Omeros Corporation (OMER) 2026 Q1 法說會逐字稿

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  • Operator

    Operator

  • Good afternoon and welcome to today's earnings call for Omeros Corporation. (Operator Instructions)

    下午好,歡迎參加 Omeros Corporation 今日的財報電話會議。(接線員指示)

  • Please be advised that this call is being recorded at the company's request, and a replay will be available on the company's website.

    請注意,應公司要求,本次電話會議將被錄音,並將於公司網站提供重播。

  • I'll now turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead.

    現在我將把電話會議交給 Omeros 投資人關係部的 Jennifer Williams。請開始。

  • Jennifer Williams - Investor Relations

    Jennifer Williams - Investor Relations

  • Thank you, and good afternoon, everyone. Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially.

    謝謝,大家下午好。在開始之前,請注意今日的討論將包含前瞻性陳述。這些陳述反映管理層截至今日的目前預期與信念,並受風險與不確定性影響,可能導致實際結果與陳述內容出現重大差異。

  • For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the risk factors sections in our quarterly report on Form 10-Q filed today with the SEC, as well as our most recent annual report on Form 10-K.

    關於這些風險與不確定性的詳細討論,請參閱我們今日向美國證券交易委員會(SEC)提交的 Form 10-Q 季度報告中「前瞻性陳述特別說明」及「風險因素」章節,以及我們最近一期的 Form 10-K 年度報告。

  • Today's call will include a discussion of certain non-GAAP financial measures. A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included with Omeros' earnings press release issued earlier today, which is available on the Investor Relations page of our website and has been furnished with the Form 8-K we filed with the SEC earlier today.

    今日電話會議將討論若干非 GAAP 財務衡量指標。這些非 GAAP 指標與相對應 GAAP 指標之調節表,已包含於 Omeros 今日稍早發布的財報新聞稿中;該新聞稿可於我們網站的投資人關係頁面取得,並已隨同我們今日稍早向 SEC 提交的 Form 8-K 一併提供。

  • With that, I'll turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

    接下來,我將把電話會議交給 Omeros 董事長兼執行長 Greg Demopulos 博士。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer; Dr. Cathy Melfi, our Chief Regulatory Officer, and Dr. Steve Whitaker, Vice President of Clinical.

    謝謝你,Jennifer,大家下午好。今天與我一同出席的有:我們的首席會計長 David Borges、首席法規長 Cathy Melfi 博士,以及臨床副總裁 Steve Whitaker 博士。

  • I'll start with an overview of our first quarter 2026 operations and financial results, followed by program updates. After that, David will cover the financials in more detail, and then we'll open the call for questions.

    我將先概述我們 2026 年第一季的營運與財務結果,接著更新各項計畫進展。之後 David 會更詳細說明財務狀況,然後我們將開放提問。

  • We entered 2026 with two catalysts, the closing of our previously announced transaction with Novo Nordisk for zaltenibart, our lead investigational MASP-3 inhibitor, and the FDA approval of YARTEMLEA, our lead MASP-2 inhibitor, for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA.

    我們以兩項催化因素進入 2026 年:其一是與 Novo Nordisk 就 zaltenibart(我們領先的 MASP-3 抑制劑研發中藥物)先前宣布之交易完成交割;其二是 FDA 核准 YARTEMLEA(我們領先的 MASP-2 抑制劑)用於治療造血幹細胞移植相關之血栓性微血管病變(TA-TMA)。

  • This approval made YARTEMLEA the first and only approved treatment for this often fatal complication, and the first and only approved inhibitor of the lectin pathway of complement. We launched in January with initial shipments to distributors beginning mid-month, followed shortly by first sales.

    此項核准使 YARTEMLEA 成為此一常致命併發症的首個且唯一核准治療,亦為補體凝集素途徑(lectin pathway)首個且唯一核准抑制劑。我們於 1 月啟動上市,月中開始向經銷商出貨,隨後不久即產生首批銷售。

  • In the first quarter, YARTEMLEA gross revenues were $11.1 million, with net revenues of $9.9 million, reflecting gross to net adjustments of approximately 11%. Early demand and uptake are strong. YARTEMLEA became cash flow positive in the first quarter, despite a mid-January launch, and we expect it to drive company-wide positive cash flow within 18 months.

    第一季 YARTEMLEA 毛收入為 1,110 萬美元,淨收入為 990 萬美元,反映毛轉淨(gross-to-net)調整約 11%。早期需求與採用情況強勁。儘管於 1 月中旬才上市,YARTEMLEA 在第一季即達到現金流轉正,我們預期其將在 18 個月內帶動公司整體現金流轉正。

  • Net income for the first quarter was $56.1 million, or $0.78 per share, including a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes.

    第一季淨利為 5,610 萬美元,或每股 0.78 美元,其中包含與我們 2029 年可轉換公司債相關之嵌入式衍生工具的 7,310 萬美元非現金按市價評價(mark-to-market)收益。

  • Excluding this non-cash item, adjusted net gross loss was -- or net loss was $17.1 million or $0.24 per share. We ended the quarter with $135.3 million in cash and investments after retiring our remaining 2026 convertible notes.

    排除此非現金項目後,調整後淨毛損為——或淨損為 1,710 萬美元,或每股 0.24 美元。在償還我們剩餘的 2026 年可轉換公司債後,本季末現金及投資為 1.353 億美元。

  • During the first quarter, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million. We may continue to repurchase shares from time to time, subject to market conditions and other considerations.

    第一季期間,我們以每股平均 11.70 美元回購並註銷約 36 萬股普通股,總金額為 420 萬美元。我們可能會視市場狀況及其他考量,不定期持續回購股份。

  • Our transaction with Novo Nordisk provided substantial non-dilutive capital to support our growth. At closing, we received $240 million in upfront cash funding operations, including the YARTEMLEA launch. We are also eligible for another $100 million in near-term milestone payments from Novo. The deal is valued at up to $2.1 billion in upfront and milestone payments, plus royalties in the high-single-digit to high-teen range.

    我們與 Novo Nordisk 的交易提供了可觀的非稀釋性資金以支持成長。交割時,我們收到 2.40 億美元的預付款現金,用於資助營運,包括 YARTEMLEA 的上市推進。此外,我們亦有資格自 Novo 取得另一筆 1.00 億美元的近期里程碑款。該交易的價值最高可達 21 億美元(包含預付款與里程碑款),另加上介於高個位數至高十幾個百分點區間的權利金。

  • Our early launch has been focused on four priorities. First, educating transplant care teams to drive earlier recognition and treatment of TA-TMA. Second, securing rapid institutional access through pharmacy and therapeutics, or P&T, committee approvals and streamlined ordering. Third, ensuring consistent, timely reimbursement. And finally, demonstrating strong economic value through Health Economics and Outcomes Research, or HEOR.

