Fennec Pharmaceuticals Inc (FENC) 2024 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals first quarter 2024 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference call is being recorded. Now I'd like turn the conference over to Fennec's Chief Financial Officer, Robert Andrade. Please go ahead.

早安，女士們、先生們，歡迎參加 Fennec Pharmaceuticals 2024 年第一季財報和公司更新電話會議。（操作員說明）提醒一下，今天的電話會議正在錄音。現在我想將會議交給 Fennec 的財務長 Robert Andrade。請繼續。

Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals first quarter 2024 earnings conference call, During which we will review our financial results as well as provide a general business update.

謝謝接線員，大家早安。我們感謝您今天參加 Fennec Pharmaceuticals 2024 年第一季財報電話會議，會議期間我們將審查我們的財務表現並提供一般業務更新。

Joining me from Fennec this morning are Rosty Raykov, our Chief Executive Officer; and Adrian Haigh , our Chief Operating Officer. Before we begin, I would like to remind you that during this call, the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements.

今天早上，我們的執行長 Rosty Raykov 從 Fennec 與我一起來。和我們的營運長 Adrian Haigh。在我們開始之前，我想提醒您，在這次電話會議中，公司將做出前瞻性陳述，這些陳述存在風險和不確定性，可能導致實際結果與前瞻性陳述中討論的結果不同。

Reference to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the United States Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date.

今天的新聞稿中提到了這些風險和不確定性，並在公司向美國證券交易委員會提交的定期和當前事件文件中詳細揭露了這些風險和不確定性。此外，本次電話會議中所做的任何前瞻性陳述僅代表我們截至今天的觀點，不應被視為代表我們在任何後續日期的觀點。

We specifically disclaim any obligation to update or revise any forward-looking statements. This conference call is being recorded for audio rebroadcast on Fennec website, www.fennecpharma.com, where it will be available for the next 30 days.

我們特別聲明不承擔更新或修改任何前瞻性陳述的義務。本次電話會議正在錄製並在 Fennec 網站 www.fennecpharma.com 上進行音訊重播，並將在未來 30 天內提供。

With that, I will now turn the call over to our Chief Executive Officer, Rosty Raykov. Rosty?

現在，我將把電話轉給我們的執行長羅斯蒂·雷科夫 (Rosty Raykov)。羅斯蒂？

Thank you, Robert, and good morning, everyone. On today's call, we’ll detail our first quarter financial results, all of which were outlined in our earnings press release issue this morning prior to this call. We'll also discuss ongoing commercial launch efforts and progress that we're making with PEDMARK in the US and abroad, following the exclusive licensing agreement announcement we executed in March with Norgine to commercialize PEDMARQSI in Europe, Australia and New Zealand.

謝謝羅伯特，大家早安。在今天的電話會議上，我們將詳細介紹第一季的財務業績，所有這些都在今天早上召開的電話會議之前的收益新聞稿中概述。繼我們於 3 月與 Norgine 簽署獨家許可協議以在歐洲、澳洲和紐西蘭商業化 PEDMARK 後，我們還將討論我們與 PEDMARK 在美國和海外正在進行的商業發布工作和進展。

In the first quarter, PEDMARK delivered total net revenues to $25.4 million, including $18 million in licensing revenues from Norgine transaction and $7.4 million in net PEDMARK product sales. Robert will further elaborate on the $18 million in the licensing revenue related to the Norgine transaction, but to be clear, we received $43.2 million from the transaction, which is reflected on our balance sheet as of March 31, and cash of $51.2 million.

第一季度，PEDMARK 的總淨收入達到 2,540 萬美元，其中包括來自 Norgine 交易的 1,800 萬美元授權收入和 PEDMARK 產品淨銷售額 740 萬美元。Robert 將進一步詳細說明與Norgine 交易相關的1,800 萬美元授權收入，但需要明確的是，我們從該交易中獲得了4,320 萬美元（反映在截至3 月31 日的資產負債表上），以及現金5120萬美元。

We believe that a couple of things affected PEDMARK sales during the first quarter of this year. First, the public reminder that the US FDA issued to healthcare professional organizations in January stating that PEDMARK is not substitutable with auto sodium thiosulfate products may have caused some unintended confusion in the marketplace.

我們認為，有幾件事影響了今年第一季 PEDMARK 的銷售。首先，美國 FDA 1 月向醫療保健專業組織發出的公開提醒，顯示 PEDMARK 不能取代車用硫代硫酸鈉產品，這可能在市場上造成了一些意想不到的混亂。

Initially the professional affairs and stakeholder engagement staff at the FDA issued the potential health risks with substitution as a targeted outreach to the following organizations. Alliance for Pharmacy Compounding, American Academy of Pediatrics, American College of Apothecaries, American Hospital Association, American Pharmacies Association, American Society of Medical Oncology, American Society of Health System Pharmacies, Association of American Cancer Institutes, Children's Hospital Association, Federation of American Hospitals, Hematology, Oncology Pharmacy Association, International Academy of Compounding Pharmacies, and Professional Compounding Centers of America.

最初，FDA 的專業事務和利害關係人參與人員向以下組織發布了潛在的健康風險和替代品，作為有針對性的外展活動。配藥聯盟、美國兒科學會、美國藥劑師學院、美國醫院協會、美國藥房協會、美國腫瘤內科學會、美國衛生系統藥房協會、美國癌症研究所協會、兒童醫院協會、美國醫院聯合會、血液學、腫瘤學藥學協會、國際調配藥學院及美國專業調配中心。

We believe that in turn some of these organizations communicated the FDA safety message to their respective members. Recently the Office of New Drugs and the FDA added the safety communication issued by CDARS Professional Affairs and Stakeholders Engagement staff to PEDMARK approval at the FDA page.

我們相信，其中一些組織反過來向各自的成員傳達了 FDA 的安全訊息。最近，新藥辦公室和 FDA 在 FDA 頁面上將 CDARS 專業事務和利益相關者參與人員發布的安全通訊添加到 PEDMARK 批准中。

Now it is clear that substitution posts potential health risks including potassium chloride exposure which at high doses can lead to increased risk of acute cardiac events and other serious adverse reactions. Potassium chloride is not present in PEDMARK.

