Xeris Biopharma Holdings Inc (XERS) 2024 Q2 法說會逐字稿

Hello, everyone, and Welcome to today's Xeris Biopharma second-quarter 2024 financial results call. My name is Drew, and I'll be your operator today. (Operator Instructions) I will now turn the call over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications to begin. Please go ahead.

大家好，歡迎參加今天的 Xeris Biopharma 2024 年第二季財務業績電話會議。我叫德魯，今天我將成為您的接線生。（操作員指示）我現在將電話轉給投資者關係和企業傳播高級副總裁 Allison Wey 開始。請繼續。

Thank you, Drew. Good morning, and welcome to Xeris's Biopharma second quarter and first half 2024 financial results conference call and webcast. This morning, we issued our press release, which can be found on our website. We're joined this morning by John Shannon, our new CEO; and Steve Piper, our CFO. After our prepared remarks, we will open the lines for questions.

謝謝你，德魯。早安，歡迎來到 Xeris 生物製藥 2024 年第二季和上半年財務業績電話會議和網路廣播。今天早上，我們發布了新聞稿，可以在我們的網站上找到。今天早上，我們的新任執行長約翰·香農 (John Shannon) 也加入了我們的行列。以及我們的財務長 Steve Piper。在我們準備好發言後，我們將開始提問。

Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, prospects, 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. For more information on such risks, please refer to our earnings release and risk factors included in our SEC filings. Any forward-looking statements in this call represent our views only as of the date of this call and subject to applicable law, we disclaim any obligation to update such 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、前景和財務業績的前瞻性陳述。前瞻性陳述存在風險和不確定性，可能導致實際結果與前瞻性陳述有重大差異。有關此類風險的更多信息，請參閱我們向 SEC 備案的收益發布和風險因素。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，根據適用法律，我們不承擔更新此類陳述的義務。

I will now turn the call over to John Shannon.

我現在將把電話轉給約翰·香農。

Thank you, Allison, and good morning, everyone. I'm honored to speak with you for the first time as the CEO of Xeris. It's an exciting time for our company as we start this new era, and I'm thrilled to serve in this role. As you all saw from this morning's earnings release, we had an outstanding second quarter.

謝謝你，艾莉森，大家早安。作為 Xeris 的首席執行官，我很榮幸第一次與您交談。對於我們公司來說，這是一個令人興奮的時刻，我們開始了這個新時代，我很高興能夠擔任這個角色。正如大家從今天早上的財報中看到的那樣，我們的第二季表現出色。

But before we get into the results, I want to take a moment to outline my near-term priorities as the new CEO. I'm focused on three key priorities to guide our strategic initiatives and decision-making processes in the near term. These represent important opportunities for creating value for our stakeholders.

但在我們討論結果之前，我想花點時間概述我作為新任執行長的近期優先事項。我專注於三個關鍵優先事項，以指導我們近期的策略性舉措和決策流程。這些代表了為我們的利害關係人創造價值的重要機會。

The first priority is maintaining rapid commercial growth and expanding the reach of our treatments to the patient communities they serve. We have three great commercial products making meaningful impact on patients' lives. We aim to pursue growth strategies that are both ambitious and sustainable. We're confident that our existing products can continue to deliver meaningful growth in the near and long term, and we intend to consistently optimize how we deploy the resources necessary to drive them.

首要任務是保持快速的商業成長，並將我們的治療範圍擴大到他們所服務的患者社區。我們擁有三種出色的商業產品，對患者的生活產生有意義的影響。我們的目標是追求雄心勃勃且可持續的成長策略。我們相信，我們現有的產品能夠在短期和長期內繼續帶來有意義的成長，並且我們打算不斷優化我們部署驅動這些產品所需資源的方式。

The second priority is a renewed commitment to financial discipline, ensuring investments are made wisely and remain focused on value accretion. We've built a diverse and resilient business model that can weather market fluctuations and deliver consistent performance. We can achieve our business objectives by employing prudent financial planning, appropriate risk management, and by maintaining a strong cash reserve. We ended the second quarter with a very healthy $77 million in cash and investments, and we intend to deploy those financial resources judiciously as business needs or opportunity warrants.

第二個優先事項是重新承諾遵守財務紀律，確保明智地進行投資並繼續專注於價值增值。我們建立了多元化且富有彈性的業務模式，可以抵禦市場波動並提供穩定的績效。我們可以透過審慎的財務規劃、適當的風險管理以及維持充足的現金儲備來實現我們的業務目標。第二季結束時，我們擁有 7,700 萬美元的現金和投資，非常健康，我們打算根據業務需求或機會保證明智地部署這些財務資源。

Given our strong cash position and rapid growth of our business, I do not plan to raise any cash by adding any incremental debt or equity that would result in shareholder dilution. Given our differentiated and enviable portfolio of assets, any M&A activity will be measured and opportunistic. In the near to intermediate term, we expect business development activity will be focused on the addition of new technology partnerships or commercial partnerships that can leverage our existing products, formulations or commercial capabilities, which adds to our growth. The third priority is to improve the quality of our external communications and guidance. Our external stakeholders are critical to our success, and it is extremely important that we listen closely to feedback and communicate in the best manner possible, setting the right expectations around the ability of our products to deliver growth and value.

