Fennec Pharmaceuticals Inc (FENC) 2023 Q3 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' Third Quarter 2023 Earnings and Corporate Update conference call. (Operator Instructions) As a reminder, today's conference is being recorded. Now I would like to 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 2023 年第三季收益和公司最新動態電話會議。 （操作員指示）提醒一下，今天的會議正在錄製中。現在我想將會議轉交給 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' Third Quarter 2023 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning is Rosty Raykov, our Chief Executive Officer, and Adrian Haigh, our Chief Operating Officer.

謝謝接線員，大家早安。我們感謝您今天參加 Fennec Pharmaceuticals 2023 年第三季財報電話會議，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。今天早上從 Fennec 與我一起來的是我們的執行長 Rosty Raykov 和我們的營運長 Adrian Haigh。

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. References 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 Security US Securities and Exchange Commission.

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。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。

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. We specifically disclaim any obligation to update or revise any forward-looking state. This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com. We'll be available for the next 30 days and with that, I will now turn the call over to Rosty Raykov.

此外，本次電話會議中所做的任何前瞻性陳述僅代表我們今天的觀點。並且不應被視為代表我們在任何後續日期的觀點。我們特別聲明不承擔更新或修改任何前瞻性狀態的義務。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。我們將在接下來的 30 天內為您服務，現在我將把電話轉給 Rosty Raykov。

Thank you, Robert, and good morning, everyone. The focus of today's call is to review updates on the ongoing commercial launch efforts underway for PEDMARK in the United States and review our global opportunities, including the recent approval in the UK and Europe. Further, we will detail our third quarter 2023 financial results, all of which were outlined in our earnings press release issued this morning. Prior to this call.

謝謝羅伯特，大家早安。今天電話會議的重點是審查 PEDMARK 在美國正在進行的商業發布工作的最新情況，並審查我們的全球機會，包括最近在英國和歐洲的批准。此外，我們將詳細介紹 2023 年第三季的財務業績，所有這些都在我們今天早上發布的收益新聞稿中概述。在這次通話之前。

We are very pleased to report that PEDMARK delivered strong third quarter revenues of $6.5 million, a 96% increase over the second quarter of 2023. Further, this represents more than tripling our revenue since Q1 2023, from $1.7 million reported in Q1. We continue to be very encouraged with the progress we've made with PEDMARK's launch to date, and we are even prouder of the work that is underway to sustain this momentum throughout the remainder of 2023 and as we head into 2024.

我們非常高興地報告，PEDMARK 第三季營收強勁，達到650 萬美元，比2023 年第二季成長96%。此外，這意味著我們的營收自2023 年第一季以來增加了兩倍多，而第一季報告的收入為170 萬美元。迄今為止，我們對 PEDMARK 的推出所取得的進展感到非常鼓舞，我們對為在 2023 年剩餘時間和進入 2024 年保持這一勢頭而正在進行的工作感到更加自豪。

As a reminder, PEDMARK was approved by the FDA in September of 2022. It is the first and only FDA-approved therapy to reduce the risk of cisplatin-induced hearing loss in pediatric patients one month of age and older with localized non-metastatic solid tumors.

需要提醒的是，PEDMARK 於2022 年9 月獲得FDA 批准。這是FDA 批准的第一個也是唯一一個用於降低1 個月及以上患有局部非轉移性實體瘤的兒科患者順鉑引起的聽力損失風險的療法。腫瘤。

We launched PEDMARK in the US. in October 2022, so we're just marked on our one-year anniversary since PEDMARK became commercially available. We're very proud of the team's ongoing commercial progress and our enthusiasm for PEDMARK and passion for supporting the pediatric college community continues to grow.

我們在美國推出了 PEDMARK。 2022 年 10 月，我們剛迎來 PEDMARK 上市一週年紀念。我們對團隊持續取得的商業進展感到非常自豪，我們對 PEDMARK 的熱情以及對支持兒科大學社區的熱情不斷增長。

In fact, the team had a busy fall season, engaging in robust discussions with key opinion leaders on the issue of cisplatin-induced ototoxicity. We recently attended the International Society of Pediatric Oncology Annual Meeting, the Connective Tissue Oncology Society Annual Meeting, the Health Connect Partners 2023 Fall Hospital Pharmacy Conference, and the Association of Pediatric Hematology Oncology Nurses Annual Meeting, where we saw and heard firsthand about the importance of our work.

事實上，團隊度過了一個忙碌的秋季，與關鍵意見領袖就順鉑引起的耳毒性問題進行了熱烈的討論。我們最近參加了國際兒科腫瘤學會年會、結締組織腫瘤學會年會、Health Connect Partners 2023 年秋季醫院藥學會議以及小兒血液腫瘤護士協會年會，在會上我們親眼目睹並聽到了這一重要性我們的工作。

These conferences followed on the heels of an event where we sponsored the Hillsdale College Pediatric Cancer Awareness Day football game, in which proceeds from the day went to support multiple organizations engaged in the fight against childhood cancer. These are just a few examples of how we are continuing to build strong relationships within the community.

這些會議緊接著我們贊助希爾斯代爾學院兒科癌症意識日足球賽的活動之後舉行，當天的收益將用於支持多個致力於對抗兒童癌症的組織。這些只是我們如何繼續在社區內建立牢固關係的幾個例子。

In terms of commercial efforts to establish PEDMARK as a necessary complementary agent when prescribing a cisplatin-based therapy for a child with a localized non-metastatic solid tumor, our sales force is currently targeting 200 pediatric hospital centers, including COG, NCI, and NCM institutions across the US. that drive 80% of cisplatin use.

在為患有局部非轉移性實體瘤的兒童開出基於順鉑的治療處方時，將PEDMARK 建立為必要的補充藥物的商業努力方面，我們的銷售團隊目前的目標是200 個兒科醫院中心，包括COG 、NCI 和NCM美國各地的機構。推動了 80% 的順鉑使用。

Based on these efforts, we estimate that approximately 20% have written a PEDMARK prescription. In fact, we believe that some of the leading centers have already prescribed more than 25% of eligible patients under their care. We're highly encouraged by the third quarter's double-digit growth in new pediatric hospital centers prescribing PEDMARK, and with the consistent repeat orders from existing accounts.

基於這些努力，我們估計大約 20% 的人開出了 PEDMARK 處方。事實上，我們相信一些領先的中心已經為超過 25% 的符合條件的患者開出處方。第三季開立 PEDMARK 處方的新兒科醫院中心的兩位數成長以及現有客戶的持續重複訂單令我們深受鼓舞。

Further, we continue to see success in large academic centers, including continuous formulary approvals at several major pediatric hospital centers in the third quarter. Geographically, all of our territories have seen HCPs prescribing PEDMARK, and we have seen highly encouraging adoption within our target accounts that are increasing over time. In terms of patients, we have seen utilization across several tumor types, including hepatoblastoma, osteosarcoma, and germ cell tumors.