    我們的早期上市工作聚焦於四項優先事項。第一,教育移植照護團隊,以促進更早辨識並治療 TA-TMA。第二,透過藥事與治療(P&T)委員會核准及簡化訂購流程,快速取得機構端的使用准入。第三,確保穩定且及時的給付。最後,透過健康經濟與結果研究(HEOR)展現強勁的經濟價值。

  • Execution is ahead of plan. Our field force is fully deployed, detailing all 175 transplant centers nationwide. By March 31, 30 unique accounts had ordered YARTEMLEA, reflecting accelerated adoption. Despite the typical six to nine-month timeline for P&T committee approvals, accounts are moving faster than expected. By quarter end, we understand that 60% of the top 10 centers, 40% of the top 20, 38% of the top 40, and approximately 30% of the top 80 US centers had received P&T committee approval.

    執行進度超前於計畫。我們的外勤團隊已全面部署,覆蓋全美 175 家移植中心並進行產品推廣。截至 3 月 31 日,已有 30 個不同帳戶訂購 YARTEMLEA,反映採用速度加快。儘管 P&T 委員會核准通常需 6 至 9 個月,帳戶端推進速度快於預期。截至季末,據我們了解,前 10 大中心中有 60%、前 20 大中心中有 40%、前 40 大中心中有 38%,以及美國前 80 大中心約 30% 已取得 P&T 委員會核准。

  • Looking at reimbursement, all prior authorization requests submitted to third-party commercial payers to date have been approved and centers have begun receiving full payment. HEOR analyses, which support the YARTEMLEA pricing and show compelling quality of life improvements, are being finalized and prepared for publication.

    在給付方面,截至目前提交給第三方商業保險支付方的所有事前授權(prior authorization)申請均已獲核准,且各中心已開始收到全額付款。支持 YARTEMLEA 定價並顯示具說服力生活品質改善的 HEOR 分析正在定稿,並準備發表。

  • Early indicators, including strong receptivity from transplant centers, formulary momentum, and payer alignment with the label support our expectation that YARTEMLEA can become standard of care for TA-TMA. In April, the US Centers for Medicare and Medicaid Services, or CMS, assigned a Permanent Healthcare Common Procedure Coding System, J-code, for YARTEMLEA. This simplifies billing and reimbursement across payers, reduces administrative burden, supports faster patient access, and improves reimbursement predictability. The J-code becomes effective July 1.

    早期指標——包括移植中心的高度接受度、處方集(formulary)推進動能,以及支付方對標籤適應症的支持——支持我們的預期:YARTEMLEA 可望成為 TA-TMA 的標準治療。4 月,美國醫療保險與醫療補助服務中心(CMS)為 YARTEMLEA 指派永久性醫療保健通用程序編碼系統(HCPCS)J-code。此舉可簡化跨支付方的帳務申報與給付流程、降低行政負擔、支持更快的病患可近性,並提升給付可預測性。該 J-code 將於 7 月 1 日生效。

  • Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-on Payment, or NTAP, for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost, innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August with NTAP effective October 1 of this year.

    同樣在 4 月,CMS 於其住院前瞻性支付制度(Inpatient Prospective Payment System)擬議規則中,建議核准 YARTEMLEA 的新技術附加支付(New Technology Add-on Payment,NTAP)。NTAP 針對特定高成本、創新技術向醫院提供額外支付,協助在標準支付系統納入之前,彌補支付落差。最終規則預計於 8 月公布,NTAP 將於今年 10 月 1 日生效。

  • We remain focused on expansion opportunities for YARTEMLEA and our MASP-2 program. Beyond the US, our marketing authorization application for YARTEMLEA in TA-TMA is under review by the European Medicines Agency. We continue to expect a decision mid-year. We are evaluating potential partnerships, including broad ex-US and regional collaborations to support commercialization outside the US.

    我們仍專注於 YARTEMLEA 及我們 MASP-2 計畫的擴張機會。在美國以外,我們針對 TA-TMA 的 YARTEMLEA 上市許可申請目前正由歐洲藥品管理局(EMA)審查中。我們仍預期將於年中取得決定。我們正在評估潛在合作夥伴關係,包括廣泛的美國以外(ex-US)及區域性合作,以支持在美國以外的商業化。

  • Beyond TA-TMA, we're assessing opportunities to expand the YARTEMLEA label to other indications involving lectin pathway activation, including acute respiratory distress syndrome, or ARDS, sickle cell disease, acute kidney injury, solid organ transplant-related TMA, and delayed graft function.

    除 TA-TMA 外,我們也在評估將 YARTEMLEA 標籤適應症擴展至其他涉及凝集素途徑活化的適應症之機會,包括急性呼吸窘迫症候群(ARDS)、鐮狀細胞疾病、急性腎損傷、實體器官移植相關 TMA,以及移植物功能延遲。

  • We're also broadening our MASP-2 inhibitor platform beyond YARTEMLEA, advancing both our Phase 2 ready long-acting MASP-2 antibody OMS1029 and our oral MASP-2 small molecule program. Both are well-suited for chronic indications, including membranous nephropathy, other renal diseases, and neurological disorders such as Parkinson's and Alzheimer's. We're finalizing the initial Phase 2 indication for once-quarterly OMS1029. We're now also working to advance our small molecule program to IND-enabling studies, targeting once-daily oral delivery.

    我們也正將我們的 MASP-2 抑制劑平台擴展至 YARTEMLEA 之外,推進我們已具備第 2 期試驗條件的長效 MASP-2 抗體 OMS1029,以及我們的口服 MASP-2 小分子計畫。兩者皆非常適合用於慢性適應症,包括膜性腎病、其他腎臟疾病,以及帕金森氏症與阿茲海默症等神經系統疾病。我們正在敲定 OMS1029 每季一次給藥的初始第 2 期適應症。我們也正在推進小分子計畫至 IND 申請前的支援性研究(IND-enabling studies),目標為每日一次口服給藥。

  • Let's now turn to development programs beyond our complement inhibitor franchise. Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. We successfully completed animal-cocaine interaction studies supporting a scheduled inpatient human study evaluating OMS527 in cocaine users.

    接下來我們把焦點轉向補體抑制劑產品線以外的研發計畫。我們的 PDE7 抑制劑計畫正在評估 OMS527 用於可卡因使用障礙,該計畫仍由美國國家藥物濫用研究所(NIDA)的補助金全額資助。我們已成功完成動物—可卡因交互作用研究,支持一項預定的住院人體研究,以評估可卡因使用者中的 OMS527。

  • Recently, together with NIDA representation, we met with FDA to discuss the agency's request for additional non-clinical information before starting the inpatient study. The meeting was productive, and we are working with FDA to streamline the path to initiate the inpatient clinical trial, which is targeted to start by year-end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a wide range of addictions and compulsive disorders.

    近期,我們與 NIDA 代表一同與 FDA 會面,討論在啟動住院研究前,主管機關要求補充的額外非臨床資訊。此次會議富有成效,我們正與 FDA 合作以簡化啟動住院臨床試驗的路徑,目標於年底前開始。基於其作用機轉以及我們大量的臨床前數據,我們相信 OMS527 可能對廣泛的成癮與強迫性疾患具有療效。

  • Turning to our Targeted Complement Activating Therapy, or T-CAT, platform, this represents a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites.

