CorMedix Inc (CRMD) 2023 Q1 法說會逐字稿

Good afternoon, and welcome to the CorMedix First Quarter 2023 Earnings Conference Call. (Operator Instructions) Please note, this event is being recorded.

下午好，歡迎參加 CorMedix 2023 年第一季度收益電話會議。 （操作員說明）請注意，正在記錄此事件。

I would now like to turn the conference over to Monique Kosse. Please go ahead.

現在我想將會議轉交給莫妮克·科斯 (Monique Kosse)。請繼續。

Thank you. Good afternoon, everyone, and welcome to the CorMedix First Quarter 2023 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; Dr. Phoebe Mounts, EVP and General Counsel; and Erin Mistry, EVP and Chief Commercial Officer.

謝謝。大家下午好，歡迎參加 CorMedix 2023 年第一季度收益電話會議。今天主持電話會議的是 CorMedix 首席執行官 Joe Todisco；執行副總裁兼首席財務官 Matt David 博士也加入其中； Phoebe Mounts 博士，執行副總裁兼總法律顧問；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 subject to certain risks and uncertainties and include, but are not limited to, any of the following: any statements other than statements of historical fact regarding management's expectations, beliefs, goals and plans about the company's prospects, including its clinical development program, manufacturing activities and NDA approval for DefenCath in the U.S. or other product candidates; future financial position; future revenues and projected costs; and potential market acceptance of DefenCath or other product candidates.

在開始之前，我想提醒大家，在電話會議期間，管理層可能會做出 1995 年《私人證券訴訟改革法案》規定的所謂前瞻性陳述。這些陳述存在一定的風險和不確定性包括但不限於以下任何內容：除了有關管理層對公司前景的期望、信念、目標和計劃的歷史事實陳述之外的任何陳述，包括其臨床開發計劃、製造活動和 DefenCath 的 NDA 批准美國或其他候選產品；未來的財務狀況；未來收入和預計成本； DefenCath 或其他候選產品的潛在市場接受度。

More specifically, forward-looking statements include any statements about our clinical development plans the timing, cost, progress, results, estimates and interpretations thereof; projections as to the company's future capital raising and spending and cash position; expectations to the timing and nature of anticipated regulatory actions; possible product licensing, business development or other transactions; any commercial plans and expectations; market projections for our product candidates; and expectations as to manufacturing and product component costs.

更具體地說，前瞻性陳述包括有關我們的臨床開發計劃的時間、成本、進展、結果、估計和解釋的任何陳述；對公司未來融資和支出以及現金狀況的預測；對預期監管行動的時間和性質的期望；可能的產品許可、業務開發或其他交易；任何商業計劃和期望；我們候選產品的市場預測；以及對製造和產品組件成本的預期。

Actual results may differ materially from these projections or estimates due to a variety of important factors, including, but not limited to, uncertainties related to clinical development, regulatory approvals and commercialization. These risks are described in greater detail in CorMedix's filings with the SEC, including the latest quarterly report on Form 10-Q and annual report on Form 10-K, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve these goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements. Please note that CorMedix does not intend to update these forward-looking statements, except as required by law.

由於各種重要因素，包括但不限於與臨床開發、監管批准和商業化相關的不確定性，實際結果可能與這些預測或估計存在重大差異。這些風險在 CorMedix 向 SEC 提交的文件中進行了更詳細的描述，包括最新的 10-Q 表季度報告和 10-K 表年度報告，這些報告的副本可在 SEC 網站 www.sec 上免費獲取。 gov 或根據 CorMedix 的要求。 CorMedix 可能實際上無法實現這些前瞻性聲明中描述的這些目標或計劃，投資者不應過度依賴這些聲明。請注意，除非法律要求，否則 CorMedix 不打算更新這些前瞻性陳述。

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 首席執行官 Joe Todisco。喬，請繼續。

Thank you, Monique. Good afternoon, everyone, and thank you for joining us on this call. Since our last earnings call in March, the company has achieved a number of key milestones, most importantly, today's announcement that the NDA for DefenCath is being resubmitted to the FDA.

謝謝你，莫妮克。大家下午好，感謝您參加我們的這次電話會議。自從我們三月份的上次財報電話會議以來，該公司已經實現了許多關鍵的里程碑，最重要的是，今天宣布將 DefenCath 的 NDA 重新提交給 FDA。

I'm incredibly proud of the team that has worked so hard to ensure the company would achieve this important objective. Phoebe will provide more color around the substance of our Type A meeting with FDA in April. And as we announced a few weeks ago, we do expect the resubmission to be classified as a Class II with a 6-month review and anticipate a target action date in November. We will update investors once we have confirmation from FDA regarding the submission status of the NDA.

