Xeris Biopharma Holdings, Inc. (XERS) 2026 Q1 法說會逐字稿

Good morning, and welcome to the Xeris Biopharma Q1-26 earnings conference call. Please note that before we begin, this conference is being recorded on Thursday, May 7 at 8:30 AM.

早安，歡迎參加 Xeris Biopharma 2026 年第一季（Q1-26）財報電話會議。請注意，在我們開始之前，本次會議將於 5 月 7 日（週四）上午 8:30 進行錄音。

I will now pass the call over to Allison Wey for opening remarks. Please go ahead.

我現在把電話交給 Allison Wey 進行開場致詞。請開始。

Thank you, Sarah. Good morning, everyone, and welcome to Xeris' first quarter financial results conference call. Earlier this morning, we issued a press release detailing our first quarter 2026 financial and operating results. This press release can be found on our website.

謝謝你，Sarah。各位早安，歡迎參加 Xeris 第一季財務結果電話會議。今天稍早，我們發布新聞稿，詳述 2026 年第一季的財務與營運成果。該新聞稿可在我們的網站上查閱。

Joining me today is John Shannon, our Chief Executive Officer; and Steve Pieper, our Chief Financial Officer. Following our prepared remarks, we will open the call for your questions.

今天與我一同出席的有我們的執行長 John Shannon，以及財務長 Steve Pieper。在我們的準備稿發言之後，我們將開放提問。

Before we begin, I'd like to remind you that today's discussion will include forward-looking statements regarding Xeris' future expectations, plans, strategies, objectives and financial performance. These forward-looking statements are based on management's current assumptions and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied. For a discussion of these risks and uncertainties, please refer to the risk factors described in our filings with the SEC.

在開始之前，我想提醒各位，今天的討論將包含前瞻性陳述，涉及 Xeris 對未來的預期、計畫、策略、目標與財務表現。這些前瞻性陳述係基於管理階層目前的假設與信念，並受多項風險與不確定性影響，可能導致實際結果與明示或暗示的內容出現重大差異。關於這些風險與不確定性的討論，請參閱我們向美國證券交易委員會（SEC）提交文件中所述的風險因素。

Any forward-looking statements made on this call speak only as of today's date. And except as required by law, the company undertakes no obligation to update or revise these statements. In addition, during today's call, we will reference certain financial measures that are represented on a non-GAAP basis. A reconciliation of these non-GAAP measures to the most directly comparable GAAP measures is included in our press release.

本次電話會議中所作的任何前瞻性陳述僅截至今日有效。除法律要求外，公司不承擔更新或修訂這些陳述的任何義務。此外，在今天的電話會議中，我們將提及若干以非 GAAP 基礎呈列的財務衡量指標。這些非 GAAP 指標與最直接可比的 GAAP 指標之調節表已包含於我們的新聞稿中。

With that, I will now turn the call over to John for his opening remarks.

接下來，我將把電話交給 John 進行開場致詞。

Thank you, and good morning, everyone. We are off to an amazing start in 2026. First quarter net product revenue grew an impressive 43% to more than $82 million, driven by Recorlev, which nearly doubled with 95% growth, while Keveyis increased 4% and Gvoke remained flat year-over-year. Given the strong start to the year and the positive demand trends we are seeing overall, especially for Recorlev, we are raising the bottom end of our revenue guidance. We now expect full year revenue of $380 million to $390 million, representing more than 30% revenue growth.

謝謝，各位早安。我們在 2026 年有一個非常亮眼的開局。第一季產品淨營收大幅成長 43%，超過 8,200 萬美元，主要由 Recorlev 帶動，其營收幾乎翻倍、成長 95%；Keveyis 成長 4%，而 Gvoke 與去年同期持平。鑑於今年強勁的開局以及我們整體看到的正向需求趨勢，特別是 Recorlev，我們上調營收指引區間的下緣。我們目前預期全年營收為 3.80 億至 3.90 億美元，代表超過 30% 的營收成長。

Turning now to each product, starting with Recorlev. As I said, Recorlev revenue nearly doubled to $50 million, representing a $24 million increase compared to last year. This was driven by both record referrals and record new patient starts. Importantly, coming out of the typical Q1 payer resets, we saw a significant increase in new patients, especially in March, which is fueling our optimism for another outstanding year.

接下來談各項產品，先從 Recorlev 開始。如我所說，Recorlev 營收幾乎翻倍至 5,000 萬美元，較去年增加 2,400 萬美元。這主要由轉介量創新高以及新病患開始用藥人數創新高所帶動。重要的是，在第一季典型的付款方（payer）重設期之後，我們看到新病患顯著增加，尤其在 3 月，這也強化了我們對今年再創佳績的樂觀預期。

I'm also pleased to share that our commercial expansion was completed exactly as planned, significantly expanding our sales force and patient support teams. This enhanced infrastructure will allow us to increase both the quantity and quality of our interactions with health care providers and patients, driving even greater awareness of Recorlev's value proposition in treating hypercortisolemia and Cushing's syndrome.

