Xeris Biopharma Holdings Inc (XERS) 2022 Q4 法說會逐字稿

Hello, and welcome to the Xeris Biopharma Fourth Quarter and Year-end 2022 Conference Call. My name is Alex. I'll be coordinating the call today. (Operator Instructions) I'll now hand over to your host, Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

您好，歡迎來到 Xeris Biopharma 第四季度和 2022 年底電話會議。我的名字叫亞歷克斯。我將協調今天的電話會議。 （操作員說明）我現在將交給您的主持人，投資者關係和企業傳播高級副總裁 Allison Wey。請繼續。

Thank you, Alex. Good morning, and welcome to Xeris' fourth quarter and full year 2022 financial results conference call and webcast. A press release with the company's financial results was issued earlier this morning and can be found on our website.

謝謝你，亞歷克斯。早上好，歡迎來到 Xeris 的第四季度和 2022 年全年財務業績電話會議和網絡直播。今天上午早些時候發布了一份包含公司財務業績的新聞稿，可以在我們的網站上找到。

We are joined this morning by Paul Edick, Chairman and CEO; and Steve Pieper, CFO. Paul will provide opening remarks. Steve will provide details on our financial results. And after a few closing remarks by Paul, we will open the call for Q&A.

今天上午，董事長兼首席執行官 Paul Edick 加入了我們的行列；和首席財務官 Steve Pieper。保羅將提供開場白。史蒂夫將提供我們財務業績的詳細信息。在 Paul 發表幾句結束語之後，我們將開啟問答環節。

Before we begin, I would like to remind you that this call will contain forward-looking statements, which may include, but are not limited to, statements concerning our business practices, future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy and performance, which constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by the forward-looking statements made during this call as a result of various factors, including our financial position and need for financing, including to fund our product, the development programs or commercialization efforts, whether our products will achieve and maintain market acceptance, our reliance on third-party suppliers, including single-source suppliers, our reliance on third parties to conduct clinical trials, the ability of our product candidates to complete successfully with existing and new drugs, the effect of uncertainties related to the impact of COVID-19 on our business operations and clinical activities and our and collaborators ability to protect our intellectual property and proprietary technology as well as other risk factors set forth in our filings with the Securities and Exchange Commission. Any forward-looking statements in this call represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. Subject to obligations under applicable laws, we disclaim any obligations 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前瞻性陳述，其中可能包括但不限於有關我們的業務實踐、未來預期、計劃、前景、臨床批准、商業化、公司戰略的陳述和業績，構成 1995 年《私人證券訴訟改革法案》含義內的前瞻性陳述。由於各種因素，包括我們的財務融資的地位和需求，包括為我們的產品、開發計劃或商業化努力提供資金，我們的產品是否會獲得併保持市場接受度，我們對第三方供應商（包括單一來源供應商）的依賴，我們對第三方進行的依賴臨床試驗，我們的候選產品成功完成現有藥物和新藥的能力，與 COVID-19 對我們的業務運營和臨床活動的影響相關的不確定性的影響，以及我們和合作者保護我們的知識產權和專有技術的能力以及我們向美國證券交易委員會提交的文件中規定的其他風險因素。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，不應被視為代表我們截至任何後續日期的觀點。根據適用法律規定的義務，我們不承擔任何更新此類聲明的義務。

I'll now turn the call over to Paul.

我現在將電話轉給保羅。

Thank you, Allison. Good morning, everyone, and thank you for joining us today.

謝謝你，艾莉森。大家早上好，感謝您今天加入我們。

Before highlighting our achievements for the quarter and full year, I want to reiterate what we are building at Xeris. Everyone at Xeris is intensely focused on building a substantial patient-centric, commercially focused, self-sustaining biopharmaceutical enterprise with multiple products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise and increasingly value-added technology partnerships. What you will hear today is we are continuing to progress very successfully on that journey. We are executing our vision.

在強調我們本季度和全年的成就之前，我想重申我們在 Xeris 的建設。 Xeris 的每個人都非常專注於建立一個實質性的以患者為中心、以商業為中心、自我維持的生物製藥企業，在多個治療領域擁有多種產品，一個具有重大長期承諾和越來越多的增值技術合作夥伴關係的高度針對性的開發管道。您今天將聽到的是，我們將繼續在此旅程中取得非常成功的進展。我們正在執行我們的願景。

On to our key highlights. We ended 2022 with another record-breaking quarter and full year, delivering net product revenue growth of 52% and 38%, respectively, on a pro forma basis. We finished the year with $110 million in total revenue and more than $120 million in cash on hand. Steve will provide more specific details on all of that. We also advanced our levothyroxine pipeline program, added another high-profile and potentially very valuable XeriJect program with Horizon and prudently manage expenses and cash utilization. Our momentum carries into 2023 and set the stage for what I believe will be the most meaningful period in our company's history, achieving cash flow breakeven in the fourth quarter without the need for additional capital to fund our operations.

關於我們的主要亮點。我們以另一個創紀錄的季度和全年結束了 2022 年，在備考基礎上實現了 52% 和 38% 的淨產品收入增長。我們以 1.1 億美元的總收入和超過 1.2 億美元的手頭現金結束了這一年。史蒂夫將提供所有這些的更具體細節。我們還推進了我們的左旋甲狀腺素管道項目，增加了另一個備受矚目的且可能非常有價值的 XeriJect 項目與 Horizon 並審慎地管理費用和現金利用。我們的勢頭將延續到 2023 年，並為我認為這將是我們公司歷史上最有意義的時期奠定基礎，即在第四季度實現現金流收支平衡，而無需額外資本來為我們的運營提供資金。

I'll break down these achievements by product and program starting with Gvoke. Gvoke had another record quarter and year in terms of net revenue and prescriptions, $15 million in net revenue, a 36% increase compared to the fourth quarter of 2021 and an 8% increase from the third quarter of 2022. For the full year of 2022, Gvoke net revenues increased 35% compared to 2021. Total prescriptions for the fourth quarter were over 41,000, growing more than 42% compared to the same period last year. Gvoke total prescriptions for the full year were over 145,000, growing approximately 54% compared to 2021.

我將從 Gvoke 開始按產品和程序分解這些成就。 Gvoke 在淨收入和處方方面的季度和年度再創新高，淨收入為 1500 萬美元，比 2021 年第四季度增長 36%，比 2022 年第三季度增長 8%。2022 年全年， Gvoke 淨收入與 2021 年相比增長了 35%。第四季度的總處方量超過 41,000，與去年同期相比增長了 42% 以上。 Gvoke 全年總處方量超過 145,000 張，與 2021 年相比增長約 54%。

The total glucagon market also grew 6% in the fourth quarter versus fourth quarter 2021. For the full year 2022, the total glucagon market grew 9% versus 2021. And so far, in January of 2023, market growth is back to double digits, with Gvoke continuing to outpace and drive market growth. At the end of February, Gvoke's market share of new prescriptions in the glucagon market grew to approximately 28%. Ready-to-use glucagon products now represent almost 75% of the total new prescription market for rescue glucagon. While more and more patients on insulin are getting a ready-to-use glucagon such as Gvoke, there are still over 7 million who remain at high risk and don't have a ready-to-use Gvoke available, just in case. To address this critical situation and motivate healthcare professionals to do more, the ADA and Endo Society and other groups have recently updated their guidelines and include an important focus on the incorporation of ready-to-use glucagon into clinical practice. For example, the Endo Society expanded the definition of those at high risk for severe low and strongly recommends that ready-to-use glucagon should be prescribed for all patients with diabetes on insulin or sulfonylureas, confirming what we've been saying all along.

