CorMedix Inc (CRMD) 2024 Q1 法說會逐字稿

Good morning, and welcome to the CorMedix first-quarter-2024 earnings conference call. Today's conference call is being recorded. There will be a question-and-answer session at the end of today's presentation, and instructions on how to ask a question will be given at that time. At this time, I would like to turn the call over to Dan Ferry from LifeSci Advisors. Please go ahead.

早安，歡迎參加 CorMedix 2024 年第一季財報電話會議。今天的電話會議正在錄音。今天的演講結束時將有一個問答環節，屆時將給出如何提問的說明。此時，我想將電話轉給 LifeSci Advisors 的 Dan Ferry。請繼續。

Good morning. And welcome to the CorMedix first-quarter-2024 earnings conference call. 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; Beth Zelnick Kaufman, EVP and Chief Legal Officer; Liz Hurlburt, EVP and Chief Clinical Strategy and Operations Officer; and Erin Mistry, EVP and Chief Commercial Officer.

早安.歡迎參加 CorMedix 2024 年第一季財報電話會議。今天主持電話會議的是 CorMedix 執行長 Joe Todisco；執行副總裁兼財務長 Matt David 博士也加入其中； Beth Zelnick Kaufman，執行副總裁兼首席法務長； Liz Hurlburt，執行副總裁兼首席臨床策略和營運長；和艾琳·米斯特里（Erin Mistry），執行副總裁兼首席商務官。

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.

在開始之前，我想提醒大家，在電話會議期間，管理階層可能會做出 1995 年《私人證券訴訟改革法案》規定的所謂前瞻性陳述。這些陳述不是關於管理階層對公司前景和未來財務狀況的預期、信念、目標和計劃的歷史事實陳述。

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's filings with the SEC, which are available free of charge at the SEC's Web site or upon request from CorMedix. 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.

由於各種重要因素，實際結果可能與這些陳述所依據的估計和預測有重大差異。 ——包括 CorMedix 向 SEC 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 SEC 網站上免費取得或應 CorMedix 的要求提供。CorMedix 實際上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。CorMedix 不打算更新這些前瞻性陳述，除非法律要求。

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

此時此刻，我很高興將電話轉給 CorMedix 執行長 Joe Todisco。喬，請繼續。

Thank you, Dan. Good morning, everyone, and thank you for joining us on this call. Though it has only been two months since our full-year earnings call back in March, the company has achieved a number of key milestones. Most notably, CMS approval of the DefenCath HCPCS J-code application and subsequent determination that DefenCath is eligible for a transitional drug add-on payment adjustment to the ESRD bundle for outpatient reimbursement with a July 1, 2024, effective date.

謝謝你，丹。大家早安，感謝您參加我們的這次電話會議。儘管距離我們三月的全年財報電話會議才過去兩個月，但該公司已經實現了許多關鍵的里程碑。最值得注意的是，CMS 批准了 DefenCath HCPCS J 代碼申請，並隨後確定 DefenCath 有資格獲得 ESRD 套餐的過渡性藥物附加付款調整，以進行門診報銷，生效日期為 2024 年 7 月 1 日。

Most importantly, we have commenced the commercial launch of DefenCath in the inpatient setting, an important milestone for CorMedix and for patients undergoing chronic hemodialysis who are at risk for a catheter-related bloodstream infection. I would like to thank and congratulate the countless individuals, including CorMedix employees, contractors and consultants who worked tirelessly over the last decade to bring this innovative drug product to patients in need.

最重要的是，我們已經開始在住院患者環境中商業化推出 DefenCath，這對於 CorMedix 以及對於有導管相關血流感染風險的接受慢性血液透析的患者來說是一個重要的里程碑。我要感謝並祝賀無數個人，包括 CorMedix 員工、承包商和顧問，他們在過去十年中不知疲倦地工作，將這種創新藥物產品帶給有需要的患者。

Our field team has been actively engaged in discussions with numerous hospitals and health systems in the inpatient setting, and I'm pleased with the progress we've made in only a few weeks of field deployment. Our initial core focus is targeting approximately 900 hospital facilities where those facilities are responsible for roughly 65% of inpatient dialysis procedures in the US. As a frame of reference, this represents only about 12% of US hospitals, but accounts for the majority of the potential DefenCath inpatient market opportunity.