我為我們的團隊感到無比自豪，他們為確保公司實現這一重要目標而付出了巨大的努力。 Phoebe 將為我們 4 月份與 FDA 舉行的 A 類會議的實質內容提供更多的信息。正如我們幾週前宣布的那樣，我們確實預計重新提交的申請將被歸類為 II 類，並進行為期 6 個月的審查，並預計目標行動日期為 11 月。一旦 FDA 確認 NDA 的提交狀態，我們將向投資者通報最新情況。

In addition to our resubmission, we also announced 2 key business updates that can be important value drivers for DefenCath. The first, with it following our submission of a duplicate New Technology Add-on Payment or NTAP application in the fourth quarter of 2022 to the Centers for Medicare & Medicaid Services. CMS has now issued the Inpatient Prospective Payment System 2024 proposed rule that includes an NTAP of up to $17,111 per hospital stay for DefenCath. This is a meaningful increase above the previously approved NTAP and represents reimbursement to inpatient facilities at 75% of the anticipated WAC price of $1,170 per 3-milliliter vial, with an average utilization of 19.5 vials per hospital stay.

除了重新提交之外，我們還宣布了 2 項關鍵業務更新，這些更新可能成為 DefenCath 的重要價值驅動因素。第一個是在我們於 2022 年第四季度向醫療保險和醫療補助服務中心提交了重複的新技術附加付款或 NTAP 申請之後。 CMS 現已發布 2024 年住院預期支付系統擬議規則，其中包括 DefenCath 每次住院最高 17,111 美元的 NTAP。與之前批准的 NTAP 相比，這是一個有意義的增長，並且代表以每 3 毫升小瓶 1,170 美元的 WAC 預期價格的 75% 向住院機構報銷，每次住院期間平均使用 19.5 瓶。

As we mentioned in our recent update, CorMedix will be migrating DefenCath from a 5-milliliter to a 3-milliliter vial volume based upon market preferences. This NTAP application was submitted with that migration in mind. The final IPPS rule will be published in late summer, and we expect this payment amount to be issued in that final rule. This NTAP is conditioned upon the DefenCath NDA obtaining final FDA approval prior to July 1, 2024.

正如我們在最近的更新中提到的，CorMedix 將根據市場偏好將 DefenCath 從 5 毫升小瓶容量遷移到 3 毫升小瓶容量。此 NTAP 申請是在考慮到該遷移的情況下提交的。最終的 IPPS 規則將於夏末發布，我們預計該付款金額將在該最終規則中發布。本 NTAP 的條件是 DefenCath NDA 在 2024 年 7 月 1 日之前獲得 FDA 最終批准。

The company also recently announced that the U.S. Patent and Trademark Office has issued a notice of allowance of patent claims directed to the composition of a catheter lock solution for preventing infection and reduced blood flow in central venous catheters. This newly allowed U.S. patent application reflects the unique and proprietary nature of DefenCath and will extend our current intellectual property protection to anticipated expiration date in 2042, which is beyond the 10.5 years of marketing exclusivity available upon an FDA approval of the DefenCath NDA.

該公司最近還宣布，美國專利商標局已發布一項專利申請批准通知，涉及用於預防感染和減少中心靜脈導管血流量的導管封閉溶液的成分。這項新獲批的美國專利申請反映了 DefenCath 的獨特性和專有性，並將把我們目前的知識產權保護延長至預期的 2042 年到期日，這超出了 FDA 批准 DefenCath NDA 後可獲得的 10.5 年營銷獨占權。

Once this patent is granted, we plan to seek listing in FDA's publication, Approved Drug Products with Therapeutic Equivalence Evaluations, known as the Orange Book, which identifies approved drug products and includes related patent and exclusivity information as part of the NDA approval process. While our technical and regulatory teams have been working diligently toward our resubmission and preparing the supply chain for potential commercialization, our commercial and medical affairs teams have been engaging with key stakeholders across settings of care to ensure CorMedix is in position to maximize the value of DefenCath.

一旦獲得該專利，我們計劃尋求在 FDA 的出版物《具有治療等效性評估的已批准藥品》（稱為橙皮書）中上市，該出版物標識了已批准的藥品，並包括相關專利和排他性信息，作為 NDA 批准流程的一部分。雖然我們的技術和監管團隊一直在努力重新提交並為潛在的商業化準備供應鏈，但我們的商業和醫療事務團隊一直在與各個護理環境中的主要利益相關者進行接觸，以確保 CorMedix 能夠最大限度地發揮 DefenCath 的價值。

As the initial phase of our launch will focus on inpatient utilization, we have begun engaging with leadership members of pharmacy and technology committees at multiple health systems, hospitals and integrated delivery networks to better prepare for the formulary process. We expect to work with health institutions during the upcoming months to establish baseline infection rates at their respective institutions, such that the impact of DefenCath utilization in the system can be quantified.

