CorMedix Inc. (CRMD) 2025 Q4 法說會逐字稿

Good morning and welcome to the CorMedix fourth quarter and full year 2025 earnings and corporate update conference call. Today's conference call is being recorded. (Operator Instructions) At this time, I would like to turn the conference call over to Dan Ferry from LifeSci Advisors. Please go ahead.

早安，歡迎參加 CorMedix 2025 年第四季暨全年財報與公司最新進展電話會議。今天的電話會議將進行錄音。(接線員指示) 現在，我想將電話會議交給 LifeSci Advisors 的 Dan Ferry。請開始。

Good morning, and welcome to the CorMedix fourth quarter and full year 2025 earnings and corporate update conference call.

早安，歡迎參加 CorMedix 2025 年第四季暨全年財報與公司最新進展電話會議。

Leading the call today is Joe Todisco, Chairman and Chief Executive Officer of CorMedix. And he is joined by Liz Hurlburt, EVP and Chief Operating Officer; and Susan Blum, EVP and Chief Financial Officer. In addition, Beth Zelnick Kaufman, EVP and Chief Legal and Compliance Officer; Mike Seckler, EVP and Chief Commercial Officer; and Dr. Matt David, EVP and Chief Business Officer, are also on the line and will be available during the Q&A session.

今天由 CorMedix 董事長兼執行長 Joe Todisco 主持本次電話會議。他與執行副總裁兼營運長 Liz Hurlburt，以及執行副總裁兼財務長 Susan Blum 一同出席。此外，執行副總裁兼法務與合規長 Beth Zelnick Kaufman、執行副總裁兼商務長 Mike Seckler，以及執行副總裁兼商務發展長 Matt David 醫師也在線上，並將在問答環節提供回應。

Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meaning set forth in the Private Security Litigation Reform Act of 1995. These statements are statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects and future financial position.

在開始之前，我想提醒各位，在本次電話會議中，管理層可能會發表所謂的前瞻性陳述，其定義見於 1995 年《私人證券訴訟改革法》。這些陳述並非歷史事實，而是關於管理層對公司前景與未來財務狀況的預期、信念、目標與計畫。

Actual results may differ materially from the estimates and projections on which these statements are based due to a variety of important factors, including the risks and uncertainties described in greater detail in CorMedix filings with the SEC, which are available free of charge at the SEC's website or upon request from CorMedix.

由於多項重要因素，實際結果可能與這些陳述所依據的估計與預測存在重大差異，包括在 CorMedix 向美國證券交易委員會（SEC）提交之文件中更詳細描述的風險與不確定性；相關文件可於 SEC 網站免費取得，或向 CorMedix 申請索取。

CorMedix may not actually achieve the goals or plans described in these forward-looking statements. Investors should not place undue reliance on these statements. CorMedix Does not intend to update these forward-looking statements except as required by law.

CorMedix 未必能實現這些前瞻性陳述中所描述的目標或計畫。投資人不應過度依賴這些陳述。除法律要求外，CorMedix 無意更新這些前瞻性陳述。

During this call, the company will discuss certain non-GAAP measures of its performance. GAAP to non-GAAP financial reconciliations and supplemental financial information are provided in CorMedix earnings release in the current report on Form 8-K filed with the SEC. This information is also available on the investor relations section of CorMedix website.

在本次電話會議中，公司將討論若干非 GAAP 的績效衡量指標。GAAP 與非 GAAP 財務數據之調節表及補充財務資訊，已載於 CorMedix 的財報新聞稿，並收錄於向 SEC 提交的 Form 8-K 當期報告中。相關資訊亦可於 CorMedix 官網的投資人關係專區取得。

At this time, it is now my pleasure to turn the call over to Joe Todisco, Chairman and Chief Executive Officer of CorMedix. Joe, please go ahead.

現在，我很榮幸將電話會議交給 CorMedix 董事長兼執行長 Joe Todisco。Joe，請開始。

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. 2025 was truly a transformational year for CorMedix.

謝謝你，Dan。各位早安，感謝各位參加本次電話會議。2025 年對 CorMedix 而言確實是具有轉型意義的一年。

While DefenCath achieved peak sales of just under $260 million, we are excited to have both announced and closed the acquisition of Melinta Therapeutics in the third quarter of the year. In addition, the team worked expeditiously to facilitate integration and achieve our target synergy of $35 million during the fourth quarter of 2025. This was a monumental achievement and truly a testament to the operational execution capabilities of the CorMedix leadership team.

在 DefenCath 達到接近 2.6 億美元的峰值銷售之際，我們也很高興在今年第三季宣布並完成對 Melinta Therapeutics 的收購。此外，團隊迅速推動整合，並於 2025 年第四季達成我們 3,500 萬美元的目標協同效益。這是一項里程碑式的成就，也充分展現 CorMedix 領導團隊的營運執行能力。

As we turn our attention to the year ahead, there is much focus on our post-TDAPA add-on period strategy for maintaining patient utilization rates for DefenCath in outpatient hemodialysis. As a reminder, on July 1 of this year, the TDAPA reimbursement for DefenCath will transition from a buy and bill format to a bundled add-on mechanism.