此外，我們繼續看到大型學術中心的成功，包括第三季度在幾個主要兒科醫院中心連續獲得處方批准。從地理位置來看，我們所有的地區都出現了 HCP 開出 PEDMARK 的處方，而且我們的目標客戶中的採用情況非常令人鼓舞，而且隨著時間的推移，這種採用率正在增加。就患者而言，我們已經看到了多種腫瘤類型的使用，包括肝母細胞瘤、骨肉瘤和生殖細胞腫瘤。

PEDMARK also continues to have broad and favorable payer coverage, as evidenced by payer-approved US. prescription claims with commercial insurance plans and Medicare Part D plans. As a reminder, we estimate among current PEDMARK patients, approximately 50% are commercially insured, with another 50% insured through government-sponsored programs.

PEDMARK 也繼續擁有廣泛且有利的付款人覆蓋範圍，付款人認可的美國證明了這一點。商業保險計劃和 Medicare D 部分計劃的處方索賠。提醒一下，我們估計在目前的 PEDMARK 患者中，大約 50% 擁有商業保險，另外 50% 透過政府資助的計劃獲得保險。

The remainder have no or limited insurance coverage and may be eligible to receive PEDMARK at no cost to them under our patient assistance program, Fennec-Heers, which is a comprehensive, single-source program designed to connect PEDMARK patients to both patient financial and product access support.

其餘的人沒有保險或保險範圍有限，可能有資格根據我們的患者援助計劃 Fennec-Heers 免費獲得 PEDMARK，該計劃是一項綜合性單一來源計劃，旨在將 PEDMARK 患者與患者財務和產品聯繫起來訪問支持。

With regard to expanding in Europe, we announced in June the e-mail approval of PEDMARK, which will be marketed under the name PEDMARC-C. PEDMARC-C will be the first and only treatment approved in the European Union to address this area of significant medical need. Further, in October, the Medicines, and Healthcare Products Regulatory Agency, or MHRA, in the UK., approved PEDMARK-C for the same indication.

關於在歐洲的擴張，我們在 6 月宣布了 PEDMARK 的電子郵件批准，該產品將以 PEDMARC-C 的名稱進行銷售。 PEDMARC-C 將是歐盟批准的第一個也是唯一一個治療方法，用於解決這一領域的重大醫療需求。此外，10 月，英國藥品和保健品監管機構 (MHRA) 批准了 PEDMARK-C 用於相同的適應症。

Following up on our strong UK. peer opinion leader relationships, earlier this fall, we presented background and data on PEDMARK-C at a hearing therapeutic summit organized by RNID, with the UCL Institute and UCLH Biomedical Research Center in London. We continue to evaluate the best commercial pathway for the company in Europe and the rest of the world, either go it alone or with a partner.

跟進我們強大的英國。同儕意見領袖關係，今年秋天早些時候，我們在 RNID 與倫敦大學學院研究所和倫敦大學學院生物醫學研究中心組織的聽力治療高峰會上介紹了 PEDMARK-C 的背景和數據。我們繼續評估公司在歐洲和世界其他地區的最佳商業途徑，無論是單獨行動還是與合作夥伴合作。

Whatever pathway we select, we see Europe as another significant opportunity to create shareholder value. In closing, I want to reiterate the focus of our commercial strategy remains on executing the following. Establishing PEDMARK as a necessary complement agent when prescribing a cisplatin-based therapy for a child with localized nonmetastatic solid tumor, minimizing the barriers to access, and rapid responses to product questions, and establishing Fennec as the premier partner of choice among the pediatric oncology community.

無論我們選擇何種途徑，我們都將歐洲視為創造股東價值的另一個重要機會。最後，我想重申我們商業策略的重點仍然是執行以下內容。在為患有局部非轉移性實體瘤的兒童開出基於順鉑的治療處方時，將PEDMARK 確立為必要的補體藥物，最大限度地減少獲取障礙，并快速響應產品問題，並將Fennec 確立為兒科腫瘤學界的首選合作夥伴。

With that, I will now turn the call over to Adrian, who has been on the board of Fennec since 2014 and joined the executive management team of Fennec in August of this year as chief operating officer. Adrian will share his observations and opportunities after his first 100 days on the job. Adrian, over to you.

現在，我將把電話轉給 Adrian，他自 2014 年以來一直是 Fennec 董事會成員，並於今年 8 月加入 Fennec 執行管理團隊，擔任營運長。 Adrian 將分享他入職 100 天後的觀察和機會。阿德里安，交給你了。

Thanks, Rosty. Indeed, it's been an exciting first few months since joining Fennec full-time as chief operating officer. As expressed on the call in August, I've got two priorities. The first is accelerating the adoption of PEDMARK in the US., and second, preparing PEDMARK for launch in Europe as we continue to evaluate the strategic direction of the business. As Rosty mentioned, adoption of PEDMARK in the US continues to make solid progress.

謝謝，羅斯蒂。事實上，自從全職加入 Fennec 擔任營運長以來，頭幾個月是令人興奮的。正如八月份的電話會議中所表達的，我有兩個優先事項。首先是加速 PEDMARK 在美國的採用，其次是在我們繼續評估業務策略方向的同時，為在歐洲推出 PEDMARK 做好準備。正如 Rosty 所提到的，PEDMARK 在美國的採用繼續取得紮實進展。

We continue to work with a number of key pharmacy committees and key academic centers, ensuring that PEDMARK is included as standard of care in all treatment protocols. We benefited during the third quarter from growth in adoption and, importantly, repeat orders and growth from existing customers and hospitals. Additionally, we won pharmacy and therapeutics committee approval at several leading institutions. Further, we're now putting increased focus on the opportunity offered by PEDMARK's NCCN endorsement in adolescents and young adults, AYAs.

我們繼續與許多主要藥學委員會和主要學術中心合作，確保 PEDMARK 成為所有治療方案中的護理標準。第三季度，我們受益於採用率的成長，更重要的是，現有客戶和醫院的重複訂單和成長。此外，我們也獲得了許多領先機構的藥學和治療委員會的批准。此外，我們現在更加關注 PEDMARK 的 NCCN 認可為青少年和年輕人 (AYA) 提供的機會。

And, importantly, we have a category 2 rating, a 2A rating, which was achieved earlier this year. To support this effort, during the third quarter, we strengthened our sales team with several new hires who have significant expertise in selling into community oncology centers where many of the AYA patients are treated.

重要的是，我們今年早些時候獲得了 2 類評級，即 2A 評級。為了支持這項努力，在第三季度，我們加強了我們的銷售團隊，招募了幾名新員工，他們在向社區腫瘤中心進行銷售方面擁有豐富的專業知識，許多AYA 患者都在這些中心接受治療。

Additionally, we've strengthened our focus on managing the relationship with group purchasing organizations, and we've signed contracts with a number of leading groups. GPO endorsement will support the use of PEDMARK, not only in the pediatric oncology centers, but in these community hospitals, infusion centers, and administration in the home.

