CorMedix Inc (CRMD) 2025 Q3 法說會逐字稿

Good day, and welcome to the CorMedix third-quarter 2025 earnings and corporate update conference call. (Operator Instructions) Please note this event is being recorded.

大家好，歡迎參加 CorMedix 2025 年第三季財報及公司最新動態電話會議。（操作說明）請注意，本次活動正在錄影。

I would now like to turn the conference over to Daniel Ferry of LifeSci Advisors. Please go ahead.

現在我將把會議交給 LifeSci Advisors 的 Daniel Ferry。請繼續。

Thank you, operator. Good morning, and welcome to the CorMedix third-quarter 2025 earnings and corporate update conference call. Leading the call today is Joe Todisco, 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; and Dr. Matt David, EVP and Chief Business Officer, are on the line and will be available during the Q&A session.

謝謝接線生。早安，歡迎參加 CorMedix 2025 年第三季財報及公司最新進度電話會議。今天主持電話會議的是 CorMedix 執行長 Joe Todisco；與他一同出席的還有執行副總裁兼營運長 Liz Hurlburt 和執行副總裁兼財務長 Susan Blum。此外，執行副總裁兼首席法律和合規官 Beth Zelnick Kaufman 和執行副總裁兼首席商務官 Matt David 博士也將在線，並在問答環節中提供解答。

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 Securities 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. 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.

在開始之前，我想提醒大家，在電話會議期間，管理階層可能會發表一些在 1995 年《私人證券訴訟改革法案》中定義的前瞻性聲明。這些聲明是除歷史事實陳述之外的，關於管理層對公司前景和未來財務狀況的預期、信念、目標和計劃的聲明。由於各種重要因素，實際結果可能與這些聲明所依據的估計和預測有重大差異，這些因素包括CorMedix向美國證券交易委員會提交的文件中更詳細描述的風險和不確定性，這些文件可在美國證券交易委員會網站上免費獲取，或向CorMedix索取。

CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and 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 可能無法實現這些前瞻性聲明中描述的目標或計劃，投資者不應過度依賴這些聲明。除法律要求外，CorMedix不打算更新這些前瞻性聲明。

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 and the current report on Form 8-K filed with the SEC. This information is available on the Investor Relations section of CorMedix website.

在本次電話會議中，本公司將討論其績效的某些非GAAP指標。CorMedix 的收益發布和向美國證券交易委員會提交的 8-K 表格當前報告中提供了 GAAP 與非 GAAP 財務調節表和補充財務資訊。這些資訊可在CorMedix網站的投資者關係部分查閱。

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

現在，我很高興將電話轉交給 CorMedix 的執行長 Joe Todisco。喬，請繼續。

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. This has been an exciting quarter in the evolution of CorMedix as we announced and closed the acquisition of Melinta Therapeutics in a combination of cash and stock transaction. This deal is transformational for CorMedix creating a diversified specialty pharmaceutical company with a broad portfolio of commercial and late-stage pipeline products.

謝謝你，丹。各位早安，感謝各位參加本次電話會議。對於 CorMedix 而言，這是一個令人興奮的季度，因為我們宣布並完成了對 Melinta Therapeutics 的收購，收購方式為現金加股票交易。這項交易對CorMedix具有變革性意義，它將打造一家多元化的專業製藥公司，擁有廣泛的商業化和後期研發管線產品組合。

Integration of the legacy CorMedix and Melinta operations has progressed faster than originally expected. And as we announced in October, we expect to capture approximately $30 million of the projected $35 million to $45 million of total synergies on a run rate basis before the end of 2025.

CorMedix 和 Melinta 兩家原有企業的整合進展比預期更快。正如我們在 10 月宣布的那樣，我們預計在 2025 年底之前，按年率計算，總協同效應預計為 3500 萬至 4500 萬美元，其中約 3000 萬美元將實現。

I'm excited to announce today that as part of our integration, CorMedix, Inc. will be rebranding as CorMedix Therapeutics, and all employees will unify under this company name. We're also adopting a new logo to signify the go-forward organizational commitment to develop and commercialize novel therapies for the prevention and treatment of life-threatening conditions.

今天我很高興地宣布，作為我們整合的一部分，CorMedix, Inc. 將更名為 CorMedix Therapeutics，所有員工都將統一在該公司名下。我們也採用了一個新的標誌，以表明本組織致力於開發和商業化用於預防和治療危及生命的疾病的新療法。

This past quarter marks the most successful quarter from a financial perspective in company history, registering record levels for revenue of $104.3 million, net income of $108.6 million and adjusted EBITDA of $71.8 million (sic - see press release, "$71.9 million"). Our revenue performance was largely driven by faster-than-expected adoption by our DefenCath LDO customer, utilization growth from our existing customer base as well as partial quarter contribution from the Melinta portfolio assets.

從財務角度來看，上個季度是公司歷史上最成功的一個季度，收入創下 1.043 億美元的紀錄，淨收入創下 1.086 億美元的紀錄，調整後的 EBITDA 創下 7180 萬美元的紀錄（原文如此 - 請參閱新聞稿，“7190 萬美元”）。我們的營收表現主要得益於DefenCath LDO客戶比預期更快地採用我們的產品、現有客戶群的利用率成長以及Melinta投資組合資產的部分季度貢獻。

Based on the recent momentum, today, we are raising our pro forma combined full-year revenue guidance from a minimum of $375 million to a range of $390 million to $410 million. In addition, we are increasing our previous guidance for pro forma fully synergized adjusted EBITDA for 2025 from a range of $165 million to $185 million to a new range of $220 million to $240 million.

根據近期的發展勢頭，今天我們將全年合併收入預期從至少 3.75 億美元上調至 3.9 億美元至 4.1 億美元。此外，我們將先前對 2025 年備考完全協同調整 EBITDA 的預期從 1.65 億美元至 1.85 億美元上調至 2.2 億美元至 2.4 億美元。

On the business development front, we also successfully closed our strategic minority investment in Talphera, Inc. This small strategic investment gives us a foothold in a late-stage critical care product that is highly complementary to CorMedix' acute care portfolio. As part of the transaction, CorMedix has granted a right-of-first negotiation to acquire Talphera following the announcement of Phase 3 results, which we anticipate to be available in the first half of 2026. We will continue to evaluate Talphera in the coming months as their clinical trial progresses toward completion.

