Omeros Corp (OMER) 2025 Q2 法說會逐字稿

Good afternoon and welcome to today's earnings call for Omeros Corporation. At this time, all participants are on a listen-only mode. After the company's remarks, we will conduct a question-and-answer session. 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 for one week from today.

下午好，歡迎參加今天的 Omeros Corporation 財報電話會議。此時，所有參與者都處於只聽模式。公司發言結束後，我們將進行問答環節。請注意，應本公司要求，本次通話將被錄音，重播將從今天起在公司網站上提供一週。

I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.

我將把電話轉給 Omeros 投資者關係部的 Jennifer Williams。

Good afternoon, and thank you for joining the call today. I'd like to remind you that some of the statements that will be made on the call today will be forward-looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special notes in the Risk Factors section regarding forward-looking statements and the company's quarterly report on Form 10-Q, which was filed today with the SEC, and the Risk Factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties.

下午好，感謝您參加今天的電話會議。我想提醒大家，今天電話會議上的一些演講將具有前瞻性。這些聲明僅基於管理層截至今天的信念和期望，可能會發生變化。所有前瞻性陳述都涉及風險和不確定性，可能導致公司的實際結果產生重大差異。有關這些風險和不確定性的討論，請參閱「風險因素」部分中有關前瞻性陳述的特別說明和公司今天向美國證券交易委員會提交的 10-Q 表季度報告，以及公司最新 10-K 表年度報告中的「風險因素」部分。

Now I would like to turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

現在我想把電話轉給 Omeros 董事長兼執行長 Greg Demopulos 博士。

Thank you, Jennifer, and good afternoon everyone. I'm joined on today's call by David Borges, our Chief Accounting Officer; Nadia Dac, our Chief Commercial Officer; Andreas Grauer, our Chief Medical Officer; Cathy Melfi, our Chief Regulatory Officer; and Steve Whitaker, our Vice President of Clinical.

謝謝你，詹妮弗，大家下午好。參加今天電話會議的還有我們的首席會計官 David Borges、我們的商務長 Nadia Dac、我們的首席醫療官 Andreas Grauer、我們的首席監管官 Cathy Melfi 和我們的臨床副總裁 Steve Whitaker。

Today I'll start with an overview of our first-quarter financial results and provide updates across our development programs. David will then go through our financials in more detail, and we'll open the call for questions.

今天，我將首先概述我們的第一季財務業績，並提供我們開發計劃的最新進展。然後，大衛將更詳細地介紹我們的財務狀況，然後我們將開始提問。

Now let's look at our financial results for the first quarter. Our net loss was $33.5 million or $0.58 per share, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of last year. As of March 31, 2025, we had $52.5 million of cash and investments on hand.

現在讓我們來看看第一季的財務表現。我們的淨虧損為 3,350 萬美元，即每股 0.58 美元，而去年第四季的淨虧損為 3,140 萬美元，即每股 0.54 美元。截至 2025 年 3 月 31 日，我們手頭上有 5,250 萬美元的現金和投資。

I'd like to start with how we are strengthening our balance sheet and addressing our liquidity position and the options available to us for raising capital.

我想先談談我們如何加強資產負債表、解決流動性狀況以及可供我們選擇的融資方案。

While we've been focused on achieving significant milestones across our development programs, which I'll discuss shortly, we've also been actively pursuing ways to strengthen our balance sheet and manage our debt maturities. Earlier this week, we announced an exchange agreement with certain holders of our 2026 convertible notes, exchanging about $71 million in principal for new 9.5% convertible senior notes due out in 2029. We also reached an agreement with two affiliated holders to convert $10 million of their 2026 notes into equity over a period of 90 to 120 days, with the entire amount to be converted by September of this year.

雖然我們一直致力於在我們的發展項目中實現重要的里程碑（我很快就會討論這一點），但我們也一直在積極尋求加強資產負債表和管理債務到期的方法。本週早些時候，我們宣布與 2026 年可轉換票據的部分持有人達成交換協議，以約 7,100 萬美元的本金交換 2029 年到期的 9.5% 可轉換優先票據。我們也與兩家關聯持有人達成協議，在 90 至 120 天內將其 2026 年票據中的 1,000 萬美元轉換為股權，並將在今年 9 月前全部轉換完畢。

As a result, the outstanding balance on the 2026 notes will be reduced to approximately $17 million, eliminating the need to make a $20 million mandatory prepayment of our existing term loan by November 1 to avoid triggering an accelerated maturity of the term loan balance. Overall, this will reduce our total debt by $10 million and lower our near-term repayment obligations by over $100 million, reducing it from approximately $118 million to $17 million. The debt extension moves maturity out to 2029 and removes a major overhang for all routes of securing near-term capital.

因此，2026 年票據的未償還餘額將減少至約 1,700 萬美元，因此無需在 11 月 1 日之前強制預付 2,000 萬美元的現有定期貸款，以避免觸發定期貸款餘額的加速到期。總體而言，這將使我們的總債務減少 1,000 萬美元，並將我們的近期還款義務降低 1 億多美元，從約 1.18 億美元減少到 1,700 萬美元。債務延期將到期日延長至 2029 年，並消除了所有獲取短期資本途徑面臨的重大障礙。

We also have an active at-the-market facility in place with the capacity to raise up to $150 million in aggregate, providing meaningful flexibility to access additional capital when needed. With the debt exchange now having been completed, we're in the process of securing additional capital to support our operations through the anticipated approval and launch of narsoplimab, including active discussions around partnerships which would bring non-dilutive funding.