展望未來一年，我們將高度聚焦於 TDAPA 加成期結束後的策略，以維持 DefenCath 在門診血液透析的病患使用率。提醒各位，今年 7 月 1 日起，DefenCath 的 TDAPA 給付將由「買入並請款」（buy and bill）模式轉換為「打包式加成」（bundled add-on）機制。

We've had multiple conversations with our top customers and are in the process of finalizing supply pricing for Q3 and Q4 of 2026 as well as for 2027. At this time, we are affirming our 2026 DefenCath guidance of $150 million to $170 million and 2027 DefenCath guidance of $100 million to $125 million. With respect to 2026, we expect much of the revenue concentration to be front loaded in the first half of the year as price erosion related to the post-TDAPA add-on occurs in the third and fourth quarter.

我們已與主要客戶進行多次溝通，目前正完成 2026 年第三季與第四季以及 2027 年的供貨定價。目前，我們重申 2026 年 DefenCath 指引為 1.5 億至 1.7 億美元，並重申 2027 年 DefenCath 指引為 1 億至 1.25 億美元。就 2026 年而言，我們預期營收將較集中於上半年，因為與 TDAPA 加成期後相關的價格下滑將在第三季與第四季發生。

Assuming CMS utilizes the same methodology to calculate the 2027 bundle edition, we do expect a meaningful increase in traditional Medicare provider reimbursement in 2027, which we expect to translate into a higher net selling price in 2027 compared to Q3 and Q4 of 2026. To that extent, we took the extra step of issuing 2027 DefenCath guidance, which is based on existing patient utilization rates, as well as our current estimates for the range of net selling prices and does not include potential upside from new customers or managed care contracting.

假設 CMS 採用相同的方法計算 2027 年的打包調整，我們確實預期 2027 年傳統 Medicare 對提供者的給付將顯著提高，並預期這將轉化為 2027 年相較於 2026 年第三季與第四季更高的淨售價。因此，我們進一步提供 2027 年 DefenCath 指引；該指引係基於目前的病患使用率，以及我們對淨售價區間的現行估計，且未納入新客戶或管理式照護（managed care）簽約所帶來的潛在上行空間。

In addition to DefenCath guidance, the company is also affirming its full year 2026 financial guidance of revenue of $300 million to $320 million and adjusted EBITDA of $100 million to $125 million. That said, we are actively in discussions with multiple Medicare Advantage providers, as well as new potential customers for DefenCath in both the inpatient and outpatient settings of care focused on execution of sales and marketing efforts for REZZAYO, MINOCIN, and VABOMERE. And we'll evaluate appropriate updates to financial guidance as we progress throughout 2026.

除 DefenCath 指引外，公司亦重申 2026 全年財務指引：營收 3 億至 3.2 億美元，調整後 EBITDA 為 1 億至 1.25 億美元。不過，我們正積極與多家 Medicare Advantage 供應商，以及 DefenCath 在住院與門診照護場景中的新潛在客戶進行洽談，同時聚焦於推動 REZZAYO、MINOCIN 與 VABOMERE 的銷售與行銷執行。我們將在 2026 年推進過程中，評估是否需要對財務指引進行適當更新。

This past month, we completed our first analyst R&D day, in which we focused on educating our analysts and investor community on the market opportunity for our antifungal product, REZZAYO, in its current approved indication in the treatment of invasive fungal infections, as well as our key pipeline assets of REZZAYO in development for prophylaxis of invasive fungal infections and DefenCath in development for prevention of CLABSI in adult patients receiving Total Parenteral Nutrition. Liz will provide an update on the status of these development programs shortly.

上個月，我們完成首次分析師研發日，重點在於向分析師與投資人社群說明我們抗黴菌產品 REZZAYO 在目前核准適應症（治療侵襲性黴菌感染）下的市場機會，以及我們的關鍵研發管線資產：REZZAYO 用於侵襲性黴菌感染預防的開發計畫，以及 DefenCath 用於預防接受全靜脈營養（TPN）的成人病患發生 CLABSI 的開發計畫。Liz 稍後將就這些開發計畫的進度提供更新。

During the Analyst Day event, stakeholders were given the opportunity to engage with multiple panels of physician thought leaders around key aspects for each of these three growth opportunities for CorMedix. The webcast of the event and associated materials remains available on our website. I encourage all investors to review those materials.

在分析師日活動中，利害關係人有機會與多個由醫師意見領袖組成的座談小組互動，針對 CorMedix 這三項成長機會的關鍵面向進行交流。該活動的網路直播與相關資料仍可於我們網站上取得。我鼓勵所有投資人查閱這些資料。

The feedback from thought leaders was excellent and underscores our view for the large potential market opportunity for REZZAYO, which we estimate at approximately $2.5 billion across both potential indications, and for DefenCath and TPN, which we estimate between $500 million and $750 million. 2026 is expected to be a transitional year for CorMedix, with a heightened investor focus on new catalysts and value drivers, most notably our Phase III ReSPECT data for REZZAYO and prophylaxis, which is on track for the second quarter of this year.

