Fennec Pharmaceuticals Inc (FENC) 2025 Q1 法說會逐字稿

Good morning, ladies and gentlemen, and welcome to Fennec Pharmaceuticals' first-quarter 2025 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference call is being recorded.

女士、先生們，早上好，歡迎參加 Fennec Pharmaceuticals 2025 年第一季財報和公司更新電話會議。（操作員指示）提醒一下，今天的電話會議正在被錄音。

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

現在，我想將會議交給 Fennec 的財務長 Robert Andrade。

Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals' first-quarter 2025 earnings conference call, in which we will review our financial results as well as provide a general business update.

謝謝接線員，大家早安。感謝您今天參加 Fennec Pharmaceuticals 2025 年第一季財報電話會議，我們將在會上回顧我們的財務表現並提供一般業務更新。

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.

今天早上與我一起從 Fennec 來的還有我們的執行長兼董事會成員 Jeff Hackman。在我們開始之前，我想提醒您，在本次電話會議中，公司將做出前瞻性陳述，這些陳述受風險和不確定性的影響，可能導致實際結果與前瞻性陳述中討論的結果不同。

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

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

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

我們明確否認有更新或修改任何前瞻性陳述的義務。此次電話會議將被錄音並在 Fennec 的網站 www.fennecpharma.com 上重播，並將在未來 30 天內在該網站上提供。現在，我將把電話轉給傑夫·哈克曼。

Thank you, Robert, and good morning, everyone. I want to thank you all for joining us today as we review our first quarter performance and show the outlook for the year ahead. I'm excited to share the details and highlights of our results for Q1 and 2025. So the alignment of our organization around clear commercial priorities to enhance field execution and support sustainable growth across key PEDMARK segments really began back in Q4 2024.

謝謝你，羅伯特，大家早安。我要感謝大家今天加入我們，一起回顧第一季的業績並展望未來一年。我很高興與大家分享我們第一季和 2025 年業績的詳細資訊和亮點。因此，我們組織圍繞著明確的商業優先事項的調整，以加強現場執行並支持 PEDMARK 關鍵部門的可持續成長，實際上始於 2024 年第四季。

Much of the work was implemented though, in Q1 of this year. Therefore, Q1 was a quarter marked by a stronger strategic focus, disciplined execution, and a much more meaningful progress across all areas of our business. This was accomplished with really just a few critical activities.

不過，大部分工作已經在今年第一季實施。因此，第一季的標誌是策略重點更加明確、執行更加規範，並且我們業務的各個領域都取得了更有意義的進展。這實際上僅透過幾項關鍵活動就實現了。

Let me go into those. The first is the development and implementation of a targeting model, a much more sophisticated model than the organization had in the past. It was data-driven and prescriber and practice list to guide field execution and engagement were used. This was a critical step to better understand our business and our opportunities, especially given our expansion beyond pediatrics into the adolescent and young adult or AYA patient population.

讓我來詳細解釋一下。首先是開發和實施目標定位模型，該模型比該組織過去的模型複雜得多。它是數據驅動的，並使用處方者和實踐清單來指導現場執行和參與。這是更好地了解我們的業務和機會的關鍵一步，特別是考慮到我們的業務範圍已從兒科擴展到青少年和青年人或 AYA 患者群體。

This targeting includes a structured tiering of cisplatin prescribers nationally, prioritizing tiers like Tier 1 through 5, or those who treat high number of patients with cisplatin, allowing us to focus on engagement in key academic institutions and large community practices where PEDMARK can have the greatest clinical and commercial impact.

這一目標包括在全國範圍內對順鉑處方者進行結構化分層，優先考慮 1 至 5 級，或使用順鉑治療大量患者的人員，這使我們能夠專注於參與 PEDMARK 可以產生最大臨床和商業影響的關鍵學術機構和大型社區實踐。

As a result, the first quarter Tier 1 targets prescribed for PEDMARK demonstrated early traction and validation of our focused engagement strategy. Some of the examples of these accounts are Tampa General Hospital in Florida, Rady Children's in San Diego, Huntsman's Cancer in Salt Lake, Suni Comprehensive Health Center in New Mexico and City of Hope, which is one of the largest advanced cancer centers in the country.

因此，PEDMARK 規定的第一季一級目標證明了我們專注於參與策略的早期吸引力和驗證。這些帳戶的一些例子包括佛羅裡達州的坦帕綜合醫院、聖地亞哥的拉迪兒童醫院、鹽湖城的亨茨曼癌症中心、新墨西哥州的蘇尼綜合健康中心和希望之城，後者是美國最大的晚期癌症中心之一。

These are just some accounts and others that have begun to integrate PEDMARK into their treatment plans, further validating its clinical utility and expanding patient access in real-world settings. As a part of these efforts, we continue to be encouraged by the interest and adoption we see in the AYA segment. We've mentioned on prior calls that this opportunity for this segment is very significant in the US.

這些只是一些帳戶，其他帳戶已開始將 PEDMARK 整合到他們的治療計劃中，進一步驗證了其臨床實用性並擴大了患者在現實環境中的使用機會。作為這些努力的一部分，我們繼續對 AYA 領域的興趣和採用感到鼓舞。我們在之前的電話會議上提到過，這一領域在美國的機會非常重要。

Fennec estimates that approximately 20,000 cisplatin chemotherapy patients are treated annually in the primary type, tumor types, fibroid cancer, breast cancer, germ cell and testicular. The market potential in AYA is greater than the size of the pediatric market and has a favorable reimbursement profile via outpatient reimbursement. We also made significant strides on the medical front, increasing positive engagements with key opinion leaders and building momentum around awareness of the impact of cisplatin-induced ototoxicity.