與 2021 年第四季度相比，第四季度胰高血糖素市場總量也增長了 6%。到 2022 年全年，胰高血糖素市場總量與 2021 年相比增長了 9%。到目前為止，到 2023 年 1 月，市場增長又回到了兩位數， Gvoke 繼續超越並推動市場增長。 2月底，國沃克在胰高血糖素市場的新處方市場份額增長至約28%。即用型胰高血糖素產品現在幾乎佔救援胰高血糖素新處方市場總量的 75%。雖然越來越多使用胰島素的患者正在使用 Gvoke 等即用型胰高血糖素，但仍有超過 700 萬人仍處於高風險中，並且沒有現成可用的 Gvoke，以防萬一。為了解決這一危急情況並激勵醫療保健專業人員做更多事情，ADA 和 Endo 協會以及其他團體最近更新了他們的指南，並重點關注將即用型胰高血糖素納入臨床實踐。例如，Endo Society 將高危人群的定義擴展為嚴重低危人群，並強烈建議所有使用胰島素或磺脲類藥物的糖尿病患者都應開具即用型胰高血糖素處方，這證實了我們一直在說的話。

Moving on to Keveyis. Keveyis also had a record quarter and year, approximately $14 million for the quarter and just over $49 million for the full year. which represent increases of 33% and 23%, respectively, on a pro forma basis. To date, in 2023, we have not experienced negative impact on Keveyis from the first generic entry. That isn't to say there won't be an impact. However, this is a challenging marketplace that requires significant work to identify patients and initiate therapy. We have yet to see how the generics may impact that process and the market as a whole. We will see how it plays out over the course of the year. That said, given the market dynamics, historically, we are continuing to invest in Keveyis. Despite the entrance of a generic, we believe we can maintain a considerable portion of the business, we've worked so hard to build on behalf of the PPP community.

繼續前往凱維伊斯。 Keveyis 也有創紀錄的季度和年度，本季度約為 1400 萬美元，全年略高於 4900 萬美元。在備考基礎上分別增長了 33% 和 23%。迄今為止，在 2023 年，我們還沒有遇到第一個仿製藥對 Keveyis 的負面影響。這並不是說不會有影響。然而，這是一個充滿挑戰的市場，需要大量工作來識別患者並開始治療。我們還沒有看到仿製藥會如何影響該過程和整個市場。我們將看到它在這一年中的表現如何。也就是說，鑑於市場動態，從歷史上看，我們將繼續投資於 Keveyis。儘管仿製藥進入市場，但我們相信我們可以維持相當一部分業務，我們一直努力代表 PPP 社區進行建設。

On to Recorlev. Recorlev is generating $3.8 million in net revenue for the fourth quarter, an increase of 51% from the third quarter. Total 2022 revenue for Recorlev was $7.4 million, and that's only in about 3/4 of patient referrals and initiations with minimal dose titration. This is totally in line with our expectations for the early stages of the launch. Referral and initiation of therapy in Cushing's is a very deliberate process. And since launch in mid-first quarter of last year, we have steadily grown the number of patient referrals to Recorlev, and we are continuing to steadily increase the number of patients started on therapy. We are also starting to see many of those patients that started on therapy last year begin to slowly titrate up their average daily dose. It's still very early in the launch, but Recorlev continues to grow nicely and continues to show great long-term growth potential.

前往 Recorlev。 Recorlev 第四季度的淨收入為 380 萬美元，比第三季度增長 51%。 Recorlev 的 2022 年總收入為 740 萬美元，這僅佔約 3/4 的患者轉診和啟動最小劑量滴定。這完全符合我們對上線初期的預期。庫欣病的轉診和治療啟動是一個非常慎重的過程。自去年第一季度中推出以來，我們已經穩步增加了轉診到 Recorlev 的患者數量，並且我們正在繼續穩步增加開始接受治療的患者數量。我們也開始看到許多去年開始接受治療的患者開始慢慢增加他們的平均每日劑量。它仍處於發布初期，但 Recorlev 繼續保持良好增長，並繼續顯示出巨大的長期增長潛力。

Turning to our pipeline and our partner programs using our unique XeriSol and XeriJect technologies. For our internal development and eventual commercialization, our focus is on advancing the levothyroxine program. This program is the development of our small volume, ready-to-use once-weekly liquid formulation of levothyroxine for subcutaneous injection using our XeriSol technology. As you will recall, last fall, we reported positive top line results from the Phase 1 pharmacokinetic comparison of oral Synthroid versus subcutaneous XP-8121 in healthy volunteers. As we discussed at the time, all of the data from that Phase 1 study were then combined to develop a population pharmacokinetic model. That model allowed us to perform simulations of various chronic dosing scenarios. Based on comparable exposure at steady state, the model estimated that 1,200 micrograms of once-weekly XP-8121 could provide similar exposure to 300 micrograms of daily oral Synthroid, implying a 4x conversion factor between once daily and once weekly. We presented these data at a Type C meeting with the FDA at the end of last year. Based on the FDA's feedback, we will now initiate a Phase 2 study in subjects currently taking oral thyroid replacement therapy to confirm the dose conversion to once weekly XP-8121. We expect to begin that study by mid-2023. Data from this Phase 2 study will then inform our proposal to the FDA for a pivotal Phase 3 program.