由於我們推出的初始階段將重點關注住院患者的利用，因此我們已開始與多個衛生系統、醫院和綜合交付網絡的藥房和技術委員會的領導成員進行接觸，以更好地為處方流程做好準備。我們預計在未來幾個月內與衛生機構合作，確定各自機構的基線感染率，以便量化 DefenCath 在系統中的使用所產生的影響。

On the outpatient side, we have also intensified engagements with potential customers and stakeholders as we prepare for discussions with CMS related to outpatient reimbursement. Catheter-related blood stream infections remain one of the most severe complications associated with receiving hemodialysis through a central venous catheter, and adequate reimbursement to dialysis providers for infection prevention is essential to improving patient outcomes. A formal application for outpatient reimbursement cannot be submitted until after an NDA receives FDA approval. However, we do expect to begin a dialogue with CMS, providing the agency with documentation supporting our reimbursement position over the upcoming months.

在門診方面，我們還加強了與潛在客戶和利益相關者的接觸，準備與 CMS 討論門診報銷相關事宜。導管相關的血流感染仍然是通過中心靜脈導管接受血液透析相關的最嚴重的並發症之一，向透析提供者提供足夠的感染預防補償對於改善患者的治療效果至關重要。 NDA 獲得 FDA 批准後，才能提交正式的門診報銷申請。然而，我們確實希望開始與 CMS 對話，向該機構提供支持我們在未來幾個月的報銷立場的文件。

I will now turn the call over to Phoebe to discuss our Type A meeting with FDA and potential time lines for FDA approval. Phoebe?

我現在將把電話轉給 Phoebe，討論我們與 FDA 的 A 類會議以及 FDA 批准的潛在時間表。菲比？

Thanks, Joe. Good afternoon, everyone. First, I would like to start by expressing my gratitude to the technical and regulatory teams that have worked diligently to prepare to resubmit the DefenCath NDA as soon as possible.

謝謝，喬。大家下午好。首先，我要向技術和監管團隊表示感謝，他們為盡快重新提交 DefenCath NDA 做準備。

As you know, CorMedix received a complete response letter in August of 2022 due solely to deficiencies cited at contract manufacturers of active pharmaceutical ingredients and finished products, but citing no DefenCath for clinical-related deficiencies. Since August, our technical and regulatory teams have been developing 3 different pathways, utilizing alternative CMO and API suppliers to ensure NDA resubmission as quickly as possible, which we have discussed during the last 2 earnings calls.

如您所知，CorMedix 於 2022 年 8 月收到了完整的回复信，僅僅是因為活性藥物成分和成品合同製造商提到的缺陷，但沒有引用 DefenCath 的臨床相關缺陷。自 8 月以來，我們的技術和監管團隊一直在開發 3 種不同的途徑，利用替代 CMO 和 API 供應商來確保盡快重新提交 NDA，我們在過去兩次財報電話會議中對此進行了討論。

In March, we submitted a Type A meeting request to FDA to discuss plans for NDA resubmission, and we were gratified that FDA granted the request for a meeting in April. We provided FDA with significant documentation and compelling justification for pathway 1 that would utilize our existing CMO and existing API supplier to support a Class 1 resubmission with a 60-day review period.

3月份，我們向 FDA 提交了 A 類會議請求，討論 NDA 重新提交的計劃，我們很高興 FDA 在 4 月份批准了會議請求。我們向 FDA 提供了有關途徑 1 的重要文件和令人信服的理由，該途徑將利用我們現有的 CMO 和現有的 API 供應商來支持 1 類重新提交，審查期為 60 天。

The discussion with FDA related to pathway 1 was very positive and productive. However, based upon FDA's feedback, it was apparent that CorMedix will be better served by resubmitting the NDA, not only with our existing CMO when incorporating multiple sources of heparin API. The inclusion of multiple sources of heparin API necessitated the inclusion of new manufacturing information in the submission, which we expect to result in a Class II resubmission with a 6-month review period.

與 FDA 就途徑 1 進行的討論非常積極且富有成效。然而，根據 FDA 的反饋，很明顯，在合併多個來源的肝素 API 時，重新提交 NDA 可以更好地服務於 CorMedix，而不僅僅是我們現有的 CMO。由於包含多個來源的肝素 API，因此需要在提交的材料中包含新的製造信息，我們預計這將導致 II 類重新提交，審查期為 6 個月。

We view the discussion with FDA as highly valuable. And following our receipt of the formal meeting minutes from this discussion, CorMedix is now resubmitting the DefenCath NDA in accordance with agency guidance. We believe that when the NDA is accepted for filing, it will be deemed a Class II resubmission with a 6-month review and receive a PDUFA target action date in November.

我們認為與 FDA 的討論非常有價值。在我們收到本次討論的正式會議記錄後，CorMedix 現在根據機構指導重新提交 DefenCath NDA。我們相信，當 NDA 被接受提交時，它將被視為 II 類重新提交，並經過 6 個月的審查，並在 11 月收到 PDUFA 目標行動日期。

As Joe mentioned, CorMedix will provide additional updates if and when these milestones are achieved. I would now like to turn the call over to Matt, who will provide a financial update. Matt?

