee schedule which was proposed a few weeks ago. We did not. So the next best thing that could happen is for the MACs to implement the proposed LCDs in their current or some similar format.

但話雖這麼說，圍繞這些我們稱之為人為高價產品的銷售活動仍然非常多。所以我們要透過它來戰鬥。可能發生的最好的事情是政府盡快採取某種補救措施。我們本來希望在幾週前提出的醫生費用表中看到它。我們沒有。因此，下一個可能發生的事情是 MAC 以當前或某種類似的格式實現建議的 LCD。

Again, this would curtail most of the behavior because those super high-priced products are not on the approved list. But we have to plan for the worst. That being the case, we felt it was prudent to take guidance down to the mid- to high single digits with potential upside that the LCDs are implemented.

同樣，這將限制大部分行為，因為那些超高價產品不在批准清單上。但我們必須做最壞的打算。在這種情況下，我們認為將指引下調至中高個位數是謹慎的做法，因為 LCD 的實作具有潛在的上行空間。

We plan for no upside in that guidance with LCD implementation because we can't predict when that will happen. But we thought it was the most prudent thing to do. And that assumes kind of a similar run rate in sales to what we're seeing right about now.

我們計劃在 LCD 實施方面不會有任何好處，因為我們無法預測這種情況何時會發生。但我們認為這是最謹慎的做法。這假設銷售運行率與我們現在看到的類似。

Yeah. Ross, I'd also just add that sort of our back half guidance certainly anticipate continued momentum behind our recent launch of our xenograft HELIOGEN. EPIEFFECT is off to a good start this year and certainly gaining traction with AMNIOEFFECT and our surgical suite. And our international business continues to grow.

是的。羅斯，我還想補充一點，我們的後半部分指導肯定預計到我們最近推出的異種移植物 HELIOGEN 背後的持續勢頭。EPIEFFECT 今年有了一個良好的開端，並且肯定會隨著 AMNIOEFFECT 和我們的手術套件而受到關注。我們的國際業務持續成長。

But the vast majority of the turbulence we think will happen as Joe indicated because a lot of this happened in the second half of the second quarter. From a cadence perspective, I'd expect that continue to play out as we recover. And we've already filled almost all the gaps at this point for Q3. And we've also got some traditional healthcare seasonality playing out in Q3. So I'd see Q3 as being more impacted than Q4.

但我們認為絕大多數動盪將會發生，正如喬指出的那樣，因為很多這樣的事情發生在第二季後半段。從節奏的角度來看，我預計隨著我們的恢復，這種情況會繼續發揮作用。目前，我們已經填補了第三季幾乎所有的空白。第三季我們也遇到了一些傳統醫療保健季節性因素。因此，我認為第三季比第四季受到的影響更大。

Okay, got it. That's very helpful. And then lastly for us before I jump back in queue. Could we spend a little bit more time on the RCT for EPIEFFECT just in terms of the size, timeline and cost assumptions there?

好的，明白了。這非常有幫助。最後是我們，然後我又重新排隊了。我們是否可以在 EPIEFFECT 的 RCT 上多花一點時間來考慮其規模、時間表和成本假設？

Yeah, we did not put out the size in terms of number of patients. I would just refer to it as a highly-powered well-designed RCT. It's already been through IRB, so the study is underway. We're at the outset of patient enrollment. We think -- timeline I think we had talked about probably around a year with interim report out in like the six-month time frame. And I don't think we've put out a number on it. But well within our budget and we'll forecast. So it will have a huge impact on our R&D spend as a percent of revenue.

是的，我們沒有公佈患者人數的規模。我只是稱之為高性能、精心設計的 RCT。它已經通過了IRB，所以研究正在進行中。我們正處於患者登記的開始階段。我們認為——時間表我認為我們可能討論過大約一年的時間，並在六個月的時間範圍內發布中期報告。我認為我們還沒有給出具體數字。但完全在我們的預算之內，我們會預測。因此，這將對我們的研發支出佔收入的百分比產生巨大影響。

Got it. Thanks for taking the questions.