    談到我們的標靶補體活化治療(Targeted Complement Activating Therapy,T-CAT)平台,這代表一類新穎的重組抗體,旨在鎖定並直接殺死病原體,包括細菌、真菌、病毒與寄生蟲。

  • Our initial focus is on multidrug-resistant organisms, or MDROs, one of the most critical unmet needs in medicine. Unlike marketed antimicrobials, T-CAT is designed to kill pathogens, regardless of resistance profile, without promoting resistance.

    我們的初始重點聚焦於多重抗藥性微生物(multidrug-resistant organisms,MDROs),這是醫療領域最關鍵的未被滿足需求之一。不同於已上市的抗微生物藥物,T-CAT 的設計目標是在不促進抗藥性的情況下,不論其抗藥性特徵如何,皆能殺死病原體。

  • Data from our T-CAT platform were recently featured in a podium presentation at the Annual Congress of the European Society of Clinical Microbiology and Infectious Diseases, and the seminal manuscript describing our T-CAT technology was accepted for publication in Science Translational Medicine.

    我們 T-CAT 平台的數據近期在歐洲臨床微生物學與感染疾病學會(European Society of Clinical Microbiology and Infectious Diseases)年會上以口頭報告形式發表,而描述我們 T-CAT 技術的奠基性論文亦已獲《Science Translational Medicine》接受刊登。

  • Last but not least, we're pleased with the continued progress of OncotoX-AML, the lead development program in our Oncotox Oncology platform. OncotoX-AML is an engineered biologic agent designed to treat acute myeloid leukemia or AML, the most common and deadliest form of adult leukemia.

    最後但同樣重要的是,我們對 Oncotox 腫瘤學平台的首要研發計畫 OncotoX-AML 持續取得進展感到滿意。OncotoX-AML 是一種工程化生物製劑,旨在治療急性骨髓性白血病(AML),這是成人白血病中最常見且致死率最高的類型。

  • In both human tumor-bearing animal and in-vitro human AML cell line studies, OncotoX-AML has consistently shown superior efficacy to current standard-of-care treatments even at very low doses and across mutations associated with AML, such as TP53 and FLT3, which have historically been difficult to treat.

    在帶有人類腫瘤的動物研究以及體外人類 AML 細胞株研究中,即使在非常低的劑量下,且涵蓋與 AML 相關的多種突變(如歷來難以治療的 TP53 與 FLT3),OncotoX-AML 仍一貫展現出優於現行標準治療的療效。

  • In a non-human primate study, a single course of OncotoX-AML demonstrated the desired pharmacologic response, a marked, selective, reversible, and dose-related reduction in myeloid progenitor cells, the cells that can mutate and lead to AML, by up to 99%. Safety was equally strong. The treatment was well-tolerated with no safety signal of concern. IND-enabling studies are underway, and we are preparing for a first-in-human trial targeted for late 2027.

    在一項非人靈長類研究中,單一療程的 OncotoX-AML 展現了預期的藥理反應:骨髓系祖細胞(可能發生突變並導致 AML 的細胞)出現顯著、選擇性、可逆且與劑量相關的下降,降幅最高達 99%。安全性同樣表現強勁。治療耐受性良好,未見令人擔憂的安全性訊號。IND 申請前的支援性研究正在進行中,我們正為預計於 2027 年底進行的首次人體試驗做準備。

  • So that concludes our Financial, Corporate, and Development Program update. I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed discussion of our financial results. David?

    以上即為我們的財務、公司與研發計畫更新。接下來我將把電話會議交給我們的首席會計官 David Borges,請他就我們的財務結果進行更詳細的說明。David?

  • David Borges - Chief Accounting Officer, Vice President - Finance, Treasurer

    David Borges - Chief Accounting Officer, Vice President - Finance, Treasurer

  • Thanks, Greg. Net income for the first quarter of 2026 was $56.1 million or $0.78 per share compared to net income of $86.5 million or $1.22 per share in the fourth quarter of 2025. First quarter results include a $73.1 million non-cash gain related to the mark-to-market adjustment on the embedded derivative associated with our 2029 convertible notes.

    謝謝,Greg。2026 年第一季淨利為 5,610 萬美元,或每股 0.78 美元;相較之下,2025 年第四季淨利為 8,650 萬美元,或每股 1.22 美元。第一季結果包含一筆 7,310 萬美元的非現金收益,係與我們 2029 年可轉換公司債相關之嵌入式衍生工具按市價評價(mark-to-market)調整所致。

  • By comparison, fourth quarter results included a net gain of $237.6 million on the sale of zaltenibart to Novo Nordisk, partially offset by a $136 million non-cash loss related to mark-to-market adjustments on embedded derivatives associated with our 2029 convertible notes and term loan.

    相較之下,2025 年第四季結果包含將 zaltenibart 出售予 Novo Nordisk 所產生的 2.376 億美元淨收益,部分被與我們 2029 年可轉換公司債及定期貸款相關之嵌入式衍生工具按市價評價調整所致的 1.36 億美元非現金損失所抵銷。

  • A clearer view of the company's operating performance excludes the non-cash remeasurements of our embedded derivatives, excluding the $73.1 million embedded derivative adjustment. Non-GAAP adjusted net loss for the first quarter of '26 was $17.1 million and non-GAAP adjusted net loss per share was $0.24 per share.

    若要更清楚地檢視公司的營運表現,可排除嵌入式衍生工具的非現金重新衡量影響,也就是排除 7,310 萬美元的嵌入式衍生工具調整。2026 年第一季非 GAAP 調整後淨損為 1,710 萬美元,非 GAAP 調整後每股淨損為每股 0.24 美元。

  • As of March 31, 2026, we had $135.3 million in cash and investments. This balance includes the repayment of the remaining $17.1 million principal on our notes -- on our 2026 notes at maturity in February of 2026. Following that repayment, our only remaining debt is $70.8 million of principal outstanding on our unsecured 2029 convertible notes, which are due in June 2029.

    截至 2026 年 3 月 31 日,我們持有現金及投資合計 1.353 億美元。該餘額包含我們於 2026 年 2 月到期時償還 2026 年票據剩餘 1,710 萬美元本金。在該次償還後,我們僅剩的債務為 2029 年到期之無擔保可轉換公司債未償還本金 7,080 萬美元,該債券將於 2029 年 6 月到期。

  • During the first quarter, we repurchased and retired approximately 360,000 shares of our common stock at an average price of $11.70 per share for a total of $4.2 million.

    第一季期間,我們以每股平均 11.70 美元回購並註銷約 36 萬股普通股,總金額為 420 萬美元。

  • As Greg mentioned, YARTEMLEA launched in mid-January 2026. Gross revenues for the first quarter were $11.1 million, all from YARTEMLEA product sales, reflecting strong early demand following launch. Uptake was driven by prescriber adoption and increasing market penetration, and we continue to expand access and build awareness.