此外，我們也加強了對集團採購組織關係的管理，並與多家領先集團簽訂了合約。 GPO 的認可將支持 PEDMARK 的使用，不僅在兒科腫瘤中心，而且在這些社區醫院、輸液中心和家庭管理中。

We also will be partnering with a leading specialty pharmacy to provide home administration and, importantly, white bag delivery to the hospital with direct billing to the insurance provider or to Medicaid. Turning to Europe, we're making steady progress in the preparation for the launch of PEDMARK in the first half of 2024. Some of these activities include the submission and approval of the German NUB price application. This was done in October 2023, and it was accepted.

我們還將與一家領先的專業藥房合作，提供家庭管理服務，更重要的是，向醫院提供白袋遞送服務，並直接向保險公司或醫療補助機構計費。轉向歐洲，我們正在為 2024 年上半年推出 PEDMARK 的準備工作取得穩步進展。其中一些活動包括提交和批准德國 NUB 價格申請。該工作於 2023 年 10 月完成，並被接受。

This allows us to sell PEDMARK in German hospitals during 2024. The health technology assessment dossiers required for price approval are now at an advanced stage of development and will be submitted in quarter one in Germany, the UK, France, Italy, and Spain. Additionally, we've had early and favorable interactions with several key countries regarding pricing and reimbursement.

這使我們能夠在 2024 年在德國醫院銷售 PEDMARK。價格批准所需的衛生技術評估檔案目前處於開發的後期階段，將於第一季在德國、英國、法國、義大利和西班牙提交。此外，我們在定價和報銷方面與幾個主要國家/地區進行了早期且有利的互動。

And as Rosty said, we recently received MHRA approval in the UK. With that, I'll turn the call over to Robert to go over the financials for the quarter. Robert?

正如 Rosty 所說，我們最近在英國獲得了 MHRA 的批准。這樣，我將把電話轉給羅伯特，讓他檢查本季的財務狀況。羅伯特？

Thank you, Adrian. Our press release contains details of our financial results for the third quarter of 2023. They can be viewed on the investors and media section of our website. Rather than read through all of those details, my comments today will focus on some key financial results, and we anticipate filing our 10-Q this week with further details.

謝謝你，阿德里安。我們的新聞稿包含 2023 年第三季財務業績的詳細資訊。您可以在我們網站的投資者和媒體部分查看這些資訊。我今天的評論將重點放在一些關鍵的財務業績，而不是通讀所有這些細節，我們預計本週將提交 10-Q 報告，其中包含更多細節。

The company recorded net product sales of $6.5 million in the third quarter of 2023 versus $3.3 million in the second quarter for a net revenue growth of approximately 96%. As mentioned by Rosty, net revenue has more than tripled since Q1 2023, and we look forward to building from the momentum in the first nine months of 2023.

該公司 2023 年第三季的產品淨銷售額為 650 萬美元，而第二季為 330 萬美元，淨收入成長約 96%。正如 Rosty 所提到的，自 2023 年第一季以來，淨收入成長了兩倍多，我們期待在 2023 年前 9 個月繼續保持這一勢頭。

To reiterate remarks from Rosty and Adrian, we are pleased with the growing acceptance of PEDMARK within healthcare providers during the third quarter and with the recent hospital formulary access approvals continuing early in Q4. Overall, our OpEx during the period has remained well controlled and within anticipated ranges.

重申 Rosty 和 Adrian 的言論，我們很高興第三季度醫療保健提供者對 PEDMARK 的接受度不斷提高，並且最近的醫院處方准入批准在第四季度初繼續進行。總體而言，我們在此期間的營運支出保持良好控制並處於預期範圍內。

General and administrative expenses for the third quarter of 2023 were $3.8 million, which compares to $5.3 million in the second quarter of 2023. The decrease is largely attributable to lower non-cash employee remuneration and lower administrative and legal expenses. As stated in previous quarters, the company began recording, selling, and marketing expenses when it expanded its payroll to include an internal sales force.

2023 年第三季的一般和行政費用為 380 萬美元，而 2023 年第二季為 530 萬美元。減少的主要原因是非現金員工薪資下降以及行政和法律費用下降。正如前幾個季度所述，該公司在擴大工資範圍以納入內部銷售人員時開始記錄、銷售和行銷費用。

Selling and marketing expenses include distribution costs, logistics, shipping and insurance, advertising, wages and commissions, and out-of-pocket expenses. The company recorded $3.3 million in selling and marketing expenses in the third quarter of 2023 compared to $2.3 million in the second quarter of 2023 as the company increased marketing expenses in the US and pre-commercial activities in Europe. We expect these levels to continue in the fourth quarter, but overall OpEx to be consistent with Q3 when including GNA.

銷售和行銷費用包括分銷成本、物流、運輸和保險、廣告、工資和佣金以及自付費用。該公司 2023 年第三季的銷售和行銷費用為 330 萬美元，而 2023 年第二季為 230 萬美元，因為該公司增加了美國的行銷費用和歐洲的預商業活動。我們預計第四季將繼續保持這一水平，但包括 GNA 在內的整體營運支出將與第三季保持一致。

R&D expenses are negligible as the company reduced research and development costs when it received FDA approval of PEDMARK. The majority of traditional R&D expenses associated with PEDMARK are now recorded as GNA or capitalized into inventory and eventually recorded to cost of product sales.

PEDMARK 獲得 FDA 批准後，公司降低了研發成本，因此研發費用可以忽略不計。與 PEDMARK 相關的大部分傳統研發費用現在記錄為 GNA 或資本化到庫存中，並最終記錄到產品銷售成本中。

Our GAAP net loss for third quarter of 2023 was $1.8 million or $0.07 per share compared to a GAAP net loss of $5.4 million or $0.21 per share in the second quarter of 2023 and $8.1 million or $0.31 per share loss in the second quarter of 2022. As evident in the results, we have made significant progress in getting closer to breakeven on a GAAP-EPS.

我們2023 年第三季的GAAP 淨虧損為180 萬美元，即每股0.07 美元，而2023 年第二季的GAAP 淨虧損為540 萬美元，即每股0.21 美元，2022 年第二季的GAAP 淨虧損為810 萬美元，即每股虧損0.31 美元。從結果中可以明顯看出，我們在接近 GAAP-EPS 損益平衡方面取得了重大進展。

And finally, our cash position. We ended the third quarter with approximately $12.4 million in cash, cash equivalents, and investment securities, which includes $25 million of capital drawn under our existing Petrocorp convertible debt facility. Our cash burn for the third quarter was approximately $2.5 million compared to $3.3 million in the second quarter of 2023. As a reminder, we remain focused on reaching cash flow breakeven in the US as revenues grow and look forward to reporting our Q4 progress in 2024.