在業務發展方面，我們也成功完成了對 Talphera, Inc. 的策略性少數股權投資。這項小額策略投資使我們得以涉足後期重症監護產品領域，該產品與 CorMedix 的急性護理產品組合高度互補。作為交易的一部分，CorMedix 已授予在 Talphera 公佈 3 期臨床試驗結果後優先收購該公司的權利，我們預計該結果將於 2026 年上半年公佈。接下來的幾個月，我們將繼續對Talphera進行評估，因為其臨床試驗正在逐步完成。

With respect to DefenCath, we are very pleased overall with the utilization of DefenCath in the outpatient hemodialysis segment during our initial phase of TDAPA and we have now begun planning with customers for the post-TDAPA add-on periods, which we expect will begin in July of 2026. In line with our strategy to increase patient utilization of DefenCath during our post-TDAPA add-on periods, we'll be working over the coming months to finalize supply pricing with customers under existing contracts based upon the final post-TDAPA add-on framework as well as engaging in conversations with Medicare Advantage payers following the publication of our real-world evidence data later this year.

關於 DefenCath，我們對 DefenCath 在 TDAPA 初期階段在門診血液透析領域的應用總體上非常滿意，我們現在已經開始與客戶一起規劃 TDAPA 之後的附加期，我們預計該附加期將於 2026 年 7 月開始。為了配合我們在 TDAPA 附加期提高患者對 DefenCath 的使用率的策略，我們將在未來幾個月內，根據最終的 TDAPA 附加期框架，與現有合約下的客戶最終確定供應定價，並在今年稍後發布真實世界證據數據後，與 Medicare Advantage 付款方進行對話。

Lastly, as CorMedix evolves, I think it's important for investors to begin focusing on important near- and medium-term catalysts and value drivers for the company beyond the hemodialysis sector. First and most importantly, the second quarter of 2026 is expected to bring top-line data for the use of REZZAYO as prophylaxis of invasive fungal infections. We believe the total addressable market for immune-compromised patients that are currently undergoing antifungal prophylaxis is more than $2 billion.

最後，隨著 CorMedix 的發展，我認為投資者應該開始關注血液透析領域之外，對公司而言重要的近期和中期催化劑和價值驅動因素。首先也是最重要的是，預計 2026 年第二季將公佈 REZZAYO 用於預防侵襲性真菌感染的初步數據。我們認為，目前正在接受抗真菌預防治療的免疫功能低下患者的潛在市場總額超過 20 億美元。

The Phase 3 ReSPECT study is running head-to-head against the current standard of care, which is a combination of posaconazole, an antifungal, and Bactrim, an antibiotic, that also has antifungal activity. Posaconazole demonstrates severe drug-to-drug interactions with many medications the target patient population is currently taking, including immunosuppressive drugs like tacrolimas and cyclosporin as well as numerous therapeutics used in treating hematological malignancies such as leukemia, multiple myeloma or non-Hodgkin's lymphoma, all patient populations that may undergo bone and marrow transplantation as part of their therapy.

ReSPECT 第三階段研究與目前的標準療法直接對比，該標準療法是由抗真菌藥物泊沙康唑和具有抗真菌活性的抗生素複方新諾明聯合使用。泊沙康唑與目標患者群體目前正在服用的許多藥物存在嚴重的藥物交互作用，包括他克莫司和環孢素等免疫抑制劑，以及用於治療白血病、多發性骨髓瘤或非霍奇金淋巴瘤等血液惡性腫瘤的多種療法，所有這些患者群體都可能接受骨髓移植作為其治療的一部分。

For these patients, REZZAYO used as prophylaxis against these invasive fungal infections could represent a new standard of care that may allow patients to experience less drug-to-drug interactions, less frequent dosing, and more flexibility in their setting of care for treatment.

對於這些患者而言，使用 REZZAYO 作為預防這些侵襲性真菌感染的藥物，可能代表一種新的護理標準，使患者能夠減少藥物交互作用、減少給藥頻率，並在治療護理環境中擁有更大的靈活性。

Our second near-term catalyst outside of hemodialysis is the expected expansion of DefenCath into the prevention of CLABSI for adult patients receiving total parenteral nutrition, or TPN. Our most recent market research continues to highlight the critical unmet medical need and pervasively high bloodstream infection rates in this patient population.

除了血液透析之外，我們的第二個近期催化劑是DefenCath有望擴展到預防接受全腸外營養（TPN）的成年患者的CLABSI。我們最新的市場調查繼續強調了該患者群體中尚未滿足的重大醫療需求和普遍較高的血液感染率。

Prophylactic intervention is urgently needed for these vulnerable patients. We have previously guided to a total addressable market in this indication of up to $750 million and anticipate Phase 3 completion as early as the end of 2026 or beginning of 2027. I believe that CorMedix has done an exceptional job of maximizing the value of the initial TDAPA period afforded to DefenCath as a long-term strategy in hemodialysis for post-TDAPA periods and has redeployed cash flow into a pipeline that can position the company for long-term sustainable growth. I am excited about the future.

迫切需要對這些弱勢患者進行預防性介入。我們先前預測，該適應症的潛在市場規模可達 7.5 億美元，並預計 3 期臨床試驗最早將於 2026 年底或 2027 年初完成。我認為，CorMedix 在充分利用 DefenCath 初始 TDAPA 階段的價值方面做得非常出色，將其作為血液透析 TDAPA 後階段的長期策略，並將現金流重新投入到能夠使公司實現長期可持續增長的研發管線中。我對未來充滿期待。

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

現在，我想把電話交給我們的營運長 Liz Hurlburt，請她介紹臨床活動、營運和整合的最新情況。莉茲，請繼續。

Thank you, Joe, and good morning. The combined clinical development and operation teams, along with field medical affairs, have been working diligently on numerous clinical activities. As we shared in late September, enrollment for the global Phase 3 ReSPECT study evaluating REZZAYO for the prophylaxis of fungal infections in allogeneic bone marrow transplant patients has completed. This pivotal trial is being conducted by our global partner, Mundipharma, and the team has begun to progress the program in anticipation of study closeout.

謝謝你，喬，早安。臨床開發和營運團隊以及現場醫療事務團隊一直在努力進行多項臨床活動。正如我們在 9 月下旬分享的那樣，評估 REZZAYO 用於預防同種異體骨髓移植患者真菌感染的全球 3 期 ReSPECT 研究的入組工作已經完成。這項關鍵性試驗由我們的全球合作夥伴 Mundipharma 進行，該團隊已開始推進該項目，以期完成研究。

The team continues to work closely with investigators and clinical experts in the field to deepen our understanding of the evolving clinical practices and needs of these patients. We expect to announce top-line results from the ReSPECT study in the second quarter of 2026.

該團隊繼續與該領域的調查人員和臨床專家密切合作，以加深我們對不斷變化的臨床實踐和這些患者需求的了解。我們預計將於 2026 年第二季公佈 ReSPECT 研究的主要結果。

Turning to DefenCath. I'm pleased to share that the Phase 3 Nutri-Guard clinical study, which evaluates the reduction in central-line associated bloodstream infections, or CLABSI, for adult patients receiving total parental nutrition via a central venous catheter has garnered international interest. In the coming months, we will expand clinical study sites into Turkey to broaden the diversity of patients and potentially expedite enrollment time lines. At this time, we are still anticipating study completion by the end of 2026 or early 2027.