意見領袖的回饋非常正面，並強化我們對 REZZAYO 具備龐大潛在市場機會的看法；我們估計其在兩項潛在適應症合計約為 25 億美元；而 DefenCath 與 TPN 的市場機會，我們估計約為 5 億至 7.5 億美元。預期 2026 年將是 CorMedix 的過渡年，投資人將更關注新的催化劑與價值驅動因素，尤其是我們針對 REZZAYO 預防用途的第三期 ReSPECT 數據，預計可如期於今年第二季公布。

With the acquisition of Melinta, not only did we acquire what we believe will be an exceptional growth asset in REZZAYO but also added highly durable institutional investor products like MINOCIN and VABOMERE, which we expect to provide a stable base of revenue while the company builds toward future growth. I believe CorMedix has done an exceptional job of maximizing the value of the initial TDAPA period afforded to DefenCath in outpatient hemodialysis and parlayed that success into building a pipeline that positions the company for long-term sustainable growth.

透過收購 Melinta，我們不僅取得我們認為將成為卓越成長資產的 REZZAYO，也納入如 MINOCIN 與 VABOMERE 等具高度持續性的機構型產品，我們預期這些產品將在公司邁向未來成長的過程中提供穩定的營收基礎。我認為，CorMedix 在最大化 DefenCath 於門診血液透析 TDAPA 初始期間所帶來的價值方面表現出色，並將該成功延伸為建立一條可使公司實現長期、可持續成長的研發管線。

I'd now like to turn the call over to our Chief Operating Officer, Liz Hurlburt, to provide an update on clinical activities. Liz, please go ahead.

我現在想把電話會議交給我們的營運長 Liz Hurlburt，請她提供臨床活動的最新進展。Liz，請開始。

Thank you, Joe. Good morning. The combined clinical development and operations teams, along with Field Medical Affairs, have been working diligently on numerous clinical activities.

謝謝你，Joe。早安。臨床開發與營運團隊與現場醫學事務（Field Medical Affairs）一直勤奮投入多項臨床活動。

As we shared last fall, enrollment for the global Phase III ReSPECT study evaluating REZZAYO for the prophylaxis of fungal infections in adult allogeneic bone marrow transplant patients completed in September. This pivotal trial is being conducted by our global partner, Mundipharma, who has confirmed that all sites have completed study participation and they are on track for an anticipated database lock later this month. We expect to announce top-line data from the ReSPECT study in the second quarter of 2026.

如同我們去年秋天分享的，評估 REZZAYO 用於成人同種異體骨髓移植患者真菌感染預防的全球第三期 ReSPECT 研究，已於 9 月完成收案。這項關鍵性試驗由我們的全球合作夥伴 Mundipharma 執行；對方已確認所有試驗中心均已完成研究參與，並正按計畫於本月稍晚進行預期的資料庫鎖定（database lock）。我們預計在 2026 年第二季公布 ReSPECT 研究的主要（top-line）數據。

Top-line results will include the primary efficacy outcome of fungal-free survival at day 90, discontinuation of study drugs due to toxicity or intolerance, all-cause mortality and attributable mortality with invasive fungal disease as determined by the Data Review Committee, and the cumulative incidence of invasive fungal disease at day 90 by the Data Review Committee and by azole choice.

主要（top-line）結果將包括：第 90 天無真菌存活（fungal-free survival）的主要療效終點、因毒性或不耐受而停止研究用藥、全因死亡率，以及由資料審查委員會（Data Review Committee）判定之侵襲性真菌疾病相關的歸因死亡率，並包含由資料審查委員會以及依唑類藥物選擇（azole choice）分層所評估的第 90 天侵襲性真菌疾病累積發生率。

Additionally, safety data, including overall adverse events, treatment emergent adverse events, and serious adverse events, is expected to be included in top-line results. The team continues to work closely with investigators and clinical experts in the field to deepen our understanding of the evolving clinical practices and the needs of these patients as we prepare to support a potential commercialization in 2027. As Joe mentioned earlier, our panel of thought leaders provided excellent insights into the market opportunity for a long-acting echinocandin in the prophylaxis of invasive fungal infections, and we are looking forward to our Phase III data readout.

此外，安全性資料（包括整體不良事件、治療期間出現的不良事件（treatment emergent adverse events）以及嚴重不良事件）預期也將納入主要（top-line）結果。團隊持續與研究者及領域內臨床專家密切合作，以加深我們對不斷演變之臨床實務與這些患者需求的理解，並為 2027 年可能的商業化做準備。如 Joe 先前提到的，我們的意見領袖小組就長效型棘白菌素（echinocandin）在侵襲性真菌感染預防上的市場機會提供了極佳洞見，我們也期待第三期數據讀出。

Turning to DefenCath, I'm pleased to share that the Phase III Nutriguard clinical study, which is evaluating the impact on central line-associated bloodstream infections, or CLABSI, for adult patients receiving Total Parenteral Nutrition via a central venous catheter, is approximately 30% enrolled toward our minimum patient target of 90 patients. And we are working to increase enrollment rates as we progress throughout 2026 with new sites in Turkey.