正如 Joe 提到的，如果實現這些里程碑，CorMedix 將提供額外的更新。我現在想把電話轉給馬特，他將提供最新的財務信息。馬特？

Thanks, Phoebe, and good afternoon, everyone. I am pleased to be here today to provide an overview of our first quarter 2023 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, 2023. I urge you to read the information contained in the report for a more complete discussion of our financial results.

謝謝菲比，大家下午好。我很高興今天能夠概述我們 2023 年第一季度的財務業績以及 CorMedix 現金狀況的最新情況。該公司已提交截至 2023 年 3 月 31 日的季度 10-Q 表格季度報告。我強烈建議您閱讀報告中包含的信息，以便更完整地討論我們的財務業績。

With respect to our first quarter of 2023 financial results, our net loss was approximately $10.6 million or $0.24 per share compared with a loss of $7.0 million or $0.18 per share in the first quarter of 2022. The higher net loss recognized in 2023 compared with 2022 included an increase in R&D expenses and SG&A expenses versus the first quarter of 2022.

就我們 2023 年第一季度的財務業績而言，我們的淨虧損約為 1,060 萬美元或每股 0.24 美元，而 2022 年第一季度的虧損為 700 萬美元或每股 0.18 美元。2023 年確認的淨虧損高於 2022 年與 2022 年第一季度相比，包括研發費用和銷售、一般行政費用 (SG&A) 費用的增加。

Operating expenses in the first quarter of 2023 increased approximately 57% to $11 million compared with $7 million in the first quarter of 2022. R&D expense increased by approximately 49% to $3.4 million, driven primarily by an increase in personnel expenses and noncash charges for stock-based compensation and increases in costs related to medical affairs activities and costs related to the manufacturing of DefenCath prior to its potential marketing approval. These increases were partially offset by a decrease in consulting fees for the period.

2023 年第一季度的運營費用增長約 57%，達到 1100 萬美元，而 2022 年第一季度為 700 萬美元。研發費用增長約 49%，達到 340 萬美元，主要是由於人員費用和庫存非現金費用的增加基於補償和與醫療事務活動相關的成本以及與 DefenCath 的潛在上市批准之前的製造相關的成本的增加。這些增長被該期間諮詢費的減少部分抵消。

SG&A expense increased approximately 60% to $7.6 million in the first quarter of 2023 compared with $4.8 million in the first quarter of 2022. This increase was primarily attributable to an increase in costs related to market research studies and prelaunch activities in preparation for the potential marketing approval of DefenCath, an increase in personnel expenses due to additional hires and an increase in noncash charges for stock-based compensation. These increases were partially offset by decreases in legal fees for the period.

2023 年第一季度的 SG&A 費用增加約 60%，達到 760 萬美元，而 2022 年第一季度為 480 萬美元。這一增長主要歸因於與市場研究和為潛在營銷做準備的上市前活動相關的成本增加。 DefenCath 的批准、由於額外僱用而導致的人員費用增加以及基於股票的薪酬的非現金費用的增加。這些增長被該期間法律費用的減少部分抵消。

We recorded net cash used in operations during the first quarter of 2023 of $10.4 million compared with net cash used in operations of $6.7 million for the first quarter of 2022. CorMedix remains in a good position from a balance sheet perspective. The company had cash and cash equivalents of $55.6 million as of March 31, 2023. This includes approximately $7.2 million raised during the first quarter of 2023 through our ATM program, including approximately $3.7 million in net proceeds from our ATM program.

我們記錄的 2023 年第一季度運營中使用的淨現金為 1040 萬美元，而 2022 年第一季度運營中使用的淨現金為 670 萬美元。從資產負債表的角度來看，CorMedix 仍處於良好狀態。截至 2023 年 3 月 31 日，該公司擁有現金和現金等價物為 5560 萬美元。其中包括 2023 年第一季度通過我們的 ATM 計劃籌集的約 720 萬美元，其中包括來自我們的 ATM 計劃的約 370 萬美元的淨收益。

Following the end of first quarter 2023, CorMedix has March 31, 2023, pro forma cash and equivalents of approximately $59.3 million. We believe our cash and cash equivalents gives the company flexibility to fund its operations at least through the first half of 2024, after taking into consideration costs related to manufacturing activities and costs related to commercial launch preparation in anticipation of the potential FDA approval of DefenCath.

截至 2023 年第一季度末，CorMedix 預計截至 2023 年 3 月 31 日的現金及等價物約為 5930 萬美元。我們相信，在考慮到與製造活動相關的成本以及與商業上市準備相關的成本（預計 FDA 可能會批准 DefenCath）後，我們的現金和現金等價物使公司能夠靈活地至少在 2024 年上半年為其運營提供資金。

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. As I mentioned earlier, I believe the company is executing well on our key objectives, and will now increase focus on commercial readiness. Over the last few months, we have made a number of key leadership hires in both commercial operations and medical affairs, most notably, new heads of market access, government affairs, strategic partnerships and trade. We will continue to add additional resources as we progress through milestone events during the year.

