使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主
Operator
Operator
Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' second quarter 2025 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference is being recorded.
女士們、先生們,早上好,歡迎參加 Fennec Pharmaceuticals 2025 年第二季收益和公司最新進展電話會議。(操作說明)提醒各位,今天的會議正在錄音。
Now I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade.
現在,我想把會議交給 Fennec 的財務長 Robert Andrade。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Thank you, operator, and good morning, everyone. Thank you for joining us. We are pleased to host Fennec Pharmaceuticals' second quarter 2025 earnings conference call today. 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。感謝您的參與。我們很高興今天能主持 Fennec Pharmaceuticals 2025 年第二季財報電話會議。在此期間,我們將回顧財務業績並提供整體業務最新情況。
Joining me from Fennec this morning is our Chief Executive Officer and Board member, Jeff Hackman. 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.
今天早上連線 Fennec 的執行長兼董事會成員 Jeff Hackman 先生。在開始之前,我想提醒各位,在本次電話會議中,公司將發表一些前瞻性聲明,這些聲明存在風險和不確定性,可能導致實際結果與前瞻性聲明中討論的結果有所不同。
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 US Securities and Exchange Commission. In addition, any forward-looking statements made on this call represent our views as of today only 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,公司在向美國證券交易委員會提交的定期和當前事件文件中也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日的觀點,不應被視為代表我們截至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's website, www.fennecpharma.com, where it will be available for the next 30 days.
我們特此聲明,不承擔更新或修改任何前瞻性陳述的義務。本次電話會議將被錄音,並在 Fennec 的網站 www.fennecpharma.com 上進行音訊重播,該錄音將在接下來的 30 天內提供收聽。
And with that, I will now turn the call over to Jeff Hackman.
接下來,我將把電話交給傑夫哈克曼。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Thanks, Robert. Good morning, everyone. Thanks for joining the call today. Well, it's hard to believe. It's been one year since I stepped in into the CEO role here at Fennec.
謝謝你,羅伯特。各位早安。感謝您今天參加電話會議。真是難以置信。我擔任Fennec執行長一職已經一年了。
When I joined, my focus was clear. I wanted to stabilize the business, sharpen our strategy, and build a strong foundation for sustainable growth. I'm proud to say that over the last 12 months, we've been delivering on these priorities, while also driving the awareness and adoption of PEDMARK for the prevention of cisplatin-induced ototoxicity or CIO. And the results are beginning to materialize. We are now talking about three consecutive quarters of growth and more to come.
我加入時,我的目標很明確。我希望穩定公司業務,完善公司策略,並為永續發展奠定堅實的基礎。我很自豪地說,在過去的 12 個月裡,我們一直在努力實現這些優先事項,同時也推動了人們對 PEDMARK 的認識和採用,以預防順鉑引起的耳毒性或 CIO。而結果也開始顯現。我們現在談論的是連續三個季度的成長,未來還會繼續成長。
You may recall, after I joined Fennec last year, I outlined a focused set of strategic imperatives to drive our execution and accelerate the long-term growth of PEDMARK which remember, still remains the first and only FDA-approved therapy in the US and Europe to reduce the risk of CIO or permanent hearing loss associated with cisplatin treatment.
您可能還記得,去年我加入 Fennec 後,我制定了一套重點明確的策略要務,以推動我們的執行並加速 PEDMARK 的長期成長。請記住,PEDMARK 仍然是美國和歐洲第一個也是唯一一個獲得 FDA 批准的療法,可以降低與順鉑治療相關的 CIO 或永久性聽力損失的風險。
PEDMARK is specifically approved for pediatric patients one month of age and older with localized non-metastatic solid tumors and also was recognized by the National Comprehensive Cancer Network, or NCCN, with a 2A recommendation for the US for use in adolescent and young adult patients. But before we dive into the performance for the quarter, let me update you on significant progress that we've made during the first half of this year.
PEDMARK 已獲準用於治療一個月及以上患有局部非轉移性實體瘤的兒科患者,並被美國國家綜合癌症網絡 (NCCN) 認可,在美國被推薦用於治療青少年和年輕成人患者,級別為 2A。但在我們深入探討本季業績之前,讓我先向大家報告我們在今年上半年的重大進展。
First, we made significant strides in increasing awareness of the unmet need among both oncology and broader cancer care communities. We've done this through continued presence at major conferences, targeted educational campaigns, and peer-to-peer interactions. We're seeing growing recognition that hearing loss from cisplatin is not just a side effect, it's preventable, and it's an issue with long-term consequences. We're seeing the strongest momentum in both large community practices and academic centers and early validation of our targeted sales approach and enhanced patient support services.
首先,我們在提高腫瘤學界和更廣泛的癌症護理界對未滿足需求的認識方面取得了重大進展。我們透過持續參加重要會議、進行有針對性的教育活動以及進行同儕交流來實現這一目標。人們越來越認識到,順鉑引起的聽力損失不僅僅是副作用,它是可以預防的,而且是一個會產生長期後果的問題。我們看到,無論是在大型社區診所還是學術中心,都出現了最強勁的成長勢頭,而我們針對特定銷售方式和增強患者支援服務的早期驗證也證明了這一點。
And to that end, I'm pleased to share that a large national oncology group of providers recently added PEDMARK to its formulary for its use in patients under 40 years of age. This is one of the largest and fastest-growing groups in the country, it's a group of community-based oncology practices in the US. This decision reflects the growing recognition and the need to protect younger patients from cisplatin-induced hearing loss, and we're excited and encouraged by what it signals in terms of broader momentum for PEDMARK and adoption in the community settings.
為此,我很高興地宣布,一家大型全國性腫瘤醫療服務機構最近將 PEDMARK 添加到其處方集中,供 40 歲以下患者使用。這是美國規模最大、發展最快的醫療集團之一,它是由美國社區腫瘤診所組成的團體。這項決定反映了人們日益認識到保護年輕患者免受順鉑引起的聽力損失的必要性,我們對這一決定所預示的 PEDMARK 更廣泛的發展勢頭以及在社區環境中的推廣應用感到興奮和鼓舞。
Second, we are actively working to cement PEDMARK as the standard of care for CIO prevention. During the second quarter, we held multiple advisory boards with leading academic centers across the country to better understand current approaches to diagnosing and managing CIO.
其次,我們正在積極努力鞏固 PEDMARK 作為 CIO 預防護理標準的地位。第二季度,我們與全國領先的學術中心舉行了多次諮詢委員會會議,以便更好地了解目前診斷和管理 CIO 的方法。
The insights shared by key opinion leaders are now forming many of our cross-functional strategies. In parallel, positive feedback from existing accounts using PEDMARK continues to strengthen our confidence in our clinical value and support broader institutional adoption.