使用我們獨特的 XeriSol 和 XeriJect 技術轉向我們的管道和我們的合作夥伴計劃。對於我們的內部開發和最終商業化，我們的重點是推進左旋甲狀腺素項目。該項目是使用我們的 XeriSol 技術開發的用於皮下注射的小體積、即用型每週一次的左旋甲狀腺素液體製劑。你會記得，去年秋天，我們報告了在健康志願者中口服 Synthroid 與皮下注射 XP-8121 的第一階段藥代動力學比較的積極頂線結果。正如我們當時所討論的那樣，該 1 期研究的所有數據隨後被合併以開發群體藥代動力學模型。該模型使我們能夠模擬各種慢性給藥方案。基於穩定狀態下的可比較暴露，該模型估計 1,200 微克每週一次的 XP-8121 可以提供與 300 微克每日口服 Synthroid 相似的暴露，這意味著每天一次和每週一次之間的轉換係數為 4 倍。我們在去年年底與 FDA 舉行的 C 類會議上介紹了這些數據。根據 FDA 的反饋，我們現在將在目前正在接受口服甲狀腺替代療法的受試者中啟動一項 2 期研究，以確認劑量轉換為每週一次的 XP-8121。我們預計在 2023 年中期開始這項研究。來自該第 2 階段研究的數據將告知我們向 FDA 提出的關鍵第 3 階段計劃的建議。

Oral levothyroxine has been the standard of care for treatment of hypothyroidism for many years, and it continues and it is one of the most prescribed medicine in the United States, generating more than 100 million prescriptions per year. However, 49% of the patients have some GI issue or comorbid GI condition impacting oral absorption. 21% take concomitant medications that could interfere with absorption and 17% of patients admit to compliance issues with the daily oral regimen and many of whom may or may not be the same patient experiencing multiple issues. If we assume conservatively that 62 million weekly doses per year is the addressable opportunity in that population that's having difficulties with the oral dosage. At today's branded Synthroid cost, which is approximately USD35 to USD50 per weekly dose, that would equal a potential USD2.2 billion to USD3 billion market segment that would be our target opportunity. a very substantial opportunity for a once-weekly drug.

多年來，口服左旋甲狀腺素一直是治療甲狀腺功能減退症的標準療法，並且仍在繼續，它是美國開處方最多的藥物之一，每年產生超過 1 億張處方。然而，49% 的患者有一些胃腸道問題或胃腸道共病影響口服吸收。 21% 的人服用可能會干擾吸收的伴隨藥物，17% 的患者承認每日口服治療方案存在依從性問題，其中許多人可能是也可能不是遇到多個問題的同一位患者。如果我們保守地假設每年 6200 萬週劑量是該人群中口服劑量困難的可尋址機會。按照今天的品牌 Synthroid 成本，每週劑量約為 35 美元至 50 美元，這相當於潛在的 22 億美元至 30 億美元的細分市場，這將是我們的目標機會。對於每週一次的藥物來說，這是一個非常重要的機會。

In November, we announced a collaboration and option agreement with Horizon Therapeutics to use our proprietary formulation technologies XeriJect to develop an ultra-concentrated ready-to-use subcutaneous injectable version of TEPEZZA. Upon successful completion of the formulation development, Horizon will have an option to license the Xeris delivery technology for further clinical development and commercialization of TEPEZZA. You may know that TEPEZZA is the first and only medicine approved in the U.S. approved by the U.S. Food and Drug Administration or FDA for the treatment of thyroid eye disease, which is a serious, progressive and potentially vision-threatening rare autoimmune disease. TEPEZZA in its IV form generated net sales of almost $2 billion worldwide in 2022. To engage in the project to develop a subcutaneous form, we received an upfront payment from Horizon of $2.75 million in the fourth quarter and will be entitled to receive a payment of $6 million on successful achievement of the target formulation. If the commercial option is then exercised by Horizon, Xeris would also be entitled to future development, regulatory and sales-based milestones and royalties based on future sales.

11 月，我們宣布與 Horizon Therapeutics 達成合作和選擇協議，使用我們專有的配方技術 XeriJect 開發超濃縮即用型皮下注射劑 TEPEZZA。成功完成配方開發後，Horizon 將有權選擇許可 Xeris 交付技術，用於 TEPEZZA 的進一步臨床開發和商業化。您可能知道 TEPEZZA 是美國食品和藥物管理局或 FDA 批准的第一個也是唯一一個在美國批准用於治療甲狀腺眼病的藥物，甲狀腺眼病是一種嚴重的、進行性的和可能威脅視力的罕見自身免疫性疾病。 IV 形式的 TEPEZZA 到 2022 年在全球產生了近 20 億美元的淨銷售額。為了參與開發皮下形式的項目，我們在第四季度從 Horizon 收到了 275 萬美元的預付款，並將有權收到600 萬美元用於成功實現目標制定。如果 Horizon 隨後行使商業選擇權， Xeris 還將有權獲得未來的開發、監管和基於銷售的里程碑以及基於未來銷售的特許權使用費。

Moving on to our outlook for 2023. As I said at the start of this call, I believe this is a pivotal year for Xeris as we build on our 2022 momentum, achieve cash flow breakeven in the fourth quarter and do that without the need for additional capital to raise or to fund operations. We are positioned for continued growth and are providing the following 2023 guidance. We believe we can deliver total revenues of between USD135 million and USD165 million in 2023. This includes net product revenue from current commercial products and other revenue from existing and potentially new technology collaborations. The midpoint of this range implies approximately 36% growth from 2022. We expect the rate of cash utilization in 2023 to be significantly less than 2022. In 2023, we expect that to be in the range of USD57 million to USD77 million. with the first quarter being the highest and improving considerably by the second half of the year, driven by our projected revenue growth and by aggressive cash management. We expect year-end cash, cash equivalents and short-term investments of between USD45 million and USD65 million. This guidance should give you confidence that our business is self-sustainable beyond 2023.

繼續我們對 2023 年的展望。正如我在本次電話會議開始時所說，我相信今年對 Xeris 來說是關鍵的一年，因為我們將在 2022 年的勢頭基礎上再接再厲，在第四季度實現現金流收支平衡，並且無需籌集或資助運營的額外資金。我們為持續增長做好了準備，並提供以下 2023 年指導。我們相信我們可以在 2023 年實現 1.35 億美元至 1.65 億美元的總收入。這包括來自當前商業產品的淨產品收入以及來自現有和潛在新技術合作的其他收入。該範圍的中點意味著從 2022 年開始大約增長 36%。我們預計 2023 年的現金利用率將大大低於 2022 年。到 2023 年，我們預計將在 5700 萬美元至 7700 萬美元之間。第一季度是最高的，並且在我們預計的收入增長和積極的現金管理的推動下，到下半年將有顯著改善。我們預計年底現金、現金等價物和短期投資在 4500 萬美元至 6500 萬美元之間。該指南應該讓您相信我們的業務在 2023 年之後能夠自我維持。

I'll turn the call to Steve for additional details of our 2022 performance. and our 2023 guidance. Steve?

我會把電話轉給史蒂夫，了解我們 2022 年業績的更多細節。以及我們的 2023 年指南。史蒂夫？

Thanks, Paul. Good morning, everyone.

謝謝，保羅。大家，早安。

I will focus my remarks on a few of the key financial quarterly and full year '22 results and provide 2023 financial guidance, the details of which are in the press release issued this morning.

我將重點關註一些關鍵的財務季度和全年 22 年業績，並提供 2023 年的財務指導，其詳細信息在今天上午發布的新聞稿中。

Focusing on fourth quarter results, total net product revenue was a record $32.5 million, representing a 52% increase over the same quarter last year. Strong underlying patient demand for both Gvoke and Keveyis and new patient starts on therapy for Recorlev drove total product revenue growth in the quarter. On a full year basis, our total net product revenue was over $109 million, finishing the year at the top end of our most recent guidance of total net product revenue of USD105 million to USD110 million. On a pro forma basis, total net product revenue grew 38% in 2022 versus 2021. This increase was driven by continuous growth in Gvoke and Keveyis and the launch of Recorlev in the first quarter of 2022. We are pleased by the performance across all of our products driving this growth.