我們還擁有一個活躍的市場融資工具，其總融資能力高達 1.5 億美元，為在需要時獲得額外資本提供了極大的靈活性。隨著債務交換現已完成，我們正在透過預期的 narsoplimab 批准和推出來確保額外資本以支持我們的運營，包括積極討論可帶來非稀釋性資金的合作夥伴關係。

As we assess capital raising alternatives, we're also keeping a close eye on costs across the organization. We've taken meaningful steps to lower expenses while continuing to advance key initiatives and position the company for long-term growth. We've made good progress, but we know it's critical to remain disciplined. We are carefully managing our cash and liquidity to ensure we have the flexibility to deliver on our priorities and are committed to using our resources wisely, focusing investment on the areas that matter most to our shareholders and for near-term success of the company.

在評估融資替代方案時，我們也密切注意整個組織的成本。我們採取了有意義的措施來降低開支，同時繼續推動關鍵措施並為公司的長期成長做好準備。我們已經取得了良好的進展，但我們知道保持紀律至關重要。我們正在謹慎管理我們的現金和流動性，以確保我們能夠靈活地實現我們的優先事項，並致力於明智地利用我們的資源，將投資重點放在對我們的股東最重要的領域以及公司的近期成功上。

This means that certain activities and programs have been suspended or paused in order to prioritize the allocation of our currently available capital to the development of commercial infrastructure and capacities needed to ensure the successful launch of narsoplimab for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, following the anticipated approval by FDA of our resubmitted Biologics License Application, and to the completion of our ongoing zaltenibart clinical trials with enrolled patients.

這意味著某些活動和計劃已被暫停或中止，以便優先將我們目前可用的資金分配給開發商業基礎設施和能力，以確保在 FDA 預期批准我們重新提交的生物製品許可申請後成功推出用於治療造血幹細胞移植相關血栓性微血管病或 TA-TMA 的 narsoplimab，並完成我們正在進行的針對入組患者的 zaltenibart 臨床試驗。

As recently announced, the FDA has accepted our resubmitted BLA for narsoplimab in TA-TMA and has assigned a target date for FDA action of September 25. We have received and are responding to information requests as part of the process. Our primary analysis results show a hazard ratio of 0.32 with a p-value of less than 0.00001, meaning that narsoplimab resulted in a statistically significant threefold greater improvement in survival compared to the well-matched control group. All sensitivity analyses, including the analyses directed to our Expanded Access Program, or EAP, are strikingly consistent and strong, and we look forward to working closely with FDA to bring narsoplimab to market as the first approved treatment for TA-TMA.

正如最近宣布的那樣，FDA 已經接受了我們在 TA-TMA 中重新提交的 narsoplimab BLA，並指定了 FDA 採取行動的目標日期為 9 月 25 日。作為流程的一部分，我們已經收到並正在回應訊息請求。我們的主要分析結果顯示風險比為 0.32，p 值小於 0.00001，這意味著與匹配良好的對照組相比，narsoplimab 的生存率顯著提高了三倍。所有敏感性分析，包括針對我們的擴展獲取計劃 (EAP) 的分析，都非常一致且有力，我們期待與 FDA 密切合作，將 narsoplimab 推向市場，作為首個獲批的 TA-TMA 治療方法。

Additionally, the ICD-10 codes established through our collaborative efforts with transplant experts and professional societies will create reimbursement hurdles for off-label treatments since narsoplimab will be the only approved treatment for TA-TMA. We're also moving forward to complete and submit a Marketing Authorization Application, or MAA, to the European Medicines Authority for narsoplimab in TA-TMA. We're targeting to complete that submission later this quarter.

此外，我們與移植專家和專業協會合作建立的 ICD-10 代碼將為非適應症治療設置報銷障礙，因為 narsoplimab 將是唯一獲得批准的 TA-TMA 治療方法。我們也將繼續完成並向歐洲藥品管理局提交 TA-TMA 中 narsoplimab 的營銷授權申請（MAA）。我們的目標是在本季稍後完成提交。

Although pre-launch commercialization activities within our narsoplimab program will continue, we are suspending our Expanded Access Program for narsoplimab, also known as compassionate use. Physician requests for access to narsoplimab under this program continue, and we are mindful that the TA-TMA patients who lack an approved treatment for this often fatal condition will be most affected by cessation of access to narsoplimab prior to approval. Nevertheless, suspension of the program is necessary to eliminate direct costs associated with supplying the drug and the external management of the EAP. We remain committed to support patients who are currently being treated under the EAP.

儘管我們的 narsoplimab 計劃內的上市前商業化活動將繼續進行，但我們將暫停 narsoplimab 的擴展獲取計劃（也稱為同情用藥）。醫生繼續根據該計劃請求使用 narsoplimab，我們注意到，缺乏針對這種通常致命的疾病的批准治療方法的 TA-TMA 患者將因在獲得批准之前停止使用 narsoplimab 而受到最大影響。儘管如此，暫停該計劃對於消除與供應藥物和 EAP 外部管理相關的直接成本是必要的。我們將繼續致力於支持目前正在接受 EAP 治療的患者。

This discontinuation of the program will not affect these currently treated patients. Additionally, our ongoing study of narsoplimab in pediatric patients with TA-TMA will continue. A manuscript detailing the data related to the primary analysis, authored by an international group of leaders in the transplant field, has been submitted for publication in a top-tier journal. A second manuscript directed to the EAP results, again authored by international transplant leaders, is planned for submission early next week.