鑑於我們強勁的現金狀況和業務的快速成長，我不打算透過增加任何會導致股東稀釋的增量債務或股權來籌集任何現金。鑑於我們差異化且令人羨慕的資產組合，任何併購活動都將是經過衡量和機會主義的。在中短期內，我們預計業務開發活動將專注於增加新技術合作夥伴關係或商業合作夥伴關係，這些合作夥伴關係可以利用我們現有的產品、配方或商業能力，從而促進我們的成長。第三個重點是提高對外溝通和指導的品質。我們的外部利害關係人對我們的成功至關重要，我們密切傾聽回饋並以盡可能最好的方式進行溝通，圍繞我們的產品實現成長和價值的能力設定正確的期望，這一點極為重要。

To that end, we understand that our initial 2024 revenue guidance suggested that we were not confident in the growth prospects of this business. As I explained with my first priority, we are committed to driving rapid and sustained growth of our commercial products. Given our first half performance and our momentum going into the second half of the year, we are confident in the performance and growth of our business. Therefore, we are raising the low end of our total revenue outlook for the full year from $175 million to $190 million. Our updated total revenue range is now $190 million to $200 million. By executing on these three priorities, I expect to build upon the strong foundation we've created, which will drive our overall business performance to new heights.

為此，我們了解到我們最初的 2024 年收入指引表明我們對該業務的成長前景沒有信心。正如我首先解釋的那樣，我們致力於推動我們的商業產品的快速和持續成長。鑑於我們上半年的業績和下半年的勢頭，我們對業務的業績和成長充滿信心。因此，我們將全年總收入預期的下限從 1.75 億美元上調至 1.90 億美元。我們更新後的總收入範圍現在為 1.9 億至 2 億美元。透過執行這三個優先事項，我希望在我們已經創建的堅實基礎上再接再厲，這將使我們的整體業務績效推向新的高度。

Now let's move on to the highlights of the second quarter. I'm very pleased to report that we posted an outstanding quarter of total revenue, $48 million, a 26% increase over Q2 last year, driven by continued strong demand of all three products as well as contributions from our partnerships.

現在讓我們來看看第二季的亮點。我很高興地向大家報告，在所有三種產品持續強勁的需求以及我們合作夥伴的貢獻的推動下，我們季度總收入表現出色，達到 4800 萬美元，比去年第二季度增長 26%。

Our portfolio of commercially available products, Recorlev, Gvoke, and Keveyis, each of which is a transformative therapeutic in their own respective markets collectively generated more than $46 million in revenue, a 26% increase over the same quarter in 2023. This marks the 11th quarter in a row of greater than 20% growth. For the first half of 2024, these products are up 25% over the same period last year. Our commercial engine is clearly working. We're enjoying continuing rapid growth in both Gvoke and Recorlev and a very sturdy commitment to Keveyis from both patients and healthcare professionals.

我們的商用產品組合 Recorlev、Gvoke 和 Keveyis 各自在各自的市場中都是一種變革性的治療方法，總共產生了超過 4,600 萬美元的收入，比 2023 年同一季度增長了 26%。這標誌著連續第 11 個季度成長超過 20%。2024年上半年，這些產品比去年同期成長了25%。我們的商業引擎顯然正在運轉。我們享受 Gvoke 和 Recorlev 的持續快速增長，以及患者和醫療保健專業人員對 Keveyis 的堅定承諾。

Let's get into a little more of the details, starting with Recorlev. As a reminder, Recorlev is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypocortisolemia in patients with Cushing's syndrome for whom surgery is not an option or hasn't worked. Importantly, Recorlev is the only treatment approved for all etiologies of Cushing's syndrome and has been proven in long-term studies to normalize cortisol levels. Cushing's syndrome is an extremely challenging disorder with a 2 times to 4 times higher mortality rate than the general population and comorbidities that drastically impact a person's quality of life.

讓我們從 Recorlev 開始了解更多細節。提醒一下，Recorlev 是一種皮質醇合成抑制劑，適用於治療無法選擇手術或手術無效的庫欣氏症候群患者的內源性低皮質醇血症。重要的是，Recorlev 是唯一被批准用於治療庫欣氏症候群所有病因的治療方法，並且已在長期研究中證明可以使皮質醇水平正常化。庫欣氏症候群是一種極具挑戰性的疾病，其死亡率比一般人群高 2 至 4 倍，其合併症嚴重影響一個人的生活品質。

While there are multiple approved medical treatments available, patients often struggle to gain control over the disease given its complexities. Clinicians increasingly recognize the burden of hypocortisolemia and are expanding their testing efforts. Not surprisingly, more patients with the disease are being discovered every day. In Q2, Recorlev generated a record number of referrals, and a record number of new patient starts. With such favorable dynamics, we're confident Recorlev is entering into a period of accelerating growth.

