Fennec Pharmaceuticals Inc (FENC) 2023 Q2 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals second-quarter 2023 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference call is being recorded.

早上好，女士們、先生們，歡迎參加 Fennec Pharmaceuticals 2023 年第二季度收益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。

Now, I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.

現在，我想將會議轉交給 Fennec 的首席財務官 Robert Andrade。

Thank you, operator, and good morning, everyone. We are delighted that you can join us today for Fennec Pharmaceuticals' second-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 our newly appointed Chief Operating Officer, Adrian Haigh.

謝謝接線員，大家早上好。我們很高興您今天能夠參加 Fennec Pharmaceuticals 的 2023 年第二季度收益電話會議，會議期間我們將審查我們的財務業績並提供一般業務更新。今天早上，我們的首席執行官 Rosty Raykov 從 Fennec 與我一起來。以及我們新任命的首席運營官 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 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披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 statements.

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。我們特別聲明不承擔更新或修改任何前瞻性陳述的義務。

This conference call is being recorded for audio rebroadcast on Fennec's website, www.fennecpharma.com, where it will be available for the next 30 days.

本次電話會議正在錄製並在 Fennec 網站 www.fennecpharma.com 上進行音頻重播，並將在未來 30 天內提供。

And with that, I will now turn this call over to Rosty Raykov.

現在，我將把這個電話轉給羅斯蒂·雷科夫。

Thank you, Robert, and good morning, everyone. We'll be discussing our recent progress, as we have achieved many significant milestones over the past several months. The focus of today's call is to review updates on the ongoing launch efforts underway for PEDMARK in the US, and discuss our global opportunities, including the recent approval in Europe. Further, we'll detail our second-quarter financial results, all of which were outlined in our earnings press release issued this morning prior to this call.

謝謝羅伯特，大家早上好。我們將討論我們最近的進展，因為我們在過去幾個月中取得了許多重要的里程碑。今天電話會議的重點是回顧 PEDMARK 在美國正在進行的啟動工作的最新情況，並討論我們的全球機遇，包括最近在歐洲的批准。此外，我們將詳細介紹第二季度的財務業績，所有這些都在我們今天早上在本次電話會議之前發布的收益新聞稿中概述。

As a reminder, PEDMARK 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. The availability of PEDMARK has ushered in a critical breakthrough for the pediatric oncology community, which was enthusiastically awaiting a rigorously tested and FDA-approved option to safely increase the potential long-term quality of life of these young patients.

需要提醒的是，PEDMARK 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。 PEDMARK 的上市為兒科腫瘤學界帶來了重大突破，他們熱切地等待著經過嚴格測試和 FDA 批准的選擇，以安全地提高這些年輕患者的潛在長期生活質量。

In June, we announced Pedmarqsi was granted marketing authorization by the European Commission. Pedmarqsi is the first and only approved therapy in the EU for prevention of hearing loss induced by cisplatin chemotherapy in patients 1 month to 18 years of age with localized non-metastatic solid tumors. Further, Pedmarqsi was granted pediatric use marketing authorization, PUMA, which includes eight years plus two years of data and market protection.

6 月，我們宣布 Pedmarqsi 獲得歐盟委員會的營銷授權。 Pedmarqsi 是歐盟第一個也是唯一一個批准的治療方法，用於預防 1 個月至 18 歲局部非轉移性實體瘤患者因順鉑化療引起的聽力損失。此外，Pedmarqsi 還獲得了兒科使用營銷授權 PUMA，其中包括八年加兩年的數據和市場保護。

In terms of our commercial strategy, we're pleased to share the results of the second quarter, as we believe they underscore the growth potential of PEDMARK. We remain focused on executing the following: establishing PEDMARK as a necessary complement agents when prescribing cisplatin-based therapy for a child with localized non-metastatic solid tumor, minimizing the barriers to access and ensuring rapid responses to product questions; and establishing Fennec as the premier partner of choice among the pediatric oncology community.

就我們的商業戰略而言，我們很高興分享第二季度的業績，因為我們相信它們強調了 PEDMARK 的增長潛力。我們仍然專注於執行以下任務：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 確立為必要的補充藥物，最大限度地減少獲取障礙並確保對產品問題的快速響應；並將 Fennec 打造為兒科腫瘤學界的首選合作夥伴。

To help address these goals, we have established a best-in-class patient services and support offering called Fennec HEARS, which is a comprehensive single-source program designed to connect PEDMARK patients to both patient financial and product access support. In addition, we have built out a strong commercial team to execute US marketing, distribution, access, and launch of PEDMARK with a sales team that is highly focused on targeting the approximately 200 pediatric hospital centers, including COG, NCI, and NCCN institutions across the US that drive 80% of cisplatin use.