現在很明顯，替代品會帶來潛在的健康風險，包括接觸氯化鉀，高劑量可能導致急性心臟事件和其他嚴重不良反應的風險增加。PEDMARK 中不存在氯化鉀。

Overexposure to boric acid can cause health risks including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia, and indigestion. Although PEDMARK also contains boric acid, it is at a lower concentration than other STS products. Over-exposure to sodium nitrate, which can lead to health risks including Methemoglobinemia. Sodium nitrate is called packaged with sodium thiosulfate as a separate vial in some products and it's not present in PEDMARK.

過度接觸硼酸會導致健康風險，包括頭痛、體溫過低、煩躁、疲倦、腎損傷、皮膚炎、脫髮、厭食和消化不良。儘管 PEDMARK 也含有硼酸，但其濃度低於其他 STS 產品。過度暴露於硝酸鈉可能導致健康風險，包括高鐵血紅蛋白血症。在某些產品中，硝酸鈉與硫代硫酸鈉一起包裝為單獨的小瓶，PEDMARK 中不存在。

Unfortunately, Fennec continues to see unlawful compounding of copies of PEDMARK with pediatric hospital pharmacies. Unnecessarily putting costs in front of children's safety. The majority of these hospitals are affiliated with Children's Oncology Group and thus far the FDA safety communication has not changed their behavior.

不幸的是，Fennec 繼續看到兒科醫院藥房非法混合 PEDMARK 的情況。不必要地將成本置於兒童安全之上。這些醫院中的大多數都隸屬於兒童腫瘤學組，迄今為止 FDA 的安全溝通尚未改變他們的行為。

Fennec continues to diligently work with the FDA to address this issue. Additionally, prior to April 1st of this year, our J-code did not differentiate between PEDMARK and other formulations of STS. As a consequence, which we discussed in our call last quarter, there had been some confusion and some impact to the adaptation of PEDMARK. The good news is that, as of April 1, this issue has been fully resolved with CMS amending our J-code to specify PEDMARK.

Fennec 繼續與 FDA 努力合作解決這個問題。此外，在今年 4 月 1 日之前，我們的 J 代碼沒有區分 PEDMARK 和 STS 的其他配方。因此，我們在上個季度的電話會議中討論了這一點，PEDMARK 的適應出現了一些混亂和一些影響。好消息是，截至 4 月 1 日，這個問題已透過 CMS 修改我們的 J 代碼以指定 PEDMARK 完全解決。

Now that this change is effective, we expect uptake to improve in the quarters to follow. Despite significant challenges, we remain optimistic that it will be an exciting year for Fennec given the strong performance with PEDMARK in 2023, the first full fiscal year following our US commercial launch. We're confident in our ability to navigate through these marketplace challenges to achieve our long-term objectives.

既然這項變更已經生效，我們預計接下來幾季的採用率將會提高。儘管面臨重大挑戰，但我們仍然樂觀地認為，鑑於 PEDMARK 在 2023 年（我們在美國商業推出後的第一個完整財年）的強勁表現，這對 Fennec 來說將是激動人心的一年。我們對應對這些市場挑戰以實現我們的長期目標的能力充滿信心。

Our outlook over the next few quarters will largely depend on our ability to successfully target the community hospitals and infusion centers, the treat in the outpatient setting, all the pediatric patients within our label, and the NCCN guidelines for adolescents and young adults.

我們未來幾季的前景將在很大程度上取決於我們成功瞄準社區醫院和輸液中心、門診治療、我們標籤內的所有兒科患者以及針對青少年和年輕人的 NCCN 指南的能力。

PEDMARK continues to have growth and favorable payer coverage as evidenced by payer approval, approved use prescription claims with commercial insurance plans and Medicare Part D plans. Regarding our partnership with Norgine to commercialize PEDMARQSI in Europe, Australia and New Zealand efforts are well underway in these territories with a targeted launch date of fourth quarter this year.

PEDMARK 繼續保持成長和有利的付款人覆蓋範圍，這可以透過付款人批准、商業保險計劃和醫療保險 D 部分計劃的批准使用處方索賠來證明。關於我們與 Norgine 合作在歐洲、澳洲和紐西蘭將 PEDMARQSI 商業化的努力正在這些地區順利進行，目標推出日期為今年第四季。

PEDMARQSI is the first and only approved therapy in the EU and UK for prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to 18 years of age with localized non-metastatic solid tumors. As a reminder, under the terms of the licensing agreement, Fennec received approximately $43.2 million in a prompt consideration and the potential of up to approximately $230 million in additional commercial and regulatory milestone payments and tiered royalties on net sales of PEDMARQSI in the licensed territories up to the mid -20s.

PEDMARQSI 是歐盟和英國第一個也是唯一一個核准的治療方法，用於預防 1 個月至 18 歲局部非轉移性實體腫瘤患者順鉑化療引起的耳毒性。提醒一下，根據許可協議的條款，Fennec 立即獲得約 4320 萬美元的對價，並有可能獲得高達約 2.3 億美元的額外商業和監管里程碑付款以及 PEDMARQSI 在許可地區淨銷售額的分級特許權使用費到-20年代中期。

Norgine will be responsible for all commercialization activities in the licensed territories and will hold all marketing authorizations. As we previously communicated, this partnership represents an important step in achieving our mission of expanding PEDMARQSI patients across the globe who are at risk of suffering from cisplatin-induced ototoxicity.

Norgine 將負責許可地區的所有商業化活動，並持有所有行銷授權。正如我們先前所傳達的，這種合作關係代表了我們實現在全球範圍內擴大有順鉑引起的耳毒性風險的 PEDMARQSI 患者的使命的重要一步。

Their terms provided us with many important benefits, including an upfront payment for the solidifying our balance sheet, tracking economic terms providing meaningful participation in the ex-US success of PEDMARQSI and, in important and experienced partner to successfully launch PEDMARQSI in the licensed territories.

他們的條款為我們提供了許多重要的好處，包括用於鞏固我們的資產負債表的預付款、追蹤經濟條款，為PEDMARQSI 在美國以外的成功提供有意義的參與，以及重要且經驗豐富的合作夥伴在許可地區成功推出PEDARQSI。

With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations. Adrian?

現在，我將把電話轉給阿德里安，他將提供我們商業策略和營運的最新資訊。阿德里安？

Thanks, Rosty. As Rosty has said, in the first quarter, our salesforce has switched the focus of their activities to the community-treated AYA population that fall within our label. We believe that there are many more patients in this segment compared to the inpatient hospital-treated pediatric population.