最後，我們的現金狀況。截至第三季末，我們擁有約 1,240 萬美元的現金、現金等價物和投資證券，其中包括根據我們現有的 Petrocorp 可轉換債務融資提取的 2,500 萬美元資本。我們第三季的現金消耗約為250 萬美元，而2023 年第二季為330 萬美元。提醒一下，隨著營收的成長，我們仍然專注於在美國實現現金流收支平衡，並期待在2024年報告我們第四季的進展。

Finally, we believe our available capital, when coupled with PEDMARK revenue assumptions, will give us sufficient capital to fund our operations through at least the next 12 months. And operator, with that, we are ready for questions.

最後，我們相信我們的可用資本，加上 PEDMARK 收入假設，將為我們提供足夠的資本，至少在未來 12 個月內為我們的營運提供資金。接線員，現在我們準備好回答問題了。

Thank you. Ladies and gentlemen, if you have a question or comment at this time, please press star one on your telephone. If your question has been answered, you wish and with yourself from the queue, please press star one. Once again, we'll pause for a moment while we compile our Q&A roster. Our first question comes from Chase Knickerbocker with Craig-Hallum. Your line is open.

謝謝。女士們、先生們，如果您此時有任何疑問或意見，請按電話上的一號星星。如果您的問題已得到解答，並且您希望自己退出佇列，請按星號一。我們將再次暫停一下，整理我們的問答名單。我們的第一個問題來自蔡斯·尼克博克和克雷格·哈勒姆。您的線路已開通。

Good morning, guys. Congrats on the next quarter here. Maybe just to start for me, if we look at the model, it seems to me that you're executing to your plan on launch, where it seems like the initial expectation was cash flow breakeven at Q4 this year. Looking at the model with revenue growing nearly 100% again sequentially, you would need either, drastic deceleration in that revenue or meaningfully elevated OpEx to not post positive cash flow from operations or, you know, positive operating income in my model.

早上好傢伙。在這裡恭喜下個季度。也許只是對我來說，如果我們看看這個模型，在我看來，你正在執行你的發布計劃，最初的預期似乎是今年第四季度的現金流盈虧平衡。看看收入連續增長近 100% 的模型，您需要要么收入大幅減速，要么大幅提高營運支出，才能在我的模型中不發布來自運營的正現金流，或者您知道的正營業收入。

You know, that paired with the strong commentary on center penetration, you know, penetration within some of those centers, seems like breakeven is the right way to think about the business in Q4. Is there anything that you would caution me on, you know, on the go forward that I should be thinking about when I think about the model?

你知道，再加上對中心滲透率的強烈評論，你知道，其中一些中心的滲透率，似乎盈虧平衡是考慮第四季度業務的正確方式。你知道，當我思考這個模型時，在前進過程中我應該考慮什麼嗎？

Yeah. Hi, Chase. Good question. Perhaps Robert can answer that.

是的。嗨，蔡斯。好問題。也許羅伯特可以回答這個問題。

Yeah, thanks, Chase. Yeah, as stated, our OpEx during the period has remained well controlled and within, you know, previously guided ranges. For the third quarter specifically, if you look at our OpEx, it was roughly $7 million to $7.5 million in cash expenses. So, based on those Q3 results, we are on our way to getting to breakeven. Of course, this does exclude an EU launch, which, as we've mentioned, we are evaluating.

是的，謝謝，蔡斯。是的，如前所述，我們在此期間的營運支出保持了良好的控制，並且在先前指導的範圍內。具體到第三季度，如果你看看我們的營運支出，你會發現現金支出約為 700 萬至 750 萬美元。因此，根據第三季的業績，我們正在實現損益平衡。當然，這確實排除了歐盟的推出，正如我們所提到的，我們正在評估歐盟的推出。

But further, we feel comfortable that our existing cash, when coupled with PEDMARK revenue assumptions in the quarters to grow, will give us sufficient capital to fund our operations to cash flow, breakeven, and positivity. That's what we're working towards.

但進一步而言，我們感到放心的是，我們現有的現金，加上 PEDMARK 各季度收入成長的假設，將為我們提供足夠的資本，為我們的營運提供現金流、損益平衡和積極性。這就是我們正在努力的方向。

Great. Thanks for the call there. Maybe just two on Europe for me as well. Maybe help investors think about the frameworks that inform, you know, decision on whether to partner or go it alone. Is it in terms of a licensing deal? Is it, you know, the royalty level? Is it the money up front?

偉大的。謝謝你的來電。也許對我來說也只有兩件關於歐洲的事情。也許可以幫助投資人思考決定是否合作或單獨行動的框架。是在授權協議方面嗎？你知道嗎，是版稅等級嗎？是先給錢嗎？

And then, I guess, paired with that, just what geographies within Europe should we think about from a country perspective generating the most meaningful volume within, you know, the first 12 to 18 months of launch that, you know, the UK and Germany? Just kind of more color there.

然後，我想，同時，我們應該從國家的角度考慮歐洲的哪些地區，在推出後的前 12 到 18 個月內產生最有意義的銷量，例如英國和德國？只是那裡有更多的顏色。

Yeah, thanks, Chase. I'll send it over to Adrian because he's been working intimately in Europe from Dublin and will be able to share his experience for the last 100 days. Adrian? I think you might be on mute there.

是的，謝謝，蔡斯。我會將其發送給 Adrian，因為他一直在都柏林在歐洲密切工作，並且能夠分享他過去 100 天的經驗。阿德里安？我想你可能處於靜音狀態。

Sorry. Yeah, Chase, thanks for the question. I think, first of all, with Europe, if we choose to go alone, we don't bite off more than we can chew. So I think, you know, if we were going to do it ourselves, we would partner in the major, sorry, we do it ourselves in the major markets in Western Europe. And then we look to establish relationships with distributors for Eastern Europe and perhaps some of the smaller markets.

對不起。是的，蔡斯，謝謝你的提問。我認為，首先，對於歐洲來說，如果我們選擇單獨行動，我們就不會貪多嚼不爛。所以我認為，如果我們要自己做，我們會在主要市場合作，抱歉，我們在西歐的主要市場上自己做。然後我們希望與東歐以及一些較小市場的經銷商建立關係。

I have to say that in discussions that we've had with the vendors that are helping us develop the health technology assessment dossiers, I've been very encouraged by their views on what price we will be able to achieve. I think the economic argument is very strong when you cover, when you look at the costs of deafness that are covered by the health systems in most of these countries.

我必須說，在我們與幫助我們開發衛生技術評估檔案的供應商進行的討論中，他們對我們能夠達到的價格的看法讓我深受鼓舞。我認為，當你看到大多數國家的衛生系統所承保的耳聾費用時，經濟論點是非常強烈的。

Depression is heavily associated with deafness, for example. So we feel we can make a strong argument for an acceptable price in Europe. In Germany, as I said, we submitted the price for six months, and that has been accepted. So when we do launch, we will launch at that price, and then enter into negotiations with the insurance companies for the final price.