Fennec 估計，每年約有 20,000 名順鉑化療患者接受原發性、腫瘤類型、子宮肌瘤癌、乳癌、生殖細胞癌和睪丸癌的治療。AYA 的市場潛力大於兒科市場的規模，並且透過門診報銷具有良好的報銷狀況。我們在醫學方面也取得了重大進展，增加了與關鍵意見領袖的積極互動，並增強了人們對順鉑引起的耳毒性影響的認識。

Our medical team also strengthened their clinical messaging based upon the data and interactions and new medical science liaisons, or MSLs, that joined our team and are already engaging with national KOLs. As an example of our cross-functional alignment in late April, Fennec and our teams had an advisory board comprised of key opinion leaders from across the nation, with specialties in medical oncology, urologic surgery, directors of pharmacy.

我們的醫療團隊還根據數據和互動以及加入我們團隊並已與國家 KOL 接觸的新醫學科學聯絡員 (MSL) 加強了他們的臨床訊息傳遞。作為我們 4 月底跨職能協調的一個例子，Fennec 和我們的團隊有一個由來自全國各地的關鍵意見領袖組成的顧問委員會，其專長是腫瘤內科、泌尿外科和藥房主任。

This discussion focused on AYA treatment paths within academic institutions in these large community practices. During this meeting, Fennec's team gathered additional market insights to further inform and refine our executional excellence moving forward. We're also actively working to further enhance our Fennec HEARS patient support program to ensure a more seamless supportive experience for both providers and patients at every step of the PEDMARK journey.

本次討論的重點是這些大型社區實踐中學術機構內的 AYA 治療途徑。在這次會議期間，Fennec 的團隊收集了更多市場見解，以進一步指導和完善我們未來的卓越執行力。我們也積極致力於進一步加強我們的 Fennec HEARS 患者支援計劃，以確保在 PEDMARK 旅程的每一步中為提供者和患者提供更無縫的支援體驗。

These upgrades designed to improve access, streamline reimbursement and expand home nursing capabilities. Fennec HEARS is critical for the health care providers adoption and patient adherence. We experienced improvement in patient adherence throughout the quarter, and we expect this to continue throughout the year as we bolster and support our offerings, both with the HCPs and patients that we serve.

這些升級旨在改善醫療服務、簡化報銷流程並擴大家庭照護能力。Fennec HEARS 對於醫療保健提供者的採用和患者的依從性至關重要。整個季度，我們的患者依從性都有所改善，我們預計這種狀況將持續全年，因為我們將加強和支持我們為所服務的 HCP 和患者提供的服務。

By removing some of these friction points and delivering a very high-touch experience across the treatment journey we're not only supporting better care, but we're also helping to empower providers to identify and treat more eligible patients. This is essential and critical given the growing recognition of hearing loss, which is an essential part of cancer survivorship.

透過消除一些摩擦點並在整個治療過程中提供高接觸體驗，我們不僅支持更好的護理，而且還幫助醫療服務提供者識別和治療更多符合條件的患者。鑑於人們越來越認識到聽力損失是癌症生存的重要組成部分，這一點至關重要。

As awareness increases, our program ensures providers are equipped with the right tools and support to proactively engage patients. who may benefit from PEDMARK intervention, helping us to advance both clinical and also outcomes to care. Now I'd like to also address the commercial launch efforts and the progress that we're making with PEDMARK outside the US

隨著意識的提高，我們的計劃確保提供者配備正確的工具和支持，以主動吸引患者。他們可能會受益於 PEDMARK 幹預，幫助我們推進臨床和護理結果。現在，我還想談談商業啟動工作以及我們在美國以外與 PEDMARK 合作的進展

Following our exclusive licensing agreement, that Fennec executed back in March 2024 with Norgine Pharmaceuticals, the product has now launched commercially in Germany and in the UK And just this past week, Norgine announced that the Scottish Medicine Consortium or SMC, has accepted PEDMARQSI for use in Scotland. Collectively, these recent launches market important steps in achieving Fennec's mission of expanding access to PEDMARK and PEDMARQSI to cancer patients at risk of hearing loss in the European Union and the UK.

根據 Fennec 於 2024 年 3 月與 Norgine Pharmaceuticals 簽訂的獨家授權協議，該產品現已在德國和英國進行商業推廣。就在上週，Norgine 宣布蘇格蘭醫學聯盟 (SMC) 已接受 PEDMARQSI 在蘇格蘭使用。總的來說，這些最新推出的產品標誌著 Fennec 朝著實現其使命邁出了重要一步，即擴大歐盟和英國有聽力損失風險的癌症患者獲得 PEDMARK 和 PEDMARQSI 的機會。

Also on the global front, the investigator-initiated trial in Japan or STSJ01 evaluating PEDMARK was fully now enrolled as of October 2024. And the clinical trial, STS-J01, evaluates the efficacy and safety of PEDMARK in reducing ototoxicity, induced by cisplatin in children and AYAs with localized solid tumors. The primary endpoint of this trial is to assess the frequency of hearing impairment at the end of treatment. Results of the trial are expected in the second half of 2025 with potential evaluation of both the registration and partnering or licensing of PEDMARK in Japan thereafter.

同樣在全球範圍內，截至 2024 年 10 月，日本研究者發起的評估 PEDMARK 的試驗或 STSJ01 現已完全招募。臨床試驗 STS-J01 評估了 PEDMARK 在降低局部實體瘤兒童和 AYA 患者中順鉑引起的耳毒性方面的有效性和安全性。此試驗的主要終點是評估治療結束時聽力障礙的頻率。預計試驗結果將於 2025 年下半年公佈，之後可能會對 PEDMARK 在日本的註冊、合作或許可進行評估。

Looking ahead, we are building a solid foundation with a laser-focused vision, as I mentioned, as we entered into 2025. This includes deepening our relationships with our key accounts, expanding in adoption with new existing customers and seeking evident-based data generation through investigator-sponsored trials or we call them ISTs. Based on our sharpened messaging, our strategic focus and this disciplined execution in the first quarter, we made some meaningful progress across all areas of our business.