    如 Greg 所提,YARTEMLEA 於 2026 年 1 月中旬上市。第一季毛收入為 1,110 萬美元,全部來自 YARTEMLEA 產品銷售,反映上市後早期需求強勁。採用率的提升主要由處方醫師採用與市場滲透率提高所帶動,我們也持續擴大可及性並提升市場認知。

  • Net revenues were $9.9 million, reflecting gross-to-net adjustments of approximately 11%. Gross-to-net adjustments were relatively modest and consisted of chargebacks and distribution fees. Costs and expenses from continuing operations for the first quarter before interest and other income were $27.3 million, a decrease of $1.8 million from the fourth quarter of 2025.

    淨收入為 990 萬美元,反映約 11% 的毛轉淨(gross-to-net)調整。毛轉淨調整相對溫和,主要由回扣(chargebacks)與通路配送費用構成。第一季持續營運之成本與費用(扣除利息及其他收入前)為 2,730 萬美元,較 2025 年第四季減少 180 萬美元。

  • Concurrently with the closing of the sale of zaltenibart to Novo Nordisk, we entered into a transition services agreement to facilitate the transfer of the acquired assets and support the continued operation of relevant studies and program activities. Cost incurred by Omeros under the Transition Services Agreement, including third-party expenses and internal full-time employee or FTE cost, are being reimbursed by Novo Nordisk.

    在完成將 zaltenibart 出售予 Novo Nordisk 的交易交割同時,我們簽訂了過渡服務協議(Transition Services Agreement),以促進所收購資產的移轉,並支援相關研究與計畫活動的持續運作。Omeros 依過渡服務協議所發生的成本(包括第三方費用與內部全職員工(FTE)成本)將由 Novo Nordisk 予以償付。

  • Interest expense in the first quarter was $5.9 million. The primary components of interest expense include the DRI royalty obligation and interest on the 2029 convertible notes. Excluding the DRI and midway royalty obligation, which represents pass-through interest from Rayner to DRI and has no economic impact to us and excluding non-cash amortization of debt issuance costs and discounts, contractual cash interest expense for the first quarter of '26 was $1.8 million compared to $3.2 million in the prior quarter. The decrease was primarily due to the full repayment of our secured term loan in November 2025.

    第一季利息費用為 590 萬美元。利息費用的主要組成包括 DRI 權利金義務以及 2029 年可轉換公司債的利息。若排除 DRI 與 Midway 權利金義務(其為 Rayner 轉付予 DRI 的過手利息,對我們不具經濟影響),並排除債務發行成本與折價的非現金攤銷,則 2026 年第一季的合約現金利息費用為 180 萬美元,較前一季的 320 萬美元下降。下降主要係因我們已於 2025 年 11 月全額償還有擔保定期貸款。

  • Interest and other income totaled $1.5 million in the first quarter, up from $1.1 million in the fourth quarter of '25, primarily reflecting higher average cash balances. As previously mentioned, during the first quarter, we recorded a $73.1 million non-cash gain from mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes.

    第一季利息及其他收入合計 150 萬美元,高於 2025 年第四季的 110 萬美元,主要反映平均現金餘額較高。如前所述,第一季我們因 2029 年可轉換公司債相關之嵌入式衍生工具按市價評價調整,認列 7,310 萬美元的非現金收益。

  • The change in valuation was primarily driven by the decline in our stock price during the quarter, which decreased from $17.18 per share at December 31, 2025, to $10.56 per share at March 31, 2026. An increase in stock price in the second quarter would similarly result in a non-cash loss during the quarter. Conversely, a decrease in our stock price during the second quarter would result in a non-cash gain.

    估值變動主要是由於本季我們股價下跌所致,股價由2025年12月31日每股17.18美元降至2026年3月31日每股10.56美元。若第二季股價上漲,同樣會在該季度產生非現金損失。相反地,若第二季股價下跌,則會產生非現金收益。

  • This embedded derivative reflects certain features of the notes, including the conversion option and interest made whole provision available to the note holders. Because the valuation of this derivative is influenced by our stock price and other market inputs, it can introduce significant volatility in our reported results from quarter to quarter.

    此嵌入式衍生工具反映票據的若干特徵,包括轉換選擇權以及提供給票據持有人的利息補足(interest made whole)條款。由於該衍生工具的估值受我們股價及其他市場輸入因素影響,可能使我們每季所報告的結果出現顯著波動。

  • This adjustment is non-cash and does not affect our operating performance or liquidity. Accordingly, we present non-GAAP adjusted net income and net loss to exclude the non-cash nature of these volatile swings.

    此項調整為非現金項目,不影響我們的營運表現或流動性。因此,我們提供非GAAP調整後淨利與淨損,以排除這些波動所帶來的非現金性質影響。

  • Income from discontinued operations in the first quarter was $4.8 million, a decrease of $1.8 million from the fourth quarter. Primarily reflecting lower than forecasted US-based OMIDRIA royalties. Because US-based OMIDRIA royalties are fully passed through to DRI, fluctuation in these payments do not affect our cash position.

    第一季停業部門收益為480萬美元,較第四季減少180萬美元。主要反映美國OMIDRIA權利金低於預期。由於美國OMIDRIA權利金會全數轉付給DRI,這些款項的波動不會影響我們的現金部位。

  • Now let's look at our expected second quarter 2026 results. We anticipate that overall operating expenses from continuing operations will be slightly higher compared to the first quarter of '26. Sales and marketing expenses are expected to increase, reflecting costs associated with building our commercial infrastructure, including marketing expenses and other commercial launch activities for YARTEMLEA.

    接下來我們看看2026年第二季的預期結果。我們預期持續營運的整體營運費用將較2026年第一季略高。銷售與行銷費用預計將增加,反映我們建置商業化基礎設施的相關成本,包括YARTEMLEA的行銷費用及其他商業上市活動。

  • As YARTEMLEA is in the early stages of launch, we are not providing revenue guidance at this time. This is consistent with our approach following a new product launch. While market access and physician adoption are still developing and until we are able to estimate revenue with greater accuracy, we remain focused on building physician awareness, expanding disease education, and ensuring continued timely reimbursement.

    由於YARTEMLEA仍處於上市初期,我們目前不提供營收指引。這與我們在新產品上市後的一貫做法一致。在市場准入與醫師採用仍在發展、且在我們能更精準估計營收之前,我們將持續專注於提升醫師認知、擴大疾病教育,並確保持續且及時的給付報銷。

  • Interest and other income are expected to be higher than in the first quarter. Interest expense is expected to be approximately $7.1 million, reflecting the reduction in our outstanding debt and excludes any potential non-cash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be in the $5 million to $6 million range, excluding any non-cash remeasurement adjustment related to the OMIDRIA contract royalty asset.

