Organogenesis Holdings Inc (ORGO) 2025 Q1 法說會逐字稿

Welcome, ladies and gentlemen, to the first-quarter 2025 earnings conference call for Organogenesis Holdings Inc. (Operator Instructions)

女士們、先生們，歡迎參加 Organogenic Holdings Inc. 2025 年第一季財報電話會議。（操作員指示）

Please note that this conference call is being recorded and that the recording will be available on the company's website for replay shortly.

請注意，本次電話會議正在錄音，錄音很快就會在公司網站上提供重播。

Before we begin, I would like to remind everyone that our remarks today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including the risks and uncertainties described in the company's filings with the Securities and Exchange Commission, including Item 1A, Risk Factors, of the company's most recent annual report and its subsequently filed quarterly reports.

在我們開始之前，我想提醒大家，我們今天的言論可能包含前瞻性陳述，這些陳述基於管理層當前的預期，並涉及固有風險和不確定性，可能導致實際結果與所示的結果存在重大差異，包括公司向美國證券交易委員會提交的文件中描述的風險和不確定性，包括公司最新年度報告和隨後提交的季度報告的第 1A 項「風險因素」。

You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

請注意不要過度依賴任何前瞻性陳述，這些陳述僅代表截至當時的觀點。儘管公司可能不時自願這樣做，但公司不承諾更新或修改前瞻性陳述，無論是由於新資訊、未來事件或其他原因，除非適用的證券法要求。

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

此次電話會議也將提及某些未依照公認會計原則或 GAAP 計算的財務指標。我們通常稱之為非公認會計準則財務指標。這些非 GAAP 財務指標與依照 GAAP 計算和呈現的最具可比性的指標的對帳表可在我們網站投資者關係部分的收益新聞稿中找到。

I would now like to turn the call over to Mr. Gary S. Gillheeney, Sr., Organogenesis Holdings President, Chief Executive Officer and Chief of the Board. Please go ahead.

現在，我想將電話轉給 Organogenic Holdings 總裁、執行長兼董事會主席 Gary S. Gillheeney 先生。請繼續。

Thank you, operator, and welcome, everyone, to Organogenesis Holdings first-quarter 2025 earnings conference call. I'm joined on the call today by Dave Francisco, our Chief Financial Officer.

謝謝接線員，歡迎大家參加 Organogenic Holdings 2025 年第一季財報電話會議。我們的財務長戴夫·弗朗西斯科 (Dave Francisco) 也參加了今天的電話會議。

Let me start with a brief agenda of what we'll cover during our prepared remarks. I'll begin with an overview of our first quarter revenue results and provide an update on key operating and strategic developments in recent months. Dave will then provide you with an in-depth review of our first quarter financial results, our balance sheet and financial condition at quarter end as well as our financial guidance for 2025, which we reaffirmed in our press release this afternoon. Then we'll open it up for questions.

首先，請容許我簡單介紹一下我們在準備好的發言中將要討論的內容。我將首先概述我們第一季的收入結果，並提供近幾個月來主要營運和策略發展的最新情況。然後，戴夫將為您深入回顧我們的第一季財務業績、季度末的資產負債表和財務狀況以及 2025 年的財務指導，我們在今天下午的新聞稿中重申了這一點。然後我們將開始提問。

Beginning with a review of our revenue results in Q1, we delivered sales in line with our guidance range outlined on our fourth quarter call. Our first quarter results reflected the expected disruption in customer demand and ordering patterns given the continued uncertainty related to the effective date of the final LCD for skin substitute grafts and cellular/tissue-based products for the treatment of DFU and VLU.

從回顧第一季的收入結果開始，我們的銷售額符合我們在第四季度電話會議上概述的指導範圍。由於用於治療糖尿病足潰瘍 (DFU) 和下肢靜脈潰瘍 (VLU) 的皮膚替代移植和細胞/組織產品的最終 LCD 生效日期仍然存在不確定性，我們的第一季業績反映了客戶需求和訂購模式的預期中斷。

Rumors of further delays in the effective date in late March added additional ambiguity and disruption in customer behavior, but we are proud of the team's execution in a challenging environment during the first quarter. They remained focused on ensuring our customers were both informed and well positioned to continue to treat patients with our full portfolio of [highly] efficacious products.

3 月底有關生效日期進一步推遲的傳言增加了額外的模糊性和客戶行為的混亂，但我們對團隊在第一季充滿挑戰的環境中的表現感到自豪。他們始終致力於確保我們的客戶能夠了解情況並做好充分準備，繼續使用我們全系列（高效）產品來治療患者。

This process and this focus proved to be even more valuable in the weeks leading up to CMS' stated effective date of April 13, 2025, and in the weeks following the announcement of the third delay in the implementation of the LCD until January 1, 2026. Organogenesis supports CMS' decision to delay the LCD implementation to review its coverage policies.

在 CMS 宣布的 2025 年 4 月 13 日生效日期之前的幾週內，以及在宣布第三次將 LCD 實施推遲至 2026 年 1 月 1 日之後的幾週內，這一流程和關注被證明更有價值。Organogenic 支援 CMS 推遲實施 LCD 以審查其覆蓋政策的決定。

As mentioned on previous earnings calls, we applaud the CMS and MACs for continuing to prioritize coverage with demonstrated clinical efficacy for skin substitute products. And we've been pushing for reform for many years and believe the LCD represented a substantial step forward towards cleaning up the market and providing access to all who need care.

正如在先前的收益電話會議上所提到的，我們讚揚 CMS 和 MAC 繼續優先報告具有明顯臨床療效的皮膚替代產品。多年來，我們一直在推動改革，並相信液晶顯示器代表著在淨化市場和為所有需要護理的人提供醫療服務方面邁出了實質的一步。

Importantly, we continue to believe that patients should have access to products with high-quality evidence of effectiveness that includes real-world evidence. We believe real-world evidence not only demonstrates a product safety and efficacy but also outcomes in the actual clinical use.