謝謝，馬特。正如我之前提到的，我相信公司在我們的關鍵目標上執行得很好，現在將更加關注商業準備情況。在過去的幾個月裡，我們在商業運營和醫療事務方面聘用了許多關鍵領導層，其中最引人注目的是市場准入、政府事務、戰略合作夥伴關係和貿易方面的新負責人。隨著年內里程碑事件的進展，我們將繼續增加額外資源。

As we said earlier, we anticipate a target action date in the middle of November, and we'll plan for commercial launch as early as the beginning of 2024. In the upcoming quarters, we will provide more clarity around market opportunities, launch expectations and timing.

正如我們之前所說，我們預計目標行動日期為 11 月中旬，並且我們將計劃最早在 2024 年初進行商業發布。在接下來的幾個季度中，我們將更明確地介紹市場機會、發布預期和定時。

Thank you for your continued support of and interest in CorMedix.

感謝您對 CorMedix 的持續支持和關注。

(Operator Instructions) And the first question will be from Joon Lee from Truist Securities.

（操作員說明） 第一個問題將由 Truist Securities 的 Joon Lee 提出。

This is Les on from Joon. First, what would be the protocol with the FDA for when you are ready to add in the -- actually, the CMO #2?

這是來自 Joon 的 Les。首先，當您準備好添加 CMO #2 時，FDA 的協議是什麼？

Les, I think our current plan for the additional CMO would be presumably post approval of the NDA, submitting it as a supplement. And that's the current plan.

Les，我認為我們目前關於額外 CMO 的計劃可能是在 NDA 批准後，將其作為補充提交。這就是目前的計劃。

Got it. Can you talk a little bit more about the reasoning behind the vial fill rate change? And why now that has been proposed and not earlier?

知道了。您能多談談小瓶填充率變化背後的原因嗎？為什麼現在才提出而不是更早提出呢？

Well, as we began doing additional market research out, engaging the inpatient and outpatient side, we saw a preference for a smaller vial fill that they would tap only one time as opposed to the 5 mL that they would tap twice. If we had pursued the original heparin API supplier only, we would have probably gotten approval with the 5 mL and then submitted the 3 mL as a supplement. But given that the agency wanted multiple sources of heparin, it made sense to include it in this submission.

好吧，當我們開始進行額外的市場研究並吸引住院患者和門診患者時，我們發現人們更喜歡較小的小瓶灌裝，他們只會輕敲一次，而不是 5 毫升，他們會輕敲兩次。如果我們只尋求原始肝素 API 供應商，我們可能會獲得 5 mL 的批准，然後提交 3 mL 作為補充。但考慮到該機構想要多種來源的肝素，將其包含在本次提交中是有意義的。

Got it. That's helpful. And just one more for me. Can you talk a little bit more about the strength of the newly issued patent and perhaps indicate the exclusivity time line that you expect? And then also, as a follow-up to that, what would be your strategy to deal with any potential NDA filers?

知道了。這很有幫助。還給我一個。您能否多談談新頒發專利的優勢，並指出您期望的獨占時間線？然後，作為後續行動，您處理任何潛在 NDA 申報者的策略是什麼？

Okay. Les, actually, I mean we do think the newly added claims are very meaningful. We think that once the patent is issued, it's going to be eligible to be listed in the Orange Book, right, which means that generic filers would have to certify against it, right, if it's Orange Book-listed. And post expiration of the 10.5 years of marketing exclusivity, right, this can be a material barrier to generic competition.

好的。事實上，我的意思是我們確實認為新添加的聲明非常有意義。我們認為，一旦專利發布，它將有資格被列入橙皮書，對吧，這意味著通用申請者必須對其進行證明，對吧，如果它被列入橙皮書。 10.5 年的營銷獨占權到期後，這可能會成為仿製藥競爭的實質性障礙。

So generic versions of injectable solutions have to demonstrate that they are quantitatively and qualitatively the same in terms of an active ingredients in order to obtain a designation from the FDA as substitutable. In our view, it's going to be very difficult for a generic to design around these patent claims while also demonstrating substitutability to the FDA. So we feel good about the patent claims.

因此，注射溶液的通用版本必須證明它們在活性成分方面在數量和質量上是相同的，才能獲得 FDA 的可替代品稱號。我們認為，仿製藥很難圍繞這些專利權利要求進行設計，同時又向 FDA 展示可替代性。所以我們對專利權利要求感到滿意。

In terms of -- the second question was you were asking about the NDA process, can you clarify that question?