    利息及其他收入預期將高於第一季。利息費用預計約為710萬美元,反映我們未償債務的降低,且不包含任何與OMIDRIA權利金義務相關的潛在非現金調整。停業部門收益預期約在500萬至600萬美元區間,不包含任何與OMIDRIA合約權利金資產相關的非現金重新衡量調整。

  • And finally, as a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative tied to our 2029 convertible notes. These adjustments are non-cash, can be volatile, and are driven by -- largely driven by changes in our stock price and other market inputs. As a result, we present non-GAAP adjusted net income and loss measures to provide additional visibility into our underlying operating performance.

    最後提醒一下,我們的報告結果將持續反映與2029年可轉換公司債相關之嵌入式衍生工具的按市價(mark-to-market)調整。這些調整為非現金、可能波動很大,且主要——在很大程度上——由我們股價變動及其他市場輸入因素所驅動。因此,我們提供非GAAP調整後淨利與淨損指標,以更清楚呈現我們的基礎營運表現。

  • With that, I'll turn the call back over to Greg.

    接下來我把電話交回給Greg。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Thanks, David. Operator, please open the call to questions.

    謝謝,David。接線員,請開放提問。

  • Operator

    Operator

  • (Operator Instructions) Steve Brozak, WBB.

    (接線員指示) Steve Brozak,WBB。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Yeah. Hi. Thanks for taking the question. I'd like to go into some granularity on YARTEMLEA. First question has to deal with from the time the clinician or request drug to the time you get it, can you detail how long -- you get it to the hospital? Can you detail us how long it takes and the process, please?

    是的。嗨。謝謝讓我提問。我想更深入了解一下YARTEMLEA。第一個問題是,從臨床醫師提出用藥需求或申請藥品,到你們把藥送到醫院為止——你能否說明大概需要多久以及流程,謝謝?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Sure. Thanks, Steve. The distributors deliver drug to the sites within about 24 hours of receipt of the request.

    當然。謝謝你,Steve。經銷商在收到需求後,大約24小時內就會把藥品送達各據點。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Okay.

    好的。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • And -- so the process is pretty straightforward. The request is made to the distributors. Distributors deliver within 24 hours.

    那——所以流程相當直接。需求會向經銷商提出。經銷商在24小時內送達。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Okay. And can you give us some detail on -- it's typically on stem cell TA-TMA, on the transplant side, you're looking at about roughly 15% of the population are peds. How does that reflect in terms of what you've seen so far on the requests for YARTEMLEA, please?

    好的。另外能否請你提供一些細節——通常在幹細胞移植相關的TA-TMA,在移植端大約有15%的族群是兒科病患。就目前你們看到的YARTEMLEA申請/需求而言,這在比例上反映如何?謝謝。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Right. And you're correct about that. The split between adult and pediatric patients in TA-TMA is roughly 85/15, as you noted. We only have, again, through the first quarter, a little over two months of data. So these data may be skewed, but we are seeing a greater percentage of these patients being pediatric than the 15% that you cited. So it appears that we're having really rapid adoption across both adult and pediatric patients.

    是的。你說得沒錯。如你所述,TA-TMA成人與兒科病患的比例大約是85/15。我們目前也只有到第一季為止、略多於兩個月的資料。因此這些資料可能有偏,但我們看到兒科病患的占比高於你提到的15%。所以看起來我們在成人與兒科病患兩端都出現非常快速的採用。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Okay. Now, I don't want to put words in your mouth, but typically you would see the pediatric hematological oncologists being the most conservative. So you're saying that they are. They are asking for YARTEMLEA in a greater number than the distribution. And I -- look, I know it's only a partial quarter, but so far you're seeing a trend that these more conservative prescribers are asking for drug at a greater rate than you would expect. Is that what I'm hearing?

    好的。我不想替你下結論,但一般來說,兒科血液腫瘤科醫師通常會是最保守的。所以你的意思是他們確實——他們對YARTEMLEA的需求量高於該分布比例。而且——我知道這只是部分季度,但到目前為止你們看到的趨勢是,這些較保守的處方醫師提出用藥需求的速度高於你原本預期。我聽到的是這個意思嗎?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Well, I'm not sure that a point would create a trend, but what we're seeing is what I said, which is that there is a larger percentage of pediatric transplanters than is represented by the overall split in TA-TMA between adults and pediatrics. We are seeing those pediatric transplanters requesting narsoplimab or YARTEMLEA.

    嗯,我不確定單一數據點是否能形成趨勢,但我們看到的如我所說:兒科移植醫師的占比高於TA-TMA整體成人與兒科的分布比例。我們確實看到這些兒科移植醫師在申請narsoplimab或YARTEMLEA。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Okay. Thanks. I thought I was the only person that was mixing narsoplimab by YARTEMLEA. You may have stated this earlier, but out of -- how many facilities out of the total targeted have you started to get prescribing -- or get requests from so far?

    好的。謝謝。我還以為只有我會把narsoplimab和YARTEMLEA混著叫。你可能先前提過,但在——截至目前,你們在總目標機構中,有多少家已開始開立處方——或至少已提出需求申請?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • We have at the end of March, so by March 31, we had 30 separate accounts requesting YARTEMLEA. And of that 30, let me just give you a little more color. We went through this in the prepared comments, but we were speaking there in percentages, so I think if I put it in absolute numbers, it may be helpful to everyone. Of the top 10, 6 of the top 10 sites had ordered by March 31, 24 of the top 80 centers had ordered by March 31.

    截至3月底,也就是3月31日,我們有30個不同的客戶帳戶提出YARTEMLEA需求。在這30個之中,我再補充一些背景。我們在事先準備的講稿中提過,但當時用的是百分比,所以我想用絕對數字可能對大家更有幫助。在前10大據點中,截至3月31日有6個已下單;在前80家中心中,截至3月31日有24家已下單。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Okay. Okay. Last question, I'll get back in the queue. What kind of feedback, even if it's anecdotal, are you getting from the hematological oncologist in prescribing -- or anyone else on the clinician side? Thank you. I'll jump back in the queue.

    好的。好的。最後一個問題,我之後再回到排隊序列。你們從血液腫瘤科醫師在開立處方——或其他臨床端人員那裡,收到什麼樣的回饋?即使是軼事性的也可以。謝謝。我回到排隊序列。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Sure. Again, it's early, but the feedback that we have received has been effectively, uniformly positive. I think that the results that are being seen with the YARTEMLEA are impressive. And again, we're early in the launch, but as I said, all signs look very encouraging. And we do expect that YARTEMLEA will become standard of care for the treatment of TA-TMA.

    當然。同樣地,現在還早,但我們收到的回饋基本上、幾乎一致地是正面的。我認為目前在YARTEMLEA上看到的結果令人印象深刻。而且我們仍在上市初期,但如我所說,各項跡象都非常令人鼓舞。我們也預期YARTEMLEA將成為治療TA-TMA的標準照護。

  • Steve Brozak - Analyst

    Steve Brozak - Analyst

  • Great. Well, thank you for the granularity, and I'm looking forward to the next call to see the trend after one point. How's that?

    很好。嗯,感謝你提供這麼細的拆解,我也期待下一次電話會議,看看在某個時間點之後的趨勢。這樣可以嗎?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Very good. Thanks. Yes, we look forward to that as well.

