CorMedix Inc (CRMD) 2025 Q2 法說會逐字稿

Good day, and welcome to the CorMedix, Inc., second-quarter 2025 financial results conference call. (Operator Instructions) Please note this event is being recorded.

大家好，歡迎參加 CorMedix, Inc. 2025 年第二季財務業績電話會議。（操作員指示）請注意，此事件正在被記錄。

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

現在，我想將會議交給 LifeSci Advisors 的董事總經理 Daniel Ferry。請繼續。

Good morning, and welcome to the CorMedix second-quarter 2025 earnings and corporate update conference call.

早安，歡迎參加 CorMedix 2025 年第二季財報和公司更新電話會議。

Leading the call today is Joe Todisco, Chief Executive Officer of CorMedix, and he is joined by Dr. Matt David, Executive Vice President and CFO. In addition, Beth Zelnick Kaufman, EVP and Chief Legal and Compliance Officer; Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer, are on the line and will be available during the Q&A session.

今天主持電話會議的是 CorMedix 執行長喬·托迪斯科 (Joe Todisco)，執行副總裁兼財務長 Matt David 博士也出席了會議。此外，執行副總裁兼首席法律與合規官 Beth Zelnick Kaufman、執行副總裁兼首席臨床策略與營運長 Liz Hurlburt 以及執行副總裁兼首席商務官 Erin Mistry 也將在線，並在問答環節中提供服務。

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 facts 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.

在我們開始之前，我想提醒大家，在電話會議期間，管理階層可能會做出《1995 年私人證券訴訟改革法案》所規定意義內的前瞻性陳述。這些陳述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期望、信念、目標和計劃的陳述。由於各種重要因素，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，實際結果可能與這些聲明所依據的估計和預測存在重大差異，這些文件可在美國證券交易委員會網站上免費獲取，或應 CorMedix 的要求獲取。

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 可能無法真正實現這些前瞻性聲明中所描述的目標或計劃，投資者不應過度依賴這些聲明。CorMedix 不打算更新這些前瞻性聲明，除非法律要求。

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公認會計準則衡量指標。CorMedix 收益報告和向美國證券交易委員會提交的 8-K 表當前報告中提供了 GAAP 與非 GAAP 財務對帳和補充財務資訊。此資訊可在 CorMedix 網站的投資者關係部分找到。

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. Joe, please go ahead.

現在，我很高興將電話轉給 CorMedix 執行長喬·托迪斯科 (Joe Todisco)。喬，請繼續。喬，請繼續。

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call.

謝謝你，丹。大家早安，感謝大家參加這次電話會議。

Today, concurrent with our second-quarter earnings announcement, CorMedix announced the acquisition of Melinta Therapeutics in a combination cash and stock transaction. This deal is transformational for CorMedix, creating a fully diversified specialty pharmaceutical company with a broad portfolio of commercial and pipeline products concentrated in the acute care and anti-infectives areas. The Melinta product portfolio and existing operational infrastructure are highly synergistic with CorMedix current commercial portfolio and sales deployment and also provides an exceptional complement to future potential expanded indications for our lead product, DefenCath.

今天，與我們發布第二季度收益公告同時，CorMedix 宣布以現金和股票交易的方式收購 Melinta Therapeutics。這筆交易對 CorMedix 來說具有變革意義，它將創建一家完全多元化的專業製藥公司，擁有廣泛的商業和管道產品組合，主要集中在急性護理和抗感染領域。Melinta 產品組合和現有營運基礎設施與 CorMedix 目前的商業組合和銷售部署高度協同，同時也為我們的主要產品 DefenCath 未來潛在的擴展適應症提供了卓越的補充。

I would like to congratulate Christine Miller, Melinta Therapeutics President and CEO and her team on building such a high-performing organization with deep expertise in the hospital acute care and infectious disease arena. From a financial standpoint, Melinta adds to CorMedix a stable base of revenue for which we are currently guiding full-year 2025 Melinta revenue between $125 million and $135 million spread across multiple assets, including six commercial stage products in the acute care and infectious disease space. We see opportunities for growth from both the existing commercial assets as well as their lead pipeline drug opportunity, a potential expanded indication for REZZAYO for the prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic blood and marrow transplantation.

我要祝賀 Melinta Therapeutics 總裁兼執行長 Christine Miller 和她的團隊建立了這樣一個高績效組織，並在醫院急性護理和傳染病領域擁有深厚的專業知識。從財務角度來看，Melinta 為 CorMedix 增加了穩定的收入基礎，我們目前預計 2025 年全年 Melinta 收入將在 1.25 億美元至 1.35 億美元之間，分佈在多項資產中，包括急性護理和傳染病領域的六種商業階段產品。我們從現有商業資產及其領先的藥物管道機會中看到了成長機會，REZZAYO 的潛在擴展適應症是預防接受異基因血液和骨髓移植的成年患者的侵襲性真菌疾病。

In terms of key highlights of the transaction, the acquisition is expected to be near-term accretive with double-digit EPS accretion in 2026, and we are forecasting that will drive mid- to long-term revenue and cash flow growth. The addition of the pipeline opportunity of REZZAYO's expanded indication for prophylaxis provides a valuable growth driver of future revenue, and we estimate that if approved, peak annual sales potential in this indication could exceed $200 million. In the combined company, we also expect to capture significant near-term operating expense synergies estimated in the range of $35 million to $45 million, which will foster near-term EBITDA growth and EPS accretion.