例如，憂鬱症與耳聾密切相關。因此，我們認為我們可以為歐洲可接受的價格提出強有力的論點。正如我所說，在德國，我們提交了六個月的價格，並且已被接受。所以當我們推出的時候，我們會以這個價格推出，然後與保險公司協商最終的價格。

And then we have submitted an early access application, or we're about to submit an early access application in France. So we should expect to get some pre-price approval sales in France early next year. But as we said earlier on, we're continuing to evaluate all the options. And if we do license out in Europe, obviously we'll be looking for a big cash injection with hefty wealth. If that helps.

然後我們已經提交了搶先體驗申請，或者我們即將在法國提交搶先體驗申請。因此，我們預計明年初將在法國獲得一些價格批准前的銷售。但正如我們之前所說，我們正在繼續評估所有選項。如果我們在歐洲獲得許可，顯然我們將尋求巨額財富的大量現金注入。如果有幫助的話。

Yeah. And then if we kind of dig in a little bit on the Europe pricing there, is, you know, greater than a 50% decline from US net price the right way to think about it? Or should I maybe be, thinking about that a little bit differently? And then also a little bit of color on kind of inpatient versus outpatient usage in the United States, maybe percentage of sales, between both sites of service. And then kind of how the prior authorizations have been on the outpatient side from a coverage perspective.

是的。然後，如果我們稍微深入研究一下歐洲的定價，你知道，比美國淨價下降 50% 以上是正確的思考方式嗎？或者我應該以不同的方式思考這個問題？然後還有一些關於美國住院患者與門診患者使用情況的一些顏色，可能是兩個服務站點之間的銷售額百分比。然後從保險範圍的角度來看，門診方面的事先授權是如何的。

Okay. So first question, Europe pricing. Yes. Based on where we are with Germany, significantly more than a 50%. Sorry. So closer to 100% of the US price will be the initial price in Germany. And then we're subject to negotiation. What I expect to see in Europe is a request for some kind of pricing cap. So what came out of the discussions with the, well, we were negotiating the price in Germany was the high cost of a 17-year-old testicular cancer patient, where they said, it'll be close to 1EUR million.

好的。第一個問題，歐洲定價。是的。根據我們與德國的情況，顯著超過 50%。對不起。因此，德國的初始價格將接近美國價格的 100%。然後我們要進行談判。我期望在歐洲看到的是某種定價上限的要求。因此，我們在德國談判價格時得出的結論是，一名 17 歲睪丸癌患者的高昂費用，他們說，將接近 100 萬歐元。

So we can expect that, they won't be covering a million euros. So we'll have to have some kind of cap. And I think most European health authorities will expect that. But I think in terms of pricing, we're looking at something around 70% of the US price, if I'm to look at an average. With the focus of turning the focus to the AYA population, if you just look at the patient numbers, we talk about in the US, a 3,500 pediatric population, that's patients who have localized disease that are not treated with cisplatin.

所以我們可以預期，他們不會支付一百萬歐元。所以我們必須有某種上限。我認為大多數歐洲衛生當局都會預料到這一點。但我認為就定價而言，如果我要考慮平均值的話，我們正在考慮美國價格的 70% 左右。將焦點轉向 AYA 人群，如果您只看患者數量，我們在美國談論的是 3,500 名兒科人群，即患有局部疾病但未接受順鉑治療的患者。

If you look at the patient numbers in the AYA population, just taking one cancer, there are 3,500 testicular cancer patients in the 15-year to-39-year age group in the US. And if you add all the other tumor types that are likely to be treated with cisplatin, you're talking about 30,000 patients. So a tenfold increase in the number of potential patients. And of course, most of these patients are treated in the community and it's ASP plus.

如果你看一下 AYA 族群的病人數量，只考慮一種癌症，美國 15 歲至 39 歲年齡層就有 3,500 名睪丸癌患者。如果您將所有其他可能用順鉑治療的腫瘤類型加起來，那麼您談論的患者數量約為 30,000 名。因此潛在患者的數量增加了十倍。當然，這些患者中的大多數都在社區接受治療，而且是 ASP plus。

So as I said, we have just started our sales team focusing on this population and early results have been very encouraging. The sales force are reporting that this is significant unmet medical need and there's positive reaction from the community.

正如我所說，我們剛剛組建了專注於這一人群的銷售團隊，早期結果非常令人鼓舞。銷售人員報告說，這是一個重大的未滿足的醫療需求，社區做出了積極的反應。

Thanks for the question, Chase. One moment for our next question. Our next question comes from Noreen Qubier with Capital One Securities.

謝謝你的提問，蔡斯。請稍等一下我們的下一個問題。我們的下一個問題來自第一資本證券公司的 Noreen Qubier。

Hi, good morning. Thanks for taking my question and congrats on the quarter. I guess I'll start with very simple, just in terms of, you're looking at actual sales numbers and you're seeing progress there, but just out of curiosity, what kind of metrics are you personally tracking over time to gauge your progress? Is it just repeat orders? Just some specifics would help.

早安.感謝您提出我的問題並祝賀本季。我想我會從非常簡單的開始，只是就而言，你正在查看實際的銷售數字，你會看到那裡的進展，但只是出於好奇，你個人隨著時間的推移跟踪什麼樣的指標來衡量你的銷售業績進步？難道只是重複訂單嗎？只需一些具體細節就會有所幫助。

Hi, Noreen. Maybe I can start it and send it over to Robert and Adrian as well. In general, what we're looking for, obviously, our number one priority is to get the business to break even. So we're almost there from that perspective. In terms of on the sales side, we absolutely have specific, based on the populations discussed, both in the pediatric and NYA setting going forward, the sales force would be very well incentivized to perform in those populations.

嗨，諾琳。也許我可以啟動它並將其也發送給羅伯特和阿德里安。總的來說，我們所尋求的，顯然，我們的首要任務是讓業務達到收支平衡。所以從這個角度來看，我們已經快到了。在銷售方面，根據所討論的人群，我們絕對有具體的訊息，無論是在兒科還是紐約州，未來的銷售人員都會受到很好的激勵，在這些人群中表現出色。

And obviously, we're looking really to ramp the business going forward. I don't know, Robert or Adrian, if you'd like to add anything else.

顯然，我們確實希望推動業務向前發展。我不知道羅伯特或阿德里安是否還想補充任何其他內容。

Yeah, we have a number of metrics. We have formulary committees, one. We have orders and repeat orders from the census. And ultimately, obviously, it's vials, sales, and revenue.

是的，我們有很多指標。我們有一個公式委員會。我們收到了人口普查的命令和重複命令。顯然，最終是瓶子、銷售額和收入。

Got it. Thank you.

知道了。謝謝。

And they're based, sorry, let me just add, and they're based on the individual performing in their territory and not an overall team goal.

它們是基於的，抱歉，讓我補充一下，它們是基於個人在其領域內的表現，而不是整個團隊的目標。

Okay. And you did mention in the prepared remarks that you've added some folks in the sales force. So how many are you up to now? And is there a different focus for these newer individuals or if you could just help clarify that a little bit.