    非常好。謝謝。是的,我們也同樣期待。

  • Operator

    Operator

  • Olivia Saunders, Cantor.

    Olivia Saunders,Cantor。

  • Olivia Saunders - Analyst

    Olivia Saunders - Analyst

  • Hi. Good afternoon, guys, and thank you for the question. I know it's early, but Greg, how are you thinking about the split between inventory versus US wholesaler sales versus hospital demand? And how that might play out over the course of the year, just in terms of how we should think about the proportion of reported sales? And any comments on how many patients are actually on drug as of today?

    嗨。各位下午好,謝謝讓我提問。我知道現在還早,但 Greg,你如何看待庫存、相較於美國批發商銷售、以及醫院端需求之間的拆分?以及這在一年當中可能會如何演變——就我們應該如何思考已揭露銷售額的占比而言?另外,能否評論一下截至今天實際有多少病人正在用藥?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Sorry, I lost the second question, Olivia. What was that? It was a unit on my end, maybe.

    抱歉,我漏聽了第二個問題,Olivia。你剛剛說的是什麼?可能是我這邊的設備問題。

  • Olivia Saunders - Analyst

    Olivia Saunders - Analyst

  • Yeah, it was just a question about how many patients are actually on drug as of today, should have been treated with YARTEMLEA.

    是的,就是想問截至今天實際有多少病人正在用藥——也就是應該已經接受 YARTEMLEA 治療的病人數。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Sure. First of all, with respect to inventory, given the short delivery process, which, as I explained in the last response, is 24 hours. The amount of inventory carried at the distributors and certainly at the centers is relatively small. So on the distributor side, we're seeing 1, 1.5 weeks of inventory on average across those distributors.

    好的。首先,關於庫存,鑑於交付流程很短——如我在上一個回覆中解釋的,是 24 小時。因此,經銷商端、當然也包括各中心端所持有的庫存量相對較小。所以在經銷商端,我們看到這些經銷商平均約有 1 到 1.5 週的庫存。

  • I think your next question was the number of patients on drug. That's a difficult number to provide because often the centers don't share the specific information about the number of patients or the type of patients or really any patient-specific information. So really what we see is how many vials are going into a center and from which center those vials are being requested.

    我想你下一個問題是正在用藥的病人數。這個數字很難提供,因為中心往往不會分享病人數、病人類型,或任何真正與個別病人相關的資訊。所以我們實際看到的是有多少瓶(vials)送進某個中心,以及這些瓶是由哪些中心提出需求。

  • So that is -- I'm not trying to dodge the question. I'm trying to give you the best information we have, but we expect that it is a larger number of patients, obviously, than the number of accounts. But with respect to specific number, we just don't have that information.

    所以這——我不是在迴避問題。我是在提供我們所掌握的最佳資訊;但我們預期病人數顯然會大於帳戶數。不過就具體數字而言,我們確實沒有那個資訊。

  • Olivia Saunders - Analyst

    Olivia Saunders - Analyst

  • Okay. Fair enough. And can I ask, how are you thinking about the AstraZeneca ULTOMIRIS Phase 3 study that they're running in TMA? I think they're using disease relapse as an endpoint, and it is a randomized study. So I'm just curious if you have any thoughts on how that might fit into the landscape?

    好的。合理。那我可以再問一下,你們如何看待 AstraZeneca 在 TMA 進行的 ULTOMIRIS 第三期研究?我想他們使用疾病復發作為終點,而且是隨機分派研究。所以我只是好奇,你們對它可能如何融入整體競爭版圖有沒有什麼想法?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Right. Well, I understand that they've changed their endpoint. Their initial endpoint, as I understand it, and again, I want to caveat that this is my understanding. But the initial endpoint, as I understand it, was response. But following the readout of their pediatric open-label trial, which used response as the endpoint, that response was not clearly what AstraZeneca had hoped to see. I think it had a 17% response rate.

    是。嗯,我了解他們已經更改了終點。據我所知,他們最初的終點——我也要先聲明這是我的理解。但據我理解,最初的終點是反應(response)。不過在他們兒科開放標籤試驗讀出之後(該試驗以反應為終點),那個反應並不明確符合 AstraZeneca 原本希望看到的結果。我記得反應率大約是 17%。

  • So I know that subsequently -- or as I understand it, subsequently, they revised the endpoint for their adult trial from response to survival. I don't know if they're looking at relapse. Our understanding is that the patients in that controlled adult trial, by definition, would really, our expectation would be, need to be less severe than the patients we treated by virtue of the fact that in the patients we treated, running a controlled trial would really not be possible.

    所以我知道之後——或據我理解,之後他們把成人試驗的終點從反應修訂為存活(survival)。我不確定他們是否在看復發。我們的理解是,在那個受控的成人試驗中,依定義而言,病人應該會比我們治療的病人嚴重程度更低;因為就我們治療的那些病人而言,要進行受控試驗其實是不可能的。

  • So I think there's a difference in the severity of the patients. Don't know if they're looking at relapse. I'll open the question up to Steve and/or Cathy, if you have any other information about AstraZeneca and their data.

    所以我認為病人嚴重程度是有差異的。不確定他們是否在看復發。我把這個問題也開放給 Steve 和/或 Cathy,看看你們是否有關於 AstraZeneca 及其數據的其他資訊。

  • J. Steven Whitaker - Vice President, Chief Medical Officer

    J. Steven Whitaker - Vice President, Chief Medical Officer

  • Hi, Greg. This is Steve. We only know what's on clinicaltrials.gov at this point, and the primary endpoint is event-free survival, and that is death or clinical worsening. So it's not really relapses, as Greg said. It'd be worsening from their baseline condition.

    嗨,Greg。我是 Steve。目前我們只知道 clinicaltrials.gov 上公開的資訊,主要終點是無事件存活(event-free survival),也就是死亡或臨床惡化。所以並不是真的在看復發,如 Greg 所說。而是相對於其基線狀態的惡化。

  • They do look at duration of response, and they relapse, but those are lower secondary endpoints. And I -- obviously, I don't have the protocol, so I don't know how these were ranked hierarchically, but those are pretty far down the line, if that helps.

    他們也會看反應持續時間,以及復發,但那些是較低階的次要終點。而且——我當然沒有研究方案,所以不知道這些終點在層級上如何排序,但如果這能幫助你理解的話,它們確實排得很後面。

  • Olivia Saunders - Analyst

    Olivia Saunders - Analyst

  • Yes. That's great. Thank you, guys. I appreciate it.

    是的。這很棒。謝謝各位。我很感激。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Yeah. Thank you, Olivia. I think also that there have been a number of recent publications and data presentations around the increased infection rates and increased infection-related mortality with C5 inhibition. I know coming out of an adult study at MSK, Memorial Sloan Kettering, a pediatric study out of Children's Hospital in Atlanta associated with Emory. And I understand that there also has been additional data generated and presented by Dana-Farber and Boston Children's, again, in the pediatric center. All of those data align quite nicely with each other. So those might be something that would help you as well.