就交易的主要亮點而言，此次收購預計將在短期內帶來增值，到 2026 年每股收益將實現兩位數成長，我們預測這將推動中長期收入和現金流成長。REZZAYO 擴大預防適應症的管道機會的增加為未來收入提供了寶貴的成長動力，我們估計，如果獲得批准，該適應症的年銷售峰值潛力可能超過 2 億美元。在合併後的公司中，我們也預計將獲得顯著的近期營運費用綜效，預計在 3,500 萬美元至 4,500 萬美元之間，這將促進近期 EBITDA 成長和 EPS 成長。

We have already submitted the necessary filings to the Federal Trade Commission in order to comply with the Hart-Scott-Rodino Act, otherwise known as HSR, and we expect to close this transaction as early as September 1, pending regulatory approval and other customary conditions of closing. The deal was structured as a combination of cash and stock with Deerfield Management Company to receive $40 million of the upfront purchase price in the form of CorMedix equity. Deerfield has also subscribed to $35 million of the $150 million debt offering executed concurrently with the transaction, which was used to fund the cash portion of the purchase price. We are excited to have Deerfield as a long-term investor in the new combined company given their long history as an investor in Melinta and in the healthcare space.

我們已經向聯邦貿易委員會提交了必要的文件，以遵守《哈特-斯科特-羅迪諾法案》（也稱為 HSR），我們預計最早將於 9 月 1 日完成這筆交易，但需獲得監管部門的批准並滿足其他慣例成交條件。該交易採用現金和股票相結合的方式，Deerfield Management Company 將以 CorMedix 股權的形式獲得 4,000 萬美元的預付購買價。迪爾菲爾德還認購了與此次交易同時執行的 1.5 億美元債務發行中的 3,500 萬美元，用於支付購買價格的現金部分。鑑於 Deerfield 作為 Melinta 和醫療保健領域長期投資者的歷史，我們很高興他們能成為新合併公司的長期投資者。

On a pro forma basis, we are guiding to full year combined 2025 revenue of $305 million to $335 million with $180 million to $200 million of contribution from DefenCath net sales. In addition, we are guiding to pro forma fully synergized adjusted EBITDA for 2025 in the range of $150 million to $170 million.

根據備考數據，我們預計 2025 年全年綜合收入為 3.05 億至 3.35 億美元，其中 DefenCath 淨銷售額貢獻 1.8 億至 2 億美元。此外，我們預計 2025 年完全協同調整後的 EBITDA 將在 1.5 億美元至 1.7 億美元之間。

Turning now to the CorMedix business and our second-quarter updates. We were excited to announce a few weeks ago that our LDO customer initiated purchases of DefenCath, and we can now confirm that they have initiated utilization in patients beginning in early July. Based upon feedback from the LDO, their rollout plan involved a limited clinic rollout for the month of July to establish workflow practices and a system-wide rollout that is taking place this week across all of their more than 2,000 clinics. We expect the system-wide rollout to initially target approximately 6,000 patients. However, we do not yet have visibility from the LDO into the pace for that rollout. As we get more information and better visibility from our LDO partner, we will update investors accordingly.

現在來談談 CorMedix 業務和我們的第二季更新。幾週前，我們很高興地宣布，我們的 LDO 客戶開始購買 DefenCath，現在我們可以確認他們已從 7 月初開始在患者身上使用。根據 LDO 的回饋，他們的推廣計劃包括在 7 月在有限的診所內推廣，以建立工作流程實踐，並在本週在其所有 2,000 多家診所內進行全系統推廣。我們預計全系統推廣最初將涵蓋約 6,000 名患者。然而，我們尚未從 LDO 了解推出的速度。隨著我們從 LDO 合作夥伴那裡獲得更多資訊和更好的知名度，我們將相應地向投資者更新資訊。

On the clinical front, we have made great progress on our Phase 3 study for DefenCath in the reduction of CLABSI in adult patients receiving parental nutrition through a CVC. We now have multiple sites up and running and patients enrolled, and we are on track to complete the study and submit the NDA in the late 2026 to early 2027 timeframe. We have also begun enrollment in our pediatric study for the reduction in CRBSI in pediatric patients undergoing hemodialysis through a CVC, with the first patient expected to begin dosing in August.