我也很高興分享，我們的商業擴張已完全依計畫如期完成，大幅擴充了銷售團隊與病患支援團隊。這套強化後的基礎建設將使我們能提升與醫療照護提供者及病患互動的數量與品質，進一步提高對 Recorlev 在治療高皮質醇血症與庫欣氏症候群方面價值主張的認知。

We anticipate the impact of this commercial expansion to begin contributing incrementally in the second half of this year and continue to deliver sustained benefits well into the future. The trajectory we are seeing reinforces our conviction that Recorlev is well positioned to realize its full commercial potential. It remains solidly on path for significant continued growth and is well on its way to achieving $1 billion in revenue by 2035.

我們預期此商業擴張的影響將於今年下半年開始逐步貢獻，並在未來持續帶來長期效益。我們所看到的成長軌跡，進一步強化我們的信念：Recorlev 已具備實現其完整商業潛力的良好條件。它仍穩健地朝向顯著且持續的成長前進，並正邁向在 2035 年達成 10 億美元營收的目標。

Turning to Gvoke. Gvoke generated revenue of nearly $21 million in the first quarter. While we anticipated some seasonal headwinds from typical payer resets, Gvoke's performance was slightly below our internal expectations. This was primarily due to Medicare policy and plan changes, which impacted patients' coverage, deductibles and most importantly, out-of-pocket costs, resulting in a reduction in the number of patients getting their prescriptions filled.

接著談 Gvoke。Gvoke 第一季營收接近 2,100 萬美元。雖然我們預期會受到典型付款方重設所帶來的季節性逆風影響，但 Gvoke 的表現仍略低於我們內部預期。這主要是由於 Medicare 政策與方案變更，影響了病患的給付範圍、免賠額，最重要的是自付費用，導致實際領藥（處方配藥）的人數下降。

We expect Gvoke to recover from its first quarter challenges, and it's already beginning to see an increase in prescription demand. Importantly, Gvoke's growth potential remains well intact and untapped since the vast majority of the 15 million patients who should have a ready-to-use glucagon rescue therapy still do not have one.

我們預期 Gvoke 將從第一季的挑戰中恢復，目前也已開始看到處方需求增加。重要的是，Gvoke 的成長潛力仍然完整且尚未被充分開發，因為在應該備有即用型胰高血糖素急救療法的 1,500 萬名病患中，絕大多數仍未擁有此類產品。

Finally, Keveyis. Keveyis once again delivered exceptional performance in the first quarter with revenue of approximately $12 million, representing a 4% increase year-over-year. This is the second consecutive quarter of year-over-year growth and demonstrates the remarkable brand strength and durability of Keveyis in this ultra-rare market. This performance not only highlights the inherent clinical value of Keveyis itself, but also the importance of the comprehensive patient-centered support infrastructure we have built to serve individuals living with primary periodic paralysis.

最後是 Keveyis。Keveyis 在第一季再次交出優異表現，營收約 1,200 萬美元，較去年同期成長 4%。這是連續第二季的年增成長，展現 Keveyis 在此超罕見市場中卓越的品牌力與持久性。這項表現不僅凸顯 Keveyis 本身固有的臨床價值，也彰顯我們所建立、以病患為中心的完整支援基礎建設之重要性，用以服務罹患原發性週期性麻痺的患者。

Turning to our pipeline. XP-8121 is progressing well, and we are on track to begin Phase III later this year. Millions of hypothyroid patients still struggle to achieve stable hormone levels due to GI absorption issues, and XP-81 is designed to address this important unmet medical need. XP-8121 will also enable us to leverage a tremendous amount of existing capability. First, it requires our XeriSol formulation technology, the same technology inside of Gvoke. It will also leverage our drug device combination expertise, our deep connections with the endocrinology community and our extensive commercial infrastructure.

接著談我們的研發管線。XP-8121 進展順利，我們正按計畫於今年稍晚啟動第三期（Phase III）試驗。由於腸胃道吸收問題，仍有數以百萬計的甲狀腺功能低下患者難以達到穩定的荷爾蒙濃度，而 XP-81 的設計旨在解決這項重要的未被滿足醫療需求。XP-8121 也將使我們能運用大量既有能力。首先，它需要我們的 XeriSol 配方技術，也就是 Gvoke 內部所使用的同一項技術。它也將運用我們在藥物—裝置組合方面的專業、我們與內分泌科社群的深厚連結，以及我們廣泛的商業基礎建設。

From a medical communication standpoint, XP-8121 is receiving significant attention this year as the medical conference season gets underway. This quarter alone, we're presenting 4 separate abstracts, each carefully designed to advance the understanding of hypothyroidism management while highlighting the persistent clinical challenges that prevent many patients from achieving and maintaining stable control. Building on this momentum, we'll plan to host a comprehensive program review later this fall, where we will share additional details of our Phase III trial design.