關鍵意見領袖分享的見解正在塑造我們許多跨職能策略。同時,現有使用 PEDMARK 的帳戶的正面回饋不斷增強我們對自身臨床價值的信心,並支持更廣泛的機構採用。
I'm pleased to also share today that NCODA recently issued a positive quality intervention or PQI for PEDMARK. This is an important development that provides peer-reviewed, practical guidance to oncology care teams on the use, administration and timing of PEDMARK to prevent CIO in pediatric and AYA or adolescent and young adult patients.
今天我很高興地宣布,NCODA 最近發布了針對 PEDMARK 的積極品質幹預措施 (PQI)。這是一項重要的進展,它為腫瘤護理團隊提供了同儕審查的實用指導,指導他們如何使用、管理和使用 PEDMARK 來預防兒童、青少年和青年患者的 CIO。
NCODA PQIs are widely used tools that support multidisciplinary cancer teams, including pharmacists, nurses, and oncologists in delivering a high-quality care for patients receiving oral and IV therapies in oncology. But most importantly, we see PQI as a strong signal of growing clinical alignment around importance of preventing cisplatin-induced ototoxicity and it supports our goal of establishing PEDMARK as the standard of care in this space.
NCODA PQI 是廣泛使用的工具,可支援包括藥劑師、護理師和腫瘤學家在內的多學科癌症團隊為接受口服和靜脈注射腫瘤治療的患者提供高品質的護理。但最重要的是,我們認為 PQI 是一個強烈的訊號,表明臨床上越來越重視預防順鉑引起的耳毒性,這支持了我們將 PEDMARK 確立為該領域標準治療的目標。
Third, we are expanding our CIO -- and we are expanding and educating on CIO and an important role of PEDMARK in preventing it. Not just with oncologists, but beyond. Many healthcare professionals are involved in the patient journey, including ENTs, audiologists, nurses, and pharmacists.
第三,我們正在擴大我們的 CIO——我們正在擴大和普及 CIO 相關知識,以及 PEDMARK 在預防 CIO 方面的重要作用。不僅限於腫瘤科醫生,而是涵蓋更廣泛的群體。許多醫療保健專業人員參與患者的治療過程中,包括耳鼻喉科醫生、聽力學家、護士和藥劑師。
These groups are now engaging with Fennec and PEDMARK and we're seeing the benefit of this multidisciplinary support in day-to-day clinical practices. We are reminded that in the expansion that the care of these oncology patients, especially when it comes to survivorship and quality of life, it goes beyond the role of just the oncologists.
這些團體現在正與 Fennec 和 PEDMARK 合作,我們已經看到這種多學科支持在日常臨床實踐中帶來的好處。我們應該意識到,在擴大治療範圍的過程中,對這些腫瘤患者的護理,尤其是在生存和生活品質方面,已經超越了腫瘤科醫生的職責範圍。
Fourth point I want to make is on the access front. We've made significant progress with payers and providers alike. Our field access and reimbursement teams have been instrumental in ensuring smoother coverage and pathways and fewer barriers for the sites that are ready to treat.
我想提出的第四點是關於准入方面。我們在與支付方和醫療服務提供方的合作中都取得了顯著進展。我們的現場准入和報銷團隊在確保更順暢的覆蓋範圍和途徑以及減少準備接受治療的地點的障礙方面發揮了重要作用。
The strengthening of our Fennec HEARS patient assistance program has been central to this work. We've seen quarter-over-quarter growth in enrollment in Fennec HEARS programs and the newly revamped offerings that we're delivering, which are giving improved experiences through strengthened healthcare provider practices, patient services, expanded payer reimbursement support, and streamlined access to home nursing resources.
加強我們的 Fennec HEARS 病患援助計畫是這項工作的核心。我們看到 Fennec HEARS 計畫的註冊人數逐季增長,我們正在推出的全新改進方案,透過加強醫療保健提供者實踐、患者服務、擴大支付方報銷支持以及簡化家庭護理資源的獲取途徑,為患者帶來更好的體驗。
And finally, on the activation side, while our near-term commercial focus remains on educating healthcare providers to support a shift in the standard of care, we are also strengthening our efforts to educate and engage patients and caregivers. We are doing this through the support of several advocacy associations or organizations, such as the testicular cancer awareness foundation and activity surrounding initiatives like the childhood cancer awareness month. These efforts help raise awareness of the risk of CIO and encourage families to inform and have informed conversations about hearing protection during their treatment planning.
最後,在推廣方面,雖然我們近期的商業重點仍然是教育醫療保健提供者以支持護理標準的轉變,但我們也在加強對患者和護理人員的教育和參與。我們正在透過多個倡導協會或組織的支持來實現這一目標,例如睪丸癌意識基金會,以及圍繞兒童癌症意識月等倡議的活動。這些努力有助於提高人們對 CIO 風險的認識,並鼓勵家庭在製定治療計劃時了解聽力保護方面的資訊並進行知情的討論。
Further, we are excited to announce that Fennec's senior leadership team and employees along with several PEDMARK patients and their families will ring the closing bell of the Nasdaq stock market on Friday, September 5, 2025. While this is an exciting business milestone for Fennec, it's important -- it's a really important symbolic reminder of our mission, which is to help more patients be able to hear their own remission belts.
此外,我們很高興地宣布,Fennec 的高級領導團隊和員工,以及幾位 PEDMARK 患者及其家人,將於 2025 年 9 月 5 日星期五敲響納斯達克股票市場的收盤鐘。雖然這對 Fennec 來說是一個令人興奮的商業里程碑,但它也很重要——它像徵性地提醒我們,我們的使命是幫助更多的患者能夠聽到他們自己的緩解帶。
Now turning to our second quarter 2025 results. Revenue grew 33% year over year and 10% sequentially with net revenues of $9.7 million. This kind of quarter-over-quarter growth just doesn't happen by chance. It reflects a disciplined execution and a completely overhauled go-to-market strategy and having a top-down talent in the right positions to execute this excellence.
現在來看我們2025年第二季的業績。營收年增 33%,季增 10%,淨營收達 970 萬美元。這種季度季增絕非偶然。這體現了嚴謹的執行力、徹底改革的市場進入策略,以及自上而下地將人才安排在合適的職位上以執行這種卓越策略。
This quarter-over-quarter growth includes the addition of 14 new accounts, some of which are part of two large community oncology groups or purchase or GPOs. Within these networks, we've seen PEDMARK activation in Q2, which continues to grow into Q3.