展望未來，正如我所提到的，當我們進入 2025 年時，我們正在以雷射聚焦的願景建立堅實的基礎。這包括深化我們與主要客戶的關係、擴大新現有客戶的採用範圍以及透過研究者贊助的試驗（我們稱之為 IST）尋求基於證據的數據生成。基於我們第一季清晰的訊息傳遞、策略重點和嚴格的執行，我們在所有業務領域都取得了一些有意義的進展。

We're seeing positive momentum in our strategy to move healthcare providers from trial to adoption of PEDMARK. The strong momentum has continued in early Q2, and I look forward to progress and sharing those results with you throughout the year.

我們看到，我們的策略正在推動醫療保健提供者從試用到採用 PEDMARK，並呈現出積極的勢頭。強勁的勢頭在第二季初得以延續，我期待全年取得進展並與大家分享這些成果。

With that, I'll turn it back over to Robert.

說完這些，我會把話題還給羅伯特。

Thank you, Jeff. Our press release contains details of our financial results for the first 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. For the first quarter of 2025, the company recorded net product sales of approximately $8.8 million compared to $7.4 million in the first quarter of 2024. This reflects 18% growth compared to the same period last year, and an 11% increase over the fourth quarter of 2024.

謝謝你，傑夫。我們的新聞稿包含我們 2025 年第一季財務業績的詳細信息，您可以在我們網站的「投資者和媒體」部分查看。我今天的評論不會通讀所有這些細節，而是專注於一些關鍵的財務結果。2025 年第一季度，該公司淨產品銷售額約為 880 萬美元，而 2024 年第一季為 740 萬美元。與去年同期相比成長了 18%，與 2024 年第四季相比成長了 11%。

Of significance, we are pleased to report our second consecutive quarter of growth in net product sales. As mentioned in March 2025, we are focusing on growing net product sales and anticipate the most significant quarterly growth in the second half of 2025, when all the foundational pillars and initiatives we are putting in place are expected to materially impact the growth of PEDMARK.

值得注意的是，我們很高興地報告，我們的淨產品銷售額連續第二季實現成長。正如 2025 年 3 月所提到的，我們專注於增加淨產品銷售額，並預計 2025 年下半年將實現最顯著的季度增長，屆時我們正在實施的所有基礎支柱和舉措預計將對 PEDMARK 的增長產生重大影響。

The company recorded $2.9 million in selling and marketing expenses in the first quarter of 2025 compared to $3.9 million in the fourth quarter of 2024 and $5.2 million in the first quarter of 2024. The decrease on a year-over-year basis is primarily attributable to the elimination of expenses associated with European pre-commercialization activities which occurred in 2024 prior to the announcement of the Norgine partnership.

該公司 2025 年第一季的銷售和行銷費用為 290 萬美元，而 2024 年第四季為 390 萬美元，2024 年第一季為 520 萬美元。與去年同期相比，這一下降主要歸因於消除了與 Norgine 合作夥伴關係宣布之前於 2024 年發生的歐洲預商業化活動相關的費用。

To be clear, and as stated previously, European pre-commercialization expenses are not expected in 2025. The company recorded $6.1 million in G&A expenses in the first quarter of 2025 compared to $4.1 million in the fourth quarter of 2024, and $5.9 million in the comparable quarter of 2024.

需要明確的是，如前所述，2025 年歐洲預計不會出現商業化前的費用。該公司 2025 年第一季的 G&A 費用為 610 萬美元，而 2024 年第四季為 410 萬美元，2024 年同期為 590 萬美元。

For the first quarter of 2025, G&A expenses were consistent on a year-over-year basis and increased quarter-over-quarter, largely due to noncash-based stock compensation traditionally done in the first fiscal quarter. Cash and cash equivalents were $22.6 million as of March 31, 2025. Company burned approximately $4 million in cash in the first quarter of 2025. As stated in our March 2025 call, we remain confident in the full year cash operating expenses to be similar in '25 to '24 were approximately $33 million.

2025 年第一季度，一般及行政費用與去年同期持平，且環比增加，這主要是由於傳統上在第一財政季度進行的非現金股票薪酬。截至 2025 年 3 月 31 日，現金及現金等價物為 2,260 萬美元。該公司在 2025 年第一季消耗了約 400 萬美元現金。正如我們在 2025 年 3 月的電話會議上所述，我們仍然相信 25 年至 24 年全年現金營運費用將相似，約為 3,300 萬美元。

This includes a step-up in marketing expenses and increased headcount offset by the elimination of European pre-commercialization expenses. 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 and fiscal year spending patterns.

這包括增加行銷費用和增加員工人數，但取消歐洲商業化前費用可以抵消這一增加。按照我們業務的慣例，財政年度上半年的現金營運費用較高，這主要是由於商業和行銷支出以及財政年度支出模式造成的。

Before concluding, I'd like to offer some initial perspective on the recent discussions regarding potential tariffs. As you may know, PEDMARK is manufactured in the United States. And as such, we don't anticipate that currently proposed tariffs will have a material impact on our gross margins for overall financial performance.

在結束之前，我想就最近有關潛在關稅的討論提供一些初步看法。您可能知道，PEDMARK 是在美國製造的。因此，我們預計目前提出的關稅不會對我們的整體財務表現的毛利率產生重大影響。

Operator, with that, we will now open up the call for questions.

