Xeris Biopharma Holdings Inc (XERS) 2025 Q1 法說會逐字稿

Good morning.

早安.

Thank you for attending today's Xeris Biopharma first quarter 2025, results conference call. My name is Makaya, and I'll be the moderator for today's call.

感謝您參加今天的 Xeris Biopharma 2025 年第一季業績電話會議。我叫 Makaya，我將擔任今天電話會議的主持人。

(Operator Instructions).

（操作員指令）。

At this time, I'd like to pass the call over to our Senior Vice President of Investor Relations and Corporate communications, Allison.

現在，我想將電話轉給我們的投資者關係和企業傳播高級副總裁艾莉森 (Allison)。

Allison, you may proceed.

艾莉森，你可以繼續了。

Thank you, Makaya. Good morning, everyone. We appreciate you joining our call this morning. Today I'm joined by John Shannon, our CEO, and Steve Pieper, our CFO. Early this morning we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the line for questions.

謝謝你，Makaya。大家早安。感謝您今天上午參加我們的電話會議。今天，我們的執行長約翰·香農 (John Shannon) 和財務長史蒂夫·皮珀 (Steve Pieper) 也和我一起出席了會議。今天早上我們發布了一份新聞稿，其中包含我們的詳細結果，可以在我們的網站上找到。在我們準備好發言之後，我們將開放提問熱線。

Before we begin, I'd like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, projects, and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements.

在我們開始之前，我想提醒您，本次電話會議將包含有關公司未來預期、計劃、專案和財務業績的前瞻性陳述。前瞻性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有重大差異。

For more information on our risks, please refer to our earnings release and risk factors, including in our SEC filing. Any forward-looking statements on this call represent our views only as of the date of this call and subject to applicable law. We disclaim any obligations to update such statements. But please note some metrics we will discuss today are presented on a Non-GAAP basis. We reconcile the comparable GAAP and Non-GAAP figures in our earnings.

有關我們的風險的更多信息，請參閱我們的收益報告和風險因素，包括我們的 SEC 文件。本次電話會議中的任何前瞻性陳述僅代表我們截至本次電話會議之日的觀點，並受適用法律的約束。我們不承擔更新此類聲明的任何義務。但請注意，我們今天討論的一些指標是以非公認會計準則為基礎呈現的。我們對我們的收益中的可比較 GAAP 和非 GAAP 數據進行了調整。

Let me pass the call over now to John for opening remarks.

現在，請容許我把電話轉給約翰，請他致開幕詞。

Thanks Alison and good morning everyone. I'm excited to announce that we're off to an exceptional start this year. In the first quarter, we delivered another record breaking performance, growing total revenue by 48%, a testament to the strength of our strategy and execution.

謝謝艾莉森，大家早安。我很高興地宣布，我們今年有了一個非凡的開始。第一季度，我們再次創下紀錄，總收入成長了 48%，證明了我們的策略和執行力的強大。

As such, we are raising the bottom end of our revenue guidance from $255 to $260 million increasing our implied full year total revenue growth to nearly 32% at the midpoint of our guidance range.

因此，我們將營收預期的底線從 2.55 億美元提高到 2.6 億美元，將隱含的全年總收入成長率提高到預期範圍中點的近 32%。

Our momentum is being fueled by the foundation we established in the back half of 2024. Our Q1 success was driven by continued commercial strength across our entire portfolio with Recorlev leading the charge.

我們在 2024 年下半年建立的基礎為我們的勢頭提供了動力。我們第一季的成功得益於我們整個產品組合持續的商業實力，其中 Recorlev 發揮了主導作用。

Recorlev continues to distinguish itself as our fastest growing and now our largest product, gaining traction as a uniquely differentiated therapy for patients with hypercortisolemia and endogenous Cushing's syndrome. At the same time, Gvoke delivered steady growth supported by our ongoing efforts to enhance both awareness and compliance with the medical guidelines.

Recorlev 繼續成為我們成長最快、目前最大的產品，作為針對高皮質醇血症和內源性庫欣氏症候群患者的獨特差異化療法，越來越受到關注。同時，在我們不斷努力提高對醫療指南的認識和遵守程度的支持下，Gvoke 實現了穩步增長。

Let's take a closer look at each of the products, starting with recoilla.

讓我們仔細看看每一款產品，從 recoilla 開始。

In the first quarter, revenue for Recorlev level was up 141%, exceeding $25 million.

第一季度，Recorlev 的營收成長了 141%，超過 2,500 萬美元。

The average number of patients on therapy grew 124% compared to the same period in 2024.