好的。您在準備好的評論中確實提到您已經在銷售團隊中增加了一些人。那你現在有多少了？這些新人是否有不同的關注點，或者您是否可以幫助澄清這一點。

Yeah. So we've kept the sales force consistent. We have 12 salespeople in the field right now, based on the territories that we've discussed in some of our earlier calls to target this 80% of cisplatin use. And yes, the focus, as you can imagine, there is also some natural turnover in the sales force team. And we were able to, we're lucky enough to pick up in the sales force team.

是的。因此，我們保持了銷售隊伍的一致性。我們目前在該領域有 12 名銷售人員，根據我們之前的一些電話會議中討論過的區域，目標是 80% 的順鉑使用。是的，正如您可以想像的那樣，重點是銷售團隊中也存在一些自然流動。我們能夠，我們很幸運能夠加入銷售團隊。

And we were able to, we're lucky enough to pick up some really talented individuals that sold in the community center and can really expand the push to use the NCCN guidelines for AYA for the use of PEDMARK in this population. So we think just the timing worked out very well.

我們能夠，我們很幸運地找到了一些在社區中心銷售的真正有才華的人，並且可以真正擴大推動使用 AYA 的 NCCN 指南，以便在這一人群中使用 PEDMARK。所以我們認為時機非常好。

Okay.

好的。

And if I could add there, I think there are three key things you need to have or four, actually. First of all, the NCCN guidelines with a category 2A. Secondly, you need to have the agreements in place and endorsement from the GPO organizations. You need a specialty pharmacy that can supply, direct to the community, direct to the hospitals, direct to the patient's home.

如果我可以補充一下，我認為實際上您需要具備三件或四件關鍵的東西。首先，NCCN 指引屬於 2A 類。其次，您需要獲得 GPO 組織的協議和認可。您需要一家可以直接供應到社區、直接到醫院、直接到病人家中的專業藥局。

And then you need an experienced sales force that is used to selling in this environment. And we now have all of that in place. So a major focus now is the AYA population, in addition to chipping away at the pediatric oncology centers.

然後，您需要一支經驗豐富、習慣在這種環境下進行銷售的銷售團隊。現在我們已經完成了所有這些。因此，除了削減兒科腫瘤中心之外，現在的主要焦點是 AYA 族群。

Terrific. So just one more from me. You did, Adrian, mention in your prepared remarks about partnering with Spec Pharma and the home admin angle, administration angle. What percentage of that is that part of the market? Just out of curiosity.

了不起。所以我再發一份。阿德里安，您在準備好的發言中確實提到了與 Spec Pharma 合作以及家庭管理角度、管理角度。這部分市場佔多大比例？只是出於好奇。

Well, if you look at the pediatric oncology centers, which accounts for 3,500 patients, then I think the majority of those right now, the younger ones, are treated in the specialist oncology centers. But all the older patients are either treated in fusion centers or at home or in community hospitals. And as I said, there's probably around 30,000 in total there.

嗯，如果你看看兒科腫瘤中心，那裡有 3,500 名患者，那麼我認為現在大多數患者，即年輕患者，都在專科腫瘤中心接受治療。但所有老年患者要麼在融合中心、在家或社區醫院接受治療。正如我所說，那裡總共可能有大約 30,000 人。

So I think the opportunity, the real opportunity, lies in with the AYA population, where we've got NCCN endorsement, we've got reimbursement because it's a 2A, and it's financially attractive. And also bear in mind that these patients are obviously older and heavier, so they're going to use more vials.

所以我認為機會，真正的機會在於 AYA 人群，我們得到了 NCCN 的認可，我們得到了報銷，因為它是 2A，而且在經濟上具有吸引力。還要記住，這些患者顯然年齡更大、體重更重，因此他們將使用更多的小瓶。

Right. Okay. Thank you. Thank you.

正確的。好的。謝謝。謝謝。

And just to add one more, the ability for us to provide vials into the home setting of a patient, we, up to this point, we did not have this capability, and we're having this capability now. So that's certainly very encouraging, in addition to the skillset required to sell into the community oncology, as Adrian mentioned earlier. So we have the full suite of products and the sales force to execute on this plan.

再補充一點，我們能夠向患者的家中提供小瓶，到目前為止，我們還沒有這種能力，但我們現在有了這種能力。因此，正如阿德里安之前提到的，除了向社區腫瘤學推銷所需的技能之外，這當然非常令人鼓舞。因此，我們擁有全套產品和銷售人員來執行該計劃。

And that has been in place since the middle of October, all of these things. So we think we've got everything in place now.

所有這些事情自十月中旬以來一直在實施。所以我們認為現在一切都已就位。

Great. Thank you. That's all from me.

偉大的。謝謝。這就是我的全部。

(Operator Instructions) Our next question comes from Charles Duncan with Cantor Fitzgerald & Co

（操作員說明）我們的下一個問題來自 Charles Duncan 和 Cantor Fitzgerald & Co

Hey, good morning, Rosty and team. Congrats on a good quarter, and thanks for taking our questions. I had just a couple of them. First of all, if you fast forward a year from now, would you anticipate the majority of your vial use to come from pediatric younger patients, call it centers for excellence, treated in centers for excellence.

嘿，早上好，羅斯蒂和團隊。恭喜季度表現良好，並感謝您提出我們的問題。我只有幾個。首先，如果你快轉一年後，你會預期你使用的大部分小瓶將來自年輕兒科患者，稱之為卓越中心，在卓越中心接受治療。

Or would it be perhaps more from the AYA patient population, given that they're generally larger folks, et cetera.? And so what is the goal over the course of the next 12 months beyond just, you know, call it revenue that you would like to achieve? Thanks.

或者可能更多來自 AYA 患者群體，因為他們通常體型較大，等等。那麼，除了您希望實現的收入之外，未來 12 個月的目標是什麼？謝謝。

Yeah, hi, Jeff. Very good question. I think the goal is, I mean, it's really since Adrian has been here, we really have been focusing on two additional opportunities. One is the AYA, and the second one is international. In addition to all the work that we have done with a large pediatric hospital center. So I think all of these three things in place a year from now,

是的，嗨，傑夫。非常好的問題。我認為目標是，我的意思是，自從阿德里安來到這裡以來，我們確實一直在關注另外兩個機會。第一個是 AYA，第二個是國際的。除了我們與大型兒科醫院中心所做的所有工作之外。所以我認為一年後這三件事都會到位，

I would imagine that we could speak to all three of them contributing substantial amounts. And of course, the AYA, as you mentioned very well, by the nature of the tumor types treated there, and the nature of the cisplatin therapies treated there, would require significantly more in the larger size of the patients, of course, would require significantly more vials of PEDMARK.