重要的是，我們仍然相信患者應該能夠獲得具有高品質有效性證據（包括真實世界證據）的產品。我們相信真實世界的證據不僅能證明產品的安全性和有效性，也能證明實際臨床使用的結果。

Studies that use real-world evidence are important because they provide affirmative data demonstrating the safety and effectiveness of medical interventions in everyday settings, leading to more informed clinical decision-making. They also allow for larger sample sizes, more sites as well as the ability to include more patients with a profile similar to the Medicare population as compared to an RCT.

使用真實世界證據的研究很重要，因為它們提供了肯定的數據，證明了日常環境中醫療幹預的安全性和有效性，從而可以做出更明智的臨床決策。與 RCT 相比，它們還可以提供更大的樣本量、更多的站點，並且能夠納入更多與醫療保險人群相似的患者。

That said, we continue to believe that coverage policy alone are not sufficient to address the rapidly escalating Medicare cost while ensuring cost-effective patient care and innovation. To that end, we recommend that CMS implement an integrated coverage and payment policy. And as a leader in the space, we will continue to bring stakeholders together to develop an advocate for such an integrated policy that will ensure patient access to the most appropriate products while achieving significant cost savings to Medicare.

儘管如此，我們仍然認為，單靠保險政策不足以解決迅速上漲的醫療保險成本，同時確保具有成本效益的病患照護和創新。為此，我們建議 CMS 實施綜合覆蓋和支付政策。作為該領域的領導者，我們將繼續聯合利益相關者，倡導這種綜合政策，確保患者能夠獲得最合適的產品，同時為醫療保險節省大量成本。

While we were prepared to execute our strategy in a post-LCD environment, following the CMS announcement on April 11, we quickly pivoted to maximize our substantial competitive advantages during the period of extended LCD delay. Organogenesis' strong brand equity, diverse portfolio and deep customer relationships have us well positioned to navigate a challenging market.

雖然我們已準備好在後 LCD 時代環境中執行我們的策略，但在 4 月 11 日 CMS 發布後，我們迅速做出調整，以在 LCD 延遲期間最大限度地發揮我們巨大的競爭優勢。Organogenic 強大的品牌資產、多樣化的產品組合和深厚的客戶關係使我們能夠在充滿挑戰的市場中佔據有利地位。

And we are encouraged by the early progress in our team's broad-based efforts to engage with our customers to ensure our full portfolio of products are available and approved in their healing algorithms and formularies.

我們團隊在與客戶廣泛合作方面取得了初步進展，這讓我們感到鼓舞，以確保我們的全系列產品均可在他們的治療演算法和處方集中使用並獲得批准。

We have reaffirmed our financial guidance for 2025 and are confident in the team's ability to execute our commercial strategy this year. Importantly, we remain confident in the long-term opportunity for Organogenesis as well. We continue to believe the material changes from the MACs in the coverage of skin substitutes to be implemented in 2026 represents an enormous opportunity for Organogenesis to serve more patients and importantly will be positive for the long-term health of the wound care market.

我們重申了 2025 年的財務指導，並對團隊今年執行商業策略的能力充滿信心。重要的是，我們對 Organogenic 的長期機會仍然充滿信心。我們仍然相信，2026 年即將實施的 MAC 在皮膚替代品覆蓋範圍方面的重大變化，為 Organogenic 服務更多患者提供了巨大的機會，而且重要的是，這將對傷口護理市場的長期健康產生積極影響。

We are aggressively pursuing our strategy to secure and submit additional clinical and real-world evidence to the MACs by the newly established deadline of November 1, 2025, and expect to submit a compelling case to secure coverage for PuraPly AM when the LCDs are implemented in 2026. We expect to remain a leader in the space with highly innovative, highly efficacious products that deliver on our mission of advancing healing and recovery beyond our customers' expectations.

我們正在積極推行我們的策略，在新設立的 2025 年 11 月 1 日截止日期之前向 MAC 確保並提交額外的臨床和真實世界證據，並期望在 2026 年實施 LCD 時提交令人信服的案例，以確保 PuraPly AM 獲得覆蓋。我們期望憑藉高度創新、高效的產品繼續保持在該領域的領先地位，實現我們的使命，即超越客戶的期望，推動治療和康復。

Now before turning the call over to Dave, I wanted to provide a brief update on a key area of strategic focus for our company. We believe gathering robust and comprehensive clinical and real-world evidence is an essential component of developing a competitive product portfolio and driving further penetration in the markets where we compete. With respect to our ReNu program, we remain on plan and continue to expect that all patients will complete the second Phase III study by the end of the second quarter. We expect to complete the initial statistical analysis and have top line data results from the second Phase III study to share publicly in September of this year.

現在，在將電話轉給戴夫之前，我想先簡單介紹一下我們公司策略重點的關鍵領域。我們相信，收集可靠、全面的臨床和現實世界證據是開發具有競爭力的產品組合和進一步滲透我們所競爭的市場的重要組成部分。關於我們的 ReNu 計劃，我們仍在按照計劃進行，並繼續預計所有患者將在第二季末完成第二階段 III 期研究。我們預計在今年 9 月完成初步統計分析，並公開第二階段 III 期研究的頂線數據結果。

Our time line continues to target completion of the final clinical study report required for the modular BLA submission in the fourth quarter, which has us on track for a BLA submission by the end of this year. We continue to believe, if approved, introducing ReNu to a large and growing pain management market represents a transformational opportunity for Organogenesis.