與上一季相比,本季成長包括新增 14 個帳戶,其中一些是兩個大型社區腫瘤集團或採購組織 (GPO) 的一部分。在這些網路中,我們在第二季度看到了 PEDMARK 的激活,而這種激活趨勢在第三季度繼續增長。
Looking into Q3, we expect additional accounts within both of these networks to activate and prescribe PEDMARK. I'm incredibly proud of the Fennec team and encouraged by the continued growth that we're seeing, which reinforces our belief in the scalability of this model and the growing demand for PEDMARK across these key markets.
展望第三季度,我們預計這兩個網路中將有更多帳戶啟動並開立 PEDMARK 處方。我為 Fennec 團隊感到無比自豪,並對我們所看到的持續成長感到鼓舞,這增強了我們對該模式可擴展性的信念,以及 PEDMARK 在這些關鍵市場日益增長的需求。
With that, I'll now turn it back over to Robert.
這樣,我現在就把麥克風交還給羅伯特。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Thank you, Jeff. Really amazing to think that just one year ago, we did our first conference call together and the amount of progress to date under your leadership. I remember on that call, both thanking our shareholders for their support and patience as we underwent the transition.
謝謝你,傑夫。難以置信的是,就在一年前,我們第一次一起開了電話會議,而迄今為止,在您的領導下,我們取得瞭如此巨大的進步。我記得在那次電話會議上,我們都感謝了股東們在我們過渡期間給予的支持和耐心。
And stating that I believe the opportunity for Fennec was significant with proper execution ahead of us. Further, I'd like to give much appreciation and recognition to our new leadership team that Jeff brought into Fennec only nine months ago and who have been on the front lines in this execution.
我認為,只要執行得當,Fennec 的發展機會非常巨大。此外,我還要對傑夫九個月前帶到芬尼克的全新領導團隊表示衷心的感謝和認可,他們一直奮戰在執行這項任務的第一線。
Christi Cioffi, our Chief Strategy Officer and leader in many areas, including our awareness and marketing initiatives; Terry Evans, our Chief Commercial Officer; who has primed our commercial team for optimal excellence; and Pierre Sayad, our Chief Medical Officer, whose experience and knowledge has transformed our medical team with new energy and vigor and the proper tools to educate and support providers and patients. I believe we are just getting started.
克里斯蒂·喬菲,我們的首席戰略官,也是包括我們的宣傳和營銷舉措在內的許多領域的領導者;特里·埃文斯,我們的首席商務官,他使我們的商業團隊達到了最佳水平;以及皮埃爾·薩亞德,我們的首席醫療官,他的經驗和知識為我們的醫療團隊注入了新的活力和熱情,並提供了適當的工具來教育和支持患者。我相信我們才剛起步。
Now on to the details. Our press release contains some of our financial results for the second quarter of 2025, which can be viewed on the Investors & Media section of our website. Rather than read through all those details, my comments today will focus on some key financial results.
接下來是細節部分。我們的新聞稿包含我們 2025 年第二季的部分財務業績,您可以在我們網站的「投資者與媒體」部分查看。與其逐條細說,我今天的發言將重點放在一些關鍵的財務結果上。
As Jeff outlined, for the second quarter of 2025, the company recorded net product sales of $9.7 million, representing a 33% increase compared to the same period last year and 10% growth over the first quarter of this year and matching the highest quarterly net product sales in the history of Fennec.
正如傑夫所概述的那樣,2025 年第二季度,公司淨產品銷售額為 970 萬美元,比去年同期增長 33%,比今年第一季增長 10%,與 Fennec 歷史上最高的季度淨產品銷售額持平。
Of significance, we are pleased to report our third consecutive quarter of sequential growth in net product sales. We have a great trend forming. Our revenue performance continues to demonstrate strong growth and commercial momentum, and we believe this is just getting started. As mentioned in our previous earnings, we are focused on growing net product sales throughout 2025.
值得一提的是,我們很高興地宣布,我們的淨產品銷售額已連續第三個季度實現環比增長。我們正在見證一個強勁的趨勢正在形成。我們的營收表現持續展現出強勁的成長動能和商業發展勢頭,我們相信這只是個開始。正如我們在先前的財報中所提到的,我們的目標是在 2025 年實現淨產品銷售額的成長。
Importantly, we anticipate the most significant quarterly growth in the second half of 2025, when all the foundational pillars and initiatives we have implemented and continue to optimize are expected to materially impact growth of PEDMARK. The strong performance reflects both successful retention of existing customers, and the exciting new uptake in demand for PEDMARK by new customers.
重要的是,我們預計 2025 年下半年將出現最顯著的季度增長,屆時我們已經實施並將繼續優化的所有基礎支柱和舉措預計將對 PEDMARK 的增長產生實質性影響。強勁的業績既反映了現有客戶的成功留存,也反映了新客戶對 PEDMARK 的令人興奮的新需求成長。
Further, the launch of PEDMARQSI by Norgine in the EU is well underway in the United Kingdom and Germany, and we are pleased with the traction to date. We expect to provide additional updates on milestones and royalties from this partnership with Norgine in the quarters to come.
此外,Norgine 的 PEDMARQSI 在歐盟的推出工作已在英國和德國順利進行,我們對迄今為止的進展感到滿意。我們預計將在未來幾季提供有關與 Norgine 合作的里程碑和版稅的更多最新消息。
Turning to our expenses. Our total cash operating expenses for the quarter exclude noncash stock-based compensation was approximately $11 million. This represents an increase of roughly $2 million compared to the first quarter of this year.
接下來談談我們的開支。本季我們的現金營運支出總額(不包括非現金股票選擇權費用)約為 1,100 萬美元。與今年第一季相比,這相當於增加了約200萬美元。
The quarter-over-quarter increase was primarily driven by ongoing investments in marketing, additional head count as well as continued efforts related to our intellectual property. As is customary with our business, cash operating expenses are higher in the first half of the fiscal year, largely as a result of commercial and marketing spending patterns and we expect these cash expenses to decrease in the second half of 2025.
季度環比成長主要得益於行銷方面的持續投入、員工人數的增加以及我們在智慧財產權方面的持續努力。按照我們業務的慣例,財政年度上半年的現金營運支出較高,這主要是由於商業和行銷支出模式所致,我們預計這些現金支出將在 2025 年下半年下降。
The company recorded $4.4 million in selling and marketing expenses in the second quarter of '25 compared to $2.9 million in the first quarter of '25 and $4.7 million in the second quarter of 2024. The primary drivers of the increase in the quarter include additional marketing expenses and a onetime accrual reversal that occurred only in Q1 2025.