在臨床方面，我們在 DefenCath 的 3 期研究中取得了巨大進展，該研究旨在減少透過 CVC 接受腸外營養的成年患者的 CLABSI。我們目前已有多個站點投入營運並招募患者，我們預計在 2026 年底至 2027 年初完成研究並提交 NDA。我們也開始招募兒科研究對象，以減少透過 CVC 進行血液透析的兒科患者的 CRBSI，預計第一位患者將於 8 月開始服藥。

Lastly, we have made the decision to perform an interim analysis of our real-world evidence study with US Renal Care and hope to be in a position to provide interim data by the end of 2025. This is significant as we aim to evaluate patient outcomes and the impact of DefenCath utilization on the cost of patient care, infection rates, hospitalizations, and mortality, all metrics that are critical to our goal of making DefenCath the standard of care for the reduction of bloodstream infections in patients getting hemodialysis through a CVC.

最後，我們決定與美國腎臟護理中心合作對我們的真實世界證據研究進行中期分析，並希望能夠在 2025 年底之前提供中期數據。這很重要，因為我們的目標是評估患者的治療結果以及 DefenCath 的使用對患者護理成本、感染率、住院率和死亡率的影響，所有這些指標對於我們實現使 DefenCath 成為透過 CVC 進行血液透析的患者血流感染減少的護理標準的目標都至關重要。

I'd now like to turn the call over to Matt to discuss the company's second-quarter financial results and financial position. Matt?

現在我想把電話轉給馬特，討論公司第二季的財務表現和財務狀況。馬特？

Thanks, Joe, and good morning, everyone. I'm excited to be here today to provide an overview of our second-quarter 2025 financial results as well as an update on CorMedix's cash position and recent financing activities. The company will soon file its quarterly report on Form 10-Q for the quarter ended June 30, 2025. I urge you to read the information contained in the report for a more complete discussion of our financial results.

謝謝，喬，大家早安。我很高興今天能在這裡概述我們的 2025 年第二季財務業績以及 CorMedix 的現金狀況和近期融資活動的最新情況。該公司將很快提交截至 2025 年 6 月 30 日的 10-Q 表格季度報告。我建議您閱讀報告中包含的信息，以便更全面地討論我們的財務結果。

With respect to our second quarter of 2025 financial results, our net revenue for the second quarter of 2025 amounted to $39.7 million. Our net income was approximately $19.8 million or $0.29 per share compared with a net loss of $14.2 million or $0.25 per share in the second quarter of 2024. The positive net income recognized in 2025 was driven by commercial sales of DefenCath. Operating expenses in the second quarter of 2025 increased approximately 18% to $18.3 million compared with $15.6 million in the second quarter of 2024. R&D expense increased by approximately 275% to $2.4 million, primarily driven by increases in personnel and clinical trial services in support of the ongoing clinical studies.

關於我們 2025 年第二季的財務業績，我們 2025 年第二季的淨收入為 3,970 萬美元。我們的淨收入約為 1,980 萬美元或每股 0.29 美元，而 2024 年第二季的淨虧損為 1,420 萬美元或每股 0.25 美元。2025 年實現的正淨收入是由 DefenCath 的商業銷售所推動的。2025 年第二季的營運費用與 2024 年第二季的 1,560 萬美元相比成長約 18%，達到 1,830 萬美元。研發費用增加了約 275%，達到 240 萬美元，主要原因是支持正在進行的臨床研究的人員和臨床試驗服務的增加。

Selling and marketing expense decreased 14% to $6.4 million in the second quarter of 2025 compared with $7.4 million in second quarter of 2024. G&A expense increased 25% to $9.5 million in the second quarter of 2025 versus $7.6 million in second quarter of 2024. The decrease in selling and marketing expense was attributable primarily to marketing costs related to the commercial launch of DefenCath. The increase in G&A expense was primarily driven by the noncash charges for stock-based compensation and an increase in costs related to business development. We recorded net cash provided by operating activities during the second quarter of 2025 of $30 million compared with net cash used in operations of $14 million in the second quarter of 2024.

2025 年第二季的銷售和行銷費用為 640 萬美元，而 2024 年第二季為 740 萬美元，下降 14%。2025 年第二季的一般及行政費用 (G&A) 成長 25%，達到 950 萬美元，而 2024 年第二季為 760 萬美元。銷售和行銷費用的減少主要歸因於與 DefenCath 商業發布相關的行銷成本。一般及行政費用的增加主要是由於股票薪酬的非現金費用以及與業務發展相關的成本增加。我們記錄了 2025 年第二季經營活動提供的淨現金為 3,000 萬美元，而 2024 年第二季經營活動所使用的淨現金為 1,400 萬美元。

The increase is primarily driven by net income for the period versus a net loss in the prior comparison period and a decrease in trade receivables. On June 27, CorMedix announced the pricing of an underwritten public offering of common stock for which we received net proceeds of $82.4 million. We noted in the press release at the time that the use of proceeds from the offering included general corporate purposes, expenses related to R&D, and potential strategic transactions that complement CorMedix's business. In addition to strengthening our balance sheet, the transaction included a number of high-quality new and existing investors. Concurrent with our announcement today of the acquisition of Melinta Therapeutics, we are also announcing the pricing of $150 million convertible debt offering with use of proceeds to fund the acquisition of Melinta.