與 2024 年同期相比，接受治療的患者平均數量增加了 124%。

This significant achievement is a direct result of the targeted investments we made last year, which were designed to support patient access, enhance healthcare provider engagement, and accelerate overall brand performance. These investments have proven highly effective in driving sustained growth and establishing a strong foundation for the future.

這項重大成就直接歸功於我們去年進行的目標投資，旨在支持患者就醫、增強醫療保健提供者的參與度並加速整體品牌績效。事實證明，這些投資在推動持續成長和為未來奠定堅實基礎方面非常有效。

As we progress through the first half of the year, we are excited by our growth trajectory and remain confident that this momentum will continue to build. We believe Rekorolev is the right product at the right time and expect that it will continue to deliver value for patients and stakeholders alike well into the future.

隨著上半年的進展，我們對我們的成長軌跡感到興奮，並堅信這種勢頭將繼續增強。我們相信 Rekorolev 是在正確時間推出的正確產品，並期望它將在未來繼續為患者和利害關係人帶來價值。

Turning to Govke, Gvoke continues to deliver steady, reliable growth, reinforcing its position as a key contributor to our commercial portfolio.

談到 Govke，Gvoke 繼續實現穩定、可靠的成長，鞏固了其作為我們商業組合主要貢獻者的地位。

Q1 revenue of nearly $21 million reflected strong, consistent increases in prescriptions which were up 8% compared to Q1 last year. Our efforts to attract new prescribers while also increasing prescriptions among existing prescribers remains on pace. This growth trajectory reflects the strength of our strategic efforts to expand Govke's reach and highlights the value it consistently delivers to both patients and prescribers.

第一季營收接近 2,100 萬美元，反映出處方量強勁、持續的成長，與去年第一季相比成長了 8%。我們仍在努力吸引新的處方者，同時增加現有處方者的處方量。這一成長軌跡反映了我們為擴大 Govke 影響力而做出的策略性努力的力度，並凸顯了它始終如一地為患者和處方者提供的價值。

As we look ahead, we remain confident in Govke's ability to sustain its current momentum as Govke remains an important contributor to our growth.

展望未來，我們仍然對 Govke 維持當前發展勢頭的能力充滿信心，因為 Govke 仍然是我們成長的重要貢獻者。

Finally, let's talk about the durability of convey.

最後我們來談談傳達的耐用性。

Revenues were over $11 million for the quarter, growing slightly over Q4 2024.

本季營收超過 1,100 萬美元，比 2024 年第四季略有成長。

Remains a key product within our portfolio, continuing to serve patients with unwavering support from the medical and patient communities. The average number of patients on Cavaus improved slightly in Q1, underscoring our ongoing success in identifying and engaging new PPP patients.

仍然是我們產品組合中的關鍵產品，在醫療和患者社區的堅定支持下繼續為患者提供服務。第一季度，Cavaus 的平均患者數量略有增加，凸顯了我們在識別和吸引新的 PPP 患者方面持續取得的成功。

New patient starts grew compared to the prior year period, further reinforcing this progress.

與去年同期相比，新患者數量有所增加，進一步鞏固了這項進展。

Cavala's resilience highlights the broader value our products bring to patients and healthcare providers, strengthening our commitment to delivering impactful, reliable treatment options.

Cavala 的韌性凸顯了我們的產品為患者和醫療保健提供者帶來的更廣泛的價值，加強了我們提供有影響力的可靠治療方案的承諾。

In addition to our strong Q1 commercial performance, I want to take a moment to highlight a key achievement from this past quarter that reflects the strength of our strategy, discipline, and commitment to delivering sustained growth.

除了我們第一季強勁的商業表現外，我還想花點時間強調上個季度的一項關鍵成就，這反映了我們的策略、紀律和實現持續成長的承諾的力度。

In March, we proudly announced that the FDA approved our supplemental new drug application for Gvoke Keveyis. This approval expands Gvoke's use as an IV administration, enabling its utilization as a diagnostic aid during radiologic examinations.

今年三月，我們很自豪地宣布，FDA 批准了我們針對 Gvoke Keveyis 的補充新藥申請。此次批准擴大了 Gvoke 作為靜脈注射藥物的用途，使其能夠作為放射學檢查期間的診斷輔助。

In tandem with the regulatory approval, we also announced a strategic partnership with American Region to commercialize Keveyis in the US.

在獲得監管部門批准的同時，我們也宣布與美國地區建立戰略合作夥伴關係，在美國實現 Keveyis 的商業化。

Under the terms of this collaboration, Xero will be responsible for product supply, while American Region will oversee a commercialization efforts. The partnership is positioned to maximize the market reach and success of Keveyis, particularly within the hospital and acute care settings.

