オメロス（OMER）2026年第2四半期決算説明会：YARTEMLEAの売上高は2,850万ドルに到達

要点

• YARTEMLEAは発売後初のフル四半期において、総売上高3,220万ドル、純売上高2,850万ドルを記録し、2026年第1四半期からそれぞれ190％増および188％増となりました。
• オメロスが発表した2026年第2四半期の純利益は1,320万ドル（1株当たり0.18ドル）でした。金融商品の非現金再測定を除く非GAAP調整後純利益は180万ドル（1株当たり0.02ドル）となりました。
• 当四半期の全社営業活動による純キャッシュインフローは410万ドルとなりました。オメロスの6月末時点の現金および投資の残高は1億3,200万ドルでした。
• 6月30日時点で、YARTEMLEAを発注した新規顧客口座数は3月31日比で143％増の73口座となりました。第2四半期の売上高の約75％を成人患者が占めました。
• 7月の買い戻しにより、オメロスの2029年満期9.5％転換社債の未償還元本は7,080万ドルから4,030万ドルへと43％減少し、将来の支払利息860万ドルが削減されました。
• 経営陣は、2027年半ばまでにオメロスが全社ベースでキャッシュフロー黒字化を達成するとの見通しを維持したものの、売上高ガイダンスの提示は見送りました。

主要財務データ

事業および業績の動向

2025年12月に造血幹細胞移植関連血栓性マイクロアンギオパチー（TA-TMA）の治療薬としてFDAの承認を受けたYARTEMLEAは、同社の主要な商用成長ドライバーであり続けています。本剤はTA-TMAに対して初めて承認された治療薬であり、レクチン補体経路阻害薬としても初の承認薬です。

オメロスの商業化チームは、全米175か所の移植センターすべてとの関係強化を進めています。当四半期末までに73の顧客口座から注文を受注しました。同社の推計によると、YARTEMLEAは追跡対象である上位10、20、40、80の移植センターコホートのそれぞれにおいて、約55％〜60％で薬事委員会（P&T委員会）の承認を獲得しています。

第2四半期における成人への使用拡大スピードは小児の2倍以上となり、売上高の約75％を占めました。経営陣によると、卸売業者の在庫レベルは約1.5週間分と安定して推移しており、報告された売上高に流通チャネルへの押し込み在庫は含まれていないことを示しています。

保険償還アクセスも進展しました。製品固有の恒久的なHCPCS Jコードが7月1日に発効しました。CMS（メディケア・メディケイドサービスセンター）は、入院環境でのYARTEMLEA治療に対して最大28万7,000ドルの新規医療技術追加支払金（NTAP）を認定し、10月1日に発効する予定です。経営陣はまた、民間保険での事前承認や医療提供者への支払いは堅調に推移していると述べています。

欧州では、欧州医薬品庁（EMA）のヒト用医薬品委員会（CHMP）がTA-TMAを対象とするYARTEMLEAの販売承認申請に対して否定的な見解を出しました。オメロスは再審査を請求しており、これには独立した外部専門家および新たな主査（ラポルトゥール）による審査が含まれます。同社は小児を優先し、拡大アクセスプログラムを通じて欧州の患者への薬剤提供を継続しています。

オメロスは、同社が支援する2つの医師主導治験（1つは過剰炎症性急性呼吸窮迫症候群、もう1つは重症化が予測される小児TA-TMA患者におけるYARTEMLEAの予防的投与を評価する治験）の症例登録が年内に開始されると見込んでいます。

YARTEMLEA以外では、同社は持続性MASP-2抗体「OMS1029」の最初の第2相適応症の確定を進めています。経口MASP-2阻害薬プログラムでは、開発候補化合物の選定に向けて残る試験はあと1つとなっています。またオメロスは、要求されている非臨床試験の完了を前提として、コカイン使用障害を対象としたOMS527の入院治験の症例登録が年内に開始されると見込んでいます。急性骨髄性白血病を対象としたOMS805のヒト初回投与（FIH）試験は2027年後半に向けて準備を進めています。

経営陣の見通し（ガイダンス）

• 2026年第3四半期の継続事業からの営業費用は、第2四半期をわずかに上回る見込みです。
• 研究開発費は、主にOMS805 OncotoXプログラムへの投資増加により増加する見通しです。
• オメロスがYARTEMLEAのインフラ、マーケティング、発売支援活動への投資を継続することから、販売・マーケティング費用は増加する見込みです。
• 第2四半期に計上されたノボノルディスクからの在庫払戻金330万ドルが一時的なものであるため、第3四半期の受取利息およびその他収益は減少する見込みです。
• 第3四半期の支払利息は、OMIDRIAロイヤリティ義務に関連する非現金の調整可能性を除き、約650万ドルとなる見込みです。
• 非継続事業からの利益は、OMIDRIA契約ロイヤリティ資産に関連する再測定調整を除き、500万ドルから600万ドルの間になる見込みです。
• 経営陣は、2027年半ばまでに全社ベースでキャッシュフロー黒字化を達成するとの見通しを維持しました。処方動向、患者需要、市場動向に関する情報収集を重ねているため、売上高ガイダンスの提示は見送っています。