為了幫助實現這些目標，我們建立了名為 Fennec HEARS 的一流患者服務和支持服務，這是一個全面的單一來源計劃，旨在將 PEDMARK 患者與患者財務和產品獲取支持聯繫起來。此外，我們還建立了一支強大的商業團隊來執行 PEDMARK 在美國的營銷、分銷、准入和推出，銷售團隊高度專注於針對約 200 個兒科醫院中心，包括全美各地的 COG、NCI 和 NCCN 機構美國占順鉑使用量的80%。

More specifically, we're pleased with the second quarter's double-digit growth in new pediatric hospital centers prescribing PEDMARK and the consistent repeat orders from existing accounts. Further, we have had recent success in larger academic centers, including formulary approvals early in the third quarter at major pediatric hospital centers.

更具體地說，我們對第二季度開用 PEDMARK 的新兒科醫院中心的兩位數增長以及現有賬戶的持續重複訂單感到滿意。此外，我們最近在大型學術中心取得了成功，包括第三季度初在主要兒科醫院中心獲得處方批准。

As a reminder, early adoption has come from both major academic centers and regional practices. More recently, we have had adoption coming from some of the most recognized pediatric centers of excellence. 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.

提醒一下，早期採用來自主要學術中心和區域實踐。最近，我們得到了一些最受認可的兒科卓越中心的採用。從地理上看，我們所有的地區都有 HCP 開 PEDMARK 處方。我們看到目標客戶的採用率非常令人鼓舞，而且隨著時間的推移，這種採用率正在不斷增加。

In terms of patients, we have seen patient utilization across several tumor types, including hepatoblastoma, osteosarcoma, and germ cell tumors. Further, given our broad and favorable payer coverage and streamlined reimbursement process, we have been successful in securing coverage for prescribed patients.

就患者而言，我們已經看到多種腫瘤類型的患者使用，包括肝母細胞瘤、骨肉瘤和生殖細胞腫瘤。此外，鑑於我們廣泛且有利的付款人承保範圍以及簡化的報銷流程，我們已成功為處方患者提供承保。

So we're pleased that the efforts and execution of the team is starting to become evident in the 98% net revenue growth experienced in the second quarter. We're continuing to execute against our strategic launch plans and are confident in our disciplined and targeted approach to building share within the US market.

因此，我們很高興看到團隊的努力和執行力開始在第二季度實現 98% 的淨收入增長中得到體現。我們將繼續執行我們的戰略發布計劃，並對我們在美國市場上建立份額的嚴格和有針對性的方法充滿信心。

With regard to expanding in Europe, we announced in June the marketing authorization for PEDMARK, which will be marketed as Pedmarqsi. Pedmarqsi will be the first and only treatment approval in the European Union to address this area of significant unmet medical need.

關於在歐洲的擴張，我們於 6 月宣布了 PEDMARK 的營銷授權，該產品將以 Pedmarqsi 名義進行營銷。 Pedmarqsi 將是歐盟第一個也是唯一一個獲得批准的治療方法，用於解決這一未滿足的重大醫療需求領域。

We continue to evaluate the best commercial pathway for the company in Europe and rest of the world, either go it alone or with a partner or both. Whatever pathway we select, we see Europe as another significant opportunity to create shareholder value.

我們將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或兩者兼而有之。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。

Finally, as announced today, I am very pleased to have Adrian Haigh join the executive management team of Fennec as Chief Operating Officer. Adrian has been a major contributor to Fennec's success since joining the Board in 2014 and is part of the Fennec family. We are fortunate to have him available to help us at this pivotal stage in the commercial evolution of Fennec.