接著談 DefenCath，我很高興分享：第三期 Nutriguard 臨床研究（評估成人患者透過中心靜脈導管接受全靜脈營養（Total Parenteral Nutrition, TPN）時，對中心靜脈導管相關血流感染（central line-associated bloodstream infections, CLABSI）的影響）目前已完成約 30% 的收案，朝我們最低 90 名患者的目標邁進。隨著 2026 年推進並在土耳其新增試驗中心，我們正努力提升收案速度。

At this time, we are still anticipating study completion in early 2027. The adaptive design of the Nutriguard study allows for a minimum of 90 and maximum of 200 participants based on the incidence rate of CLABSI. An interim assessment will be made by the Independent Data Monitoring Committee after 15 participants have experienced a CLABSI event.

目前我們仍預期研究將於 2027 年初完成。Nutriguard 研究的適應性設計（adaptive design）允許依 CLABSI 發生率，最少納入 90 名、最多 200 名受試者。在有 15 名受試者發生 CLABSI 事件後，將由獨立資料監測委員會（Independent Data Monitoring Committee）進行期中評估。

I would now like to turn the call over to Susan to discuss the company's fourth quarter and full-year financial results and financial position. Susan?

我現在想把電話會議交給 Susan，請她說明公司第四季與全年財務結果以及財務狀況。Susan？

Thanks, Liz. Good morning, everyone. We are pleased to share our fourth quarter and full year 2025 financial results, which reflect our ongoing commercial and operational execution. A few things to note on the financial results before I jump in.

謝謝，Liz。各位早安。我們很高興分享 2025 年第四季與全年財務結果，反映我們持續的商業與營運執行。在我開始之前，先就財務結果提醒幾點。

Following the close of the Melinta acquisition on August 29, 2025, the fourth quarter of 2025 represents the first full reporting period incorporating Melinta's operations into our consolidated results. Also, the company has filed its annual report on Form 10-K for the year ended December 31, 2025. And I encourage you to review this filing for a more comprehensive discussion of our financial re-performance and operating results.

在 2025 年 8 月 29 日完成 Melinta 收購案交割後，2025 年第四季是首次將 Melinta 營運納入我們合併報表的完整申報期間。此外，公司已提交截至 2025 年 12 月 31 日止年度的 Form 10-K 年報。我也鼓勵各位查閱該申報文件，以更全面了解我們的財務表現與營運結果。

As Joe mentioned, we had a strong quarter on the revenue front. For the fourth quarter, net revenue of $128.6 million reflected continued growth across our commercial portfolio, driven primarily by DefenCath, which contributed $91.2 million and supplemented by a full quarter contribution from the Melinta portfolio, which totaled $37.4 million. Compared to net revenue of $31.2 million in the fourth quarter of 2024, which included only results from DefenCath, this represents a meaningful year-over-year increase and highlights the company's ability to execute on product launches and business development initiatives.

如 Joe 所提到，我們在營收方面有一個強勁的季度。第四季淨營收為 1.286 億美元，反映我們商業產品組合持續成長，主要由 DefenCath 帶動（貢獻 9,120 萬美元），並由 Melinta 產品組合的完整季度貢獻補充（合計 3,740 萬美元）。相較於 2024 年第四季淨營收 3,120 萬美元（僅包含 DefenCath 的結果），這代表顯著的年增幅，並凸顯公司在產品上市與業務開發計畫上的執行能力。

Total revenue on a pro forma basis for 2025, which is full year revenue for both the CorMedix and Melinta businesses, was $401.3 million, which is in line with our previously established guidance. Of the total, DefenCath generated $258.8 million in net sales for the year.

以備考（pro forma）基礎計算的 2025 年總營收（即 CorMedix 與 Melinta 兩項業務的全年營收）為 4.013 億美元，符合我們先前所建立的財測指引。其中，DefenCath 全年淨銷售額為 2.588 億美元。

Turning to OpEx, fourth quarter operating expenses of $48.2 million increased from $17.1 million in the comparable prior year period, reflecting the expanded cost structure of the combined organization, merger related costs associated with the Melinta acquisition, including severance expenses and additional investment in expanded indications for DefenCath, most notably our Phase III clinical program focused on the prevention of CLABSI in TPN patients. Our operating expenses for the fourth quarter were consistent with our expectations and aligned with our strategic focus on building a platform for long-term sustainable growth, which was supported by the execution and integration of the Melinta acquisition.

接著談營業費用（OpEx），第四季營業費用為 4,820 萬美元，較去年同期的 1,710 萬美元增加，反映合併後組織擴大的成本結構、與 Melinta 收購相關的併購成本（包括資遣費用），以及對 DefenCath 擴大適應症的額外投資，尤其是我們聚焦於預防 TPN 患者 CLABSI 的第三期臨床計畫。第四季營業費用符合我們的預期，並與我們建立長期可持續成長平台的策略重點一致，而此策略亦受惠於 Melinta 收購案的執行與整合。

Our employee base has grown significantly in connection with the merger and scaling of the business. Last year at this time, we had a workforce of approximately 100 people. Today, we have just under 200 employees. The expanded infrastructure serves to support growth and is expected to provide significant operating leverage in the periods to come.