儘管有多種經批准的治療方法可供選擇，但由於疾病的複雜性，患者往往難以控制疾病。臨床醫生越來越認識到低皮質醇血症的負擔，並正在擴大他們的檢測工作。毫不奇怪，每天都會發現更多患有這種疾病的患者。在第二季度，Recorlev 產生了創紀錄的轉診數量和創紀錄的新患者數量。憑藉如此有利的動態，我們相信 Recorlev 正在進入加速成長時期。

Moving on to Gvoke. I'm sure you'll recall that Gvoke HypoPen is our liquid ready-to-use glucagon in an auto-injector used for the treatment of severe hypoglycemia in people with diabetes. Owing to the prevalence and preventable hospitalization and mortality associated with severe low blood sugar, the health advocacy organizations, including the American Diabetes Association and the Endo Society have reached consensus opinion that any person with diabetes taking either insulin or sulfonylurea should always be carrying a ready-to-use glucagon product like Gvoke.

轉向 Gvoke。我相信您會記得 Gvoke HypoPen 是我們的液體即用型胰高血糖素自動注射器，用於治療糖尿病患者的嚴重低血糖。由於與嚴重低血糖相關的住院和死亡的發生率和可預防性，包括美國糖尿病協會和遠藤協會在內的健康倡導組織已達成共識，即任何服用胰島素或磺酰脲類藥物的糖尿病患者都應隨時攜帶準備好的胰島素或磺脲類藥物。

We estimate that of the approximately 15 million people in the US that should be protected, fewer than 1 million currently are. Thankfully, our ongoing efforts to increase awareness of this discrepancy and the need to protect patients at risk is gaining traction and driving market growth. Total prescriptions for Gvoke in Q2 grew 13% sequentially over Q1 and 27% over the same quarter last year. Importantly, Gvoke's market share increased to 34%. In the quarters and years ahead, we expect to steadily add more prescribers and protect more and more of the 14 million-plus patients who remain unprotected.

我們估計，美國大約有 1500 萬人應該受到保護，但目前只有不到 100 萬人。值得慶幸的是，我們不斷努力提高人們對這種差異的認識以及保護處於危險中的患者的需要，這些努力正在獲得關注並推動市場成長。第二季 Gvoke 的總處方數比第一季成長 13%，比去年同期成長 27%。重要的是，Gvoke的市佔率增至34%。在未來的幾個季度和幾年裡，我們預計將穩定增加更多的處方醫生，並為 1,400 多萬名尚未受到保護的患者提供保護。

Last, but by no means least, we turn to Keveyis. What an amazing story Keveyis continues to be for the patients that need it and for our Xeris business. Just to remind you, Keveyis is used to treat primary periodic paralysis or PPP, which is an ultra-rare genetic neuromuscular condition that interferes with the normal functioning of muscle movement. Keveyis lost orphan exclusivity in August of 2022, yet has proven extremely resistant to generic substitution, given the uniqueness of the disorder and the PPP community's critical reliance on Xeris' support for both healthcare professionals and our patients.

最後但並非最不重要的一點是，我們轉向凱維伊斯。對於需要它的患者和我們的 Xeris 業務來說，Keveyis 仍然是一個多麼令人驚奇的故事。只是提醒您，Keveyis 用於治療原發性週期性麻痺或 PPP，這是一種極其罕見的遺傳性神經肌肉疾病，會幹擾肌肉運動的正常功能。Keveyis 於2022 年8 月失去了孤兒藥專營權，但鑑於該疾病的獨特性以及PPP 社區對Xeris 對醫療保健專業人員和患者的支持的嚴重依賴，該藥物已被證明對仿製藥替代具有極強的抵抗力。

During Q2, the number of patients being treated with Keveyis was nearly equivalent to Q1, and that trend has continued into Q3, a remarkable achievement. We're increasingly optimistic about the longer-term strength and resilience of Keveyis and will continue to provide services that matter most for the well-being of patients suffering from PPP.

在第二季度，接受 Keveyis 治療的患者數量幾乎與第一季相當，且趨勢一直延續到第三季度，這是一項了不起的成就。我們對 Keveyis 的長期實力和復原能力越來越樂觀，並將繼續提供對 PPP 患者的福祉最重要的服務。

Quickly shifting to our pipeline. In late May, we announced positive top line results of our Phase II study of XP-8121, our once-weekly subcutaneous injectable formulation of levothyroxine. The team is busy preparing for an end of Phase II meeting with the FDA this fall. During which time, we will seek clarification about the Phase III requirements necessary to earn approval for this novel product.

快速轉移到我們的管道。5 月下旬，我們宣布了 XP-8121（每週一次皮下注射左旋甲狀腺素製劑）的 II 期研究取得了積極的頂線結果。該團隊正忙於準備今年秋天與 FDA 舉行的第二階段會議。在此期間，我們將尋求澄清該新穎產品獲得批准所需的第三階段要求。

The more we evaluate the data and market potential of XP-8121, the more excited we get, owing to the size of the hypothyroidism marketplace and the desperate need for innovation to serve patients struggling for control. Innumerable reports have been published documenting the various compliance and absorption challenges that can interfere with bioavailability of oral levothyroxine. Of note, in our Phase II study, 40% of the patients considered stable at the time of screening were found to have their TSH or T4 outside of normal range.