轉向DefenCath。我很高興地宣布，評估透過中心靜脈導管接受全腸外營養的成年患者中心靜脈導管相關血流感染（CLABSI）減少情況的 3 期 Nutri-Guard 臨床研究已引起國際關注。在接下來的幾個月裡，我們將把臨床研究地點擴展到土耳其，以擴大患者群體的多樣性，並有可能加快患者招募速度。目前，我們仍預期研究將於 2026 年底或 2027 年初完成。

Lastly, our real-world evidence study in collaboration with US Renal Care has entered the second year of data collection. The team is currently conducting an analysis of the first year of data, and we anticipate sharing those interim results by the end of this year. This study is designed to demonstrate the real-world effects of the broad use of DefenCath in a real-world setting and examines not only the reduction in catheter-related bloodstream infections, or CRBSI, but also reduction in costly infection-related hospitalizations. Secondary data points of missed treatment sessions, antibiotic utilization, and TPA utilization are also being reviewed.

最後，我們與美國腎臟護理中心合作進行的真實世界證據研究已進入資料收集的第二年。目前團隊正在對第一年的數據進行分析，我們預計在今年年底前分享這些中期結果。本研究旨在展示在真實世界環境中廣泛使用DefenCath的實際效果，並不僅考察導管相關血流感染（CRBSI）的減少情況，還考察昂貴的感染相關住院治療的減少情況。我們也檢視了錯過治療療程、抗生素使用和 TPA 使用等次要數據點。

Now turning to integration progress. I am heartened by the significant efforts of the teams to both integrate and optimize operations as a unified organization. We have made meaningful strides in merging the teams, identifying synergies, and creatively preserving key elements of both legacy organizations. In addition to our new corporate branding as CorMedix Therapeutics, we have refined our mission, vision and values as a new organization and are excited to see our integrated teams work together to create a new culture and execute together on key objectives.

現在來看整合進展。我對各團隊為整合和優化運營，使其成為一個統一的組織所付出的巨大努力感到鼓舞。我們在團隊合併、尋找協同效應以及創造性地保留兩個原有組織的關鍵要素方面取得了實質進展。除了啟用新的企業品牌 CorMedix Therapeutics 之外，我們還完善了作為一家新公司的使命、願景和價值觀，並很高興看到我們整合後的團隊共同努力，創造一種新的文化，並共同實現關鍵目標。

Currently, all functional areas have fully integrated from a personnel standpoint, which includes clinical, medical affairs, technical operations, supply chain, finance, legal, quality, human resources, and commercial. Systems integration is still underway and expected to complete in 2026 in line with our original estimates. The legacy contracted hospital sales team for DefenCath will conclude its service by the end of this year, and DefenCath promotion in the hospital setting will transition in January to the post-integration internal field organization.

目前，從人員配備的角度來看，所有職能領域都已完全整合，包括臨床、醫療事務、技術營運、供應鏈、財務、法律、品質、人力資源和商業。系統整合仍在進行中，預計將於 2026 年完成，與我們最初的估計一致。DefenCath 原有的醫院銷售團隊將於今年底結束其服務，DefenCath 在醫院的推廣工作將於 1 月過渡到整合後的內部現場組織。

Beginning in early Q1 2026, our unified sales organization covering acute care clinics and hospitals will seamlessly support all promoted portfolio products, including both DefenCath and REZZAYO and will offer enhanced capabilities and customer support. The collective expertise of our team positions us to deliver comprehensive solutions to many challenges in the acute care space and ultimately with the goal of driving better patient outcomes. We are incredibly proud of the team and their hard work in moving this integration forward while continuing to focus on sales and patient access.

從 2026 年第一季初開始，我們涵蓋急診診所和醫院的統一銷售組織將無縫支援所有推廣的產品組合，包括 DefenCath 和 REZZAYO，並將提供增強的功能和客戶支援。我們團隊的集體專業知識使我們能夠為急診護理領域的許多挑戰提供全面的解決方案，並最終實現改善患者治療效果的目標。我們為團隊及其在推進此次整合過程中所付出的辛勤努力感到無比自豪，同時他們也繼續專注於銷售和病患准入。

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

現在我想把電話交給蘇珊，讓她來討論公司第三季的財務表現和財務狀況。蘇珊？

Thanks, Liz, and good morning, everyone. We are pleased to report our third-quarter financial results, reflecting continued commercial momentum and a path towards sustained profitability. Our results demonstrate solid growth across the business, including strong performance from DefenCath and growth in the legacy Melinta product portfolio.

謝謝莉茲，大家早安。我們很高興地宣布第三季財務業績，這反映了持續的商業發展勢頭和實現可持續盈利的道路。我們的業績顯示公司整體業務穩定成長，其中 DefenCath 表現強勁，傳統 Melinta 產品組合也實現了成長。

We closed the Melinta acquisition on August 29, 2025, and therefore, one month of its operations are included in our consolidated financial results for the third quarter. The company has filed its quarterly report on Form 10-Q for the quarter ended September 30, 2025. I encourage you to read the information contained in the report for a more complete discussion of our financial results.

我們於 2025 年 8 月 29 日完成了對 Melinta 的收購，因此，其一個月的營運情況已計入我們第三季的合併財務業績中。該公司已提交截至 2025 年 9 月 30 日的季度報告（10-Q 表格）。我建議您閱讀報告中的信息，以便更全面地了解我們的財務表現。

As Joe mentioned, for the third quarter, net revenue was $104.3 million, including the DefenCath sales of $88.8 million, representing a total net revenue increase of $77.5 million year over year. The remainder of revenue totaling approximately $15.5 million reflects the contribution from Melinta for the month of September, $12.8 million of which was driven by Melinta portfolio sales.

正如喬所提到的，第三季淨收入為 1.043 億美元，其中包括 DefenCath 的銷售額 8,880 萬美元，淨收入年增 7,750 萬美元。剩餘的收入總計約 1550 萬美元，反映了 Melinta 在 9 月的貢獻，其中 1280 萬美元來自 Melinta 產品組合的銷售。

Operating expenses for the third quarter were $42.6 million (sic - see press release, "$41.7 million") compared to $14.1 million for CorMedix on a stand-alone basis in the same quarter last year. The increase of $28.5 million over the prior period includes nonrecurring costs of $12.7 million associated with the transaction and integration as well as severance costs associated with the Melinta acquisition. Other increases in costs were driven by stock-based compensation, OpEx contribution from Melinta's business, and increased investment in R&D associated with expanded indications for DefenCath, including the Phase 3 clinical study for prevention of CLABSI and TPN patients.