該公司在 2025 年第二季錄得 440 萬美元的銷售和行銷費用,而 2025 年第一季為 290 萬美元,2024 年第二季為 470 萬美元。本季成長的主要原因是額外的行銷費用和僅在 2025 年第一季發生的一次性應計項目衝回。
On the G&A front, the company recorded $7 million in the second quarter of 2025 compared to $6.1 million in the earlier quarter, first quarter of '25 and $6.9 million in the second quarter of '24. For the second quarter of 2025, G&A expenses were consistent on a year over year basis and increased quarter over quarter, largely due to the following. One, increased noncash stock compensation; and two, ongoing litigation and intellectual property expenses.
在一般及行政費用方面,該公司在 2025 年第二季錄得 700 萬美元,而上一季(2025 年第一季)為 610 萬美元,2024 年第二季為 690 萬美元。2025 年第二季度,一般及行政費用與去年同期持平,較上季成長,主要原因是以下原因。第一,增加非現金股票補償;第二,持續的訴訟和智慧財產權費用。
For the quarter, the company spent roughly $4 million in cash. Cash and cash equivalents were approximately $18.7 million as of June 30, 2025. We remain confident that full year cash operating expenses will be similar in '25 to that of '24 or roughly $33 million.
該季度,該公司現金支出約為 400 萬美元。截至2025年6月30日,現金及現金等價物約1,870萬美元。我們仍相信,2025 年全年現金營運支出將與 2024 年類似,約 3,300 萬美元。
This includes an increase in commercial expenses, including higher head count and marketing expenses offset by the elimination of European pre-commercialization costs, which only occurred in 2024. Importantly, we have several levers to potentially increase the cash balance in the second half of 2025.
這包括商業支出的增加,包括更高的員工人數和行銷支出,但這些支出將被歐洲商業化前成本的取消所抵消,而歐洲商業化前成本的取消直到 2024 年才發生。重要的是,我們有多種手段可以增加 2025 年下半年的現金餘額。
Product revenues continued to gain momentum, and we aim towards cash profitability as cash expenses also decreased in the second half. Two, potential milestones and royalties from the Norgine partnership. And three, the possible monetization or partnership after the release of the Japan study results, which are expected in the fourth quarter.
產品收入持續成長,隨著下半年現金支出減少,我們的目標是實現現金獲利。第二,與 Norgine 合作可能帶來的里程碑和特許權使用費。第三,在第四季公佈日本研究結果後,可能會出現貨幣化或合作的情況。
And operator, with that, we will now open up the call for questions.
操作員,接下來我們將開始提問環節。
Operator
Operator
(Operator Instructions) Chase Knickerbocker, Craig-Hallum.
(操作說明)Chase Knickerbocker,Craig-Hallum。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Jeff, maybe just to start, would you guys be willing to share active -- an prescribers number particularly obviously within AYA as just it would be helpful to see kind of the number of active prescribers you have within that kind of cohort.
Jeff,或許可以先問一下,你們是否願意分享一下活躍處方醫生的數量,尤其是在青少年和青年群體中,因為了解你們在這個群體中活躍處方醫生的數量會很有幫助。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. The -- we don't share the number -- the cumulative number, obviously, for a bunch of different reasons on that guidance. Tell me a little bit more about what your -- maybe a little bit more detail, though, and I can maybe share some other specifics what you're looking for.
是的。出於各種不同的原因,我們不會透露累積數字——顯然,這與相關指導有關。請您再詳細說說您的需求—也許可以提供更多細節,這樣我或許可以分享一些您正在尋找的具體資訊。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Just an active number of current writers basically. I mean you shared kind of double-digit accounts increase sequentially I mean, maybe on that front, kind of if you'd be willing to share kind of an active account number just as we can -- so we can think about kind of the ramp from here in AYA.
基本上就是目前活躍的作家數量。我的意思是,您分享了兩位數的帳戶連續增長,我的意思是,也許在這方面,如果您願意分享一個活躍帳戶號碼,就像我們可以做到的那樣——這樣我們就可以考慮 AYA 從這裡開始的增長情況。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. Let me go back and look at that. It might be something that we might be able to share in the future quarters, Chase. I don't see that -- I want to be careful, especially when you start getting a little bit more detail, right, on actual accounts that are out there. And obviously, you have to protect that relationship. But obviously, doing something with some numbers might not be -- it could be something we could do in the future. So --
是的。讓我回去看一下。Chase,這或許是我們未來幾季可以分享的訊息。我並不這麼認為——我想謹慎一些,尤其是在你開始了解更多細節的時候,對吧,關於那些真實存在的帳戶。很顯然,你必須維護這段關係。但顯然,現在用一些數字做點什麼可能還不行——這可能是我們將來可以做的事情。所以--
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Maybe if we just focus on that double-digit account sequentially, Jeff. I mean, can you give us some kind of visibility into maybe how many patients within those accounts in AYA are treated with cisplatin kind of what your kind of overall opportunity is maybe just in those accounts that have kind of added on sequentially?
傑夫,或許我們應該集中精力逐一分析那兩位數的帳戶。我的意思是,您能否讓我們了解一下,在 AYA 患者中,有多少患者接受了順鉑治療?或者說,在那些陸續新增的患者中,您的整體機會有多大?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. I mean, we talked about in the AYA market, it's 10 times the size of the pediatric. It's about 20,000 patients in that population between ages 15 to 39 that are treated with cisplatin. And so that population is significant. That's our market. That's where we've divided up the country into our commercial teams and supply them with that data.
是的。我的意思是,我們之前討論過,青少年及青年(AYA)市場規模是兒科市場的 10 倍。在15至39歲的人群中,約有20,000名患者接受了順鉑治療。因此,這個人口群體非常重要。這就是我們的市場。這就是我們把全國各地劃分成各個商業團隊,並向他們提供這些數據的地方。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Yeah. And Chase, I'll add, which is important, it starts generally with one patient at a center or at a hospital. We have successful administration. We can create the awareness. We have successful administration, and we have successful reimbursement, that expands. And what we've been able -- what we've witnessed in particular in Q2 over Q1 is the retention of those existing customers and that also augmenting the amount of patients within those existing customers.
是的。還有,Chase,我要補充一點,這一點很重要,它通常是從中心或醫院的一名患者開始的。我們的行政管理運作良好。我們可以提高人們的意識。我們擁有成功的管理體系和成功的報銷體系,而且仍在不斷發展壯大。我們已經能夠——尤其是在第二季度與第一季相比——看到的是現有客戶的留存率,以及現有客戶的患者數量的增加。
So I think what we wanted to shed light was we had 14 new accounts, don't get focused on the amount of accounts because each account is unique, but we are growing. And the goal is obviously then to build that existing base and augment that as well.