該計劃的終止不會影響目前正在接受治療的患者。此外，我們將繼續對 TA-TMA 兒科患者進行 narsoplimab 的研究。一份詳細介紹與主要分析相關的數據的手稿由移植領域的國際領導者撰寫，並已提交給頂級期刊發表。針對 EAP 結果的第二份手稿也由國際移植領袖撰寫，並計劃於下週初提交。

A manuscript from Weill Cornell describing the role of MASP-2 in the lectin pathway in long COVID is also under review in a major peer-reviewed journal. We expect that narsoplimab will be the first approved therapy in TA-TMA and nearly $1 billion annual market opportunity. Narsoplimab is positioned to become a cornerstone asset for transplant experts with label expansion opportunity in other transplant complications and to other disease fields. Our focus remains bringing narsoplimab to market as quickly as possible. Transplanters and their patients globally are waiting for it.

威爾康奈爾大學的一篇手稿描述了 MASP-2 在長期 COVID 凝集素途徑中的作用，也正在接受一家主要同行評審期刊的審查。我們預計 narsoplimab 將成為 TA-TMA 領域首個獲批的療法，每年的市場機會接近 10 億美元。Narsoplimab 的定位是成為移植專家的基石資產，並有機會在其他移植併發症和其他疾病領域擴展標籤。我們的重點仍然是盡快將 narsoplimab 推向市場。全球的器官移植者和他們的患者都在等待這一刻。

Our other prioritized program is the development of zaltenibart, our lead antibody targeting MASP-3, the most proximal and key inhibitor of the alternative pathway of complement. The initial indication for zaltenibart is paroxysmal nocturnal hemoglobinuria, or PNH. The global market for PNH, including multiple treatment modalities, is estimated to grow about 11% annually to over $10 billion in 2032. There remains significant unmet need for PNH patients, and the complement inhibitor market specifically is expected to more than double from about $2.2 billion today to $4.7 billion in that same timeframe. We expect zaltenibart to carve out a significant share of that growing market.

我們的另一個優先項目是開發扎替尼巴特，這是我們針對 MASP-3 的主要抗體，MASP-3 是補體旁路途徑最接近且最關鍵的抑制劑。扎替尼巴特的最初適應症是陣發性睡眠性血紅蛋白尿症（PNH）。預計包括多種治療方式在內的 PNH 全球市場每年將成長約 11%，到 2032 年將超過 100 億美元。PNH 患者仍存在大量未滿足的需求，預計補體抑制劑市場規模將在同一時間內從目前的約 22 億美元增長一倍以上至 47 億美元。我們預計扎爾替尼巴特將在這個不斷成長的市場中佔據相當大的份額。

Our ongoing clinical trial evaluating zaltenibart for the treatment of PNH in treatment-naive patients will continue. Also continuing is the extension study, which enrolls PNH patients treated with zaltenibart who have completed any of our prior zaltenibart studies in this indication. Our Phase 2 study in C3G will also remain ongoing. Our Phase 3 zaltenibart program in PNH began initiating clinical trial sites last quarter.

我們正在進行的臨床試驗將繼續進行，以評估扎替尼巴特對初治患者 PNH 的治療效果。擴展研究也在繼續進行，該研究招募了接受扎替尼巴特治療的 PNH 患者，這些患者已完成我們先前針對該適應症的任何扎替尼巴特研究。我們對 C3G 的第二階段研究也將持續進行。我們在 PNH 的第三階段扎替尼巴特計畫上個季度開始啟動臨床試驗地點。

And based on capital considerations, the anticipated ramp-up in spending as well on those trials, we are pausing our Phase 3 PNH program temporarily and are working with our vendors and investigators to ensure that the program is ready to restart with as little disruption to the timeline as possible after securing capital. Market research confirms that zaltenibart's target profile is differentiated from the evolving PNH landscape. Preference drivers for zaltenibart include a compelling efficacy and safety profile with low treatment burden, four to six times per year dosing, which minimizes how often patients have to think about their disease, and infrequent IV administration, which minimizes both the risk of non-compliance and subsequent breakthrough disease while aligning with the existing economic and treatment model of physicians' practices in PNH.

並且基於資本考慮，預計這些試驗的支出也會增加，我們將暫時暫停我們的第 3 階段 PNH 計劃，並與我們的供應商和研究人員合作，以確保該計劃在獲得資本後準備重新啟動，並儘可能減少對時間表的干擾。市場研究證實，扎爾替尼巴特的目標市場與不斷發展的 PNH 市場模式有所不同。扎替尼巴特的偏好驅動因素包括令人信服的療效和安全性，治療負擔低，每年給藥四到六次，最大限度地減少患者考慮自己疾病的頻率，以及不頻繁的靜脈注射，最大限度地降低不依從性和隨後的突破性疾病的風險，同時與 PNH 醫生執業的現有經濟和治療模式保持一致。

Development spending on our long-acting next-generation MASP-2 inhibitor OMS1029 remains limited. That asset is Phase 2 ready, with drug product needed to support Phase 2 trials having already been manufactured and stored, pending the selection of the first indication and the resources to initiate Phase 2 studies. We've also reduced spending in our other areas of the complement franchise, including our small molecule MASP-2 and MASP-3 programs, as part of our effort to focus resources on core development priorities. Apart from our complement programs, our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder, or CUD, will continue moving forward, funded entirely by a grant from the National Institute on Drug Abuse, or NIDA.