就第二個問題而言，您問的是 NDA 流程，您能澄清這個問題嗎？

Yes, I guess, your strategy, your legal defense strategy to deal with any potential NDA filers that you might come across. I think we've seen that recently in the industry happen at an early stage of launch. So I just want to see if you had any problem.

是的，我想，你的策略，你的法律辯護策略來處理你可能遇到的任何潛在的 NDA 申報者。我認為我們最近在行業中看到了這種情況在發布的早期階段發生的情況。所以我只是想看看你是否有任何問題。

It can't really happen at the early stage. So let's clarify a couple of things. Because we have NCE exclusivity on -- related to taurolidine, the taurolidine component of DefenCath. That NCE exclusivity means that a generic filer who is not challenging our patent can't even submit an application for 5 years. One, that is challenging, and the patent -- can submit it in 4 years.

這在早期階段是不可能真正發生的。讓我們澄清一些事情。因為我們擁有與牛磺羅定（DefenCath 的牛磺羅定成分）相關的 NCE 獨家權。 NCE 排他性意味著不挑戰我們專利的通用申請人甚至在 5 年內都無法提交申請。第一，這是具有挑戰性的，而且專利——可以在 4 年內提交。

So we've got quite a lot of time before someone can even submit. And the 10.5 years that we do have means, regardless of patents, an NDA can't be approved for 10.5 years. So there's quite a lot of time between now and when I think we do need to comment on IP litigation strategy, let's say.

因此，在有人提交之前，我們還有很長的時間。我們擁有的 10.5 年意味著，無論專利如何，新藥申請在 10.5 年內都無法獲得批准。因此，從現在到我認為我們確實需要對知識產權訴訟策略發表評論之間還有相當長的時間。

(Operator Instructions) The next question will be from Serge Belanger from Needham & Company.

（操作員說明）下一個問題將由來自 Needham & Company 的 Serge Belanger 提出。

A couple of questions for us. I guess, first, on the NTAP reimbursement. I think the most recent approval included a 20% bump on the prior total that was approved. So just curious what drove that pretty significant bump. And how does that price level for -- how is that reimbursement level kind of inform your pricing for the outpatient segment?

有幾個問題要問我們。我想，首先是關於 NTAP 報銷。我認為最近的批准比之前批准的總數增加了 20%。所以只是好奇是什麼推動瞭如此顯著的增長。這個價格水平如何影響門診部分的定價？

Okay. Thanks, Serge. So in terms of the NTAP and the application, migrating from the 5 mL to the 3 mL essentially meant that we -- for each patient, you're getting 2- to 3-milliliter vials, which is 6 milliliters of liquid. So the amount of liquid dispensed increases. So that's a large portion of the increase in the 19.5 vials as opposed to 9.5, right, that were in the original NTAP application. So that drives the most of the change in the NTAP.

好的。謝謝，塞爾日。因此，就 NTAP 和應用而言，從 5 mL 遷移到 3 mL 本質上意味著我們為每位患者提供 2 至 3 毫升小瓶，即 6 毫升液體。因此分配的液體量增加。因此，這是 19.5 瓶增量的很大一部分，而不是最初 NTAP 應用中的 9.5 瓶，對吧。因此，這推動了 NTAP 的大部分變化。

The second part of your question was around outpatient pricing?

您問題的第二部分是關於門診定價？

Yes. Does this NTAP reimbursement inform the pricing? Yes.

是的。此 NTAP 報銷是否告知定價？是的。

Yes, I'd say that they're not necessarily related, right? We're still working on what the outpatient and inpatient pricing strategy is going to be, right? So we have an NTAP, which is reimbursement to the health care institution, but it may not necessarily be reflective of what the true net price is going to be, right, to the institutions.

是的，我想說它們沒有必然的關係，對嗎？我們仍在研究門診和住院的定價策略，對吧？因此，我們有一個 NTAP，它是對醫療保健機構的報銷，但它可能不一定反映機構的真實淨價格。

And I mean, we've said, on the outpatient side, net pricing is going to be materially lower, right? So we're not going to guide today as to just how much lower and where we see that going. But we understand that there are different therapeutic segments, different patient size to patient population. So the pricing is going to have to be different in those 2 settings.

我的意思是，我們已經說過，在門診方面，淨定價將會大幅降低，對嗎？因此，今天我們不會就具體下降多少以及我們認為下降的方向進行指導。但我們知道有不同的治療領域、不同的患者規模和人群。因此，這兩種設置的定價必須有所不同。

Okay. And just thinking ahead of a product launch early next year, especially in the inpatient setting. How should we think about kind of the trajectory? Do you expect each facility will do pilot studies and economic studies before they implement or incorporate the product that's part of the practice?