謝謝，羅斯蒂。正如 Rosty 所說，在第一季度，我們的銷售人員已將活動重點轉向我們品牌內接受社區治療的 AYA 人群。我們相信，與住院治療的兒科族群相比，這一細分市場的患者數量要多得多。

Additionally, these older patients require approximately four times as much PEDMARK as the younger patients. On our prior quarterly call, I alluded to the challenges that we faced during the early stages of our relaunch into this segment. Prior to April 1, 2024, our J-Code did not differentiate between PEDMARK and other formulations of STS.

此外，這些老年患者所需的 PEDMARK 大約是年輕患者的四倍。在我們之前的季度電話會議上，我提到了我們在重新進入這一領域的早期階段所面臨的挑戰。在 2024 年 4 月 1 日之前，我們的 J 代碼沒有區分 PEDMARK 和 STS 的其他配方。

Consequently, there has been some confusion and some impact on the adoption of PEDMARK. In January, CMS did two important things to address this matter. First, they issued a new J-Code for the Hope STS product, and second, they amended Fennec’s J-Code to specify PEDMARK. Encouragingly, CMS also stated that the two formulations are not interchangeable.

因此，PEDMARK 的採用出現了一些混亂和一些影響。一月份，CMS 做了兩件重要的事情來解決這個問題。首先，他們為 Hope STS 產品發布了新的 J 代碼，其次，他們修改了 Fennec 的 J 代碼以指定 PEDMARK。令人鼓舞的是，CMS 也表示這兩種配方不可互換。

As a reminder, the new J-Code specifying PEDMARK was not active until April 1. It is also important to understand that the J-Code becoming effective on April 1 is not a simple on-off event. It is taking some considerable time to get the code uploaded into the electronic prescribing systems and payment plans, and this task is still ongoing.

提醒一下，指定 PEDMARK 的新 J 代碼直到 4 月 1 日才生效。同樣重要的是要了解，J 代碼於 4 月 1 日生效並不是一個簡單的開關事件。將代碼上傳到電子處方系統和付款計劃需要相當長的時間，而這項任務仍在進行中。

Additionally, we are awaiting updates to the NCCN Compendia and others, for example, drug Dex and Lexicon. These Compendia are the proof source for payers to reimburse PEDMARK, and this process is expected to take 60 days to 90 days to complete and validate from April 1.

此外，我們正在等待 NCCN Compendia 和其他藥物（例如 drug Dex 和 Lexicon）的更新。這些 Compendia 是付款人償還 PEDMARK 的證據來源，從 4 月 1 日起，這一過程預計需要 60 天到 90 天的時間才能完成和驗證。

Another ongoing challenge has been extending infusion center hours to accommodate the time it takes to administer PEDMARK six hours after the cisplatin infusion. Again, this doesn't happen overnight, and requires the intervention of senior management at the Infusion Center. We've had greater penetration in those centers that are open for 16 hours to 24 hours.

另一個持續的挑戰是延長輸注中心的工作時間，以適應順鉑輸注後 6 小時給予 PEDMARK 所需的時間。同樣，這不會在一夜之間發生，需要輸液中心高階管理層的干預。我們在那些營業 16 小時到 24 小時的中心有更大的滲透率。

Despite these acute challenges, we remain encouraged by the reaction to PEDMARK and the possibility to dramatically improve the quality of life for cancer survivors by preventing or significantly reducing hearing loss caused by cisplatin. We are confident that once these logistical hurdles are overcome, PEDMARK will become the standard of care and be routinely used in the AYA population.

儘管面臨這些嚴峻的挑戰，我們仍然對 PEDMARK 的反應以及透過預防或顯著減少順鉑引起的聽力損失來顯著改善癌症倖存者的生活品質的可能性感到鼓舞。我們相信，一旦克服這些後勤障礙，PEDMARK 將成為護理標準，並在 AYA 族群中常規使用。

We've had a very busy conference season with participation in 11 regional oncology conferences, as well as seven key scientific meetings, including the American Society of Pediatric Hematology Oncology, the Community Oncology Alliance, the National Comprehensive Cancer Network, and the American Academy of Audiology Annual conferences.

我們度過了一個非常繁忙的會議季，參加了 11 個區域腫瘤學會議以及 7 個重要的科學會議，其中包括美國兒科血液腫瘤學會、社區腫瘤學聯盟、國家綜合癌症網絡和美國癌症學會聽力學年會。

And we're looking forward to ASCO, where we intend to spread the word to as many AYA treating physicians as possible. So in closing, we see promising opportunities for PEDMARK, including the steps we take into educating the marketplace, along with executing on our commercialization plans. And we look forward to the acceleration in revenue in the coming months.

我們期待 ASCO，在那裡我們打算向盡可能多的 AYA 治療醫生傳播這一訊息。因此，最後，我們看到 PEDMARK 充滿希望的機會，包括我們為教育市場所採取的步驟，以及執行我們的商業化計劃。我們期待未來幾個月營收加速成長。

With that, I'll turn the call over to Robert to go over the financials for the quarter.

這樣，我將把電話轉給羅伯特，讓他檢查本季的財務狀況。

Thank you, Adrian. Our press release contains details of our financial results for the first quarter of 2024, which can be viewed on the Investors and Media section of our website. Rather than read through all of those details as previous conference calls, my comments today will focus on some key financial results.

謝謝你，阿德里安。我們的新聞稿包含 2024 年第一季財務業績的詳細信息，您可以在我們網站的投資者和媒體部分查看。我今天的評論將重點放在一些關鍵的財務業績，而不是像之前的電話會議那樣仔細閱讀所有這些細節。

The company recorded PEDMARK net sales of $7.4 million for the first quarter of 2024. Net sales in the first quarter were more highly impacted than previous quarters by discounts, including an impact from select product that was returned due to expiry. The return product was due to production and launch dynamics in the first year after launch, which we don't anticipate to continue beyond the first quarter of 2024.

該公司 2024 年第一季 PEDMARK 淨銷售額為 740 萬美元。第一季的淨銷售額比前幾季受到折扣的影響更大，其中包括因過期而退回的精選產品的影響。退回產品是由於發布後第一年的生產和發布動態，我們預計這種情況不會持續到 2024 年第一季之後。

Total net sales for the first quarter were $25.4 million, which, as mentioned, included $18 million for the accounting of licensing revenues for the Norgine transaction. The company evaluated the Norgine license agreement under ASC 606 and concluded that Norgine represents a customer in the transaction. As such, a portion of the transaction price was recognized as license revenue in the first quarter of 2024, and a portion of the transaction price associated with the material right is deferred and is reflected as deferred revenue.