根據此合作條款，Xero 將負責產品供應，而美國地區將負責監督商業化工作。此次合作旨在最大限度地擴大 Keveyis 的市場覆蓋範圍和成功率，特別是在醫院和急診護理領域。

I want to express my sincere gratitude to the Xeris team, our partners in the American Region, and the broader medical community for their dedication to making this achievement possible. Together we're continuing to deliver solutions that improve lives and advance medical practices.

我要向 Xeris 團隊、我們在美洲地區的合作夥伴以及更廣泛的醫學界表示誠摯的感謝，感謝他們為實現這一成就所做的奉獻。我們將共同繼續提供改善生活和推進醫療實踐的解決方案。

Building on this momentum, I'd like to highlight the progress we've made within our pipeline, particularly with XP 8121.

在此勢頭的基礎上，我想強調一下我們在產品線中取得的進展，特別是 XP 8121。

As we stated before, we are really excited about this product and the unmet medical need it can address in the hypothyroidism market. This metabolic condition affects approximately $20 million people in the US.

正如我們之前所說，我們對這款產品以及它能夠滿足甲狀腺功能減退症市場未滿足的醫療需求感到非常興奮。這種代謝疾病影響了美國約 2000 萬人。

We estimate that at least 20% of these patients do not consistently meet the clinical goal of normalizing thyroid hormone levels, and they cannot reach their goals with oral forms of therapy for a multitude of factors, all of which affect oral bioavailability. If approved, XP 8121 will be the first and potentially the only self-administered therapy designed to overcome these obstacles.

我們估計，這些患者中至少有 20% 無法持續達到甲狀腺激素水平正常化的臨床目標，並且由於多種因素，他們無法透過口服療法達到目標，所有這些因素都會影響口服生物利用度。如果獲得批准，XP 8121 將成為第一個也是唯一一個旨在克服這些障礙的自我管理療法。

As a reminder, the development of XP 8121 is made possible by our proven XeriSol technology, a cornerstone of our innovation.

提醒一下，XP 8121 的開發得益於我們成熟的 XeriSol 技術，而這正是我們創新的基石。

Furthermore, XP 8121 leverages our clinical development, regulatory, and commercial infrastructure while expanding our commitment to the endocrinology community.

此外，XP 8121 利用我們的臨床開發、監管和商業基礎設施，同時擴大我們對內分泌學界的承諾。

In keeping with our commitment to transparency and open communication, we are pleased to share that we will provide a more comprehensive update of XP 8121 at our first analyst and investor date scheduled on June 3.

為了履行我們對透明度和開放溝通的承諾，我們很高興地告訴大家，我們將在 6 月 3 日安排的第一次分析師和投資者會議上提供 XP 8121 的更全面更新。

As a company, we remain focused on the 3 strategic priorities I outlined back in August of last year when I became CEO. As a reminder, those are 1, drive rapid and sustained growth of our commercial products through improved adoption and utilization. 2, manage our business with financial discipline, maintaining a healthy balance sheet and funding our growth opportunities while most importantly, not diluting shareholders. And finally enhance our communication and transparency with you, our stakeholders.

作為一家公司，我們仍然專注於我去年 8 月擔任執行長時提出的三大策略重點。提醒一下，這些是1，透過提高採用率和利用率來推動我們的商業產品快速持續成長。 2、依照財務紀律管理我們的業務，保持健康的資產負債表並為我們的成長機會提供資金，最重要的是不稀釋股東權益。最後，加強我們與利害關係人之間的溝通和透明度。

We have delivered exceptional performance in Q1, further strengthening our outlook for the year ahead.

我們在第一季取得了出色的業績，進一步增強了我們對未來一年的展望。

By staying true to our priorities, we are well positioned and even more confident we will achieve our full year financial objectives.

透過堅持我們的優先事項，我們處於有利地位，並且更有信心實現我們的全年財務目標。

Before I hand the call over to Steve for a detailed financial update, I want to emphasize the importance of our first ever analyst and investor Day scheduled for June 3 in New York City.

在我將電話交給史蒂夫進行詳細的財務更新之前，我想強調一下我們定於 6 月 3 日在紐約市舉行的首屆分析師和投資者日的重要性。

This event will offer an excellent opportunity to share deeper insights into our strategic vision and the promising initiatives we have planned for the future.

這項活動將提供一個絕佳的機會來更深入地了解我們的策略願景以及我們為未來規劃的有前景的舉措。

I will be joined by several members of the Xir management team as well as key opinion leaders, and together we will discuss evolving market dynamics, unmet medical needs, and the near and long term outlook for both Recorlev and XP 8121.

我將與 Xir 管理團隊的幾位成員以及關鍵意見領袖一起討論不斷變化的市場動態、未滿足的醫療需求以及 Recorlev 和 XP 8121 的近期和長期前景。

We hope you'll join us for what promises to be an informative and impactful session.