我們的現場團隊一直在積極與住院環境中的眾多醫院和衛生系統進行討論，我對我們在短短幾週的現場部署中取得的進展感到高興。我們最初的核心目標是大約 900 家醫院設施，這些設施負責美國約 65% 的住院病患透析程序。作為參考，這僅占美國醫院的 12% 左右，但佔據了 DefenCath 潛在住院市場機會的大部分。

Our field team has met with more than half of our targeted institutions. And as of today, roughly 50 key accounts representing more than 200 individual hospitals have recommended DefenCath for formulary review in the coming months at their respective institutions. In addition, a few hospitals have already added DefenCath on a non-formulary basis, while P&T formulary review remains pending.

我們的現場團隊已經與超過一半的目標機構進行了會面。截至今天，代表 200 多家醫院的大約 50 個重要客戶已推薦 DefenCath 在未來幾個月在各自的機構進行處方審查。此外，一些醫院已經在非處方基礎上添加了 DefenCath，而 P&T 處方審查仍在等待中。

As we have communicated previously, the inpatient process to obtain formulary inclusion followed by facility adoption and product orders can span several months. To that extent, we have guided that we do not expect material inpatient sales in the second quarter, and we'll look for inpatient uptake to increase as we move throughout the year.

正如我們之前所傳達的，住院患者獲得處方納入、隨後設施採用和產品訂單的流程可能需要幾個月的時間。從這個意義上來說，我們預計第二季度住院患者銷售額不會出現實質增長，隨著全年的發展，我們將尋求住院患者數量的增加。

On the outpatient front, we remain on track to commence outpatient commercialization in July. We were pleased that CMS took timely action on our TDAPA application, which ensures that Medicare fee-for-service reimbursement claims submitted by outpatient providers beginning July 1 will be reimbursed by CMS. We are also very happy to announce our first outpatient procurement contract with ARC Dialysis. One of the largest regional dialysis providers in the Southeast US. We are currently engaged in commercial discussions with 8 of the top-10 US dialysis providers to help to communicate new procurement contracts over the next few months.

在門診方面，我們仍有望在 7 月開始門診商業化。我們很高興 CMS 對我們的 TDAPA 申請及時採取了行動，這確保了 CMS 能夠報銷門診提供者自 7 月 1 日起提交的 Medicare 按服務收費報銷索賠。我們也非常高興地宣布與 ARC Diaanalysis 簽訂第一份門診採購合約。美國東南部最大的區域透析提供者之一。我們目前正在與美國十大透析供應商中的 8 家進行商業討論，以幫助溝通未來幾個月的新採購合約。

From a guidance standpoint, we reiterate our operating expense guidance disclosed previously of $15 million to $18 million per quarter for calendar-year 2024. And continue to believe we can achieve breakeven profitability on a run-rate basis by the end of 2024, if we achieve our base case assumptions for product utilization. Our base assumptions do include limited adoption by at least one of the two large dialysis organizations as well as some utilization from midsize and smaller facilities.

從指導的角度來看，我們重申先前揭露的 2024 日曆年營運費用指引為每季 1,500 萬至 1,800 萬美元。並且繼續相信，如果我們實現產品利用率的基本假設，我們可以在 2024 年底之前實現盈虧平衡的獲利能力。我們的基本假設確實包括兩個大型透析組織中至少之一的有限採用以及中型和小型設施的一些利用。

At present, we are in advanced stages of negotiations with one of the two large operators for the implementation of DefenCath as well as several midsize and smaller operators, and we are working through their respective operational dynamics as we structure our commercial offering to each of them. There is a significant amount of planning and logistics involved in DefenCath implementation, especially for larger organizations. And we are working with those organizations to understand how we can better support patient adoption within their facilities.