接線員，好了，我們現在可以開始提問了。

(Operator Instructions)

（操作員指示）

Chase Knickerbocker, Craig-Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Hi, good morning. Thanks for the questions. Just a couple kind of metrics, I think, would be helpful on the AYA side first. So now that you've got a little bit more experience in that segment of the market. Can you cue us in on kind of what the average number of vials per patient per full treatment has been and kind of how that's compared to your expectations? And then kind of what percentage of patients are kind of making it through that full course? And maybe how that has improved and that's informed your patient support program.

嗨，早安。感謝您的提問。我認為，首先，幾個指標對 AYA 方面會有所幫助。現在您對該領域市場有了更多的經驗。您能否告訴我們，每位患者在每次完整治療中平均使用的藥瓶數量是多少，以及與您的預期相比如何？那麼有多少比例的患者能夠完成整個療程呢？也許這已經得到了改善，並且已經告知了您的患者支持計劃。

Sure. Hey, Chase, how are you? Thanks for the question. Yeah. We are seeing, on average, about 30 vials per patient in the AYA space, that can range, obviously. But on average, about 30%. Again, you know this is kind of a weight-based dosing regimen.

當然。嘿，Chase，你好嗎？謝謝你的提問。是的。我們看到，AYA 領域中每位患者平均需要大約 30 瓶藥物，顯然，這個數字可能會有所不同。但平均而言，約30％。再說一次，您知道這是一種基於體重的給藥方案。

So it depends on the size, as you can imagine. We're seeing -- and one of the things that we're improving on is our adherence numbers, and we're seeing that, that range is around 50% of the patients are getting through full dose or full adherence.

所以這取決於尺寸，正如您所想像的。我們看到——我們正在改進的事情之一就是我們的依從性數字，我們看到，大約有 50% 的患者服用了全劑量或完全依從。

And so kind of some of the focus that I had mentioned was is about getting Fennec HEARS in the right place. Fennec HEARS was kind of designed for pediatric use in large institutions. But as this product now gets moved out into the community setting and a little bit more of the use in home administration, adherence is really critical for the product, and that's why we needed to really focus our efforts on kind of revamping Fennec HEARS and making sure that we increase those adherence numbers as high as we can get them, and we'll see that increase as we move throughout the year.

因此，我之前提到的重點是讓 Fennec HEARS 出現在正確的位置。Fennec HEARS 是專為大型機構的兒科使用而設計的。但隨著這款產品現在進入社區環境，並在家庭管理中得到更廣泛的應用，依從性對於產品來說至關重要，這就是為什麼我們需要集中精力改進 Fennec HEARS，確保盡可能提高依從性數字，並且我們將看到這一數字在全年不斷增長。

And what capabilities in the Fennec HEARS program have kind of been the biggest drivers of improvement or where you kind of sought to drive adherence improvement from?

Fennec HEARS 計劃中的哪些功能是推動改進的最大動力，或者您希望從哪些方面來推動依從性改進？

Yeah. I think it's just resigning the program to really be focused on giving this product and potentially in the home setting with our partners. We have partners that -- and organizations that we had set up to make sure this product can be administered there. So there are a whole bunch of different details, Chase, I can walk through with you off-line, but those details needed to be really ironed out to make sure that, that experience went well in when we gave -- when we get this product at home, right?

是的。我認為，這只是放棄該計劃，真正專注於提供這種產品，並可能在家庭環境中與我們的合作夥伴合作。我們擁有合作夥伴以及我們設立的組織，以確保產品能夠在那裡管理。因此，有很多不同的細節，Chase，我可以離線與您一起討論，但這些細節需要真正解決，以確保當我們在家中收到該產品時，體驗良好，對嗎？

Because remember, we're giving this product, in some cases, 6 hours after -- in many -- in all cases, 6 hours after the (inaudible) has been given. So it's in the home setting, it's all the details have to be [ironed] out to make sure that, that administration goes well.

因為請記住，我們給予該產品，在某些情況下，在 6 小時後 - 在很多情況下 - 在所有情況下，在（聽不清）給予 6 小時後。因此，在國內環境中，必須解決所有細節，以確保管理順利進行。

Yeah. And Chase, I'll just add a little bit, as you know, but just to make other people aware, when you're -- when we're administering the AYA population largely done outpatient or as Jeff said in the home health setting. So the education of the product, the awareness and in particular, the administration what to expect the antiemetics, the proper hydration.

是的。蔡斯，如你所知，我只想補充一點，只是為了讓其他人知道，當我們管理 AYA 人群時，大部分是在門診進行，或者像傑夫所說的那樣，在家庭保健環境中進行。因此，需要對產品進行教育，提高認識，特別是管理，了解止吐藥的預期效果以及適當的補水。

And so we've really put a focused effort in a concentrated effort with our Fennec HEARS program and with our medical team. And as you know, we've augmented. So I think that all speaks well to what progress we've made in the last quarter, but also what we hope to happen throughout the year.

因此，我們確實專注於開展 Fennec HEARS 計畫並與醫療團隊一起努力。正如你所知，我們已經增強了。所以我認為這一切都很好地說明了我們在上個季度所取得的進展，也說明了我們希望全年取得的進展。

Great. And then Robert, can you maybe just speak to -- so the OpEx, call it, flat into Q2 and then we should see a little bit of a step down in the back if it sounds like. And then just as far as kind of how that launch with Norgine has went so far? I mean, has that kind of been a long -- I know it's early, but along kind of what expectations were and how does that inform your confidence in kind of future milestones over the next 12 months?