隨著合併與業務規模擴張，我們的員工人數大幅成長。去年此時，我們約有 100 名員工。目前，我們員工人數接近 200 人。擴增後的基礎設施用以支援成長，並預期在未來期間帶來顯著的營運槓桿。

Now that we have successfully streamlined the two organizations, we can focus on executing our business growth strategy and preparation for the anticipated new launch opportunities of DefenCath and TPN and REZZAYO for prophylaxis. On the bottom line, CorMedix recognized net income of $14 million in the fourth quarter of 2025.

現在我們已成功精簡並整合兩個組織，便能專注於執行業務成長策略，並為 DefenCath 在 TPN 領域以及 REZZAYO 用於預防用途的預期新上市機會做準備。在損益表底線方面，CorMedix 於 2025 年第四季認列淨利 1,400 萬美元。

Net income was impacted by tax expense of $42.4 million, the majority of which was non-cash, resulting from the utilization of deferred tax assets that were established in the third quarter of 2025. On a pre-tax basis for the fourth quarter, income was $56.4 million, an increase of $43 million from the fourth quarter of 2024.

淨利受到 4,240 萬美元所得稅費用影響，其中大部分為非現金項目，源自於動用在 2025 年第三季建立的遞延所得稅資產。以稅前基礎計算，第四季稅前利益為 5,640 萬美元，較 2024 年第四季增加 4,300 萬美元。

Turning to non-GAAP results, adjusted EBITDA for the fourth quarter was $77.2 million, which was within our previously established guidance and reflects modest growth quarter over quarter. This metric excludes one-time acquisition-related and reorganization costs, stock-based compensation, and the tax benefits and expenses recognized during the year. And it provides additional insight into the strengths of our core operating performance. A reconciliation to GAAP results is included in the press release issued with our earnings announcement.

接著談非 GAAP 結果，第四季調整後 EBITDA 為 7,720 萬美元，落在我們先前建立的財測指引範圍內，並反映較上一季小幅成長。此指標排除一次性的收購相關與重整成本、以股份為基礎的薪酬，以及年度內認列的稅務利益與費用。它也能提供我們核心營運表現強勁程度的額外洞見。與 GAAP 結果的調節表已包含在我們隨財報公告發布的新聞稿中。

From a liquidity perspective, we ended the quarter with cash and cash equivalents and short-term investments of $148.5 million, driven by strong operating cash flow of almost $100 million during the quarter and ongoing working capital optimization. Where we stand today, given our financial flexibility and commercial momentum, we believe we are well-positioned for both organic growth from existing pipeline and promoted assets and potential inorganic growth from new business development opportunities. I'm excited to be a part of the journey as we move forward.

就流動性而言，本季末我們的現金及約當現金與短期投資為 1.485 億美元，主要受惠於本季接近 1 億美元的強勁營運現金流，以及持續的營運資金最佳化。以我們目前的財務彈性與商業動能來看，我們相信公司已具備良好定位，可同時推動既有研發管線與推廣資產帶來的有機成長，以及透過新業務開發機會帶來的潛在非有機成長。我很期待能參與我們持續前進的旅程。

And now I will turn the call back to Joe for closing remarks. Joe?

現在我把電話交回給 Joe 作結語。Joe？

Thanks, Susan. As I mentioned, 2025 was a transformational year, and 2026 will be a transitional year that we believe sets up CorMedix for long-term sustainable growth in 2027 and beyond. We recently announced the share repurchase program and have been active in repurchasing shares throughout the first quarter. We intend to continue to be active throughout the year, subject to normal blackout periods, applicable volume restrictions and other business needs as we believe our balance sheet has sufficient flexibility to pursue this repurchase while leaving sufficient dry powder for new business development opportunities.

謝謝，Susan。如我提到的，2025 年是具有轉型意義的一年，而 2026 年將是過渡的一年；我們相信這將為 CorMedix 在 2027 年及之後的長期可持續成長奠定基礎。我們近期宣布了股份回購計畫，並在第一季期間積極回購股份。我們打算在全年持續積極進行（受一般禁售期、適用的交易量限制及其他業務需求所限），因為我們相信資產負債表具備足夠彈性，可在進行回購的同時，仍保留充足的資金餘裕以把握新業務開發機會。

The company sits here today with a diversified product portfolio, multiple late-stage pipeline opportunities, financial flexibility, and a capital structure to support future growth. We remain confident in the outlook for this year and our path to future growth and sustained profitability.

公司目前擁有多元化的產品組合、多項後期研發管線機會、財務彈性，以及可支撐未來成長的資本結構。我們對今年的展望以及邁向未來成長與持續獲利的路徑仍然充滿信心。

I would like to now open up the call for Q&A.

我現在想開放電話進行問答。

(Operator Instructions) Roanna Ruiz, Leerink.

(接線員指示) Roanna Ruiz，Leerink。

Hey, good morning, everyone. A couple questions for me. I was thinking in terms of your conversations with dialysis customers and talking about supplying contract pricing for DefenCath, could you give a little bit more color how those are going? Are you trying to build in certain features to drive DefenCath volume in 2026 and beyond? Or how are you thinking about these different levers?