    好的。謝謝你,Olivia。我也想補充,近期有不少發表與數據報告,提到在 C5 抑制下感染率上升,以及感染相關死亡率上升。我知道有一項成人研究來自 MSK(Memorial Sloan Kettering,紀念斯隆—凱特琳癌症中心),另有一項兒科研究來自亞特蘭大兒童醫院(與 Emory 相關)。我也了解 Dana-Farber 與波士頓兒童醫院也產生並發表了額外數據,同樣是在兒科中心。這些數據彼此之間相當一致。所以這些也許也能對你有所幫助。

  • Catherine Melfi - Vice President - Regulatory Affairs and Quality Systems, Chief Regulatory Officer

    Catherine Melfi - Vice President - Regulatory Affairs and Quality Systems, Chief Regulatory Officer

  • And, Greg, you had mentioned the change in the endpoint, and I did confirm that on clinicaltrials.gov, your understanding was correct. It had been response, and currently it's, as Steve said, event-free survival.

    另外,Greg,你提到終點的變更,我也在 clinicaltrials.gov 上確認過,你的理解是正確的。原本是反應(response),目前則如 Steve 所說,是無事件存活(event-free survival)。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • So, thank you, Cathy. So, yes, so they had changed from response to survival. Okay. Anything else, Olivia?

    所以,謝謝你,Cathy。是的,所以他們已從反應改為存活。好的。Olivia,還有其他問題嗎?

  • Olivia Saunders - Analyst

    Olivia Saunders - Analyst

  • No. That's perfect. Thank you, guys. I appreciate the follow-up.

    沒有。這樣很完美。謝謝各位。也謝謝後續補充。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Great. Thank you very much.

    很好。非常感謝。

  • Operator

    Operator

  • Brandon Folkes, H.C. Wainwright.

    Brandon Folkes,H.C. Wainwright。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Hi. Thanks for taking my questions and congrats on all the progress. Maybe just one for me, Greg. I think I heard you say you're working on efforts to recognize TMA earlier. Can you just elaborate on those efforts and whether you believe once NTAP comes into practice, that may facilitate less friction to earlier intervention? Or what do you think drives earlier intervention? Thank you.

    嗨。謝謝回答我的問題,也恭喜你們取得各項進展。我這邊可能只有一題,Greg。我想我聽到你說你們正在推動更早識別 TMA 的工作。你能否更詳細說明這些工作?以及你是否認為一旦 NTAP 開始實施,可能有助於降低更早介入時的摩擦?或者你認為是什麼因素驅動更早介入?謝謝。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Hi, Brandon. Thank you. Certainly, we're interested in earlier intervention. We want to save as many patients as possible. Our expectation in the data support that the earlier one jumps on this problem, the greater the likelihood of success in outcome.

    嗨,Brandon。謝謝你。我們當然對更早介入很有興趣。我們希望能拯救盡可能多的病人。我們的預期以及數據都支持:越早介入處理這個問題,成功改善結局的可能性就越高。

  • So I think that there certainly seems to be an increasing awareness of that within the transplant community. We are receiving incoming questions about the temporally upstream administration of YARTEMLEA. All of that, I think, bodes well for patients.

    所以我認為在移植社群內,對此的認知確實正在提升。我們也收到一些主動詢問,關於在時間上更上游(更早期)給予 YARTEMLEA 的使用。我認為這些對病人而言都是正面的訊號。

  • With respect to will the NTAP assist that? Yes, the NTAP increases the subsidization, so actually subsidizes in good part for Medicare patients, the payment on the inpatient side. And that's where you would expect that earliest treatment to begin. So I think your thought around whether the NTAP would help in that respect, I think is insightful.

    至於 NTAP 是否會有幫助?會的,NTAP 提高了補助程度,因此對 Medicare 病人而言,住院端的給付在很大程度上會被補貼。而最早期的治療通常就是從住院端開始。所以你關於 NTAP 是否能在這方面提供幫助的想法,我認為很有洞見。

  • So we're waiting to see, but we do expect that there will be an increasing move to earlier treatment, particularly given that initially a good number of the patients we were treating were eculizumab failures. So we were really catching patients, and in the first quarter, catching patients who were [falling knives]. And yet, those patients, very many of them responded very well to narsoplimab or to YARTEMLEA.

    所以我們正在觀察後續發展,但我們確實預期治療時點會愈來愈往前移,特別是考量到一開始我們治療的相當一部分患者是依庫珠單抗(eculizumab)治療失敗者。因此我們其實是在接住患者,而在第一季,是在接住那些[正在下墜的刀子]的患者。然而,這些患者中有非常多對 narsoplimab 或 YARTEMLEA 的反應非常好。

  • So, I think that there's a greater understanding and increasing awareness of moving temporally upstream in the administration process. I think that's a good thing. I think it's good for patients. Does that help? Okay.

    所以,我認為大家對於在給藥流程中把時間點往更上游移動,有了更深入的理解與愈來愈高的認知。我認為這是好事。我認為這對病人有利。這樣有幫助嗎?好。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • It does. Thanks so much, Greg. Sorry.

    有的。非常感謝你,Greg。抱歉。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Okay. Thanks, Brandon.

    好的。謝謝你,Brandon。

  • Brandon Folkes - Equity Analyst

    Brandon Folkes - Equity Analyst

  • Sorry, just dealing with the mute button.

    抱歉,我剛剛在處理靜音按鈕。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • No. That's fine. Any other questions?

    不會。沒問題。還有其他問題嗎?

  • Operator

    Operator

  • Serge Belanger, Needham.

    Needham 的 Serge Belanger。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Hi. Good afternoon. Thanks for taking my questions. I guess a few on just to get a little more granularity on the 1Q sales number. Greg, can you disclose what the number of vials that were, I guess, dispersed from your distributor over the quarter?

    嗨。下午好。謝謝讓我提問。我想先問幾個問題,以便更細緻地了解第一季的銷售數字。Greg,你能否透露本季從你們經銷商端出貨(我想應該是發放)的藥瓶數量是多少?

  • And then secondly, I think you talked about a gross-to-net of 11%. For the first quarter here. Just curious where you expect that gross-to-net to go once you have more comprehensive formulary coverage? And then I have a couple of reimbursement questions.

    第二,我記得你提到第一季的毛轉淨(gross-to-net)為 11%。就第一季而言。想請教一旦你們取得更全面的處方集(formulary)覆蓋後,你預期毛轉淨會走向何處?另外我還有幾個給付(reimbursement)相關問題。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Sure. In response to your first question, no, we aren't providing the number of vials. We're providing gross and net revenue numbers. With respect to your second, around what is -- what constitutes that gross-to-net number, that really is made-up of chargebacks and fees. So chargebacks meaning governmental programs, so 340B, and fees being largely bona fide fees to distributors. So that's largely it. We would expect that over time to increase as 340B participation increases.