リスクおよび注視事項

CHMPの否定的な見解により、再審査を請求しているものの、欧州におけるYARTEMLEAの規制上の不確実性が生じています。承認が保証されているわけではありません。

経営陣によると、移植センター間でのTA-TMAの診断基準は依然として統一されておらず、歴史的に除外診断として扱われてきました。さらなる普及は、スクリーニング慣行、治療プロトコル、電子カルテ、医療機関の発注システムの変更にかかっています。

特に小児領域において、エクリズマブの適応外使用（オフレーベル使用）が一部で継続しています。経営陣はこれを主に医師の確立された診療習慣によるものと説明しており、C5阻害薬を長期的な実質的競合とはみなしていないものの、臨床実務の変更には時間がかかる可能性があるとしています。

公表される業績は、残存する2029年満期転換社債に組み込まれたデリバティブに関する非現金の時価評価調整による変動リスクを引き続き抱えることになります。

アナリスト質疑応答の要点

経営陣は、YARTEMLEAの売上高は流通押し込みではなく最終市場の需要を反映したものだと述べました。卸売業者の在庫レベルは初期の発売期間以降、約1.5週間分を維持しています。

治療パターンについて問われた経営陣は、バイアルの使用量は成人患者と小児患者の間で大きな差はないと述べました。早期診断が進むことで、長期的にはより少ないバイアル数で治療を受ける患者が増え、外来治療への移行が進むと見込んでいます。

オメロスは主に治療センターへのバイアル出荷実績しか把握できないため、治療を受けた患者の正確な人数は把握できません。それでも経営陣は、医療機関が除外診断から積極的なスクリーニングへと移行するにつれ、市場には依然として大きな開拓余地があると考えています。

同社は、同種移植の56％でTA-TMAの発症が見られたとする最近のMIDAS研究を引用し、診断実務の進化に伴い発症率の推計値が上昇する可能性があると述べました。なお、これは正式な市場ガイダンスではなく経営陣の見解として提示されたものです。

決算説明会 トランスクリプト全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Good afternoon and welcome to today's earnings call for Omeros Corporation. [Operator Instructions] 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. I'll now turn the call over to Jennifer Williams, Investor Relations. Please go ahead.

Jennifer Williams

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.

For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the risk factors 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. Today's call also will include certain non-GAAP financial measures.

A reconciliation of these measures to the corresponding GAAP measures is included in Omeros's earnings release issued earlier today, available on the Investor Relations page of our website and furnished with the Form 8-K we filed today with the SEC.

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

Gregory Demopulos

Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Dr. Cathy Melfi, our Chief Regulatory Officer, Dr. Steve Whitaker, Vice President of Clinical, and Bill Woodman, our Chief Commercial Officer. Promoted from within the company, Bill was recently appointed as our Chief Commercial Officer. Let me tell you a bit more about him.

Bill joined Omeros 6 years ago as our Vice President of Sales and Market Development, bringing more than 25 years of industry experience, including sales and marketing leadership roles at Amgen, Spectrum Pharmaceuticals, and Jazz Pharmaceuticals, where he led the global launch of defibrotide. At Omeros, Bill largely built our commercial team and was instrumental in designing and executing the YARTEMLEA launch.

I have long believed that Bill's background, capabilities, and achievements are ideally suited to Omeros's current and future objectives. Under his leadership, our commercial team is driving YARTEMLEA toward becoming the standard of care for TA-TMA and preparing for its expansion into a broad range of MASP-2 driven indications. Beyond complement, Bill's track record of driving growth across oncology, rare disease, and specialty biopharma products will serve Omeros well.

Before I turn to the financial details, let me highlight 3 points. First, YARTEMLEA generated $32.2 million in gross sales in its first full quarter on the market. Second, operations generated $4.1 million of positive cash flow during the quarter. And third, we meaningfully strengthened our capital structure through our share and note repurchases. So I'll now begin with an overview of our second quarter operations and financial results, followed by program updates. David will then review the financials in more detail, after which we'll open the call for questions.