我們的時間表繼續瞄準在第四季度完成模組化 BLA 提交所需的最終臨床研究報告，這使我們能夠在今年年底前提交 BLA。我們仍然相信，如果獲得批准，將 ReNu 引入龐大且不斷成長的疼痛管理市場對 Organogenic 來說是一個轉型機會。

We believe ReNu, if approved, will potentially address an unmet medical need for all patients suffering from symptomatic knee OA, a degenerative joint disease that affects more than 30 million Americans. And we have a clear road map and time line for our ReNu BLA submission. And if successful, ReNu would be the only FDA-approved biologic intra-articular injection to improve pain symptoms related to symptomatic knee OA.

我們相信，ReNu 一旦獲得批准，將有可能滿足所有患有症狀性膝關節骨關節炎 (一種影響 3000 多萬美國人的退化性關節疾病) 的患者尚未滿足的醫療需求。我們對 ReNu BLA 提交有明確的路線圖和時間表。如果成功，ReNu 將成為唯一獲得 FDA 批准的用於改善膝關節骨關節炎相關疼痛症狀的生物關節內注射劑。

Respect to our recent progress in expanding our clinical validation of our wound care solutions, our [PREPARE] study evaluating PuraPly AM plus standard of care versus standard of care alone continues to progress. We initiated enrollment of up to 170 patients with chronic DFUs last August and have enrolled more than 60 patients to date. We accelerated investigator site activation during the quarter and expect to complete an interim analysis in the third quarter.

關於我們在擴大傷口護理解決方案的臨床驗證方面取得的最新進展，我們評估 PuraPly AM 加標準護理與單獨標準護理的 [PREPARE] 研究正在繼續取得進展。我們從去年 8 月開始招募多達 170 名慢性糖尿病足潰瘍 (DFU) 患者，迄今已招募超過 60 名患者。我們在本季加快了研究站點的啟動速度，並預計將在第三季完成中期分析。

Our RCT evaluating Affinity for patients with VLU completed last patient, last visit for the initial patient cohort in Q1, and we are currently engaged in data monitoring and management activities. We expect to initiate new RCTs evaluating NuShield for patients with VLU and Novachor for patients with Mohs surgical excision wounds in the third quarter of 2025 and the first quarter of 2026, respectively.

我們對 VLU 患者親和力進行評估的 RCT 於第一季完成了對初始患者群的最後一位患者、最後一次訪問，我們目前正在從事數據監測和管理活動。我們預計將分別於 2025 年第三季和 2026 年第一季啟動新的 RCT，評估 NuShield 對下肢靜脈潰瘍 (VLU) 患者的療效和 Novachor 對莫氏手術切除傷口患者的療效。

We continue to invest in generating clinical data for our existing products and pipeline products and believe such data enhances sales efforts with physicians and reimbursement dynamics with payers over time.

我們將繼續投資於為現有產品和管道產品產生臨床數據，並相信這些數據將隨著時間的推移增強醫生的銷售力度和付款人的報銷動態。

And finally, we are pleased with the significant progress we've made in our efforts to expand our manufacturing capabilities, efficiencies and capacity with our newly leased biomanufacturing facility in Smithfield, Rhode Island. Upon completion, this new facility will support the reintroduction of both Dermagraft and TransCyte. TransCyte is a bioengineered cellular tissue scaffold that promotes burn healing and has received PMA approval for the treatment of deep second- and third-degree burns.

最後，我們很高興看到，我們在羅德島史密斯菲爾德新租賃的生物製造工廠在擴大製造能力、效率和產能方面取得了重大進展。新設施竣工後將支援 Dermagraft 和 TransCyte 的重新引入。TransCyte 是一種生物工程細胞組織支架，可促進燒傷癒合，並已獲得 PMA 批准，可用於治療深二度和三度燒傷。

This new facility will also support the introduction of FortiShield, a biosynthetic transitional wound matrix for second degree burns. Together, we believe these new products and the expansion of our manufacturing capacity overall will enhance our long-term growth and margin profile.

該新設施還將支援引進 FortiShield，這是一種用於二度燒傷的生物合成過渡傷口基質。我們相信，這些新產品和我們整體製造能力的擴大將增強我們的長期成長和利潤率。

With that, let me turn the call over to Dave.

說完這些，讓我把電話轉給戴夫。

Thanks, Gary. I'll begin with a review of our first quarter financial results. Unless otherwise specified, all growth rates referenced during my prepared remarks are on a year-over-year basis.

謝謝，加里。我將首先回顧我們的第一季財務表現。除非另有說明，我在準備好的發言中提到的所有成長率都是以同比計算的。

Net revenue for the first quarter was $86.7 million, down 21%. As Gary mentioned, these results were in line with the expectations we provided on our Q4 call, which called for total revenue in a range of $85 million to $95 million. Our Advanced Wound Care net revenue for the first quarter was $79.9 million, down 23%. Net revenue from Surgical & Sports Medicine products for the first quarter was $6.8 million, up 11%.

第一季淨營收為8,670萬美元，下降21%。正如加里所提到的，這些結果符合我們在第四季度電話會議上提出的預期，即總收入在 8,500 萬美元至 9,500 萬美元之間。我們第一季的高級傷口護理淨收入為 7,990 萬美元，下降 23%。第一季外科和運動醫學產品淨收入為 680 萬美元，成長 11%。

Gross profit for the first quarter was $63 million or 72.6% of net revenue compared to 73.9% last year. Gross profit was unfavorably impacted in the period due primarily from lower revenue over our fixed costs as well as the expiration of excess product resulting from the delayed implementation of the LCD and related uncertainty.

第一季毛利為 6,300 萬美元，佔淨收入的 72.6%，去年同期為 73.9%。本期間毛利受到不利影響，主要原因是收入低於我們的固定成本，以及由於 LCD 實施延遲和相關不確定性導致過剩產品到期。

Operating expenses for the first quarter were $89.7 million compared to $85.1 million last year, an increase of $4.6 million or 5%. The year-over-year change in operating expenses was driven by a $6.6 million write-down of cost to adjust certain assets held for sale to their fair market value, offset partially by a $2.2 million reduction in research and development expenses, which declined 17% year-over-year due to the timing of expenses associated with clinical research and trials.