關注第四季度業績，產品總淨收入達到創紀錄的 3250 萬美元，比去年同期增長 52%。患者對 Gvoke 和 Keveyis 的強勁潛在需求以及新患者開始接受 Recorlev 治療推動了本季度產品總收入的增長。在全年基礎上，我們的產品淨收入總額超過 1.09 億美元，在我們最近的產品淨收入總額 1.05 億美元至 1.1 億美元的指引的頂端結束了這一年。在備考基礎上，2022 年淨產品總收入比 2021 年增長了 38%。這一增長是由 Gvoke 和 Keveyis 的持續增長以及 2022 年第一季度 Recorlev 的推出推動的。我們對所有業務的表現感到滿意我們的產品推動了這一增長。

Breaking it down by product. Gvoke net revenue for the quarter was a record $14.9 million, representing a 36% increase compared to the same period last year. This increase in revenue was driven by continued growth in Gvoke prescriptions, topping 41,000 for the first time, more than a 42% increase compared to the same period in 2021. This growth in demand was partially offset by a decrease in net pricing. Consistent with prior years, the total glucagon prescription market declined in Q4 versus Q3. Notably, Gvoke total prescriptions grew 8% in the same period, significantly outpacing the market. Full year 2022, Gvoke net revenue was $52.5 million, representing a 35% increase compared to 2021. This increase was driven by a 54% growth in total prescriptions when compared to 2021, which was partially offset by a decrease in net pricing. As we mentioned last quarter, our net pricing has stabilized in the second half of 2022.

按產品分解。 Gvoke 本季度的淨收入達到創紀錄的 1490 萬美元，與去年同期相比增長了 36%。這一收入增長是由 Gvoke 處方的持續增長推動的，首次超過 41,000 種，與 2021 年同期相比增長超過 42%。這種需求增長被淨定價的下降部分抵消。與往年一樣，與第三季度相比，第四季度胰高血糖素處方藥市場總量有所下降。值得注意的是，Gvoke 的總處方藥同期增長了 8%，大大超過了市場。 2022 年全年，Gvoke 淨收入為 5250 萬美元，比 2021 年增長 35%。這一增長是由於處方藥總量比 2021 年增長了 54%，部分被淨定價下降所抵消。正如我們上個季度提到的，我們的淨定價在 2022 年下半年已經穩定下來。

Moving to Keveyis. Keveyis net revenue for the quarter was $13.8 million, representing a 33% increase when compared to the same period last year. On a full year basis, Keveyis net revenue was $49.3 million, representing a 23% increase compared to 2021 on a pro forma basis. Revenue growth was driven by continued increases in the number of patients on Keveyis, coupled with a net pricing increase. Our commercial strategy on Keveyis since day 1 has been preparing ourselves for the possibility of losing orphan drug exclusivity status in August of 2022 and the potential entrance of generic competition. As we have discussed previously, we continue to seek patents to restore our exclusive rights. In late 2022, the FDA approved the generic version of Keveyis. Our 2023 revenue guidance, which I will cover later in my remarks, assumes an impact of generic competition on Keveyis in 2023.

搬到凱維伊斯。 Keveyis 本季度的淨收入為 1380 萬美元，與去年同期相比增長了 33%。按全年計算，Keveyis 的淨收入為 4930 萬美元，與 2021 年相比增長了 23%。收入增長是由 Keveyis 患者數量持續增加以及淨價格上漲推動的。從第一天開始，我們對 Keveyis 的商業策略就一直在為 2022 年 8 月失去孤兒藥獨占地位的可能性以及仿製藥競爭的潛在進入做準備。正如我們之前所討論的，我們繼續尋求專利以恢復我們的專有權。 2022 年底，FDA 批准了 Keveyis 的仿製藥。我們的 2023 年收入指引假設 2023 年仿製藥競爭對 Keveyis 產生影響，我將在稍後的評論中介紹。

Moving to Recorlev. Recorlev net revenue for the quarter was $3.8 million, which represents a 51% increase over prior quarter and is a direct result of the steady growth of patients on therapy during Q4. Full year Recorlev net revenue was $7.4 million. Given we are less than 1 year in the launch, we continue to be pleased with our initial financial performance of Recorlev.

搬到 Recorlev。 Recorlev 本季度的淨收入為 380 萬美元，比上一季度增長 51%，這是第四季度接受治療的患者穩步增長的直接結果。 Recorlev 全年淨收入為 740 萬美元。鑑於我們推出不到 1 年，我們仍然對 Recorlev 的初始財務表現感到滿意。

In addition to our total product revenue of $109 million, we generated $1 million of revenue from existing collaborations and partnerships for total revenue of $110 million in 2022. Looking ahead for the full year 2023 and -- we expect our total revenue to be in the range of USD135 million to USD165 million, reflecting combined Gvoke, Keyevis and Recorlev net product revenue and other revenue from existing and potential collaborations and partnerships. Other revenues in the year are expected to be episodic based upon our ability to attract new partners and successfully execute work plans, meet target product profiles and/or achieve other development milestones on existing agreements.

除了我們 1.09 億美元的產品總收入外，我們還從現有的合作和夥伴關係中獲得了 100 萬美元的收入，2022 年的總收入為 1.1 億美元。展望 2023 年全年，我們預計我們的總收入將達到1.35 億美元至 1.65 億美元，反映了 Gvoke、Keyevis 和 Recorlev 的合併淨產品收入以及來自現有和潛在合作夥伴關係的其他收入。根據我們吸引新合作夥伴和成功執行工作計劃、滿足目標產品概況和/或實現現有協議的其他發展里程碑的能力，預計今年的其他收入將是偶發的。

Moving down the P&L. All of my remarks will be focused on full year results. Cost of goods sold increased by $9.3 million for the year 2022 compared to '21. The increase was mainly attributable to our sales growth. Research and development expenses decreased $4.2 million in 2022 when compared to 2021. The decrease was primarily a result of lower product development costs, driven by internal capital prioritization. In 2023, we will continue to practice disciplined prioritization and we'll be funding our levo Phase 2 program, the completion of the Recorlev OPTICS study and continued development work on our proprietary formulation science. All of this will result in a projected modest year-over-year increase in R&D in 2023.