目前，我們正與兩家大型業者之一以及幾家家中小型業者就實施 DefenCath 進行談判，談判已進入後期階段，我們正在研究他們各自的營運動態，同時為他們建立我們的商業產品。DefenCath 的實施涉及大量的規劃和後勤工作，特別是對於大型組織而言。我們正在與這些組織合作，了解如何更好地支持患者在其設施內收養。

As we roll out our launch and continually gauge progress against our base case assumptions, we intend to be prudent with our cash management. With this in mind, we are taking practical steps from a balance sheet management standpoint to provide ourselves with options in the event any additional capital is beneficial or needed down the road, be it to fund M&A and business development, organic growth or additional working capital for accounts receivable and inventory.

當我們推出產品並根據基本情況假設不斷評估進度時，我們打算謹慎對待現金管理。考慮到這一點，我們正在從資產負債表管理的角度採取切實可行的步驟，以便在任何額外資本有利或未來需要時為自己提供選擇，無論是為併購和業務發展、有機增長還是額外營運資金提供資金對於應收帳款和庫存。

To that extent, today, we are announcing a letter of intent with a large US-based lender for a revolving credit facility of up to $25 million, which allows CorMedix to access certain tranches of debt depending on our run rate of accounts receivable. The credit facility will not require us to draw any minimum amount and will be a helpful instrument for managing our balance sheet and working capital in a non-dilutive manner. We expect to close the revolving credit facility over the next few weeks.

就此而言，今天，我們宣布與美國大型貸方簽訂了一份高達 2500 萬美元循環信貸額度的意向書，這使得 CorMedix 能夠根據我們的應收帳款運行率獲得某些債務。信貸安排不會要求我們提取任何最低金額，並將成為以非稀釋方式管理我們的資產負債表和營運資金的有用工具。我們預計在未來幾週內關閉循環信貸安排。

Simultaneously with the credit facility letter of intent today, filing to renew our expiring shelf registration statement as well as replace the expired ATM facility. My objective is to be able to make cost of capital based decisions between equity and debt, should any additional capital be required in the future, keeping focus on minimizing shareholder dilution when possible. Matt will discuss the company's cash position in more detail momentarily.

今天與信貸便利意向書同時提交，更新我們即將到期的貨架註冊聲明並更換過期的 ATM 設施。我的目標是，如果將來需要任何額外資本，能夠在股權和債務之間做出基於資本成本的決策，並盡可能減少股東稀釋。馬特將立即更詳細地討論公司的現金狀況。

In terms of our plans for label expansion, as we communicated previously, we have submitted to FDA a Type-C meeting request to discuss a pathway to additional indications. FDA has accepted that meeting request, and we anticipate receiving feedback from the agency on our proposals by end of June. We have also used this Type-C meeting request as an opportunity to readdress the pediatric study requirement that is outlined in our approval letter.

就我們的標籤擴展計劃而言，正如我們之前溝通的那樣，我們已向 FDA 提交了 Type-C 會議請求，以討論其他適應症的途徑。FDA 已接受該會議請求，我們預計在 6 月底之前收到該機構對我們提案的回饋。我們也利用此 C 類會議請求作為重新解決批准信中概述的兒科研究要求的機會。

Based upon feedback from potential study investigators, we do not believe it will be feasible to run the pediatric study in hemodialysis in a manner previously discussed with FDA. FDA has granted us an extension on our final study protocol, and we expect to have feedback on a revamped pediatric study or a potential waiver by the end of June as well.

根據潛在研究人員的回饋，我們認為以先前與 FDA 討論的方式進行血液透析兒科研究是不可行的。FDA 已批准我們對最終研究方案進行延期，我們預計在 6 月底之前收到有關修改後的兒科研究或潛在豁免的回饋。

From a label expansion standpoint, we have elected to propose a clinical pathway for total parenteral nutrition or TPN, as a first step before we put forward a proposal for any uses of oncology. Once we have feedback from FDA and alignment on our proposal related to TPN, we can then craft a proposed study for use in oncology.