As you know, the FDA approved YARTEMLEA, our lead MASP-2 inhibitor, in December 2025 for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. YARTEMLEA is the first and only approved treatment for this often fatal complication of stem cell transplantation, and YARTEMLEA is also the first and only approved inhibitor of the lectin pathway of complement. We launched YARTEMLEA in mid-January, with initial distributor shipments beginning mid-month and first sales following shortly thereafter.

The second quarter was our first full quarter of YARTEMLEA sales, and we're pleased to share the results today. As I mentioned, in the second quarter, YARTEMLEA generated $32.2 million in gross sales and $28.5 million in net sales, reflecting strong physician adoption and market penetration and a gross-to-net adjustment of 11.5%. Compared with the first quarter, gross sales increased 190% and net sales increased 188%. We'll discuss the launch in more detail in just a bit.

Net income for the second quarter was $13.2 million, or $0.18 per share. As we have previously discussed, our reported results include non-cash mark-to-market adjustments related to the derivative embedded in our 2029 convertible notes. Excluding non-cash remeasurements of embedded derivatives and other financial instruments, second quarter non-GAAP adjusted net income was $1.8 million, or $0.02 net income per share. David will walk through the quarter-over-quarter comparisons and accounting details shortly.

We ended the quarter with $132 million in cash and investments. Importantly, company-wide, operations provided net positive cash flow in the second quarter of $4.1 million. Our share repurchases and subsequent note repurchases further strengthened our capital structure. During the 6 months ended June 30, we repurchased and retired approximately 843,000 shares of Omeros common stock, nearly 60% of those shares in the second quarter, at a volume-weighted average price of $11.70 per share.

Then in July, through two privately negotiated transactions, we repurchased $30.5 million aggregate principal amount of our 9.5% convertible notes due in 2029, reducing the outstanding principal by 43% to $40.3 million. The repurchases also reduced the number of shares issuable upon conversion from approximately 11.4 million to 6.5 million shares. We achieved this reduction at a weighted average cost of $12.21 per underlying conversion share and concurrently eliminated $8.6 million in future interest payments. Together, our open market share repurchases and our negotiated note repurchases have reduced our potential fully diluted share count by 5.8 million shares year-to-date.

Turning back to YARTEMLEA, our launch remains focused on 4 priorities: one, educating transplant teams to recognize and treat TA-TMA earlier; two, securing institutional access through pharmacy and therapeutics, or P&T, committee approvals and streamlined ordering; three, ensuring timely reimbursement; and four, demonstrating YARTEMLEA's economic value through Health Economics and Outcomes Research, or HEOR.

Together, these priorities are intended to change how transplant centers approach TA-TMA. Historically, particularly at adult transplant centers, TA-TMA often has been treated as a diagnosis of exclusion and considered only after other potential causes are ruled out. We are working to shift that paradigm toward proactive screening, enabling clinicians to identify and treat more patients earlier and ultimately improve transplant outcomes. Execution remains strong.

Our field sales organization is actively engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered YARTEMLEA, a 143% increase since March 31. As discussed on our first quarter call, pediatric patients initially represented an outsized share of utilization. With rapid adoption at adult transplant centers, however, the mix has shifted significantly. In the second quarter, adult utilization grew at more than twice the rate of pediatric utilization, and adult patients represented approximately 75% of YARTEMLEA sales.

This mix is closely approaching the historical 85% 15% split between adult and pediatric transplant procedures in the U.S. Formulary adoption also continues to progress rapidly. By quarter-end, we understand that YARTEMLEA had received P&T committee approval at approximately 55% to 60% across the top 10, 20, 40, and 80 U.S. transplant center cohorts that we track. Ordering frequency also increased meaningfully, indicating deeper utilization within centers.

We also achieved key reimbursement milestones during the quarter. The Centers for Medicare and Medicaid Services, or CMS, assigned YARTEMLEA a permanent, product-specific, Healthcare Common Procedure Coding System, or HCPCS, J-code, effective July 1. The J-code establishes a clear and consistent outpatient reimbursement pathway, reduces administrative burden, and supports more predictable payment for providers.

CMS also recommended a New Technology Add-on Payment, or NTAP, for YARTEMLEA under the fiscal year 2027 proposed rule for the Inpatient Prospective Payment System, or IPPS, and has now granted the NTAP in the final IPPS rule. The NTAP provides up to $287,000 in additional Medicare reimbursement for inpatient treatment with YARTEMLEA. This is particularly important because Medicare beneficiaries represent approximately 30% of U.S. allogeneic transplant recipients. The NTAP for YARTEMLEA is expected to become effective October 1.