第一季營運費用為 8,970 萬美元，而去年同期為 8,510 萬美元，增加了 460 萬美元，增幅為 5%。營業費用同比變化的原因是，為調整某些持有待售資產的公平市場價值而減記了 660 萬美元的成本，但研發費用減少 220 萬美元，部分抵消了這一變化。由於與臨床研究和試驗相關的費用發生時間因素，研發費用較去年同期下降了 17%。

SG&A expenses were essentially flat year-over-year as continued investments in our key long-term projects were offset by lower commissions and our focus on managing discretionary expenses in the period.

銷售、一般及行政費用與去年同期基本持平，因為我們對長期重點項目的持續投資被較低的佣金和我們對管理可自由支配費用的關注所抵消。

Operating loss for the first quarter was $26.7 million compared to an operating loss of $3.9 million last year, an increase of $22.9 million. Excluding noncash amortization expenses in both periods and the write-down of assets held for sale in the quarter, our non-GAAP operating loss was $19.3 million compared to $3 million last year. GAAP net loss for the first quarter was $18.8 million compared to a net loss of $2.1 million last year, an increase of $16.7 million. Net loss to common for the first quarter was $21.6 million compared to a net loss of $2.1 million last year. Net loss to common includes both the impact of the cumulative dividend and the noncash accretion to redemption value on our convertible preferred stock.

第一季營業虧損為 2,670 萬美元，而去年同期的營業虧損為 390 萬美元，增加了 2,290 萬美元。不包括兩個期間的非現金攤銷費用和本季持有待售資產的減記，我們的非公認會計準則營業虧損為 1,930 萬美元，而去年同期為 300 萬美元。第一季 GAAP 淨虧損為 1,880 萬美元，而去年淨虧損為 210 萬美元，增加了 1,670 萬美元。第一季普通股淨虧損為 2,160 萬美元，去年淨虧損為 210 萬美元。普通股淨虧損包括累積股利的影響以及可轉換優先股贖回價值的非現金增值。

Adjusted EBITDA loss for the first quarter was $12.5 million compared to adjusted EBITDA of $2.6 million last year.

第一季調整後 EBITDA 虧損為 1,250 萬美元，而去年調整後 EBITDA 為 260 萬美元。

And turning to the balance sheet. As of March 31, 2025, the company had $110.5 million in cash, cash equivalents and restricted cash with no outstanding debt obligations. And that compared to $136 million in cash, cash equivalents and restricted cash with no outstanding debt obligations as of December 31, 2024. We expect to see improving cash performance over the balance of 2025 and believe we have the requisite capital to execute our growth strategies with $110.5 million in cash, cash equivalents and restricted cash and $125 million available for future revolving borrowings under our revolving facility.

再來看資產負債表。截至 2025 年 3 月 31 日，該公司擁有 1.105 億美元現金、現金等價物和受限現金，且無未償還債務。相較之下，截至 2024 年 12 月 31 日，現金、現金等價物和受限現金為 1.36 億美元，且無未償還債務。我們預計到 2025 年，現金表現將會改善，並且相信我們擁有實施成長策略所需的資本，其中現金、現金等價物和限制性現金為 1.105 億美元，而我們的循環信貸額度下的未來循環借款為 1.25 億美元。

Turning to a review of our 2025 revenue guidance, which we reaffirmed this afternoon's press release. For 12 months ending December 31, 2025, the company continues to expect net revenue of between $480 million and $535 million, representing a year-over-year change in the range of roughly flat to an increase of 11%. The 2025 net revenue guidance range continues to assume net revenue from Advanced Wound Care products of between $450 million and $500 million, representing a year-over-year change in the range of a decline of 1% to an increase of 10%; net revenues from Surgical & Sports Medicine products of between $30 million and $35 million, representing a year-over-year increase in the range of 6% to 23%.

談到我們 2025 年收入指引的回顧，我們在今天下午的新聞稿中重申了這一點。截至 2025 年 12 月 31 日的 12 個月，該公司繼續預計淨收入在 4.8 億美元至 5.35 億美元之間，同比變化範圍在大致持平至增長 11% 之間。2025 年淨收入指導範圍繼續假設高級傷口護理產品的淨收入在 4.5 億美元至 5 億美元之間，同比變化範圍在下降 1% 到增長 10% 之間；外科和運動醫學產品的淨收入在 3000 萬美元至 3500 萬美元之間，同比增長 6% 至 23%。

With respect to our profitability and EBITDA guidance, the company now expects GAAP net income in the range of $4.7 million to $34 million compared to $9.5 million and $38.8 million previously; EBITDA in the range of $20 million to $59.6 million compared to $27 million to $66.6 million previously; non-GAAP adjusted net income in the range of $15.3 million to $44.6 million, unchanged versus our prior guidance; and adjusted EBITDA in the range of $43.6 million to $83.2 million, again, unchanged versus our prior guidance.

關於我們的獲利能力和 EBITDA 指導，公司現在預計 GAAP 淨收入將在 470 萬美元至 3400 萬美元之間，而之前預計為 950 萬美元至 3880 萬美元； EBITDA 在 2000 萬美元至 5960 萬美元之間，而之前為 27060 萬美元的會計準則4,460 萬美元之間，與我們先前的預期相比保持不變；調整後的 EBITDA 在 4,360 萬美元至 8,320 萬美元之間，與我們先前的預期相比保持不變。

In addition to our formal financial guidance for 2025, we are providing some considerations for modeling purposes. We continue to expect the environment to be very challenging through the first half of 2025, followed by a significant improvement in our business trends beginning in the third quarter. For modeling purposes, we expect the second quarter revenue in the range of approximately $100 million to $110 million.