成長的主要原因是本期淨收入與上一比較期淨虧損以及應收貿易款減少有關。6 月 27 日，CorMedix 宣布了普通股承銷公開發行的定價，我們獲得的淨收益為 8,240 萬美元。我們在當時的新聞稿中指出，發行所得款項的用途包括一般公司用途、與研發相關的費用以及補充 CorMedix 業務的潛在策略交易。除了加強我們的資產負債表之外，此次交易還吸引了許多高品質的新投資者和現有投資者。今天，在我們宣布收購 Melinta Therapeutics 的同時，我們也宣布發行 1.5 億美元可轉換債券，並將所得款項用於收購 Melinta。

The key terms of the convertible debt are five-year tenor with a 4% annual coupon and priced at a premium of 30%. In addition to Deerfield, the investors include a small group of high-quality life sciences institutional and convertible debt investors. As reported today, CorMedix has cash and cash equivalents of $190.7 million as of June 30, 2025. The company expects to use approximately $110 million of cash on hand in addition to the convertible debt proceeds to fund the upfront portion of the purchase price in the acquisition. While CorMedix on a stand-alone basis continues to track toward the low end of previously guided cash OpEx, we expect to issue updated guidance over the coming months for the combined entity.

可轉換債券的主要條款為五年期，年票面利率為 4%，溢價 30%。除了迪爾菲爾德之外，投資者還包括一小群高品質的生命科學機構和可轉換債務投資者。根據今天報道，截至 2025 年 6 月 30 日，CorMedix 的現金和現金等價物為 1.907 億美元。該公司預計，除了可轉換債務收益外，還將使用約 1.1 億美元的現金來支付收購價的前期部分。雖然 CorMedix 的獨立營運支出繼續接近先前指導的現金營運支出的低端，但我們預計將在未來幾個月內為合併後的實體發布更新的指導。

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

現在我將把電話轉回給喬，請他做最後發言。喬？

Thanks, Matt. CorMedix is now firing on all cylinders with the implementation by our LDO customer commencing in July and the acquisition of Melinta targeted for closing in September. We intend to provide additional updates on the integration with Melinta over the coming months. We are excited about the platform we are creating for future growth and the opportunity to continue to create shareholder value.

謝謝，馬特。CorMedix 目前正全力以赴，我們的 LDO 客戶將於 7 月開始實施，而對 Melinta 的收購預計將於 9 月完成。我們打算在未來幾個月內提供更多與 Melinta 整合的更新。我們對為未來成長而創建的平台以及繼續創造股東價值的機會感到非常興奮。

I appreciate everyone's continued support in CorMedix, and I'm happy to take questions.

我感謝大家對 CorMedix 的持續支持，並且很樂意回答問題。

(Operator Instructions) Leonid Timashev, RBC Capital Markets.

（操作員指示）Leonid Timashev，RBC Capital Markets。

It's Anish on for Leo. Congrats on the progress this quarter and the deal with Melinta. Just a couple of quick questions from us. First, if you could just talk to us about the guidance dynamics, how you're getting to the $180 million to $200 million range for DefenCath and what the sensitivities are there? And second, just quickly on Melinta, how are you thinking about the potential risks to the ongoing BARDA collaborations given the current policy and regulatory environment?

阿尼什 (Anish) 取代利奧 (Leo)。恭喜本季取得的進展以及與 Melinta 的交易。我們只想問幾個簡單的問題。首先，您能否與我們談談指導動態，您如何將 DefenCath 的估值定在 1.8 億至 2 億美元之間，以及其中的敏感度是什麼？其次，關於 Melinta，您如何看待當前政策和監管環境下正在進行的 BARDA 合作的潛在風險？

Look, so in terms of putting the guidance together, which to reiterate for DefenCath, we're guiding revenue in the $180 million to $200 million range. It's based on what we see today in terms of customer orders and our estimation for what we think is a conservative ramp towards the back part of the year, right? We have some visibility, but not full visibility yet of what we think the LDO could convert in the coming months.

看起來，就制定指導方針而言，對於 DefenCath 重申一下，我們指導的收入在 1.8 億美元到 2 億美元之間。這是基於我們今天看到的客戶訂單情況以及我們對今年下半年保守增長的估計，對嗎？我們對於 LDO 在未來幾個月內可能實現的轉換有一些了解，但還不完全清楚。

But obviously, we want to give ourselves room, right? We do think there's potential upside, but this is where we are comfortable today establishing guidance at this part -- this point in the year. Look, in terms of risk from a BARDA standpoint, certainly, as we look at the value that Melinta brings, and I'm going to go through a couple of things. We view the collaboration with BARDA as upside potential, not really something that underwrote the value of the deal. So to that extent, not a tremendous amount of concern on our part in terms of what's driving the value of this transaction for CorMedix.