好的。只是在明年初推出產品之前就考慮一​​下，尤其是在住院環境中。我們應該如何思考軌蹟的類型？您是否期望每個工廠在實施或納入實踐中的產品之前都會進行試點研究和經濟研究？

Look, I think, right now, we're having a lot of conversations with institutions of what's going to be required to work through the P&T process. I think with the initial phase of the launch, it's going to take some time to work through the P&T process for each system. Some are going to be faster than others. Obviously, the conversations and partnerships we're pursuing right now are going to lay the groundwork for a better launch.

我認為，現在我們正在與機構進行大量對話，討論完成 P&T 流程所需的內容。我認為在發布的初始階段，需要一些時間來完成每個系統的 P&T 流程。有些人會比其他人更快。顯然，我們現在正在進行的對話和合作將為更好的發布奠定基礎。

I think, Erin, do you want to provide any more color?

我想，艾琳，你想提供更多的顏色嗎？

Sure. Thanks, Joe. Yes, to that point, we have had -- we're running in parallel strategic partnership discussions as well as obviously a full commercial launch. It's dependent on the institution, right? Some are heavier lift than others. And that's part of the segmentation and analytics that we're running right now is to understand who will want to do pilots, who will take this for face value, what's the ease of getting on formulary.

當然。謝謝，喬。是的，到目前為止，我們已經進行了並行的戰略合作夥伴討論，並且顯然還進行了全面的商業發布。這取決於機構，對嗎？有些比其他的升力重。這是我們現在正在進行的細分和分析的一部分，目的是了解誰想要進行試點，誰會認為這是表面價值，獲得處方的難易程度如何。

And frankly, what are the relationships, right, the physician champions that can help shepherd that process through. So to your -- to answer your question, it's institution dependent.

坦率地說，有哪些關係，對吧，醫生擁護者可以幫助引導這一過程。因此，要回答你的問題，這取決於機構。

And ladies and gentlemen, at this time, I'd like to turn the call back over to Monique Kosse for additional questions from our audience.

女士們、先生們，此時，我想將電話轉回莫妮克·科斯（Monique Kosse），詢問觀眾的其他問題。

Thank you, operator. We'll now go -- we did get some questions in, written questions, and I will read those questions here. Okay. The first question, there's a couple of parts to it. When would you expect FDA to inspect your CMO 1? And why do you think the outcome will be different this time? What's changed? And does the CMO have any other NDAs pending?

謝謝你，接線員。我們現在開始——我們確實收到了一些書面問題，我將在這裡閱讀這些問題。好的。第一個問題有幾個部分。您預計 FDA 何時會檢查您的 CMO 1？為什麼你認為這次的結果會有所不同？發生了什麼變化？ CMO 是否還有其他未決的 NDA？

Okay. Thanks, Monique. Those are good questions. I think in terms of what might be different this time, the last 8 months, we've seen significant increase in engagement of the CMO with external consultants, and those consultants have deep FDA experience. So we're encouraged by what we've seen in terms of corrective action implementation and those corrective actions that came out of the original inspection, and we're optimistic they are ready for potential PAI reinspection now.

好的。謝謝，莫妮克。這些都是好問題。我認為這一次可能會有所不同，在過去 8 個月中，我們看到 CMO 與外部顧問的互動顯著增加，而且這些顧問擁有豐富的 FDA 經驗。因此，我們對糾正措施實施情況以及最初檢查中得出的糾正措施感到鼓舞，我們樂觀地認為他們現在已經為潛在的 PAI 重新檢查做好了準備。

So that said, we don't own the CMO. So all we can do is provide support. And once we do have PAI date, to also use our best efforts to do final prep for inspection, and post any inspection, help them address any new observations that could arise. But I think we're optimistic with what we've seen from the site in terms of implementing corrective actions.

也就是說，我們不擁有 CMO。所以我們能做的就是提供支持。一旦我們確定了 PAI 日期，我們也會盡最大努力為檢查做最後的準備，並發布任何檢查，幫助他們解決可能出現的任何新觀察結果。但我認為我們對從該網站看到的實施糾正措施持樂觀態度。

In terms of other NDA filings, we've been told that they have other NDAs pending from different sites in Western Europe that could potentially get a PAI before we do. So we're certainly going to be in close contact with them to understand any FDA observations at other facilities or anything that could impact to our application.

就其他 NDA 申請而言，我們被告知他們還有來自西歐不同地點的其他 NDA 正在等待中，這些地點可能會在我們之前獲得 PAI。因此，我們肯定會與他們保持密切聯繫，以了解 FDA 對其他設施的觀察結果或任何可能影響我們申請的因素。

Okay. Thank you. All right. Another question here from the audience. Can you provide more color on why the FDA wanted 2 sources that happened in the application? And what will happen if the initial supplier of heparin has not resolved its warning letter before your target action date?

好的。謝謝。好的。還有一個來自觀眾的問題。您能否提供更多信息來解釋為什麼 FDA 想要申請中發生的 2 個來源？如果肝素的初始供應商未在您的目標行動日期之前解決其警告信，將會發生什麼？

Okay. Thanks. I think the first part of that question, I think Phoebe did a good job addressing the script, but it's pretty straightforward. We were hoping to get a Class 1 submission with the original heparin source, given that the CMO and the API supplier had rectified the compliance concerns, or in our view, they rectified the compliance concerns.