第三季的營運支出為 4,260 萬美元（原文如此 - 請參閱新聞稿，「4,170 萬美元」），而去年同期 CorMedix 的獨立營運支出為 1,410 萬美元。與上期相比，增加了 2,850 萬美元，其中包括與交易和整合相關的 1,270 萬美元非經常性成本，以及與收購 Melinta 相關的遣散費。其他成本增加的原因包括股票選擇權激勵、Melinta 業務的營運支出貢獻，以及與 DefenCath 擴大適應症相關的研發投入增加，包括針對 CLABSI 和 TPN 患者預防的 3 期臨床研究。

While costs have increased in these areas this past quarter, they are aligned with our previously communicated expectations and support our strategic priority, which is to position the company for long-term sustainable growth. In addition, as Joe mentioned, we are working to quickly capture synergies associated with the Melinta acquisition with approximately $30 million of synergies on a run rate basis expected to be captured from actions taken prior to the end of the year. We expect to realize these synergies in the P&L beginning in the fourth quarter of 2025.

雖然上個季度這些領域的成本有所增加，但這與我們先前公佈的預期相符，並支持我們的策略重點，即使公司實現長期可持續成長。此外，正如喬所提到的，我們正在努力盡快實現與收購 Melinta 相關的協同效應，預計在年底前採取的行動將帶來約 3000 萬美元的年度協同效應。我們預計從 2025 年第四季開始，這些綜效將在損益表中反映出來。

Overall, for the third quarter of 2025, we achieved net income of $108.6 million or $1.26 per diluted share marking meaningful progress compared to the third quarter of 2024, during which period, we recognized a loss of $2.8 million and a net loss per diluted share of $0.05. A large driver of net income for the quarter was a substantial tax benefit of $59.7 million due primarily to the realization of deferred tax assets, equating to 100% of the CorMedix' historical net operating losses, or NOLs. The recognition of this sizable tax benefit underscores our confidence in sustained future profitability, which will drive the utilization of our NOL carryforwards against taxable income, which equates to cash tax savings and tangible value for the company and for shareholders.

整體而言，2025年第三季度，我們實現淨利1.086億美元，即每股攤薄收益1.26美元，與2024年第三季度相比取得了顯著進展。 2024年第三季度，我們錄得虧損280萬美元，每股攤薄虧損0.05美元。本季淨利成長的主要驅動因素是5,970萬美元的巨額稅收優惠，這主要源自於遞延所得稅資產的實現，相當於CorMedix公司歷史淨經營虧損（NOL）的100%。這項可觀的稅收優惠的確認，凸顯了我們對未來持續盈利能力的信心，這將推動我們利用淨經營虧損結轉抵扣應稅收入，從而為公司和股東帶來現金稅收節省和切實價值。

Turning to non-GAAP measures. Adjusted EBITDA for the third quarter of 2025 was $71.8 million (sic - see press release, "$71.9 million") up from a loss of $2 million in the third quarter of 2024, reflecting the momentum of our operations over the past year. This non-GAAP measure provides additional insight into our core operating performance and profitability trends, highlights the underlying strength of our operations, and excludes onetime acquisition-related costs, stock-based compensation, and the tax benefit we realized this quarter. Please refer to our press release that we issued this morning for a reconciliation of this non-GAAP measure to GAAP net income.

接下來我們來看非GAAP指標。2025 年第三季調整後 EBITDA 為 7,180 萬美元（原文如此 - 請參閱新聞稿，「7190 萬美元」），而 2024 年第三季虧損 200 萬美元，這反映了我們過去一年的營運勢頭。這項非GAAP指標進一步揭示了我們的核心營運績效和獲利趨勢，突顯了我們營運的內在實力，並且不包括一次性收購相關成本、股票選擇權費用以及我們本季實現的稅收優惠。有關此非GAAP指標與GAAP淨收入的調節情況，請參閱我們今天早上發布的新聞稿。

On the cash front, we raised gross proceeds of $150 million in a convertible debt offering and those proceeds together with cash on hand and $40 million in common stock issued to the seller were used to fund the acquisition of Melinta in August 2025. This financing strategy supported the transaction while maintaining what we believe to be a healthy liquidity position and flexibility for future growth investments. As a result, our cash flow during the third quarter reflects the timing of these financing and acquisition activities, and we ended the quarter with cash, cash equivalents and short-term investments of $55.7 million.

在現金方面，我們透過可轉換債券發行籌集了 1.5 億美元的總收益，這些收益連同手頭現金和向賣方發行的 4,000 萬美元普通股一起，用於在 2025 年 8 月收購 Melinta。這項融資策略為交易提供了支持，同時保持了我們認為健康的流動性狀況和未來成長投資的靈活性。因此，我們第三季的現金流反映了這些融資和收購活動的時機，本季末我們持有現金、現金等價物和短期投資 5,570 萬美元。

Looking ahead, we expect significant cash generation in the fourth quarter, driven by strong operational performance. We anticipate ending the year with approximately $100 million of cash and cash equivalents, supported by ongoing positive operating cash flow and working capital optimization. To drive this balance, we are guiding to fourth-quarter net revenue in the range of $115 million to $135 million, reflecting continued momentum from DefenCath and a full-quarter contribution from Melinta.

展望未來，我們預計第四季將產生大量現金流，這主要得益於強勁的營運業績。我們預計年底將擁有約 1 億美元的現金及現金等價物，這得益於持續的正向經營現金流和營運資本優化。為了實現這一平衡，我們預計第四季度淨收入將在 1.15 億美元至 1.35 億美元之間，這反映了 DefenCath 的持續成長勢頭以及 Melinta 的整個季度貢獻。

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

現在我將把電話轉回給喬，請他作總結發言。喬？

Thank you, Susan. The third quarter of 2025 marked a period of meaningful progress and disciplined execution. We advanced our strategic objectives, strengthened our financial foundation, and delivered solid results while completing a transformative acquisition. The company now has a diversified product portfolio, multiple late-stage pipeline opportunities, financial flexibility, and a diversified capital structure to support future growth. We remain confident in the outlook for the remainder of this year and the path to sustained growth and profitability.

謝謝你，蘇珊。2025 年第三季標誌著一段取得實質進展和執行有條不紊的時期。我們推進了策略目標，鞏固了財務基礎，並在完成一項變革性收購的同時取得了穩健的成果。公司目前擁有多元化的產品組合、多個後期研發管線機會、財務靈活性和多元化的資本結構，以支持未來的成長。我們對今年剩餘時間的前景以及實現持續增長和盈利的道路仍然充滿信心。

I'd now like the operator open up for questions.

現在我想請接線生回答問題。

(Operator Instructions)

（操作說明）

Les Sulewski, Truist.

萊斯·蘇萊夫斯基，Truist。

Congrats on the progress. First, on DefenCath, do you have a sense of inventory stocking versus utilization in 3Q? And we understand you're not providing guidance for next year at this time, but how should we think about potential seasonality throughout the year? Or how ordering rates could impact quarterly revenue cadence? And then outside of additional cohort expansion, is 4Q implied guidance, I guess, a good representation of a normalized utilization patterns? And I have a follow-up.