但顯然，我們想給自己留出空間，對吧？我們確實認為存在潛在的上升空間，但這是我們今天在這個階段（今年的這個時候）制定指導意見時感到滿意的。從 BARDA 的角度來看風險，當然，當我們看看 Melinta 帶來的價值時，我將討論幾件事。我們認為與 BARDA 的合作具有上升潛力，但並不真正保證交易的價值。因此，從這個程度上來說，我們並不太擔心是什麼推動了 CorMedix 這次交易的價值。

I mean, let's -- first and foremost, right, this diversifies our revenue base and gives us a stable base of revenue. It's expected to be near term and possibly immediately accretive depending on how quickly we can start to capture synergies, which we will get a sense for in the upcoming weeks. It's highly synergistic and not just from a operational overlap standpoint, but from a strategic direction standpoint and where we want to take DefenCath in terms of future indications, their additional potential indication for REZZAYO expands our pipeline, gives us multiple shots on goal, gives us an asset with significant growth potential. And from a valuation standpoint, I think this is a very attractive post-synergy valuation deal multiple for us, right, given the growth potential of the platform and the other assets.

我的意思是，首先，這使我們的收入基礎多樣化，並為我們提供穩定的收入基礎。預計這將是短期的，並且可能立即產生增值，這取決於我們能夠多快開始捕捉協同效應，我們將在接下來的幾週內對此有所了解。它具有高度的協同作用，不僅從營運重疊的角度來看，而且從戰略方向的角度來看，以及我們希望在未來的適應症方面採用 DefenCath 的地方，它們對 REZZAYO 的額外潛在適應症擴大了我們的產品線，為我們提供了多個目標，為我們提供了具有巨大增長潛力的資產。從估值的角度來看，考慮到平台和其他資產的成長潛力，我認為這對我們來說是一個非常有吸引力的協同效應後估值交易倍數。

And not to be overlooked, they have a very strong and established team in the hospital and acute care arena, right? So this -- when we have been talking over the last month about the types of transactions we would consider, this really checks all the boxes and then some, right? So we are super thrilled with the transaction, and this is absolutely transformational for us.

而且不容忽視的是，他們在醫院和急性護理領域擁有一支非常強大且成熟的團隊，對嗎？所以這個——當我們上個月談論我們會考慮的交易類型時，這確實檢查了所有的箱子，然後是一些，對吧？所以我們對這筆交易感到非常興奮，這對我們來說絕對是一個改變。

Jason Butler, Citizens.

傑森·巴特勒，公民。

Let me add my congrats on the quarter and the acquisition. Joe, could you talk to us a little bit about the growth potential of the current approved portfolio commercial profile of the Melinta assets?

讓我對本季和此次收購表示祝賀。喬，您能否向我們簡單介紹一下 Melinta 資產目前已獲批准的投資組合商業概況的成長潛力？

Sure. Is that the -- are you going to have any follow-ups, Jason? Is that the --

當然。這是──你還有什麼後續問題嗎，傑森？那是--

Yeah, sure.

是的，當然。

Okay. All right.

好的。好的。

And then just in terms of your commercial infrastructure in the hospital setting, how should we think about what Melinta looks like today and what the combined company will look like as a footprint targeting the hospital setting?

那麼，就您在醫院環境中的商業基礎設施而言，我們應該如何看待 Melinta 目前的狀況以及合併後的公司作為針對醫院環境的足跡將會是什麼樣子？

That's fair. Okay. That's good. Look, in terms of the growth of the existing portfolio, there's absolutely growth potential there. Certainly, we see it with REZZAYO in the treatment space for its current indication for MINOCIN, a little bit for VABOMERE and for ORBACTIV and KIMYRSA.

這很公平。好的。那挺好的。從現有投資組合的成長來看，絕對存在成長潛力。當然，我們看到 REZZAYO 在治療領域有其應用，其目前的適應症為 MINOCIN，少量用於 VABOMERE 以及 ORBACTIV 和 KIMYRSA。

So the biggest growth driver, obviously, is the potential expanded indication for REZZAYO. We do think BAXDELA and VABOMERE have upside as part of that BARDA collaboration that I mentioned, but that's not something that we've really incorporated into our valuation to underwrite the deal.

因此，最大的成長動力顯然是 REZZAYO 的潛在擴大適應症。我們確實認為 BAXDELA 和 VABOMERE 作為我提到的 BARDA 合作的一部分具有優勢，但這並不是我們真正納入估值以承銷該交易的內容。

Look, from a commercial synergy and overlap standpoint on that side, that's something we're going to look at over the next couple of weeks and see what makes the most sense from a structure standpoint. Obviously, we've got a strong team. They've got a strong team. We want to look at the best ways to put these two together and put them together in a way that makes the most sense for the organization.

從商業協同和重疊的角度來看，我們將在接下來的幾週內研究這個問題，看看從結構的角度來看什麼是最有意義的。顯然，我們擁有一支強大的團隊。他們有一支強大的隊伍。我們希望找到將這兩者結合起來的最佳方法，並以對組織最有意義的方式將它們結合起來。

Les Sulewski, Truist.