知道了。感謝您提出問題。

Thanks for initiating coverage, Ross. We appreciate our relationship with Cantor.

感謝您發起報道，羅斯。我們很重視與坎託的關係。

Likewise. Thanks.

同樣地。謝謝。

Chase Knickerbocker, Craig-Hallum Capital Group.

蔡斯‧尼克博克 (Chase Knickerbocker)，克雷格‧哈勒姆資本集團 (Craig-Hallum Capital Group)。

Just first, help me understand a little bit here Joe what was different in Q2, and going forward relative to Q1 and last year? Obviously there's been these high ASP products in the market. Maybe speak to what happened kind of specifically in the second half of Q2 that was driving additional churn of customers and sales reps in this quarter relative to others. Was there new strategy from some of these players or just speak to exactly what was different? Thanks.

首先，請幫我了解一下喬，第二季有何不同，以及相對於第一季和去年有何不同？顯然，市場上已經存在這些高ASP產品。也許可以談談第二季下半年發生的具體事件，該事件導致本季相對於其他季度的客戶和銷售代表流失更多。其中一些參與者是否有新的策略，或只是說明具體的差異？謝謝。

I think it's just more of a chase. You've been following us for a while now. We've been talking about this is an issue for a couple of years. Originally, we were lobbying to have people -- other participants be required to report their ASP so that everyone's quote-unquote, playing on the even playing field. Folks were using you may recall WACC in invoice pricing and not reporting rebates so that was causing a lot of issues.

我認為這更像是一場追逐。您關注我們已經有一段時間了。我們已經討論這個問題好幾年了。最初，我們正在遊說其他參與者報告他們的 ASP，以便每個人都能在公平的競爭環境中競爭。人們可能還記得發票定價中使用的是 WACC，而不是報告回扣，因此導致了許多問題。

And then quickly people started to migrate to the ASP prices. We saw this huge spike up of the number of products on that list. Then we saw companies start to price these things at dramatically high level 10 times what the normal price levels were and using a scheme to rotate multiple products in and out of the market in order to keep that price at those high levels.

然後很快地人們開始轉向平均售價。我們看到該清單中的產品數量大幅增加。然後我們看到公司開始將這些東西的價格定得非常高，是正常價格水平的 10 倍，並使用一種計劃將多種產品輪流進出市場，以將價格保持在高水準。

So I think what's happened is a couple of things. One, there's just more and more people get into the game and there's a lot more product in the market. There's a lot of people making a fortune by doing this. It kind of makes my stomach a little ill when I think about it, because what they're doing is using these schemes to overbill Medicare at this artificially high prices which hurts the trust of taxpayers and most of all, some of those vulnerable members of our society, elderly people who are dealing with chronic wounds. So it's unfortunate.

所以我認為發生的事情有幾件事。第一，越來越多的人進入遊戲，市場上的產品也越來越多。有很多人靠這樣做致富。當我想到這一點時，我的胃有點不舒服，因為他們正在做的是利用這些計劃以人為的高價超額支付醫療保險費用，這損害了納稅人的信任，最重要的是，傷害了一些弱勢群體的信任。所以這是不幸的。

But I think to your point it's accelerated. We did a pretty good job keeping it at bay for a while. We've been lobbying the government to make change and have had no success. So frankly we're probably losing a little credibility in that argument, telling people that this is wrong and shouldn't be doing it. It's tough when everybody else is doing it and you see your friends making a bunch of money. And then doctors are telling you how rich they're getting. So it was -- it's a hot mess and it needs to be addressed.