從標籤擴展的角度來看，我們選擇提出全腸外營養或 TPN 的臨床路徑，作為我們提出腫瘤學任何用途提案之前的第一步。一旦我們收到 FDA 的回饋並同意我們與 TPN 相關的提案，我們就可以製定一項用於腫瘤學的擬議研究。

The decision to prioritize TPN before submission and FDA discussion was based upon the expected timing and cost of the clinical program being proposed relative to the expected market size. Though oncology is potentially a larger market opportunity, we've elected to prioritize the potentially faster program first. Assuming acceptable feedback from the agency in June, anticipate submission of an oncology proposal to FDA later this year.

在提交和 FDA 討論之前優先考慮 TPN 的決定是基於相對於預期市場規模提出的臨床計劃的預期時間和成本。儘管腫瘤學可能是一個更大的市場機會，但我們選擇首先優先考慮可能更快的項目。假設該機構在 6 月收到可接受的回饋，預計將在今年稍後向 FDA 提交腫瘤學提案。

Lastly, from a supply chain perspective and our efforts to derisk our reliance on a single finished dose manufacturer, earlier this week, we submitted a supplement to our NDA, adding Siegfried Hameln site as an alternate manufacturer. Pending a successful FDA review of the supplement, we anticipate Siegfried coming online as a manufacturer as early as the end of '24. CorMedix has now grown to approximately 90 employees, and I'm proud of what we have accomplished over these recent months.

最後，從供應鏈的角度來看，以及我們為消除對單一成品劑量製造商的依賴所做的努力，本週早些時候，我們提交了 NDA 的補充，將 Siegfried Hameln 工廠添加為備用製造商。在 FDA 成功審查該補充劑之前，我們預計 Siegfried 最早將於 24 年底作為製造商上線。CorMedix 現已擁有約 90 名員工，我對我們最近幾個月所取得的成就感到自豪。

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

我現在想把電話轉給馬特，討論公司第一季的財務表現和財務狀況。馬特？

Thanks, Joe, and good morning, everyone. I am pleased to be here today to provide an overview of our first-quarter-2024 financial results as well as an update on CorMedix's cash position. The company has filed its quarterly report on Form 10-Q for the quarter ended March 31, 2024. 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。我很高興今天能夠概述我們 2024 年第一季的財務表現以及 CorMedix 現金狀況的最新情況。該公司已提交截至 2024 年 3 月 31 日的季度 10-Q 表格季度報告。我敦促您閱讀報告中包含的信息，以便對我們的財務表現進行更完整的討論。

With respect to our first quarter of 2024 financial results, our net loss was approximately $14.5 million or $0.25 per share compared with the loss of $10.6 million or $0.24 per share in the first quarter of 2023. The higher net loss recognized in 2024 compared with 2023 was driven by an increase in SG&A expenses versus the first quarter of 2023, partially offset by the sale of New Jersey NOLs for $1.4 million.

就我們 2024 年第一季的財務業績而言，我們的淨虧損約為 1,450 萬美元或每股 0.25 美元，而 2023 年第一季的淨虧損為 1,060 萬美元或每股 0.24 美元。與 2023 年相比，2024 年確認的淨虧損較高，這是由於 SG&A 費用較 2023 年第一季度有所增加，但以 140 萬美元出售新澤西州 NOL 部分抵消了這一增加。

Operating expenses in the first quarter of 2024 increased approximately 44% to $15.9 million compared with $11 million in the first quarter of 2023. R&D expense decreased by approximately 75% to $0.8 million, driven by the approval of DefenCath. As a result of the post-FDA approval commercial operations, costs related to medical affairs and certain personnel expenses that supported R&D efforts prior to the FDA approval of DefenCath have been recognized in SG&A expense.