Commercial payer experience also remains positive. Prior authorization requests are being approved consistently, and centers receiving appropriate payment reflect growing acceptance of YARTEMLEA among commercial insurers. We are preparing our HEOR analyses for presentation at upcoming scientific meetings and for peer-reviewed publication. We expect these analyses to further demonstrate YARTEMLEA's clinical and economic value and support continued adoption.

Overall, early commercial indicators, including strong transplant center engagement, continued formulary and ordering momentum, and payer alignment with the approved label, reinforce our expectation that YARTEMLEA can become the standard of care for TA-TMA. Looking ahead, we continue to pursue expansion opportunities for YARTEMLEA and our broader MASP-2 platform.

In June, following an oral explanation before the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, the committee adopted a negative opinion on our marketing authorization application for YARTEMLEA in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. The application is supported by our pivotal narsoplimab trial data in TA-TMA, survival analyses comparing narsoplimab-treated patients with an external registry of patients who did not receive narsoplimab, and data from more than 220 adult and pediatric patients treated through our expanded access program.

This same body of evidence supported YARTEMLEA's FDA approval. As part of the re-examination, an Ad Hoc Expert Group, or AHEG, comprising independent external scientific and clinical experts in hematology, stem cell transplantation, and TA-TMA, will review the evidence and address questions central to CHMP's assessment. The AHEG will hear from Omeros and from transplant experts with direct experience using narsoplimab, and new rapporteurs will review the application.

We remain focused on obtaining approval in Europe. Meanwhile, we continue to provide YARTEMLEA to European patients with TA-TMA through our expanded access program, prioritizing children. We also continue to assess opportunities to expand the YARTEMLEA label. We are prioritizing indications with a strong biologic rationale for MASP-2 inhibition, particularly those involving endothelial injury, lectin pathway activation, and thromboinflammation.

These encompass an extensive list of indications, including chemotherapy-induced TMA, acute respiratory distress syndrome, or ARDS, and other transplant-related endothelial injury syndromes. We plan to evaluate new indications through preclinical research, investigator-initiated studies, and clinical trials, each as appropriate. By year-end, we expect enrollment to begin in 2 investigator-sponsored and Omeros-supported studies, one evaluating YARTEMLEA in hyperinflammatory ARDS, and the other assessing prophylactic YARTEMLEA in pediatric patients with predictably severe TA-TMA.

Our MASP-2 platform extends beyond YARTEMLEA. We are advancing our Phase 2-ready long-acting MASP-2 antibody OMS1029 and an oral small molecule MASP-2 inhibitor program. Both are designed for chronic indications requiring long-term administration, including membranous nephropathy and neurodegenerative diseases such as Parkinson's and Alzheimer's. In Phase 1 clinical trials, OMS1029 demonstrated the clear ability to inhibit MASP-2 over an extended duration with once-quarterly subcutaneous or intravenous dosing.

And our small molecule MASP-2 inhibitor is targeting once-daily oral dosing. We are finalizing selection of the initial Phase 2 indication for OMS1029. Clinical drug product and matching placebo have been manufactured and are available. For our MASP-2 small molecule program, we have one ongoing study to complete, after which we expect to select an orally delivered development candidate for that program.

Our collaboration with Novo Nordisk also continues to progress smoothly. The Novo transaction provides up to $2.1 billion in upfront and milestone payments, plus royalties ranging from high single digits to the high teens. At closing in the fourth quarter of 2025, we received $240 million in upfront cash, which funded the YARTEMLEA launch and other operations. We also are eligible to receive up to an additional $100 million in near-term milestone payments. Our interactions with Novo remain collaborative and productive, and we continue to provide transition services at Novo's cost.

Turning now 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. Earlier this year, we met with FDA regarding the agency's request for additional non-clinical information before initiating the inpatient study. That non-clinical work has initiated, and we expect to start enrollment in the inpatient clinical trial by year-end.

Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a broad range of addiction and compulsive disorders. Our Targeted Complement Activating Therapy, or T-CAT platform, is a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on infections caused by multidrug-resistant organisms, among medicine's most critical unmet needs.

Unlike antimicrobial agents on the market, T-CAT is designed to kill pathogens regardless of resistance profile and without promoting or enhancing resistance. The foundational manuscript describing our T-CAT technology was published in Science Translational Medicine in June of this year. The manuscript details the technology and demonstrates that T-CAT monoclonal antibodies safely and effectively treated infections in translationally relevant murine models of sepsis and pneumonia caused by multiple different drug-resistant bacterial species prioritized by the World Health Organization as posing the greatest threat to human health. The data underscore T-CAT's potential as a next-generation platform with broad applicability across microbial species, including multidrug-resistant pathogens. And we look forward to advancing T-CAT for the clinic.