我想我們可以與他們三個人交談，他們都貢獻了大量資金。當然，正如您很好地提到的，根據那裡治療的腫瘤類型的性質以及那裡治療的順鉑療法的性質，AYA 需要更多的患者，當然，需要更多的患者。顯著增加PEDMARK 瓶數。

So yes, so I would say that probably given that it's starting at almost zero right now, would be probably the largest. But don't underestimate both the pediatric hospital, I mean, the pediatric hospital, we made substantial progress, there's still good, good amount of activity [PVT] and PNT wins under our belt as well as newer ones that we're expecting.

所以是的，所以我想說，考慮到它現在幾乎從零開始，這可能是最大的。但不要低估兒科醫院，我的意思是，兒科醫院，我們取得了實質進展，我們仍然取得了大量的活動 [PVT] 和 PNT 勝利，以及我們期待的更新的活動。

So yeah, we could also pleasantly be surprised there as well. And on the international side, of course, what really is going to drive revenues there is the is particularly Germany and the UK, right, and France. So certainly, very encouraged by what Adrian's been able to do in Germany.

所以，是的，我們也可以在那裡感到驚喜。當然，在國際方面，真正能夠推動營收成長的是德國、英國（右）和法國。當然，阿德里安在德國所做的一切讓我深受鼓舞。

Yeah, and that's a great segue to my next question. I was a little bit confused on some of Adrian's answers regarding pricing and beyond pricing, and I know that can be kind of an artifact of a certain country. I guess I'm wondering if you could perhaps talk about the pharmacoeconomic value of PEDMARK in Europe or in the UK versus here in the United States.

是的，這是我下一個問題的一個很好的延續。我對阿德里安關於定價和定價之外的一些答案有點困惑，我知道這可能是某個國家的產物。我想我想知道您是否可以談談 PEDMARK 在歐洲或英國與美國的藥物經濟學價值。

Do you think there's a good recognition of the downstream cost of you know, cisplatin-induced hearing loss? And if you could gauge timing as to being able to talk about your strategy, is it a goal for the first half of next year to be able to, you know, really come to a conclusion on what next steps are ex-US?

您認為人們對順鉑引起的聽力損失的下游成本有很好的認識嗎？如果你能衡量能夠談論你的策略的時機，那麼明年上半年的目標是否能夠真正就美國以外的下一步行動得出結論？

Thanks. Yeah, I would answer the latter one and I'll hand it over to Adrian. So yeah, so our goal would be sometimes between now and middle of next year to have that answer on what we plan on doing, either keeping the major five to ourselves and partnering the rest or selling the European business to someone else, right, so that all would depend on several factors.

謝謝。是的，我會回答後一個問題，然後將其交給阿德里安。所以，是的，所以我們的目標有時是從現在到明年年中，就我們計劃做什麼找到答案，要么把主要的五個公司留給我們自己，然後與其餘的公司合作，要么將歐洲業務出售給其他人，對吧，所以這一切都取決於幾個因素。

Importantly, what is the cash up front? So, and maybe Adrian, over to you in terms of the value proposition of European health dossiers for the health economics of PEDMARK to their healthcare systems.

重要的是，預付現金是多少？那麼，也許阿德里安（Adrian）就歐洲健康檔案對 PEDMARK 健康經濟學對其醫療保健系統的價值主張交給您了。

Yeah, so I think the first thing to remind everyone of is that although you've got actually in Europe two regulatory authorities now, you've got the UK's MHRA and the EMA, the other 27 countries, you've got 28 different ways of assessing whether the country can afford to pay for a drug. So in terms of the health economic argument that we are putting together, i.e. can this country justify paying X for the drug, we're well advanced in most of the European countries.

是的，所以我認為首先要提醒大家的是，雖然現在歐洲實際上有兩個監管機構，有英國的 MHRA 和 EMA，其他 27 個國家有 28 種不同的方式評估該國是否有能力支付藥品費用。因此，就我們正在整理的健康經濟論點而言，即這個國家能否證明為該藥物支付 X 的費用是合理的，我們在大多數歐洲國家都處於領先地位。

In terms of the dossier preparation and we feel strongly that we will be able to present a convincing argument to justify paying something like at least 70% to 100% of the US price in Europe, if that's clearer.

就檔案準備而言，我們強烈認為，如果情況更清楚的話，我們將能夠提出令人信服的論據，證明在歐洲支付至少相當於美國價格 70% 至 100% 的費用是合理的。

That makes sense. I didn't know if it was a discount or the actual price, so that helps.

這就說得通了。我不知道這是折扣還是實際價格，所以有幫助。

I think there will be a mixture of some degree of discounts and caps because whilst they will be willing to pay full price for a 5 kilo hepatoblastoma patient, they won't be willing to pay full price for a 80 kilo testicular cancer patient. So there's got to be some kind of cap.

我認為會有一定程度的折扣和上限，因為雖然他們願意為 5 公斤重的肝母細胞瘤患者支付全價，但他們不願意為 80 公斤重的睪丸癌患者支付全價。所以必須有某種上限。

That makes sense. And is there a recognition, I think you mentioned depression as an example, of the downstream costs of losing one's hearing and how that accrues costs to not only the patient but the community over time.

這就說得通了。我想你提到了憂鬱症作為一個例子，是否認識到失去聽力的下游成本以及隨著時間的推移，這種成本不僅對患者而且對社區造成的損失。

And different countries have different approaches. For example, some will take into account the fact that a deaf patient is unlikely to be able to contribute because they drop out of school, they don't get well-paid jobs, they become a burden on the social security system. Some countries will take that into account in their assessment.

而且不同的國家有不同的做法。例如，有些人會考慮到聾啞患者不太可能做出貢獻，因為他們輟學，沒有找到高薪工作，成為社會安全體系的負擔。有些國家會在評估中考慮到這一點。

Others will say, well, how much are they just costing the healthcare system, for example, and not taking into account social security costs and loss of earnings, etc. So each one of these countries has a slightly different way of looking at it, so it's very difficult to generalize. Where I would generalize is that we feel that in most of the countries we've got sufficiently strong arguments to justify a good price.

其他人會說，例如，他們只花了醫療保健系統多少錢，而不考慮社會安全成本和收入損失等。因此，這些國家中的每一個都有稍微不同的看待它的方式，所以很難一概而論。我想說的是，我們認為在大多數國家，我們都有足夠有力的論點來證明一個好的價格是合理的。

It's helpful. Looking forward to seeing the progress next year, ex-US as well as US. Congrats on the progress in the quarter. Thank you.

這很有幫助。期待明年看到進展，包括美國以外的地區。恭喜本季取得的進展。謝謝。

Our next question comes from Dipesh Patel with H.C. Wainwright.

我們的下一個問題來自 Dipesh Patel 和 H.C.溫賴特。

Thank you, guys. This is Dipesh (inaudible) on for Ram Selvaraju. What kinds of information do you expect to disclose going forward regarding the commercial trajectory of PEDMARK in the US? So, for instance, number of patients on therapy, number of new and repeat prescriptions written, total number of prescribers, or number of prescribers who have written, for example, greater than one prescription, etc.