我們希望您能參加這次內容豐富、影響深遠的會議。

We will issue a follow-up press release with further details on the agenda and participation logistics in the coming weeks.

我們將在未來幾週內發布後續新聞稿，提供有關議程和參與後勤的更多詳細資訊。

And with that, I will now turn the call over to Steve who will provide a comprehensive review of our financial performance for the quarter.

現在，我將把電話轉給史蒂夫，他將對我們本季的財務表現進行全面回顧。

Thanks, John, and good morning everyone. We had another record breaking quarter. On a year over year basis, total revenue grew 48% to $60.1 million, while net product revenue increased 44% to $57.8 million.

謝謝，約翰，大家早安。我們又迎來了一個破紀錄的季度。與去年同期相比，總營收成長 48% 至 6,010 萬美元，而淨產品收入成長 44% 至 5,780 萬美元。

This strong performance marks the 14th consecutive quarter of greater than 20% product revenue growth.

這一強勁表現標誌著產品收入連續第 14 個季度成長超過 20%。

Underscoring our unwavering commitment to our top priority, driving rapid and sustained revenue expansion.

強調我們對首要任務的堅定承諾，推動快速和持續的收入成長。

Recorlev net revenue was $25.5 million, up 141% compared to last year.

Recorlev 淨收入為 2,550 萬美元，較去年同期成長 141%。

Sequentially, Recorlev net revenue grew $3 million.

Recorlev 淨收入連續成長 300 萬美元。

The average number of patients on Recorlev increased 124% and 15% respectively.

使用 Recorlev 的患者平均數量分別增加了 124% 和 15%。

This growth reaffirms our expectation that patient demand in 2025, will meet or exceed the levels we drove in the second half of 2024.

這一增長再次證實了我們的預期，即 2025 年的患者需求將達到或超過 2024 年下半年的水平。

Gvoke net revenue was $20.8 million, increasing 26% versus last year. This increase was attributable to total Gvoke prescriptions growing 8%, coupled with lower wholesaler purchases in Q1 2024.

Gvoke 淨收入為 2,080 萬美元，較去年增長 26%。這一增長歸因於 Gvoke 處方總量增加了 8%，再加上 2024 年第一季批發商採購量下降。

Keveyis net revenue was $11.4 million, up slightly compared to the fourth quarter of 2024.

Kevey 的淨收入為 1,140 萬美元，與 2024 年第四季相比略有成長。

These results reflect the continued resilience of the Keveyis brand.

這些結果反映了 Keveyis 品牌的持續韌性。

Other revenue generated in the quarter was $2.3 million. As we announced in March, Xeris received FDA approval for Gvoke, which triggered a milestone payment that made up a majority of the other revenue in the quarter.

本季產生的其他收入為 230 萬美元。正如我們在 3 月宣布的那樣，Xeris 的 Gvoke 獲得了 FDA 批准，這觸發了一項里程碑付款，構成了本季其他收入的大部分。

As John highlighted, American Regent will lead commercialization efforts for this product, while Xeris will maintain responsibility for product supply.

正如約翰所強調的，American Regent 將領導該產品的商業化工作，而 Xeris 將負責產品供應。

Turning to gross margin in the quarter was 85%. Sequentially, gross margin improved by 200 basis points driven by favorable product mix.

本季毛利率為85%。受良好產品組合的推動，毛利率環比提高了 200 個基點。

Research and development expenses were $7.8 million for the quarter, relatively flat compared to last year. These expenses were comprised of costs associated with XB 8121 and continued investment in our technology platforms and partnerships.

本季研發費用為 780 萬美元，與去年同期相比基本持平。這些費用包括與 XB 8121 相關的成本以及對我們的技術平台和合作夥伴關係的持續投資。

Selling general and administrative expenses were $44 million an increase of 15% compared to prior year. The increase in SGNA expenses primarily reflects the impact from the Q3 2024, Recorlev commercial expansion, as well as other personnel related costs.

銷售一般及行政開支為 4,400 萬美元，較前一年增加 15%。SGNA 費用的增加主要反映了 2024 年第三季、Recorlev 商業擴張以及其他與人員相關的成本的影響。

Rounding out our first quarter results, I'm excited to report adjusted EBITDA in the quarter was a positive $4.4 million in line with our commentary last quarter and further supporting our commitment to delivering positive adjusted EBITDA going forward.

總結我們第一季的業績，我很高興地報告本季調整後的 EBITDA 為正 440 萬美元，與我們上個季度的評論一致，並進一步支持了我們致力於在未來實現正調整後的 EBITDA 的承諾。

Our solid financial position provides us with the flexibility to advance our strategic priorities without the need for dilutive financing. These efforts underscore our disciplined approach to financial management and our commitment to delivering long-term value.