Finally, OncotoX-AML, or OMS805, is the lead program in our oncology platform. It's an engineered biologic designed to treat acute myeloid leukemia, or AML, the most common and one of the deadliest acute leukemias in adults.

Across tumor-bearing animal models and in vitro human AML cell line studies, OncotoX-AML has consistently demonstrated efficacy superior to current standards of care, even at very low doses. Importantly, this efficacy was independent of AML-related mutations, including TP53 and FLT3, which historically have been very difficult to treat. In a non-human primate study, a single course of OncotoX-AML produced the desired pharmacologic response, a marked, selective, reversible, and dose-related reduction in myeloid progenitor cells by up to 99%.

Treatment was well tolerated with no safety signal of concern. We have entered into agreement with a leading contract biologics manufacturer for process development and clinical supply of OMS805 drug substance, and IND-enabling studies are underway. Given the novelty of the OncotoX program, its potential applicability across hematologic malignancies, and the breadth of our unpublished data and pending patent claims, we plan to limit further public disclosure until OMS805 enters human studies and begins generating clinical data.

Working with our Advisory Board of leading AML experts, we are preparing for a first-in-human trial to begin in late 2027. So that concludes our corporate and program update.

I'll now turn the call over to David for a more detailed review of our financial results. David?

David Borges

Thanks, Greg. Our second quarter results reflect continued focus on commercial execution of the YARTEMLEA launch and actions to strengthen our capital structure. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared with net income of $56.1 million, or $0.78 per share, in the first quarter of 2026.

Second quarter results included a $12.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes and a $700,000 remeasurement loss on our payment obligation for the 2029 note repurchases. By comparison, first quarter results included a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with the 2029 convertible notes.

To provide additional visibility into our operating performance, we also present non-GAAP adjusted results that exclude non-cash remeasurements of embedded derivatives and other financial instruments. Excluding these non-cash remeasurements, non-GAAP adjusted net income for the second quarter was $1.8 million, or $0.02 net income per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 net loss per share, for the first quarter.

As of June 30, 2026, we had $132 million in cash and investments, and company-wide net cash provided by operations in the second quarter was $4.1 million. During the second quarter, we repurchased and retired approximately 489,000 shares of our common stock at an average price of $11.70 per share for a total of $5.7 million. Through June 30, 2026, we had repurchased and retired approximately 843,000 shares at the same average price for a total of $9.9 million.

In June and July of '26, we entered into agreements for two privately negotiated cash repurchases totaling $30.5 million aggregate principal amount of our 2029 convertible notes. Both transactions closed in July, reducing our outstanding debt, which consists solely of the '29 notes, by approximately 43%, from $70.8 million to $40.3 million. The aggregate purchase price was $60.2 million, plus $200,000 of accrued and unpaid interest.

These transactions reduce leverage, future cash interest expense, and potential dilution by opportunistically repurchasing and retiring a portion of the '29 convertible notes. We also reduced the number of shares issuable on conversion from approximately 11.4 million to 6.5 million. As Greg noted, YARTEMLEA maintained strong commercial momentum in the second quarter. Gross product revenues were $32.2 million, all from YARTEMLEA sales, compared with $11.1 million in the first quarter, and net revenues were $28.5 million, compared with $9.9 million in the first quarter.

Gross-to-net adjustments were approximately 11.5% compared with approximately 11% in the first quarter and remained within our expectations. These adjustments consisted primarily of chargebacks and distribution fees. Costs and expenses from continuing operations before interest and other income were $28.5 million, an increase of $1.1 million from the first quarter. Under the transition services agreement entered into in connection with the zaltenibart transaction, we continue to be reimbursed for costs incurred in providing transition services, including third-party expenses and internal personnel costs.

We also recognized $3.3 million of reimbursement from Novo Nordisk for zaltenibart inventory transfer during the quarter, which we recorded in other income. Interest expense was $7.6 million. The primary components were the DRI royalty obligation and interest on the 2029 convertible notes. Excluding the OMIDRIA royalty obligations to DRI, which is fully offset by amounts received from Rayner and therefore has no economic impact on Omeros, and non-cash amortization of debt issuance costs and discounts, contractual cash interest expense was $1.7 million, down $100,000 from the first quarter.

Interest and other income totaled $4.6 million in the second quarter compared with $1.5 million in the first quarter. The increase was primarily attributable to the Novo Nordisk inventory reimbursement. As previously noted, we recorded a $12.1 million non-cash mark-to-market gain on the embedded derivative related to our '29 convertible notes. The change was driven primarily by the decline in our stock price from $10.56 per share at March 31 to $9.51 per share at June 30.