我們對 XP-8121 的數據和市場潛力評估得越多，我們就越興奮，因為甲狀腺功能減退症市場規模龐大，而且迫切需要創新來為難以控制的患者提供服務。已發表的無數報告記錄了可能幹擾口服左旋甲狀腺素生物利用度的各種依從性和吸收挑戰。值得注意的是，在我們的 II 期研究中，40% 在篩檢時被認為穩定的患者被發現其 TSH 或 T4 超出正常範圍。

Finally, in Q2, we welcomed Beta Bionics to our stable of partners seeking to leverage our formulation technology to create novel medicine. As announced in May, we're aiding Beta Bionics in the development of a novel ready-to-use glucagon formulation that could work optimally in their dual-hormone pump program. So once again, I couldn't be more excited for Xeris as we enter a new era, and I'm confident that we are well on our way to building an innovative, self-sustaining, fast-growing biopharmaceutical company committed to making a difference in patients' lives.

最後，在第二季度，我們歡迎 Beta Bionics 加入我們穩定的合作夥伴，尋求利用我們的配方技術創造新藥。正如 5 月宣布的那樣，我們正在幫助 Beta Bionics 開發一種新型即用型胰高血糖素配方，該配方可以在其雙激素泵計劃中發揮最佳作用。因此，當我們進入一個新時代時，我再一次對 Xeris 感到無比興奮，我相信我們正在建立一家創新、自我維持、快速成長的生物製藥公司，致力於打造一個患者生活的差異。

And with that, I'm going to pass over to Steve to walk you through the details of our second quarter financial results.

接下來，我將請史蒂夫向您介紹我們第二季財務業績的詳細資訊。

Thanks, John. Good morning, everyone. We ended the quarter with net product revenue of $46.5 million and total revenue of $48.1 million, both increasing by approximately 26% compared to prior year. Year-to-date net product revenue was $86.8 million, and total revenue was $88.7 million, both increasing by approximately 25% compared to prior year. This growth in revenue was driven by strong performance from both Recorlev and Gvoke.

謝謝，約翰。大家早安。本季結束時，我們的淨產品收入為 4,650 萬美元，總收入為 4,810 萬美元，均較上年增長約 26%。年初至今，產品淨收入為 8,680 萬美元，總收入為 8,870 萬美元，均較上年增長約 25%。這項營收成長得益於 Recorlev 和 Gvoke 的強勁表​​現。

Recorlev net revenue was $13.3 million for the quarter, increasing 86% compared to prior year. On a sequential basis, Recorlev net revenue increased by an impressive $2.7 million, representing growth of 26%. These increases were driven by the average number of patients on Recorlev increasing 124% from last year and 25% compared to Q1. We expect this rapid growth to continue based on our robust pipeline of referrals growing 31% compared to Q1, our ability to convert these referrals into patients on Recorlev as well as our field expansion, which we completed in early July.

Recorlev 本季淨收入為 1,330 萬美元，比去年同期成長 86%。Recorlev 淨收入環比增長了 270 萬美元，增幅高達 26%，令人印象深刻。這些增長是由於 Recorlev 患者的平均數量比去年增加了 124%，與第一季相比增加了 25%。我們預計這種快速成長將持續下去，因為我們的轉診管道比第一季度增加了 31%，我們將這些轉診轉化為 Recorlev 患者的能力以及我們於 7 月初完成的領域擴展。

Gvoke net revenue was $20 million for the quarter, representing a 28% increase compared to the same period last year. This growth was driven by a 27% increase in Gvoke prescriptions. As we mentioned during our prior quarter remarks, the Change Healthcare cybersecurity breach temporarily impacted Gvoke net revenue in the first quarter. Although, we do not believe we recovered the lost revenue from the first quarter, growth in patient demand, which consistently exceeded 5,000 weekly prescriptions since May as well as increased orders from our wholesalers have signaled to us the impact has been resolved.

Gvoke 本季淨收入為 2,000 萬美元，較去年同期成長 28%。這一增長是由 Gvoke 處方增加 27% 所推動的。正如我們在上一季的評論中提到的，Change Healthcare 網路安全漏洞暫時影響了 Gvoke 第一季的淨收入。儘管我們不相信我們能挽回第一季的收入損失，但患者需求的增長（自 5 月以來每週處方量持續超過 5,000 份）以及批發商訂單的增加，都向我們表明影響已經解決。

Keveyis net revenue for the quarter and year-to-date was $13.1 million and $26.2 million. Despite generic competition, revenue only decreased slightly by 2% on a year-to-date basis. As we have repeatedly stated, Keveyis is resilient, and we will continue to invest and defend the brand. Our commitment to this strategy has proven to be successful as we continue to generate a healthy pipeline of patient referrals.

Keveyis 本季和年初至今的淨收入分別為 1,310 萬美元和 2,620 萬美元。儘管有仿製藥競爭，但年初至今收入僅小幅下降 2%。正如我們一再聲明的那樣，Keveyis 具有韌性，我們將繼續投資並捍衛品牌。事實證明，我們對這項策略的承諾是成功的，因為我們不斷建立健康的病患轉診管道。

Given the strong performance of all three of our products in the first half of the year and the momentum we are currently generating, we are confident in tightening our total revenue guidance by substantially raising the low end of the range with revised guidance of $190 million to $200 million from the previous guidance of $175 million to $200 million.