    好的。回覆你的第一個問題,我們不會提供藥瓶數量。我們會提供毛收入與淨收入數字。至於第二個問題,關於——毛轉淨數字的構成,主要由回扣(chargebacks)與費用(fees)組成。回扣指的是政府計畫,也就是 340B;費用則主要是支付給經銷商的合規(bona fide)費用。大致就是這些。我們預期隨著時間推進,隨著 340B 參與度提高,這個比例會上升。

  • With respect to a target, I would not expect that to be reaching the 20 percentile. I would be thinking we're going to remain in the teens on that, Serge. But we'll to see how that plays out. We are not planning at all to discount the drug. And I think returns are -- I don't think we've had any, but I think that will be negligible. So going forward, I would expect the components of the gross-to-net to be what they were in Q1, which is the chargebacks and the fees only.

    至於目標水準,我不預期會到 20% 這個區間。我認為會維持在十幾個百分點,Serge。但我們會看看實際發展如何。我們完全沒有計畫對藥品打折。而退貨——我認為我們目前沒有退貨,但我認為未來也會是可忽略不計。所以往後看,我預期毛轉淨的構成會與第一季相同,也就是只有回扣與費用。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • Got it. And then regarding P&T approvals, clearly got some good traction through the end of the first quarter here with the numbers you gave us. Curious when you expect the rest of them to go through the P&T approval process. Are they already scheduled?

    了解。接著關於 P&T(藥事與治療)核准,你們在第一季末以前,從你提供的數字來看,顯然取得了不錯的進展。想請教你預期其餘機構何時會完成 P&T 核准流程?它們是否已經排程?

  • And then secondly, you talked that you got approval for a J-code as well as the NTAP for later this year. Curious, since you said that most centers have had some very good access to the product, access hasn't been an issue. Will these J-codes and I guess an NTAP, what kind of impact could they have on further uptake once they are in effect?

    第二,你提到你們也取得了 J-code 的核准,以及今年稍晚的 NTAP。想請教,既然你說多數中心對產品的取得情況都很好、取得並不是問題,那麼這些 J-code 以及 NTAP 在生效後,對於進一步的採用(uptake)可能會帶來什麼影響?

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • Yeah. First of all, with respect to P&T committees, there are a number of them that are in process. Remember, we launched this in mid-January, third week of January. So we are really still very early in the process, and the P&T committee approvals that we've seen, as I mentioned, are quite satisfying in that they are well ahead of what we would have expected in terms of just timeline and number of P&T approvals.

    是的。首先,關於 P&T 委員會,目前有不少仍在審核流程中。請記得我們是在 1 月中旬、1 月第三週才上市。所以我們其實仍處於非常早期的階段;而我們目前看到的 P&T 核准,如我提到的,相當令人滿意,因為無論是時間進度或核准數量,都明顯快於我們原先的預期。

  • So clearly, there is an urgency, I think, that's being recognized and manifest across the sites with physicians and pharmacists recognizing the value of YARTEMLEA and moving quickly to make it available. There are centers, obviously, that are approving access to the drug absent P&T approvals, but additional P&T approvals will certainly help that access, streamline it, make it more quick, more efficient.

    所以很明顯地,我認為各據點都已意識到某種急迫性,並且在各站點展現出來:醫師與藥師都認可 YARTEMLEA 的價值,並迅速推動其可用性。當然也有中心在尚未完成 P&T 核准的情況下就先核准用藥取得,但更多的 P&T 核准無疑會有助於取得流程,讓流程更順暢、更快速、更有效率。

  • With respect to when we would expect all of those to have gone through the P&T process, all of the -- is an absolute number, I would expect that the large majority of them will be coming through in the next few months.

    至於我們預期何時能讓「全部」都走完 P&T 流程——「全部」是絕對數字——我預期其中絕大多數會在接下來幾個月內完成。

  • Your second question about the J-code and the NTAP, well, the J-code certainly streamlines the billing process and the reimbursement process. So, certainly, having the J-code now awarded and going into effect on July 1, I think, will be very helpful.

    你第二個問題關於 J-code 與 NTAP。J-code 當然能讓開帳(billing)流程與給付流程更順暢。因此,既然 J-code 已經核發並將於 7 月 1 日生效,我認為會非常有幫助。

  • The NTAP CMS has, in its proposed Inpatient Prospective Payment Systems rule has indicated that they support the approval of the NTAP for YARTEMLEA. That, we expect, will be finalized in the Inpatient final rule in August. Assuming that's the case, it will become or should become finalized and available for use on November 1 or sometime very close to November 1. It runs on CMS's schedule.

    至於 NTAP,CMS 在其提出的住院前瞻性支付制度(Inpatient Prospective Payment Systems)規則中已表示支持核准 YARTEMLEA 的 NTAP。我們預期會在 8 月的住院最終規則中定案。若確實如此,它將會——或應該會——在 11 月 1 日或非常接近 11 月 1 日時定案並可開始使用。這是依 CMS 的時程運作。

  • Both of those, the J-code and the NTAP, I expect, will obviously help with reimbursement any time you have secured reimbursement. That certainly helps with utilization. So I think, I'm quite -- it's been quite surprising, frankly, how broadly YARTEMLEA has been used in the absence of the historical reimbursement already in place.

    我預期這兩者——J-code 與 NTAP——在任何時候只要你已確保給付,顯然都會對給付有所幫助。而這當然也會有助於使用量(utilization)。所以坦白說,YARTEMLEA 在尚未建立既有、傳統的給付機制之前,就能如此廣泛地被使用,確實相當令人意外。

  • But once, as you know, Serge, once that reimbursement becomes much more standard and much more well recognized, that just drives front-end utilization as it should.

    但如你所知,Serge,一旦給付變得更標準化、也更被廣泛認知,就會推動前端使用量的提升——這也正是應有的情況。

  • Serge Belanger - Analyst

    Serge Belanger - Analyst

  • All right. Thank you.

    好的。謝謝。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • All right. Thank you.

    好的。謝謝。

  • Operator

    Operator

  • There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.

    目前沒有其他問題。我現在把電話會議交回給 Demopulos 醫師作結語。

  • Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

    Gregory Demopulos - Founder, President, Chairman of the Board, and Chief Executive Officer

  • All right. Thank you, operator, and thank you all for joining us this afternoon. As we've said, we're pleased with the strength of the YARTEMLEA launch and the continued progress across our pipeline and our platform programs.

    好的。謝謝接線員,也謝謝各位今天下午加入我們。如同我們所說,我們對 YARTEMLEA 上市的強勁表現,以及我們在研發管線與平台計畫上的持續進展感到滿意。

  • With expanding commercial momentum, multiple near-term catalysts, and continued execution across the organization, we believe Omeros is well-positioned for continued growth and long-term value creation. As always, we appreciate your continued support and confidence. Have a good evening.

    隨著商業動能擴大、多項短期催化劑,以及組織各面向的持續執行力,我們相信 Omeros 已具備持續成長與創造長期價值的良好定位。一如既往,我們感謝各位持續的支持與信任。祝各位晚安。

  • Operator

    Operator

  • 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。