2024 年第一季的營運支出成長約 44%，達到 1,590 萬美元，而 2023 年第一季的營運支出為 1,100 萬美元。受 DefenCath 批准的推動，研發費用下降約 75% 至 80 萬美元。由於 FDA 批准後的商業運營，與醫療事務相關的成本以及在 FDA 批准 DefenCath 之前支持研發工作的某些人員費用已在 SG&A 費用中確認。

SG&A expense increased approximately 98% to $15 million in the first quarter of 2024, compared with $7.6 million in the first quarter of 2023. This increase was primarily attributable to increases in personnel expenses due to the hiring of sales force, medical affairs and marketing personnel. In addition, certain costs related to medical affairs and certain personnel expenses that had been previously recognized in R&D are now recognized in SG&A following the FDA approval of DefenCath. To a lesser extent, the increase was also driven by increases in non-cash charges for stock-based compensation and increases in consulting fees.

2024 年第一季的 SG&A 費用增加約 98%，達到 1,500 萬美元，而 2023 年第一季為 760 萬美元。這一增長主要是由於僱用銷售人員、醫療事務和行銷人員而導致人員費用增加。此外，在 FDA 批准 DefenCath 後，先前在研發中確認的與醫療事務相關的某些成本和某些人員費用現在在 SG&A 中確認。在較小程度上，這一增長也是由股票薪酬非現金費用的增加和諮詢費的增加所推動的。

We recorded net cash used in operations during the first quarter of 2024 of $17.3 million compared with net cash used in operations of $10.4 million in the first quarter of 2023. The increase is primarily driven by an increase in net loss and decreases in accrued expenses and accounts payable. The company has cash and cash equivalents of $58.6 million as of March 31, 2024.

我們記錄的 2024 年第一季營運中使用的淨現金為 1,730 萬美元，而 2023 年第一季營運中使用的淨現金為 1,040 萬美元。這一增長主要是由於淨虧損增加以及應計費用和應付帳款減少所致。截至2024年3月31日，該公司擁有現金及現金等價物5,860萬美元。

As we have discussed previously, we expect our operating expenses, especially SG&A, to remain at increased levels given the growth of the company and the cost driven by the commercial launch of DefenCath. CorMedix anticipates 2024 quarterly operating expenses to range from around $15 million to $18 million to support commercial infrastructure and the ongoing launch of DefenCath. We believe our cash, cash equivalents, short-term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months and to fund the commercial launch of DefenCath through to anticipated profitability, which may occur on a run-rate basis by the end of 2024, assuming we were able to achieve our internal base case assumptions for DefenCath demand, uptake, net pricing and reimbursement.

正如我們之前所討論的，鑑於公司的成長以及 DefenCath 商業推出所驅動的成本，我們預計我們的營運支出，尤其是銷售、管理費用將保持在增加的水平。CorMedix 預計 2024 年季度營運費用約為 1,500 萬美元至 1,800 萬美元，以支援商業基礎設施和 DefenCath 的持續推出。我們相信，我們的現金、現金等價物、短期投資和預計的未來營運現金流使公司有能力為至少12 個月的營運提供資金，並為DefenCath 的商業啟動提供資金，直至達到預期的盈利能力（這可能會在擠兌時發生） - 到 2024 年底的費率基礎，假設我們能夠實現 DefenCath 需求、使用、淨定價和報銷的內部基本情況假設。

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，讓他發表結束語。喬？

Thanks, Matt. CorMedix is executing well on our key objectives, and is hopeful to provide more substantive updates on sales progress on our next quarterly call in August. I appreciate everyone's continued support of CorMedix, and I'm happy to now take questions.

謝謝，馬特。CorMedix 在我們的關鍵目標上執行得很好，並希望在 8 月的下一個季度電話會議上提供有關銷售進度的更多實質更新。我感謝大家對 CorMedix 的持續支持，我很高興現在回答問題。

(Operator Instructions) Les Sulewski, Truist Securities.

（操作員指示）Les Sulewski，Truist Securities。

Good morning. Thank you for taking my questions. I have two on the outpatient side, and then one follow up. So can you give us a little bit more color around the economics of the ARC partnership? Essentially, will all of their dialysis centers convert to full use of the DefenCath on day one upon the switch into your outpatient launch or is that an option left to the patient?