我們對長效下一代 MASP-2 抑制劑 OMS1029 的開發支出仍然有限。該資產已準備好進入第二階段，支持第二階段試驗所需的藥品已經生產並儲存，等待選擇第一個適應症和啟動第二階段研究的資源。為了將資源集中在核心發展重點上，我們還減少了補體特許經營的其他領域的支出，包括小分子 MASP-2 和 MASP-3 項目。除了我們的補體計畫之外，我們的 PDE7 抑制劑計畫也將繼續推進，該計畫評估 OMS527 對可卡因使用障礙（CUD）的療效，該計畫完全由美國國家藥物濫用研究所（NIDA）資助。

Work on an upcoming inpatient clinical trial evaluating safety and preliminary efficacy of OMS527 in patients with CUD is ongoing, with readout of those clinical data expected late this year or early next. In addition, we continue on a limited basis preclinical studies in our novel oncology platform, including IND-enabling studies in our Oncotox program. Oncotox is designed to target and kill only dividing cancer cells.

目前正在進行一項住院臨床試驗，以評估 OMS527 對 CUD 患者的安全性和初步療效，預計今年年底或明年年初讀取這些臨床數據。此外，我們繼續在有限的範圍內進行新型腫瘤學平台的臨床前研究，包括 Oncotox 計畫中的 IND 支持研究。Oncotox 旨在瞄準並殺死正在分裂的癌細胞。

Treatment of acute myeloid leukemia, or AML, is the lead indication. Our Oncotox AML therapeutic has consistently demonstrated superior efficacy to current AML standard-of-care treatments, both in vitro and in vivo with human cell lines. Oncotox AML shows broad application across AML regardless of genetic mutations, including TP53, NPM1, KMT2A, and FLT3. This broad application certainly appears to be unique.

治療急性骨髓性白血病（AML）是主要適應症。我們的 Oncotox AML 療法在體外和體內人類細胞系中均顯示出優於目前 AML 標準治療方法的療效。Oncotox AML 在 AML 中顯示出廣泛的應用，無論是否存在基因突變，包括 TP53、NPM1、KMT2A 和 FLT3。這種廣泛的應用顯然是獨一無二的。

Well tolerated in preliminary tolerability studies, IND-enabling work is ongoing, and we expect to be in the clinic in 18 to 24 months. This work, as well as clinical trials, will be aided and guided by our distinguished clinical steering committee, all of whom lead AML treatment and research at their respective premier cancer centers. Based on positive feedback from stealth unveiling of our Oncotox data last month at the American Association for Cancer Research with prospective partners, we believe that this program has potential to drive substantial value at an early stage of development, meaning in the near term.

在初步耐受性研究中表現出良好的耐受性，IND 支持工作正在進行中，我們預計將在 18 至 24 個月內進入臨床階段。這項工作以及臨床試驗將得到我們傑出的臨床指導委員會的協助和指導，他們都在各自的頂級癌症中心領導 AML 治療和研究。根據上個月在美國癌症研究協會與潛在合作夥伴秘密披露的 Oncotox 數據的正面回饋，我們相信該計畫有可能在開發的早期階段（即短期內）帶來巨大的價值。

I'll now turn the call over to David, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?

現在我將把電話轉給我們的首席會計官戴維，以更詳細地討論我們的財務結果。戴維？

Thanks, Greg.

謝謝，格雷格。

Our net loss for the first quarter of 2025 was $33.5 million or $0.58 per share, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of last year. As of March 31, 2025, we had $52.4 million of cash and investments on hand. As Greg just mentioned, earlier this week, we entered into an exchange agreement with certain holders of our 2026 convertible notes. We exchanged $70.8 million in aggregate principal amount of the 2026 convertible notes for newly issued 9.5% convertible senior notes due in June 2029 on a one-for-one basis.

我們 2025 年第一季的淨虧損為 3,350 萬美元，即每股 0.58 美元，而去年第四季的淨虧損為 3,140 萬美元，即每股 0.54 美元。截至 2025 年 3 月 31 日，我們手頭上有 5,240 萬美元的現金和投資。正如格雷格剛才提到的，本週早些時候，我們與 2026 年可轉換票據的某些持有人達成了交換協議。我們將 2026 年可轉換票據的本金總額 7,080 萬美元以一對一的方式兌換為 2029 年 6 月到期的新發行的 9.5% 可轉換優先票據。

In addition, we reached an agreement with one holder to convert $10 million of the 2026 notes into shares of the company's stock in three separate tranches over the next 90 to 120 days, with the conversion to be finalized by September 2025.