嗨，各位早安。我有幾個問題。我在想，就你們與透析客戶的對話、以及討論 DefenCath 的供應合約定價而言，能否再多提供一些進展細節？你們是否正嘗試納入某些機制，以在 2026 年及之後帶動 DefenCath 的用量？或者你們如何看待這些不同的槓桿？

So I'd say conversations, I believe, are going fairly well. The near-term focus is on preserving patient utilization through the back part of '26 and creating a structure for an increase in selling price in '27. And that's what we've been working toward negotiating with customers, and that's what we're hopeful we'll be finalizing shortly.

我會說，這些對話我認為進展相當順利。短期重點是在 2026 年下半年維持病患使用量，並建立一個架構，以在 2027 年提高銷售價格。這正是我們一直在與客戶協商談判、並希望能在近期完成定案的方向。

We are also setting these up with flexibility to allow for changes in the event we are successful with Medicare Advantage contracting as we progress through this year and into next year. So overall, I'm happy with the progress that we've made and hopeful in the near term, we'll have some things finalized for the back part of the year.

我們也在設計這些安排時保留彈性，以便在我們今年及明年推進 Medicare Advantage 合約、若取得成功時能因應調整。整體而言，我對目前取得的進展感到滿意，也希望在短期內能把一些事項敲定，涵蓋今年下半年。

Sounds good. And then I had a different question about REZZAYO. It sounds like you're going to share a lot of interesting information with the top line for the Phase III. Could you help frame what in that information you think is most clinically meaningful for physicians? How do you plan to leverage some of this data and potential future discussions with payers, et cetera, if all goes well and the top line is positive?

了解。接著我有一個關於 REZZAYO 的不同問題。聽起來你們會在第三期試驗的頂線結果中分享很多有趣資訊。你能否協助說明，在這些資訊中，你認為對醫師而言最具臨床意義的是哪些？如果一切順利且頂線結果為正，你們打算如何運用這些數據，以及在未來與支付方等的討論中如何加以槓桿？

Before I let Liz comment, I'll just give you a little bit of my thoughts. And the way I look at the REZZAYO top line data, I think there's obviously various degrees of success, right? There's meeting the top line endpoint and then there's going to be different aspects of the pathogen data with -- in the top line data as well as, right, secondary endpoint around the discontinuation of the standard of care.

在我讓 Liz 回應之前，我先分享一些我的想法。我看 REZZAYO 的頂線數據時，顯然會有不同程度的成功，對吧？有達成頂線主要終點，另外在頂線數據中也會有不同面向的病原體數據，以及對吧，還有關於停止標準治療的次要終點。

And I think, obviously, what we're able to show will guide toward right, the commercial utility and how we're going to think about marketing and promoting the product. But Liz, do you want to comment any further?

我認為，我們能展示的內容將引導我們判斷其商業效用，以及我們將如何思考產品的行銷與推廣。不過 Liz，你還想補充嗎？

Sure. Roanna, I think when it comes to how we're going to use the data, a lot of this is going to be dependent on the pathogens that we see in top line. Obviously, the more, the better. I think if we are successful in the way that ReSPECT reads out, there is a lot of opportunity for us to be able to talk to the payers about an option that does not have the drug-drug interactions that the Azoles and some of the other therapeutics are presenting right now.

當然。Roanna，我認為就我們如何使用這些數據而言，很大一部分將取決於我們在頂線結果中看到的病原體類型。顯然，越多越好。我認為如果 ReSPECT 的讀出結果如我們所願成功，將有很大機會讓我們與支付方溝通：有一個選項不會像目前的唑類（Azoles）及其他一些治療方式那樣帶來藥物—藥物交互作用。

And we're hopeful that that will lead to understanding around less hospitalizations, getting patients out quickly and to more safely be on their anticancer regimen. So it will be certainly data dependent, but I'm confident that once it comes out, we'll be able to take a look at that data and strategically place it with payers and the clinical community.

我們也希望這能讓大家理解：住院次數更少、能更快讓病患出院，並且更安全地持續其抗癌療程。因此這確實會取決於數據，但我有信心，一旦結果出來，我們將能檢視數據，並以策略性方式向支付方與臨床社群傳達。

Understood. Thanks.

了解。謝謝。

Les Sulewski, Trust Securities.

Les Sulewski，Trust Securities。

This is [Jean] on for Les. First, any developments on the bipartisan proposed TDAPA extension bills and if the timing here has changed based on recent global events? And then also, any updates on a potential partnership with the other LDO and how post-TDAPA dynamics change the odds here?

我是代 Les 提問的 [Jean]。首先，關於兩黨提出的 TDAPA 延長法案，有沒有任何進展？以及基於近期全球事件，這裡的時程是否有所改變？另外，關於與另一家 LDO 的潛在合作夥伴關係，有沒有更新？以及在 TDAPA 之後的市場動態如何改變這件事的可能性？

Look, the legislation is always speculative. What I can say is that we've spent a lot of time. We're working closely with the other company that's actively in TDAPA, Akebia. We've been pounding the payment on the Hill as well as with career staff at CMS, political point staff at CMS. We've been -- we've got a large number of cosponsors of the bill.