第一季的總淨銷售額為 2,540 萬美元，其中如前所述，其中包括用於 Norgine 交易許可收入核算的 1,800 萬美元。該公司根據 ASC 606 評估了 Norgine 許可協議，並得出結論：Norgine 在交易中代表客戶。因此，交易價格的一部分在2024年第一季被確認為授權收入，與實質權利相關的交易價格的一部分被遞延並反映為遞延收入。

To be clear, for the three months ended March 31, 2024, the company did not recognize any milestone or royalty revenue payments from the Norgine transaction. G&A expenses for the first quarter of 2024 were $5.9 million, which compares to $4.3 million in the fourth quarter of 2023.

需要明確的是，截至 2024 年 3 月 31 日的三個月，該公司並未確認 Norgine 交易產生的任何里程碑或特許權使用費收入。2024 年第一季的一般管理費用為 590 萬美元，而 2023 年第四季為 430 萬美元。

This increase is largely attributable to pre-commercialization expenses in preparation for the potential European launch or partnership. The company recorded $5.2 million in selling and marketing expenses in the first quarter of 2024, compared to $2.5 million in the fourth quarter of 2023. The increase was largely attributable to higher payroll and increased marketing expenses related to the previously mentioned AYA initiatives.

這一增長主要歸因於為潛在的歐洲推出或合作夥伴關係做準備的預商業化費用。該公司 2024 年第一季的銷售和行銷費用為 520 萬美元，而 2023 年第四季為 250 萬美元。這一增長主要歸因於與前面提到的 AYA 計劃相關的工資增加和行銷費用增加。

And finally, on our cash position, we ended the first quarter with approximately $51.2 million in cash, cash equivalents and investment securities, which includes the approximately $43 million received from the licensing of Europe, Australia and New Zealand to Norgine.

最後，就我們的現金狀況而言，第一季結束時，我們擁有約 5,120 萬美元的現金、現金等價物和投資證券，其中包括從歐洲、澳洲和紐西蘭向 Norgine 的許可獲得的約 4,300 萬美元。

Further, as a reminder, the next anticipated milestone related to our Norgine agreement will be obtaining pricing approval in Germany in which Fennec will receive a EUR10 million milestone payment. Further, Fennec's royalties on net sales will commence in the mid-teens percentages once PEDMARQSI is launched later in 2024.

此外，提醒一下，與我們的 Norgine 協議相關的下一個預期里程碑將是在德國獲得定價批准，其中 Fennec 將獲得 1000 萬歐元的里程碑付款。此外，一旦 PEDMARQSI 於 2024 年稍後推出，Fennec 的淨銷售額特許權使用費將開始達到百分之十幾。

We anticipate that our cash, cash equivalents and investment securities as of March 31, 2024, when coupled with PEDMARK revenue assumptions and the recently announced license agreement for Europe in March ‘24 will be sufficient to fund our planned operations for at least the next 12 months.

我們預計，截至2024 年3 月31 日，我們的現金、現金等價物和投資證券，再加上PEDMARK 收入假設和最近於3 月24 日宣布的歐洲許可協議，將足以為我們的計劃運營提供資金，至少未來 12 個月。

And operator, with that, we are ready for questions.

接線員，現在我們準備好回答問題了。

(Operator Instructions) Charles Duncan, Cantor Fitzgerald.

（操作員說明）查爾斯鄧肯、坎托菲茨傑拉德。

Yes, good morning, Rosty and team. Thanks for taking the questions. And congrats on the progress in the quarter with the Norgine collaboration. Had a couple of questions regarding the unlawful compounding and you mentioned children oncology group. I guess I'm wondering if you could provide some additional color on the initiatives that you're taking to really correct this behavior. And then can you provide us any color on the level of compounding that you anticipate to occur in Europe versus here? Thanks.

是的，早上好，羅斯蒂和團隊。感謝您提出問題。並祝賀本季與 Norgine 的合作取得的進展。有幾個關於非法混合的問題，您提到了兒童腫瘤學小組。我想我想知道您是否可以就您為真正糾正這種行為而採取的舉措提供一些額外的資訊。然後您能否向我們提供您預計在歐洲與這裡發生的複合水平的任何顏色？謝謝。

Hi, Charles, I'll take this. Yes, so if you saw from the FDA announcement and then subsequently putting that announcement on the approval of PEDMARK at the FDA page. The FDA is taking this issue very seriously. The problem that we run into at the pediatric hospital level is that they have a committee called the Expensive Drug Committee where -- and typically these committees are stacked with folks in the hospital that are not pediatric oncologists or pharmacists for that matter. But they're really there to do everything possible but to avoid paying for an expensive drug, which they consider PEDMARK to be one. So this is what we're facing.

嗨，查爾斯，我會接受這個。是的，如果您看到 FDA 的公告，然後將該公告放在 FDA 頁面上的 PEDMARK 批准上。FDA 非常重視這個問題。我們在兒科醫院層級遇到的問題是，他們有一個名為「昂貴藥物委員會」的委員會，通常這些委員會中都是醫院裡的非兒科腫瘤學家或藥劑師的人員。但他們確實會盡一切可能，但為了避免支付昂貴的藥物費用，他們認為 PEDMARK 就是其中之一。這就是我們面臨的情況。

In terms of initiatives, what I would say is that we continue to work with the FDA on this. The FDA is very concerned. There is significant safety risk associated with the use of compounded products in this vulnerable population, particularly if you're pushing over 15 minutes to make a copy of PEDMARK, a very large and significant dose of potassium chloride in younger children. So with that, I think our engagement with FDA is ongoing and if there's anything more to report, we will hopefully soon.