此外，我們與一位持有人達成協議，將在未來 90 至 120 天內分三批將 2026 年票據中的 1,000 萬美元轉換為公司股票，轉換將於 2025 年 9 月完成。

Following these transactions, the outstanding principal balance of the 2026 notes will be reduced to approximately $17.1 million. Most importantly, this reduction in principal of the 2026 convertible notes enables the company to avoid making a $20 million mandatory prepayment under our term loan agreement, which otherwise would have been required on or before November 1, 2025, to avoid an accelerated maturity of the term loan.

經過這些交易，2026 年票據的未償還本金餘額將減少至約 1,710 萬美元。最重要的是，2026 年可轉換票據本金的減少使公司能夠避免根據我們的定期貸款協議進行 2000 萬美元的強制預付款，否則我們將在 2025 年 11 月 1 日或之前要求支付這筆款項，以避免定期貸款加速到期。

As a result, our total outstanding debt will be reduced by $10 million, and our potential debt repayments over the next 12 months would be lowered by over $100 million from $117.9 million to $17.1 million. These actions improve our financial flexibility, strengthen our balance sheet, and position the company to better execute on its long-term plans.

因此，我們的未償債務總額將減少 1,000 萬美元，未來 12 個月的潛在債務償還將降低 1 億多美元，從 1.179 億美元降至 1,710 萬美元。這些舉措提高了我們的財務靈活性，增強了我們的資產負債表，並使公司能夠更好地執行其長期計劃。

Costs and expenses from continuing operations for the first quarter before interest and other income were $35 million, which was a decrease of $691,000 from the fourth quarter of last year. Research and development expenses in the first quarter were heavily focused on narsoplimab and zaltenibart.

第一季扣除利息和其他收入前的持續經營成本和費用為 3,500 萬美元，較去年第四季減少 691,000 美元。第一季的研發費用主要集中在 narsoplimab 和 zaltenibart 上。

Interest expense for the first quarter was $3.7 million, which reflects a $477,000 increase as compared to the fourth quarter of last year. The primary components of interest expense are the 2026 notes, the DRI-OMIDRIA royalty obligation, and the secured term loan.

第一季的利息支出為 370 萬美元，與去年第四季相比增加了 477,000 美元。利息費用的主要組成部分是 2026 年票據、DRI-OMIDRIA 特許權使用費義務和擔保定期貸款。

In the first quarter, we recorded a $3.4 million non-cash remeasurement adjustment to interest expense related to changes made to the OMIDRIA royalty obligation. This credit was $700,000 lower than a similar adjustment recorded in the fourth quarter of last year and is a primary driver of the increase in interest expense for the first quarter.

在第一季度，我們記錄了與 OMIDRIA 特許權使用費義務變化相關的 340 萬美元非現金重估利息費用調整。該抵免比去年第四季記錄的類似調整低 70 萬美元，是第一季利息支出增加的主要原因。

Interest and other income totaled $1.1 million in the first quarter of 2025, compared to $2.3 million in the fourth quarter of last year. The decrease is primarily attributable to lower interest income and NIDA grant reimbursement revenue from completion of our animal studies on addiction.

2025 年第一季利息和其他收入總計 110 萬美元，而去年第四季為 230 萬美元。下降的主要原因是，我們完成成癮動物研究後，利息收入和 NIDA 撥款報銷收入減少。

Income from discontinued operations in the first quarter was $4.1 million, down $1.1 million from the fourth quarter. The first quarter total includes two primary components: $3.9 million of interest earned on the OMIDRIA contract royalty asset and a $166,000 remeasurement adjustment to the contract asset.

第一季非持續經營業務收入為 410 萬美元，較第四季減少 110 萬美元。第一季總額包括兩個主要部分：OMIDRIA 合約特許權使用費資產賺取的 390 萬美元利息和合約資產的 166,000 美元重估調整。

As previously discussed, royalties earned are recorded as a reduction of the OMIDRIA contract royalty asset on our balance sheet rather than recognized in our income statement. The OMIDRIA royalties for the first quarter totaled $6.7 million based on OMIDRIA net sales of $22.3 million. This compares to royalties of $10.1 million on fourth quarter net sales of $33.6 million, representing a decrease of $3.4 million in royalties and a reduction of $11.3 million in net sales quarter over quarter.

如前所述，賺取的特許權使用費在我們的資產負債表上記錄為 OMIDRIA 合約特許權使用費資產的減少，而不是在我們的損益表中確認。根據 OMIDRIA 2,230 萬美元的淨銷售額，第一季 OMIDRIA 特許權使用費總額為 670 萬美元。相較之下，第四季淨銷售額為 3,360 萬美元，特許權使用費為 1,010 萬美元，環比特許權使用費減少 340 萬美元，淨銷售額減少 1,130 萬美元。

And compared to the first quarter of 2024, first-quarter 2025 OMIDRIA royalties decreased by $2.7 million, corresponding to an $8.9 million decline in net sales.

與 2024 年第一季相比，2025 年第一季 OMIDRIA 特許權使用費減少了 270 萬美元，對應淨銷售額下降 890 萬美元。

And as a reminder, in February 2024, we entered into an amended agreement with DRI under which they acquired the right to receive all US and OMIDRIA royalties payable by Rayner through December 31, 2031. Omeros retains all royalty rights to ex-US sales of OMIDRIA, and we're entitled to receive all US royalties on OMIDRIA sales from and after January 1, 2032. In other words, all global royalty payments will accrue to Omeros beginning January 1, 2032.