Because the derivative's value is closely tied to our stock price, increases in our share price generally produce non-cash losses, while decreases generally produce non-cash gains. This adjustment does not affect our operating performance or liquidity and is excluded from our non-GAAP adjusted results. Following the July note repurchases, future mark-to-market adjustments will reflect the reduced principal balance.

In connection with the June agreement to repurchase the first tranche of our 2029 convertible notes comprising $16 million principal amount, we recorded a $1.9 million loss. The loss reflects the difference between the fair value of the payment obligation, the carrying amount of the repurchased notes, net of unamortized discount and issuance cost, and the derecognition of the associated embedded derivative liability. Because the agreements for the second tranche comprising $14.5 million principal amount were entered into in July 2026, the related accounting will be reflected in our third quarter results. Income from discontinued operations in the second quarter was $6.6 million, up $1.8 million from the first quarter, primarily due to a lower remeasurement adjustment. Because U.S. OMIDRIA royalties pass directly to DRI, fluctuations in these payments do not affect our cash position.

Now let me turn to our expectations for the third quarter of 2026. We expect total operating expenses from continuing operations to be slightly higher than in the second quarter.

Research and development expenses are expected to increase primarily due to increased spending on our OMS805 Oncotox program. Sales and marketing expenses are also expected to increase, reflecting continued investment in the YARTEMLEA commercial infrastructure, marketing, and launch activities. Although we're encouraged by YARTEMLEA's continued commercial momentum, we're not providing revenue guidance at this time. We believe it is prudent to gain additional experience with prescribing trends, patient demand, and market dynamics.

We remain focused on expanding physician awareness and disease education and ensuring continued timely reimbursement. Interest and other income are expected to be lower in the third quarter, primarily because the Novo Nordisk inventory reimbursement recognized in the second quarter will not recur. Interest expense is expected to be approximately $6.5 million, reflecting the reduction in the outstanding debt following the repurchases. This estimate excludes potential non-cash adjustments related to the OMIDRIA royalty obligation.

Income from discontinued operations is expected to be between $5 million and $6 million, again, excluding any remeasurement adjustments related to the OMIDRIA contract royalty asset. And finally, as a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative relating to our remaining '29 convertible notes. These adjustments are non-cash. They can be volatile and are driven largely by stock price and other market inputs. We therefore present non-GAAP adjusted income and loss to provide additional visibility into underlying operating performance.

And with that, I'll turn the call back over to Greg. Greg?

Gregory Demopulos

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

Operator

[Operator Instructions] Your first question comes from the line of Brandon Folkes with H.C. Wainwright. Your line is open. Please go ahead.

質疑応答

Brandon Folkes

Maybe just two from me. I guess firstly, with the AstraZeneca, Ultomiris data release, are you having any updated conversations around C5 use at all? Obviously, it's off-label, right? But I guess any color in terms of why a transplant center would still use the C5 at all for these TA-TMA patients.

And then secondly, obviously a very good quarter here. Congrats on that, meaningfully ahead of a lot of forecasts. So I wanted to see if you could just try to put this in perspective relative to your internal forecasts, especially the company-wide cash flow forecast you put out earlier. And then along those lines, do you still expect month-to-month variability as you called out at your AGM?

Gregory Demopulos

Thanks, Brandon. With respect to the first question regarding C5 inhibition, as you noted, ravulizumab previously missed the endpoint on its open-label pediatric study and then recently reported that it as well had missed the endpoint on its controlled adult trial. So as far as we all understand, and you understand, they did not meet their endpoints across any of the ravulizumab TA-TMA trials.

Your question as to whether there remains off-label, primarily eculizumab use, because the dosing, frankly, for ravulizumab is not really conducive to the acute indication of TA-TMA. Eculizumab is more frequently dosed, shorter half-life. There is some continued eculizumab off-label use. We don't really know how much. We don't frankly focus on how much. I'll ask Bill to speak to that and his thoughts around the competition there, which I'll preempt a bit by saying we don't really see it as competition for YARTEMLEA.

I think with respect to why there might be continued use for a while of eculizumab. I think, certainly, it's hard to break old habits among physicians, and that is likely what we're seeing. But when you look at the adoption of narsoplimab, the breadth of the adoption, the depth of the adoption, I think that speaks volumes about how physicians see our drug. I also think certainly the safety profile. I mean, let's put aside the efficacy, which we're very pleased with the efficacy that we're seeing with narsoplimab in the commercial setting.

But let's look at the safety issues. I mean, narsoplimab is not associated with the same issues as C5 inhibition. It's a biological fact. When you inhibit C5, you inhibit the lytic arm of the classical pathway. That increases the risk of infection. Inhibition of MASP-2 with narsoplimab or YARTEMLEA is upstream. So we're inhibiting the lectin pathway at really near the top of the lectin pathway. And by doing so, we maintain that adaptive immune response.