偉大的。然後羅伯特，您能否談談 - 營運支出在第二季度持平，然後如果聽起來的話，我們應該會看到後面有一點下降。那麼，與 Norgine 合作推出的產品目前進展如何？我的意思是，這是否已經是一個漫長的過程了——我知道現在還為時過早，但您的期望是什麼？這如何影響您對未來 12 個月里程碑的信心？

Sure. Yeah. With the OpEx, yes, as stated in the remarks and in the script, it's front-end loaded for the year. That's just the spending patterns and also as we get into -- we're trying to trying to create additional awareness contracts, generally half upfront and then amortized over the rest of the year.

當然。是的。是的，正如評論和腳本中所述，OpEx 是今年的前端負載。這只是支出模式，而且當我們進入時 - 我們正在嘗試創建額外的意識合同，通常是預付一半，然後在一年剩餘的時間內攤銷。

So that's just traditional. It will see a tailing off in particular, as we start Q3 and Q4. Norgine, we're very enthused as we stated, they've launched in the UK with an official list pricing, about 10% less in the US, but we're excited about that. Germany as well, it's early on, but we're really pleased with the progress. They've commented on some positive indicators of engagement and uptake. So we look forward to giving you more updates and material updates as the quarters progress.

這只是傳統。隨著第三季和第四季的開始，這一趨勢將尤其明顯。Norgine，正如我們所說的那樣，我們非常熱情，他們已經在英國推出了官方定價，比美國的價格低了約 10％，但我們對此感到非常興奮。德國也一樣，雖然還處於早期階段，但我們對進展感到非常滿意。他們對參與度和接受度的一些積極指標進行了評論。因此，我們期待隨著季度的進展為您提供更多更新和材料更新。

As it relates to the sales milestones, there are two milestones that we've communicated before that are a particular note as it relates to 2025. One is the official pricing in Germany. That has one milestone related to it. And the second one would be for the first year sales. So as we get closer towards the end of 2025, we hope to give some more progress updates as it relates to those milestones.

就銷售里程碑而言，我們之前已經傳達過兩個里程碑，它們與 2025 年特別相關。一是德國官方定價。這與一個里程碑有關。第二個是第一年的銷售額。因此，隨著 2025 年底的臨近，我們希望提供與這些里程碑相關的更多進展更新。

Great. Thanks, guys. Congrats on the progress.

偉大的。謝謝大家。恭喜你取得進展。

(Operator Instructions)

（操作員指示）

Sudan Loganathan, Stephens.

蘇丹·洛加納坦，史蒂芬斯。

Hi, good morning. Thanks for taking my questions, and great to hear about your new targeting strategy and how it's really showing in the stronger first quarter. On that front, do the prescribers know where they land on the tiering algorithm that you have? And is there any incentives in terms of reimbursements that they may get if they -- if a Tier 2, Tier 3 prescriber we're able to move up to be considered Tier 1?

嗨，早安。感謝您回答我的問題，很高興聽到您的新目標策略以及它在更強勁的第一季的實際表現。在這方面，開處方者是否知道他們在您的分層演算法中處於什麼位置？如果他們從 2 級、3 級開藥者晉升為 1 級，他們是否可以獲得報銷方面的任何激勵措施？

Yeah. I mean we don't -- Sudan, thanks for the question. I appreciate it. And yes, we don't typically share that information with our providers. Obviously, they are realize they're high prescribers of flat, and that's one of the reasons why we're in their offices trying to educate them. And I think many of them realize that the impact of ototoxicity is having.

是的。我的意思是我們不——蘇丹，謝謝你的提問。我很感激。是的，我們通常不會與我們的供應商分享這些資訊。顯然，他們意識到他們是平板的高級處方者，這也是我們在他們的辦公室試圖教育他們的原因之一。我認為他們中的許多人都意識到了耳毒性的影響。

I think the more where we see the interest and the reason why we target these high prescribers is because they do see the impact of what's happening. And in some cases, there's still a significant lack of awareness, not only at PEDMARK, but also of what the impact of ototoxicity is having on their patients. And so I think it's really critical for us to get -- to start there and to start at that top tier.

我認為，我們之所以針對這些高處方者，是因為他們確實看到了正在發生的事情的影響。在某些情況下，人們仍然嚴重缺乏認識，不僅是 PEDMARK，他們也不知道耳毒性對病人的影響。所以我認為從那裡開始，從頂層開始，對我們來說真的很重要。

When it comes to physicians throughout that tiering or that targeting process. We're starting at Tier 1 because of our size, and because of the amount of folks that we have out there, but eventually, we'll move down throughout, and we shouldn't see any differences in reimbursement or any differences in our conversations as you start to move out throughout the rest of that list.

當談到整個分層或目標確定過程中的醫生時。由於我們的規模和人員數量，我們從第 1 層開始，但最終，我們會逐步向下移動，當您開始移動到該列表的其餘部分時，我們不應該看到報銷方面有任何差異，或者我們的對話中有任何差異。

Yeah, just to add, there is no difference in terms of our pricing or reimbursement as it relates to the tiers. It's really more so that we can focus our commercial team on those top-level accounts. But obviously, if we make progress on a Tier 2 or Tier 3, we're just as focused and provided just equal support and as well as pricing and reimbursement options.

是的，補充一下，我們的定價或報銷在各個層級上沒有區別。這實際上更重要的是讓我們的商業團隊專注於那些頂級帳戶。但顯然，如果我們在第 2 層或第 3 層取得進展，我們也會同樣專注並提供同等的支援以及定價和報銷選項。

Yeah. That's great to hear. And is currently like regionally, at least in the United States, do you have pretty much most regions covered now among the Tier 1? Do you have Tier 1 accounts in each region at this point that you're honed in on? Or is there areas that still need to be kind of targeted and maybe just get more foothold in certain areas in the United States?