提醒一下，2024 年 2 月，我們與 DRI 簽訂了一項修訂協議，根據該協議，他們獲得了截至 2031 年 12 月 31 日 Rayner 應付的所有美國和 OMIDRIA 特許權使用費的權利。Omeros 保留 OMIDRIA 在美國以外銷售的所有特許權使用費權利，並且我們有權獲得 2032 年 1 月 1 日及之後 OMIDRIA 在美國銷售的所有特許權使用費。換句話說，從 2032 年 1 月 1 日起，所有全球特許權使用費將歸於 Omeros。

Now let's take a look at our expected second-quarter 2025 results. We anticipate that overall operating expenses from continuing operations in the second quarter of 2025 will be lower compared to the first quarter of '25 as we begin to pause on clinical development of zaltenibart and other programs.

現在讓我們來看看我們預期的 2025 年第二季業績。我們預計，隨著我們開始暫停扎替尼巴特和其他項目的臨床開發，2025 年第二季持續經營的整體營運費用將低於 2025 年第一季。

Interest and other income for the second quarter is expected to be approximately $625,000, and interest expense excluding any non-cash adjustments related to the OMIDRIA royalty obligation should be around $7.6 million. This represents a non-cash increase of $3.3 million from the first quarter, primarily reflecting the absence of significant non-cash adjustment tied to the OMIDRIA royalty obligation and incremental interest expense of about $370,000 associated with the newly issued 2029 convertible notes.

第二季的利息和其他收入預計約為 625,000 美元，不包括與 OMIDRIA 特許權使用費義務相關的任何非現金調整的利息支出應約為 760 萬美元。這意味著非現金較第一季增加了 330 萬美元，主要反映了與 OMIDRIA 特許權使用費義務相關的重大非現金調整的缺失以及與新發行的 2029 年可轉換票據相關的約 370,000 美元的增量利息支出。

The senior term loan transaction we closed in June 2024 included a $29.8 million gain resulting from repurchasing a portion of our 2026 convertible notes. Under GAAP, we are unable to recognize that gain immediately. The $29.8 million gain is deferred and amortized as a premium over the term of the senior loan, reducing interest expense. Inclusive of the deferred gain, we calculate the annual effective interest rate to be 1.4%. We expect to incur $600,000 (sic - $6.6 million) in interest expense on the senior term loan for the second quarter of 2025. And finally, income from discontinued operations is expected to be in the $6 million to $7 million range, excluding any non-cash remeasurement adjustments to the OMIDRIA contract asset.

我們於 2024 年 6 月完成的高級定期貸款交易包括因回購部分 2026 年可轉換票據而產生的 2,980 萬美元收益。根據 GAAP，我們無法立即確認該收益。2980 萬美元的收益被遞延並作為優先貸款期限內的溢價攤銷，從而減少了利息支出。包含遞延收益後，我們計算出的年實際利率為 1.4%。我們預計 2025 年第二季高級定期貸款的利息支出為 60 萬美元（原文如此 - 660 萬美元）。最後，預計終止經營業務的收入將在 600 萬至 700 萬美元之間，不包括 OMIDRIA 合約資產的任何非現金重估調整。

With that, I'll turn it back over to Greg.

說完這些，我就把麥克風交還給格雷格。

Thanks, David. Operator, now let's please open the call to questions.

謝謝，大衛。接線員，現在讓我們開始提問。

(Operator Instructions) Steve Brozak, WBB Securities.

（操作員指令）Steve Brozak，WBB 證券。

I do have one, and since everything is pretty much being driven to the launch, can you give us as much detail as you can on not just launch plans but how you are prepared for the launch itself and what does this mean as far as patient access and anything else you want to add? Thanks, and I'll hop back in the queue.

我確實有一個，而且由於一切都在為發布做準備，您能否向我們提供盡可能詳細的信息，不僅是發布計劃，還包括您如何為發布本身做準備，以及這對患者訪問意味著什麼以及您想補充的其他內容？謝謝，我會重新回到隊列中。

Yeah, thanks, Steve. Look, we're well prepared for the launch. Our commercial team has done a lot of work, and I think we are expecting, again, assuming approval, which we do, that the launch will be very successful.

是的，謝謝，史蒂夫。看，我們已經為發射做好了充分的準備。我們的商業團隊已經做了很多工作，我認為，我們再次期待，假設獲得批准，那麼這次發射將會非常成功。

Let me turn that over though to Nadia for more detail.

讓我把這個問題交給納迪亞來了解更多細節。

Thanks, Greg. Now, we have a small but mighty team that's been extremely focused in this area, and the good news is that the consolidated prescriber base. We know where the transplant centers are. We understand the allogeneic volume by center, and so our team has been focused on what we call the top 40 centers that are responsible for driving just about 60% of the allogeneic transplant volume.