所以,我們想強調的是,我們新增了 14 個帳戶,不要過於關注帳戶數量,因為每個帳戶都是獨一無二的,但我們正在成長。因此,目標顯然是鞏固現有基礎並加以擴展。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Maybe just a little bit additional color on that. When that account starts out, and let's say it's a single patient, what's kind of the cadence in which you start seeing increased writing from set account?
或許可以再加點顏色。當一個帳戶剛開始使用時,假設只有一個病人,那麼你會看到該帳戶的寫作量以怎樣的節奏增加?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah, we see it -- we saw it more in the second quarter as we started to get experience, Chase. That's exactly where Robert was going was we needed to have that initial patient in that center or that practice go through PEDMARK therapy, see the positive outcome, see that it works, how they administer it, in some cases, actually using our Fennec HEARS program.
是的,我們看到了——尤其是在第二季度,隨著我們開始累積經驗,我們看到的就更多了,Chase。這正是羅伯特想要表達的意思:我們需要讓那個中心或診所的第一位患者接受 PEDMARK 療法,看看積極的療效,看看它是否有效,以及他們是如何進行治療的,在某些情況下,實際上是使用我們的 Fennec HEARS 程序。
And now we -- that's the area where, obviously, a lot of our folks will focus their efforts to expand now in those same practices because remember, these physicians in these oncology practices have multiple cisplatin patients that they're going through. So that's where we saw a lot of our growth was through expansion of current accounts in Q2, and we'll see even more of that as we go through the year.
現在,很顯然,我們許多人會將精力集中在這個領域,努力在這些實踐中拓展業務,因為請記住,這些腫瘤科醫生要面對許多接受順鉑治療的患者。因此,我們在第二季度透過擴大活期帳戶實現了很大程度的成長,而且隨著今年的推進,我們將看到更多這樣的成長。
Chase Knickerbocker - Senior Research Analyst
Chase Knickerbocker - Senior Research Analyst
Got it. Maybe just last for me, guys. Sorry to get so many in here. But on the EU side, could you share the amount of royalty revenue that was in the quarter from Norgine? And then just kind of general thoughts on kind of how that ramp is going with your partner, particularly as we go into the back half of the year here. And then on kind of final German pricing, I mean, do you have a thought on when we should hear back on that?
知道了。也許對我來說,這只是最後一件事了,夥計們。不好意思,這裡進來這麼多東西。但是,在歐盟方面,您能否分享本季來自 Norgine 的特許權使用費收入金額?然後,就你和你的伴侶在坡道上的進展情況,特別是隨著我們進入下半年,想聽聽你的一些整體想法。那麼關於德國的最終定價,您認為我們什麼時候能得到答案呢?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. Thanks, Chase. To step back a little, as you're aware, the Norgine partnership has two primary components. The first component is -- are the royalties, and that is a percent starts in the mid-teens of Norgine sales. And the second component is north of $200 million potential milestones. We started to see some significant traction in the second quarter from that partnership.
是的。謝謝你,蔡斯。稍微回顧一下,如您所知,Norgine 的合作關係主要包含兩個部分。第一個組成部分是版稅,版稅的百分比從 Norgine 銷售額的百分之十幾開始。第二個組成部分是超過 2 億美元的潛在里程碑。第二季度,我們開始看到這項合作取得了顯著成效。
As a reminder, they launched late in the first quarter. The second quarter, we started to see some traction really out of the UK as they work to get the different P&T approvals within Germany and final pricing later in the year. That number is not material enough at this point to move our own financials on an aggregate basis. But the sequential certainly increase and traction is significant.
提醒一下,他們是在第一季末推出的。第二季度,我們開始看到英國市場取得一些真正的進展,因為他們正在努力獲得德國的各種藥品和藥品審批,並在今年稍後確定最終價格。目前來看,這個數字還不足以對我們的整體財務狀況產生重大影響。但這種連續成長動能確實十分顯著。
They plan to then roll that out to the broader EU5 later this year, early next year. You're talking Italy, Spain, France, and also to the Nordic regions. So we're quite enthusiastic about that opportunity. Near term, there are two primary milestones ahead of us. One is based on aggregate calendar year sales and the other one is based on German pricing and we look forward to giving an update on that in the quarters to come.
他們計劃在今年稍後或明年年初將該方案推廣到更廣泛的歐盟五國。你說的包括義大利、西班牙、法國,還有北歐地區。所以我們對這個機會感到非常興奮。短期內,我們面前有兩個主要里程碑。其中一項是基於全年累積銷售額,另一項是基於德國定價,我們期待在接下來的幾季中對此進行更新。
Operator
Operator
Sudan Loganathan, Stephens.
蘇丹·洛加納坦,史蒂芬斯。
Sudan Loganathan - Equity Analyst
Sudan Loganathan - Equity Analyst
Congrats on the progress in the second quarter. My first one, I wanted to just get some color on the mix of new and repeat customers. Maybe you can provide a percentage amount of either to kind of get a look at the potential net penetration and how that's progressing?
恭喜你們在第二季的進展。我的第一份報告,只是想了解新客戶和回頭客的比例。或許您可以提供其中一項或兩項的百分比數值,以便了解潛在的淨滲透率以及進展?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. Initially, when we started, we jumped out to mostly new customers, right? So we saw -- I mean, if I could give you percentages when we first started in the AYA space, all of our customers were new, right? We really got out and tried to get experience with PEDMARK in these patients.
是的。最初,當我們起步時,我們主要面向的是新客戶,對吧?所以我們看到——我的意思是,如果我能給出一些百分比的話,當我們剛開始進入 AYA 領域時,我們所有的客戶都是新客戶,對吧?我們確實走出去,嘗試在這些患者身上累積使用 PEDMARK 的經驗。
We saw in the second quarter now that start to shift down to some higher percentages of these repeat customers. And so we will see -- we -- I don't want to give a percentage because it's a moving target as we go. But we are seeing new patients coming in. We talked about 14 new accounts. We talked about growing these new accounts, and it's really critical for us because there are so many accounts out there not touching PEDMARK.
我們看到,在第二季度,回頭客的比例開始上升。所以,我們拭目以待——我不想給出具體的百分比,因為這是一個不斷變化的目標。但我們看到有新病人入院。我們討論了14個新帳戶。我們討論瞭如何發展這些新帳戶,這對我們來說至關重要,因為有很多帳戶還沒有接觸過 PEDMARK。
So I think we'll continue to see this new account additions. But as we grow our business and get bigger, we'll start -- you'll add those additional accounts behind those that are repeat customers. So at this point, it's -- we're starting to see the mix start to even out a little bit more new customers versus repeat customers, and we'll probably continue to see that throughout the rest of this year.