向下移動損益表。我所有的評論都將集中在全年業績上。與 21 年相比，2022 年的銷售成本增加了 930 萬美元。增加主要歸因於我們的銷售增長。與 2021 年相比，2022 年的研發費用減少了 420 萬美元。減少的主要原因是在內部資本優先排序的推動下產品開發成本降低。 2023 年，我們將繼續實行嚴格的優先排序，我們將資助我們的 levo 第二階段計劃，完成 Recorlev OPTICS 研究，並繼續開展我們專有配方科學的開發工作。所有這些都將導致 2023 年的研發支出預計同比溫和增長。

Selling, general and administrative expenses increased by $12 million in 2022 when compared to '21. This increase was driven by the inclusion of a full year of Keveyis' commercial infrastructure and our 2022 financial results, which is not a change on a pro forma basis; Recorlev commercial costs related to the product's launch in 2022, and a previously communicated Gvoke sales expansion executed in the fourth quarter. The overall increase to SG&A was partially offset by lower Strongbridge acquisition-related transaction and restructuring costs in 2022 when compared to 2021. Looking ahead to 2023, even with the aforementioned sales force expansion in the fourth quarter of 2022, we expect total SG&A to be relatively flat in 2023 when compared to 2022.

與 21 年相比，2022 年的銷售、一般和管理費用增加了 1200 萬美元。這一增長是由於納入了 Keveyis 的全年商業基礎設施和我們 2022 年的財務業績，這不是備考基礎上的變化； Recorlev 與該產品於 2022 年推出相關的商業成本，以及先前傳達的第四季度執行的 Gvoke 銷售擴張。與 2021 年相比，2022 年 Strongbridge 收購相關交易和重組成本的降低部分抵消了 SG&A 的總體增長。展望 2023 年，即使上述銷售人員在 2022 年第四季度擴張，我們預計 SG&A 總額將與 2022 年相比，2023 年相對平穩。

From a cash perspective, as of December 31, 2022, Xeris had total cash, cash equivalents and short-term investments of $122 million compared to $93 million at September 30, 2022. Our year-end cash, cash equivalents and short-term investments exceeded the high end of our previously issued cash guidance. As a reminder, the $122 million included a drawdown of the final $50 million tranche from the Hayfin debt facility and an upfront payment of $2.75 million from the Horizon Therapeutics collaboration and option agreement.

從現金角度來看，截至 2022 年 12 月 31 日，Xeris 的現金、現金等價物和短期投資總額為 1.22 億美元，而 2022 年 9 月 30 日為 9300 萬美元。我們的年終現金、現金等價物和短期投資超過了我們之前發布的現金指導的上限。提醒一下，這 1.22 億美元包括從 Hayfin 債務融資中提取的最後一筆 5000 萬美元，以及從 Horizon Therapeutics 合作和期權協議中預付的 275 萬美元。

Cash utilized in operating activities improved over the course of 2022, supported by strong revenue growth from all 3 brands, disciplined expense management and synergy realization after completing the Strongbridge integration. Cash utilization from operating activities, including restricted cash, was $103 million in 2022. In 2023, we project cash utilization from operating activities in the range of USD57 million to USD77 million. As we experienced last year, cash utilization in the first quarter is expected to be the highest quarter in 2023, driven by changes in working capital, including investments in inventory to support revenue growth. Cash utilization is expected to moderate through the middle of 2023 until the fourth quarter when we expect to achieve cash flow breakeven. As noted, our SG&A expenses to be relatively flat to 2022 and are projecting a modest increase in R&D expenses for 2023, mainly driven by the programs we are funding that I previously mentioned. Considering our growing revenue and anticipated operating expenses in 2023, we expect our total cash, cash equivalents and short-term investments to end the year in the range of USD45 million to USD65 million meaning total cash utilized from operating activities for the year is expected to be in the range of USD57 million to USD77 million.

在所有 3 個品牌的強勁收入增長、嚴格的費用管理和完成 Strongbridge 整合後協同效應的實現的支持下，經營活動中使用的現金在 2022 年有所改善。 2022 年來自經營活動的現金使用量（包括受限現金）為 1.03 億美元。到 2023 年，我們預計來自經營活動的現金使用量在 5700 萬美元至 7700 萬美元之間。正如我們去年所經歷的那樣，第一季度的現金利用率預計將是 2023 年最高的一個季度，這是受營運資本變化的推動，包括為支持收入增長而進行的庫存投資。現金利用率預計將在 2023 年年中之前放緩，直到第四季度我們預計將實現現金流盈虧平衡。如前所述，我們的 SG&A 費用到 2022 年將相對持平，並且預計 2023 年的研發費用將適度增加，這主要是由我之前提到的我們正在資助的項目推動的。考慮到我們在 2023 年不斷增長的收入和預期的運營費用，我們預計我們的現金、現金等價物和短期投資總額將在 4500 萬美元至 6500 萬美元之間，這意味著今年經營活動使用的現金總額預計將介於 5700 萬美元至 7700 萬美元之間。

Assuming we are performing to our guidance, we project to reach cash flow breakeven in the fourth quarter of 2023. And from that point on, we will be a self-sustaining enterprise. I want to clarify for everyone what we mean by cash flow breakeven. Cash flow breakeven in its simplest terms means cash inflows will meet or exceed cash outflows. This will be further evidenced on our balance sheet. We expect our cash, cash equivalents and short-term investment balances at December 31, 2023, to be at or above our September 30, 2023 balances. Furthermore, and to reiterate our previous position, we do not plan to raise capital to fund our operations as we become a self-sustaining enterprise.

假設我們按照我們的指導執行，我們預計將在 2023 年第四季度實現現金流盈虧平衡。從那時起，我們將成為一家自給自足的企業。我想給大家澄清一下我們所說的現金流盈虧平衡是什麼意思。用最簡單的術語來說，現金流盈虧平衡意味著現金流入將達到或超過現金流出。這將在我們的資產負債表上得到進一步證明。我們預計 2023 年 12 月 31 日的現金、現金等價物和短期投資餘額將等於或高於 2023 年 9 月 30 日的餘額。此外，為了重申我們之前的立場，我們不打算籌集資金來為我們的運營提供資金，因為我們將成為一家能夠自我維持的企業。

I will now turn the call back to Paul.

我現在將電話轉回給保羅。

Thanks, Steve. That's a picture of outstanding performance for the quarter and the year. And as I said at the beginning of our call, we are building up substantial patient-centric, commercially focused, self-sustaining biopharma enterprise with multiple products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise and increasingly value-added technology partnerships and critically important to this journey, is consistently meeting the needs of our patients and their caregivers.

謝謝，史蒂夫。這是本季度和本年度出色表現的畫面。正如我在電話會議開始時所說的那樣，我們正在建立以患者為中心、以商業為中心、自我維持的實質性生物製藥企業，在多個治療領域擁有多種產品，這是一個具有重大長期前景和越來越多的高度針對性的開發管道增值技術合作夥伴關係對這一旅程至關重要，它始終如一地滿足我們患者及其護理人員的需求。

What you heard today is confirmation that we are continuing to progress very successfully on that journey. We started 2023 building on our tremendous 2022 performance, through continued revenue growth, careful allocation of resources and prudent expense management, we expect 2023 to be a pivotal year for Xeris on that journey. Now operator, if you would please open the lines for questions.