但我認為就你的觀點而言，它正在加速。我們在一段時間內做得很好。我們一直在遊說政府做出改變，但沒有成功。坦白說，我們可能會在這個論點中失去一點可信度，告訴人們這是錯誤的，不應該這樣做。當其他人都在做而你卻看到你的朋友賺了很多錢時，這是很困難的。然後醫生會告訴你他們有多富有。所以這是一個混亂的局面，需要解決。

Do you think there's any dynamic that now that these LCDs are out there and slated to potentially go into effect that there's a little bit of some spurring of usage because some of these loopholes might be closed in the fairly near term?

您認為現在這些 LCD 已經面世並且可能會生效，因為其中一些漏洞可能會在相當短的時間內得到彌補，因此會刺激使用嗎？

(inaudible) I would love to see it. I think the fact that the LCDs are looming and we should hear something at any day or any day is helpful. The fact that the Department of Justice has now put a spotlight on it, they're starting to be -- some media coverage is picking up on it. We're lobbying with CMS. We're talking to the MACs. We're talking to lawmakers. We're talking to media.

（聽不清楚）我很想看看。我認為液晶顯示器即將出現，我們隨時都應該聽到一些消息，這一事實是有幫助的。事實上，司法部現在已經開始關注這個問題，一些媒體正在開始對此進行報告。我們正在與 CMS 進行遊說。我們正在與 MAC 交談。我們正在與立法者交談。我們正在與媒體交談。

So people are starting to see this for what it is. It's a pretty elaborate scam. And when you look at if you saw the chart from our presentation look at the slope. When you go from like what $500 million or less than $500 million in 2020 to over $4 billion in 2023. There's no other product category that does that. This wasn't the introduction of a new life-saving drug. They’re just using fairly mature products to overbill the government. That's what this is all about. It's a very elaborate scheme to overbill the government and as I indicated, some critical or some vulnerable members of our society. So it has to change, right? You would think that this is going to get shut down.

所以人們開始認識到它的本質。這是一個相當精心設計的騙局。當您查看我們演示中的圖表時，請查看斜率。當你從 2020 年的 5 億美元或不到 5 億美元增加到 2023 年的超過 40 億美元。沒有其他產品類別可以做到這一點。這並不是推出一種新的救命藥物。他們只是使用相當成熟的產品來向政府收取過高的費用。這就是這一切的全部內容。這是一個非常複雜的計劃，目的是向政府以及我們社會中的一些關鍵或弱勢成員收取過高的費用。所以它必須改變，對吧？您可能會認為這將被關閉。

That being said, the people that we're talking to have to work through a process. There has to be a publication of proposed rule changes. There has to be comment periods et cetera, et cetera. So they're working through the process which unfortunately takes time. Yeah, it's great that the DOJ is going after people that are really abusing it. But that's -- they still need to close the front end of this problem.

話雖這麼說，與我們交談的人必須經歷一個過程。必須公佈擬議的規則變更。必須有評論期等等。所以他們正在完成這個過程，但不幸的是需要時間。是的，司法部正在追捕真正濫用它的人，這真是太好了。但那就是——他們仍然需要解決這個問題的前端。

And Chase, I would say don't forget that this is one side of service and one payer that we're having this turbulence in. So I would expect that to normalize over time but we believe that generally it's less than 25% of our total top-line. The remainder of the business remains strong and healthy with a lot of growth drivers.

蔡斯，我想說，不要忘記，這是服務的一方面，也是我們遇到這種動盪的付款人。因此，我預計這一比例會隨著時間的推移而正常化，但我們相信，總體而言，這一比例不到我們總收入的 25%。該業務的其餘部分仍然強勁且健康，並有許多成長動力。

Understood. And then just last two from us. If we think about that LCD whenever it does potentially go into effect right. If we think about that first quarter for you guys, do you see that as being positive to the trajectory of revenue again in that first quarter that goes into effect even despite having some -- the revenue from EPIEFFECT likely rolling out of the model in that quarter? So again, just that quarter having a positive effect, the LCD have a positive effect on revenue that quarter.