你看，立法一向帶有不確定性。我能說的是，我們投入了很多時間。我們正與另一家同樣積極參與 TDAPA 的公司 Akebia 密切合作。我們也在國會山莊以及 CMS 的常任幕僚、CMS 的政治任命幕僚之間，持續推動支付議題。我們已經——我們已取得相當多該法案的共同提案人支持。

Now timing is tricky, right, because this likely needs to be attached to another piece of legislation. There's a war in the Middle East. So we really can't speculate on whether this can happen before June 30 or December 31. I think if it happens after June 30, I think there is a pathway for potential retroactivity of some aspects of the bill to impact positively on DefenCath. So that's something we'd actively be working on as well behind the scenes. But it's really hard to kind of pinpoint a timing with everything that's going on in Washington right now. With respect to the other LDO, I can't comment on ongoing discussions with customers.

不過時程很棘手，對吧，因為這很可能需要附加在另一項立法上。中東正在發生戰爭。因此我們無法推測這是否能在 6 月 30 日或 12 月 31 日之前完成。我認為如果在 6 月 30 日之後才發生，我認為仍存在一條路徑，使法案某些部分可能具追溯效力，從而對 DefenCath 產生正面影響。所以這也是我們在幕後會積極推動的事項。但在華盛頓目前這麼多事情同時發生的情況下，真的很難精準判定時程。至於另一個 LDO，我無法評論與客戶之間正在進行的討論。

Serge Belanger, Needham and Company.

Serge Belanger，Needham and Company。

This is John on for Serge today. One on DefenCath and then another one on the Melinta product portfolio. So first, just curious if you have any updates on the inpatient opportunity with DefenCath. Have the size of the current contributions has been growing? And just curious what growth profile you see from this segment in '26 and '27.

今天我是代 Serge 提問的 John。一個問題關於 DefenCath，另一個關於 Melinta 的產品組合。首先，想請教 DefenCath 在住院端機會方面是否有任何更新。目前的貢獻規模是否正在成長？也想了解你們對該細分市場在 2026 與 2027 年的成長輪廓有何看法。

And then on the Melinta portfolio, you mentioned MINOCIN and VABOMERE being potential -- significant contributors along with REZZAYO. Curious if there's anything promotionally sensitive that you could kind of reinforce into these products to see some growth in the future?

另外關於 Melinta 產品組合，你們提到 MINOCIN 與 VABOMERE 可能——會與 REZZAYO 一樣成為重要貢獻者。想請教是否有任何在推廣上較敏感、你們可以強化的作法，以在未來帶動這些產品的成長？

All right. Thanks, John. And I'm not sure I fully understood your DefenCath question, but what I'll kind of touch on is our guidance and how we constructed our guidance for '26 and '27. So the way we looked at 2026, obviously, with the way CMS did the calculation for the bundle adjustment, the $2.37 that goes into the bundle for the third and fourth quarter, it doesn't fully reimburse providers, right, for -- based on current utilization rates. They use an older period of time to do that calculation that was based on our first year of launch.

好的。謝謝，John。我不確定我是否完全理解你關於 DefenCath 的問題，但我想稍微談一下我們的指引，以及我們如何建構 2026 年與 2027 年的指引。我們看 2026 年的方式是：很明顯，依 CMS 對組合式支付（bundle）調整的計算方式，第三與第四季納入 bundle 的 2.37 美元，並未能在目前的使用率水準下，完全補償提供者，對吧——他們用較早期的一段期間來做該計算，而那段期間是以我們上市的第一年為基礎。

But we have provisions in our agreements with customers that allow for that type of situation where there are certain floor pricing under these contracts. What we're working on now is hopefully getting a little bit better than that floor pricing. But our guidance was somewhat based on the floor, right? And we're working through that process now.

但我們與客戶的協議中有條款，允許在這類情況下適用，也就是這些合約下會有某些底價（floor pricing）。我們目前正在努力，希望能拿到比底價更好一些的價格。但我們的指引在某種程度上是以底價為基礎，對吧？而我們現在正在推進這個流程。

Now for 2027, what we wanted to do was give investors comfort that there's at least a base business level of DefenCath for which we expect to see price appreciation and hopefully stable volumes based on what we're doing now in the outpatient hemodialysis sector to kind of steady the market with customers. Now we elected not to include in that 2027 guidance potential upside from what we're trying to do with Medicare Advantage contracting with a potential new customers, both in outpatient hemodialysis and on the inpatient side. Because when it comes to a guidance, it's very difficult, right, to guide towards something that is still under the way in terms of execution, right?

至於 2027 年，我們想做的是讓投資人放心：DefenCath 至少有一個基本業務水準，我們預期在價格上會有提升，且在我們目前於門診血液透析領域所做的工作下，為了與客戶一起穩定市場，量能希望能維持穩定。我們選擇不把 2027 年指引中可能的上行空間納入，也就是我們正嘗試透過 Medicare Advantage 合約、與潛在新客戶（包含門診血液透析與住院端）所帶來的增量。因為在提供指引時，要去指引一個仍在執行推進中的事項，確實非常困難，對吧？

So as we progress throughout the year and should we get a Medicare Advantage contract across the goal line, and we have the ability to look and make a forecast around volumes, we would update our guidance accordingly as we progress through the year. On the Melinta portfolio question, look, I think MINOCIN and VABOMERE are two really good durable products that have entrenched utilizations in the hospital inpatient segment for treatments of niche infections, right? I think MINOCIN is closing in and around $50 million in sales.