就舉措而言，我想說的是，我們將繼續與 FDA 就此展開合作。FDA 非常擔心。在這一弱勢群體中使用複合產品存在重大安全風險，特別是如果您需要花費超過 15 分鐘來複製 PEDMARK，PEDMARK 是一種針對年幼兒童的非常大且顯著劑量的氯化鉀。因此，我認為我們與 FDA 的合作仍在繼續，如果有更多資訊需要報告，我們希望很快就會報告。

In terms of Europe, what I would say is there's a bit of a difference because there you're dealing with -- so we have a pediatric use marketing authorization, which by definition gives exclusivity to the market on the data of the studies -- from the studies to, in this case, Norgine. How is that different in the United States is that you're not dealing by hospital by hospital basis, you're dealing with a healthcare system and regulations that have already been approved for the use of an older drug in a pediatric population with a 10-year exclusivity.

就歐洲而言，我想說的是，存在一些差異，因為您正在處理 - 所以我們擁有兒科使用行銷授權，根據定義，該授權賦予市場對研究數據的排他性 -在本例中，從研究到Norgine 。在美國，這有何不同之處在於，您不是按醫院進行處理，而是處理已經批准在患有 10 歲兒童的兒科人群中使用較舊藥物的醫療保健系統和法規。

So that's well understood that you're bringing in tremendous value to this vulnerable population because you've invested in these studies and you have this 10-year exclusivity. And so you're also dealing with a single payer system. So there it's really the negotiations that will be ongoing between Norgine and each respected country in terms of the price achieved. But once it happens, this drug would be available and approved by a single payer. So there should not be a significant issue with compounding in Europe.

因此，眾所周知，您為這些弱勢群體帶來了巨大的價值，因為您投資了這些研究，並且擁有 10 年的獨家經營權。因此，您也要處理單一付款人系統。因此，Norgine 與每個受尊敬的國家之間實際上將就達成的價格進行談判。但一旦發生，這種藥物將由單一付款人提供和批准。因此，在歐洲複利應該不存在重大問題。

And maybe I could turn it over to Adrian to elaborate on that as well.

也許我也可以把它交給阿德里安來詳細說明這一點。

Yes, thanks, Rosty. It's exactly as you said, we have the pediatric use marketing authorization, which is specifically designed for older products repurposed for children, and once there's an approved drug, in most of the European markets, compounding is illegal. As you can imagine, there was a lot of diligence done by the parties that were bidding for the European rights, and all of them came to the conclusion, obviously including Norgine, that compounding would not be an issue in Europe.

是的，謝謝，羅斯蒂。正如您所說，我們擁有兒科使用行銷授權，該授權是專門為兒童重新設計的舊產品而設計的，一旦有批准的藥物，在大多數歐洲市場，複合是非法的。正如你可以想像的那樣，競標歐洲權利的各方都做了很多努力，所有人都得出了這樣的結論：複利在歐洲不會成為問題，顯然也包括 Norgine。

That makes sense. One quick follow-up then for you, Adrian or Rosty, with regard to the J-Code. Nice to see that happen in April, and appreciate all the caveat with regard to the timing of that going from effective to actually effective. But when you think about either the second quarter or the second half of this year, how would you measure success beyond the obvious of revenue? What are the key operating metrics that you're looking at to see that PEDMARK get interaction in the AYA population? Thanks.

這就說得通了。Adrian 或 Rosty，請您快速跟進 J 代碼。很高興看到這在四月發生，並感謝所有關於從有效到實際有效的時間的警告。但是，當您考慮今年第二季或下半年時，除了明顯的收入之外，您將如何衡量成功？為了確保 PEDMARK 在 AYA 人群中獲得互動，您正在考慮哪些關鍵營運指標？謝謝。

Great question, Charles. So let me kind of maybe tell you how I look at the business holistically. So we got several components of this. One is our medical education. So how well do we engage and educate the staff at a community center that historically has not treated ototoxicity. So I think that's very, very critical. The second component is market access, and I think Adrian alluded to that in his comments. That's the payer coverage, which so far, we haven't had any significant issues with.

好問題，查爾斯。那麼，讓我來告訴你我如何從整體上看待這個業務。所以我們得到了其中的幾個組成部分。一是我們的醫學教育。那麼，對於歷史上從未治療過耳毒性的社區中心，我們該如何更好地吸引和教育其工作人員？所以我認為這非常非常關鍵。第二個組成部分是市場准入，我認為阿德里安在他的評論中提到了這一點。這就是付款人保險範圍，到目前為止，我們還沒有遇到任何重大問題。

The Compendia update, which is really important. Then we have to deal with field reimbursement and ultimately pull-through, and these are all ongoing activities. Then we have the logistics and distribution piece, where we are working with the office, but importantly, we must listen to these offices to make sure we can provide PEDMARK despite the six-hour gap between the spotting therapy and when a PEDMARK is administered.

概要更新，這非常重要。然後我們必須處理現場報銷並最終完成，這些都是持續進行的活動。然後我們有物流和配送部分，我們正在與辦公室合作，但重要的是，我們必須聽取這些辦公室的意見，以確保我們能夠提供 PEDMARK，儘管點滴治療和實施 PEDMARK 之間有 6 小時的間隔。

And lastly, I think it's just establishing best practices and really learning from the experiences. It is very important that we get it right. So basically, I look at this as sort of a mini pilot at the moment, what we learn from that, and how do we then scale it? And so this goes back to the on and off switch that Adrian referred to. It's like, let's get this thing right now so that when it scales, we know how to exactly do this. And then we can expect obviously a meaningful inflection points when all the barriers are sort of removed and we've learned how to navigate through this. So I hope this is helpful.

最後，我認為這只是建立最佳實踐並真正從經驗中學習。我們做對了這一點非常重要。所以基本上，我目前將其視為一個小型試點，我們從中學到了什麼，然後我們如何擴展它？這又回到了阿德里安提到的開關。就像，讓我們現在就開始做這個事情，這樣當它擴展時，我們就知道如何準確地做到這一點。然後，當所有障礙都被消除並且我們已經學會如何克服這一點時，我們顯然可以期待一個有意義的轉折點。所以我希望這會有所幫助。

Would that increased visibility occur in the second half of this year, you anticipate, Rosty?

Rosty，您預計今年下半年能見度的提升會發生嗎？

That would be my anticipation, correct.

這就是我的預期，正確的。

Yeah, as I said, I think it's taking between 60 days to 90 days to get everything loaded up into the [electronic] prescribing systems to get the Compendia updated. Just doesn't happen overnight. And once that's done, then we expect to see the inflection point. So I think you're right, second half of the year.