你今天聽到的是我們在這一旅程中繼續非常成功地取得進展的確認。我們在 2022 年的巨大業績基礎上開始了 2023 年，通過持續的收入增長、謹慎的資源分配和審慎的費用管理，我們預計 2023 年將成為 Xeris 在這一旅程中的關鍵一年。現在接線員，如果你願意，請打開問題線路。

(Operator Instructions) Our first question for today comes from Oren Livnat from H.C. Wainwright.

（操作員說明）我們今天的第一個問題來自 H.C. 的 Oren Livnat。溫賴特。

Congrats on executing across the board and solid guidance. I have a few on that guidance. I think that's a wider range than you've given in the past. And so obviously, there's several moving parts. I was wondering if you could just talk about those. Is this mostly giving a wide birth for potential Recorlev growth so early in the launch? Or is the Keveyis generic impact uncertainty, the biggest lever there, up or down? And I have a follow-up.

祝賀您全面執行並提供可靠的指導。我有一些關於該指導的信息。我認為這比你過去給出的範圍更廣。很明顯，有幾個活動部件。我想知道你是否可以談談這些。這主要是在發布這麼早的時候為潛在的 Recorlev 增長提供了廣泛的誕生嗎？或者是 Keveyis 的一般影響不確定性，那裡最大的槓桿，向上或向下？我有一個後續行動。

You're absolutely correct. It's a wider range than normal. And yes, it's because there are a lot of moving parts. We're in the early stages of the Recorlev launch. How that goes is going to be yet to be determined. We've yet to see any real impact on Keveyis, but not to say there won't be some. And we don't know it's sitting here today what that's going to look like. That being said, the low end of our range is still 30%, 32%-ish growth over prior year. So at any point in the range, we're still growing really, really nicely.

你完全正確。它的範圍比正常範圍更廣。是的，這是因為有很多移動部件。我們正處於 Recorlev 發布的早期階段。這將如何進行還有待確定。我們尚未看到對 Keveyis 有任何實際影響，但並不是說不會有任何影響。我們不知道它今天坐在這裡會是什麼樣子。話雖這麼說，我們範圍的低端仍然是 30%，比上一年增長 32%。因此，在該範圍內的任何時候，我們仍在非常非常好地增長。

Right. And I guess regarding Keveyis, to your understanding, is there anything operationally for sale out there in the market at all at this point? Or is this just a theoretical threat that the Torrent or whoever is actually commercializing that has to really set up infrastructure that doesn't even exist as far as you can tell? Is a doc even able to write or someone able to fill a generic prescription?

正確的。我想關於 Keveyis，據您了解，目前市場上是否有任何可操作的產品可供出售？或者這只是一個理論上的威脅，Torrent 或任何實際商業化的人必須真正建立據您所知甚至不存在的基礎設施？醫生甚至可以寫字或者有人可以開普通處方嗎？

Yes. So, so far, no. But we heard as recently as Friday, that they now have a specialty pharmacy and are beginning to ship product to specialty pharmacy. Physicians have yet to be able to substitute. There hasn't been product in the chain. The one thing to keep in mind is when you look at a Keveyis patient, we surround that patient with more than just a drug delivered from the pharmacy. We have a group called our patient affairs managers that really spend a great deal of time with patients, helping them through their drug initiation, their titration, if they have any side effects, they're there to call them on a regular basis. They help them with insurance. they help them navigate the pharmacy and make sure that they've got their drug and they get the prescription filled. We have a group that are mentors and we have current Keveyis patients who spend time, hold hands with new Keveyis patients. And we have the specialty pharmacy that is one single pharmacy dedicated to their well-being, interacts with their physicians on a regular basis. So until such time as a generic company sets up all of that, we believe patients will be inclined to take the time and energy and effort to appeal a generic mandate. And that's one of the reasons we think we can defend a considerable amount of this business. We'll see how that goes.

是的。所以，到目前為止，沒有。但就在周五，我們聽說他們現在有一家專業藥房，並開始將產品運送到專業藥房。醫生尚未能夠替代。鏈中沒有產品。要記住的一件事是，當你看 Keveyis 患者時，我們圍繞該患者提供的不僅僅是藥房提供的藥物。我們有一個叫做我們的患者事務經理的小組，他們真的花了很多時間與患者在一起，幫助他們完成藥物啟動、劑量調整，如果他們有任何副作用，他們會定期給他們打電話。他們幫助他們購買保險。他們幫助他們在藥房中導航，並確保他們拿到了他們的藥並且他們得到了處方。我們有一群導師，我們有現有的 Keveyis 患者，他們花時間與新的 Keveyis 患者握手。我們擁有專業藥房，這是一家致力於他們的福祉的單一藥房，定期與他們的醫生互動。因此，在仿製藥公司建立起所有這些之前，我們相信患者將傾向於花時間、精力和努力來呼籲仿製藥的授權。這就是我們認為我們可以捍衛相當數量的這項業務的原因之一。我們將看看情況如何。

All right. You actually segue to my last one, and I appreciate it. On Recorlev...

好的。你實際上繼續我的最後一個，我很感激。在 Recorlev...

Just as said, might well that we have [Laurent]...

正如所說，很可能我們有 [Laurent]...

Yes, exactly. So that patient support, and you mentioned walking them through initiation, titration, et cetera. On Recorlev, obviously, patient titration is an important part of that dynamic. And you mentioned, I think, some small uptick or patients beginning to up-titrate there. What are you seeing from existing patients, the earliest patients in terms of that trend in up-titration, and is that a process that you guys and your specialty pharmacy and your support hub or services are sort of holding their hands or walking them and/or their physicians through that process? Or at this point, you really just have to hope docs once initiated are doing the follow-up, the monitoring and the titration?

對，就是這樣。所以病人的支持，你提到過引導他們完成啟動、滴定等。顯然，在 Recorlev 上，患者滴定是該動態的重要組成部分。我認為你提到了一些小的上升或患者開始在那裡滴定。你從現有患者身上看到了什麼，最早的患者就滴定趨勢而言，你們和你的專業藥房以及你的支持中心或服務正在牽著他們的手或走他們和/或者他們的醫生通過那個過程？或者在這一點上，你真的只需要希望文檔一旦啟動就可以進行跟進、監控和滴定？

Yes. So good question. It isn't a hope. Hope is not a really good strategy, but it is different. When you look at the clinical study, the clinical study was a very structured environment. Patients were brought back every couple of weeks and the titration was on a schedule. In the real world, physicians are starting at the lowest dose, and they are managing the patients on the lowest possible dose throughout the process. So the titration is happening slower than you would have seen in the clinical study, but more or less what we had anticipated because physicians tend to like to start low and go slow, because that's a prudent approach, and we support that. So in this situation, it's more in the hands of the physician than it is in our patient managers. Our people do interact with the physician, and we interact with them on behalf of the patient to make sure that they are going back to the tests that need to be monitored that they are at the right dose when they get to the end of the month, the pharmacy says, you still want them on this dose. Do you want to titrate them just to make sure. So there's interactions that help manage the patient, but it is a slower and more painstaking process on the part of the physician.