從醫學溝通的角度來看，隨著醫學會議季節展開，XP-8121 今年受到高度關注。僅本季，我們就將發表 4 篇不同的摘要，每一篇都經過精心設計，以推進對甲狀腺功能低下管理的理解，同時凸顯持續存在的臨床挑戰，這些挑戰使許多患者無法達成並維持穩定控制。在此動能基礎上，我們計畫於今年秋季稍晚舉辦一場全面性的計畫回顧，屆時將分享第三期試驗設計的更多細節。

Before I turn the call over to Steve, I want to briefly recap the strong progress we have made against the three priorities I outlined in March. First, we remain clearly focused on driving rapid revenue growth. Our first quarter performance and upward revised full year outlook gives us tremendous confidence that our business is on track.

在我把電話交給 Steve 之前，我想先簡要回顧一下我們針對我在三月提出的三項優先事項所取得的強勁進展。第一，我們仍然明確聚焦於推動營收快速成長。我們第一季的表現以及上調後的全年展望，讓我們對業務正按計畫推進充滿信心。

Second, we remain focused on advancing our pipeline with key deliverables on track and XP-8121's Phase III start anticipated later this year. And third, we remain committed to disciplined financial management and to maintaining a strong balance sheet, which is driving much of the outstanding performance that Steve will highlight in more detail.

第二，我們仍專注於推進研發管線，關鍵交付項目均按計畫進行，並預期 XP-8121 的第三期臨床試驗將於今年稍晚啟動。第三，我們仍致力於嚴謹的財務管理並維持強健的資產負債表，這也推動了 Steve 稍後將更詳細說明的多項卓越表現。

With that, I'll turn the call over to Steve.

接下來，我把電話交給 Steve。

Good morning, everyone. As John highlighted, we are off to a strong start in 2026. Our results reflect solid execution and growing confidence in the performance of our business. Total revenue reached $83.1 million in the first quarter, representing growth of 38% year-over-year. This performance demonstrates the strength of our commercial execution and the traction Recorlev continues to generate as we drive rapid and sustained revenue growth.

各位早安。如 John 所強調的，我們在 2026 年有一個強勁的開局。我們的結果反映出穩健的執行力，以及對業務表現日益增強的信心。第一季總營收達到 8,310 萬美元，年增 38%。這項表現展現了我們商業執行的實力，以及 Recorlev 在我們推動快速且持續的營收成長過程中持續獲得市場牽引力。

Net product revenue grew 43% year-over-year to $82.5 million, an increase of nearly $25 million compared to Q1 of last year. Recorlev generated net revenue of $49.8 million, representing growth of 95% year-over-year, an increase of $24.2 million, reflecting continued expansion of our patient base with momentum gaining in March and continuing into April.

產品淨營收年增 43% 至 8,250 萬美元，較去年第一季增加近 2,500 萬美元。Recorlev 的淨營收為 4,980 萬美元，年增 95%，增加 2,420 萬美元，反映我們病患基礎持續擴大，且動能在三月加速並延續至四月。

Gvoke generated net revenue of $20.8 million in the first quarter, flat year-over-year with soft prescription demand partially offset by favorable net pricing. As John mentioned, Gvoke's soft start to the year reflects lower total prescription volume, which was primarily driven by a decline in the Medicare channel, resulting from higher-than-normal out-of-pocket costs and a reduction in patients getting their prescriptions filled.

Gvoke 第一季淨營收為 2,080 萬美元，與去年同期持平；處方需求疲弱部分被有利的淨價格所抵銷。如 John 所提到，Gvoke 年初表現偏弱反映總處方量下降，主要是由 Medicare 通路下滑所致，原因在於自付費用高於常態，以及領藥填方的病患人數減少。

Even with this soft start, we still expect modest growth from Gvoke this year, and we are confident it will return to being a steady growth contributor for years to come. Keveyis delivered strong financial results in the first quarter, generating net revenue of $11.9 million. The year-over-year growth of 4% reflects modest improvements in both net pricing and the number of patients on therapy compared to the first quarter of 2025.