So with respect to why folks would -- physicians would continue for a while to use eculizumab, I think the best answer to that is one of habit and just perhaps not fully understanding the benefits yet that YARTEMLEA brings. But I frankly expect that, that will not be a long-lived challenge for us. But Bill, let me ask you to comment on that.

Bill Woodman

Sure. Thanks, Greg. Yes, I totally agree. Physicians are humans too, and humans generally do not welcome change with open arms. Eculizumab was their only option for 10 or 12 or 15 years. In peds, it was widely adopted, adults not so much. But in peds, even in peds, we're seeing adoption across centers, use in both first- and second-line. In adults, it's pretty much first-line. So we expect this to be a temporary hiccup to our goal of being really the best-in-class first-line therapy for TA-TMA in both adult and pediatric centers.

Gregory Demopulos

Thank you, Bill. Brandon, your next question was how our internal forecasts, I believe, compare to what we've seen. We won't comment today on our internal or external forecast. We won't guide the other part of that question. I think, though, it was around our cash flow forecast. Certainly, we hold to our statement previously that by mid-2027, we expect to be cash flow positive company-wide.

And in fact, you saw the result we generated this quarter from operations, $4.1 million of net positive cash. So I think we're quite comfortable holding to that prediction. David, any comments on that?

David Borges

I would say that states it really well and agree with what you just said, Greg.

Gregory Demopulos

Thank you. Anything else, Brandon?

Brandon Folkes

No, other than to say congrats on a really good quarter and a good launch so far.

Operator

Your next question comes from the line of Stephen Brozak with WBB.

Stephen Brozak

Congrats on these numbers. I'm thrilled, and I'm sure that patients being treated with yours are also thrilled. Financial questions. Can you just iterate, are any of these numbers from any kind of channel stocking, or do they represent pure numbers for drug going out? And I've got a follow-up after that, please.

Gregory Demopulos

Sure. Thanks, Steve. In answer to that first question, no, categorically no. This drug is available to patients from the wholesaler or distributor to the medical centers within 24 hours. So there really is no incentive or rationale to stock or stuff the channel. And frankly, we have seen inventories at about 1.5 weeks of supply, and that has been consistent since Q1, really since the very first quarter. It's been quite consistent at about 1.5 weeks of supply held by the distributors. So the answer to your question is really no. These are, as you put it, I'll use your term, these are pure numbers.

Stephen Brozak

Okay. Last question and I'll jump back in the queue. NTAPs, okay. I've been familiar with different NTAP programs, but your numbers are obviously much, much higher. Can you tell us in terms of reimbursement, can you tell us the NTAP process and how you're set up for that, because that is something that not that many people are familiar with. And I'll hop back into the queue. Thank you.

Gregory Demopulos

Sure. NTAP is a CMS program that frankly subsidizes the cost of new drugs entering the market while that period of time occurs over which the DRGs are adjusted to account for those new drugs. So as you know, CMS has set an amount up to $287,000 for a course of treatment for YARTEMLEA. We're quite pleased with that. It's at that roughly 65% cap that CMS will allow.

CMS, as you saw in their proposed IPPS rule, recommended the NTAP for YARTEMLEA and subsequently in the final rule confirmed it. So I think they recognize the utility and the importance of the drug, and we're quite pleased that becomes effective or is scheduled to become effective on October 1. Cathy, do you want to add anything else?

Catherine Melfi

No, I think, Greg, you explained it well. I mean, as you know, the reimbursement for these DRGs doesn't account for the new technology. And so with the approval of YARTEMLEA and its use in this condition, CMS has to add this on. And so again, we submitted the application, proposed the add-on payment, and we're pleased with the result that we got in terms of what they'll be including for the use of YARTEMLEA.

Gregory Demopulos

Steve, did that answer?

Stephen Brozak

Perfectly, on both counts. Thank you, and again, congrats on these strong, strong numbers.

Gregory Demopulos

Thank you. We're all pleased and we look forward to the continued growth.

Operator

Your next question comes from the line of Samuel Rodriguez Santiago with Cantor Fitzgerald.

Samuel Rodriguez

This is Sam on for Olivia. Quick question, since you mentioned the adults are making up 75% of the orders now, have you seen a difference in the amount of vials used per patient?

Gregory Demopulos

Yes, Sam, to I think our collective knowledge, no. We don't really have great visibility into vial utilization at specific centers. As you understand with all of the HIPAA and confidentiality issues around patient information, we just don't get that information. But certainly the ordering patterns are consistent across the pediatric and the adult centers. So I think my answer to that would be no, but let me ask Bill again, who may have information that I don't have.