感謝你們。我是 Ram Selvaraju 的迪佩什（聽不清楚）。關於 PEDMARK 在美國的商業軌跡，您希望揭露哪些類型的資訊？例如，正在接受治療的患者數量、新開立的處方和重複開出的處方數量、處方者總數或開出多於一張處方的處方者數量等。

Yes, that's a good question. As you could see, we started giving a little more granularity as the business started building up, particularly with the accounts where we have one P&T, right? As well as the repeat orders from those places and the penetration within the physicians within the physicians within those places. So, I think as the business builds up, I think we will be more granular on that. Absolutely. Keep in mind, what we don't know, of course, is that given our label, it covers many, many tumor types. At best, we're guessing what the tumor types are that are being treated.

是的，這是一個好問題。正如您所看到的，隨著業務的開始發展，我們開始提供更多的粒度，特別是對於我們擁有一個 P&T 的帳戶，對嗎？以及來自那些地方的重複命令以及那些地方的醫生內部的滲透。因此，我認為隨著業務的發展，我們將在這方面更加細緻。絕對地。請記住，當然，我們不知道的是，鑑於我們的標籤，它涵蓋了很多很多腫瘤類型。充其量，我們只是猜測正在治療的腫瘤類型是什麼。

Okay, thank you for that. I have several more questions. How would you describe the current status of reimbursement and formulary access for PEDMARK?

好的，謝謝你。我還有幾個問題。您如何描述 PEDMARK 報銷和處方准入的當前狀態？

So, in terms of reimbursement, we have not seen any major issues. So, that certainly has been encouraging. In terms of the formulary process, as you could imagine, hospitals in the US are under tremendous financial pressure. Their margins, net operating margins, are very thin. On the other hand, something very positive is happening to them, which is they are creating a tremendous margin at their pharmacy level, in particular, the savings from bio-simulators.

所以，在報銷方面，我們沒有看到任何重大問題。所以，這確實令人鼓舞。就處方流程而言，可以想像，美國的醫院承受著巨大的財務壓力。他們的利潤率，即淨營業利潤率，非常微薄。另一方面，一些非常積極的事情正在發生在他們身上，那就是他們在製藥層面創造了巨大的利潤，特別是生物模擬器的節省。

So, as we are moving forward to get through a P&T committee, and sometimes it takes us more than once, those type of considerations come into play. But, obviously, it's not easy. It's not easy to get through a P&T committee, given all the considerations, given that this comes from their DRG.

因此，當我們正在努力通過 P&T 委員會時，有時我們需要不只一次，這些類型的考慮因素就會發揮作用。但顯然，這並不容易。考慮到所有的因素，考慮到這來自他們的 DRG，要通過 P&T 委員會並不容易。

All right, that's very helpful. And then, how are partnership discussions progressing in Europe, and when do you expect to launch the product there?

好的，這非常有幫助。那麼，歐洲的合作討論進度如何？您預計什麼時候在歐洲推出產品？

So, I just, from the previous question, yes, we expect to launch sometimes in the second quarter next year, probably May, June next year. It's our best guess at the moment. We are still going through a type 2 variation, where we're switching the manufacturer from the US, basically, into Europe. Our current manufacturer of PEDMARK is also manufacturing PEDMARK-C, and they will have to be approved in the type 2 variation.

所以，我只是，從上一個問題來看，是的，我們預計有時會在明年第二季推出，可能是明年五月、六月。這是我們目前最好的猜測。我們仍在經歷第 2 類變化，我們基本上將製造商從美國轉移到歐洲。我們目前的 PEDMARK 製造商也在生產 PEDMARK-C，它們必須獲得 2 型變體的批准。

So, I think as soon as we have that, and then we obviously ship and label product into the European market, then I think we'll be able to give you a little more granularity of what month the launch would be. But Adrian is certainly working on that, given all the preparation work he's doing on the health economics.

因此，我認為一旦我們有了這個，然後我們顯然會將產品運送到歐洲市場並貼上標籤，那麼我認為我們將能夠為您提供更詳細的發布月份資訊。但考慮到阿德里安在衛生經濟學方面所做的所有準備工作，他肯定正在為此努力。

Got it. And then just a couple more questions. Do you have any plans to advance other drug candidates from your discovery stage pipeline into the clinic at this time?

知道了。還有幾個問題。您目前是否有計劃將其他候選藥物從發現階段的管道推進到臨床？

Well, I don't know if you know much about the history of Fennec, which was the presence of companies with [hearx], but we started with three and we have one. So, I think it's very important for us to establish this one on the market before looking into bringing something else in.

好吧，我不知道你是否了解 Fennec 的歷史，當時有 [hearx] 公司的存在，但我們一開始有 3 家，現在已經有了 1 家。因此，我認為在考慮引入其他產品之前，先將這款產品推向市場對我們來說非常重要。

Got it. Okay. And then last question, gentlemen. What does the long-term competitive landscape look like for PEDMARK in the US?

知道了。好的。最後一個問題，先生們。 PEDMARK 在美國的長期競爭格局如何？

I mean, I think the most critical piece is, would cisplatin remain a mainstay treatment in pediatric cancer? And we believe it will be. Pediatric tumors in general and AYA tumors in general are very receptive, sensitive to cisplatin. Oncologists see a good use for the drug. They know a good use for the drug. They know how to use it. They've optimized it. So, anything else that usually comes on top of cisplatin, it comes at later stages.

我的意思是，我認為最關鍵的是，順鉑是否仍然是兒科癌症的主要治療方法？我們相信它會的。一般來說，小兒腫瘤和 AYA 腫瘤對順鉑非常容易接受和敏感。腫瘤學家看到了這種藥物的良好用途。他們知道這種藥物的良好用途。他們知道如何使用它。他們已經優化了它。因此，通常在順鉑之上出現的任何其他藥物都會在後期出現。

So, I don't see anyone looking to replace cisplatin. So, that's really the view that we have and what we see in the marketplace. So, yeah, I don't expect substitution of cisplatin anytime soon.

因此，我認為沒有人希望取代順鉑。所以，這確實是我們的觀點以及我們在市場上看到的情況。所以，是的，我預計順鉑不會很快被取代。

Got it. Thank you, Rosty and gentlemen, for the update. Appreciate it.

知道了。謝謝羅斯蒂和先生們的更新。欣賞它。

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

目前我不會提出任何進一步的問題。我想將電話轉回給 Rusty，讓其結束語。

Yes. Yeah. I would like to thank you all for joining us today, and we look forward to updating you on our continued launch progress and corporate milestones on future quarterly calls. Thank you and have a great day.

是的。是的。我要感謝大家今天加入我們，我們期待在未來的季度電話會議上向您通報我們的持續發布進度和公司里程碑。謝謝您，祝您有美好的一天。

Well, ladies and gentlemen, this concludes today's presentation. You may now disconnect and have a wonderful day.

好了，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。