是的。聽到這個消息真是太好了。目前就地區而言，至少在美國，您是否已經涵蓋了 Tier 1 中的大多數地區？目前，您是否在每個地區都擁有您所關注的一級客戶？或者是否仍需要針對某些領域，或許只是在美國某些地區獲得更多立足點？

We're covering -- yeah, we're now deploying our commercial organization throughout the United States in this tiering or these focused and large academic centers and large community centers are being targeted by our commercial organization. So it's throughout the country.

我們正在涵蓋——是的，我們現在正在美國各地部署我們的商業組織，這些重點大型學術中心和大型社區中心正是我們商業組織的目標。全國各地都是如此。

Okay. Cool. And then next on the since you've kind of been on the market now for a year and you may be able to see the differences between the pharmacy formulation, the compounding component versus PEDMARK or just how much of a breakdown there could be between the two?

好的。涼爽的。接下來，由於您已經進入市場一年了，您可能能夠看到藥房配方、複合成分與 PEDMARK 之間的差異，或者兩者之間可能存在多大的差異？

Is the more education and the ability to get out to the physicians and prescribers kind of helped get PEDMARK more traction there? Or do you still see a small percentage of maybe some company pharmacies coming through trying to get a solution out to education that way. Any way to eat into that, if possible?

更多的教育和接觸醫生和處方者的能力是否有助於 PEDMARK 在那裡獲得更大的吸引力？或者您是否仍然看到一小部分公司藥房試圖透過這種方式來獲得教育解決方案。如果可以的話，有什麼辦法可以解決嗎？

Yeah. No, it's a good question. And I think what you're asking is are we seeing any inroads even in the -- not just AYA, but pediatric setting and in accounts that potentially were compounding in the past. And our medical team has -- and I've asked them to continue to target these institutions. And we've had some really exciting discussions with institutions where we've maybe in the past have been kind of shut out of those discussions because of the compounding issue and any issue with reimbursement in the DRGs.

是的。不，這是個好問題。我認為您要問的是，我們是否看到了任何進展——不僅僅是在 AYA，還包括兒科環境以及過去可能複合的帳戶。我們的醫療團隊已經—我已經要求他們繼續針對這些機構。我們與一些機構進行了一些非常令人興奮的討論，而過去我們可能因為複合問題和 DRG 報銷問題而被排除在這些討論之外。

So we're reengaging every instance that we can in these organizations. And I'm hoping to share potentially some successes in the future with some of these discussions that we're having. But this is all real surrounding around, I think, as we upgraded and improved our competencies with our medical team.

因此，我們正在盡我們所能重新參與這些組織中的每一個事例。我希望將來能夠分享我們正在進行的一些討論中可能取得的一些成功。但我認為，這一切都是真實存在的，因為我們升級並提高了醫療團隊的能力。

Got you. Great. And one more last one if I can squeeze it in. Maybe more a question for Robert. In terms of revenue growth and the progress that you're making maybe in the second half of this year being a little bit better on that side.

明白了。偉大的。如果我能擠出時間的話，我還有最後一個。這也許更是一個針對羅伯特的問題。就收入成長和所取得的進展而言，今年下半年可能會更好一些。

Is there a revenue number and with the current level of OpEx or maybe slightly lower that you think that can consistently break even or also obviously be EPS positive going forward? Is that something that we can maybe expect for the second half of this year?

是否有收入數字，並且以當前的營運支出水平或可能略低的水平，您認為未來可以持續收支平衡或明顯實現 EPS 正值？這是我們今年下半年可以期待的事嗎？

Yeah. Thanks for the question, Sudan. I mean, as stated, we're pleased with 2 consecutive quarters of growth. And I think that should be specifically highlighted and noted. But we're not done yet.

是的。謝謝蘇丹的提問。我的意思是，正如所說，我們對連續兩個季度的成長感到滿意。我認為應該特別強調和注意這一點。但我們還沒完成。

So our goal is to continue that growth throughout the year. We are focused on the back half of the year as having that growth from all these pillars and the foundation have put in place with the initiatives, including our new commercial leadership team, augmentation of staff, et cetera. So we look forward to giving you more progress there. As it relates to cash flow breakeven, another metric that for us internally is very, very important. We were close to in Q4.

因此我們的目標是全年繼續保持這種成長。我們專注於下半年，因為所有這些支柱和基礎都已實現成長，包括我們新的商業領導團隊、員工擴充等等。因此，我們期待您在那裡取得更多進步。因為它與現金流損益平衡有關，所以對於我們內部來說，另一個指標非常非常重要。我們在第四季已經接近了。

And -- but what hasn't changed is the total revenue product sale number that we need to get there. And that's roughly $8.5 million to $9 million of sales. As I stated for the year, we will have roughly $33 million to $34 million of cash OpEx. So that's how we think of it internally. From a GAAP EPS perspective, there is some fluctuation quarter-to-quarter primarily based on the stock-based comp with the higher parts obviously being in Q1. But if we get to those levels, $8.5 million, $9 million, we start generating cash, we start generating earnings. And internally, that's a big focus for us.

但不變的是我們需要達到的總收入產品銷售數字。銷售額約 850 萬至 900 萬美元。正如我所說的那樣，今年我們的現金營運支出將約為 3,300 萬至 3,400 萬美元。這就是我們內在的想法。從 GAAP EPS 的角度來看，季度間存在一些波動，主要基於股票補償，其中較高的部分顯然出現在第一季。但如果我們達到這些水平，850萬美元，900萬美元，我們就開始產生現金，開始產生收益。從內部來看，這是我們關注的重點。

Appreciate all the excellent questions and congrats on the great quarter.

感謝大家提出的所有優秀問題，並祝賀本季取得如此出色的成績。

Jason McCarthy, Maxim Group.