我們穩固的財務狀況使我們能夠靈活地推進我們的策略重點，而無需稀釋性融資。這些努力凸顯了我們嚴謹的財務管理方法以及我們致力於實現長期價值的承諾。

Turning to our near term outlook and guidance.

談談我們的近期展望和指導。

First, it's important to highlight the meaningful strides we have taken in enhancing the financial health of the enterprise.

首先，必須強調我們在增強企業財務健康方面所取得的重大進展。

With the recent appreciation in our stock price, we accelerated the redemption of our 2025, convertible notes, reducing our total debt by $15 million and in turn generating interest expense savings this year.

隨著近期股價上漲，我們加速了 2025 年可轉換票據的贖回，從而減少了 1,500 萬美元的總債務，從而節省了今年的利息支出。

It is worth noting that there was only a partial impact of the convertible note redemption in the first quarter, and the remaining portion will be reflected in our second quarter results.

值得注意的是，可轉換票據贖回在第一季僅產生了部分影響，其餘部分將反映在我們的第二季業績中。

Second, while there has been recent speculation regarding the potential implementation of sector-specific tariffs, based on the information available to us today, we do not anticipate any material impact to our operations or financial performance, given the vast majority of our operations are US based.

其次，儘管最近有關於可能實施針對特定行業的關稅的猜測，但根據我們今天掌握的信息，考慮到我們的絕大多數業務都在美國，我們預計這不會對我們的營運或財務業績產生任何重大影響。

With that context, and as John mentioned earlier, we are tightening our full year revenue outlook.

基於這種背景，正如約翰之前提到的，我們正在收緊全年收入預期。

We are raising the bottom end of our total revenue guidance from $255 to $260 million.

我們將總收入預期的底線從 2.55 億美元提高到 2.6 億美元。

Increasing our implied full year total revenue growth to nearly 32% at the midpoint of our guidance range. Further, we continue to expect a modest improvement in gross margin compared to 2024.

將我們預計的全年總收入成長率提高至指導範圍中點的近 32%。此外，我們仍然預計毛利率將比 2024 年略有改善。

SGNA and R&D expenses are still projected to increase modestly, with a mid to high single digit growth rate relative to 2024.

預計 SGNA 和研發費用仍將小幅成長，相對於 2024 年將實現中高個位數成長率。

Lastly, I want to affirm our expectation that we will continue to be adjusted EBITDA positive going forward.

最後，我想確認我們的預期，即我們未來的調整後 EBITDA 將繼續保持正成長。

With that, I'll now hand the call over to the operator for Q&A.

說完這些，我現在將電話交給接線員進行問答。

Operator.

操作員。

(Operator Instructions).

（操作員指令）。

The first question is from the line of [David Aalam with Piperinler]. You may proceed.

第一個問題來自[大衛·阿拉姆與派普林勒]。您可以繼續。

Thanks. So I wanted to drill down on the growth you're seeing in Recorlev. I mean, clearly the overall market is expanding, so I'm wondering out loud, where ultimately do you see peak sales potential.

謝謝。所以我想深入了解您在 Recorlev 中看到的成長。我的意思是，顯然整體市場正在擴張，所以我很想知道，您最終在哪裡看到銷售潛力的峰值。

Settling out here just given the market expansion and this evolving understanding of the prevalence of hypercortisolism, that's number one, and with this market expansion, how should we think about your commercial infrastructure and the extent to which you're going to be calling on a wider audience of endocrinologists and potentially general practitioners.

鑑於市場擴張和對皮質醇增多症流行情況的不斷了解，我們決定在這裡設立辦事處，這是首要問題。隨著市場擴張，我們應該如何看待您的商業基礎設施，以及您將在多大程度上吸引更廣泛的內分泌學家和潛在的全科醫生。

Thank you.

謝謝。

Thanks David.

謝謝大衛。

This is John Shannon. Let's start with your second question first. So as we expanded our sales organization in the back half of last year in anticipation and as we saw this market expansion happening with Recorlev. So we saw an opportunity for us to expand in that, and we made that happen, and that's really what's driving a lot of our current growth is our expansion in the back half of last year. In terms of peak year sales, we haven't changed, we haven't updated our guidance on that. We haven't given any guidance on that, but that's something that we are, we'll probably give a lot more color to at our analyst and investor day in June, not probably, we will give more color to that. And we think that's a good opportunity for us to lay that out, but we, as you can imagine, like you pointed out here, there's significant expansion going on there, and we think there's a great opportunity for us and record in that.