早安.感謝您回答我的問題。我有兩個在門診，然後一個跟進。那麼您能否為我們介紹一下 ARC 合作夥伴關係的經濟效益？從本質上講，他們所有的透析中心是否會在切換到門診啟動的第一天就完全使用 DefenCath，還是留給病人選擇？

And then second, I guess it's very interesting to hear that you're in discussions with one of the two leading national outpatient dialysis operators, how can we think about that conversation moving along? Is this a pilot run program that could be put in place? And ultimately, what terms and impact on net pricing could we expect if a deal were to occur?

其次，我想聽到您正在與兩家領先的全國門診透析運營商之一進行討論非常有趣，我們如何看待該對話的進展？這是一個可以實施的試點計畫嗎？最終，如果交易發生，我們可以預期哪些條款以及對淨定價的影響？

Thanks, Les. I appreciate the question. And I'm actually going to, I think, blend these two questions together to some extent. So we're not going to disclose specific terms in any one specific outpatient or ultimately inpatient agreement. I think the way we've guided you on price over the past year, it remains consistent on the outpatient side. I think there'll be a healthy gross to net, that leaves room for discounts and rebates, volume incentive rebates, things like that, that you'll have to a less -- you'll have that to a lesser extent on the inpatient side.

謝謝，萊斯。我很欣賞這個問題。我認為，我實際上將在某種程度上將這兩個問題融合在一起。因此，我們不會在任何一項特定門診或最終住院協議中披露具體條款。我認為我們過去一年指導價格的方式在門診方面保持一致。我認為會有一個健康的淨毛額，這為折扣和回扣、數量獎勵回扣等留下了空間，你必須減少住院病人的支出邊。

When we think about uptake in the facilities, and as we've communicated previously, TDAPA today applies to Medicare fee-for-service patients, which are probably about 40% to 45% of catheterized dialysis patients in any one site. So some, I think, facilities will elect to roll out potentially on a payer basis. We're actively in discussions with the Medicare Advantage plans around additional reimbursement. I think they want to see uptake in demand, so they'll be looking to see fee-for-service volumes to some extent.

當我們考慮設施的使用情況時，正如我們之前所傳達的那樣，現在的 TDAPA 適用於 Medicare 按服務收費的患者，這可能佔任何一個地點的導管透析患者的 40% 至 45% 左右。因此，我認為，一些設施可能會選擇以付款方式推出。我們正在與 Medicare Advantage 計劃積極討論額外報銷事宜。我認為他們希望看到需求的增長，因此他們將希望看到一定程度的按服務付費的數量。

I do think the potential rollout for a larger operator could be some combination of payer based or patient based focused on potentially high-risk patients. There's a large volume of patients over many facilities. So the rollout will take time to implement regardless of the customer.

我確實認為，大型營運商的潛在推出可能是基於付款人或基於患者的某種組合，重點關注潛在的高風險患者。許多設施都有大量患者。因此，無論客戶如何，部署都需要時間來實施。

Got it. Appreciate that. And as a follow up more on the general corporate strategy, given the favorable price of CorMedix stock performance and then you're factoring your cash burn, just to give you a little bit of a cushion as you head into closer to profitability or breakeven. Have you considered that an equity raise or any other source of financing, such as a convertible note or warrants? Thank you.

知道了。很欣賞這一點。作為一般公司策略的後續行動，考慮到 CorMedix 股票表現的有利價格，然後你考慮你的現金消耗，只是為了在你接近盈利或盈虧平衡時給你一點緩衝。您是否考慮過股權融資或任何其他融資來源，例如可轉換票據或認股權證？謝謝。

Well, thanks, Les. In the script today, we announced the letter of intent for the credit facility, which we do expect to close over the next couple of weeks. Certainly, that facility is based upon or would be contingent upon receivables. We've also announced the ATM facility, which will give us some flexibility to utilize it down the road.