除了我們對 2025 年的正式財務指導之外，我們還提供了一些建模目的的考慮因素。我們仍然預計 2025 年上半年的環境將非常具有挑戰性，但從第三季開始我們的業務趨勢將顯著改善。為了建立模型，我們預計第二季的營收約為 1 億美元至 1.1 億美元。

Our profitability guidance for 2025 now assumes gross margin in the range of approximately 78% to 79% compared to 76% to 78% previously, GAAP operating expenses up low single digits year-over-year and excluding noncash intangible amortization of approximately $3.3 million, the nonrecurring FDA payment related to our BLA filing of $4.6 million and the $6.6 million write-down of assets in Q1. Our total non-GAAP operating expenses will increase approximately 5% to 7% year-over-year.

我們對 2025 年的盈利預測現在假設毛利率在約 78% 至 79% 之間，而之前為 76% 至 78%，GAAP 運營費用同比增長低個位數，不包括約 330 萬美元的非現金無形資產攤銷、與我們的 BLA 申請 460 萬美元的第 460 萬美元的非現金無形資產、與我們的 BLA 申請 60 萬美元的資產預記 60 萬美元。我們的非公認會計準則總營運費用將比去年同期增加約 5% 至 7%。

There are no material changes to the other modeling assumptions for 2025 we outlined in our fourth quarter call.

我們在第四季度電話會議上概述的 2025 年其他建模假設沒有重大變化。

With that, I'll turn the call over to the operator to open up the call for your questions.

說完這些，我將把電話轉給接線員，以便回答您的​​問題。

(Operator Instructions) Brooks O'Neil, Lake Street Capital Markets.

（操作員指示）布魯克斯奧尼爾（Brooks O'Neil），Lake Street Capital Markets。

This is Aaron on the line for Brooks. Just curious maybe about the cadence as we move throughout the year, understanding the back half being more weighted, but -- and also there's some still uncertainty out there. But maybe just more curious about some of the key puts and takes that are embedded within the guidance and maybe what you're most confident with moving forward.

這是亞倫為布魯克斯接電話。只是好奇我們全年的節奏，了解下半年的權重更大，但是 - 而且仍然存在一些不確定性。但也許只是對指導中包含的一些關鍵內容更加好奇，也許您對未來最有信心。

Yes, sure, Aaron. This is Dave. So look, we're very confident in our prior guide. I think what we've illustrated here is we have a lot of optionality in our portfolio given the uncertainty that we saw in 2024 regarding the reimbursement landscape that we see now. So we're pretty excited about that opportunity.

是的，當然，亞倫。這是戴夫。所以，我們對之前的指南非常有信心。我認為我們在這裡說明的是，鑑於我們在 2024 年看到的報銷前景的不確定性，我們的投資組合中有很多可選性。所以我們對這個機會感到非常興奮。

We have all the tools, products and people that we need to execute against that initiative that we've got this year. So I'd say, look, from the last time we guided, there was a significant change in the market environment. But nonetheless, we've reaffirmed our guidance on the top line and the bottom line.

我們擁有執行今年的計劃所需的所有工具、產品和人員。所以我想說，從我們上次指導以來，市場環境已經發生了重大變化。但儘管如此，我們還是重申了對營收和利潤的指引。

And I think the big piece there is we've got a situation where PuraPly is now available across the full healing algorithms, so all indications, inclusive of DFU and VLU. We've got the full portfolio beyond PuraPly as well for all indications. And we see in the back half a stabilization of the market and customer buying behavior.

我認為最重要的是我們現在擁有這樣的情況：PuraPly 現在可用於完整的治療演算法，因此所有適應症，包括 DFU 和 VLU。除了 PuraPly 之外，我們還擁有適用於所有適應症的完整產品組合。我們看到下半年市場和客戶購買行為趨於穩定。

The offset to that to some extent that gets us to the same level is, obviously, we've got a situation where we've got to get those products back on to formularies. The competition remains in a push-off of the LCD that's been challenging for us in the past, but obviously, we executed very, very well in 2024.

在某種程度上，讓我們達到同一水平的抵消顯然是，我們必須將這些產品重新納入處方集。競爭仍然在 LCD 的推動下進行，這在過去對我們來說是一個挑戰，但顯然，我們在 2024 年表現得非常非常好。

And there is some uncertainty that remains probably in the back half of the fourth quarter of this year as well. So we're also seeing some high-ASP entrants still continue to enter the market as well. So those are the kinds of puts and takes that I see from the overall guidance perspective.

今年第四季後半段可能仍存在一些不確定性。因此，我們也看到一些高平均售價的進入者仍在繼續進入市場。所以這些就是我從整體指導角度看到的各種優點和缺點。

Right. Okay. That makes sense. Appreciate that. And maybe just a little bit more color on the gross margin. I appreciate again the guidance there at the end of the call. But is there anything we should be thinking about as far as based on your typical historical margin sort of sequential growth? Or just maybe any more color there would be fantastic.

正確的。好的。這很有道理。非常感謝。或許毛利率會稍微高一點。我再次感謝您在通話結束時提供的指導。但是，根據您典型的歷史利潤率連續成長，我們是否應該考慮什麼？或者也許再多一點顏色就更棒了。

Yes, sure. So similar to the revenue, it should be back-end loaded. And the issue there is that we've got -- just based on the dynamics of the marketplace, we've got a major mix shift in the product portfolio. And I also mentioned that we had excess inventory in our living technology that expired in the first quarter. Some of that will spill into the second quarter as well. We don't expect that to repeat in the second half.

是的，當然。因此與收入類似，它應該是後端加載的。我們面臨的問題是——僅基於市場動態，我們的產品組合就發生了重大變化。我還提到，我們的生活科技庫存過剩，這些庫存在第一季就到期了。其中一部分也將延續至第二季。我們預計下半年不會再有這種情況。

And that's all related to delays in the LCD as we really -- obviously, the living technology was on the covered list. And therefore -- we have a six-week lead time for the demand pull for those products. And so obviously, it had some extra expiry that we saw in the first quarter and expect that to continue into the second quarter as well. So a big jump up in gross margin overall based on that mix shift and the lack of expiry going forward.