即便年初偏弱，我們仍預期 Gvoke 今年將有溫和成長，並有信心它將在未來多年重新成為穩定的成長貢獻來源。Keveyis 在第一季交出強勁的財務成果，淨營收達 1,190 萬美元。年增 4% 反映淨價格與接受治療的病患人數相較 2025 年第一季均有小幅改善。

Turning to gross margin. Our gross margin for the first quarter was 87%, an increase of 2% versus last year. This improvement was primarily driven by favorable product mix dynamics. R&D expenses totaled $8.8 million in the first quarter, representing an increase of 13% compared to the prior year period. This increase reflects higher personnel costs related to incremental investments in our XP-8121 program as we advance towards Phase III initiation later this year.

接著談毛利率。我們第一季毛利率為 87%，較去年提高 2 個百分點。此改善主要由有利的產品組合變化所帶動。第一季研發費用合計 880 萬美元，較去年同期增加 13%。此增幅反映人員成本上升，與我們對 XP-8121 計畫的額外投資相關，因我們正推進至今年稍晚啟動第三期試驗。

SG&A expenses were $53.1 million for the quarter, reflecting growth of 21% year-over-year. This increase was primarily related to our strategic commercial expansion activities associated with the nearly doubling of our Recorlev commercial team. These incremental investments in both R&D and our commercial organization represent our disciplined approach to scaling the organization in alignment with our growth trajectory, ensuring we have the infrastructure necessary to maximize the potential of both our current commercial portfolio and our Phase III-ready asset.

本季銷售、一般及行政（SG&A）費用為 5,310 萬美元，年增 21%。此增幅主要與我們的策略性商業擴張活動相關，包含 Recorlev 商業團隊規模幾近倍增。這些在研發與商業組織上的增量投資，體現我們以紀律方式、依循成長軌跡擴大組織規模的做法，確保我們具備必要的基礎設施，以最大化現有商業產品組合以及已具備第三期試驗條件之資產的潛力。

Adjusted EBITDA for the first quarter was $15.1 million, an improvement of $10.7 million versus last year, demonstrating our continued commitment to profitable growth. Underscoring the progress we have made in our profitability journey, we delivered net income of $2.2 million in the first quarter, a significant improvement of more than $11 million compared to last year. Together, these metrics reflect the operating leverage we are generating as we scale our business and validate our disciplined approach to balancing growth investments with financial performance.

第一季調整後 EBITDA 為 1,510 萬美元，較去年改善 1,070 萬美元，展現我們對獲利性成長的持續承諾。為凸顯我們在獲利進程上取得的進展，我們第一季實現淨利 220 萬美元，較去年大幅改善超過 1,100 萬美元。綜合而言，這些指標反映出我們在擴大業務規模時所產生的營運槓桿，並驗證我們在成長投資與財務表現之間維持平衡的紀律性做法。

Moving to our revised 2026 guidance and outlook. As John mentioned earlier, the overall growth of our diversified portfolio is ahead of our initial expectations and the strong performance of both Recorlev and Keveyis are more than offsetting early softness from Gvoke. We expect our overall strong performance to continue as we move throughout the balance of 2026.

接著談我們修訂後的 2026 年指引與展望。如 John 先前提到，我們多元化產品組合的整體成長優於初始預期，Recorlev 與 Keveyis 的強勁表現已足以抵銷 Gvoke 年初的疲弱。隨著我們走過 2026 年剩餘期間，我們預期整體強勁表現將持續。

As such, we are raising the low end of our total revenue guidance to a range of $380 million to $390 million compared to our prior range of $375 million to $390 million. This upward revision reflects the outstanding results we delivered in the first quarter and our confidence that this momentum will continue throughout the year, especially as incremental contributions from Recorlev's expanded commercial infrastructure begin to yield more meaningful results in the second half of the year.

因此，我們將總營收指引區間的下限上調至 3.80 億至 3.90 億美元，先前區間為 3.75 億至 3.90 億美元。此次上修反映我們第一季交出的卓越成果，以及我們對此動能將貫穿全年持續的信心，特別是 Recorlev 擴增後的商業基礎設施所帶來的增量貢獻，預期將在下半年開始產生更具意義的成果。

On R&D, we continue to expect an increase of approximately $25 million year-over-year, driven by the planned Phase III initiation of XP-8121 later this year, a deliberate and disciplined investment to unlock what we believe is a $1 billion to $3 billion peak sales opportunity. On SG&A, we continue to assume an increase of approximately $45 million, reflecting primarily the full year cost of the Recorlev commercial expansion.