謝謝，格雷格。現在，我們擁有一支規模雖小但強大的團隊，非常專注於這一領域，好消息是，我們的處方醫生基礎得到了鞏固。我們知道移植中心在哪裡。我們了解各個中心的同種異體移植量，因此我們的團隊一直專注於所謂的前 40 個中心，這些中心負責推動約 60% 的同種異體移植量。

With time, we've actually gone a little deeper to the next 40 that gets us to about 80% of that volume. So we've cultivated what we're calling fast start accounts, and we understand the decision-making in these accounts. We know who the transplant champion is. And not only that, these are centers that are actively and proactively monitoring for TA-TMA signs and symptoms, so they understand the complication of allogeneic transplants. And then we also know the transition from inpatient to outpatient because with profiled narsoplimab, we believe its efficacy plus safety profile lends itself to be infused both in inpatient as well as outpatient settings based on those experts' preference.

隨著時間的推移，我們實際上對接下來的 40 個進行了更深入的研究，達到了數量的 80% 左右。因此，我們培育了所謂的快速啟動帳戶，並且我們了解這些帳戶中的決策。我們知道誰是移植冠軍。不僅如此，這些中心還積極主動監測 TA-TMA 的徵兆和症狀，因此他們了解同種異體移植的併發症。然後，我們也知道從住院到門診的轉變，因為有了 narsoplimab，我們相信它的功效和安全性使其可以根據專家的偏好在住院和門診環境中註入。

And we've also been engaging with payers. The exciting news is after we resubmitted our BLA, we've had several payers reach out for what we call product information exchanges. In fact, we've got one set up next week and several immediately after, and we expect that we'll have even more requests for those as we approach our PDUFA day. This is important because for economic plans, they've got to evaluate what's on the horizon, and having a significant value driver for a complication where nothing is currently approved is important to them. And they do view the fact that narsoplimab being the only potential product indicated for TA-TMA is a significant value driver.

我們也一直在與付款人接觸。令人興奮的消息是，在我們重新提交 BLA 後，已經有幾位付款人與我們聯繫，進行所謂的產品資訊交換。事實上，我們下週已經設立了一個，之後馬上還會設立幾個，我們預計，隨著 PDUFA 日的臨近，我們會收到更多的此類請求。這很重要，因為對於經濟計畫來說，他們必須評估未來的情況，並且在目前未獲批准的複雜情況下，擁有一個重要的價值驅動因素對他們來說很重要。他們確實認為，narsoplimab 作為唯一潛在適用於 TA-TMA 的產品，是一個重要的價值驅動因素。

So the disease education continues, the identification of accounts, knowing all of the stakeholders, not just the transplant physician, puts us in a really successful position. Plus, the data is just so compelling with a significant value proposition for all of those stakeholders involved. So we are excited for that approval to come in.

因此，疾病教育的持續進行、帳戶的識別、了解所有利害關係人（而不僅僅是移植醫生）使我們處於真正成功的地位。此外，這些數據非常引人注目，對所有相關利害關係人具有重要的價值主張。因此，我們很高興能夠獲得批准。

Thank you, Nadia. Did that answer your question, Steve?

謝謝你，納迪亞。這回答了你的問題嗎，史蒂夫？

Yeah, it did, but it also raised two more. So I will throw them in the equation as well. On the first one, obviously, there's something that has to be, I guess, detailed more. These are extremely sick patients. So as far as that goes, if you can provide any color on those -- on the patients we're talking about because obviously this is a life-threatening situation for which there's just no other reasonable therapy that works. Can you talk more about those patients and how they got there?

是的，確實如此，但它還增加了兩個。所以我也會將它們納入等式中。對於第一個問題，顯然，我認為有些事情需要更詳細地說明。這些都是病情極為嚴重的病人。就此而言，如果您能提供任何有關我們正在討論的患者的詳細信息，因為顯然這是一種危及生命的情況，而且沒有其他合理的治療方法。您能否詳細談談這些病人以及他們是如何到達那裡的？

And the additional question along that, and this time I do promise to hop back in the queue, a great deal of money has been spent on these patients. They've had stem cell transplants. And these are not easy procedures, but they're also extremely laborious in terms of healthcare costs. Can you go into any detail about that? And the whole purpose there is to talk about the support of these patients buying narsoplimab and what it means. And I leave it to you as to how much detail you can give us on that.

還有一個附加問題，這次我保證再次回答，這些病人身上已經花了大量的錢。他們已經接受了幹細胞移植。這些過程並不容易，而且從醫療成本來看也極為費力。能詳細說明一下嗎？其全部目的是為了討論這些患者購買 narsoplimab 的支持及其意義。至於您能提供我們多少細節，那就交給您了。

Sure. Let me just make sure we understand the first question. It was, how did those patients get there? And I just want to make sure we're answering that question. What specifically are you referencing when you say how did they get there?

當然。我只是想確保我們理解第一個問題。問題是，那些病人是怎麼到那裡的？我只是想確保我們回答了這個問題。當您說他們如何到達那裡時，您具體指的是什麼？

These are hematological oncology patients who've wound up through medical intervention that are there. So can you detail some of that? Because that's the part that people automatically assume of stem cell TA-TMA.

這些都是透過醫療介入治癒的血液腫瘤患者。那你能詳細說明一下嗎？因為這是人們自動假設的幹細胞 TA-TMA 的部分。

Yeah, sure. Look, TA-TMA is a complication of stem cell transplant, but it's really wholly unpredictable. So patients, their families, their loved ones go through the transplant process, which, as you can imagine, is stressful, is costly, as you've already identified, and there's obviously a tremendous amount of hope that that stem cell transplant is going to extend the life of or cure the patient.