最後，正如今天宣布的那樣，我很高興 Adrian Haigh 加入 Fennec 的執行管理團隊，擔任首席運營官。自 2014 年加入董事會以來，Adrian 一直是 Fennec 成功的主要貢獻者，並且是 Fennec 家族的一員。我們很幸運能有他在 Fennec 商業發展的關鍵階段為我們提供幫助。

Adrian comes to us from PTC Therapeutics, where his last role was Senior Vice President and Head of International. Prior to that, Adrian worked with our Chairman, Dr. Khalid Islam, as Chief Operating Officer of Gentium, where he built and managed Gentium's commercial and medical affairs organization and was also responsible for business development, playing a pivotal role in the sale of Gentium to Jazz Pharmaceuticals for $1 billion.

Adrian 就職於 PTC Therapeutics，他最後的職位是高級副總裁兼國際主管。在此之前，Adrian 與我們的董事長 Khalid Islam 博士一起工作，擔任 Gentium 的首席運營官，他建立和管理 Gentium 的商業和醫療事務組織，並負責業務開發，在 Gentium 的銷售中發揮了關鍵作用以10 億美元收購Jazz Pharmaceuticals。

Adrian, it's great to have you with us on this call. Can you give us a brief overview of the opportunity you see for Fennec, given your new role?

阿德里安，很高興您能參加這次電話會議。鑑於您的新角色，您能否向我們簡要介紹一下您為 Fennec 看到的機會？

Thanks, Rosty. I'm delighted to have been asked to join Fennec full time as Chief Operating Officer. As many of you are aware, this has been quite a rollercoaster ride over the last 10 years. But through everything, we've remained laser-focused on our mission to ensure that all pediatric cancer patients at risk of hearing loss caused by cisplatin chemotherapy have access to PEDMARK.

謝謝，羅斯蒂。我很高興受邀加入 Fennec 全職擔任首席運營官。正如你們許多人所知，過去 10 年的情況就像坐過山車一樣。但儘管如此，我們仍然專注於我們的使命，確保所有因順鉑化療而導致聽力損失的兒科癌症患者都能獲得 PEDMARK。

I left PTC at the end of last year after eight years building and leading the international commercial organization. Retirement was not for me, and I'm delighted that the Board believes that my experience in leading global commercial teams in generating significant pre- and post-approval sales while, at the same time, evaluating all strategic options is the skill set that Fennec needs right now.

在創建和領導這家國際商業組織八年之後，我於去年年底離開了 PTC。退休不適合我，我很高興董事會相信我在領導全球商業團隊方面的經驗，在批准前和批准後產生顯著的銷售額，同時評估所有戰略選擇，這是 Fennec 所具備的技能。現在需要。

For example, at Gentium, the fact that we had a small commercial team in place across Europe with all the key HTA dossiers submitted or in preparation, combined with significant pre-launch revenue, that enabled us to generate considerable value for shareholders. Doing the same at Fennec will be a priority.

例如，在 Gentium，我們在歐洲各地擁有一個小型商業團隊，負責提交或準備中的所有關鍵 HTA 檔案，再加上啟動前的大量收入，這使我們能夠為股東創造可觀的價值。在 Fennec 做同樣的事情將是一個優先事項。

Now that we have EU approval, work needs to be done and done quickly to ensure a speedy and successful launch, whatever strategic direction we ultimately take. Of course, equally important is accelerating adoption of PEDMARK in the United States.

現在我們已經獲得了歐盟的批准，無論我們最終採取什麼戰略方向，都需要盡快完成工作，以確保快速成功的啟動。當然，同樣重要的是加速 PEDMARK 在美國的採用。

As Rosty said, we've made considerable progress in the last quarter, but we still need approval by a number of key pharmacy committees. Concluding these reviews and ensuring that PEDMARK is included as standard of care in all treatment protocols will be critical over the coming months. These will be my two priorities.

正如 Rosty 所說，我們在上個季度取得了相當大的進展，但我們仍然需要一些主要藥學委員會的批准。在未來幾個月內，完成這些審查並確保將 PEDMARK 作為護理標準納入所有治療方案至關重要。這將是我的兩個優先事項。

So once again, it's a real pleasure to be a full-time executive team member, and I look forward to the next call where we will provide further updates on our progress.

因此，再次成為一名全職執行團隊成員真的很高興，我期待下一次電話會議，我們將提供有關進展的進一步更新。

With that, I'll now turn the call over to Robert to review our financial results for the quarter.

現在，我將把電話轉給羅伯特，以審查我們本季度的財務業績。

Thank you, Adrian. Our press release contains details of our financial results for the second quarter of 2023, which 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.