恭喜你取得進展。首先，DefenCath，您能否了解第三季的庫存持有量與利用率？我們理解您目前不打算提供明年的指導，但我們應該如何考慮全年的潛在季節性因素？或者，訂購率會如何影響季度營收節奏？那麼，除了進一步擴大隊列規模之外，第四季的隱含指引是否能很好地代表正常化的利用模式？我還有一個後續問題。

Thanks, Les. I'll try and make sure I get all these right. So in terms of third-quarter stocking, I think our smaller customers from what we've seen are holding on average about two to three weeks on hand. The LDO is somewhere between three to four weeks, and I think that's what we saw normalized.

謝謝你，萊斯。我會盡量確保全部答對。所以就第三季的庫存而言，我認為根據我們所看到的，我們的小客戶平均會儲備兩到三週的庫存。LDO（長期病假）大約在三到四週之間，我認為這就是我們看到的正常情況。

I'd say there was probably a couple of million dollars shipped at the cutover if you're trying to kind of back into third-quarter versus fourth-quarter DefenCath revenue and kind of where we're trending. So there was a couple of million dollars right on that cutoff that probably that ended up getting captured in Q3 that a day later is going to be in Q4. But for the most part, I wouldn't say there's a significant amount of stocking in Q3, just normal stocking that they hold on hand.

如果要比較第三季和第四季DefenCath的營收以及我們目前的趨勢，我認為在切換過程中可能交付了數百萬美元。所以，在截止日期前有幾百萬美元，可能最終會被計入第三季度，但一天後就會被計入第四季。但總的來說，我認為第三季並沒有大量的庫存，只是他們通常持有的正常庫存。

The second question, I believe, was about quarter-to-quarter guidance and seasonality. The business -- certainly we'll separate the DefenCath business from the Melinta business, doesn't have a historic seasonality in terms of times of the year where patients receive hemodialysis more than others. As we've been progressing over the last two years and we've added new customers, we've added new cohorts, we've continued to see, right, an increase in utilization and growth in overall revenue.

我認為第二個問題是關於季度業績指引和季節性因素的。該業務——當然，我們會將 DefenCath 業務與 Melinta 業務分開——在患者接受血液透析的時間方面，並沒有明顯的季節性規律。在過去的兩年裡，隨著我們不斷發展壯大，新增了客戶，新增了用戶群體，我們也持續看到利用率和整體收入的成長。

Obviously, I think there's a lot of eyes focused on next year. I don't know at what point we're going to be ready to provide financial guidance for 2026. I think everyone is aware, just by the nature of TDAPA and the change that comes in July, there should be a little bit of front-endedness, right, to the overall revenue, not necessarily utilization for the overall year, and we're still trying to figure out what the full year is going to look like.

顯然，我認為很多人都在關註明年。我不知道我們何時才能準備好提供 2026 年的財務指導。我認為大家都明白，由於TDAPA的性質以及7月份的變化，總收入應該會有一些提前確認的情況，對吧？這不一定是全年的利用率，我們仍在努力弄清楚全年的情況會是什麼樣子。

Now in the Melinta portfolio, again, they're not -- though a large number of them are anti-infectives, they're not cough/cold type products. So you wouldn't see that type of winter seasonality. I think the -- there's always a small amount of December stocking into January of all products. I don't know that it's going to be overly material to the business case, but we don't -- wouldn't expect to see significant seasonality there as well.

現在，在 Melinta 的產品組合中，雖然有很多是抗感染藥物，但它們並不是咳嗽/感冒類產品。所以你不會看到那種冬季季節性變化。我認為——總是會有一些產品從十二月開始積壓到一月。我不知道這是否會對商業案例產生過大的影響，但我們也不認為這方面會出現明顯的季節性波動。

In terms of cohort expansion, I do believe that there's still opportunities with all of the customers that I think that was -- that question is specific to DefenCath, that there's still an opportunity to grow with our existing customer base. And that's something that we are continuing to focus on over the coming months and even in the post-TDAPA period.

就客戶群擴張而言，我相信對於所有客戶來說，仍然存在機會——這個問題是專門針對 DefenCath 的，我們仍然有機會與現有的客戶群共同發展。在接下來的幾個月裡，甚至在TDAPA之後，我們將繼續關注這一點。

A big part of our post-TDAPA strategy is the engagement with Medicare Advantage. We currently believe the overwhelming majority of the patients in which DefenCath is being used in the outpatient setting are Medicare fee-for-service patients. Medicare Advantage is now the largest cohort of patients and a big part of the opportunity for our future expansion post-TDAPA.

TDAPA 之後我們策略的重要組成部分是與 Medicare Advantage 計劃的合作。我們目前認為，在門診環境中使用 DefenCath 的絕大多數患者都是 Medicare 按服務收費的患者。Medicare Advantage 目前是最大的患者群體，也是我們在 TDAPA 之後未來擴張的重要機會。

And you had a follow-up, Les?

萊斯，你還有後續問題嗎？

I do. It is on TDAPA actually. So is the real-world evidence data mutually inclusive with agreements on final pricing around the post-TDAPA period. Can you provide maybe some sort of a sense of your inklings into the price negotiation period into -- heading into July on the TDAPA side?

我願意。實際上，它受TDAPA監管。因此，現實世界的證據數據是否與 TDAPA 生效後時期的最終定價協議相互包含？您能否就 TDAPA 即將進入 7 月份的價格談判期，提供一些您的看法？

Well, look, if you have to separate, the real-world evidence in our view is going to be most applicable and useful with Medicare Advantage, right? Medicare Advantage is not bound by the post-TDAPA add-on. They have the flexibility to contract separately, right? That's the strategy we want to employ.

嗯，你看，如果一定要區分的話，我們認為現實世界的證據對於聯邦醫療保險優勢計劃來說最為適用和有用，對吧？Medicare Advantage 不受 TDAPA 之後附加條款的約束。他們可以靈活地單獨簽訂合同，對嗎？這就是我們想要採取的策略。

We have very little market share right now of Medicare Advantage patients, and we think it's a compelling value proposition for the MA plan. Ultimately, they are the payer of those downstream costs, those hospitalizations that drive so much cost in the health care system. So we want to -- obviously, with data, make the argument that investing in prevention, right, is going to save them a significant amount of value.

目前我們在聯邦醫療保險優勢計劃 (Medicare Advantage) 患者中的市場份額非常小，我們認為這對聯邦醫療保險優勢計劃來說是一個極具吸引力的價值主張。歸根結底，他們是這些下游成本的支付者，也就是那些推高醫療保健系統成本的住院治療費用的支付者。所以，我們顯然想用數據來論證，投資預防將會為他們節省大量的價值。

On the traditional Medicare side, there's not much of an opportunity for negotiation, Les. It's really based on when the ESRD final rule publishes what they ultimately determine is going to be the fee-for-service adjustment, and we'll work around that once it's published.