鑑於我們所有三種產品在今年上半年的強勁表現以及我們目前所產生的勢頭，我們有信心通過大幅提高範圍的低端來收緊我們的總收入指導，修訂後的指導為 1.9 億美元從之前的指導值1.75 億美元增至2 億美元，增加了2 億美元。

Moving down the P&L. Cost of goods sold as a percentage of total product revenue decreased by 4% for the quarter compared to the prior year. This decrease was primarily the result of an increase in Recorlev revenue, resulting in a product mix with lower costs. Research and development expenses were $5.8 million for the second quarter. These expenses were relatively flat compared to the second quarter of 2023 and were primarily comprised of costs for our pipeline, notably a XP-8121 and further development of our technology platform, XeriSol and XeriJect.

損益表向下移動。本季銷售成本佔產品總收入的百分比與去年同期相比下降了 4%。這一下降主要是由於 Recorlev 收入增加，導致產品組合成本降低。第二季的研發費用為 580 萬美元。與 2023 年第二季相比，這些費用相對持平，主要包括我們的管道成本，特別是 XP-8121 以及我們技術平台 XeriSol 和 XeriJect 的進一步開發。

On a year-to-date basis, research and development expenses were $13.6 million, a $2.4 million increase compared to prior year, which was primarily a result of investments in our pipeline and increased employee costs to support XeriSol and XeriJect. Consistent with my previous remarks, we are focused on advancing our pipeline and supporting our XeriSol and XeriJect technology platform, which will result in an increase in R&D costs this year compared to 2023. We expect a modest increase in R&D spend relative to the first half.

年初至今，研發費用為 1,360 萬美元，比上年增加 240 萬美元，這主要是由於我們對管道的投資以及支持 XeriSol 和 XeriJect 的員工成本增加。與我先前的言論一致，我們的重點是推進我們的產品線並支援我們的 XeriSol 和 XeriJect 技術平台，這將導致今年的研發成本較 2023 年增加。我們預計研發支出相對上半年將小幅成長。

Selling, general and administrative expenses were $40 million for the quarter and $78.4 million for the year, an increase of 6% and 10% compared to prior year. These increases were driven by higher personnel costs primarily due to our field expansion in the fourth quarter of last year. Looking ahead for the full year, we expect a modest increase in second half expenses relative to the first half as we have made investments that are focused on supporting our revenue growth.

本季銷售、一般和管理費用為 4,000 萬美元，全年為 7,840 萬美元，較上年同期分別增長 6% 和 10%。這些成長是由於去年第四季我們的現場擴張導致人員成本上升所致。展望全年，我們預計下半年費用將相對上半年略有增加，因為我們進行了專注於支持收入成長的投資。

Moving to cash. We ended the quarter in a healthy cash position of $77.6 million. Looking ahead to our year-end, we are tightening our cash guidance to $60 million to $75 million from the original $55 million to $75 million, which considers our revised revenue guidance as well as the additional investments we have made in the Recorlev business. We are able to make these investments as a result of continued strong revenue growth. We are seeing great momentum across our business, which is translating to consistent and meaningful revenue growth and driving the financial health of our enterprise.

轉向現金。本季結束時，我們的現金狀況良好，為 7,760 萬美元。展望年底，我們將現金指引從原來的 5,500 萬美元至 7,500 萬美元收緊至 6,000 萬美元至 7,500 萬美元，其中考慮了我們修訂後的收入指引以及我們在 Recorlev 業務中進行的額外投資。由於收入持續強勁成長，我們能夠進行這些投資。我們看到整個業務的強勁勢頭，這正在轉化為持續且有意義的收入成長，並推動我們企業的財務健康。

With that, operator, please open the line for questions.

那麼，接線員，請開通提問線路。

(Operator Instructions) Roanna Ruiz, Leerink Partners.

（操作員說明）Roanna Ruiz，Leerink Partners。

Great. Good morning, everyone. So I have a question for Recorlev first. It seems like the new patient starts are growing well in the quarter. How do you think that will trend into the second half this year? And I'm also curious with the newly expanded sales force, could that continue to be a tailwind later this year and possibly into 2025?

偉大的。大家早安。我首先有一個問題要問Recorlev。本季新增患者數似乎成長良好。您認為今年下半年的趨勢如何？我還對新擴大的銷售團隊感到好奇，這是否會繼續成為今年稍後甚至 2025 年的推動力？

Hi Roanna, it's John. Yes. I mean we -- as I said, we're -- it's accelerating. We're growing the new starts and new referrals. We see that are continuing to accelerate in Q3, and we see that through the end of the year.

嗨，羅安娜，我是約翰。是的。我的意思是，正如我所說，我們正在加速。我們正在增加新的開始和新的推薦。我們看到第三季繼續加速，我們看到這種情況一直持續到年底。

And we just put the new sales force on -- out in the -- additional sales reps out into the field in the last couple of weeks, and they'll start contributing early -- later this year or early next year.