Les Sulewski，Truist。

A couple for me. Just provide perhaps, Joe, a little bit of a background on the Melinta transaction, specifically if there was a competitive process. And then second, across their portfolio of products, how competitive is this space either from branded and other or generic offerings?

對我來說是一對。喬，也許請提供一些有關 Melinta 交易的背景信息，特別是是否存在競爭過程。其次，在他們的產品組合中，這個領域與品牌產品、其他產品或通用產品的競爭力如何？

And then second, on the integration and the synergies, what sort of integration expenses can we assume for this year and the progress within your Syneos sales team in inpatient side? Is this something that could be multiple product offerings, including DefenCath with Melinta on board?

其次，關於整合和綜效，我們可以假設今年的整合費用是多少，以及您的 Syneos 銷售團隊在住院方面取得了哪些進展？這是否可以是多種產品組合，包括與 Melinta 合作的 DefenCath？

You went through those quick, and I think I wrote them down and got them. Look, in terms of the background on the process, yes, this was a competitive auction process, which we understand there were multiple bidders involved. There were multiple rounds of bidding. And we participated in that process, right?

你很快就看完了這些，我想我已經把它們記下來並拿到了。從流程背景來看，是的，這是一個競爭性拍賣過程，據我們了解有多個競標者參與。經過多輪競標。我們參與了這個過程，對嗎？

I'm not sure how much more detail you're looking for on that front. But from a portfolio and competitive standpoint, obviously, the anti-infective space, certainly, those that are used on the inpatient setting, yes, it is competitive. There's typically a triage that infectious disease docs go through likely using less expensive generics first before getting to newer branded products. That's a known dynamic of that space, right?

我不確定您在這方面需要多少詳細資訊。但從產品組合和競爭的角度來看，顯然，抗感染領域，當然，那些用於住院治療的領域，是的，是有競爭力的。傳染病醫生通常會進行分類，首先使用較便宜的仿製藥，然後再使用較新的品牌產品。這是該空間已知的動態，對嗎？

I think one of the things that makes the expanded indication for REZZAYO so attractive is that it's used in the outpatient setting, right, in the largely infusion clinics, oncology clinics, where, right, it's not inpatient DRG reimbursement, but outpatient buy-and-bill reimbursement. So that is certainly an attractive opportunity from that standpoint. In terms of integration expenses, we're not guiding on that at this time, and perhaps we'll provide more color once we are post close.

我認為 REZZAYO 擴大適應症如此有吸引力的原因之一是它用於門診環境，對，在主要是輸液診所、腫瘤診所，對，它不是住院 DRG 報銷，而是門診買單報銷。從這個角度來看，這無疑是一個有吸引力的機會。至於整合費用，我們目前還沒有給出指導，也許我們會在交易結束後提供更多資訊。

And then I think in terms of the operational synergies with our existing team, I somewhat touched on that with -- I think it was Jason's last question, right, we're going to look at that over the coming weeks. We think we have a very strong team. We know that they have a very strong organization, and we're going to look at the best ways to put these two together.

然後我認為就與我們現有團隊的營運協同作用而言，我在某種程度上觸及了這一點 - 我想這是傑森的最後一個問題，對，我們將在接下來的幾週內研究這個問題。我們認為我們擁有一支非常強大的團隊。我們知道他們有一個非常強大的組織，我們將尋找將兩者結合的最佳方法。

Roanna Ruiz, Leerink.

Roanna Ruiz，Leerink。

This is Mazi on for Roanna Ruiz. So I guess just building on the Melinta acquisition. So what key asset that you're acquiring are you most excited about?

這是 Mazi 為 Roanna Ruiz 表演的。所以我猜這只是基於 Melinta 收購。那麼，對於您所收購的哪一項關鍵資產，您最興奮呢？

And then secondly, I guess, beyond the Melinta acquisition, how are you thinking about capital allocation? Are there other strategic opportunities you're evaluating? And I guess big picture, what's your philosophy on returning cash to shareholders versus reinvesting for future growth?

其次，我想，除了收購 Melinta 之外，您如何考慮資本配置？您是否正在評估其他策略機會？我想從總體上看，您對向股東返還現金與為未來成長進行再投資的理念是什麼？

So -- and so I guess in terms of the asset I'm most excited about, it's kind of like being asked to pick your favorite kid. But certainly, I think the expanded indication for REZZAYO, right, has huge or potential upside, right, that is attractive to us and that we are very excited about. But certainly, as I said before, the full portfolio of assets largely diversifies our revenue base and adds right, stability as well as growth. And that's highly attractive to us as an organization.