在研發方面，我們仍預期年增約 2,500 萬美元，主要由今年稍晚規劃啟動 XP-8121 第三期試驗所帶動；這是一項審慎且具紀律的投資，用以釋放我們認為可達 10 億至 30 億美元峰值銷售的機會。在 SG&A 方面，我們仍假設增加約 4,500 萬美元，主要反映 Recorlev 商業擴張的全年成本。

Finally, we remain committed to delivering positive adjusted EBITDA in 2026, growing on an absolute dollar basis versus 2025. Our financial story this quarter is one of solid execution and confidence. We are driving exceptional top line growth, improving already strong gross margins and investing deliberately in the commercial and pipeline initiatives that will grow Xeris for years to come.

最後，我們仍致力於在 2026 年實現正向的調整後 EBITDA，且相較 2025 年以絕對金額計將持續成長。本季我們的財務故事，是穩健執行與信心的展現。我們正推動卓越的營收成長、改善原本已相當強勁的毛利率，並以審慎方式投資於商業與研發管線計畫，讓 Xeris 在未來多年持續成長。

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

接下來，我把電話交給接線員進行問答。

Thank you. We will now begin the question-and-answer session. (Operator Instructions)

謝謝。我們現在開始問答環節。（接線員指示）

Chase Knickerbocker, Craig Hallum.

Chase Knickerbocker，Craig Hallum。

Good morning. Thanks for taking the questions, and congrats on a nice quarter here. Can you maybe just help us understand a little bit more on the Gvoke dynamics? Were there any actual formulary changes in the quarter? Or are these strictly kind of redesign dynamics? And then if it's the latter, can you just give us some thoughts on why you guys might be getting a little bit more impacted than some other assets, particularly your competitor in the ready-to-use space? Thanks.

早安。謝謝讓我提問，也恭喜本季表現不錯。能否請你們協助我們更了解一些 Gvoke 的動態？本季是否有任何實際的處方集（formulary）變更？還是這些完全屬於某種重新設計（redesign）的影響？另外，如果是後者，能否談談為什麼你們受到的影響似乎比其他一些產品更大，特別是你們在即用型（ready-to-use）領域的競爭對手？謝謝。

Thanks, Chase. So a couple of things there. One is there's always payer change resets that happen in the first quarter. There's probably a couple of small changes that are in there, nothing really big. It's primarily the Medicare resets. And as I said, that really impacted deductibles and mostly out-of-pocket costs in -- especially in the first quarter for Gvoke. And we saw that pretty standard in the first part of the quarter, and then it started to creep back up a little bit in March, but not quite as much as we would expect, and we can see that it was primarily in Medicare.

謝謝，Chase。所以這裡有幾點。第一季總是會發生付款方（payer）變更重設。裡面可能有幾個小幅變動，沒有什麼真正重大的。主要是 Medicare 的重設。如我所說，這確實影響了自付額（deductibles）以及多數自付費用（out-of-pocket costs）——特別是在第一季對 Gvoke 而言。我們在本季前段看到這是相當標準的情況，之後在 3 月開始略有回升，但沒有我們預期的那麼多；而我們也看得出主要發生在 Medicare。

So we're confident we know where it's at and what's going on there. And then in terms of did it affect BAQSIMI? In Medicare, yes, it did. We can see that in the data. But overall, BAQSIMI probably has a very much -- a very different split of their channel mix than we do. We are -- we've always done very well in the Medicare space, and I think this hit us particularly harder than our competitors.

所以我們很有信心知道它發生在哪裡、以及那裡發生了什麼。接著就「是否影響 BAQSIMI」而言？在 Medicare 方面，是的，確實有影響。我們從數據中看得到。但整體而言，BAQSIMI 的通路組合拆分可能與我們非常不同。我們——我們在 Medicare 領域一向表現很好，我認為這次對我們的衝擊特別比競爭對手更大。

And just a follow-up there and then one on Recorlev. So just on another one there on -- with the redesign dynamics, I mean, would you expect a pretty significant recovery in the second half then as some of these beneficiaries hit catastrophic? And then second, just on Recorlev, can you help us understand if you're seeing any benefit yet from the commercial team expansion? Maybe discuss the top of the funnel a little bit if there are some early indicators on some benefit from those new reps. Thanks.

再追問一下，然後還有一題關於 Recorlev。就重新設計（redesign）的動態而言，我的意思是，當部分受益人達到災難性給付（catastrophic）後，你們是否預期下半年會有相當顯著的復甦？第二題，關於 Recorlev，你能否協助我們了解商業團隊擴編是否已經帶來任何效益？也許可以談談漏斗頂端（top of the funnel）一些情況，是否有早期指標顯示這些新業務代表帶來了某些效益。謝謝。

Yes. So back to Gvoke, yes, we expect it to recover. We feel good about that. And there's 15 million people out there, again, that don't have a ready-to-use rescue med, and we need to get it in their hands. So there's plenty of opportunity. We'll continue to drive that, and we feel good about the long-term potential of Gvoke.