這是約翰·香農。我們先從你的第二個問題開始。因此，我們預期在去年下半年擴大了銷售組織，並且我們看到 Recorlev 正在實現市場擴張。因此，我們看到了擴張的機會，我們實現了這一目標，這也是我們當前成長的真正推動力，也是我們去年下半年的擴張。就高峰年銷售而言，我們沒有改變，也沒有更新這方面的指導。我們還沒有對此給出任何指導，但這是我們正在進行的事情，我們可能會在 6 月份的分析師和投資者日上對此給出更多說明，不是可能，我們會對此給出更多說明。我們認為這對我們來說是一個很好的機會，但正如您所想像的，正如您在這裡指出的那樣，那裡正在進行重大擴張，我們認為這對我們來說是一個很好的機會，並且可以記錄下來。

If I may squeak in a follow up, I think your competitor has had multiple salesforce expansions.

如果我可以進一步跟進的話，我認為您的競爭對手已經多次擴大了銷售團隊。

I'm alluding to courses, the expansion of their commercial organization last year and then also this year, so I guess my question is, do you anticipate further infrastructure, commercial infrastructure expansion.

我指的是課程、去年以及今年的商業組織的擴張，所以我想我的問題是，您是否預計基礎設施、商業基礎設施會進一步擴張。

The more recent one not with standing.

較新的一個沒有立足之地。

So we, like you pointed out, we've had two expansions as well, and the last one was 50% expansion of our existing sales organization.

因此，正如您所指出的，我們也進行了兩次擴張，最後一次是將現有銷售組織擴張 50%。

So right now we're good where we're at in terms of our infrastructure, but as this market grows and as the opportunity grows, we see an opportunity for further expansion.

因此，目前我們的基礎設施狀況良好，但隨著這個市場的成長和機會的成長，我們看到了進一步擴張的機會。

And when that comes, we'll see, but it'll really follow the market expansion.

當這一切到來時，我們會看到，但它確實會跟隨市場擴張。

Okay, thank you.

好的，謝謝。

Thank you. The next question is from [Milan of Mazir Alimon with Lerink Partners]. You may proceed.

謝謝。下一個問題來自[Lerink Partners 的 Mazir Alimon 的米蘭]。您可以繼續。

Hi, this is [Maisy on for Rona].

你好，這是[Maisy 替換 Rona]。

Just two from us. So the first one is, what are the primary drivers behind the operational efficiency and the level of profitability improvement that you have? Do you feel that's sustainable as you continue to invest in the commercial organization? And then a second one would be, can you just highlight for us if you have some additional color maybe on the key development, milestones and strategies for XP 8121 that we should be focusing on and monitoring throughout the remainder of the year.

離我們只有兩個了。那麼第一個問題是，你們的營運效率和獲利水準提高的主要驅動力是什麼？隨著您繼續投資商業組織，您認為這種做法可持續嗎？然後第二個問題是，如果您對 XP 8121 的關鍵發展、里程碑和策略有一些額外的了解，我們是否應該在今年剩餘時間內關注和監控這些方面？

Thank you.

謝謝。

Yeah, so I'll take this is Steve. I'll take the first question around the operational efficiency. Yeah, I think, as John laid out, one of our priorities, key priorities is to remain financially disciplined and I think we've done just that, just given the guidance that I reiterated, and it really starts with driving the growth at the top line. We're seeing significant growth, primarily from Recorlev.

是的，我認為這是史蒂夫。我將回答有關營運效率的第一個問題。是的，我認為，正如約翰所說，我們的優先事項之一、關鍵優先事項是保持財務紀律，我認為我們已經做到了這一點，根據我重申的指導，這實際上始於推動營收成長。我們看到了顯著的成長，主要來自 Recorlev。

You can see it in the gross margin improvement over the last, couple of quarters. And then you know from an expense management perspective we're keeping SGNA expenses, R&D expenses relatively in check. So I think that's creating a lot of the operational efficiency that you're seeing in our in our financial results and you know as we we got it to in March and we reiterated this morning. We expect to be adjusted that positive moving forward, so, you can assume that's going to carry on into the future.

您可以從過去幾季的毛利率提高中看到這一點。然後你知道，從費用管理的角度來看，我們正在相對控制 SGNA 費用和研發費用。因此，我認為這在很大程度上提高了我們的營運效率，正如您在我們的財務表現中所看到的，正如我們在三月所實現的，我們在今天早上也重申了這一點。我們期望在未來做出積極的調整，因此，你可以假設這種情況會持續下去。

And I'll answer your question on on the XP 8121. The next key milestone is June 3, at our analyst and investor meeting.