所以——所以我想就我最興奮的資產而言，這有點像被要求挑選你最喜歡的孩子。但可以肯定的是，我認為 REZZAYO 的擴大適應症具有巨大或潛在的上升空間，這對我們很有吸引力，我們對此感到非常興奮。但正如我之前所說，完整的資產組合在很大程度上使我們的收入基礎多樣化，並增加了權利、穩定性和成長。這對我們這個組織來說非常有吸引力。

And I think your -- the second question was kind of like a combination of capital allocation/business development question. And yes, we certainly are -- once we get a chance to catch our breath, willing to start looking at other opportunities. that would be, again, highly synergistic with the organization, near-term accretive, right? These are the criteria that we've kind of long established that -- of what the deals we are looking at or willing to look at right now should be, right, in terms of generating near-term value for shareholders, right? That is a big focus.

我認為你的第二個問題有點像是資本配置/業務發展問題的結合。是的，我們確實會這樣做——一旦我們有機會喘口氣，就願意開始尋找其他機會。這將再次與組織產生高度協同作用，實現短期增值，對嗎？這些是我們早已確定的標準——就為股東創造短期價值而言，我們現在正在考慮或願意考慮的交易應該是什麼樣的，對嗎？這是一個重點。

And that's the primary focus right now as opposed to looking at a future dividend policy. So that's where we stand today.

這是目前的主要關注點，而不是考慮未來的股利政策。這就是我們今天的立場。

Brandon Folkes, H.C. Wainwright.

布蘭登福克斯、H.C. 溫賴特。

Congratulations on the deal and the quarter. Maybe just following on from the prior question. As you take these steps to build a specialty pharma company, how do you look at the post-close commercial infrastructure you will have? I guess, twofold. One, especially in terms of adding TPN to the bag, do you think TPN now potentially largely drops to the bottom line?

恭喜這筆交易和本季的順利完成。也許只是接著上一個問題。當您採取這些步驟建立專業製藥公司時，您如何看待公司收購後將擁有的商業基礎設施？我想，是雙重的。第一，特別是在將 TPN 添加到袋子中方面，您是否認為 TPN 現在有可能大幅下降到底線？

And then as you go forward and do add potential additional products, how do you feel about the number of products in the acute care reps bags today versus additional acquisitions coming with additional sales force versus just the bringing in products to the combined commercial infrastructure?

然後，隨著您繼續前進並添加潛在的附加產品，您對目前急性護理代表包中的產品數量、額外收購帶來的額外銷售隊伍以及僅將產品引入合併的商業基礎設施有何看法？

That's fair. So I think, again, a lot of the -- I guess, the first part of that question, I somewhat answered to Jason Butler. I'll reiterate that, as I said, we think both teams are incredibly strong. We're going to look at how to put them together. Now I think in terms of the Melinta team, you hit the nail on the head.

這很公平。所以我再次認為，很多——我想，這個問題的第一部分，我在某種程度上回答了傑森·巴特勒。我重申一下，正如我所說，我們認為兩支球隊都非常強大。我們將研究如何將它們組合在一起。現在我認為，就 Melinta 團隊而言，你說得一針見血。

The TP -- the potential TPN indication fits very well within their existing sales deployment as well as with our hospital sales deployment. In terms of how many, right, products a typical account manager can carry in their bag, I think it varies.

TP——潛在的 TPN 適應症非常適合他們現有的銷售部署以及我們醫院的銷售部署。至於典型的客戶經理可以攜帶多少產品，我認為這是不同的。

And at all points in time, every product is not necessarily getting the same amount and level of attention in a detail, right? There's products that will be fairly stable without significant promotion and others that require right, significant effort and constant education. So it's going to be a mix. This is something that we're going to work on quite intensely in the upcoming months and put together an organization, right, that is strong and positioned for growth.

並且在任何時間點，每個產品不一定都會在細節上獲得相同數量和程度的關注，對嗎？有些產品無需大力推廣就能相當穩定，而有些產品則需要正確、大量的努力和持續的教育。所以這將是一個混合體。在接下來的幾個月裡，我們將非常努力地進行這項工作，並組成一個強大且具有成長潛力的組織。

And maybe just one follow-up, if I may, just coming back to DefenCath. Any additional color, and I understand if you can't, what you contemplate in terms of the LDO ordering in your updated guidance? And then secondly, is the outpatient setting for DefenCath now a little bit more hands off and you as a company can focus more on the inpatient setting? Or is there still sort of quite a high touch in that outpatient setting as well as you grow the inpatient setting? That's all for me.

如果可以的話，也許我只想跟進一下，回到 DefenCath。還有什麼其他細節嗎？如果您不能，我理解，您在更新的指南中對 LDO 訂購有何考慮？其次，DefenCath 的門診設置現在是否不再那麼重要了，而你們作為一家公司是否可以更專注於住院設置？或者，在擴大住院治療的同時，門診治療是否仍具有相當高的接觸率？對我來說就這些了。

Yes. Look, I'll take the second question first, actually. In terms of -- I think you're guiding -- you're asking about kind of sales and marketing effort. And I think you're right. In the outpatient setting, as I said, I think on some prior calls, it's a smaller footprint that's needed.