是的。回到 Gvoke，是的，我們預期會復甦。我們對此感覺良好。而且外面仍有 1,500 萬人——再次強調——沒有可即用的急救藥（ready-to-use rescue med），我們需要把它交到他們手上。所以機會非常多。我們會持續推動，我們也對 Gvoke 的長期潛力感到樂觀。

With Recorlev, yes, I mean, it's -- we saw an unbelievable start to the quarter and driven by record new starts, record referrals at the top of the funnel, as you indicated. But understand this, we don't really think we'll see the real kind of drive and expansion until later in the year. We know from prior experience, this takes six to nine months for them to really fully hit stride. And so that real push will come more in the back half of the year.

至於 Recorlev，是的，我的意思是——我們看到本季開局非常驚人，這是由創新高的新啟用（new starts）與漏斗頂端創新高的轉介（referrals）所帶動，正如你所提到的。但請理解，我們不認為會在短期內看到真正的推動力與擴張，可能要到今年稍晚。根據以往經驗，我們知道這需要 6 到 9 個月才能真正完全進入狀態。因此，真正的推進會更多出現在今年下半年。

Very helpful. Thank you.

非常有幫助。謝謝。

Dennis Ding, Jefferies.

Dennis Ding，Jefferies。

Hi, this is Georgia Bank on the line for Dennis Ding. Thank you so much for taking our questions. Two from me. One, despite some Q1 payer resets and any winter-related disruption, Recorlev showed strong sequential growth. Maybe you can help unpack what's driving that underlying momentum a little bit more and what you're seeing in terms of any recovery from seasonal dynamics as you move through March and April into May?

嗨，我是 Georgia Bank，代 Dennis Ding 在線上。非常感謝你們回答我們的問題。我有兩題。第一，儘管第一季有一些付款方重設以及任何與冬季相關的干擾，Recorlev 仍展現強勁的季比（sequential）成長。也許你們可以更進一步拆解一下，究竟是什麼在驅動這股基本動能？以及隨著你們從 3 月、4 月走到 5 月，在季節性因素的回復方面你們看到了什麼？

And then given the raised low end of guidance, how much contribution from the January commercial expansion is already assumed in your outlook versus what still represents upside as the team ramps through the year? Thank you so much.

另外，鑑於你們上調了財測指引區間的低端，1 月商業擴編的貢獻在你們的展望中已經假設了多少？相較之下，還有多少仍屬於隨著團隊在全年逐步到位而可能帶來的上行空間？非常感謝。

Let me start with kind of the payer resets. I think we saw typical resets, specifically around Recorlev. And then as March kicked in, we continue to grow. And that growth really comes into play with the market dynamics. There are still -- there's lots and lots of people with -- that are being tested and screened and diagnosed with hypercortisolemia. And we're in a perfect position now with our expanded field organization to capture more and more of those patients and get them on drug. So -- and we see that will continue to progress throughout the year. Steve, do you want to --

我先從付款方重設談起。我認為我們看到的是典型的重設，特別是在 Recorlev 方面。然後進入 3 月後，我們持續成長。而這個成長其實與市場動態密切相關。仍然——有非常非常多的人正在接受檢測、篩檢，並被診斷為高皮質醇血症（hypercortisolemia）。而我們現在透過擴大的前線組織，處於完美位置去掌握越來越多這些病患，並讓他們開始用藥。所以——我們也看到這會在全年持續推進。Steve，你要不要--

Yeah, I'll take the -- yes, I'll take the second question on the guidance. So I think based on our prepared remarks, Recorlev performed better than our initial expectations, and that's part of the reason why we raised the bottom end of our guidance. The contribution from the expanded commercial footprint was already embedded in our original guidance. And that's predicated on history, our experience with these expansions. So I think that's what's already assumed in our guidance of $380 million to $390 million.

好的，我來回答——是的，我來回答第二題，關於指引。我想根據我們事先準備的發言，Recorlev 的表現優於我們最初的預期，這也是我們上調指引下限的部分原因。擴大的商業覆蓋（commercial footprint）所帶來的貢獻，原本就已經納入我們最初的指引之中。而這是基於歷史與我們對這類擴編的經驗。所以我認為這就是我們在 3.80 億到 3.90 億美元指引中已經假設的內容。

Brandon Folkes, H.C. Wainwright.

Brandon Folkes，H.C. Wainwright。

Hi, thanks for taking my questions and congratulations on a very good quarter. Maybe just 2 for me. I'll switch gears a little bit. Can you just update us on your latest capital allocation thinking, especially as things track better than anticipated? And then secondly, can you just update us on the gating factors between now and starting the 8121 trial that needs to be done? Thank you.