我將回答您有關 XP 8121 的問題。下一個關鍵里程碑是 6 月 3 日，在我們的分析師和投資者會議上。

We've been talking about this. We're going to lay out what the opportunity is. We'll be bringing in key opinion leaders as well so people can understand the opportunity that we can hit with XP 8121. And and in there we'll lay out more about the development pathway, the regulatory pathway, and that will also be able to lay out timing of various things throughout the next several years. So more to come on that and and just in a few weeks, maybe 3 weeks away, we'll we'll be ready to talk about all of that.

我們一直在談論這件事。我們將闡述這一機會是什麼。我們還將引入關鍵意見領袖，以便人們了解我們可以透過 XP 8121 獲得的機會。我們將在其中詳細闡述發展路徑、監管路徑，並規劃未來幾年內各種事項的時間表。關於這一點我們還會進行更多討論，再過幾週，也許三週，我們就可以準備好討論所有這些問題了。

Sounds great, thank You.

聽起來不錯，謝謝。

Thank you. The next question is from Alan of Jason Dore with Oppenheimer. You may proceed.

謝謝。下一個問題來自奧本海默公司的 Jason Dore 的 Alan。您可以繼續。

Hey, this is Jason representing Oppenheimer today, and thank you for taking the question.

嘿，我是今天代表奧本海默的傑森，感謝您回答這個問題。

Piggybacking off the last question as we wait for more details on the upcoming XP 8121program at the upcoming industry analyst Day, are there any details you can preview on the pivotal study design?

在我們等待即將到來的行業分析師日即將推出的 XP 8121 計劃的更多細節時，順便問一下最後一個問題，您是否可以預覽有關關鍵研究設計的任何細節？

No, I don't think we should do that. Let's wait for the, let's wait 3 more weeks. And Jason, we planned this. We've been talking about this. We want to do this all at once. We want to lay out what the opportunity is, how we're going to go about that opportunity. There's a real unmet medical need here, and we really think we can solve it and we want to be able to, communicate and articulate that all at once and then help then people can understand how we're going to develop this going forward. So and that's why we plan to do this in an analyst investor day on June 3.

不，我認為我們不應該這麼做。讓我們再等三個星期吧。傑森，我們計劃好了這一點。我們一直在談論這件事。我們想一次完成這一切。我們想闡明這個機會是什麼，以及我們將如何抓住這個機會。這裡確實存在未滿足的醫療需求，我們真的認為我們可以解決它，我們希望能夠一次溝通和表達這一點，然後幫助人們了解我們將如何向前發展。這就是我們計劃在 6 月 3 日的分析師投資者日上這樣做的原因。

Yeah, that sounds great. I'm really looking forward to it.

是的，聽起來很棒。我非常期待。

Thank you.

謝謝。

Thank you. The next question is from the line of Chase Knickerbocker with Craig Hallum. You may proceed.

謝謝。下一個問題來自 Craig Hallum 的 Chase Knickerbocker。您可以繼續。

Good morning. Thanks for taking the questions.

早安.感謝您回答這些問題。

I actually wanted to ask on the glucagon market here, can you just kind of give us an update on what you're seeing competitively from your major branded competitors relates to kind of any impact that you've seen from any formula strategy there and then just kind of on their sales strategy, are they, driving market growth as well, or, kind of what have you seen from them competitively from a commercial perspective?

我實際上想問一下這裡的胰高血糖素市場，您能否向我們介紹一下您從主要品牌競爭對手那裡看到的競爭情況，以及您從那裡的任何配方策略中看到的任何影響，然後只是對他們的銷售策略的影響，他們是否也在推動市場增長，或者，從商業角度來看，您從他們的競爭力中看到了什麼？

Yeah, competitively I haven't seen much. I think this first quarter we saw, there's occasionally every other year or every year or so there's things that change in the formulary aspects.

是的，從競爭角度來說我沒見過太多。我認為，在第一季度，我們看到，每隔一年或每年左右，處方方面就會發生一些變化。

We saw a little bit of that in Q1. I think all of that's behind us from a market growth. We're the ones driving the market growth. The market grew about 5% we grew 8%, when I look at prescriptions, and that's really what we're we're trying to do is focus on driving market growth, getting more and more clinicians compliant with the medical guidelines and getting more and more patients protected.

我們在第一季看到了一些這樣的情況。我認為所有這些都已經隨著市場成長而過去了。我們是推動市場成長的人。當我查看處方時，市場成長了約 5%，我們成長了 8%，而這正是我們真正想要做的，專注於推動市場成長，讓越來越多的臨床醫生遵守醫療指南，讓越來越多的患者受到保護。

That's what we're doing and and. By doing that, we focus on the market growth and getting, these new patients protected and we're beating that market growth right now. So that's how we attribute to what our performance is and I'm really excited about the performance we had in Q1.