明白了。然後是我們的最後兩個。如果我們考慮一下 LCD，無論何時它確實可能生效。If we think about that first quarter for you guys, do you see that as being positive to the trajectory of revenue again in that first quarter that goes into effect even despite having some -- the revenue from EPIEFFECT likely rolling out of the model in that四分之一?再說一遍，就在那個季度產生了積極的影響，液晶顯示器對該季度的收入產生了積極的影響。

And then second for Doug just on EBITDA. Do we still expect kind of 20% margins or how should we be thinking about EBITDA through the remainder of the year? Thanks.

道格 (Doug) 在 EBITDA 上排名第二。我們是否仍然期望 20% 的利潤率，或者我們應該如何考慮今年剩餘時間的 EBITDA？謝謝。

Yeah. I would expect an uptick in the business soon after these things are implemented. I don't think there is a lot of inventory burnoff when the inventory is priced at $2,000 per square centimeter. I just don't think people are carrying a lot of it. So my guess is we'll probably see the market shift pretty quickly. Doug?

是的。我預計這些事情實施後不久業務就會有所成長。我認為，當庫存定價為每平方公分 2,000 美元時，庫存消耗不會很大。我只是不認為人們攜帶了很多。所以我的猜測是我們可能會看到市場很快就會改變。道格？

Yeah. From just an adjusted EBITDA perspective we didn't guide but the way I think about the back half of the year is we're certainly built to grow we're built to scale, and we believe that a lot of the turbulence today is transient. And we'll certainly recover, and we want to maintain the good infrastructure that we already have.

是的。從調整後的 EBITDA 角度來看，我們沒有提供指導，但我對今年下半年的看法是，我們肯定會實現成長，我們會擴大規模，而且我們相信今天的許多動盪都是短暫的。我們肯定會恢復，我們希望維持我們已有的良好基礎設施。

But I would expect that while we had about 22% EBITDA in the first half of the year, we've guided previously that we thought would be north of 20%. I think we'll approach 20%. I think we'll be modestly below 20% for the back half of the year. And I would look at that as sort of gross margin in the low-80s at this point as we have less volume in this particular side of service to cover our fixed costs.

但我預計，雖然今年上半年我們的 EBITDA 約為 22%，但我們之前的預測是高於 20%。我認為我們會接近 20%。我認為今年下半年我們的成長率將略低於 20%。我認為目前的毛利率在 80 左右，因為我們在這一特定服務方面的銷量較少，無法涵蓋我們的固定成本。

And I think the other big driver here is that as the EPIEFFECT RCT ramps up that we would expect R&D to be closer to mid-single-digits at that point instead of the 3% or so that they run in the first half of the year.

我認為這裡的另一個重要驅動因素是，隨著 EPIEFFECT RCT 的推進，我們預計研發屆時將接近個位數，而不是上半年的 3% 左右。

Chase, it's Joe. Listen I know we're talking a lot about LCDs and I'm sure the rest of the questions we're going to get are going to revolve around this as well because of the nature of the issue. And as you indicated it's been going on for a while. This is really the first quarter that we've talked about it this much and that we've been impacted by it.

蔡斯，是喬。聽著，我知道我們談論了很多關於 LCD 的問題，並且由於問題的性質，我確信我們將收到的其餘問題也將圍繞此展開。正如你所指出的，這種情況已經持續了一段時間了。這確實是我們第一次如此頻繁地談論它並受到它的影響。

We do see it as transitory. We don't think it impacts the business long term. It's a nuisance that we have to deal with. However, as difficult as it is to deal with, we still recorded $87 million of revenue in the quarter which is tied for the highest quarter we've ever had and we're still generating a lot of cash and a lot of adjusted EBITDA. So we will get through this.