嗨，謝謝你們回答我的問題，也恭喜你們這一季表現非常好。我有兩題。我稍微換個話題。你們能否更新一下最新的資本配置（capital allocation）思考，特別是在進展優於預期的情況下？第二，你們能否更新一下，從現在到啟動必須進行的 8121 試驗之間，還有哪些關鍵門檻因素（gating factors）？謝謝。

Do you want to start with 8121?

你想先從 8121 開始嗎？

Yes. Why don't I start with 8121. As I said, we're on track. We're hitting our milestones this year. We're on track to start this trial by the start of the year. But what I've also said is that we're not going to start this trial until we have kind of the go-to-market commercial presentation ready. It's really important that we start this trial with the go-to-market presentation.

是的。我先從 8121 談起。如我所說，我們進度如期。我們今年正在達成各項里程碑。我們按計畫在年初前啟動這項試驗。但我也說過，在我們把上市策略（go-to-market）的商業呈現準備好之前，我們不會啟動這項試驗。以上市策略的呈現來啟動這項試驗非常重要。

So what we're doing now and what we've been doing over the last several months is really scaling up all of that, the device, the formulation, the commercial scale formulation and then putting those 2 things together before we put -- start the trial. So we're going to get all that stuff done prior, and we're on track to do that. And we'll stay on pace and we'll share more about that later this year as we kind of do a full kind of program review later in the fall.

所以我們現在在做、以及過去幾個月一直在做的，是把所有這些內容真正放大到位：裝置、配方、商業規模配方，然後在我們——啟動試驗之前，把這兩件事整合在一起。因此我們會在事前把這些都完成，而我們也按計畫在推進。我們會保持節奏，並在今年稍晚、約在秋季進行一次完整的專案回顧時，分享更多相關內容。

And then, Brandon, from a capital allocation perspective, yes, certainly, the performance of the business is driving towards a healthy and -- healthier balance sheet that gives us a lot of optionality with our business. I would say, first and foremost, we're focused on reinvesting in the business for growth. So that's kind of the primary lens by which we're deciding on where to invest our next dollar.

然後，Brandon，從資本配置的角度來看，是的，當然，業務表現正推動我們走向一個健康、而且更健康的資產負債表，這讓我們在業務上擁有很大的選擇彈性。我會說，首先也是最重要的，我們專注於再投資於業務以促進成長。因此，這就是我們在決定下一筆資金投向何處時的主要考量角度。

And then obviously, we have options around what we can do with our balance sheet and our capital structure in terms of debt. That's always -- it's always an option for us. But I'd say primarily, we're focused on things that are going to drive additional growth.

然後很明顯地，就負債而言，我們在資產負債表與資本結構方面也有一些選項可做。那一直——一直都是我們的一個選項。但我想主要來說，我們專注在能夠帶動額外成長的事情上。

Great. Thank you very much. And congrats again on a good quarter.

很好。非常感謝。也再次恭喜你們這一季表現不錯。

Thanks, Brandon.

謝謝，Brandon。

Jason Dorr, Oppenheimer.

Jason Dorr，Oppenheimer。

Hi, everyone. It's Jason on for Leland. Congrats on the quarter. To what degree is there appetite to expand the pipeline beyond 8121? And if there's appetite there, would that involve bringing in external innovation, something to tune for Recorlev? Or would that be more on the end of developing new molecules with the XeriSol, XeriJect technologies?

嗨，各位好。我是 Jason，代替 Leland 提問。恭喜本季表現。你們在多大程度上有意願把產品研發管線擴展到 8121 之外？如果有這樣的意願，會涉及引進外部創新、例如為 Recorlev 量身調整的項目嗎？或者會更偏向利用 XeriSol、XeriJect 技術來開發新分子？

Thanks, Jason. You just heard Steve talk about our flexibility around our capital and the fact that we're -- our performance is driving our ability to do more things. And we'll focus those things on growth. So things that can drive growth will be the areas we'll spend that capital on. And if that's future pipeline, yes, if it's external inorganic things, yes, especially if they fit in and allow us to leverage our capabilities, both from an R&D perspective as well as from a commercial perspective. So we're looking at all those things with an eye on growth, additional growth.

謝謝你，Jason。你剛剛也聽到 Steve 談到我們在資本運用上的彈性，以及我們——我們的表現正在提升我們做更多事情的能力。而我們會把這些事情聚焦在成長上。因此，凡是能推動成長的領域，將會是我們投入資本的方向。如果是未來的研發管線，是的；如果是外部的、非有機的機會，也是的，尤其是當它們契合並能讓我們發揮自身能力時，無論是研發面向或商業化面向。所以我們以成長、額外成長為目標，評估所有這些選項。

Appreciate the color. Thank you.