因此，隨著我們在今年的進展，如果我們能把 Medicare Advantage 合約推到終點線，並且有能力針對量能做出預測，我們會在年度進程中相應更新指引。關於 Melinta 產品組合的問題，我認為 MINOCIN 與 VABOMERE 是兩個非常好的、具耐久性的產品，在醫院住院端針對特定利基感染治療上，已有根深蒂固的使用量，對吧？我認為 MINOCIN 的銷售額正接近約 5,000 萬美元。

VABOMERE is just under $30 million. So we do have a little bit of promotional efforts on there. We don't think that they are hugely promotionally sensitive the way a launch product would be, but we think there's a couple of percentage points of growth there that we expect to get this year.

VABOMERE 則略低於 3,000 萬美元。所以我們確實在這些產品上投入了一些推廣資源。我們不認為它們會像新上市產品那樣對推廣高度敏感，但我們認為今年可望帶來幾個百分點的成長。

That's helpful, thanks.

這很有幫助，謝謝。

Brandon Folkes, H.C. Wainwright.

Brandon Folkes，H.C. Wainwright。

Congrats on the quarter. Maybe just two for me. Firstly, on DefenCath. Can you just talk about the customer mix currently and whether you anticipate any change of that in your 2026 and 2027 guidance? How should we think about the opportunity in the other midsized operators for DefenCath?

恭喜本季表現。我這邊可能兩個問題。第一個，關於 DefenCath。你能談談目前的客戶組合（customer mix）嗎？以及你是否預期在 2026 與 2027 年指引中，這個組合會有任何變化？我們應該如何看待 DefenCath 在其他中型營運商的機會？

So right now, I'd say we're fairly heavily concentrated volume-wise with one of the LDOs and then two of the three midsized players are driving probably 90-something percent of our volume amongst the three of them. We have -- there's a third midsized provider that's utilizing, but not at the scale of others.

就目前而言，我會說從量的角度，我們相當集中在其中一家大型透析營運商（LDO），另外三家中型業者中的兩家，合計大概貢獻了我們量的 90% 多。我們還有——第三家中型提供者也有在使用，但規模不如其他幾家。

And then we have a number of small accounts that even if they're utilizing it fairly broadly, they don't represent as large of a market impact because they may only have 20 clinics or 15 clinics. So that's certainly kind of the mix today. Now in terms of changes we would anticipate in '26 and '27, right, would depend in a large extent to our ability to onboard either the other LDO or to get the third midsized player to meaningfully increase volume.

此外，我們也有一些小型客戶，即使他們使用得相當廣泛，對市場的影響也不會那麼大，因為他們可能只有 20 家或 15 家診所。所以這大致就是目前的組合。至於我們預期在 2026 與 2027 年會有哪些變化，很大程度取決於我們是否有能力導入另一家 LDO，或讓第三家中型業者在量上有實質提升。

So the only things that would really kind of, I'd say, change the mix in any meaningful fashion. What we're doing on the inpatient side in terms of promoting DefenCath, while that's a good dollar market opportunity, we believe the volumes there would be much lower, right, from a volume distribution standpoint. So I hope that answers the question.

所以真正會在有意義的程度上改變組合的，大概就是這些因素。我們在住院端推廣 DefenCath 的工作，雖然在金額上是個不錯的市場機會，但我們認為從量的分布角度來看，那邊的量會低很多，對吧？希望這回答了你的問題。

That does. And if I just may ask one more. I know you mentioned you filed the 10-K, sorry, I haven't been through it. But can you just talk about the operating cash flow in the quarter? It looks very strong. So just anything to consider there? And then also maybe how we should think about it in 2026?

有的。如果我可以再問一個。我知道你提到你們已提交 10-K，抱歉，我還沒看完。但你能談談本季的營運現金流嗎？看起來非常強勁。所以這裡有什麼需要留意的嗎？另外，我們在 2026 年應該如何看待它？

Yes. Look, I think roughly, we'd like to say that EBITDA is -- could be a proxy for cash flow for the year. I think there's some items that could impact in terms of our need to maybe stockpile some inventory this year as we're working through a few tech transfers. We also have some rebates that -- large accrued rebates that you'll see on the balance sheet that will get paid out in the early part of this year. So those are kind of really the big items that impact cash flow.

是的。我想大致上，我們會說 EBITDA——在全年層面——可以作為現金流的代理指標（proxy）。我認為有一些項目可能會影響，例如今年我們在進行幾個技術移轉（tech transfers）時，可能需要囤積一些庫存。另外，資產負債表上你會看到一些較大的應計回扣（accrued rebates），會在今年年初支付出去。所以這些大概就是影響現金流的主要項目。

Susan, anything you want to add to that?

Susan，你有什麼要補充的嗎？

No, you covered it, Joe.

沒有，你都涵蓋到了，Joe。

Great. Thanks very much.

很好。非常感謝。

This concludes our question-and-answer session and today's conference call. Thank you for attending today's presentation. You may now disconnect.

我們的問答環節以及今天的電話會議到此結束。感謝各位參加今天的簡報。您現在可以掛線。