而這一切都與 LCD 的延遲有關，因為我們確實——顯然，生活科技也在涵蓋範圍內。因此，我們需要六週的時間來滿足這些產品的需求。顯然，我們在第一季看到了一些額外的到期日，並且預計這種情況也會持續到第二季​​。因此，基於產品組合的轉變以及未來到期期限的減少，整體毛利率將大幅上升。

Ryan Zimmerman, BTIG.

Ryan Zimmerman，BTIG。

In the fourth quarter, you had a really strong performance. And I kind of think about the environment at that time in the market with some of the uncertainty. At the time, we thought the LCD was coming. And so you saw buying patterns that were really strong for you and maybe not so much for those companies that were not included on the covered list.

在第四節，你們的表現非常出色。我認為當時的市場環境存在一些不確定性。當時，我們以為液晶顯示器即將到來。因此，您會看到購買模式對您來說確實很強勁，但對於未列入覆蓋名單的公司來說可能就沒那麼強勁了。

I guess I'm curious why that didn't follow a similar pattern this quarter given kind of going into the first quarter, again, the LCD is now delayed a second time at this point before the third delay, and I would have expected kind of a similar dynamic. So I'm curious, Gary, what you can say about kind of why that didn't follow a similar pattern this quarter.

我想我很好奇為什麼本季度沒有遵循類似的模式，因為進入第一季度，LCD 在第三次延遲之前已經第二次延遲，我本來預計會出現類似的動態。所以我很好奇，加里，你能解釋為什麼本季沒有類似的模式嗎？

Yes. Sure, Ryan. So when you look at the fourth quarter, we didn't see much of a change until the end of December, and we did start to see some softening at the end of the year with the confusion setting in. So that really did happen at the end of December, and then it continued to perpetuate in January. So a lot of the financial buyers were continuing to buy high-ASP products until such time as the LCD drops. There was a lot of caution and a little contraction in the market that we've seen in the first quarter that we hadn't seen in the fourth quarter last year.

是的。當然，瑞安。因此，當你看第四季度時，我們直到 12 月底才看到很大的變化，隨著混亂的出現，我們確實在年底開始看到一些疲軟。所以這確實發生在 12 月底，並且持續到 1 月。因此，許多金融買家會繼續購買高平均售價產品，直到液晶顯示器價格下降為止。我們在第一季看到市場表現出很大的謹慎情緒，並且出現了一些收縮，而這是去年第四季沒有看到的。

And that contraction, which we believe is temporary, has a lot to do with the confusion and also all the audits that are going on in the field right now, particularly for our customers. So the dynamics were a little different, and -- but we've pivoted and we're -- with our portfolio. We have the optionality to do extremely well with the LCD or with our optionality without the LCD.

我們認為這種收縮是暫時的，這與混亂以及目前現場進行的所有審計有很大關係，特別是針對我們的客戶。因此，動態略有不同，但我們已經調整了我們的投資組合。我們可以選擇在有 LCD 的情況下表現優異，也可以選擇在沒有 LCD 的情況下表現優異。

Very fair, Gary. That's helpful color. I guess as you think about the -- getting back on the same question, the pacing dynamics, I guess I'm curious why the second quarter now would have maybe still a slowdown relative to the back half of the year and what makes the back half of the year normal in the face of the LCDs now occurring Jan 1, 2026, in your guys' view.

非常公平，加里。這是很有幫助的顏色。我想，當你思考——回到同一個問題，節奏動態時，我想我很好奇為什麼第二季度相對於下半年可能仍然會放緩，以及在你們看來，面對 2026 年 1 月 1 日發生的 LCD，是什麼讓下半年變得正常。

Well, the first delay, which was, I guess, 60 days, there really was confusion assuming that this thing was going to drop. Now you've got it basically pushed off almost nine months. So we're now getting our customers back and our products back on formularies like PuraPly and others for DFU and VLU.

嗯，第一次延期，我猜是 60 天，人們確實很困惑，以為這件事會失敗。現在基本上已經把它推遲了將近九個月。因此，我們現在正在讓客戶回歸，並將我們的產品重新納入 PuraPly 和其他針對 DFU 和 VLU 的處方集。

So that takes time. If you recall, when we had this issue at least back in '23, it took us maybe three months to get everybody back on formulary. We're actually seeing a better trend right now. But that trend of getting folks back, we still saw in Q2 -- excuse me, in Q1.

所以需要時間。如果你還記得的話，至少在 1923 年我們遇到這個問題時，我們花了大概三個月的時間才讓每個人都重新回到處方藥目錄。事實上，我們現在看到了更好的趨勢。但是，我們在第二季度（對不起，是在第一季）仍然看到了這種讓人們回歸的趨勢。

Okay. That's very helpful. And then stepping back for a second, just given the effort that has occurred over the year -- in years past with corralling cost in the wound care market, it seems like -- again, we want to -- Medicare wants to get this right, having -- trying to read through the tea leaves here. But at the same time, it's being held off until 2026. So what in your mind is going to change? Or what are you hearing from CMS in terms of why they're holding off? And what may change between now and early 2026, if you have any thoughts, Gary?

好的。這非常有幫助。然後退一步來說，考慮到過去一年來在控制傷口護理市場成本方面所做的努力，似乎——我們再次希望——醫療保險希望把這件事做好，試圖從中看出端倪。但與此同時，該計劃將推遲至 2026 年。那你認為什麼會改變呢？或者您從 CMS 那裡聽說了他們推遲的原因是什麼？那麼，從現在到 2026 年初，您有什麼想法嗎，蓋瑞？

Sure. It's a great question. So we think that CMS is now heavily involved in driving this process. And I think they were pretty clear in their press release that they're reviewing the coverage policies that exist today in the MACs. So that's encouraging.