是的，正如我所說，我認為需要 60 天到 90 天的時間才能將所有內容加載到[電子]處方系統中以更新藥典。只是不會在一夜之間發生。一旦完成，我們預計就會看到拐點。所以我認為你是對的，下半年。

Got it. Thanks for taking the questions.

知道了。感謝您提出問題。

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning, guys. Thanks for taking the questions. So just maybe dig in a little bit on the inpatient side quickly. I understand the difficulty in setting up new customers, certainly on the inpatient side if those potential customers are compounding. But if we just kind of look at existing customers in Q4, what drove utilization there down sequentially? At least that's kind of what it looks like on the top line number, maybe just a little bit of color around existing customer utilization.

早上好傢伙。感謝您提出問題。因此，也許可以快速深入了解住院病人的情況。我理解建立新客戶的困難，尤其是在住院方面，如果這些潛在客戶正在復合的話。但如果我們只看一下第四季的現有客戶，是什麼導致利用率連續下降？至少頂行數字是這樣的，也許只是現有客戶利用率的一點點色彩。

Yes. Let me take this. So I would say there are a couple of things. One is that Robert touched on the bad debt expense and he can elaborate further on that. And then the second piece of course is -- I mean, I can just tell you that the difference between our fourth quarter and first quarter sales without the bad debt expense is basically a three to five patients. So that's sort of the delta you're looking at.

是的。讓我拿著這個。所以我想說有幾件事。一是羅伯特談到了壞帳費用，他可以進一步詳細說明。當然，第二個問題是——我的意思是，我可以告訴你，在沒有壞帳費用的情況下，我們第四季和第一季的銷售額之間的差異基本上是三到五個病人。這就是您所看到的三角洲。

And also historically changes -- to also add a little more color. If you look at kind of last year as well, maybe there's some seasonality to this as well. We had a stronger fourth quarter than we did first quarter. But (technical difficulty) too early to tell.

而且歷史上也發生了變化——也添加了更多的色彩。如果你也看看去年的情況，也許今年也有一些季節性。我們第四季的表現比第一季更強。但（技術難度）現在下結論還為時過早。

(multiple speakers) As Rosty mentioned, the FDA publishing, they do not substitute guidance on the website -- on the PEDMARK label side of the website seems to have had an impact. We've had a couple of really important pediatric hospitals just in the last week have ordered for the first time. So that's an encouraging trend in it's early days. But I think FDA publishing on the website has made an impact. But up until then, it [really happened].

（多名發言者）正如 Rosty 所提到的，FDA 發布的內容並不能取代網站上的指導——網站的 PEDMARK 標籤方面似乎產生了影響。就在上週，我們已經有幾家非常重要的兒科醫院首次訂購。因此，這在早期是一個令人鼓舞的趨勢。但我認為 FDA 在網站上發布資訊已經產生了影響。但直到那時，它[真的發生了]。

Right, because the confusion came from, we're getting this message communicated from these organizations instead of what is the FDA really saying to now look at what the FDA is really saying. But again, this is very early. We're dealing with a very challenging -- challenge hospital system with these expensive drug committees. So I want to make sure that we sort of same expectations on these and as we're getting some of them to switch, obviously that would be welcome news. But we have not, obviously we have been very, very patient with everyone and we're working with the FDA to resolve all of this. I think at one point would happen, Chase. I just don't know when.

是的，因為混亂來自於，我們從這些組織得到了這個訊息，而不是 FDA 真正在說什麼，現在看看 FDA 到底在說什麼。但話又說回來，這還太早。我們正在應對一個非常具有挑戰性的問題——這些昂貴的藥物委員會對醫院系統提出了挑戰。所以我想確保我們對這些有同樣的期望，並且當我們讓其中一些改變時，顯然這將是一個受歡迎的消息。但我們沒有，顯然我們對每個人都非常非常耐心，我們正在與 FDA 合作解決所有這些問題。我認為有一天會發生，蔡斯。我只是不知道什麼時候。

Understood. And then Robert, maybe can you just quantify what that return was as far as a headwind to top line revenue? Sorry. And then just to kind of dig in a little bit on those comments. You have seen some change in behavior in Q2, but really hasn't been material to revenue yet, but early signs of behavioral changing. Is that kind of the right way to characterize it?

明白了。然後羅伯特，也許你能量化一下這種回報對頂線收入的不利影響嗎？對不起。然後稍微深入研究一下這些評論。您已經看到第二季的行為發生了一些變化，但實際上還沒有對收入產生實質影響，而是行為改變的早期跡象。這是描述它的正確方式嗎？

Correct. We had a couple of larger accounts.

正確的。我們有幾個較大的帳戶。

Yes, I'll start with your question, Chase, as well. Just from a framework perspective, in Q4, we had gross sales of a little over $11 million and reported net sales of $9.7 million. In Q1, we had gross sales of $9.7 million and reported net sales of $7.4 million. So that delta and that jump up in percentage was, as I mentioned, largely as a result of product that, due to expiry, we had to give a credit to some distributors in the quarter.

是的，我也將從你的問題開始，蔡斯。僅從框架角度來看，第四季我們的總銷售額略高於 1,100 萬美元，淨銷售額為 970 萬美元。第一季度，我們的總銷售額為 970 萬美元，淨銷售額為 740 萬美元。因此，正如我所提到的，增量和百分比的上升主要是由於產品到期，我們不得不在本季度向一些分銷商提供信用。

Got it. Thank you. And then maybe just trends in AYA, digging in a little bit more there. It sounds like Q3 should kind of be our expectation of when that accelerates and really kind of inflexing the model. And biggest driver there -- it probably is going to take some more time to obviously get those clinics to stay open. So is the biggest driver kind of that Compendium add or just going to walk us through what the big kind of unlock on the inflection is there?

知道了。謝謝。然後也許只是 AYA 的趨勢，在那裡進行更多挖掘。聽起來第三季應該是我們對加速並真正改變模型的預期。最大的推動因素是——顯然，這些診所可能需要更多時間才能保持開放。那麼，綱要中最大的驅動因素是添加還是只是引導我們了解拐點上的重大解鎖是什麼？

Yeah, I mean, I would say it's all of the above that I listed in the previous question. It's really getting the medical education. I cannot stress the importance of that to be honest because we've got a -- we have people that want to listen to our message. It's important how well the message is delivered, how well we're engaging.