萊斯，在傳統的醫療保險方面，談判的機會不多。這實際上取決於 ESRD 最終規則何時公佈，他們最終確定的是按服務收費的調整方案，一旦公佈，我們將採取相應措施。

Jason Butler, Citizens.

傑森巴特勒，市民。

Congrats on the quarter. Two for me, Joe. First one, you mentioned that the ordering from the LDO has been faster than you'd expected. How has the use been in terms of the number of patients and the type of patients that the LDO has been using the product in?

恭喜你本季取得佳績。喬，我有兩個問題。第一個問題是，你提到從LDO訂購的速度比你預期的還要快。LDO 使用該產品的患者數量和患者類型如何？

And then secondly, when we think about the real-world data coming at the end of the year, can you just give us some color about what to expect in terms of the number of patients, the endpoints, and how we assess the benefit here relative, for example, to the Phase 3 results, if that is at all relevant?

其次，當我們考慮年底即將公佈的真實世界數據時，您能否簡要介紹一下，在患者數量、終點指標以及我們如何評估其相對於 3 期試驗結果的益處方面，我們應該期待些什麼（如果這有任何意義的話）？

All right. Thanks, Jason. So yes. So the LDO, it wasn't just a matter of ordering, right, faster, right? The data we're getting from inventory on hand demonstrates that the utilization is also faster than what we expected in the ramp.

好的。謝謝你，傑森。是的。所以，LDO 不僅僅是訂購速度的問題，對吧？我們從現有庫存中獲得的數據顯示，產能利用率也比我們預期的爬坡速度更快。

And I know that we had guided previously that the expectation was to target an initial rollout of 6,000 patients. We don't have today an exact number of where we are. We believe we are significantly higher than 6,000 patients. And we're -- so we're pleased with the rollout, but we don't have the ability to give a patient number at this time.

我知道我們之前曾表示，預計最初的目標是為 6000 名患者提供治療。我們目前還無法準確地統計我們所處的位置。我們相信我們的患者人數遠高於 6000 人。我們對推廣工作感到滿意，但目前我們無法提供患者人數。

In terms of kind of the stratification, I don't know if you were asking about high risk or type of insurance. We don't have great visibility into that data. I think our expectation is that it's mostly fee-for-service patients at this time and that there's an opportunity with Medicare Advantage.

至於分層方式，我不知道你問的是高風險族群還是特定類型的保險。我們對這些數據了解得不多。我認為我們目前的預期是，患者主要以按服務付費為主，而聯邦醫療保險優勢計劃則帶來了機會。

On the real-world evidence question, I'm going to ask Liz to address.

關於現實世界的證據問題，我將請莉茲來回答。

Sure. Jason, so we are expecting the year-one results to come out later this year. It's approximately 2,000 patients. So we're double what we had in our Phase 3 LOCK-IT study. And we expect that we're going to read out data on the reduction in actual CRBSI, reduction in hospitalizations due to CRBSI.

當然。傑森，所以我們預計第一年的結果將在今年稍後公佈。大約有2000名患者。所以，我們的人數是 LOCK-IT 第三階段研究的兩倍。我們預計我們將公佈有關實際 CRBSI 減少情況以及因 CRBSI 住院人數減少情況的數據。

There are some secondary endpoints we're looking at as well, missed-treatment sessions, utilization of TPA, and antibiotic utilization. And those are all being compared to the historic infection rates. So we should have that out sometime in the next six to seven weeks.

我們也正在關註一些次要終點，例如漏診治療、TPA 使用和抗生素使用。這些數據都將與歷史感染率進行比較。所以我們應該會在未來六到七週內發布。

Roanna Ruiz, Leerink Partners.

Roanna Ruiz，Leerink Partners。

So a couple from me. First one is, given some of the trends you're seeing in DefenCath utilization so far, how should we think about the second-half '26 revenues and pricing dynamics post-TDAPA? And what are some of the pushes and pulls that could drive DefenCath revenues either higher or lower after this TDAPA period?

我這裡也有幾個。首先，鑑於您目前看到的DefenCath使用情況的一些趨勢，我們應該如何看待TDAPA之後2026年下半年的收入和定價動態？在TDAPA期結束後，有哪些因素可能會推動DefenCath的營收上升或下降？

Thanks, Roanna. As I think I said to Les, we're not in a position to give a lot of clarity right now on that back part of '26. Obviously, we do know there's going to be price compression, right, because it's going to shift from the ASP method into the post-TDAPA add-on absent the passing of legislation that is currently pending before the Senate.

謝謝你，羅安娜。我想我跟萊斯說過，我們現在還無法就 '26 的後半部分給出太多明確的信息。顯然，我們知道價格將會受到壓縮，對吧，因為如果沒有參議院目前正在審議的立法獲得通過，價格將從 ASP 方法轉向 TDAPA 後的附加價格。

But the pushes and pulls would be related to how CMS does the calculation for utilization. The method that they had proposed in the proposed rule, which we commented on, would have created -- or will create a dynamic where the adjustment for Q3 and 4 of '26 is lower than the adjustment for '27.

但這些推拉因素與 CMS 如何計算利用率有關。他們在擬議規則中提出的方法（我們對此發表了評論）將會造成——或者將會造成一種動態，即 2026 年第三季和第四季的調整低於 2027 年的調整。

And if that's the framework, I think we're prepared to work around that. We're just waiting for a final determination in the final rule, which was expected a couple of weeks ago. I know the government shutdown has delayed quite a few things. We're expecting it to come any day now. And once we have that, we'll be able to finalize things with customers and just continue moving forward.

如果這就是既定框架，我認為我們已經準備好適應它。我們正在等待最終規則的最終決定，預計幾週前就會出台。我知道政府停擺延誤了很多事情。我們預計它隨時都會到來。一旦我們掌握了這些訊息，我們就能與客戶敲定最終事宜，並繼續推進專案。

Got it. That's helpful. And another quick follow-up for me. I was curious, with your discussions with customers into the post-TDAPA period, what are some of the goals of these discussions? And what data are you bringing forward right now to help those discussions as well?

知道了。那很有幫助。我還有一個後續問題。我很好奇，在TDAPA生效後的這段時間裡，您與客戶的討論有哪些目標？那麼，您目前提出了哪些數據來幫助這些討論呢？

Well, look, I think the real-world evidence data is going to be critical, right? And that should be the interim midpoint data available by the end of the year. And I think the ability to demonstrate the impact on the health care system is an important one.