謝謝你，阿德里安。我們的新聞稿包含 2023 年第二季度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關註一些關鍵的財務業績，而不是通讀所有這些細節。

The company recorded net product sales of $3.3 million in the second quarter of 2023 versus $1.7 million in the first quarter of 2023 for a net revenue growth of 98%. As Rosty mentioned, we are pleased with the growing acceptance of PEDMARK within healthcare providers during the second quarter and with the recent hospital formulary access approvals we have gained early in Q3.

該公司 2023 年第二季度的產品淨銷售額為 330 萬美元，而 2023 年第一季度為 170 萬美元，淨收入增長了 98%。正如 Rosty 提到的，我們很高興看到第二季度醫療保健提供者對 PEDMARK 的接受度不斷提高，以及我們在第三季度初獲得的最近醫院處方准入批准。

G&A for the second quarter of 2023 was $5.5 million, which compares to $4.4 million in the first quarter of 2023. The increase is largely attributable to non-cash employee renumeration. R&D expense is negligible, as the company reduced research and development costs when it received FDA approval of PEDMARK. The majority of traditional research and development expenses associated with PEDMARK are now recorded or capitalized into inventory and eventually recorded to cost of product sales.

2023 年第二季度的一般管理費用為 550 萬美元，而 2023 年第一季度為 440 萬美元。這一增長主要歸因於非現金員工薪酬。研發費用可以忽略不計，因為該公司在獲得 FDA 批准 PEDMARK 後降低了研發成本。與 PEDMARK 相關的大部分傳統研發費用現在都記錄或資本化到庫存中，並最終記錄到產品銷售成本中。

The company began recording selling and marketing expenses when it expanded its payroll to include an internal sales force. Selling and marketing expenses include distribution costs, logistics, shipping and insurance, advertising, wages and commissions, and out-of-pocket expenses. The company recorded $2.3 million in selling and marketing expenses in the second quarter of 2023 compared to $2.5 million in the first quarter of 2023. Our GAAP net loss for the second quarter of 2023 was $5.4 million, or $0.21 per share, compared to a GAAP net loss of $5.0 million, or $0.19 per share.

當該公司擴大工資範圍以納入內部銷售人員時，開始記錄銷售和營銷費用。銷售和營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 年第二季度的銷售和營銷費用為230 萬美元，而2023 年第一季度為250 萬美元。與GAAP 相比，我們2023 年第二季度的GAAP 淨虧損為540 萬美元，即每股0.21 美元淨虧損 500 萬美元，即每股 0.19 美元。

And finally, our cash position. We ended the second quarter with approximately $15 million in cash, cash equivalents, and investment securities. This includes $25 million of capital drawn in the second quarter under our existing Petrichor convertible debt facility.

最後，我們的現金狀況。第二季度末，我們擁有約 1500 萬美元的現金、現金等價物和投資證券。這包括第二季度根據我們現有的 Petrichor 可轉換債務融資提取的 2500 萬美元資本。

Our cash burn for the second quarter was approximately $3.4 million compared to $5.5 million in the first quarter of 2023. As a reminder, we anticipate approximately $2 million in monthly cash operating expenses during 2023. We believe our available capital, when coupled with PEDMARK revenue assumptions, will take us out for at least the next 12 months.

我們第二季度的現金消耗約為340 萬美元，而2023 年第一季度為550 萬美元。提醒一下，我們預計2023 年每月現金運營支出約為200 萬美元。我們相信我們的可用資本與PEDMARK收入相結合假設，我們至少會在未來 12 個月內陷入困境。

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

接線員，現在我們準備好回答問題了。

Thank you. We will now conduct the question-and-answer session. (Operator Instructions) Chase Knickerbocker, Craig Hallum.

謝謝。我們現在將進行問答環節。 （操作員說明）Chase Knickerbocker、Craig Hallum。

Good morning, everyone. Thanks for the questions, guys. Maybe just concerning the ramp of accounts, you haven't cleared P&T yet. We're now on the tail of that six- to nine-month period it takes to get to those P&T committees at the larger accounts. Good to hear about the account growth.

大家，早安。謝謝你們的提問，伙計們。也許只是考慮到賬戶的增加，你還沒有清算P&T。我們現在正處於與大型客戶的 P&T 委員會聯繫所需的六到九個月的時間的尾聲。很高興聽到帳戶增長的消息。

Maybe putting a finer point on it -- of those 200 focus accounts we talked about, what do you think your number of accounts is today or just general penetration there, however you want to define it? I think just a finer point there would be helpful for investors.