是的。瞧，實際上，我先回答第二個問題。就——我認為你在引導——你問的是銷售和行銷工作的類型。我認為你是對的。正如我所說，在門診環境中，我認為根據之前的一些電話，需要的只是較小的佔地面積。

It is less of a touch point. It's more key account management at a very high level within these organizations. But there's still effort. And there's also, right, smaller dialysis operators are out there, and we have a small targeted team that is working on those accounts. Right, in terms of additional color on kind of LDO ramp, as I said in, I think one of the earlier questions, we've based our guidance on what we think is a conservative ramp with the information that we have.

它不是一個接觸點。這些組織內部更高層次的關鍵客戶管理更為重要。但還是需要努力。而且，還有一些規模較小的透析業者，我們有一個小型目標團隊負責這些帳戶。是的，就 LDO 斜坡的附加顏色而言，正如我之前所說的那樣，我認為在之前的一個問題中，我們根據所掌握的信息，根據我們認為的保守斜坡做出了指導。

We've left ourselves, we think, meaningful room for upside, right, as we evaluate orders over the upcoming weeks. But we're very comfortable with the range that has been set based on the information we have today.

我們認為，當我們評估未來幾週的訂單時，我們已經為自己留下了相當大的上漲空間。但我們對根據目前掌握的資訊所設定的範圍感到非常滿意。

Serge Belanger, Needham & Company.

塞爾日·貝朗格（Serge Belanger），Needham & Company。

Congrats on the acquisition. Obviously, a big day for CorMedix. First question, regarding the Melinta portfolio, I think you highlighted six to seven products. Can you just maybe talk about which are the key ones that are generating the growth for this portfolio? Second question, it sounds like the REZZAYO label expansion opportunity is a significant potential upside for the potential of this product.

祝賀收購成功。顯然，這對 CorMedix 來說是一個重要的日子。第一個問題，關於 Melinta 產品組合，我認為您重點介紹了六到七種產品。您能否談談哪些是推動該投資組合成長的關鍵因素？第二個問題，聽起來 REZZAYO 標籤擴展機會對於該產品的潛力具有重大的潛在優勢。

Can you just maybe talk about this Phase 3 trial, when you expect results and maybe what the outcome needs to be to be successful? And then lastly, on DefenCath, any additional progress regarding the remaining LDO customer?

您能否談談這項第三階段試驗，您預計何時會出現結果，以及需要什麼樣的結果才能成功？最後，關於 DefenCath，關於剩餘的 LDO 客戶還有其他進展嗎？

Thanks, Serge. Look, as we get through closing, we'll obviously give more guidance -- directional guidance on each of the products, right? So we've just now announced the transaction. Big picture on the portfolio, as I mentioned earlier, in terms of the approved products, obviously, REZZAYO, MINOCIN, VABOMERE, right, the ORBACTIV commercial franchise, all opportunities, right, for growth. BAXDELA, right, is a fairly small product. I think you all have access to IQVIA data.

謝謝，塞爾吉。你看，當我們完成收尾工作時，我們顯然會給予更多的指導——對每種產品的方向性指導，對嗎？所以我們剛剛宣布了這項交易。正如我之前提到的，就產品組合的總體情況而言，就已批准的產品而言，顯然有 REZZAYO、MINOCIN、VABOMERE、ORBACTIV 商業特許經營權，所有機會，對，都有增長的潛力。BAXDELA（右）是一款相當小的產品。我認為你們都可以存取 IQVIA 資料。

You can see it's right now, a very small sales contributor, but something like that, that is actively part of that BARDA agreement has potential upside right down the road. In terms of the label expansion, the Phase III study is expected to complete in the first part of 2026. I don't have a commitment date for when that data will be available. The study is being run in collaboration with Melinta's partner, Mundipharma. And when we have more information, we'll certainly be able to share that.

您可以看到，它現在對銷售額的貢獻非常小，但作為 BARDA 協議的積極組成部分，它在未來具有潛在的上升空間。在標籤擴展方面，第三階段研究預計將於 2026 年上半年完成。我沒有確定何時可以發布這些數據的承諾日期。該研究由 Melinta 與合作夥伴 Mundipharma 合作進行。當我們獲得更多資訊時，我們一定能夠分享。

In terms of the other LDO customer, I would say that, as I mentioned on the last call, right, once we operationalized our existing LDO, we would attempt to resume discussions. And I'd say that's the stage that we're at. And as we make progress, we'll provide updates.

關於其他 LDO 客戶，我想說，正如我在上次電話會議中提到的那樣，一旦我們投入使用現有的 LDO，我們就會嘗試恢復討論。我想說這就是我們所處的階段。隨著我們取得進展，我們將提供更新資訊。

Thank you. That concludes the question-and-answer session as well as the event. Thank you so much for attending today's presentation. You may now disconnect your phone lines.

謝謝。問答環節和活動到此結束。非常感謝您參加今天的演講。您現在可以斷開電話線。