是的，當然。看，TA-TMA 是幹細胞移植的併發症，但它確實完全無法預測。因此，患者、他們的家人、他們的愛人都要經歷移植過程，正如您已經認識到的，這個過程壓力很大，成本很高，而且顯然人們寄予厚望，希望幹細胞移植能夠延長患者的生命或治愈患者。

And all of a sudden, out of left field, without any warning, comes TA-TMA. And this is not a disease that has a long and lingering span. This is a disease that comes hard. It can come fast, and it can result in death not in months and months, but really, days to weeks.

突然之間，毫無預警地，TA-TMA 出現了。這並不是一種病程較長且持續時間較長的疾病。這是一種很難治癒的疾病。它來得很快，而且可能導致死亡，不是在幾個月內，而是在幾天到幾週內。

And you can imagine the hit to the patient, to the family, to all of those concerned about that patient when things are looking great and all of a sudden things turn really south really quickly. So the idea here is, that is what we're facing.

你可以想像，當一切看起來都很順利，但突然間情況急轉直下時，這對病人、對家人、對所有關心病人的人來說是多麼大的打擊。所以這裡的想法是，這就是我們所面臨的。

There is no approved treatment. There are off-label treatments which really have mixed results. There are reports of some efficacy. There are also reports of actually increased safety risks. And we are working hard and expect that narsoplimab will be the first drug approved for TA-TMA.

目前尚無核准的治療方法。有一些非處方治療方法確實有好壞參半的效果。有報道稱其具有一定療效。也有報告指出安全風險實際上有所增加。我們正在努力，並期望 narsoplimab 成為第一個獲準用於治療 TA-TMA 的藥物。

With respect to your second question about the costs, let me turn that over to Nadia, and then I'll see if anyone wants to additionally comment on what I've just relayed in response to your first question.

關於您關於成本的第二個問題，讓我把它交給納迪亞，然後我會看看是否有人願意對我剛才回答您的第一個問題的內容進行補充評論。

Yeah, Steve, you're spot on in terms of the costs associated with untreated patients, whether it's ICU or inpatient. Those are the significant cost drivers. And so in terms of the economic value that we're looking at and how we're building that story for narsoplimab, when you have a treatment that's the only one indicated for TA-TMA with the kind of survival benefit that we've demonstrated in our data, when you compare that versus the cost of a patient developing end organ damage, kidneys failing, dialysis, transplant potentially, organs or death, there is no comparison, right? And preserving that patient and reducing the cost, of course. And so that is how we're looking at this, and this is also how other stakeholders are taking that into consideration.

是的，史蒂夫，你對未經治療的患者（無論是 ICU 還是住院患者）的相關費用的看法非常正確。這些都是重要的成本驅動因素。因此，就我們所關注的經濟價值以及我們如何為 Narsoplimab 構建這個故事而言，當您擁有一種唯一適用於 TA-TMA 的治療方法，並且具有我們在數據中證明的那種生存益處時，當您將其與患者發生終末器官損傷、腎衰竭、透析、移植潛在器官或死亡的成本進行比較時，就沒有可比性了，對嗎？當然，也要保留病人並降低成本。這就是我們看待這個問題的方式，也是其他利害關係人考慮這個問題的方式。

The other aspect of that that I will highlight is the ability of a drug to be used outpatient is also a significant value driver because it is less expensive to dose a patient outpatient. So with this kind of efficacy, the goal is to get the patient as quickly as possible from ICU to inpatient, and from inpatient to outpatient, and that's the goal with the -- why I say the entire profile, it's efficacy plus safety. Because we know in this space, in the transplant space, there's some treatments that are exclusively inpatient dosed, and that's quite limiting, but we don't see the same concerns with narsoplimab potentially.

我要強調的另一個面向是，藥物在門診使用的能力也是一個重要的價值驅動因素，因為給門診病人用藥的成本較低。因此，對於這種療效，我們的目標是讓患者盡快從 ICU 轉為住院，再從住院轉為門診，這就是目標——為什麼我說整個概況，就是療效加上安全性。因為我們知道在這個領域，在移植領域，有些治療方法是完全住院給藥的，這是相當有限的，但我們可能不會看到 narsoplimab 有同樣的擔憂。

(Operator Instructions)

（操作員指示）

All right, operator, it appears no other questions. So with that, I'd like to thank everyone for joining us today. We appreciate the continued support and confidence of our investors and lenders. We remain focused on executing with discipline and securing the capital resources necessary to bring us through to the anticipated approval of narsoplimab, a successful commercial launch, and the development of our pipeline.

好的，接線員，好像沒有其他問題了。因此，我要感謝大家今天的參加。我們感謝投資者和貸款人的持續支持和信任。我們將繼續專注於嚴格執行並確保必要的資本資源，以使我們獲得 narsoplimab 的預期批准、成功的商業發布以及我們管道的開發。

We expect all of those things to occur, and we look forward to providing updates over the near term. All of us at Omeros appreciate your continued support. Have a good evening, and we look forward to speaking with you again.

我們預計所有這些事情都會發生，並且我們期待在短期內提供最新消息。Omeros 全體員工感謝您的持續支持。祝您晚上愉快，我們期待再次與您交談。

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

今天的電話會議到此結束。感謝您的參與。您現在可以斷開連線。