我們確實認為它是暫時的。我們認為這不會對業務產生長期影響。這是我們必須處理的麻煩事。然而，儘管處理起來很困難，我們在本季度仍然錄得 8700 萬美元的收入，這與我們有史以來最高的季度持平，而且我們仍然產生大量現金和大量調整後的 EBITDA。所以我們會度過這個難關。

As you heard me indicate in the past that, once we're on the other side of this reimbursement issue and once we get more stability from a regulatory standpoint -- we fix regulatory and reimbursement in this industry, it's a lot more investable. And I think in the long run this will all play out and we'll look back and laugh about it at some point.

正如你過去聽到我指出的那樣，一旦我們站在報銷問題的另一邊，一旦我們從監管的角度獲得了更多的穩定性——我們解決了這個行業的監管和報銷問題，它就更具投資價值。我認為從長遠來看，這一切都會發生，我們會在某個時刻回顧並嘲笑它。

Brooks O'Neil, Lake Street Capital Markets.

布魯克斯·奧尼爾，湖街資本市場。

Thank you very much. Joe as you said a lot of questions a lot of comment on LCDs so following that I've got one more. I'm just curious. Obviously, last year significantly disrupted by proposals from some of the MACs that were subsequently withdrawn. Then they come out with a uniform LCD across seven MACs this year.

非常感謝。喬，正如您所說的很多問題，很多關於液晶顯示器的評論，所以接下來我還有一個。我只是好奇。顯然，去年一些 MAC 的提案嚴重干擾了這些提案，這些提案隨後被撤回。然後他們今年在七款 MAC 上推出了統一的 LCD。

The one thing I don't think I've heard you guys comment about is do you get any indication from these MACs following the comment period, during the comment period whether they are determined to right this wrong in the reimbursement loophole situation? Or do you think we could see additional wobbling on this topic at this time?

我認為我沒有聽到你們評論的一件事是，在評論期之後，你們是否從這些 MAC 那裡得到任何指示，在評論期內，他們是否決心糾正報銷漏洞情況下的錯誤？或者您認為我們目前可能會在這個話題上看到更多的搖擺不定？

It's a good question, Brooks. And I would say that they're fairly close to the best in terms of giving any sort of implication, whether or not they're going to implement and when they would be implemented. So I can't handicap this for you. I wish I could.

這是一個好問題，布魯克斯。我想說，無論是否要實施以及何時實施，它們在給出任何暗示方面都相當接近最好的。所以我不能為你設定障礙。我希望我能。

I would tell you though that in my meetings with the folks that we've been able to talk to we've had several they're highly sensitive to what's going on, highly sensitive and asking a lot of questions and asking for follow-up calls.

我想告訴你的是，在我與我們能夠交談的人的會議中，我們有幾個人對正在發生的事情非常敏感，非常敏感，提出了很多問題並要求採取後續行動來電。

So they're doing the work on it, which tells me and again if I apply some level of logic given the escalation of the spend, which tells me some action will be taken in some format soon. But look, if I had a crystal ball, I'd have the answer for you`, buddy.

所以他們正在做這方面的工作，這再次告訴我，考慮到支出的升級，我是否應用某種程度的邏輯，這告訴我很快就會以某種形式採取一些行動。但是看，如果我有水晶球，我就會給你答案，老兄。

Right. I hear you. Totally understand. All right. Let me just ask you one more different question and that is can you give us a sense for the timing of the full rollout of the xenograft product? And I think I heard you use a word that suggested you think the market is big, potentially big. And can you give us any sense for in dollar terms or whatever -- how big you think it is for you guys? And sort of whether you think you can begin to really see meaningful incremental revenue yet this year? Is it more a 2025 event? Is it more a '26 event as you look out into your crystal ball? Thanks a lot.

正確的。我聽到了。完全明白了。好的。讓我再問您一個不同的問題，您能否讓我們了解異種移植產品全面推出的時間？我想我聽到你用了一個詞來暗示你認為市場很大，潛力很大。您能否給我們以美元或其他方式計算的任何意義 - 您認為這對您有多大？您是否認為今年可以開始真正看到有意義的增量收入？這更像是 2025 年的事件嗎？當你看著你的水晶球時，這更像是 26 年的事件嗎？多謝。

Yeah. Really excited to get this first one out into the marketplace. And as a reminder this is a collagen-based particulate. So it's going to be used in certain surgical procedures tendon repair, et cetera. So we do think that there's a good application for this product. We plan to launch other products in the xenograft category as well.