是的，我的意思是，我想說的是我在上一個問題中列出的所有內容。這確實是在接受醫學教育。說實話，我無法強調這一點的重要性，因為我們有人想聽我們的訊息。訊息傳遞得有多好，我們的參與程度有多好，都很重要。

Just remember these physicians are not treating for ototoxicity. They haven't treated historically because these are centers that are treating basically chemo drugs, the patients. So that's one that's ongoing and obviously we're refining our strategy there. We're learning from them, et cetera. So that engagement piece is critical. Then once they want to work with us, it's obviously all the logistics, the market access, making sure that all these pieces are together. Compendia is a very important piece from that as well.

請記住，這些醫生並不治療耳毒性。他們歷史上沒有接受過治療，因為這些中心基本上治療的是化療藥物，也就是病人。所以這是一項正在進行的工作，顯然我們正在完善我們的策略。我們正在向他們學習，等等。因此，訂婚部分至關重要。一旦他們想與我們合作，顯然就是所有的物流、市場准入，確保所有這些部分都整合在一起。綱要也是其中非常重要的一環。

There's also will be few reimbursements pulled through, a bunch of things that we kind of and we have seen actually in a few patients. Again the sample size is relatively small, so we want to make sure that we have a larger sample size as I mentioned these are kind of like mini pilots at least in my mind because one thing we learned in this company historically what's worked for us well is when we simplify things and we get it down to like the very, very basics, and the very basics here are you're treating one patient at the time truly and is that a success for the patient, for the center and ultimately for Fennec and create this win-win.

也將有一些報銷完成，我們在一些患者身上實際看到了一些事情。同樣，樣本量相對較小，因此我們希望確保擁有更大的樣本量，正如我所提到的，至少在我看來，這些有點像迷你飛行員，因為我們歷史上在這家公司學到的一件事對我們很有效就是當我們簡化事情，我們把它歸結為非常非常基礎的東西，這裡的基礎知識是你當時真正治療一名患者，這對患者、中心和最終 Fennec 來說是成功的嗎？並創造這種雙贏。

And all these components are really critical to that and we're working through those. And I think there will be an inflection point because when you look at the number of volume of patients the centers are seeing, it's actually quite encouraging that those numbers are substantially higher than what we discussed with pediatrics. So this is really the opportunity ahead of us and then how do we accelerate it once we've established these best practices. How do we accelerate that through these networks.

所有這些組件對此都至關重要，我們正在努力解決這些問題。我認為將會出現一個拐點，因為當你看到這些中心接診的患者數量時，你會發現這些數字遠高於我們與兒科討論的數字，這實際上非常令人鼓舞。因此，這確實是我們面前的機會，一旦我們建立了這些最佳實踐，我們如何加速它。我們如何透過這些網路加速這一過程。

And then just last for me, maybe, Adrian, what you're hearing from the field around kind of willingness of these clinics to stay open longer? Are you getting some pushback there? Or is it mainly just kind of working with the administration takes time to kind of change protocols there?

最後對我來說，也許，阿德里安，你從現場聽到的關於這些診所願意延長營業時間的消息是什麼？你在那裡受到一些阻力嗎？或者主要是與政府合作需要時間來改變那裡的協議？

Yeah, we're getting pushback when you speak to the people in the clinic because they don't have the authority stay up longer. So you got to work your way up through senior management fund the decision maker and then explain things to them. And it just is taking a longer time than initially anticipated, but it is happening.

是的，當你與診所的人交談時，我們會遇到阻力，因為他們無權熬夜更久。因此，你必須透過高階管理層向決策者提供資金，然後向他們解釋事情。它只是比最初預期的要花更長的時間，但它正在發生。

And in the meantime, as I said in the prepared remarks, we've kind of we're searching for the centers that are open sort of 12 hours plus because then there's no issues and that's where we're really seeing uptake now.

同時，正如我在準備好的發言中所說，我們正在尋找開放時間超過 12 小時的中心，因為這樣就不會有任何問題，而這正是我們現在真正看到的地方。

The other components that

其他組件

Thanks the question.

謝謝提問。

The other component of this and I just want to get credit to the team and how resourceful they are, we're also have a relationship with a home infusion network that is able to provide the infusion of PEDMARK to the patient at home.

另一方面，我只是想讚揚團隊以及他們的足智多謀，我們也與家庭輸液網絡建立了關係，該網絡能夠為患者在家中提供 PEDMARK 輸液。

So we're just starting to utilize that, which is to me, is also encouraging because again, we're providing basically a suite of services. We're problem-solving for a lot of places. And so there's initiatives ongoing there as well. But that's Adrian mentioned this, it takes a bit of time to work through all of these.

因此，我們剛開始利用這一點，這對我來說也是令人鼓舞的，因為我們基本上提供了一套服務。我們正在為很多地方解決問題。因此，那裡也正在進行一些措施。但這是阿德里安提到的，完成所有這些需要一些時間。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Hey there. Thank you for taking my question. This is Michael Okunewitch on the line for Jason. I guess I'd like to see if you could give me a bit more color on how the value proposition varies between the under fifteens and that adolescent young adult population. And then given that they do require more vial on average, is this something where you'd have to or where you'd expect you'd need additional discounts adequately capture this larger market?

嘿。感謝您回答我的問題。我是麥可‧奧庫內維奇，正在接聽傑森的電話。我想我想看看您是否可以給我更多關於價值主張在十五歲以下和青少年群體之間的變化的信息。然後考慮到他們平均需要更多的小瓶，這是您必須或您期望需要額外折扣才能充分佔領這個更大市場的地方嗎？

Yeah. No, it's a very good question. So let me just sort of compare for you a disease which starts occurring from the age of 15, all the way to the age of 39, which is germ cell testicular cancer. So largely the -- how you treat the 15 year old is the same as how you treat the adolescent and adult and adolescent as well as the older patient.

是的。不，這是一個非常好的問題。那我給大家打個比方，有一種疾病從15歲開始，一直到39歲，就是生殖細胞睪丸癌。因此，在很大程度上，治療 15 歲患者的方式與治療青少年、成人、青少年以及老年患者的方式相同。

What changed there, of course, is the is the body surface area and our drug is administered based on that. So typically you have and also there is a decision making there, whether they go with three cycles or the five cycles, which also could vary. But bottom line is kind of when you compare it to the typical sort of pediatric patient versus you the young adult and adolescent or older patient, you have a three times to four times more vials.