嗯，你看，我認為現實世界的證據數據至關重要，對吧？而這應該是年底前可以公佈的中期數據。我認為能夠證明其對醫療保健系統的影響是一項重要的能力。

We've gotten anecdotal feedback from multiple customers that they've seen a noticeable difference, right, in their infection rates. I know that's not data, right? But it's -- if they are feeling it and visually seeing it, certainly that's a positive and something that we will want to build on.

我們從多位客戶那裡得到回饋，他們表示感染率明顯降低了，對吧？我知道那不是數據，對吧？但是，如果他們能感受到並且能親眼看到，那當然是正面的，也是我們想要繼續努力的方向。

Brandon Folkes, H.C. Wainwright.

布蘭登·福克斯，H.C. 溫賴特。

Congrats on all the progress. Two from me maybe, just firstly, any color on how you're viewing the DefenCath inpatient opportunity? How is that progressing? And how do you expect that to progress in '26, just given the scale and relationships that Melinta brings in that setting?

祝賀你們取得的所有進展。我可能要問兩個問題，首先，您對DefenCath住院治療的機會有什麼看法？進展如何？考慮到梅琳塔在2026年所擁有的規模和人脈關係，你認為這件事會如何發展？

And then maybe secondly, just changing gears to Niyad. How are you thinking about that investment well in Talphera, but sort of Niyad as a product? It seems like a product you can sort of simply drop into your commercial infrastructure and drive pretty strong EBITDA accretion on day one. Is that how you think about the product? Or do you think there's material investment required behind that opportunity should you execute on your option?

其次，或許可以換個話題，聊聊尼亞德。你如何看待對Talphera的投資，以及對Niyad這款產品的投資？這似乎是一款可以輕鬆融入商業基礎設施的產品，並且從第一天起就能帶來相當強勁的 EBITDA 成長。你就是這樣看待這款產品的嗎？或者，您認為如果您行使選擇權，是否需要進行實質投資？

Thank you, Brandon. So look, on the inpatient side, I think we're continuing to -- over the course of this year, we've seen good progress. I'd say it's a drop in the bucket compared to the magnitude of what we've seen outpatient, but it has been good steady growth over the course of the year.

謝謝你，布蘭登。所以你看，在住院治療方面，我認為我們今年以來一直在取得良好的進展。與我們所看到的門診病例數量相比，這只是滄海一粟，但今年以來一直保持著良好的穩定增長。

As Liz mentioned in the script, starting next year, as we are migrating from the legacy contracted field team that was inpatient for CorMedix into the new combined field team post-Melinta integration, we'll be training that team in December on DefenCath. And in January, they'll begin promoting in the inpatient segment. So I do expect to continue to see lift there as a good opportunity for growth.

正如 Liz 在劇本中提到的，從明年開始，隨著我們從 CorMedix 的傳統簽約現場團隊（負責住院病人）過渡到 Melinta 整合後的新聯合現場團隊，我們將在 12 月對該團隊進行 DefenCath 培訓。一月份，他們將開始在住院患者領域進行推廣。所以我預計那裡的電梯將繼續成為一個很好的成長機會。

As we talked a lot about over the last two years, while the inpatient volume might be lower, right, the pricing there is a little bit better and the revenue per patient higher, right? So it's a good profit opportunity, right, for DefenCath in the inpatient setting.

正如我們過去兩年經常討論的那樣，雖然住院人數可能較低，但那裡的定價稍微好一些，每位病人的收入也更高，對吧？所以對於 DefenCath 來說，在住院環境中這是一個不錯的獲利機會，對吧。

On Niyad, obviously, we did the strategic investment because we like the product. We like the fit with us from a commercial infrastructure standpoint. We're going to continue to watch the clinical results and evaluate the opportunity. I don't know that I'm prepared to comment that no investment, right, would be required, Brandon, if we were to acquire the business. Obviously, there's an investment if we were to acquire Talphera.

很顯然，我們對 Niyad 進行了戰略投資，因為我們喜歡這款產品。從商業基礎設施的角度來看，我們很滿意他們的合作。我們將繼續觀察臨床結果並評估機會。布蘭登，我不知道我是否準備好評論說，如果我們收購這家公司，就不需要任何投資，對吧。顯然，如果我們收購Talphera，就需要進行投資。

I imagine there's some amount of marketing expense related. But I think from a sales deployment standpoint, our current expectation is it fits very well with our existing call points.

我想這其中應該包含一些行銷費用。但我認為從銷售部署的角度來看，我們目前的預期是它與我們現有的通話點非常契合。

Serge Belanger, Needham & Company.

Serge Belanger，Needham & Company。

A couple for us, Joe. The first one, can you just give us an update on the pricing of DefenCath over the third quarter? And then on TDAPA, it sounds like the ESRD rule is going to determine the calculation for post period starting in July. Are you going to be able to provide guidance once the ESRD rule is published? And then secondly, are you aware of any legislation bills in Congress that could modify the TDAPA reimbursement?

喬，我們有兩個問題。第一個問題，可以跟我們介紹一下DefenCath第三季的定價嗎？至於 TDAPA，聽起來 ESRD 規則將決定 7 月開始的後續期間的計算。ESRD規則發布後，您能否提供指導？其次，您是否了解國會中是否有任何可能修改TDAPA報銷規定的法案？

All right. Thanks, Serge. In terms of specific pricing on DefenCath, obviously, we don't give that. We have guided historically that quarter over quarter, there is a slight erosion based on the structure of the agreements. We track -- typically, our ASP is a discount off -- our selling price is a discount off government ASP, which has kind of tracked down quarter over quarter, but volume has obviously grown significantly to more than offset the changes in price.

好的。謝謝你，塞爾吉。至於DefenCath的具體定價，顯然我們不予揭露。根據以往經驗，由於協議結構的原因，季度環比來看，會出現輕微的下滑。我們通常會追蹤——我們的平均售價是政府平均售價的折扣價——政府平均售價已經逐季下降，但銷量顯然大幅增長，足以抵消價格的變化。

So I think the TDAPA rule and the methodology will inform. We set agreements in place with all of our customers, right? And there were formulas laid out for how pricing needs to be determined.

所以我認為TDAPA規則和方法論會提供參考。我們與所有客戶都簽訂了協議，對嗎？而且，還有關於如何決定價格的公式。

I think one of the things we're waiting to see is that dynamic whether or not CMS uses a methodology where the Q3 and Q4 of '26 will be lower than '27. And if that's the case, we may try to negotiate a blended price over a period of time. But that's really the only nuance that we're looking at. I don't -- again, I don't know that I would want to give any customer-specific pricing, but we should be able to talk a little bit more directionally in the early part of next year about what we're going to see for the back part of the year.