Bill Woodman

No, they're not significantly different between the two. When you launch a new product into a deadly disease, you generally tend to get very severe patients at the beginning. You may need to see a little bit more drug at the beginning because they tend to require more medication. And I don't think there's any difference between peds and adults. Over time, we expect to treat a lot more patients with fewer vials as they start to get better at diagnosing it, treating it early, and getting better outcomes. So that's really kind of the way we expect it to go in the future.

Gregory Demopulos

And moving the treatment setting more toward the outpatient, right, Bill? And less so in the inpatient so that the response -- remember, in the absence of really an effective and safe drug, the focus on earlier and earlier treatment has not been there. In fact, the focus has been, how can we get these patients better without having to use some treatment for those patients?

I think as we spoke about during the prepared comments, we're seeing, and we're certainly helping, I think, to implement a paradigm shift to earlier and earlier utilization for increasingly improved outcomes. The sooner you get to these patients, the harder you hit them with YARTEMLEA, I think the data clearly support the better they will do.

Samuel Rodriguez

Awesome, thank you and congrats on the quarter.

Operator

Your next question comes from the line of Serge Belanger with Needham.

Serge Belanger

First on YARTEMLEA, Greg, can you just talk about maybe the number of patients that have so far been treated with the product and I guess what the market share of the overall opportunity would be based on those patients? And then secondly, you talked about in your prepared comments that TA-TMA is mostly a diagnosis of exclusion. So with the shift paradigm that you're working on, what do you expect the market opportunity could be or what is the under-diagnosis and under-treated rate for the indication?

Gregory Demopulos

Sure, Serge, thanks for the questions. First, we can't give you any really definitive numbers on patient use because we don't have patient numbers. We see vials. We see vials that go into a center. We don't have any data beyond that really, other than occasional anecdotal data that we may receive, but we have no way of determining how many patients are being treated with those vials, where in the treatment course those patients are, et cetera. So with respect to patient numbers, can't really provide that information.

With respect to the prepared comment about diagnosis of exclusion, I think what clearly is meant there is prior to an approved product, prior to YARTEMLEA being available, the diagnosis of TA-TMA was quite challenging and really very diverse across centers. So different sets of criteria being used by different centers, by different physicians, a lack of real standardization of the diagnostic criteria. So absent a really good treatment for TA-TMA, you can understand why physicians would look at a constellation of symptoms and say, let's rule out those things that we know we can treat.

And if we can't treat those, then this is going to fall to what we'll call TA-TMA. We do believe that we are simply now scratching the surface. Again, I'll look to Bill to comment on that in just a moment, but I think our collective view on this is we're just scratching the surface. And as there becomes further embedded an effective and a safe treatment for TA-TMA, the diagnosis of TA-TMA accordingly will increase. And I think that the overall incidence numbers are going to continue to move north.

I think the percentage of patients who ultimately end up being diagnosed with TA-TMA as a percentage of stem cell transplantation will also increase. We're already seeing it. The latest MIDAS study shows the incidence of TA-TMA at 56% of allogeneic transplant. And I would think that there's a reasonable possibility that those percentages will increase again. When you have a treatment, there's a good reason to identify the disorder and then the treatment becomes self-fulfilling for that set of diagnostic criteria. But again, let me turn this to Bill and see, Bill, what are your thoughts on this?

Bill Woodman

Yes, I mean, I totally agree, Greg. We're just scratching the surface. As well as we've done so far, we expect to do better in the future. Institutional organizations, large academic centers, it's very hard to get real change in an institutional center. Not because they don't want to, just because they're a huge organization and there's a lot of levers to push in order to really change the way they look at things.

That could include not just P&T committees, but order sets and EMRs, the way that they diagnose TMA, and that fundamentally has to change. And we've made that change in some centers, but we have a lot more to go. And we think it'll get better over time, pretty consistently over time.

Operator

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

Gregory Demopulos

Thank you, Operator. And again, thank you all for joining us this afternoon. As we enter the second half of the year, YARTEMLEA has demonstrated strong commercial momentum in its first full quarter on the market. Reimbursement infrastructure continues to strengthen. Our operations generated positive cash flow in the quarter, and our recent note repurchases reduced debt and reduced potential dilution.

We remain focused on execution, driving YARTEMLEA adoption in TA-TMA, advancing expansion opportunities across the MASP-2 franchise, and moving our other programs across our deep pipeline forward. We have a number of important opportunities and milestones ahead, and we look forward to updating you on our progress. Have a good evening. Thank you.

Operator

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