好吧，謝謝，萊斯。在今天的劇本中，我們宣布了信貸安排的意向書，我們預計將在未來幾週內完成。當然，該便利是基於或取決於應收帳款。我們也宣布了 ATM 設施，這將為我們今後的使用提供一定的靈活性。

What I wouldn't want to do, and I think what you're asking is why I wouldn't do a large potentially dilutive rate today, I just think that would be premature. And potentially, you're responsible to unnecessarily dilute the stock until we get better visibility on commercial execution in the back part of the year. I feel pretty good about where we are in our discussions today with customers. I think we're still in line with our base case expectations and assumptions to get to that run rate breakeven by the end of the year.

我不想做的，我想你問的是為什麼我今天不做一個大的潛在稀釋率，我只是認為這還為時過早。並且有可能，您有責任不必要地稀釋股票，直到我們在今年下半年對商業執行情況有更好的了解。我對今天與客戶的討論進度感到非常滿意。我認為我們仍然符合我們的基本情況預期和假設，以在年底前實現運行率盈虧平衡。

Now, that doesn't necessarily mean I'm going to allow minimum cash to fall below certain levels. And I think the tools that we've put in place today give us that flexibility as we move through the year to reassess, to look at customer orders as they're coming in, to evaluate our payment terms, our working capital needs and make that determination. So I hope that's sufficient.

現在，這並不一定意味著我會允許最低現金低於特定水平。我認為，我們今天部署的工具為我們在這一年中重新評估、查看收到的客戶訂單、評估我們的付款條件、我們的營運資金需求並製定計劃提供了靈活性。所以我希望這已經足夠了。

Very helpful. Thank you.

非常有幫助。謝謝。

Gregory Renza, RBC Capital Markets.

格雷戈里·倫扎（Gregory Renza），加拿大皇家銀行資本市場部。

Danish on for Greg. Congrats on the progress this quarter, and thanks for taking my questions. Just first, on the call, you mentioned BD and M&A. Just wanted to dig into that and see how you're thinking about opportunities and areas of interest that would sit well on your platform. And then secondly, maybe if you could just remind us on the commercial opportunity of TPN and PEDs, if you could quantify on lumen locks, et cetera. Thanks again.

格雷格換上丹麥人。恭喜本季的進展，並感謝您回答我的問題。首先，您在電話會議上提到了 BD 和併購。只是想深入研究一下，看看您如何考慮適合您平台的機會和感興趣的領域。其次，也許您可以提醒我們 TPN 和 PED 的商業機會，如果您可以量化流明鎖定等。再次感謝。

Thanks, Sean. Appreciate the question. So look, from an M&A standpoint, obviously, we're going to continually be opportunistic and take a look as we're moving through our commercial launch this year into next year. We've got a fixed infrastructure cost. It makes a heck of a lot of sense to try to spread that cost across multiple products.

謝謝，肖恩。感謝這個問題。因此，從併購的角度來看，顯然，我們將繼續保持機會主義，並在今年進入明年的商業發布過程中進行審查。我們有固定的基礎設施成本。嘗試將成本分攤到多種產品上是非常有意義的。

So I do think there are opportunities in the market today that could be actionable. We don't have anything that we are currently either negotiating or actively pursuing. But this is just something that I think as we move past, let's say, commercial launch could become a bigger focus in our mind as we develop as a company. We're doing a refresh right now. On your second question, we're doing a refresh in our market research around TPN and oncology and hope to put something out in the second half of the year.

因此，我確實認為當今市場上存在一些可行的機會。我們目前沒有任何正在談判或積極追求的事情。但這只是我認為隨著我們過去的事情，比方說，隨著我們作為一家公司的發展，商業發布可能會成為我們心中更大的焦點。我們現在正在進行刷新。關於你的第二個問題，我們正在刷新有關 TPN 和腫瘤學的市場研究，並希望在今年下半年推出一些成果。

Sean?

肖恩？

Greg, did you have any follow-up questions?

格雷格，您還有什麼後續問題嗎？

No. We're all good here. Thank you so much.