傑森麥卡錫，馬克西姆集團。

Hey, guys. It's Michael Okunewitch on the line. Thank you so much for taking my questions today. So I just wanted to see if you could touch a little bit on where you're making these initial inroads into the AYA setting. Is this mostly in those the smaller proportion of patients that are treated at those NCI centers? Or are you meaningfully penetrating now into the community setting?

嘿，大家好。電話那頭是麥可‧奧庫內維奇 (Michael Okunewich)。非常感謝您今天回答我的問題。所以我只是想看看您是否可以稍微談談您在 AYA 設定方面的初步進展。這是否主要發生在那些在 NCI 中心接受治療的較小比例的患者中？或者您現在是否正在積極深入社區環境？

Yeah. We're -- the NCI centers, we've said in the past are critical, obviously, where they have these AYA centers of excellence, right, and you see those in multiple places around the country. And those are places, obviously, we want to target because we know that a lot of the AYA patients will get treated in these centers. But we're also seeing this to as we move out into the community and some of these. And I think our targeting has really kind of allowed us to do that to get into places where we typically probably wouldn't have gone not just in the center itself, but in these community settings.

是的。我們 — — 我們過去曾說過，NCI 中心至關重要，顯然，他們擁有這些 AYA 卓越中心，對吧，您可以在全國各地看到它們。顯然，這些都是我們想要瞄準的地方，因為我們知道許多 AYA 患者會在這些中心接受治療。但當我們走進社區時，我們也看到了這一點。我認為我們的目標定位確實使我們能夠進入那些我們通常不會去的地方，不僅是在中心本身，而且在這些社區環境中。

So we're seeing growth in both places. I think the community setting as well as the academic are probably -- as we get much more focused on our efforts, will play critical roles for -- in both settings. So I can't tell you that one is right now more important than the other. But we've got a team that can be able to do that and be able to approach these top-tier targets and these large cisplatin users, whether they're in the academic or community setting.

因此我們看到兩個地方都在成長。我認為，隨著我們更加專注於我們的努力，社區環境和學術環境可能會在兩種環境中發揮關鍵作用。所以我現在無法告訴你哪一個比另一個更重要。但是我們有一個團隊能夠做到這一點，並且能夠接近這些頂級目標和這些大型順鉑用戶，無論他們是在學術界還是社區環境中。

All right. And then just on the Community segment, in particular, some of the infusion centers, has the operating hours of the centers remain a challenge for this AYA setting? Or some of the initiatives that you're working on kind of overcoming that challenge?

好的。那麼僅在社區部分，特別是一些輸液中心，中心的運營時間對於這個 AYA 設定來說仍然是一個挑戰嗎？或者您正在採取的一些措施可以克服​​這項挑戰？

Yeah. And it's a really good question because -- and that's why we -- I mentioned the Fennec HEARS enhancements that we had to make. And it is something that we needed to make and because when a physician realizes that he wants to prevent ototoxicity, but doesn't have the ability, he doesn't have a chair to have that available because their center closes at a certain time. That's when we move in with Fennec HEARS and with that team to be able to move into home health and into administrating outside that infusion center.

是的。這是一個非常好的問題，因為——這也是我們——我提到我們必須進行的 Fennec HEARS 增強功能。這是我們需要做的事情，因為當醫生意識到他想要預防耳毒性，但沒有能力時，他沒有椅子可以提供，因為他們的中心會在某個時間關閉。那時，我們與 Fennec HEARS 和該團隊合作，能夠進入家庭保健領域並進入輸液中心以外的管理領域。

Some infusion centers do stay open later. And those, in a lot of cases, will administer PEDMARK in that center. But we want to make it seamless to where if there is a situation where a patient wants to get this outside of these infusion centers that we have a program available. It's easy. It's -- it allows the patient to be able to be confident that this product can be given in a home setting. And we now have achieved that. We've achieved multiple administrations of PEDMARK and AYA patients in the home. And I feel really, really confident that this is a big opportunity for us as we move forward.

有些輸液中心確實會營業到很晚。在很多情況下，這些機構將在該中心管理 PEDMARK。但我們希望讓它變得無縫，如果出現患者想要在輸液中心之外獲得治療的情況，我們可以提供相應的程序。這很簡單。它可以讓患者確信該產品可以在家中使用。現在我們已經實現了這個目標。我們已經為 PEDMARK 和 AYA 患者進行了多次家庭管理。我非常有信心，這對我們前進來說是一個巨大的機會。

(Operator Instructions)

（操作員指示）

Ram Selvaraju, HC Wainwright.

拉姆·塞爾瓦拉朱、HC·溫賴特。

Hi. Thanks very much for taking my questions. Just on the ex-US front, can you maybe give us a sense of your most updated thinking regarding any additional remaining ex-US territories that you see as particularly strong potential future opportunities for PEDMARK? And also on the European side, if you could maybe run through for us what you expect to be the cadence of new country-by-country introductions of PEDMARQSI as we look through the remainder of 2025, above and beyond the countries in which the product obviously has already been launched.

你好。非常感謝您回答我的問題。僅就美國以外地區而言，您能否向我們介紹一下您對其他剩餘美國以外地區的最新想法，您認為這些地區對於 PEDMARK 來說具有特別強大的潛在未來機會？還有歐洲方面，您能否為我們介紹一下，在 2025 年剩餘時間內，除了已經推出該產品的國家之外，您預計 PEDMARQSI 在各個新國家推出的節奏如何？

Yeah. There's the big five, right, in Europe. They're focused on moving -- again, with, of course, Scotland just coming on and getting approval is exciting, but again, another country, but obviously a small market, but it's still impactful.