我們只是在過去幾週內將新的銷售隊伍派往現場，將額外的銷售代表派往現場，他們將在今年晚些時候或明年初開始儘早做出貢獻。

Got it. Helpful. And for Gvoke, I also was curious, would you consider focusing the sales force a bit more on driving back-to-school, prescribing for Gvoke to sort of maximize that going into later this year? And could you just remind us what are the Gvoke reps doing today in terms of tackling some of these prescribers versus other prescribers for adults, et cetera?

知道了。有幫助。對於 Gvoke，我也很好奇，您是否會考慮讓銷售人員更多地關注開車返校，並為 Gvoke 開出處方，以在今年晚些時候最大限度地發揮這一作用？您能否提醒我們，Gvoke 代表今天在處理其中一些處方者與其他成人處方者等問題方面正在做什麼？

Yeah. So as you pointed out, the third quarter back-to-school starts kicking in like this week and next week. And as always, we will focus in that area for that time period, which is primarily pediatric endo. And as we've shown and you guys understand is BAQSIMI has a pretty strong hold on that space, only because they launched right into it several years ago.

是的。正如您所指出的，第三季的返校活動將在本週和下週開始。與往常一樣，我們將在該時期重點關注該領域，主要是兒科內視鏡。正如我們所展示的，你們也知道，BAQSIMI 在這個領域擁有相當強大的控制力，只是因為他們幾年前就進入了這個領域。

So from our perspective, we hold on and continue to grow during this timeframe. It's our biggest growth quarter every year, and it will be that way this year. But we also then focus on how do we bring every day, how do we bring more of the 14 million people that are not protected today on Gvoke.

因此，從我們的角度來看，我們在這段時間內堅持並繼續成長。這是我們每年最大的成長季度，今年也是如此。但我們隨後也關注如何每天為 Gvoke 提供更多不受保護的 1400 萬人。

Got it. Thanks.

知道了。謝謝。

David Amsellem, Piper Sandler.

大衛·阿姆塞勒姆，派珀·桑德勒。

Hi. Thank you. This is Schuyler on for David. First, on Recorlev, can you talk about your long-term expectations in the context of the recent catalyst data from Corcept, which showed that 24% of patients with difficult-to-treat type 2 diabetes and the study actually had Cushing's syndrome, which might indicate that the true prevalence is higher than previously understood.

你好。謝謝。這是斯凱勒為大衛發言。首先，關於Recorlev，您能否結合Corcept最近的催化數據來談談您的長期期望，該數據顯示，24%的難治性2型糖尿病患者實際上患有庫欣綜合徵，而該研究表明，可能顯示真實的盛行率比以前理解的要高。

And then separately, how are you thinking about Gvoke growth over the remainder of the second half of the year? And touching on last question, just the degree of seasonality we should expect with the back-to-school season, just so we can better think about the phasing of revenue? Thank you.

另外，您如何看待 Gvoke 在今年下半年剩餘時間內的成長？談到最後一個問題，我們應該預期返校季的季節性程度如何，以便我們可以更好地考慮收入的分階段？謝謝。

Okay. Let me start with Recorlev. And I think you're pointing out part of what I had in my prepared remarks is that more and more patients are being tested and screened for high cortisol levels, which is ideal for the marketplace and ideal for our product, because Recorlev normalizes cortisol. So it fits right in for why some of the -- we're seeing some of the acceleration in our growth and how our product fits into what's going on in that space.

好的。讓我從 Recorlev 開始。我認為您在我準備好的發言中指出的部分內容是，越來越多的患者正在接受高皮質醇水平的測試和篩檢，這對於市場和我們的產品來說都是理想的選擇，因為Recorlev 使皮質醇正常化。因此，它正好解釋了為什麼我們看到我們的成長加速，以及我們的產品如何適應該領域正在發生的事情。

For Gvoke, we expect to continue to grow and drive kind of more and more people who aren't protected to prescribe and/or get Gvoke just in case, okay? That will continue strongly through the third quarter, which is always our strongest quarter and then into the fourth quarter as well. So we look to see this steady continuous growth that we've been counting out the last several quarters to continue on Gvoke.

對於 Gvoke，我們希望繼續發展並推動越來越多未受到保護的人開處方和/或獲取 Gvoke，以防萬一，好嗎？這種情況將持續到第三季度，這始終是我們最強勁的季度，然後也持續到第四季度。因此，我們希望看到 Gvoke 能夠繼續保持穩定的持續成長，而過去幾季我們一直在期待這種成長。

Yeah. Maybe just -- this is Steve, Schuyler. Just to get a little more specific on Gvoke. I think historically, we've seen in the back half of the year, 20% growth, and we've enjoyed that through the first half of the year. So I would expect that trend to continue with probably a little bit more dramatic growth in the third quarter. But I think that's kind of where I would peg things for the second half of the year.

是的。也許只是——這是史蒂夫，斯凱勒。只是為了更具體地了解 Gvoke。我認為從歷史上看，我們在今年下半年看到了 20% 的成長，並且我們在今年上半年都享受了這種成長。因此，我預計這種趨勢將持續下去，第三季的成長可能會更加顯著。但我認為這就是我將下半年的事情掛鉤的地方。

Helpful. Thank you, guys.

有幫助。謝謝你們，夥計們。

Chase Knickerbocker, Craig Hallum.