不。我們這裡都很好。太感謝了。

(Operator Instructions) Okay. So there are no further questions at this time. So this concludes the audio portion of our day. I'll now turn it back to Dan for written questions from the audience.

（操作員指示）好的。所以目前沒有其他問題。我們今天的音頻部分就到此結束。現在我將把它轉回給丹，讓觀眾提出書面問題。

Thank you, operator. Joe, we have a couple of written questions from the audience here. The first one is, are there other post-market type studies that the company is considering or that may help with uptake in the inpatient or outpatient settings?

謝謝你，接線生。喬，我們有幾個觀眾提出的書寫問題。第一個是，公司是否正在考慮其他上市後類型的研究或可能有助於住院或門診環境的吸收？

Actually, that is something that we are actively pursuing right now. I think that when you talk about post-marketing studies, we're looking at real-world evidence studies, right? We want to be able to demonstrate the efficacy and health economic benefits of DefenCath in a real-world setting. So we are currently in discussions with what I would characterize as value-based care entities to run this type of an evaluation. It's not something that will happen overnight, but I do think it's something that over the course of time, will help demonstrate the value of DefenCath and certainly be useful increasing uptake.

事實上，這也是我們現在積極追求的事情。我認為當您談論上市後研究時，我們正在研究現實世界的證據研究，對吧？我們希望能夠在現實環境中展示 DefenCath 的功效和健康經濟效益。因此，我們目前正在與我所描述的基於價值的護理實體進行討論，以進行此類評估。這不是一朝一夕就能發生的事情，但我確實認為隨著時間的推移，這將有助於展示 DefenCath 的價值，並且肯定有助於增加使用率。

Another one here. What are the formularies focused on when it comes to their decision-making? In other words, how does DefenCath fit into those themes?

這裡還有另一張。處方集在決策時重點關注什麼？換句話說，DefenCath 如何融入這些主題？

And I'm assuming from formularies that the question is asking about inpatient P&T process. So I guess I'll address that. So I think a typical P&T process in a hospital is going to focus on first clinical efficacy. And then, from there, they're going to look at price and the health economic impact of the product. I think with DefenCath, there's a couple of other unique things that might factor into the discussion that are certainly beneficial for us.

我從處方中假設問題是詢問住院病患的 P&T 流程。所以我想我會解決這個問題。因此，我認為醫院典型的 P&T 流程將首先關注臨床療效。然後，從那裡開始，他們將考慮產品的價格和健康經濟影響。我認為，對於 DefenCath，還有一些其他獨特的因素可能會納入討論，這對我們來說肯定是有益的。

The first is within these institutions, antibiotic stewardship has become an incredibly important issue for them, right? They want to minimize the use of antibiotics and to the extent that you can reduce or prevent any infections, it lessens the need for antibiotics.

首先是在這些機構內部，抗生素管理對他們來說已經成為一個極為重要的議題，對嗎？他們希望盡量減少抗生素的使用，並且在可以減少或預防任何感染的情況下，就可以減少對抗生素的需求。

The second is, as a preventative measure, these hospitals they get evaluated based on their infection rates and their readmission rates, and I think that DefenCath fits squarely within that need. So I'd say that's likely part of the discussion. I think that works well in DefenCath's favor as we're going through these P&T processes.

第二個是，作為一項預防措施，他們根據感染率和再入院率對這些醫院進行評估，我認為 DefenCath 完全符合這項需求。所以我想說這可能是討論的一部分。我認為這對 DefenCath 很有利，因為我們正在經歷這些 P&T 流程。

Okay. Great. Thanks, Joe. Operator, that concludes the written portion of the Q&A session. You may now close the call.

好的。偉大的。謝謝，喬。操作員，結束問答環節的書面部分。您現在可以結束通話了。

Ladies and gentlemen, this concludes your conference call for today. We thank you for participating and ask that you please disconnect your lines.

女士們、先生們，今天的電話會議到此結束。我們感謝您的參與，並請您斷開線路。