這就是我們正在做的事情。透過這樣做，我們專注於市場成長並保護這些新患者，我們現在正在超越市場成長。這就是我們對自身表現的評價，我對我們在第一季的表現感到非常興奮。

Got it no convey is, a bit better than we had modeled to used to hold in there, anything from a formulary perspective there as things kind of, reset here in Q1, and anything else from a competitive perspective there that we should be watching through the year.

明白了，沒有傳達的是，比我們以前建模的要好一些，從公式的角度來看，任何事情都會在第一季度重新設置，從競爭的角度來看，我們應該全年關注其他任何事情。

Nothing from a formulary, nothing from a competitive standpoint.

從處方上看沒有任何意義，從競爭角度看也沒有任何意義。

Steve talked about this, in Q4 that we kind of found, we seem to find the spot where we can really managed and we continue to find new patients every quarter, every week, and by doing that we continue to maintain this brand. Pretty flat right now. So we feel really good about where we're at with it, and that we see an opportunity to continue to maintain this pace.

史蒂夫談到了這一點，在第四季度，我們發現，我們似乎找到了真正可以管理的地方，我們每個季度、每週都會繼續尋找新患者，透過這樣做，我們繼續維護這個品牌。目前相當平穩。因此，我們對目前的狀況感到非常滿意，並且我們看到了繼續保持這種速度的機會。

But just to put a finer point to it, I mean, you would expect that brand is pretty consistent through the year typically it's one where we see any potential changes on formulary.

但為了更詳細地說明這一點，我的意思是，你會期望該品牌在全年都保持相當的一致性，通常我們會看到該品牌在處方集上發生任何潛在的變化。

Yeah, typically, although we didn't see it maybe as pronounced this quarter for Keveyis specifically, so yeah, I think we're we're expecting that it would, kind of live in where we where we saw Q1's performance for the balance of the year.

是的，通常來說，儘管我們在本季度沒有看到 Keveyis 的具體表現如此明顯，所以是的，我認為我們預計它會像我們看到的第一季全年表現一樣。

Thanks. And then just last for me on just kind of the tariff side of things can you just kind of walk us through where your drugs are manufactured, any additional kind of context you're willing to give there as the industry kind of prepares for potential sector specific tariffs.

謝謝。最後，關於關稅方面的問題，您能否向我們介紹一下您們的藥品生產地點，以及在藥品行業為潛在的特定行業關稅做準備之際，您願意提供任何其他背景信息嗎？

Thank you.

謝謝。

Yeah, thanks Chase for the question. So yeah, most of our operations, manufacturing operations are US. We are a US centric company, so we do source some materials, ingredients, US.

是的，感謝 Chase 提出這個問題。是的，我們大部分的業務、製造業務都在美國。我們是一家以美國為中心的公司，因此我們確實從美國採購一些材料和原料。

But again, as I mentioned in my prepared remarks, those have been factored into our guidance. We don't expect any material impact from the tariffs, and to maybe draw a more specific point, we don't source anything from China.

但正如我在準備好的發言中提到的那樣，這些都已計入我們的指導中。我們預計關稅不會產生任何實質影響，更具體地說，我們不從中國採購任何產品。

And finished goods and you know final manufacturing is in the US.

成品和最終製造都在美國進行。

--Yes.

- 是的。

So no impact, no material impact chase.

因此沒有影響，沒有追逐物質影響。

Thank you.

謝謝。

There are no further questions waiting at this time. I'll have to pass the call back over to John Shen for any closing remarks.

目前沒有其他問題。我必須將電話轉回給 John Shen 來做最後的總結演講。

Thank you.

謝謝。

Q1 has been another impressive quarter for Xeris, highlighting our sustained momentum and robust performance. We remain dedicated in our commitment to accelerating sustainable revenue growth across our commercial portfolio while ensuring our products continue to improve patients' lives in meaningful ways.

第一季對 Xeris 來說又是一個令人印象深刻的季度，凸顯了我們持續的發展勢頭和強勁的表現。我們始終致力於加速整個商業組合的可持續收入成長，同時確保我們的產品繼續以有意義的方式改善患者的生活。

We are more dedicated than ever to fostering a transparent communication and strengthening our relationships with all stakeholders, and we look forward to seeing you on June 3, at our analysts and Investor Day and appreciate your continued confidence in Pharma.

我們比以往任何時候都更加致力於促進透明的溝通並加強與所有利益相關者的關係，我們期待在 6 月 3 日的分析師和投資者日見到您，並感謝您對 Pharma 的持續信任。

Thank you.

謝謝。

Thank you all. This is nothing to today's call. We appreciate your participation. Hope you all have a wonderful day, and you may now disconnect your line.

謝謝大家。這與今天的電話無關。感謝您的參與。希望大家度過美好的一天，現在您可以斷開線路了。