感謝補充說明。謝謝。

David Amselem with Piper Sandler and Company. Please go ahead.

Piper Sandler and Company 的 David Amselem。請開始。

Hi, good morning. Thanks for taking our question. This is Alex von Riesemann on for David. So firstly, looking at Recorlev, can you help give us a better sense of what kinds of patients are getting the product? And how are you thinking about other subgroups of patients beyond uncontrolled hypertension and uncontrolled type 2 diabetes? And then secondly, regarding the expansion of the sales force, can you remind us how many reps you have in the field, how many doctors they're targeting and the audience breakdown? Thank you.

嗨，早安。謝謝讓我們提問。我是 Alex von Riesemann，代替 David 提問。首先，關於 Recorlev，你們能否幫我們更清楚了解目前使用該產品的是哪些類型的病患？以及你們如何看待除未控制高血壓與未控制第二型糖尿病之外的其他病患亞群？其次，關於擴編銷售團隊，你們能否提醒我們目前在外勤有多少位業務代表、他們鎖定多少位醫師，以及目標受眾的拆分？謝謝。

Thanks, Alex. Well, our patients are coming -- our patients are, I think, I've said this before, and they continue on the same path. About 60% of our patients are new to therapy, naive to drug. So most of them are first diagnosed and coming into Recorlev. And then the rest are coming from probably switches and from the various other products on the market. In terms of what your next question was around?

謝謝你，Alex。嗯，我們的病患來源——我想我之前說過，而且目前仍然沿著相同的趨勢。大約 60% 的病患是新開始治療、未曾用藥的病患。所以他們多半是剛被診斷，然後開始使用 Recorlev。其餘的則可能是從其他治療轉換過來，或是從市面上各種其他產品轉換而來。至於你下一個問題是關於……？

Number of reps.

業務代表的人數。

Yes. I think we raised our targets from about 7,000, 8,000 to somewhere in the 12,000 range. So we probably added about 6,000 targets out there with the expansion. We're up to around 80 reps. And then we've also expanded our patient services, reimbursement services and capabilities around pharmacy. So all of those things support the revenue growth that we're seeing and are anticipating.

是的。我想我們把目標醫師數從大約 7,000、8,000 提高到大約 12,000 的區間。所以隨著擴編，我們大概新增了約 6,000 個目標。我們目前大約有 80 位業務代表。此外，我們也擴充了病患服務、給付/報銷服務，以及藥局相關的能力。所有這些都在支持我們看到、並且預期將持續的營收成長。

I think you also asked another question around subgroups of patients. I think the thing to think about our patients are all of these patients have hypercortisolemia. They have cortisol levels at 1.8 above the upper limit of normal or even higher. And all of them have other comorbidities that really constitute Cushing's syndrome. And it's across the board. I think obviously, there's probably some skew towards diabetes, resistant diabetes, but it's really across the board, all the various comorbidities. So...

我想你也問到另一個關於病患亞群的問題。我認為要理解的是，我們的病患全部都有高皮質醇血症（hypercortisolemia）。他們的皮質醇水準高於正常上限 1.8 倍，甚至更高。而且他們都有其他共病，這些共病實際上構成了庫欣氏症候群（Cushing's syndrome）。這是全面性的。我想很明顯地，可能會稍微偏向糖尿病、難治型糖尿病，但整體而言是全面涵蓋各種不同的共病。所以……

Thank you. We have reached the end of the Q&A session. I will now turn the call over to John Shannon for closing remarks.

謝謝。我們的問答環節到此結束。接下來我將把電話會議交給 John Shannon 作結語。

As you just heard, Q1 marked another strong quarter for Xeris and an exceptional start for the year, underscoring sustained commercial momentum and disciplined execution against our strategic priorities. We remain focused on delivering impressive revenue growth while continuing to operate with financial discipline. Our performance to date reinforces the confidence we have in achieving our updated full year guidance. We are encouraged by underlying demand trends and the meaningful progress our teams are making to expand market penetration and strengthen long-term value creation. Thank you for joining us today.

如各位剛才所聽到的，第一季對 Xeris 而言又是一個強勁的季度，也是今年一個非常出色的開端，凸顯了持續的商業動能，以及我們在策略優先事項上有紀律的執行。我們仍專注於在維持財務紀律的同時，交出亮眼的營收成長。截至目前的表現，強化了我們對達成更新後全年財測指引的信心。我們對基本需求趨勢感到鼓舞，也看到團隊在擴大市場滲透率與強化長期價值創造方面取得了顯著進展。感謝各位今天加入我們。

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

今天的電話會議到此結束。感謝各位參與。您現在可以掛線。