也許可以說得更詳細一點——在我們討論的 200 個焦點賬戶中，您認為您今天的賬戶數量是多少，或者只是那裡的一般滲透率，無論您想如何定義它？我認為只要有一個更好的觀點就會對投資者有所幫助。

Hi, Chase. This is Rosty. Thank you for the question.

嗨，蔡斯。這是羅斯蒂。感謝你的提問。

We're shying away from giving details in terms of number of accounts. What I would say is that what we have at the moment is actually quite significant compared to where we were at this time last quarter. As I mentioned in my prepared remarks, the growth in accounts was double digits, with -- and this is prescribing accounts.

我們迴避提供賬戶數量方面的詳細信息。我想說的是，與上季度此時相比，我們目前所擁有的實際上非常重要。正如我在準備好的發言中提到的，賬戶增長了兩位數，這是處方賬戶。

In addition to that, we have had some major P&T wins in some of the most recognized and larger institutions in pediatric oncology. So hopefully, some of these accounts will be coming through this quarter. And again, that would really help further with the double-digit growth. But we still have significant opportunity ahead of us, as there more P&T committees coming up.

除此之外，我們還在兒科腫瘤學領域一些最受認可的大型機構中取得了一些重大的 P&T 勝利。因此，希望其中一些帳戶能夠在本季度完成。再說一遍，這確實有助於進一步實現兩位數的增長。但隨著更多 P&T 委員會的成立，我們仍然面臨著重大機遇。

Got it. Maybe speak to the ongoing cisplatin shortages we're seeing in the US. What are you hearing from customers? Do you think that's having any impact on your ramp at this point?

知道了。也許可以談談我們在美國看到的持續的順鉑短缺。您從客戶那裡聽到了什麼？您認為這對您目前的進度有任何影響嗎？

No, that has not been -- we have heard about the cisplatin shortages that have been ongoing for the last, at least, four months. That has not been an issue in pediatric oncology. As you know, in pediatrics, there are not that many patients to begin with, and cisplatin is -- goes to those hospitals first. We actually -- we're hearing a lot about melphalan shortages at the moment, but not cisplatin.

不，事實並非如此——我們聽說順鉑短缺已經持續了至少四個月。這在兒科腫瘤學中並不是一個問題。如你所知，在兒科，本來就沒有那麼多病人，而順鉑是——首先去那些醫院。實際上，我們目前聽到很多有關馬法蘭短缺的消息，但沒有聽說順鉑短缺。

Got it. And then how should we be thinking about bringing Adrian on here in the COO role? Was this -- is the implication that Adrian has been playing a large role in partnership discussions Europe and thus is kind of just cementing the role there? Or should we be thinking there's an increased appetite from you guys to maybe go it alone in Europe now and Adrian, through his PTC experience launching their international businesses, obviously would be a good fit there, building those capabilities out? (multiple speakers) there.

知道了。那麼我們應該如何考慮讓阿德里安擔任首席運營官呢？這是否意味著阿德里安一直在歐洲夥伴關係討論中發揮著重要作用，因此只是鞏固了在那裡的作用？或者我們是否應該認為你們現在越來越有興趣在歐洲單獨行動，而 Adrian 憑藉他在 PTC 開展國際業務的經驗，顯然非常適合在那裡建立這些能力？ （多個發言者）那裡。

Yeah, no. In our prepared remarks, well -- personally, I've known Adrian for over 10 years now. And we at Fennec, we're a small company. We work very, very closely with our Board members. And so I'm very, very thankful that he was able to join us in this pivotal moment.

是的，不。在我們準備好的發言中，就我個人而言，我認識阿德里安已有 10 多年了。我們 Fennec 是一家小公司。我們與董事會成員的合作非常非常密切。所以我非常非常感謝他能夠在這個關鍵時刻加入我們。

As you could see from his résumé, he has the necessary experience to help us with all of the above. This goes from helping set the ground up for launch in Europe to overseeing the US sales organization and medical affairs and access to partnering opportunities, both in Europe, globally, or all of the above.

正如您從他的簡歷中看到的，他擁有幫助我們解決上述所有問題所需的經驗。這包括幫助為在歐洲的推出奠定基礎，監督美國的銷售組織和醫療事務，以及在歐洲、全球或上述所有地區獲得合作機會。

So maybe, Adrian, you may want to say a couple of things as well to that.