當然。這是一個很好的問題。因此我們認為 CMS 現在深度參與推動這一進程。我認為他們在新聞稿中非常清楚地表示，他們正在審查目前 MAC 中存在的覆蓋政策。這令人鼓舞。

They're going to look at the data. They are offering time to get more data. They've indicated that where products may have big impacts in the market and could be left off or there are gaps in the market that those types of products would be looked at.

他們將查看數據。他們正在提供時間來獲取更多數據。他們指出，如果產品可能對市場產生重大影響，可能會被淘汰，或是市場上有空白，那麼就會關注這類產品。

So I think it's not just a delay, which if it was delayed in its current form, that would not be a good thing, but the fact that it's delay to reevaluate the data and look for additional data as well as giving you more time to provide the data, we think it just expands the number of products, and we think that's extremely positive for our PuraPly AM product for sure that it has the ability to get -- and we do expect with the additional data that we'll be filing that PuraPly AM will be on the approved list. That's our belief right now, and that's how we view this. So I think that's one reason for the delay.

所以我認為這不僅僅是一種延遲，如果以目前的形式延遲，那不是一件好事，而是因為延遲重新評估數據並尋找額外的數據，同時也給你更多的時間來提供數據，我們認為它只是擴大了產品的數量，我們認為這對我們的 PuraPly AM 產品來說是非常積極的，它肯定有能力獲得——我們確實希望，通過我們將要提交額外的數據，Puraly AM 將被批准。這就是我們現在的信念，這就是我們看待此事的方式。所以我認為這是延遲的原因之一。

The second is, as you know, we believe payment is a big part of the solution here. And we think CMS is aggressively looking at payment. We don't know if we'll see anything in July in the proposed rule. But if there is no payment solution, there needs to be something to baffle the cost and slow down spending, and that would be the LCD that's available to them on January 1.

第二，如你所知，我們相信支付是解決方案的重要組成部分。我們認為 CMS 正在積極考慮付款。我們不知道七月份擬議的規則中是否會有任何內容。但如果沒有支付解決方案，就需要有某種東西來緩解成本並減緩支出，那就是 1 月 1 日可供他們使用的 LCD。

So I think they're expanding the LCD. So it's more impactful to patients, meaning more products, more accessibility. But at the same time, it's a backstop. If payment doesn't happen and then they have no LCD, then it's basically where we are today, which is not a good place. So I don't know if that's helpful, Ryan, but that's my view.

所以我認為他們正在擴大 LCD。因此，它對患者的影響更大，意味著更多的產品、更高的可及性。但同時，它也是一種後盾。如果沒有付款，他們就沒有液晶顯示屏，那麼基本上這就是我們現在的處境，這不是一個好地方。所以我不知道這是否有幫助，瑞安，但這是我的觀點。

No, no, that's -- very appreciative. And it sounds like there's a range of options, maybe more so than what we saw in the original LCDs that could come out of this kind of come early January 2026, and maybe we are having that discussion around either new payment models or so forth. But yes, we'll have to see. I appreciate the color.

不，不，那是——非常感激。聽起來有很多選擇，可能比我們在最初的 LCD 中看到的還要多，這些選擇可能會在​​ 2026 年 1 月初出現，也許我們正在討論新的支付模式等。但是是的，我們必須拭目以待。我很欣賞這個顏色。

(Operator Instructions) Ross Osborn, Cantor Fitzgerald.

（操作員指示）羅斯·奧斯本，康托·菲茨杰拉德。

Starting off, and I apologize for going back to guidance, but if I remember the commentary correctly for this year, guidance that you reiterated today assumed a strong inflection point in the second half of the year due to the LCD coming through. So could you disclose, I guess, one more time, why you think you can still hit your prior guidance given the fact that the LCD is obviously not going through?

首先，我很抱歉回到指導問題，但如果我記得今年的評論沒有錯的話，您今天重申的指導假設由於 LCD 的出現，下半年將出現一個強勁的拐點。那麼，您能否再透露一次，考慮到 LCD 顯然沒有通過，為什麼您認為您仍然可以實現先前的指導？

Ross, I'm sorry, but it was very difficult to understand what you said. We can hear you loud and clear, but it's a little garbled.

羅斯，很抱歉，但我很難理解你所說的話。我們可以清楚地聽到您的聲音，但有點混亂。

Is this better now?

現在好些了嗎？

Yes.

是的。

Yes, that's much better. Great.

是的，這樣好多了。偉大的。

Okay. Great. So I was just asking about guidance, and sorry to hone on this topic, but based upon your original guidance and your commentary, it assumed a strong inflection in the second half of the year given that the LCD would go through. I'm just still a little bit confused why you guys were able to reiterate guidance given that it won't go through. So just curious what the uplift in the revenue is at this point.

好的。偉大的。所以我只是在詢問指導意見，很抱歉深入探討這個主題，但根據您最初的指導意見和評論，考慮到 LCD 將會通過，它假設下半年會出現強勁的拐點。我只是仍然有點困惑，既然它不會通過，為什麼你們能夠重申指導。所以只是好奇目前收入的成長是多少。

Yes, sure. So what I indicated a little bit earlier was the benefits that we've got is PuraPly is now available for all indications. And obviously, that's a huge win for us. We've got the full portfolio of products as well, which PuraPly and some of the licensed products are higher-margin products. So obviously, that helps gross margin as well as well as the top line.

是的，當然。因此，我之前提到的是，我們獲得的好處是 PuraPly 現在可用於所有適應症。顯然，這對我們來說是一個巨大的勝利。我們擁有全系列的產品，其中 PuraPly 和一些授權產品是利潤較高的產品。顯然，這有助於提高毛利率和營業收入。

And so we see continued stabilization of the market and customer buying behaviors in the back half. And so those all coupled together, we think, are really beneficial for us overall.