是的。非常高興能夠將第一個產品推向市場。提醒一下，這是一種基於膠原蛋白的顆粒。因此它將用於某些外科手術，如肌腱修復等。所以我們確實認為這個產品有一個很好的應用。我們也計劃推出異種移植類別的其他產品。

And as a reminder, that just opens up a lot more market opportunity for us. Amniotic tissue only accounts for about 45% in that neighbourhood of the total skin submarket with xenograft and synthetics covering the remainder.

提醒一下，這為我們開啟了更多的市場機會。羊膜組織僅佔整個皮膚子市場的 45% 左右，其餘則由異種移植和合成材料覆蓋。

So big market opportunity for us to probably at least doubling our TAM. These are areas in a market that we have been precluded from competing in for a variety of different reasons. Sometimes it's cost, sometimes it's other reasons. People don't want to use amniotic tissue. But I think it's a pretty good size market opportunity for us. We'll see some upside from the product this year and -- but really start to ramp up next year.

對我們來說，如此龐大的市場機會可能至少能讓我們的 TAM 翻倍。由於各種不同的原因，我們無法參與這些市場領域的競爭。有時是成本，有時是其他原因。人們不想使用羊膜組織。但我認為這對我們來說是一個相當好的市場機會。今年我們會看到該產品的一些優勢——但明年才會真正開始提升。

Anthony Petrone, Mizuho Group.

安東尼‧佩特龍，瑞穗集團。

First one just to follow-up on xenograft. Thanks for that detail there. Competing today in 45% of the market xenograft gets you in the remaining 55%. How many products do you need to sort of address that sort of large market opportunity? You have an initial product in. How many more xenograft products do you expect to add?

第一個只是跟進異種移植。感謝那裡的詳細資訊。今天，在 45% 的異種移植市場競爭中，您將獲得剩餘的 55% 的市場份額。您需要多少產品才能抓住這種巨大的市場機會？您有一個初始產品。您預計還會增加多少種異種移植產品？

And then just a quick follow-up on LCD. When we sort of revert back to some of the data that was out there in terms of the overall billing into Medicare, it was over $1 billion. The expectation is that some of that's going to go away some of that's going to stay. But at this juncture as this process is sort of evolving here and being extended ultimately, what do you think that opportunity is going to be in the US physician office once this settles out and we have a definitive path forward from the MACs? Thanks, again.

然後是 LCD 的快速跟進。當我們回到 Medicare 總帳單方面的一些數據時，它超過了 10 億美元。人們期望其中一些會消失，而另一些會留下來。但在這個關頭，隨著這個過程在這裡不斷發展並最終得到擴展，你認為一旦這個問題解決並且我們從 MAC 那裡得到了明確的前進道路，美國醫生辦公室將會有什麼機會？再次感謝。

So let me get back to xeno first. So yeah, we need to round out that product portfolio. I want to think of it in terms of similar to what we're doing now in amniotic tissue. We'll have sheets of different sizes and different thickness accelerated use in different procedures, sometimes with a strong potential strength that you can use in more complex surgeries, a product that can be sutured et cetera. So I would say -- I can't give you a number whether it's two, three, four, six, but we're going to have a variety of SKUs that meet the needs of the marketplace so that we can compete at all levels.