因此，阿德里安，您可能還想對此說幾句話。

Yeah, not a lot really to add. I think my experience is that -- this will be the third time, if we do build a commercial organization, that I've done it. I know how to do this. I know how to do it quickly. And I know how to do it seeing a minimal cost.

是的，其實沒什麼可補充的。我認為我的經驗是——如果我們真的建立一個商業組織，這將是我第三次這樣做。我知道該怎麼做。我知道如何快速做到這一點。我知道如何以最低的成本做到這一點。

As Rosty said earlier on in the prepared remarks, at Gentium, I was heavily involved in business development and, ultimately, in the sale of the Gentium to Jazz. So dare I say, I think I tick all the boxes. And as I said earlier, the Board believes I'm the right person at the right time.

正如 Rosty 早些時候在準備好的發言中所說，在 Gentium，我積極參與業務開發，並最終參與將 Gentium 出售給 Jazz。所以我敢說，我想我勾選了所有的方框。正如我之前所說，董事會相信我是正確時間的正確人選。

And quite honestly, I was a king, very bored in retirement and had been quite actively engaged with Fennec over the last couple of months, helping as a Board member. And we all agreed it kind of makes sense for me to take on a full-time role.

老實說，我是一位國王，退休後非常無聊，在過去的幾個月裡我一直非常積極地與 Fennec 交往，作為董事會成員提供幫助。我們都同意我擔任全職職務對我來說是有意義的。

Yeah. That makes a lot of sense. Just last for me. I'll hop back in the queue, guys. Any kind of update on how we should be thinking about launch in Europe, whether or not it's on your own or with a partner? How should investors be thinking about a potential launch timing there?

是的。這很有意義。只為我最後一次。我會回到隊列中，伙計們。關於我們應該如何考慮在歐洲推出的任何更新，無論是您自己還是與合作夥伴一起？投資者應該如何考慮那裡潛在的發佈時機？

Well, I think we're evaluating all options. I think a launch will be towards the end of the first quarter next year. But to enable that to happen, we have to do a lot of work. For example, you have to apply for a special license in Germany called a [NUB] license that has to be submitted by the end of November. If that isn't in place, then there's no way that anybody can sell in Germany, in hospitals, in 2024. And that requires quite a lot of preparation.

嗯，我認為我們正在評估所有選項。我認為將於明年第一季度末推出。但為了實現這一目標，我們必須做很多工作。例如，您必須在德國申請一種稱為 [NUB] 許可證的特殊許可證，該許可證必須在 11 月底之前提交。如果沒有做到這一點，那麼到 2024 年，任何人都無法在德國的醫院裡進行銷售。這需要大量的準備工作。

We've also started the work preparing all the HDA dossiers for the key countries. And as you know, that doesn't happen overnight. It takes several months. So we're doing whatever it takes to ensure that when PEDMARK is launched, whether it's through Fennec or whether it's through some kind of a partnership, it's the most successful, speedy launch possible.

我們還開始為主要國家準備所有 HDA 檔案。如您所知，這不會在一夜之間發生。這需要幾個月的時間。因此，我們正在盡一切努力確保 PEDMARK 推出時，無論是通過 Fennec 還是通過某種合作夥伴關係，都是最成功、最快速的推出。

Yeah, got it. Congrats on the progress guys. And great to have you on board, Adrian.

是的，明白了。恭喜你們取得的進步。很高興你加入，阿德里安。

Thanks.

謝謝。

David Nierengarten, Wedbush Securities.

大衛·尼倫加滕 (David Nierengarten)，韋德布什證券公司 (Wedbush Securities)。

Hey. Thanks for taking my question. I just had a couple on the penetration of the markets. First, has there been centers -- I know, thankfully, childhood cancer is a rare occurrence. But have there been any centers that are repeated or have repeat patient -- dosing of patients? And then on your coverage of the academic centers, are there -- do you have an estimate on how many patients utilize those centers or -- as a percentage? Is it 40%, 50%, or 80%? Thanks.

嘿。感謝您提出我的問題。我剛剛了解了一些關於市場滲透的內容。首先，是否有中心——值得慶幸的是，我知道兒童癌症很少發生。但是否有任何中心重複或對患者進行重複給藥？然後，關於您對學術中心的覆蓋範圍，您是否估計有多少患者使用這些中心或百分比？是40%、50%還是80%？謝謝。

Hi, David. Yeah. So maybe I can answer the second one first. Yeah.