所以我認為我們還會繼續看到這種新帳戶的增加。但隨著我們業務的成長和規模的擴大,我們將開始—您將在回頭客之後添加這些額外的帳戶。所以目前的情況是——我們開始看到新客戶和回頭客的比例開始趨於平衡,而且我們可能會在今年餘下的時間裡繼續看到這種情況。
Sudan Loganathan - Equity Analyst
Sudan Loganathan - Equity Analyst
Great. I appreciate that color. The second one I wanted to ask here, with the trial results in Japan expected this fall, could you elaborate on the Japanese market opportunity. For example, the prevalence of CIO in both pediatric and AYA population and then outline your plans for a potential commercial rollout, including whether you anticipate partnering locally or the size of the sales force you may implement there in that region?
偉大的。我喜歡這個顏色。我想問的第二個問題是,鑑於今年秋天將在日本公佈試驗結果,您能否詳細說明一下日本市場的機會?例如,CIO 在兒科和 AYA 族群中的盛行率,然後概述您潛在的商業推廣計劃,包括您是否預計與當地合作夥伴合作,或者您可能在該地區部署多大規模的銷售團隊?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Right. We -- so we're in the final discussions of trying to understand all the data. We'll have some meetings in September here with the investigators to really kind of go through all the data tables and get ourselves familiar with that. So that's the first part is it's really making sure we understand and get all the data.
正確的。我們現在正處於最終討論階段,試圖理解所有的數據。我們將在九月與調查人員在這裡開幾次會,仔細查看所有數據表,並熟悉這些數據。所以,第一部分就是確保我們理解並獲得所有數據。
We are working with the -- our investigators as well as with some consultants to kind of start to look at, okay, what's our approach, what is our regulatory approach and how fast do we get this product submitted. As you know, in Japan, you'll need a partner to submit it to the PDMA (sic - PMDA) and so we're doing -- we're looking at that approach and that partner strategy in parallel. We're in -- we've said this before, we're in discussions with folks. And that's an ongoing process as we move forward.
我們正在與我們的調查人員以及一些顧問合作,開始研究,好的,我們的方法是什麼,我們的監管方法是什麼,以及我們能以多快的速度提交該產品。如您所知,在日本,您需要一個合作夥伴才能向藥品和醫療器材管理局 (PMDA) 提交申請,因此我們正在並行研究這種方法和合作夥伴策略。我們已經參與其中——我們之前說過,我們正在與相關人士進行討論。這是一個持續進行的過程,我們會不斷向前邁進。
Japan is about a third of the size of the US and Europe when you look at CIO usage. And so that kind of gives you a feel for the numbers. Remember, this will be probably a pediatric indication in Japan. We had 10 centers that were -- that participated in the trial. It's a -- these centers are all excited about getting an opportunity to continue to use this product outside of the clinical trial. So we've had some really good feedback from the folks in country.
從資訊長 (CIO) 的使用情況來看,日本的規模大約是美國和歐洲的三分之一。這樣就能讓你對這些數字有個大致的了解。請記住,這在日本很可能只適用於兒科患者。我們有 10 個中心參與了試驗。這些中心都非常興奮能夠有機會在臨床試驗之外繼續使用該產品。我們從當地民眾那裡得到了非常好的回饋。
So there's more to come here. We'll probably have more updates in September as we see some of the final data and then -- and how we're going to approach this. Timing lines, we're trying to really focus it as fast as we can move this forward. We don't want these investigators and folks in Japan who have touched this product to go a long time without having to be able to have an approved product, right? So the faster we can get this into the Japanese regulatory authorities, the better.
所以,後面還有更多內容。9 月我們可能會有更多更新,屆時我們將看到一些最終數據,以及我們將如何處理這個問題。時間安排方面,我們正在努力加快進度,爭取盡快推進這項工作。我們不希望那些接觸過該產品的日本調查人員和相關人員長時間都無法獲得核准的產品,對吧?所以,我們越快將此方案提交給日本監管機構越好。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Yeah. And just to add, we've had a lot of enthusiasm from investigators, from patients, and a lot of unsolicited interest within Japan and the broader Asia area for the product. It's a known product. It's known to work. The reimbursement system is quite sophisticated. Having been through the Norgine process a year ago, I think it's quite analogous to it. So we look forward to giving more updates.
是的。另外,我們也收到了來自研究人員、患者的極大熱情,並且在日本和更廣泛的亞洲地區,該產品也引起了廣泛的關注。這是知名產品。事實證明它有效。報銷制度相當複雜。一年前我經歷過 Norgine 的過程,我覺得它和這個過程非常相似。我們期待為大家帶來更多最新消息。
Sudan Loganathan - Equity Analyst
Sudan Loganathan - Equity Analyst
Great to hear. Just lastly, if I can squeeze one more in. Do you anticipate the operating expenses to remain relatively stable in the second half of the year? And what areas do you expect will represent maybe your larger expenditures in upcoming quarters and may drive those expenditures. I know you mentioned, obviously, some of the IP expenses needed for the EU in the second quarter.
聽到這個消息真是太好了。最後,如果我還能擠出一點時間的話,再補充一點。您預計下半年的營運費用會保持相對穩定嗎?您預計未來幾季哪些領域的支出可能會較大,並可能推動這些支出?我知道您提到了第二季度歐盟的一些智慧財產權支出。
And just kind of curious if there's any more kind of maybe onetime expenses in the second half of this year as you're growing the launch?
我有點好奇,隨著你們擴大產品發布規模,今年下半年是否還有其他一次性支出?
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Yeah. Thank you. So the first half of the year is heavier from a cash OpEx. A lot of our contracts are structured with 50% upfront and then the back -- and the balance over the back half of the year. So as mentioned in the stated remarks, I expect both our second half expenses to go down, so from a cash operating expenses, we were roughly $20 million for the first half.
是的。謝謝。因此,上半年現金營運支出較多。我們的許多合約都是先支付 50%,然後剩餘部分在下半年支付。正如前面提到的,我預計我們下半年的支出都會下降,上半年的現金營運支出約為 2000 萬美元。
So I expect it to go down and the full year to be consistent with '24 from a cash OpEx, which was roughly $33 million to $34 million. In the second quarter specifically, on a noncash basis, there was also a jump up in stock-based compensation as we aligned what we believe is a really effective and exciting team here with incentives that are aligned with our shareholders.
所以我預計它會下降,全年現金營運支出將與 2024 年保持一致,約為 3,300 萬美元至 3,400 萬美元。具體到第二季度,非現金方面的股票選擇權激勵也大幅增加,因為我們將我們認為非常高效且令人興奮的團隊的激勵措施與股東利益相一致。
Operator
Operator
Jason McCarthy, Maxim Group.