好的。謝謝。我認為這個問題的第一部分，我認為菲比在處理劇本方面做得很好，但它非常簡單。鑑於 CMO 和 API 供應商已經糾正了合規問題，或者在我們看來，他們糾正了合規問題，我們希望獲得原始肝素來源的 1 類提交。

But during the FDA meeting, I think the agency strongly encouraged us to submit data from our new source of heparin, but also include the existing heparin data to give them more time to evaluate that site's compliance. I think should we get to our target action date and the FDA has not yet resolved that warning letter, we're free to withdraw that heparin supplier and only go with the new source, if that's what's needed to pursue approval.

但在 FDA 會議期間，我認為該機構強烈鼓勵我們提交來自新肝素來源的數據，但也包括現有的肝素數據，以便他們有更多時間評估該站點的合規性。我認為，如果我們到達目標行動日期，而 FDA 尚未解決該警告信，我們可以自由地撤回該肝素供應商，並且僅使用新來源（如果這是尋求批准所需的）。

Okay. Okay. Thank you, Joe. And last question here from the audience. How are you thinking about the timing of ramp-up of field-based personnel? And is there a scenario where you hire the field team ahead of NDA approval? And how about on the medical side?

好的。好的。謝謝你，喬。還有觀眾提出的最後一個問題。您如何考慮增加外地人員的時間？是否存在在 NDA 批准之前聘請現場團隊的情況？那麼在醫療方面呢？

Okay. Yes. I guess we think about commercial medical a little bit differently. So let's assume that we get a PDUFA date that's in mid-November. There's going to be milestone events that happen along the course of the summer, in early fall that could give us confidence, right, to hire more commercial personnel at risk. I think most importantly, any PAI inspection that the FDA could do at our CMO, right, that bolsters our confidence.

好的。是的。我想我們對商業醫療的看法有點不同。因此，假設我們得到的 PDUFA 日期是 11 月中旬。夏季和初秋期間將會發生一些里程碑事件，這可能會給我們信心，讓我們有信心僱傭更多有風險的商業人員。我認為最重要的是，FDA 可以對我們的 CMO 進行的任何 PAI 檢查，這都會增強我們的信心。

As I mentioned in the script, we're already adding key leader positions across functions. But when it comes to the, call it, the key -- the field-based key account managers, ideally, what we want to do is have those personnel identified and with offer letters in hand around the time of a potential approval and then onboard them immediately after. And that's certainly what we're going to try to do.

正如我在腳本中提到的，我們已經在各個職能部門中添加了關鍵領導職位。但是，當涉及到關鍵的現場大客戶經理時，理想情況下，我們想要做的是在潛在批准期間確定這些人員並拿到錄用通知書，然後上崗他們緊接著。這當然是我們要嘗試做的事情。

On the medical side, it's a bit different. We really need to have the full team staffed up ahead of any potential approval. We have 4 MSLs on board right now. Those are medical science liaisons, and we'll probably seek to have around 8 at the time of launch.

在醫學方面，情況有些不同。在任何潛在的批准之前，我們確實需要配備完整的團隊人員。我們現在船上有 4 名 MSL。這些是醫學科學聯絡員，我們可能會在啟動時尋求 8 名左右的聯絡員。

So these roles are critical, as they can have medical professional to medical professional types of conversations with physicians around disease state awareness, where commercial personnel are much more limited in what they can discuss. And we're not permitted to do any pre-approval marketing of the product. Regardless, to be successful, we're going to need to recruit qualified, capable people on both sides of the business, achieve formulary access, contract appropriately and then get channel pull-through. So...

因此，這些角色至關重要，因為他們可以與醫生圍繞疾病狀態意識進行醫療專業人員之間的對話，而商業人員可以討論的內容則受到更多限制。我們不允許對該產品進行任何預先批准的營銷。無論如何，為了取得成功，我們需要在業務雙方招聘合格、有能力的人才，實現規定的准入，適當地簽訂合同，然後獲得渠道拉通。所以...

Okay. Okay. Thank you. And that does conclude that. There are no further questions here -- written online here. I'll turn it back over to the operator now to close the call.

好的。好的。謝謝。這確實得出了這樣的結論。這裡沒有更多問題——在線寫在這裡。我現在會將其轉回給接線員以結束通話。

Absolutely. Thank you. And this concludes our question-and-answer session, and thus concludes today's call. We thank you very much for attending today's presentation. At this time, you may now disconnect your lines. Take care.

絕對地。謝謝。我們的問答環節到此結束，今天的電話會議也到此結束。我們非常感謝您參加今天的演講。此時，您可以斷開線路。小心。