是的。好問題。這不是希望。希望不是一個很好的策略，但它是不同的。當您查看臨床研究時，臨床研究是一個非常結構化的環境。病人每兩週被帶回來一次，滴定是按計劃進行的。在現實世界中，醫生從最低劑量開始，他們在整個過程中以盡可能低的劑量管理患者。所以滴定發生的速度比你在臨床研究中看到的要慢，但或多或少是我們預期的，因為醫生傾向於從低開始，然後慢慢來，因為這是一種謹慎的方法，我們支持這一點。所以在這種情況下，它更多地掌握在醫生手中，而不是我們的患者經理。我們的員工確實與醫生互動，我們代表患者與他們互動，以確保他們回到需要監測的測試，確保他們在月底時服用正確的劑量，藥房說，您仍然希望他們服用這種劑量。你想滴定它們只是為了確定嗎？因此，存在有助於管理患者的交互，但對醫生而言，這是一個更慢、更費力的過程。

All right. I'll get back in the queue. I appreciate it.

好的。我會回到隊列中。我很感激。

Our next question comes from Roanna Ruiz from SVB Securities.

我們的下一個問題來自 SVB Securities 的 Roanna Ruiz。

So wanted to tag on to the 2023 guidance question earlier. I was curious how large do you think the contribution might be from the other revenues piece that you described from partnerships and collaborations?

所以想更早地討論 2023 年的指導問題。我很好奇，您認為您描述的伙伴關係和合作帶來的其他收入貢獻有多大？

That's a really good question. Without us knowing, our partner Horizon made public the $2.75 million upfront and the potential $6 million payment on achievement of the target product profile. We don't know at this point, Roanna, those 2 could fall in both fall into 2023. It depends on how fast we go with hitting the target product profile and the formulation on a couple of others of these programs. some of them go really fast because it's easy to formulate and some of them we have to go through 3 or 4 cycles, sometimes 6 cycles of optimization to really get to the right milligrams per milliliter. So at this stage, it's hard to tell. As we do more of them and as we get more through the process, we'll be able to better guide you as to when some of those milestones might hit in the future. And you have to understand, we've moved this whole process from what was with some companies way back when we were talking years ago. It was kind of like a science project. So now it's a real development project. And at some point here, hopefully, end of the year, early next year, we'll have a good line of sight on how that development project is going to play out in each one of these deals.

這真是個好問題。在我們不知情的情況下，我們的合作夥伴 Horizon 公開了 275 萬美元的預付款和為實現目標產品配置可能支付的 600 萬美元。 Roanna，我們目前還不知道這兩個項目是否會在 2023 年同時落下。這取決於我們實現目標產品概況的速度以及這些項目中其他幾個項目的製定情況。其中一些非常快，因為它很容易配製，而其中一些我們必須經過 3 或 4 個週期，有時 6 個優化週期才能真正達到正確的毫克/毫升。所以在這個階段，很難說。隨著我們做更多的事情，隨著我們在這個過程中得到更多的東西，我們將能夠更好地指導您了解這些里程碑中的一些可能在未來何時到來。你必須明白，我們已經將整個流程從一些公司的流程中轉移到幾年前我們談論的時候。這有點像一個科學項目。所以現在這是一個真正的開發項目。在這裡的某個時候，希望在今年年底，明年年初，我們能夠很好地了解該開發項目將如何在這些交易中發揮作用。

Okay. Great. Very helpful. And I wanted to ask a bit about Recorlev too. So do you have any updates on your expectations for prescribing growth into the first half of 2023. And could it be impacted by possible deductible reset dynamics in the new calendar year?

好的。偉大的。很有幫助。我也想問一些關於 Recorlev 的問題。那麼，您對 2023 年上半年的增長預期是否有任何更新。它會受到新日曆年可能的免賠額重置動態的影響嗎？

Yes. Every rare and ultrarare product is impacted by deductible resets at the beginning of the year. As we've discussed in the past, with Keveyis, for example, you see some what we call soft discontinueds because they have to re-up their insurance at the beginning of every year. And those by and large, all come back onto therapy after a little while. We're anticipating we'll see a similar dynamic with Recorlev because it's a rare disease, they have to requalify and get insurance approved on a frequent basis, actually. That's all factored into our guidance. It's all factored into what we believe the drug is going to do over time. We were well aware of that going in.

是的。每一種稀有和超稀有產品都會在年初受到免賠額重置的影響。正如我們過去與 Keveyis 討論過的那樣，您會看到一些我們稱之為軟停產的產品，因為他們必須在每年年初重新購買保險。總的來說，他們都會在一段時間後重新接受治療。我們預計我們會看到與 Recorlev 類似的動態，因為它是一種罕見的疾病，實際上，他們必須重新獲得資格並經常獲得保險批准。這些都已納入我們的指南。隨著時間的推移，我們相信這種藥物將發揮作用，這一切都被考慮在內。我們很清楚這一點。

Yes. Makes sense. And last one for me. I was curious if you could give us any updates on payer coverage for Recorlev, like what ballpark proportion of patients seem to be having like very broad access, relatively low hurdles, things like that?

是的。說得通。最後一個給我。我很好奇您是否可以向我們提供有關 Recorlev 付款人覆蓋範圍的任何最新信息，例如患者的大概比例似乎有非常廣泛的訪問權限，相對較低的障礙，諸如此類？

The hurdles are all the same. Everybody goes through a prior authorization. I mean that just is the case. And we are successful on behalf of the patient as often as we thought we would be, we win more than we lose. I wouldn't say it's 80% or 90%, but it's definitely better than 50%. And by the way, those that we lose, we oftentimes win on appeal. So the patient has never lost, lost, lost until they're really lost, lost, lost.

障礙都是一樣的。每個人都要經過事先授權。我的意思是事實就是如此。我們代表患者成功的次數和我們想像的一樣多，我們贏的比輸的多。我不會說它是 80% 或 90%，但它肯定比 50% 好。順便說一下，我們輸掉的那些，我們通常會在上訴中獲勝。所以病人永遠不會迷失、迷失、迷失，直到他們真的迷失、迷失、迷失。

Our next question comes from David Amsellem from Piper Sandler.

我們的下一個問題來自 Piper Sandler 的 David Amsellem。

So I just had a few. First, just going back to the guidance. I know it's a fairly wide range. You mentioned a lot of moving parts. But at the lower end of the range, Paul, you talked about over 30% year-over-year growth. And I guess I'm just trying to get a sense of how you're thinking about Gvoke's role in that. Obviously, it's growing, but can you give us more granularity in terms of what you think the growth range could be here? I know that there are some things in the marketplace that have changed with the kits being discontinued, but you also have the generic as well from Amphastar. So just talk about the puts and takes on Gvoke and how aggressively you think that product could grow in 2023? That's number one.