Jason McCarthy,Maxim集團。
Unidentified Participant
Unidentified Participant
This is Chad on for Jason. We were wondering if you could provide some additional color on getting the PQI and how this differs from NCCN guidelines.
這裡是查德替傑森報道。我們想知道您能否進一步說明如何獲得 PQI 以及它與 NCCN 指南有何不同。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Sure, Chad. Nice to hear from you. Yeah, the -- they differ -- let me -- the NCODA PQIs are a peer reviewed guidance document, really, and it really is a guidance document to really help patient care and oncology practices. So it's a little bit different because it comes from the -- NCODA stands for the National Community Oncology Dispensing Association.
當然,查德。很高興收到你的來信。是的,它們有所不同——讓我來說——NCODA PQI 實際上是一份經過同行評審的指導文件,它確實是一份旨在真正幫助患者護理和腫瘤學實踐的指導文件。所以它有點不同,因為它來自——NCODA 代表全國社區腫瘤配藥協會。
So these are kind of -- these are standardized evidence-based kind of practice management type of recommendation. So they're a little bit more focused than the NCCN guidelines. right? And the purpose of these PQIs, we call them, are to kind of really focus on patient outcomes and really look at standardizing care and optimizing treatments, and enhancing communications with the oncology teams.
所以這些算是──這些是標準化的、以證據為基礎的實務管理建議。所以它們比NCCN指南更具針對性,對吧?我們稱之為 PQI 的這些指標的目的是真正關注患者的治療結果,真正著眼於規範護理、優化治療,並加強與腫瘤科團隊的溝通。
And so they're a little bit more focused. They're a little bit below the level of these NCCN guidelines. They cover various aspects, not just cancer care, but also kind of how to select patients or monitoring or counseling or management strategies. And so we really think that this is an important milestone for us to now have a PQI for PEDMARK.
所以他們更專註一些。它們比NCCN指南的標準略低一些。它們涵蓋了各個方面,不僅包括癌症治療,還包括如何選擇患者、監測、諮詢或管理策略等等。因此,我們認為獲得 PEDMARK 的 PQI 對我們來說是一個重要的里程碑。
They have now -- that's access people can have information about our product really without us having to be there, they can access that information through these PQIs. So we're very excited about it.
現在,人們可以透過這些產品品質資訊來獲取我們產品的信息,而無需我們親自到場。所以我們對此感到非常興奮。
Unidentified Participant
Unidentified Participant
That's helpful. And then also, could you just talk about how you're splitting marketing resources between the larger AYA opportunity in earlier pediatric population? Are you laser-focused on driving this newly open market? Or is there some balance you're targeting there?
那很有幫助。另外,您能否談談您是如何將行銷資源分配到更廣泛的 AYA 市場以及更早的兒科人群中的?您是否正全力以赴地開拓這個新開放的市場?或者說,你希望在這兩者之間達到某種平衡?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Yeah. The balance between the two markets. I mean, listen, we've said all along that we believe that the opportunity is much larger in AYA, but that we don't -- especially in the academic institutions, when we're in an academic institution, we're there on the pediatric side as well as the AYA side. Obviously, we know that the size and the market is much different but there's still that incredible need for PEDMARK in these pediatric settings.
是的。兩個市場之間的平衡。我的意思是,聽著,我們一直都說,我們相信 AYA 的機會要大得多,但是我們——尤其是在學術機構裡,當我們身處學術機構時,我們既參與兒科方面的工作,也參與 AYA 方面的工作。顯然,我們知道規模和市場大不相同,但兒科領域對 PEDMARK 的需求仍然非常巨大。
And so we still continue to get use there. We still continue to see growth. We don't see the growth that we see in AYA, of course, because during this launch phase and it's obviously much larger. But we instruct our commercial organization as well as our medical organization when we're in these institutions, we're doing both PED and AYA commercial marketability.
因此,我們仍然繼續在那裡獲得使用權。我們仍然看到成長。當然,我們沒有看到像 AYA 那樣的成長,因為 AYA 正處於啟動階段,而且規模顯然要大得多。但是,當我們在這些機構中時,我們會指示我們的商業機構和醫療機構,我們既要進行兒科和青少年及青年(PED 和 AYA)的商業市場推廣。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Yeah. And just to add, Chad, doors have opened for us in the AYA as a result of our pediatric relationships that we've obviously built over the last several years. And conversely, doors have also opened for pediatric as a result of the progress that we've made with AYA. And so that's really the beauty of the opportunity, different size market opportunities but really growth potential in each one.
是的。查德,我還要補充一點,由於我們在過去幾年與兒科醫生建立了良好的關係,我們在青少年及青年醫學領域也獲得了更多機會。反過來,由於我們在青少年及青年癌症治療方面取得的進展,兒科領域也迎來了新的機會。所以,這就是機會的魅力所在:不同規模的市場機遇,但每個市場都蘊藏著巨大的成長潛力。
Operator
Operator
Ram Selvaraju, H.C. Wainright.
拉姆‧塞爾瓦拉朱 (Ram Selvaraju),H.C.溫賴特。
Unidentified Participant
Unidentified Participant
This is Eduardo on for Ram. I was wondering if you could provide any details that you -- how proactive the FDA has been recently in seeking to ensure that the market is complying with its guidance, not to substitute PEDMARK with other compounded versions of your API and that formulation?
這裡是代表 Ram 的 Eduardo。我想了解一下,您能否提供一些細節,說明FDA最近在確保市場遵守其指導方針方面採取了哪些積極主動的措施,例如不以其他複合版本的API及其配方來替代PEDMARK?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
I missed the beginning of that I'm sorry. Edardo, can you repeat that again? Sorry.
很抱歉,我錯過了開頭部分。埃達爾多,你能再說一次嗎?對不起。
Unidentified Participant
Unidentified Participant
Sure. No problem. Just how proactive the FDA has been in ensuring the market is complying with its guidance, not to substitute PEDMARK with compound versions of STS?
當然。沒問題。FDA 在確保市場遵守其指導方針(即不以 STS 的複合版本替代 PEDMARK)方面究竟有多積極主動?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Well, we've had -- in the past, we've had the FDA put out a statement. I think that statement is clear. We -- that statement is part of we continue to utilize when we see that compounding happening. They are -- the FDA has been supportive the use of FDA-approved product or PEDMARK in this situation.
嗯,過去我們有過──美國食品藥物管理局(FDA)發表過聲明。我認為這個說法很清楚。我們——這句話是我們繼續利用複利效應來應對這種情況的一部分。他們是——FDA一直支持在這種情況下使用FDA批准的產品或PEDMARK產品。
So I mean it continues, Eduardo, to be probably one of the bigger areas in the pediatric discussion when we are looking at, especially opening up new institutions, we want to make sure and we talk about it all the time about that there is a -- we're the only FDA-approved product that's on the market.