讓我先回到xeno。所以，是的，我們需要完善該產品組合。我想將其視為類似於我們現在在羊膜組織中所做的事情。我們將有不同尺寸和不同厚度的片材在不同的手術中加速使用，有時具有強大的潛在強度，可以在更複雜的手術中使用，可以縫合的產品等等。所以我想說——我無法給你一個數字，是兩個、三個、四個還是六個，但我們將擁有滿足市場需求的各種 SKU，以便我們可以在各個層面上競爭。

The question about LCD market opportunity, how much of it is overutilization? How much of it is price? Again, if you look at the -- one of the slides we had in the presentation, you can see that the line portion of that is utilization. So there's massive overutilization as a result of the opportunity to make these incredible amounts of money. So I think utilization is cut way back once this is shut down and cleaned up and obviously pricing goes back in line.

關於液晶顯示器市場機會的問題，其中有多少是過度利用的？其中價格是多少？同樣，如果您查看簡報中的一張投影片，您可以看到其中的線條部分是利用率。因此，由於有機會賺取這些令人難以置信的金錢，因此出現了大規模的過度利用。因此，我認為一旦關閉並清理乾淨，利用率就會大大降低，並且顯然定價會恢復正常。

And we've done a lot of sort of sensitivity analysis around us once this market is rightsized. How much of it we would have an opportunity to compete for given our current share of amniotic tissue in some of the care settings and then looking at as patients migrate from one care setting to another, it's going to be a sizable opportunity for us, Anthony. I don't want to give -- put a number out there, but it will be a pretty decent sized opportunity for us.

一旦這個市場規模合理化，我們就圍繞著我們做了很多敏感度分析。考慮到我們目前在一些護理機構中所佔的羊膜組織份額，然後考慮到患者從一個護理機構遷移到另一個護理機構，我們將有多少機會競爭，這對我們來說將是一個相當大的機會，安東尼。我不想給出一個數字，但這對我們來說將是一個相當不錯的機會。

Carl Byrnes, Northland Capital Markets.

卡爾‧伯恩斯，北國資本市場。

Thanks for the questions. Most of my questions have been answered. Do you have any feel or expectations with respect to potential timeline of events that might lead the seven MACs to adopt the LCD? Thanks.

感謝您的提問。我的大部分問題都得到了解答。對於可能導致七個 MAC 採用 LCD 的潛在事件時間表，您有什麼感覺或期望嗎？謝謝。

No, I wish I did, Carl. Thanks for the question. We talked a little bit about that already. When we asked the question, the answer we get is, we're working through the process. We're working through the process. I would just go back and stress the fact that unlike this time last year, there is a much more heightened sensitivity at least from our perspective of various stakeholders who are involved in setting these rules.

不，我希望我這麼做了，卡爾。謝謝你的提問。我們已經談過一些了。當我們提出這個問題時，我們得到的答案是，我們正在完成這個過程。我們正在完成整個過程。我想回去強調一個事實，與去年這個時候不同，至少從我們參與制定這些規則的各個利益相關者的角度來看，我們的敏感度要高得多。

In our conversations, people are very in tuned to what's going on. And obviously, that means they're getting asked about questions as well. So I think this has been elevated to a fairly high level in the various government agencies that have responsibility to either price or implement coverage determinations on these products. But it can't go on for all. Who knew that you didn't need a gun to rob a bank? All you needed was a skin substitute.

在我們的談話中，人們非常了解正在發生的事情。顯然，這意味著他們也會被問到問題。因此，我認為，在負責對這些產品定價或實施覆蓋範圍決定的各個政府機構中，這一點已經提升到相當高的水平。但這不可能對所有人都持續下去。誰知道搶劫銀行不需要槍？您所需要的只是皮膚替代品。

There are no further questions at this time. I would now like to turn the floor back over to Joe Capper for closing comments.

目前沒有其他問題。現在我想把發言權交還給喬·卡珀以供結束評論。

I appreciate it. Thanks everybody. Appreciate your questions and your participation. Thanks for your continued interest in the company and we will talk to you next quarter.

我很感激。謝謝大家。感謝您的提問和您的參與。感謝您對公司的持續關注，我們將在下個季度與您交談。

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.

今天的電話會議到此結束。此時您可以斷開線路。感謝您的參與。