因此，我們看到下半年市場和客戶購買行為持續穩定。因此，我們認為，所有這些結合在一起，對我們整體來說確實是有益的。

The offset to that, of course, is that, as Gary mentioned, it takes time to bring the products back on to the formularies. The competition dynamics are still the same as they were in '24, which, again, we were successful in that year. But remember, we had assumed post-LCD, we'd have three commercialized products out of 18 for DFUs and VLUs. That doesn't exist anymore. The competition is still there.

當然，與此相反的是，正如加里所提到的，將產品重新納入處方集需要時間。競爭態勢與 1924 年一樣，那一年我們又成功了。但請記住，我們曾假設 LCD 之後，我們將有 18 種針對 DFU 和 VLU 的商業化產品中有 3 種。那已經不存在了。競爭仍然存在。

There's still some uncertainty, and we assume there's some offsets to the benefit in the late part of Q4, just like we saw in Q1.

仍然存在一些不確定性，我們假設第四季度後期的收益會受到一些抵消，就像我們在第一季看到的那樣。

So if you think about it, under the LCD that we had fewer products on the LCD, so the forecast is built on volume moving to those products. Now we have the breadth of our portfolio, as Dave said, which is much broader, and we do have higher-margin products in our portfolio. So you're replacing a few products with a lot of volume with a number of products with higher margins. So that offset basically is volume versus price.

所以如果你仔細想想，在 LCD 下，我們的產品較少，所以預測是建立在轉向這些產品的數量上的。正如戴夫所說，現在我們的產品組合範圍更加廣泛，而且我們的產品組合中確實有利潤率更高的產品。因此，您要用大量利潤較高的產品取代少量銷售量很大的產品。因此，這種抵銷基本上就是數量與價格的抵銷。

That's the magic of our portfolio. The optionality that we have and the flexibility we have to be able to pivot and move to different products at different pricings and different sites of care is what allows us to continue to reinforce guidance, and we're confident in the guidance.

這就是我們產品組合的神奇之處。我們擁有的可選性和靈活性使我們能夠轉向不同價格和不同護理地點的不同產品，這使我們能夠繼續加強指導，我們對指導充滿信心。

Understood, and that's helpful. And then stabilization is an interesting word obviously given all the market dynamics. Could you just expand on that a little bit and why you think that will occur?

明白了，這很有幫助。然後，考慮到所有的市場動態，「穩定」顯然是一個有趣的詞。您能否稍微詳細說明一下這一點以及您認為為什麼會發生這種情況？

Yes, I'll start and David can jump in. So as we're educating our customers, we spent a lot of time engaging with our customers. There was confusion around which products were on the LCD or not and whether or not the non-DFU and VLU wounds could still be utilizing our products. So as that information gets in, we're seeing customers starting to go back to their old buying habits and their buying patterns as we get on formulary. So we think that's the stabilization, and there's no LCD impact at all for the rest of the year.

是的，我先開始，大衛可以加入。因此，在教育客戶時，我們花了大量時間與客戶互動。人們對哪些產品屬於 LCD 範圍以及非 DFU 和 VLU 傷口是否仍可以使用我們的產品感到困惑。因此，隨著這些資訊的獲取，我們看到客戶開始恢復他們先前的購買習慣和購買模式。因此我們認為這是穩定的，並且在今年剩餘時間內不會受到 LCD 的任何影響。

So we think the combination of our education and the fact that the LCD is now pushed into another year is what the stabilization is based on.

因此，我們認為，我們的教育和 LCD 現在被推遲到另一年的事實相結合，是穩定的基礎。

Yes, I agree, Gary. I think the last announcement was on April 11. So obviously, we have some lingering impact in the second quarter, and we expect that to really be stable in the back half as people really understand the reimbursement landscape and get more comfortable in this market.

是的，我同意，加里。我認為最後一次公告是在 4 月 11 日。因此，顯然，我們在第二季度受到了一些揮之不去的影響，我們預計，隨著人們真正了解報銷狀況並對這個市場更加放心，這種影響在下半年會真正穩定下來。

Understood. And then I guess last question for me, and I'll jump back in queue. Could you guys parse out volume versus pricing for the second half of this year, meaning are you planning on introducing higher-priced products to make up for potentially lost volume kind of playing the game of the companies on LCD?

明白了。然後我想我的最後一個問題，我將回到隊列中。你們能否分析今年下半年的銷售與價格關係，這意味著你們是否計劃推出更高價格的產品來彌補可能損失的銷量，就像玩 LCD 公司的遊戲一樣？

Yes. So we're not introducing anything new necessarily. I mean we've obviously got new products periodically. But the reality is it's just the fact that, as Gary said and I think I mentioned as well, that we have the full portfolio at our disposal for DFUs and VLUs. So it really just is higher-margin products across some of the licensed products as well as our PuraPly franchise now is available for that fairly large subset of the market.

是的。所以我們沒有必要引入任何新的東西。我的意思是我們顯然會定期推出新產品。但事實是，正如加里所說，我想我也提到過，我們擁有針對 DFU 和 VLU 的全部產品組合。因此，它實際上只是一些授權產品中的高利潤產品，而我們的 PuraPly 特許經營權現在已面向相當大的市場子集。

So we can address all indications with the entire portfolio. So it's just a mix shift from only the covered products in that subset to the full portfolio.

因此我們可以利用整個投資組合來解決所有跡象。因此，這只是從該子集中僅涵蓋的產品到完整產品組合的混合轉變。

And we are currently showing no remaining questions in the queue at this time. This does conclude our conference for today. Thank you for your participation.

目前，隊列中沒有剩餘的問題。今天的會議就到此結束了。感謝您的參與。

Thank you very much.

非常感謝。