嗨，大衛。是的。所以也許我可以先回答第二個問題。是的。

So if you look at the centers overall, it varies. So you have centers where the repeat customer orders -- where they're utilizing -- most physicians are utilizing it. There are some centers where half the patients are utilizing it. So it varies. It's center by center, comfort by comfort, from a physician to physician, disease by disease, of course. Because our label plays into several tumor types.

因此，如果你從整體上看這些中心，就會發現情況有所不同。因此，你有重複顧客訂購的中心——他們正在使用的地方——大多數醫生都在使用它。在一些中心，一半的患者正在使用它。所以它有所不同。當然，這是一個中心一個中心、一個又一個舒適、從一個醫生到另一個醫生、從一個疾病到一個疾病的過程。因為我們的標籤適用於多種腫瘤類型。

And their experience -- and the growth that we're seeing comes from really writing scripts, putting patients on drug, and seeing the outstanding results both from an efficacy perspective, but importantly, safety perspective. With this product -- I mean, here we are, almost nine months into launch, and there hasn't been an [A] report, which speaks to how good the drug is.

他們的經驗——以及我們所看到的增長來自於真正編寫劇本、讓患者服用藥物，以及從功效角度，但更重要的是，從安全角度看到出色的結果。對於這個產品——我的意思是，我們已經推出了近九個月了，而且還沒有一份[A]報告來說明該藥物有多好。

And rarely would you see anything in pediatric oncology that -- or any oncology product for that matter that has that. So that's what makes us very, very excited. Because we have a really, really good treatment for these kids.

您很少會在兒科腫瘤學中看到任何具有這種功能的東西，或者任何具有這種功能的腫瘤學產品。這就是讓我們非常非常興奮的原因。因為我們為這些孩子提供了非常非常好的治療。

Sorry, what was the first question again?

抱歉，第一個問題又是什麼？

I think the first question was actually on the repeat customers. The next one was the number of academic centers signed up and the percentage of patients typically that they treat in a year out of the total population asset. Majority, is it 70%? Something -- thanks.

我認為第一個問題實際上是關於回頭客的。下一個是簽約的學術中心的數量以及他們一年內通常治療的患者佔總人口資產的百分比。大多數，是70%嗎？有事——謝謝。

Yeah. It's pretty -- like I said, it's pretty well distributed. Maybe, Robert, you have some more granularity on these numbers. But it's pretty well distributed between the academic centers and some of the smaller hospitals, which, typically, in an early launch, tend to be some of the early adopters.

是的。它很漂亮——就像我說的，它分佈得很好。羅伯特，也許你對這些數字有更詳細的了解。但它在學術中心和一些較小的醫院之間分佈得相當好，通常在早期推出時，這些醫院往往是一些早期採用者。

Yeah, I'll add, David. Similar to what Rosty said, every center is unique in the sense of the amount of patients; the type of patients it sees; and their philosophy on how they rollout, whether before formulary approval or after formulary approval. Similar to what we said already, we have gained some major academic centers recently. And so we're quite excited about that and anticipating some orders there. So hopefully, as the months go out, we actually learn more from all our centers in terms of patient numbers and market applicability. Thanks.

是的，我補充一下，大衛。與Rosty所說的類似，每個中心就患者數量而言都是獨一無二的；它看診的患者類型；以及他們如何推出的理念，無論是在處方批准之前還是在處方批准之後。與我們已經說過的類似，我們最近獲得了一些主要的學術中心。因此，我們對此感到非常興奮，並期待那裡的一些訂單。因此，希望隨著時間的推移，我們能夠從所有中心了解更多關於患者數量和市場適用性的信息。謝謝。

Thank you. This concludes our question-and-answer session. I would now like to turn the call back to Rosty Raykov.

謝謝。我們的問答環節到此結束。我現在想把電話轉回羅斯蒂·雷科夫。

I would like to thank you all for joining us today. We look forward to updating you on our continued launch progress and corporate milestones in the future quarterly calls. Thank you and have a great morning.

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中向您通報我們的持續發布進度和公司里程碑。謝謝您，祝您早上愉快。

This concludes today's conference call. Thank you for participating. You may now disconnect.

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。