我認為我們正在等待看到的一件事是，CMS 是否採用某種方法，導致 2026 年第三季和第四季的數據低於 2027 年的數據。如果情況屬實，我們可以嘗試在一段時間內協商一個混合價格。但這確實是我們唯一關注的細微差別。我不——再說一遍，我不知道我是否想給出任何針對特定客戶的定價，但我們應該能夠在明年年初更有方向性地談談我們將在今年下半年看到什麼。

And then lastly, in terms of the legislation, there is a bill that was proposed by Senator Booker, Marsha Blackburn, bi-partisan bill that would make significant changes to TDAPA in terms of incentivizing innovation. I think most importantly, it would expand the ASP-based pricing period from two years to three years. It would make the post-TDAPA add-on permanent, but also have that add-on track drug utilization in terms of that we follow drug utilization.

最後，在立法方面，布克參議員和瑪莎·布萊克本參議員提出了一項兩黨法案，該法案將對TDAPA進行重大修改，以激勵創新。我認為最重要的是，它將基於平均售價的定價週期從兩年延長至三年。這將使 TDAPA 後的附加治療永久化，但同時也要讓該附加治療追蹤藥物使用情況，以便我們追蹤藥物使用情況。

Right now, the methodology CMS uses, they bundle-ize based on market share of total dialysis, irrespective of whether drug is dispensed. The proposed methodology in the legislation would allocate that market share based on percentage of drug claims submitted over time. And I think that's certainly a better measure and hopeful that, that legislation can make its way into law in the early part of next year.

目前，CMS採用的方法是，根據透析總市場份額進行打包，而不管是否發放藥物。該立法中提出的方法將根據一段時間內提交的藥品索賠百分比來分配市場份額。我認為這無疑是一個更好的衡量標準，並希望這項立法能在明年年初成為法律。

I know the government shutdown has stalled quite a few things. But hopefully, the new Congress in early '26 can advance that forward.

我知道政府停擺導致很多事情停滯不前。但希望2026年初的新國會能推動這項進程。

I'll now pass it to Dan Ferry for written questions from the audience.

現在我將把提問環節交給丹費裡，由他來回答觀眾的書面提問。

Thank you, operator. Joe, we had quite a few here, but it looks like a lot of them were covered during the live Q&A. I do have one additional one, though that you might help us out with here.

謝謝接線生。喬，我們這裡有很多問題，但看起來很多問題在現場問答環節都已經解答過了。不過我還有一個問題，或許你可以幫我們解決一下。

What do you think is misunderstood regarding the Melinta transaction? And why are investors not crediting the value of Melinta?

您認為關於Melinta交易有哪些誤解？為什麼投資者不認可Melinta的價值？

I mean, thanks, Dan. I just chuckled a little bit because as I was going through all of the analyst questions. It struck me we didn't get a single question on REZZAYO, on the potential impact on how we're viewing Melinta, right? And I think there's obviously a lot of historic focus on DefenCath and for good reason, right? It's the largest revenue driver in the business currently.

我是說，謝謝你，丹。我當時一邊做分析師提出的問題，一邊忍不住輕笑了一聲。我突然意識到，我們竟然沒有收到一個關於 REZZAYO 的問題，也沒有收到一個關於我們如何看待 Melinta 的潛在影響的問題，對吧？我認為，歷史上人們顯然非常關注DefenCath，這是有充分理由的，對吧？它是目前公司最大的收入來源。

But when I look at what -- why we did the acquisition of Melinta, what it brings to the table, I certainly do think there's a lot of things that are not currently being appreciated. One of which is the stabilizing factor of the base business that was acquired from a risk mitigation standpoint, right? We got quite a few questions around what's going to happen in the back part of the year next year with DefenCath. And the Melinta base business gives us a good stable base of revenue from which we're able to take operating synergies and really entrench the business.

但是，當我審視我們收購 Melinta 的原因以及它能帶來什麼時，我確實認為目前有很多東西沒有得到應有的重視。其中之一是收購基礎業務以降低風險，對吧？我們收到了不少關於明年下半年DefenCath將會發生什麼的問題。Melinta 的基礎業務為我們提供了一個穩定良好的收入基礎，我們可以從中獲得營運協同效應，並真正鞏固業務。

Second, I think REZZAYO prophylaxis as a pipeline opportunity is certainly not being valued appropriately. This has the potential to be a larger peak sales product than even DefenCath, right? You've got a total addressable market over $2 billion. You've got a market segment that is already getting prophylactic antifungal therapy, right? These patients that are immune compromised. So it's not as if we have to change patterns.

其次，我認為 REZZAYO 預防藥物作為一種研發管線機會，其價值肯定沒有充分體現。這款產品有可能成為銷售量高峰超過DefenCath的產品，對吧？你的潛在市場總額超過 20 億美元。你們的目標市場中已經有一部分人正在接受預防性抗黴菌治療，對吧？這些患者免疫功能低下。所以，我們並不需要改變模式。

Similar to the launch of DefenCath, where nothing was being done prophylactically, we really had to change mindsets. This is a different situation where prophylactic action is already being taken and the standard of care has some deficiencies with it, right?

與 DefenCath 的推出類似，當時沒有任何預防措施，我們真的需要改變思考方式。這是一種不同的情況，目前已經採取了預防措施，但護理標準存在一些缺陷，對嗎？

The severe drug-drug interactions, I don't think should be discounted. The ability to shift to weekly dosing to perhaps increase convenience for the patients as well as a large amount of the dosing or administration would be in an outpatient hematology/oncology clinic setting, which is buy-and-bill reimbursement, right?

我認為不應忽視嚴重的藥物交互作用。如果能改為每週給藥，或許可以提高患者的便利性，而且大部分給藥或管理工作都可以在門診血液/腫瘤診所進行，也就是按購買和結算方式報銷，對吧？

So I think there's a lot of favorabilities and opportunity around REZZAYO prophylaxis as a future growth driver of the business as well as TPN, right? I think we're excited about the opportunity for TPN. We've just done some updated internal market research, right, that has confirmed how high the infection rates are in that patient population, how much the doctors are looking for an intervention.

所以我認為，REZZAYO 預防療法作為未來業務成長的驅動力以及 TPN，有很多有利因素和機遇，對嗎？我認為我們對TPN（全腸外營養）的機會感到興奮。我們剛剛更新了一些內部市場調查，結果證實了該患者群體中的感染率有多高，醫生們多麼渴望進行幹預。

So I think we're excited about the future growth prospects for the business outside of hemodialysis. And I think that's -- those are important catalysts that I think investors need to start focusing on.

所以我認為我們對血液透析以外的業務未來成長前景感到興奮。我認為這些都是重要的催化劑，投資人需要開始關注這些因素。

Excellent. Okay. Thank you, Joe. Operator, you may now close the call.

出色的。好的。謝謝你，喬。接線員，你可以掛斷電話了。

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

我們的問答環節到此結束。會議已經結束。感謝各位參加今天的報告會。您現在可以斷開連線了。