蔡斯·尼克博克、克雷格·哈勒姆。

Good morning. Thanks for taking the questions. And first of all, John, congrats on the new role. Looking forward to watching you execute here. First, just on housekeeping on Gvoke. Revenue -- net sales grew a little bit more than prescriptions in the year -- year-over-year, is that some stocking dynamics or was there a little bit of pricing benefit year over year? Just quick there.

早安.感謝您提出問題。首先，約翰，恭喜你擔任新角色。期待看到你在這裡執行。首先，只是 Gvoke 上的內務管理。收入－這一年的淨銷售成長比去年同期的處方成長略多，這是一些庫存動態還是同比有一點定價優勢？快點到那裡。

Yeah. Chase, this is Steve. I would say it's probably just a little bit of stocking, maybe a little bit of price, but nothing material.

是的。蔡斯，這是史蒂夫。我想說，這可能只是一點點庫存，也許一點點價格，但沒什麼實質的。

Got it. Thanks. And maybe so far through the first half of the year, at least in our data, we've seen some pretty nice share gains relative to competitors. Can you just speak to kind of what you've seen in your data kind of in the first half of the year on new Rx trends here with your ready-to-use competitors at Gvoke?

知道了。謝謝。也許到目前為止，今年上半年，至少在我們的數據中，我們已經看到相對於競爭對手的一些相當不錯的份額增長。您能否談談您在今年上半年的數據中看到的有關 Gvoke 的現成競爭對手的新 Rx 趨勢？

Yeah, I think we see the same thing you do is, yes, we're gaining share, but we're gaining that share primarily by market growth and capturing an inordinate amount of the market growth directly to Gvoke. So we're not out there directly getting it from existing BAQSIMI patients. We're getting it from the market growth that's out there and the market growth that we're driving. So -- and we think that trend will continue.

是的，我認為我們看到的和你做的一樣，是的，我們正在獲得份額，但我們主要透過市場成長來獲得份額，並將大量的市場成長直接分配給 Gvoke。所以我們不會直接從現有的 BAQSIMI 患者那裡取得它。我們從現有的市場成長和我們正在推動的市場成長中獲得它。所以——我們認為這種趨勢將會持續下去。

Yeah. And so kind of thinking about that through the remainder of the year and into next. With kind of you guys taking a majority of new patient starts from here. Maybe that is a little bit different in Q3, but you would expect that to kind of remain the case outside of maybe that back-to-school seasonality?

是的。在今年剩下的時間以及明年，我們都會思考這個問題。各位，大多數新病人的治療都是從這裡開始的。也許第三季的情況有點不同，但您認為除了返校季節性之外，這種情況還會持續下去嗎？

Yeah. If you went back and just mapped this out over the last couple of years, you see that we have share gains pretty consistent every quarter. And then we get to the third quarter and it kind of flattens out in terms of increases and then it picks up again in Q4. That trend will probably continue this quarter.

是的。如果你回顧過去幾年的情況，你會發現我們每季的份額成長都相當穩定。然後我們進入第三季度，成長趨於平緩，然後在第四季再次回升。這一趨勢可能會在本季持續下去。

Got it. And then just on Recorlev, I mean, just kind of taking a step back and looking at the market as a whole, can you help me kind of parse through what is maybe just some increased diagnosis Cushing's here versus you guys making competitive gains from some that have failed other therapies, maybe just doing better there?

知道了。然後就 Recorlev 而言，我的意思是，退後一步，看看整個市場，你能幫我分析一下，庫欣在這裡可能只是增加了一些診斷，而你們卻從某些方面獲得了競爭性收益其他療法都失敗了，也許只是在那裡做得更好？

And then I might have missed this, sorry, I'm jumping around. But just speak to the pipeline as far as kind of sequential growth there and how that kind of informs your guys' confidence in the back half of the year. Thanks.

然後我可能會錯過這個，抱歉，我正在跳來跳去。但只要談談管道中的持續成長，以及這如何影響你們下半年的信心。謝謝。

Let me try to answer your Recorlev question because there's a couple of dynamics there. There's more and more people being tested, and more and more people being diagnosed and -- with elevated cortisol. And again, we normalize cortisol. There's also a level of complexity in terms of treating this and there's no perfect product for anybody. So there's some bouncing around between therapies, and we benefit from that. So we're picking up patients from new starts to people that have switched to people that have tried other things and now are moving over. So there's all kind of -- people are coming from all places in terms of new starts. And I don't know that I understood your last question about the pipeline. Are you referring to the --

讓我嘗試回答你的 Recorlev 問題，因為那裡有一些動態。越來越多的人接受檢測，越來越多的人被診斷出皮質醇升高。再一次，我們使皮質醇正常化。治療這個問題也有一定程度的複雜性，並且沒有適合任何人的完美產品。因此，不同療法之間存在一些差異，我們可以從中受益。因此，我們正在接收從新開始的患者到已經轉向的患者以及嘗試過其他事情但現在正在轉移的患者。所以，就新的開始而言，人們來自四面八方。我不知道我是否理解你關於管道的最後一個問題。您指的是--

Just on the pipeline of patients for Recorlev, but yes -- for the Recorlev pipeline, yes.