所以我的意思是,愛德華多,這仍然是兒科討論中一個比較重要的領域,尤其是在開設新機構時,我們想要確保,而且我們一直在談論,我們是市場上唯一獲得 FDA 批准的產品。
I think it's important to realize in the AYA space, unlike the pediatric space is that the reimbursement and the usage of compounded products are much different in the community settings as well. So we don't have as much of an issue there as we do in some of the academic centers for -- in the pediatric space. But we continue to utilize that message from the FDA and continue to have support from them.
我認為,在青少年及青年(AYA)領域,與兒科領域不同的是,社區環境中複方製劑的報銷和使用情況也大不相同。所以,我們在兒科領域遇到的問題不像在一些學術中心那麼嚴重。但我們會繼續利用美國食品藥物管理局(FDA)的這項訊息,並繼續得到他們的支持。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Eduardo, when you -- when I mentioned briefly our medical team, they have really reinvigorated both the fact that PEDMARK is the first and only approved product for the prevention of hearing loss as it relates to cisplatinum.
愛德華多,當我簡要提到我們的醫療團隊時,他們確實重新強調了 PEDMARK 是第一個也是唯一一個獲準用於預防順鉑相關聽力損失的產品。
Also understanding very well why cisplatinum causes this hearing loss. What the uniqueness is of PEDMARK and we started to see that bear fruit just in recent quarters, and we expect more to come. And we've got a lot of enthusiasm, as Jeff mentioned, both in new pediatric patients and also in AYA. And in AYA specifically, we have seen no compounded use of the product today.
也完全了解順鉑導致聽力喪失的原因。PEDMARK 的獨特之處在於,我們最近幾季開始看到它取得成效,我們預計未來會有更多成果。正如傑夫所提到的那樣,我們對兒科新患者和青少年及青年患者都充滿熱情。尤其是在 AYA 患者中,我們目前還沒有看到該產品的複合使用。
Unidentified Participant
Unidentified Participant
Got it. That's really helpful. And then going back to the EU, I think you mentioned the time line for expanding. You mentioned you started with -- Norgine has started the work and found some good traction with in the UK markets. Could you repeat the time line for when you expect them to launch and you mentioned Italy, I think, and a few other countries. But yeah, just a little bit more clarity on that time line again.
知道了。這真的很有幫助。然後回到歐盟的話題,我想你提到了擴張的時間表。您提到您是從——Norgine 開始的,並且在英國市場取得了一些不錯的進展。您能否再重複一下您預計的發佈時間表?您提到了義大利,我想,還有其他一些國家。是的,我們還是希望時間軸能更清晰一些。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Sure. So as a reminder, Norgine has the rights to all of the EU, Australia, and New Zealand. Principally, that first market is the UK. They have also launched and they have their first patient in Germany. But there is not final pricing yet in Germany. There's only final pricing in the UK.
當然。再次提醒大家,Norgine擁有歐盟、澳洲和紐西蘭的全部權利。首先,第一個市場是英國。他們也已在德國啟動了該項目,並迎來了第一位患者。但德國尚未公佈最終定價。英國祇有最終價格。
The additional, as I call, the EU 5 markets on top of Germany, UK, where you have Italy, Spain, and France we expect a launch early next year with preparation later this year. And the Nordic countries, Denmark, Norway, and additionally Switzerland starting to come on later this year and early next year. In summary, they're just getting going. They're just getting started, which we're very excited about.
除了德國、英國之外,我們還將向歐盟其他五個市場(即義大利、西班牙和法國)推出服務,預計明年初啟動,並在今年稍後進行準備工作。北歐國家,如丹麥、挪威,以及瑞士,將於今年稍後和明年年初陸續加入。總之,他們才剛起步。他們才剛起步,我們對此感到非常興奮。
Robert Andrade - Chief Financial Officer
Robert Andrade - Chief Financial Officer
Yeah, we're encouraged about the positive indications that we've seen in the early engagement.
是的,我們對早期參與階段所看到的正面跡象感到鼓舞。
Unidentified Participant
Unidentified Participant
And do you have any visibility to the Germany pricing and that would trigger a milestone payment? Or is that correct?
您是否了解德國的定價情況,以及這將觸發里程碑付款嗎?這樣說對嗎?
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
That is a material milestone. We look forward to providing additional updates. What we do have is we have final pricing in the UK, which well exceeded what we were anticipating just a year ago. And so if we're consistent with that in Germany, we look forward to giving additional updates on that milestone.
這是一個重要的里程碑。我們期待提供更多最新消息。我們已經確定了英國的最終定價,這遠遠超過了我們一年前的預期。因此,如果我們在德國的情況與此一致,我們期待就這一里程碑事件發布更多最新消息。
Operator
Operator
I'm currently showing no further questions at this time. I'd like to turn the call back over to Jeff Hackman for closing remarks.
目前我沒有其他問題要問。我謹將電話交還給傑夫‧哈克曼,請他作總結發言。
Jeffrey Hackman - Chief Executive Officer, Director
Jeffrey Hackman - Chief Executive Officer, Director
Well, thank you. Thanks for your questions, everybody. I appreciate it and the continued engagement. As you heard today, we are so pleased with the momentum that we've been able to build in the first half of 2025. The revenue growth, the strong revenue growth that we've seen is the key to really all of the milestones that we've been able to achieve.
謝謝。謝謝大家的提問。我對此表示感謝,也感謝你們持續的參與。正如你們今天所聽到的,我們對2025年上半年所取得的進展勢頭感到非常滿意。我們所看到的強勁營收成長,是我們能夠實現所有里程碑的關鍵。
We remain focused on the disciplined execution that we've talked about today, the strategic imperatives, and we're confident on the path ahead. So most importantly, I'll close the call. I never want to lose sight of the patients that we serve especially the young people facing cancer treatment and the difference that our product PEDMARK can make in preserving their hearing and their quality of life.
我們將繼續專注於今天討論過的嚴謹執行和策略要務,並對未來的道路充滿信心。所以最重要的是,我要結束通話了。我始終銘記我們所服務的患者,特別是正在接受癌症治療的年輕人,以及我們的產品 PEDMARK 在保護他們的聽力和生活品質方面所能發揮的作用。
So we appreciate your support. We look forward to updating you more on our continued progress in the quarters to come, and thank you for participating today.
我們非常感謝您的支持。我們期待在接下來的幾個季度向您報告我們取得的持續進展,並感謝您今天的參與。
Operator
Operator
This concludes today's conference call. Thank you for your participation. You may now disconnect.
今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線了。