所以我只有幾個。首先，回到指南。我知道這是一個相當廣泛的範圍。你提到了很多活動部件。但在範圍的低端，保羅，你談到了超過 30% 的同比增長。我想我只是想了解你是如何看待 Gvoke 在其中的角色的。顯然，它正在增長，但是您能否就您認為增長范圍可能在這裡提供更多粒度？我知道隨著套件的停產，市場上的一些東西發生了變化，但你也有來自 Amphastar 的仿製藥。那麼就談談 Gvoke 的看跌期權和看跌期權，以及您認為該產品在 2023 年的增長有多積極？這是第一。

Number two, I wanted to pick your brain longer term on Recorlev and ask you about competitive dynamics. As you know, Corcept has got their next-generation cortisol modulator, relacorilant. And I'm just wondering to the extent that, that product bears fruit, do you think that, that could prove to be a headwind in any way for Recorlev? So just talk about that longer term.

第二，我想在 Recorlev 上更長期地挑選你的大腦，並詢問你關於競爭動態的問題。如您所知，Corcept 已經獲得了他們的下一代皮質醇調節劑 relacorilant。我只是想知道，該產品在多大程度上取得了成果，你認為這對 Recorlev 來說是否會以任何方式成為不利因素？所以只談論那個長期。

And then lastly, just remind us when you think is the earliest you could file on the levothyroxine injectable product?

最後，請提醒我們您認為最早可以提交左旋甲狀腺素注射劑產品的時間？

Okay. Let me start with Gvoke. We expect Gvoke to continue to grow very much like it has in the past. Right now, Gvoke is basically shouldering the majority of the market growth also. We're not seeing much activity from Lilly at all. So especially as the market growth continues to improve, Gvoke is going to continue to improve in terms of growth. I think we see it growing as well in '23 as it did in '22. The Amphastar generic is having 0 impact. I have to tell you, we've had a couple of people bring that up on roadshow things. The legacy products continue to decline. If there's any impact of the generic kit, it's on the legacy kits. As Lilly discontinues theirs, Novo was de-emphasizing theirs, the generics are kind of filling the void of what business still exists. But the new ready-to-use products are over 70% of the market now trending towards 75%. Will the kits still maintain 10%, 15%, 20% over time? Maybe that's what legacy products tend to do in most categories. But it's not impacting us. We continue to grow. We continue to take share and the market continues to show evidence of rebounding in terms of growth.

好的。讓我從 Gvoke 開始。我們預計 Gvoke 將像過去一樣繼續增長。現在，Gvoke 基本上也承擔了大部分市場增長。我們根本沒有看到 Lilly 有太多活動。因此，特別是隨著市場增長持續改善，Gvoke 將在增長方面繼續改善。我認為我們看到它在 23 年和 22 年一樣增長。 Amphastar 仿製藥的影響為 0。我必須告訴你，我們已經有幾個人在路演中提到了這一點。遺留產品繼續下降。如果說通用套件有任何影響，那就是對遺留套件的影響。當禮來（Lilly）停止他們的產品時，諾和諾德（Novo）不再強調他們的產品，仿製藥有點填補了仍然存在的業務空白。但新的即用型產品佔市場的 70% 以上，目前正趨向於 75%。隨著時間的推移，試劑盒是否仍會保持 10%、15%、20%？也許這就是遺留產品在大多數類別中往往會做的事情。但這對我們沒有影響。我們繼續成長。我們繼續佔據份額，市場繼續顯示出增長反彈的跡象。

In terms of Recorlev competitive dynamics, we're being very successful against everybody. As you would anticipate, when you have a new drug in a rare disease category, especially one that looks like this with multiple players, the first order of business for physicians is to see how well we do. And they give us the train wrecks. I mean, literally, people that they put on everything and it doesn't work, they give them to us. And we're proving that our patients on our drug do quite well. And then we start moving into other competitive products that our drug is a better option for. So Korlym is a perfect example because the whole objective here is to normalize cortisol. Patients on that drug feel good, but it doesn't normalize cortisol. And little by little, we're getting to a point where we're engaging in those conversations more and more with physicians in terms of great, your patient feels good, but you're not really meeting the medical need. And we're starting to get some of those patients. whether or not their drug that's coming in a couple of years is going to be changed that dynamic. I don't know at this point. I don't think so, but we'll see. Recorlev competitive dynamic. I think I handled that; Korlym, I think I handled that. And levo, we've said we're going to start the Phase 2 study midyear. By the time we complete that study, get data, It's a year later, we go to the FDA. Then we got a Phase 3 program, which is a couple of years. So I think we're targeting somewhere in the 2026 to 2028 for that drug to hit the market. It's a wide range because we're at the beginning of Phase 2. We don't have a line of sight on Phase 3 yet.

就 Recorlev 競爭動態而言，我們對所有人都非常成功。正如您所預料的那樣，當您在一種罕見疾病類別中擁有一種新藥時，尤其是看起來像這種涉及多個參與者的藥物時，醫生的首要任務就是看看我們的表現如何。他們給了我們火車殘骸。我的意思是，從字面上看，人們把所有東西都穿上了，但不管用，他們把它們給了我們。我們正在證明服用我們藥物的患者表現良好。然後我們開始轉向其他競爭產品，我們的藥物是更好的選擇。所以 Korlym 是一個完美的例子，因為這裡的整個目標是使皮質醇正常化。服用該藥物的患者感覺良好，但它並不能使皮質醇正常化。一點一點地，我們越來越多地與醫生進行這些對話，你的病人感覺很好，但你並沒有真正滿足醫療需求。我們開始接收其中一些患者。他們幾年後即將推出的藥物是否會改變這種動態。我現在不知道。我不這麼認為，但我們會看到。記錄競爭動態。我想我已經處理好了； Korlym，我想我處理了那個。 levo，我們已經說過我們將在年中開始第二階段的研究。當我們完成這項研究，獲得數據時，一年後，我們去了 FDA。然後我們得到了一個為期幾年的第三階段計劃。所以我認為我們的目標是在 2026 年到 2028 年的某個時間讓這種藥物上市。這是一個廣泛的範圍，因為我們正處於第 2 階段的開始。我們還沒有看到第 3 階段。

We have no further questions at this time. So I'll hand back to Paul Edick for any further remarks.

目前我們沒有其他問題。因此，我將返回給 Paul Edick 以徵求任何進一步的意見。

Okay. Thank you for joining the call this morning and for your continued support as we execute on our enterprise development strategy. I also want to personally thank all of our shareholders, our tremendous employees, the healthcare community, our patients and their caregivers for your patience, hard work, support and continued belief in our mission. Have a great rest of your day.

好的。感謝您今天早上加入電話會議，感謝您在我們執行企業發展戰略時的持續支持。我還想親自感謝我們所有的股東、我們優秀的員工、醫療保健界、我們的患者和他們的護理人員，感謝你們的耐心、辛勤工作、支持和對我們使命的持續信念。祝您度過愉快的一天。

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

感謝您參加今天的電話會議。您現在可以斷開線路。