是的。對了，歐洲有五大巨頭。他們專注於發展——當然，蘇格蘭剛剛加入並獲得批准，這令人興奮，但同樣，另一個國家，顯然是一個小市場，但它仍然具有影響力。

You can think of countries as we -- as they focus themselves is the next up is Spain is Italy and France, and you can start to kind of think through how the -- and obviously, then really continuing to expand both in Germany and the UK as the launches really just only got started a month or two in the first quarter. So they really -- the second quarter will really be the first full quarter of the launches in both those countries as well. So we continue to be excited and bullish on what it is that they're doing.

你可以把這些國家想像成——他們關注的重點是接下來的西班牙、義大利和法國，你可以開始思考如何——然後顯然繼續在德國和英國擴張，因為這些產品的發布實際上只是在第一季的一兩個月才開始。因此，第二季實際上也將是這兩個國家推出新產品的第一個完整季度。因此，我們繼續對他們所做的事情感到興奮和樂觀。

They've got a great team. We meet with them often. We share best practices. And we share data that we can gather and -- but it goes both ways as well. We're learning from them. There are milestones that Robert talked about that are potentially achievable towards the end of this year. And we're going to stay close to them on making sure that those get achieved.

他們有一支出色的團隊。我們經常與他們見面。我們分享最佳實踐。我們共享我們收集的數據——但這也是雙向的。我們正在向他們學習。羅伯特談到的一些里程碑有可能在今年年底實現。我們將與他們保持密切聯繫，確保實現這些目標。

And just very briefly, secondary. You had previously talked, and I suppose this is really a question for Jeff about the possibility of looking at other strategic opportunities, particularly in the context of oncology supportive care. But I was just wondering if you had any updated thoughts on that front? Or if at this juncture, at least you can kind of give us a sense of when you think it would be most appropriate to look into that further and possibly identify assets or product marketing opportunities that might be synergistic with or accretive to the PEDMARK value opportunity in the United States. Thank you.

簡而言之，這是次要的。您之前已經談過了，我想這實際上是向傑夫提出的問題，關於是否有可能尋找其他策略機會，特別是在腫瘤支持治療的背景下。但我只是想知道您對此是否有任何最新的想法？或者如果在這個關鍵時刻，您至少可以讓我們了解您認為何時最適合進一步研究這個問題，並可能確定可能與美國 PEDMARK 價值機會產生協同作用或增值的資產或產品行銷機會。謝謝。

Yeah, that's a good question. I really wanted to come in and get the organization structured correctly and also executing correctly. And so the first quarter is really my second full quarter with the organization. And I really now are starting to feel comfortable with the execution and the way we're structured, and we have the right leadership in this organization.

是的，這是個好問題。我真的很想加入並讓組織結構正確並且執行正確。因此，第一季實際上是我在該組織工作的第二個完整季度。我現在真的開始對我們的執行和組織結構感到滿意，而且我們在這個組織中擁有正確的領導。

So yes, now you start to kind of think, all right, and we have had people in the past, even in my time here in the last six months, reach out to -- that are in the supportive care space as well as not in the supportive care space to say, hey, we like -- we see what you guys are building, are there synergies there. We're going to continue to look at that. I think Robert mentioned about our financial situation as we move throughout the year and sales continue to grow.

所以是的，現在你開始有點想，好吧，過去我們曾有人，甚至在我過去六個月的時間裡，與支持性護理領域和非支持性護理領域的人進行接觸，說，嘿，我們喜歡——我們看到你們正在構建的東西，那裡有協同效應嗎？我們將繼續關注此事。我認為羅伯特提到了我們的財務狀況，因為我們全年的銷售額都在持續成長。

This is definitely an option, not only here, but also as we talked about Japan. And partnership potential opportunities if that brings itself to light as well as we get more of the data finalize. So we have a couple of opportunities like that, that I think are really critical for the future and also are additive to not only what we're doing in the commercial organization here in the US but those opportunities are additive to what it is that we potentially could deliver. That's a good question.

這絕對是一個選擇，不僅在這裡，而且正如我們談論的日本。如果我們獲得更多最終數據，合作的潛在機會就會顯現出來。因此，我們有幾個這樣的機會，我認為這些機會對未來來說非常重要，而且這些機會不僅可以補充我們在美國商業組織中所做的事情，而且還可以補充我們可能提供的內容。這是個好問題。

Thank you.

謝謝。

I'm showing no further questions at this time. I would now like to turn it back to Jeff Hackman for closing remarks.

我目前沒有其他問題。現在我想請傑夫·哈克曼作最後發言。

Thank you. And thanks for the questions, everyone, and being a participant on the call. So in closing, I'd like to say that Q1 was really a pivotal and exciting start this year for the company. And mark really strong execution of our team. It marked a strategic clarity and real momentum, and we want to continue that momentum, and you'll see that as we go throughout the year.

謝謝。感謝大家的提問，也感謝大家參與這次電話會議。最後，我想說，第一季對公司來說確實是一個關鍵且令人興奮的開始。這也標誌著我們團隊的執行力確實很強。它標誌著戰略的清晰性和真正的勢頭，我們希望繼續保持這種勢頭，隨著我們全年的發展，您將看到這一點。

We're encouraged by the early impact of our foundational work and remain to be focused on building a sustainable and valuable business here. Through deeper engagement, as I mentioned, smarter support and continued innovation in this space. So thanks for joining today. I really appreciate it. Robert and I look forward to keeping you updated on our progress throughout the year. So thank you.

我們的基礎工作早期產生的影響令我們感到鼓舞，我們將繼續致力於在這裡建立可持續的、有價值的業務。正如我所提到的，透過更深入的參與，我們可以為該領域提供更聰明的支援和持續的創新。感謝您今天的加入。我真的很感激。羅伯特和我期待著向您通報我們全年的進展。所以謝謝你。

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。您現在可以斷開連線。