當然，改變的是體表面積，我們的藥物是根據它來給藥的。因此，通常您會做出決策，無論是三個週期還是五個週期，這也可能會有所不同。但底線是，當您將其與典型的兒科患者與年輕成人、青少年或老年患者進行比較時，您的藥瓶數量是三到四倍。

Again, just to get a flavor for that. So when I truly mentioned the difference between the fourth quarter versus the first quarter numbers, it's truly a difference of that week by patients. And now in terms of in terms of giving discounts. And so now recall that you're dealing with the outpatient community where a discount, a meaningful discount is not really necessary because they have mechanisms in place by which date they get to -- they get to make up over 5% for these on the upfront.

再說一次，只是為了嚐嚐它的味道。因此，當我真正提到第四季度與第一季數字之間的差異時，這確實是患者那一周的差異。現在在給予折扣方面。所以現在回想一下，你正在與門診社區打交道，那裡的折扣，有意義的折扣並不是真正必要的，因為他們在到達日期之前已經制定了機制——他們可以在這些費用上彌補超過5% 的費用。

And of course, if you -- there's also some volume discounts available to them as well, but they're burden, they're not meaningful relative to the opportunity to treat these patients. And again, these patients are reimbursed based on the NCCN type 2A recommendation.

當然，如果你——他們也可以獲得一些批量折扣，但它們是負擔，相對於治療這些患者的機會而言，它們沒有意義。同樣，這些患者的報銷是根據 NCCN 2A 型建議進行的。

All right, thank you. And then as a follow-up, I just wanted to do a quick housekeeping question. With the EU partnered out now, should we expect that item G&A line to start to come in a little bit in subsequent quarters?

好吧。然後作為後續行動，我只想快速回答一個內務問題。現在與歐盟合作，我們是否應該期望該項目的一般行政費用在接下來的幾季中開始增加？

And maybe that's over to you, Robert.

也許這就是你的事了，羅伯特。

Yeah. Thanks, Michael. Yes, that is the expectation after this quarter being Q2 that we're in, I should comment significantly. So we did see a step up quite a bit in Q1, also some in Q4, and it's just tailing off here in Q2, but then yes, that's all being assumed by Norgine ongoing forward.

是的。謝謝，麥可。是的，這是我們在本季第二季之後的預期，我應該發表重要評論。因此，我們確實在第一季度看到了相當大的進步，在第四季度也有一些進步，而在第二季度則有所下降，但是，是的，這都是 Norgine 不斷前進的假設。

Right. Thank you very much.

正確的。非常感謝。

Raghuram Selvaraju, H.C. Wainwright.

塞爾瓦拉朱 (Raghuram Selvaraju)，H.C.溫賴特。

Thanks so much for taking my questions. I just two very quick ones. Firstly, can you just give us a sense of what the repercussions would be, if any, for those hospitals and hospital systems that deliberately do not elect to follow the FDA's guidance.

非常感謝您回答我的問題。我只有兩個非常快的。首先，您能否讓我們了解一下，對於那些故意不選擇遵循 FDA 指導的醫院和醫院系統，將會產生什麼影響（如果有的話）。

And secondly, if you can maybe elaborate upon the level of sales and marketing infrastructure that Norgine has communicated to you will be placed in the service of commercializing trademark fee in its territory. Thank you.

其次，如果您能詳細說明 Norgine 向您傳達的銷售和行銷基礎設施的水平，將在其領土上提供商標費商業化服務。謝謝。

Thank you. These are great questions. So the repercussions really are -- it's really are they causing harm and what that harm is and ultimately the parents filing a suit against the hospital for being -- for their child being treated with the unauthorized copy of a FDA approved drug, which clearly states on its label to not substitute.

謝謝。這些都是很好的問題。因此，真正的影響是——他們確實造成了傷害，傷害是什麼，最終父母對醫院提起訴訟——因為他們的孩子接受了 FDA 批准藥物的未經授權的複製品治療，其中明確指出其標籤上註明不可替代。

And now there is a public message announcement as to why it's not a good idea to substitute. In terms of Fennec repercussions, legal repercussions, we're exploring all these options. But as you know, typically in business is not a best practice to go after your customers.

現在有一個公開消息宣布為什麼替代不是一個好主意。就耳廓狐的影響和法律影響而言，我們正在探索所有這些選擇。但如您所知，通常在商業中並不是追求客戶的最佳實踐。

So again, we have been very, very patient and we're working through the FDA with that. On the Norgine transaction, maybe Adrian can elaborate a little more in terms of their commitment to PEDMARK and how important that is for them in Europe in particular?

再說一次，我們一直非常非常有耐心，我們正在透過 FDA 處理這件事。關於 Norgine 交易，也許 Adrian 可以詳細說明他們對 PEDMARK 的承諾，這對他們特別是在歐洲有多重要？

Yes, it's one of the reasons why we picked Norgine and they promised and have committed to resource the launch appropriately. And what we understand is that it's north of 50 FTEs and what I consider to be a very appropriate level of spend in terms of commercial results. So it's a much, much more firepower and Fennec could ever have done on our own. So I'm confident things are going to go off very well. And as a reminder, the launch is scheduled in Germany and for October.

是的，這就是我們選擇 Norgine 的原因之一，他們承諾並承諾為此次發布提供適當的資源。據我們了解，這超出了 50 個全職員工，而且我認為就商業成果而言，這是一個非常合適的支出水平。因此，Fennec 的火力要強大得多，我們自己就可以做到。所以我相信事情會進展順利。提醒一下，此次發布計劃於 10 月在德國舉行。

Thank you. I'm not showing any further questions at this time. I'd like to turn the call back over to Rosty for any closing remarks.

謝謝。我目前不會提出任何進一步的問題。我想將電話轉回給羅斯蒂，讓其結束語。

Thank you all for today, and we look forward to updating everyone on our progress this quarter and beyond. Thank you for your patience with us and stay tuned. We're working very hard to get this right. Thank you.

今天感謝大家，我們期待向大家通報本季及以後的進展。感謝您對我們的耐心等待，請關注。我們正在非常努力地解決這個問題。謝謝。

Ladies and gentlemen, this does conclude today's presentation. You may now disconnect and have a wonderful day.

女士們、先生們，今天的演講到此結束。您現在可以斷開連接並度過美好的一天。