就在 Recorlev 的患者管道中，但是是的 - 對於 Recorlev 管道，是的。

Yes, it's stronger than ever, and it continues to build for us. And like I said, it's coming from all places.

是的，它比以往任何時候都更強大，並且會繼續為我們發展。就像我說的，它來自各個地方。

And then just lastly on Keveyis. Would you expect kind of a consistent kind of treatment from payers' kind of through the remainder of the year and that kind of informs some of the confidence here? And then when was -- we typically think kind of Q1 for potential payer changes that would kind of be the next time where there would be something that we should think about from an investor perspective?

最後是凱維伊斯。您是否期望在今年剩下的時間裡，付款人能得到一致的待遇，這會增強人們的信心？然後，我們通常認為潛在付款人變化的第一季是什麼時候，這將是下一次我們應該從投資者角度考慮的事情？

Yeah. I would think about Q1 as you pointed out, that's when kind of -- there's all kinds of resets going on there. What we saw in Q2 and what we're seeing in Q3 is we're adding new patients at a very, very strong pace. And as I said in my prepared remarks, we were basically even Q2 to Q1 in terms of patients. And we see that trend continuing for the rest of the year.

是的。正如您所指出的，我會考慮第一季度，那時會發生各種重置。我們在第二季和第三季看到的是，我們正在以非常非常強勁的速度增加新患者。正如我在準備好的發言中所說，就患者而言，我們在第二季到第一季基本上持平。我們看到這種趨勢將在今年剩餘時間內持續下去。

Thanks for the questions, guys. Congrats on a really nice quarter.

謝謝你們的提問，夥伴們。恭喜您度過了一個非常美好的季度。

Thanks, Chase.

謝謝，蔡斯。

Rohan Mathur, Oppenheimer.

羅漢·馬圖爾，奧本海默。

Hi. This is Rohan on for Leland Gershell. Congratulations on another strong quarter. Just a couple for me. On Recorlev, can you give some detail on how the payer reception and coverage has been in the last quarter and how it's changed over time? And just on Keveyis, any granularity you could provide on the steadiness of the business and how you're thinking about how resilient the franchise might be in the coming years? Thank you.

你好。我是羅漢 (Rohan) 為利蘭‧格謝爾 (Leland Gershell) 發言。祝賀又一個強勁的季度。對我來說只是一對。關於 Recorlev，您能否詳細介紹上個季度的付款人接待情況和覆蓋範圍以及隨時間的變化情況？就 Keveyis 而言，您可以提供有關業務穩定性的任何詳細信息，以及您如何看待特許經營權在未來幾年的彈性？謝謝。

Okay. So let me talk about payer coverage with Recorlev. And I -- it's really not changed. What happens as you get -- spend more and more time in these spaces with these rare brands is you get better and better at moving patients from a referral through the payer process, and you do it faster and you do it more efficiently.

好的。讓我談談 Recorlev 的付款人保險範圍。而我——確實沒有改變。當你在這些稀有品牌的這些空間中花費越來越多的時間時，你會越來越擅長將患者從轉診轉移到付款流程，而且你做得更快、更有效率。

So -- and I think that's what's also leading to -- when you have a really strong referral pipeline that you can turn that into new starts. And we saw both of those accelerate in the second quarter and continue to see that going into the third quarter.

所以——我認為這也是導致的結果——當你擁有一個非常強大的推薦管道時，你可以將其轉化為新的開始。我們看到這兩者在第二季度都在加速，並且在第三季度繼續看到這種情況。

And for Keveyis, we said, I think we've done an amazing job of kind of managing the space for the benefit of the patients with PPP. And that is being -- we see that in the resilience that patients and physicians are willing to fight for brand. So we see that continuing. Now could it get -- maybe another player coming in or something would maybe potentially disrupt that? But until that happens, we're really confident that it's going to hold its resiliency.

對於 Keveyis，我們說，我認為我們在管理空間方面做得非常出色，為 PPP 患者造福。這就是——我們看到患者和醫生願意為品牌而戰的韌性。所以我們看到這種情況仍在繼續。現在可能會出現——也許有另一個球員加入，或者有什麼可能會擾亂這一點？但在此之前，我們確實有信心它將保持彈性。

Great. Thank you.

偉大的。謝謝。

We have no further questions in the queue at this time. So I'll hand back over to the team for closing remarks.

目前我們隊列中沒有其他問題。因此，我將把閉幕詞交回給團隊。

Well, thank you everyone for listening today. As you've just heard, Xeris is stronger than ever. I'm confident that by executing on the three priorities I talked about earlier, we will deliver a robust business result that will ultimately translate into meaningful shareholder value. Thank you again for your time this morning.

好的，謝謝大家今天的收聽。正如您剛才所聽到的，Xeris 比以往任何時候都更強大。我相信，透過執行我之前談到的三個優先事項，我們將提供強勁的業務成果，最終轉化為有意義的股東價值。再次感謝您今天早上抽出時間。

That concludes today's call. Thank you for joining. You may now disconnect your lines.

今天的電話會議到此結束。感謝您的加入。現在您可以斷開線路。